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Avectas and ONK Therapeutics to Develop Off-the-Shelf Cancer Therapy – PRNewswire

Posted: May 6, 2020 at 9:43 am

DUBLIN, May 6, 2020 /PRNewswire/ --Avectas announced that it has exclusively licenced from ONK Therapeutics (ONK) a Chimeric Antigen Receptor-directed Natural Killer (CAR NK) cell therapy incorporating ONK's proprietary Death Receptor (DR5) TRAIL variant for the treatment of B-cell malignancies. Under the collaboration, ONK will be responsible for rapidly progressing the potential therapy to a Phase I clinical trial. The potential therapy will be engineered using Avectas' proprietary non-viral cell engineering platform (Solupore). Avectas will retain worldwide development and commercialization rights to the therapy.

Avectas has also, through a holding company, acquired a minority shareholding in ONK.

The collaboration between the two companies will target the development of a CAR that uses NK cells, optimally engineered (using Avectas' Solupore technology) to both enhance targeting of specific cancer cells and increase therapeutic potency by adding a secondary cancer cell killing mechanism using the DR5 TRAIL variant. If successful, the therapy would be allogeneic allowing for an off-the-shelf solution and its cell-killing effects would be transient to enhance dose control.

Michael Maguire, PhD, CEO of Avectas, commented: "We are excited to collaborate with ONK and its expert team to develop this potentially breakthrough immuno-oncology therapy which seeks to improve on the challenges of scale and potency seen with first generation CAR therapies." He continued, "Solupore was developed to address the urgent need for non-viral cell engineering solutions to support advanced therapies and so this collaboration is a natural next step for our business."

Professor Michael O'Dwyer, CSOof ONK Therapeutics commented: "This exciting collaboration enables us to exploit Avectas' expertise in non-viral gene engineering and will greatly accelerate our efforts to move novel CAR NK cells into the clinic. While early clinical data with CAR NK cells appear promising, resistance is still an issue. Incorporation of our unique proprietary DR5 TRAIL variant into CAR-NK cells provides a powerful, complementary killing mechanism to overcome resistance, which may have applicability in a broad range of cancers."

Terms

Under the terms of the transaction, ONK will receive upfront fees, development and commercial milestones and royalties. Avectas has also, through a holding company, acquired a minority shareholding in ONK.

This collaboration builds on Avectas' recent developments including a Series C funding, the issuance of a key US patent covering Soluporation and new collaborations with Vycellix of Florida, USA, the Centre for Commercialization of Regenerative Medicine (CCRM) in Toronto, Canada and entering the new NK Cell Centre of Excellence at Karolinska Institute, Sweden, as a partner.

The collaboration also builds on ONK Therapeutics' success in securing funding under the Irish Government's Disruptive Technology Innovation Fund (DTIF) call in partnership with the Centre for Cell Manufacturing Ireland, based at NUI Galway.

About Avectas:

Avectas is a cell engineering technology business developing a unique delivery platform to enable the ex-vivo manufacture of gene-modified cell therapy products, which will retain high in-vivo functionality. Our vision is to be a leading non-viral cell engineering technology provider, integrated into manufacturing processes for multiple autologous and allogeneic therapies, commercialized through development and license agreements. For more information, please visithttp://www.avectas.com

About ONK Therapeutics:

ONK Therapeutics was founded in 2015 with the goal of developing novel anti-cancer therapies using Natural Killer (NK) cells. NK cells are one of the body's strongest defences against cancer, being one of the most tumour cytotoxic components of the human immune system. The company's strategy is to develop novel, off the shelf, NK cell-based therapies for cancer. Further, the company is seeking to enhance these NK cells through the introduction of a series of genetic modifications, creating a technology platform that can be tailored to multiple cancers. For more information, please visitwww.onktherapeutics.com

NOTE:

NK cells kill targetted cancer cells, primarily by releasing toxic granules into the cancer cell. TRAIL, a protein expressed on the NK cell also contributes to killing by binding to death receptors (e.g. DR5) on the cell surface. TRAIL variants bind more tightlythan natural TRAIL, generating a much stronger killing signal.Since TRAIL killing does not rely on recognition of a target antigen, TRAIL variants can help prevent the emergence of resistance to CARs.

SOURCE Avectas

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Guardant Health and Patient Advocacy Groups Join Forces to Raise Awareness of the Importance of Complete Biomarker Testing for Patients with…

Posted: May 6, 2020 at 9:43 am

Incomplete testing fails to meet current medical guideline standards, placing more than 80 percent1 of patients at increased risk of receiving a less effective treatment

REDWOOD CITY, Calif., May 05, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH) has launched the Clear Your View campaign to raise awareness of the important role complete biomarker testing plays in guiding initial treatment decisions for newly diagnosed advanced non-small cell lung cancer (NSCLC) patients. Current medical guidelines call for testing all 10 tumor biomarkers in advanced NSCLC.

The campaign encourages oncologists to stop, test, and wait for complete biomarker testing results before starting initial treatment. The campaign is supported by several national patient advocacy groups, including GO2 Foundation for Lung Cancer, LUNGevity Foundation, and ALK Positive. Complete biomarker testing is especially critical given the logistical challenges imposed by the COVID-19 pandemic to ensure that each and every patient is matched with an effective therapy upfront, since targeted therapy options, if appropriate, are often easier or more convenient to administer.

Receiving the right initial treatment can mean the difference between slowing disease progression, and potentially extending survival, said Bonnie J. Addario, Co-Founder, Board Chair, GO2 Foundation for Lung Cancer. While great progress has been made in treating advanced lung cancer, studies show that fewer than 20 percent of patients receive comprehensive guideline-recommended biomarker testing. We must make sure that patients receive the benefit from treatment advances through biomarker testing that matches them to the right therapy.

