CARLSBAD, Calif.--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported financial and operating results for the first quarter of 2022. Lineage management will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2022 financial and operating results and to provide a business update.

The first quarter of this year was highlighted by the rapid launch of new cell therapy programs in hearing loss and vision disorders and conducting tech transfer activities to support our alliance with Roche and Genentech for our dry AMD program, stated Brian M. Culley, Lineage CEO. Our broad strategic plan is to position Lineage as a leader in regenerative medicine through the transplant of specific cell types to treat significant unmet medical needs. As part of that plan, we have expanded our cell therapy pipeline to five distinct programs, each offering an opportunity to impact various diseases. We believe our ability to, in just a matter of months, advance from a product concept to generating new intellectual property to support the manufacture of specific cell types, is not only illustrative of the power and efficiency of our platform but also a competitive advantage compared to others in this field. Looking forward, our focus is on clinical and regulatory execution across our portfolio. We are working to advance OPC1 and VAC2 into their next phases of clinical testing, in spinal cord injury and oncology, respectively, as well as advancing our auditory neuron and photoreceptor programs through preclinical development and toward pre-IND meetings with FDA. We believe the combination of our disciplined use of capital and current balance sheet will support multiple years of progress, during which we anticipate reaching significant events with each of our clinical and preclinical programs.

Recent milestones include:

Some of the events and milestones anticipated by Lineage in the rest of 2022 include:

Balance Sheet Highlights

Cash and cash equivalents totaled $78.1 million as of March 31, 2022.

First Quarter Operating Results

Revenues: Lineages revenue is generated primarily from research grants, royalties, and licensing fees. Total revenues for the three months ended March 31, 2022 were $5.2 million, an increase of $4.8 million as compared to $0.4 million for the same period in 2021. The increase was primarily related to licensing fees recognized from deferred revenues in connection with the $50.0 million upfront licensing payment received in the first quarter of 2022 from Roche.

Operating Expenses: Operating expenses are comprised of research and development (R&D) expenses and general and administrative (G&A) expenses. Total operating expenses for the three months ended March 31, 2022 were $11.5 million, an increase of $4.2 million as compared to $7.3 million for the same period in 2021, primarily attributable to a $3.5 million non-recurring expense related to the potential settlement of the litigation concerning our 2019 acquisition of Asterias (Asterias Litigation).

R&D Expenses: R&D expenses for the three months ended March 31, 2022 were $3.0 million, a decrease of $0.4 million as compared to $3.4 million for the same period in 2021. The decrease was driven by $0.7 million in lower expenses for the OPC1 program, partially offset by $0.2 million and $0.1 million in higher expenses to support the VAC program and OpRegen related expenses to support the Roche Collaboration, respectively. Another $0.1 million of the offsetting increase was related to initial costs to support the new auditory neuron cell therapy program.

G&A Expenses: G&A expenses for the three months ended March 31, 2022 were $8.5 million, an increase of $4.6 million as compared to $3.9 million for the same period in 2021. The increase was primarily attributable to the $3.5 million non-recurring expense related to the potential settlement of the Asterias Litigation, and $0.5 million in share-based compensation.

Loss from Operations: Loss from operations for the three months ended March 31, 2022 was $6.4 million, a decrease of $0.7 million as compared to $7.1 million for the same period in 2021.

Other Income/(Expenses), Net: Other income (expenses), net for the three months ended March 31, 2022 reflected other expense, net of ($0.7) million, compared to other income, net of $5.6 million for the same period in 2021. The net change of ($6.3) million was primarily related to the gain on sale of marketable securities in the prior year.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended March 31, 2022 was $7.1 million, or $0.04 per share (basic and diluted), compared to a net loss attributable to Lineage of $1.4 million, or $0.01 per share (basic and diluted), for the same period in 2021.

Conference Call and Webcast

Interested parties may access todays conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the Lineage Cell Therapeutics Call. A live webcast of the conference call will be available online in the Investors section of Lineages website. A replay of the webcast will be available on Lineages website for 30 days and a telephone replay will be available through May 20, 2022, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 1875641.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical programs are in markets with billion dollar opportunities and include five allogeneic (off-the-shelf) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 1/2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, which is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineages VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit http://www.lineagecell.com or follow the company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as believe, aim, may, will, estimate, continue, anticipate, design, intend, expect, could, can, plan, potential, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the collaboration and license agreement with Roche and Genentech, activities expected to occur thereunder, the potential to receive upfront, milestone and royalty consideration payable to Lineage thereunder; the potential benefits of treatment with OpRegen; the power and efficiency of Lineages platform and its competitive advantages; the ability of Lineages resources to support multiple years of progress; the potential future achievements of Lineages clinical and preclinical programs; the timing of potential FDA interactions, and of anticipated clinical trials and clinical data updates; and plans and expectations of Lineages products in development. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that competing alternative therapies may adversely impact the commercial potential of OpRegen; the risk that Roche and Genentech may not be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; the risk that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; risks and uncertainties inherent in Lineages business and other risks discussed in Lineages filings with the Securities and Exchange Commission (SEC). Lineages forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading Risk Factors in Lineages periodic reports with the SEC, including Lineages most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SECs website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS)

March 31, 2022(Unaudited)

December 31, 2021

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

78,062

$

55,742

Marketable equity securities

1,882

2,616

Accounts and grants receivable, net

515

50,840

Prepaid expenses and other current assets

1,413

2,351

Total current assets

81,872

111,549

The rest is here:
Lineage Cell Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update - Business Wire

What if in the next few years patients with cancer in their lungs or blood could sit in a chair, get an infusion of their own modified cells to wipe out their cancer and go home?