Clinical studies show that patients receiving targeted or personalized treatments have improved progression-free survival and higher overall response rates compared to chemotherapy or immunotherapy.2-8 Various factors contribute to clinical adoption of personalized medicine lagging behind recommended medical guidelines.1,9-11 Physicians report rapidly changing medical guidelines and the approval of new therapies create an increasingly complex treatment landscape. In addition, patients and physicians want to start treatment as soon as possible. Finally, insurers have been slow to put coverage in place for complete biomarker testing, which may influence the oncologists decision on what biomarker tests to order.

Through the Clear Your View campaign we hope to raise awareness amongst physicians of the clear benefits of complete biomarker testing for patients with NSCLC, said Helmy Eltoukhy, Guardant Health CEO. This campaign calls attention to the risk undergenotyping can have on patient outcomes and the need for complete biomarker testing. Indeed, in this difficult time period, it has never been more critical to match patients with the right therapy the first time.

Lung cancer is by far the leading cause of cancer death among both men and women, making up almost 25 percent of all cancer deaths.12 Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined.12

The campaign is being delivered to over 10,000 oncologists nationwide. The campaign website can be found here.

About ALK Positive OrganizationWe are a patient-driven group, providing information, support, empathy, and research funding to change the future of ALK-Positive lung cancer. ALK Positive consists of 1,800+ ALK-positive lung cancer patients and their caregivers in 42+ countries. Through our foundational online support group, we are able to support each other worldwide and share information to become empowered patients-advocates. https://www.alkpositive.org/treatment-options

About GO2 Foundation for Lung CancerFounded by patients and survivors, GO2 Foundation for Lung Cancer (formerly the Bonnie J. Addario Lung Cancer Foundation and Lung Cancer Alliance), transforms survivorship as the world's leading organization dedicated to saving, extending, and improving the lives of those vulnerable, at risk, and diagnosed with lung cancer. Through our LungMATCH program patients can access free individualized guidance, including referrals for biomarker testing and discussions on treatment and clinical trial options. http://www.go2foundation.org.

About LUNGevity FoundationLUNGevity is the nation's leading lung cancer organization investing in lifesaving, translational research and providingfreesupport services and education for patients and caregivers.LUNGevitys Take Aim Initiative is focused on increasing patient and provider awareness about biomarker testing. https://lungevity.org/for-patients-caregivers/lung-cancer-101/diagnosing-lung-cancer/biomarker-testing

About Guardant HealthGuardant Healthis a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum.Guardant Healthhas launched liquid biopsy-based Guardant360 and GuardantOMNI tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

Forward Looking StatementsThis press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential scope, impact or benefit of the Clear Your View campaign, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. Such risks and uncertainties include those discussed under the caption Risk Factors in Guardant Healths Annual Report on Form 10-K for the year endedDecember 31, 2019, and in its other reports filed with theSecurities and Exchange Commission, including in its Quarterly Report on Form 10-Q for the period ended March 31, 2020, when filed. These forward-looking statements are based on current expectations, forecasts, assumptions and information available toGuardant Healthas of the date hereof, and actual outcomes and results could differ materially from these statements due to a number of factors, andGuardant Healthdisclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Healths views as of any date subsequent to the date of this press release. Investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities ofGuardant Health.

Investor Contact:

Carrie Mendivilinvestors@guardanthealth.com

Media Contacts:

Anna Czene press@guardanthealth.com

Becky Lauerbecky.lauer@uncappedcommunications.com

References:

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Guardant Health and Patient Advocacy Groups Join Forces to Raise Awareness of the Importance of Complete Biomarker Testing for Patients with...

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Cell therapies trial planned for COVID-19 – Mirage News

Posted: May 6, 2020 at 9:43 am

More than 200,000 people have died from COVID-19 since January 2020. While Australia has been relatively spared from the onslaught of infections and deaths, our nations scientists need to be part of the global effort to address this pandemic.

Research Group Head, Amnion Cell Biology

There is no effective treatment to address the ongoing damage caused by for severe COVID-19 infections, said Associate Professor Rebecca Lim, Research Group Head of Amnion Cell Biology at Hudson Institute. Our team is investigating whether a cell therapy can be effective.

Amniotic epithelial cells (amnion cells) are from the amniotic sac which surrounds a baby during pregnancy. They have stem cell-like properties and can grow into many cell types. Most importantly, they have potent effects on inflammation and tissue damage.

A/Prof Lim and Professor Euan Wallace (Clinical Director, The Ritchie Centre) are developing a clinical trial to investigate whether these cells can help treat patients with COVID-19.

The team is working closely with intensivists at Monash Healths Intensive Care Unit to deliver a Phase 1b/2a clinical trial for COVID-19 positive patients requiring hospitalisation.

The goal of the trial is to determine if allogeneic amniotic epithelial cells are an effective therapy for severe COVID-19 complications. Specifically, the trial will test whether the cells can significantly reduce the cytokine storm associated with COVID-19 infection, encourage lung tissue to repair, and reduce the incidence of blood clotting and subsequent multi-organ complications including strokes, liver and kidney failure.

We have already shown that the allogeneic amniotic epithelial cells are safe and well-tolerated in extremely premature neonates and acutely unwell adults. So far, we have observed improvements in adult patients with liver disease and severe stroke. This points to the likely benefits for patients with COVID-19. These cells may also reduce the incidence and severity of the disease damage caused by blood clotting in tissues, A/Prof Lim said.

This project involves a partnership between Hudson Institute, Monash Health and Monash University-a team that leads the way in Victoria in cell therapy clinical trials targeting inflammation and regenerative medicine.

Victoria is perfectly placed to deliver a cell therapy treatment for COVID-19, A/Prof Lim said.

However, the trial requires funding.

The other trials using our cell-based therapies are in

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Cell therapies trial planned for COVID-19 - Mirage News

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Sanger Institute researchers help identify the nose cells that act as entry points for the Covid-19 virus – Cambridge Independent

Posted: May 6, 2020 at 9:43 am

Wellcome Sanger Institute scientists have helped to identify two specific cell types in the nose that are likely initial infection points for the Covid-19 virus.

The study could help to explain why it has such a high transmission rate - and reveals potential targets for tackling the problem.

The researchers discovered that goblet and ciliated cells in the nose have high levels of entry proteins that the virus uses to get into our cells. They also found that cells in the eye and some other organs contain viral-entry proteins.

The study, published in Nature Medicine, also predicts how a key entry protein is regulated with other immune system genes.

The work is part of the ongoing international effort to use data from the Human Cell Atlas (HCA) - the project creating reference maps of all human cells - to understand infection and disease.

It is the first publication with the Lung Biological Network - a consortium of 71 scientistscollaborating to map the airway cells in our body.

Dr Sarah Teichmann, a senior author from the Wellcome Sanger Institute and co-chair of the HCA organising committee, said: As were building the Human Cell Atlas, it is already being used to understand Covid-19 and identify which of our cells are critical for initial infection and transmission.

This information can be used to better understand how coronavirus spreads. Knowing which exact cell types are important for virus transmission also provides a basis for developing potential treatments to reduce the spread of the virus.

The SARS-CoV-2 virus that causes Covid-19 uses a similar mechanismto infect our cells as the related coronavirus that caused the 2003 SARS epidemic.

A spike on the outside of the virus acts like a key to unlock an ACE2 (angiotensin converting enzyme II) receptor protein on the human cell.

A second protein inside the cell known as the TMPRSS2 protease is then used to complete entry, which then allows the virus to reproduce and transmit itself.

However, until now the exact cell types involved in the nose had not previously been confirmed.

Dr Waradon Sungnak, the first author on the paper from Wellcome Sanger Institute, said: We found that the receptor protein - ACE2 - and the TMPRSS2 protease that can activate SARS-CoV-2 entry are expressed in cells in different organs, including the cells on the inner lining of the nose.

We then revealed that mucus-producing goblet cells and ciliated cells in the nose had the highest levels of both these Covid-19 virus proteins, of all cells in the airways. This makes these cells the most likely initial infection route for the virus.

From there, the novel coronavirus can affect the airways and lungs.

The virus - which has spread to more than 184 countries - is thought to be spread via respiratory droplets released when an infected person coughs or sneezes.

The researchers analysed multiple Human Cell Atlas consortium datasets of single cell RNA sequencing from more than 20 different tissues of non-infected people.

Cells from the lung, nasal cavity, eye, gut, heart, kidney and liver were examined, and the researchers studied which individual cells expressed both of two key entry proteins that are used by the virus to infect our cells.

Speaking on behalf of the HCA Lung Biological Network, Dr Martijn Nawijn, from the University Medical Center Groningen in the Netherlands, said: This is the first time these particular cells in the nose have been associated with Covid-19.

While there are many factors that contribute to virus transmissibility, our findings are consistent with the rapid infection rates of the virus seen so far.

The location of these cells on the surface of the inside of the nose make them highly accessible to the virus, and also may assist with transmission to other people.

The study suggests that ACE2 receptor production in the nose cells is probably switched on at the same time as other immune genes that are activated when cells are damaged or fighting infection.

The researchers also found the key entry proteins ACE2 and TMPRSS2 in cells in the cornea of the eye and in the lining of the intestine.

The finding suggests another possible route of infection via the eye and tear ducts - and raises the potential of fecal-oral transmission.

The HCA Lung Biological Network is continuing to analyse the data - available at https://www.covid19cellatlas.org/ - for further insights into the cells and targets likely to be involved in Covid-19 and to relate them to patient characteristics.

Prof Jayaraj Rajagopal, a member of the network and pulmonologist in the Department of Internal Medicine at Massachusetts General Hospital, said: The cellular basis of disease often does not receive as much attention as the molecular basis of disease, even though molecules and cells are inseparably linked. In the case of Covid-19, knowing the cells that act as portals of viral entry and possible viral reservoirs helps us think about why a virus can be transmitted easily between people and why only some people progress to a lethal pneumonia.

Most studies of coronaviruses dont use cells from the actual tissues that are infected in patients.The HCA hopes to point both virologists and physicians toward the right cells and tissues for study.

All the data from the Human Cell Atlas - involving 1,600 people in 70 countries - is openly available to scientists across the globe.

Professor Sir Jeremy Farrar, director of Wellcome, said: By pinpointing the exact characteristics of every single cell type, the Human Cell Atlas is helping scientists to diagnose, monitor and treat diseases including Covid-19 in a completely new way. Researchers around the world are working at an unprecedented pace to deepen our understanding of Covid-19, and this new research is testament to this.

Collaborating across borders and openly sharing research is crucial to developing effective diagnostics, treatments and vaccines quickly, ensuring no country is left behind.

Joining the Sanger Institute at Hinxton on this study were researchers from University Medical Centre Groningen, University Cote dAzur and CNRS, Nice and their collaborators.

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Genmab Announces U.S. FDA Approval of Subcutaneous Formulation of Daratumumab, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), for the Treatment…

Posted: May 6, 2020 at 9:42 am

Company Announcement

Copenhagen, Denmark; May 01, 2020 Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of the subcutaneous formulation of daratumumab, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj). The Biologics License Application (BLA) for this formulation was submitted by Genmabs licensing partner, Janssen Biotech, Inc. (Janssen) in July 2019. DARZALEX FASPRO is approved for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT); in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. DARZALEX FASPRO is a fixed-dose formulation that can be administered over approximately three to five minutes, significantly less time than intravenous DARZALEX, which is given over several hours. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

The approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the subcutaneous formulation of daratumumab to the intravenous formulation in patients with relapsed or refractory multiple myeloma and data from the Phase II PLEIADES (MMY2040) study, which is evaluating subcutaneous daratumumab in combination with different standard multiple myeloma treatment regimens. The topline results from the COLUMBA study were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and the 24th European Hematology Association (EHA) Annual Congress. An update of the COLUMBA data as well as data from the PLEIADES study were presented during poster sessions at the 61st American Society of Hematology (ASH) Annual Meeting in December 2019.

The approval of the subcutaneous formulation of daratumumab, DARZALEX FASPRO, is a landmark event in the development of daratumumab. Not only is it now the first and only subcutaneous CD38 antibody approved for the treatment of multiple myeloma, the subcutaneous administration of DARZALEX FASPRO considerably reduces treatment burden, as the fixed-dose injection is administered in approximately three to five minutes, offering patients a more convenient treatment experience. As seen in the pivotal study supporting the approval, this reduction in infusion time from hours to minutes led to higher satisfaction levels for patients and in addition, infusion-related reactions were both mild and significantly reduced with this formulation of daratumumab. We are very much looking forward to the launch of DARZALEX FASPRO in the U.S. and the potential for positive impact it will have on the lives of the patients receiving the drug, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the COLUMBA (MMY3012) studyThe Phase III trial (NCT03277105) is a randomized, open-label, parallel assignment study that included 522 adults diagnosed with relapsed and refractory multiple myeloma. Patients were randomized to receive either: subcutaneous (SC) daratumumab, as 1,800 mg daratumumab with rHuPH20 2,000 U/mL once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study; or 16 mg/kg IV daratumumab once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The co-primary endpoints of the study are overall response rate and Maximum trough concentration of daratumumab (Ctrough; defined as the serum pre-dose concentration of daratumumab on Cycle 3 Day 1).

About the PLEIADES (MMY2040) studyThe Phase II trial (NCT03412565) is a non-randomized, open-label, parallel assignment study that includes 265 adults either newly diagnosed or with relapsed or refractory multiple myeloma. Patients with newly diagnosed multiple myeloma are being treated with 1,800 mg SC daratumumab in combination with either bortezomib, lenalidomide and dexamethasone (D-VRd) or bortezomib, melphalan and prednisone (D-VMP). Patients with relapsed or refractory multiple myeloma are being treated with 1,800 mg SC daratumumab plus lenalidomide and dexamethasone (D-Rd). An additional cohort of patients with relapsed and refractory multiple myeloma treated with daratumumab plus carfilzomib and dexamethasone (D-Kd) was subsequently added to the study. The primary endpoint for the D-VMP, D-Kd and D-Rd cohorts is overall response rate. The primary endpoint for the D-VRd cohort is very good partial response or better rate.

About DARZALEX (daratumumab) DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant (ASCT); in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for ASCT; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for ASCT; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. DARZALEX FASPRO is the first subcutaneous CD38-directed antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resul cvfting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5,6

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of three approved antibodies: DARZALEX (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Arzerra (ofatumumab, under agreement with Novartis AG), for the treatment of certain chronic lymphocytic leukemia indications in the U.S., Japan and certain other territories and TEPEZZA (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development by Novartis for the treatment of relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Contact: Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations: Andrew Carlsen, Senior Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. Arzerra is a trademark of Novartis AG or its affiliates. DARZALEX and DARZALEX FASPRO are trademarks of Janssen Pharmaceutica NV. TEPEZZA is a trademark of Horizon Therapeutics plc.

1 DARZALEX Prescribing information, April 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s027lbl.pdf Last accessed April 20202 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed October 20193 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.4 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.5 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.6 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974

Company Announcement no. 19CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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Genmab Announces U.S. FDA Approval of Subcutaneous Formulation of Daratumumab, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), for the Treatment...

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Biotech Blog: Update on Government Activities on Agricultural Biotechnology in 2020 – CSPI Newsroom

Posted: May 5, 2020 at 7:52 am

While much of the federal governments recent activity has surrounded COVID-19, some agencies are continuing their work in other areas, including agricultural biotechnology. In this blog, I invite you to take a break from the coronavirus news cycle as I summarize three developments you may have missed that have occurred in agricultural biotechnology in the United States since the start of 2020.

On March 30th, the Environmental Protection Agency (EPA) approved the herbicide Isoxaflutole for use on soybeans that were genetically engineered to be resistant to that herbicide (the soybean variety was approved by the US Department of Agriculture (USDA) years earlier). EPA concluded that under certain conditions, the herbicide could be used in an environmentally protective manner in certain parts of the country. The EPA registration classifies Isoxaflutole as a restricted-use pesticide, which means it can only be applied by applicators who receive special training, and it cannot be applied aerially or through irrigation systems. Geographically, its use on soybeans is limited to specific counties in 25 states (because those areas do not have endangered species that would have required EPA to conduct a detailed assessment to comply with the Endangered Species Act). The registration is limited to five years, which will allow EPA to review compliance with the use restrictions and monitor development of any resistant weeds. EPA also requires the registrant (Bayer CropScience) to establish a weed resistance management plan, including development and implementation of an education program encouraging farmers using the herbicide to take steps to prevent resistant weed development.

While safe and effective herbicides are necessary to produce our food, this registration raises some obvious compliance issues. First, Isoxaflutole was not approved for use in Illinois and Iowa, two of the largest growers of soybeans. Isoxaflutole is also approved for use as a pre-emergence herbicide on corn fields in 8 additional states where it is not approved for use on the herbicide-tolerant GE soybeans (and its use has been banned by state regulators in some counties in some Minnesota, Wisconsin, and Michigan to prevent groundwater contamination). How will EPA ensure that this herbicide is only used on soybeans in geographically approved regions of the country? The situation seems ripe for illegal use by some farmers.

Second, while I applaud EPAs inclusion on the label of actions to be carried out by the developer and farmers to prevent resistant weed development, those actions are not enough. The Isoxaflutole label only states that Appropriate resistance management strategies should be followed and that to delay resistance, take one or more of the following steps. Those statements suggest, but do not legally obligate, farmers to carry out activities such as pesticide rotations from season to season or adoption of integrated weed management programs. Farmers could comply just by switching to a different herbicide if resistant weeds develop or by reporting any suspected resistance to the developer (two of the actions suggested by EPA on the pesticide label under resistance management)but even those are not required. Given the history of overuse of glyphosate by farmers growing GE corn and soybeans, which has resulted in millions of acres of resistant weeds, EPA registration should have explicitly required resistant weed prevention by farmers.

On March 4th, the Food and Drug Administration (FDA) launched its Feed Your Mind website, which is the first public-facing product from the $7.5 million that Congress appropriated starting in 2017 for an Agricultural Biotechnology Education and Outreach Initiative. According to FDA, the initiatives goal is toshare science-based information that educates, informs, and broadens understanding about agricultural biotechnology for consumers. Congress (and the special interests that lobbied for the appropriation) clearly intended to use the authoritative voice of FDA to increase consumers understanding of agricultural biotechnology and correct misconceptions and misinformation.

The initiatives website includes fact sheets, infographics, and videos. It will be followed by additional materials for middle school classrooms, resources for health professionals, and consumer materials later in 2020 and in 2021.

In reviewing Feed Your Mind, one finds information that is scientifically accurate (with reliable references) and relatively easy for a non-scientist to understand. If you know nothing about GMOs and read the websites contents, you will clearly be better informed about what GMOs are, although not necessarily about why GMOs have been so controversial. The question that remains is how this website (which is not easy to find from FDAs homepage, nor does it quickly appear when entering basic questions about GMOs into an internet search engine) will educate a significant segment of American consumers. Will FDA promote the website and its materials through an ad campaign? Will they send emails or postcards to Americans telling them to visit the website?I cannot imagine that the average American consumer visits FDAs website with any great frequency. One can reasonably assume that the number of consumers who will search for the Feed Your Mind website, even if they know it exists, will be extremely small. So far, FDA has only announced the website to its list of stakeholders. Much more outreach will be needed if the information they have generated is to have the impact Congress intended

On March 19th, the Department of Interiors Fish and Wildlife Service (FWS) announced that it had completed a draft Programmatic Environmental Assessment (PEA) to assess the use of GE crops for natural resource management in the National Wildlife Refuge System. The public comment period on the PEA ended April 19th.

Lets explain how we got here. Currently, approximately 28,000 acres of refuge land in the Southeast is contracted out by FWS to farmers who grow primarily corn, soybeans and rice. In those contracts, farmers agree not to harvest 25% of their crop so it can be left as food consumed by waterfowl and other animals that the refuges support. Agricultural fields also maintain open habitat to support wildlife and control invasive species. Contract farmers utilized GE crops until 2012, when a lawsuit stopped the practice pending a PEA in compliance with the National Environmental Policy Act (NEPA). This PEA is the result of that process.

The PEA covers ten states and two territories in the Southeastern United States and recommends a policy that would allow the growing of GE crops on NWR land. The PEA compares the period before 2012 (with GE crops) and after 2012 (without them). They find that the pesticide use (pounds of active ingredient) increased 68% after farmers stopped using GE crops in 2012 and the number of active ingredients increased 76%. Other facts supporting the PEAs conclusion that the growing of GE crops should be allowed include findings that NWR staffs workload was less when farmers used GE crops and farmers had increased yields. Finally, they found using GE crops was consistent with the FWSs Integrated Pest Management Policies.

In the United States, farmers have grown GE crops for more than twenty years, reaping their benefits such as reduced insecticide use on corn and cotton crops while managing their risks (although not always well). If those same GE crops can be beneficial to farmers growing crops on NWR lands without demonstrable risk, as the PEA appears to show, then it seems like they should be permitted to plant them.

After reviewing the comments received, FWS will issue a final PEA. But the process does not end there. The PEA is necessary, but not sufficient for permitting the growing of GE crops in NWRs. Next, individual refuges in the Southeastern region can conduct their own site-specific analysis to determine whether to authorize their farmers to use a GE crop.

Now that youre caught up on the latest in agricultural biotechnology, stay tuned for additional developments we expect in the coming weeks. These include USDAs revisions to 7 C.F.R. Part 340 addressing its oversight of GE organisms that might be plant pests, and EPAs proposal on how its regulation of plant-incorporated protectants will apply to genome-edited crops. Check back with the Biotech Blog for coverage of these and more!

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The Role Of Biotechnology In Sustainable Cleaning Products – European Cleaning Journal

Posted: May 5, 2020 at 7:52 am

The first sustainable cleaning products appeared on the professional hygiene market in the early 1990s and the increase in demand for these products has led to innovation and several new technologies. Biotechnology is one of the most important, as Steve Teasdale, vice-president of scientific affairs at Innuscience explains.

The first sustainable cleaning products appeared on the professional hygiene market in the early 1990s. At the time, these technologies generally did not perform especially well and were not unanimously accepted by a generally insensitive marketplace. Since then, and with more receptive audience the demand for these products continues to grow and to the point where their use is increasingly mandated in many places.

This increase in demand for such products has in turn led to innovation and the development of several new technologies. As you would expect, some quickly disappeared while others remained on the market and continued to evolve. Biotechnology is one of the most important of these, and as market conditions evolve, it continues gaining increasingly important market awareness and share.

The list of chemical ingredients historically used in cleaning products and which are now considered undesirable, of concern or are even banned continues to grow. Given their contribution to cleaning efficacy, their removal must be compensated using new substances and/or technologies. This situation has helped to promote and encourage the technological development for alternative solutions arising from biotechnology; among other things.

It is in this context that significant efforts have been invested in to bring us to a point where it is now possible to obtain as good, or even better levels of cleaning performance using biotechnological cleaning products.

Green cleaning products which mainly used ingredients derived from biotechnological processes bacterial cultures, enzyme extracts and other bio-ingredients appeared in the late 1990s. Since then, they have become increasingly popular; with increased recognition and steady commercial growth.

Specific knowledge

The ability to develop biotech cleaning products is not universally available and requires specific technological knowledge and skills that are relatively young and unusual in the professional hygiene market. While our industry has been dominated by chemistry for decades, the arrival of biotechnology has required a significant commitment in terms of energy and resources whether it be in terms of research tools, research, performance analysis, stability assessment or at the level of standards and regulatory compliance.

The manufacture of biotech cleaning products also requires unique expertise. Manufacturing cleaning products with bio-active and/or surface active molecules requires the development of special processes, procedures and quality standards. There have been many developments in this field and the standards and processes implemented are now recognised by the scientific community (Teasdale et al., Food and Chemical Toxicology https://www.sciencedirect.com/science/article/pii/ S0278691517306270)

The evolution of biotechnologies for professional cleaning is booming. We are seeing more and more products using bio-surfactants. These are surface active molecules which are produced by microorganisms and which have unique and remarkable environmental and performance properties.

Other technologies stemming from biotechnologies are under development and already starting to be introduced on the market. This is the case with new disinfection technologies that use viruses that kill targeted microbial pathogen (bacteriophages) in a very specific way instead of disrupting the entire existing microbial flora.

The use of biotechnological cleaning products has brought cleaning to a new dimension. While traditional chemical cleaners have the ability to solubilise and/or emulsify dirt, biotech cleaning products also have the ability to break and remove dirt through hydrolysis and biodegradation. This action has the additional benefit of residual activity beyond the short period of mechanical action applied during cleaning or post-cleaning action.

This new dimension of cleaning goes towards a significant revision of the traditional foundations of the famous Sinner Circle cleaning action continues for hours beyond the application of mechanical action.

Thanks to the characteristics of their make-up and their function, biotech ingredients make it possible to develop cleaning products that are highly concentrated and contain very low concentrations of chemical ingredients (mainly surfactants) once diluted before use. It also makes it possible to achieve very high cleaning and detergency performance without having to resort to using high pH, sequestering agents, builders, solvents and other substances which contribute to increasing the pollutant load and which is the reason why traditional chemical cleaning products are harmful for the environment and cleaning staffs health.

First patent

For example, in the year 2000 the first biotechnological neutral pH degreaser for kitchen floors was patented and then marketed. This diluted degreasing solution contained less than 0.05 per cent active ingredient and degreased a kitchen floor more efficiently than a traditional alkaline degreaser containing 25 times the amount of active ingredients.

Reduction using less is the first and most effective eco-friendly cleaning approach. This products high concentration rate makes it possible, among other things, to reduce the transport and use of plastic. Its high efficiency allows for very high dilution rates reducing the amount of cleaning ingredients used.

In addition, the use of this biotech degreaser directly impacted on reducing cleaning staffs risk of having an accident. It did not lead to any increase in slipperiness on kitchen floors as can happen with alkaline chemical degreasers. Thus, this reduced the risk of slip and fall in the kitchen whilst its ensured there was no risk of skin or eye burns due to its non-corrosive classification.

Broader concept

The concept of a green cleaning product refers to cleaning products that have a lower and less harmful environmental impact than that of traditional cleaning products. Although this dimension is noble and desirable, the concept for an eco-responsible cleaning product uses a much broader concept that integrates environmental, societal and economic parameters.

In order for a cleaning product to contribute in a sustainable way to the development of our industry, it must integrate these three main axes that define the concept of sustainable development. Thus, beyond the environmental impact cleaning staffs health and wellbeing as well as the cost of use must be considered when developing new cleaning technologies.

In the previous example concerning the biotech degreasing product for kitchen floors it is clear that this products use has a direct impact on aspects which are both environmental and societal. But what about the cost of use? A cleaning product that benefits the environment and workers health cannot offer a sustainable solution if it costs more to use. However, the use of biotechnologies makes it possible to develop cleaning products that advantageously integrate the economic aspect.

Since bacterial cultures and enzymatic extracts are highly effective even at very low concentrations and considering their residual and prolonged cleansing action, biotechnological cleaning products can be diluted at very high rates while providing outstanding cleaning performance. These high dilution rates lead to high-performance cleaning solutions that have a very low cost per litre in their applicative usage.

Additionally, biotech cleaning products have the ability to reduce odours due to their mode of action and their ability to extract a greater amount of dirt from surfaces; especially those which are porous and difficult to clean. In public toilets, some odours may be generated following the passage of a user.

However, in reality the most disturbing odours are those which are permanently present and that emanate from surfaces which have accumulated water and more particularly urine. The floors near bowls and urinals are particularly prone to generating these unpleasant odours.

Solving the problem

In view of their inability to solve these problems, a number of stakeholders resort to using methods that are more or less effective and that never really solve the problem. It is common to widely distribute air fresheners to mask these odours. As a last resort, we sometimes see cleaning staff use a rotary floor scrubber and a floor stripper in an attempt to unclog the problematic surfaces with no success.

Ultimately, we have all already visited bathrooms where, in desperation, the floor had been sealed with a floor finish in order to trap smelly dirt. These solutions, which are not really solutions, are all bad for the environment, the cleaning staff and the buildings tenants.

The use of air fresheners is particularly harmful and far from being a sustainable solution. These products are essentially volatile organic compounds (VOCs) and they contribute to deteriorating indoor air quality. They also cause multiple inconveniences, discomfort and symptoms which are grouped together and recognised as the Sick Building Syndrome. In addition, these air fresheners attract bad publicity and are considered by more and more people as a pollutant and an invasive nuisance. They are frequently the subject of complaints when used unreasonably.

Now, with the help of a biotechnological all-surface toilet cleaner, it is possible to clean all surfaces, including the floors. This makes it possible to dislodge the dirt accumulated over the years, which are the main sources of bad smells. After a few days of use, bad smells gradually disappear. This approach makes it possible to better clean the floors, but above all to eliminate those air fresheners.

Conclusion

As mentioned by a famous scientist who has left a mark in our history, We cannot solve a problem by using the same approach that we had used to create it. Thus, we had and still have a desperate need for new technologies that will provide real and sustainable solutions to the environmental and societal problems associated with professional cleaning and that we are still faced with today. Biotechnology is a good example of a technological and innovative contribution in this field.

innuscience.com

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Puma Biotechnology and Bixink Therapeutics Enter into Exclusive Licensing Agreement to Commercialize NERLYNX (neratinib) in South Korea – BioSpace

Posted: May 5, 2020 at 7:52 am

Bixink will be responsible for seeking the requisite regulatory approval and, once approved, for commercializing NERLYNX in South Korea. Under the terms of the agreement, Puma will receive upfront and milestone payments of up to $6 million, as well as significant double-digit royalties on the sales of NERLYNX in South Korea.

Our new agreement with Bixink demonstrates our commitment to bringing NERLYNX to patients around the world while continuing to focus our commercial resources on the U.S. market, stated Alan H. Auerbach, Chief Executive Officer and President of Puma. We are excited about the potential to provide South Korean breast cancer patients with access to NERLYNX.

We are excited about the opportunity to provide NERLYNX to patients with HER2-positive breast cancer in South Korea and plan to file for its market authorization before the end of 2020, said Dr. Sung Chul Kim, Chief Executive Officer of Bixink Therapeutics. NERLYNX is our top priority as we aspire to be a leading South Korean company in the field of oncology therapeutics.

Neratinib is approved in the United States for both the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and HER2-positive metastatic breast cancer and is marketed in the United States as NERLYNX (neratinib) tablets.

About HER2-Positive Breast Cancer

Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

IMPORTANT SAFETY INFORMATION

NERLYNX (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS:

The most common adverse reactions (reported in 5% of patients) were as follows:

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and http://www.NERLYNX.com or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS:

Please see Full Prescribing Information for additional safety information.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at http://www.NERLYNX.com or 1-855-816-5421.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology can be found at http://www.pumabiotechnology.com.

About Bixink

Bixink Therapeutics Co. Ltd. is a new South Korean company dedicated towards establishing a new treatment paradigm via converging biotechnology and information technology. Currently focused on the field of anti-cancer drugs and digital therapeutics, Bixink will start commercialization of anti-cancer drug NERLYNX and aims to diligently secure follow up pipeline products, including cancer supportive care and oncologics with novel drug delivery. Bixink also actively seeks various opportunities for collaboration such as co-development and strategic investment to drive its momentum for growth. As one of the pioneers in the field of digital therapeutics in South Korea, Bixink is capable of analysis, R&D, development and validation, and plans to file an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration by the end of this year to launch its first digitalized cognitive behavioral therapy for obsessive compulsive disorder. In the long term, Bixink strives to create a new path by encompassing medicines and digital therapeutics with better clinical outcomes and cost-effectiveness for patients. Bixink strives to push the boundaries of technology to transform medicine.

To find out more about Bixink Therapeutics, please visit http://www.bixink-therapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the international expansion of NERLYNX. All forward-looking statements involve risks and uncertainties that could cause Pumas actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, any adverse impact on Pumas business or the global economy and financial markets, generally, from the global COVID-19 pandemic, and the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Pumas Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent reports. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law.

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Puma Biotechnology and Bixink Therapeutics Enter into Exclusive Licensing Agreement to Commercialize NERLYNX (neratinib) in South Korea - BioSpace

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Healthcare Cleanroom Consumables Market: Increasing Commercialization of Biotechnology-based Products to Boost the Demand – BioSpace

Posted: May 5, 2020 at 7:52 am

TMR estimates that the healthcare cleanroom consumables market features fragmented and highly competitive vendor landscape. The large number of companies present in the market is leading to increase level of competition in the global market. Some of the key players dominating the globalhealthcare cleanroom consumables marketare Valutek, Texwipe, Nitritex Ltd., DuPont, and Kimberly-Clark Corp. These key players collectively accounted for 52% of the overall revenue. Additionally, the key players are getting benefit from commercialization of products coupled with implication of cost-cutting measures during manufacturing. However, lack of product differentiation is creating challenge for key players. Thus, the players are increasingly trying to offer products at competitive pricing, and in turn, the intense price war is taking shape on a global level.

The analysts at TMR estimates, the global healthcare cleanroom consumables market is likely to exhibit growth at a CAGR of 4.76% during the period from 2015 to 2023. At this growth rate, the market is likely to reach a valuation of US$3 bn by 2023 from rising from a valuation of US$2 bn in 2014. This growth is attributable to rising need for new and effective drugs.

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On the basis of applications, the market is dominated by the segment of biotechnology and is estimated to remain dominant in the coming years. On the basis of geography, the market in North America is estimated to be the leading region in terms of revenue and to be dominant in coming years. The regional market stood at the US$0.7 bn in 2014 and is expected to grab a value of US$10.3 bn by the end of 2023. The Europe is expected to account for second-leading share and is estimated to grab a value of US$0.9 bn by 2023 from a value of US$0.6 bn in 2014. This growth is attributable to high demand for cleanroom consumables in the region coupled with increasing demand from the pharmaceuticals and biotechnology industry.

Booming Research Activities in Healthcare Drives Market Growth

The healthcare cleanroom consumable market has gained pace from past few years as the external factors such as chemicals, vapors, dust and other microorganisms in air is lowering the production capacity. Additionally, these external factors influence negatively on the products and facilities of drugs and medical devices. Thus, demand for the cleanroom consumables especially in the healthcare is growing substantially, which in turn is propelling growth of the healthcare cleanroom consumable market.

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Cleanroom consumables have robust applications in the healthcare and medical industry as the importance of cleanliness is higher in the sector, which is benefiting growth of the global healthcare cleanroom consumable market. The other sectors of the healthcare industry such as pharmaceuticals, devices, and hospitals are driving growth of the global healthcare cleanroom consumable market. Additionally, high demand for the cleanroom consumables from biotechnological labs is high as the devices can easily get affected due to organisms in the room or air. This is key factors driving growth of the healthcare cleanroom consumable market and is expected to be major factors influencing growth in coming years.

Need of High Investment Restrains Market Growth

However, requirement of high investment on healthcare cleanroom consumables and devices is restraining growth of the healthcare cleanroom consumable market. Additionally, availability of customized healthcare cleanroom consumables as per requirement is difficult which is hampering growth to some extent. Further, the healthcare cleanroom consumables such as gloves are not the reusable and require long time for recycling, which creates the challenge for key players. This is another key concerns and major factor slowing the growth of the healthcare cleanroom consumable market. Nonetheless, the continuous research and development coupled with robust investment and commercialization of biotechnological products for development of chronic diseases such as cancer is estimated to offer lucrative opportunities for growth in the healthcare cleanroom consumable market in coming years.

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This information is encompassed inthe report by TMR, titled, Healthcare Cleanroom Consumables Market (Product - Wipers (Dry and Wet), Cleanroom Apparels(Coverall, Frock, Boot Cover, Shoe Cover, Bouffant, Sleeves, Pants, Face Masks, and Hood), Cleaning Products (Cleanroom Mops, Buckets, Wringers, Squeegees, Validation Swabs, and Cleaning Chemicals), and Cleanroom Stationery (Paper, Notebook and Adhesive Pads, Binders and Clipboards, and Labels); Application - Pharmaceutical, Biotechnology, Medical Devices, Academia, and Hospitals) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 20152023.

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Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through ad hoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories.

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The B.R.A.I.N. Biotechnology Research and Information Network (ETR:BNN) Share Price Is Down 46% So Some Shareholders Are Getting Worried – Yahoo…

Posted: May 5, 2020 at 7:52 am

B.R.A.I.N. Biotechnology Research and Information Network AG (ETR:BNN) shareholders will doubtless be very grateful to see the share price up 54% in the last month. But that doesn't help the fact that the three year return is less impressive. In fact, the share price is down 46% in the last three years, falling well short of the market return.

Check out our latest analysis for B.R.A.I.N. Biotechnology Research and Information Network

B.R.A.I.N. Biotechnology Research and Information Network isn't currently profitable, so most analysts would look to revenue growth to get an idea of how fast the underlying business is growing. Generally speaking, companies without profits are expected to grow revenue every year, and at a good clip. As you can imagine, fast revenue growth, when maintained, often leads to fast profit growth.

In the last three years, B.R.A.I.N. Biotechnology Research and Information Network saw its revenue grow by 19% per year, compound. That's a fairly respectable growth rate. Shareholders have endured a share price decline of 19% per year. This implies the market had higher expectations of B.R.A.I.N. Biotechnology Research and Information Network. However, that's in the past now, and it's the future is more important - and the future looks brighter (based on revenue, anyway).

The graphic below depicts how earnings and revenue have changed over time (unveil the exact values by clicking on the image).

XTRA:BNN Income Statement May 4th 2020

If you are thinking of buying or selling B.R.A.I.N. Biotechnology Research and Information Network stock, you should check out this FREE detailed report on its balance sheet.

B.R.A.I.N. Biotechnology Research and Information Network shareholders may not have made money over the last year, but their total loss of 6.2% isn't as bad as the market loss of around 6.2%. Furthermore, the stock lost shareholders 19% per year over three years, so the one-year return was better in a relative sense. It is of course not much comfort to know that the losses have slowed. Shareholders will be hoping for a proper turnaround, no doubt. It's always interesting to track share price performance over the longer term. But to understand B.R.A.I.N. Biotechnology Research and Information Network better, we need to consider many other factors. Take risks, for example - B.R.A.I.N. Biotechnology Research and Information Network has 1 warning sign we think you should be aware of.

Of course B.R.A.I.N. Biotechnology Research and Information Network may not be the best stock to buy. So you may wish to see this free collection of growth stocks.

Please note, the market returns quoted in this article reflect the market weighted average returns of stocks that currently trade on DE exchanges.

If you spot an error that warrants correction, please contact the editor at editorial-team@simplywallst.com. This article by Simply Wall St is general in nature. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. Simply Wall St has no position in the stocks mentioned.

We aim to bring you long-term focused research analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Thank you for reading.

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The B.R.A.I.N. Biotechnology Research and Information Network (ETR:BNN) Share Price Is Down 46% So Some Shareholders Are Getting Worried - Yahoo...

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