Cancer researchers and doctors around the country are working on it not only replacing rounds of toxic chemotherapy with the most advanced immunotherapies but also making the cutting edge treatments more readily accessible and even comfortable.

A big piece of the effort locally starts coming together Friday when the University of Maryland Medical Center breaks ground on a new $219 million cancer center.

The Roslyn and Leonard Stoler Center for Advanced Medicine will rise in front of the downtown Baltimore hospital and house the Marlene and Stewart Greenebaum Comprehensive Cancer Center. Its slated to open in 2025.

Dr. Kevin Cullen, director of the Greenebaum Cancer Center, said the new center was designed in anticipation of medical advances and patient needs.

Well be able to offer a bone marrow transplant, for example, in an extended-stay environment. You stay for treatment and go home and come back the next day, Cullen said ahead of the groundbreaking. We dont have that capability now.

Cullen said the center already is among the first in the region to offer some immunotherapy treatments that will only expand.

Renderings of the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center slated to break ground May 13, 2022. (Courtesy of the University of Maryland Medical Center)

The building and research at the University of Maryland School of Medicine, which will jointly operate the center with the hospital, are made possible in part by state and federal moonshot investments and funding from the American Cancer Society and others with a goal of developing better therapies, and even cures, for more types of cancer the No. 2 killer in the United States with 600,000 deaths expected this year.

Fundraising for the Maryland center began in 2018 when Baltimore auto dealer Len Stoler and his wife, Roslyn, gave $25 million toward the 198,000-square-foot building to enable treatment of thousands of patients a year.

The 9-story metal and glass building designed by the Nebraska-based architectural firm HDR will double the centers capacity from the current building and accommodate patient visits that are estimated to rise more than 50% by 2028.

Officials anticipate serving patients with increasingly complex cancers that require multidisciplinary treatment and lengthy follow-up care. Most of the space will be devoted to inpatient and outpatient care with a new entrance and lobby for the hospital. Another 42,000 square feet will be renovated in the existing medical center.

A large portion of the new centers start-up funding will come from a $216 million moonshot initiative launched by Gov. Larry Hogan, whose cancer was treated at the center. Hogan accelerated $100 million in funding for the center in next years budget.

At the federal level, cancer research nationwide stands to gain from a President Joe Biden initiative with a goal of cutting cancer deaths in half in the next 25 years and improving life for survivors.

Congress already has allocated about $1.6 billion to expand research into genetic mutations found in different cancers, develop vaccines to prevent cancer, deploy new diagnostic tools to find cancers sooner and close disparities in rates of disease.

A big and promising front in those treatments focuses on immunotherapies, which train peoples own immune systems to target and kill cancer cells.

Keeping momentum will require more funding and attention, said Dr. Arif Kamal, an oncologist and chief patient officer at the American Cancer Society.

The National Cancer Institute, the largest funder of cancer research, can only accept one in 10 of the research applications it receives, Kamal said.

When receiving funding has a 90% chance of not working out, promising scientists can be deterred, and we face the threat of them leaving the field and their potential groundbreaking discoveries never coming to light, he said.

The cancer society has contributed more than $133 million in Maryland for research over the years, with the University of Maryland hospitals and university receiving $23.8 million.

Kamal said its an exciting and promising time in cancer care, and doctors have increased ability to treat more types of cancers in less damaging ways.

He cited several kinds of immunotherapies, such as checkpoint inhibitors, which block proteins that stop the immune system from attacking cancer. There is also CAR T-cell therapy, which involves taking T-cells from a patients blood and training them to attach to tumor cells before being given back to patients via viruses.

The Maryland cancer center was the first in the Maryland-Washington, D.C.-Virginia region to offer CAR T-cell therapy to treat lymphoma, a blood cancer, after having been involved in trials to show its effectiveness.

The FDA recently approved it to treat lymphoma in patients whose chemotherapy failed once rather than multiple times, giving patients earlier access, said Dr. Aaron Rapoport, director of the transplant and cellular therapy program at the Maryland cancer center.

Renderings of the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center slated to break ground May 13, 2022. (Courtesy of the University of Maryland Medical Center)

In all, the University of Maryland center is using the treatment on 250 patients.

More than half of those patients had no other option and are likely cured of their cancer, Rapoport said. This turned out to be highly effective for patients, and we were one of the leading centers demonstrating that.

Rapoport said there are many other advances in the works at Maryland and elsewhere, and some are likely to be available by the time the new cancer center opens in 2025. They also may be given in outpatient settings rather than involving hospital stays.

To prepare for that, the new center will feature an expanded outpatient center for bone marrow transplants and other immunotherapies. A cell-processing laboratory that handles patients blood will be on site. There also will be an urgent care area where cancer patients can go instead of the emergency room.

Such additions were among the changes made with input from medical and other staff and the community, said Cullen, the centers director.

The expanded patient care areas will supplement research areas largely housed nearby in the hospital.

That research will press on during construction, and will involve collaborations with other institutions including Johns Hopkins Medicine.

Dr. William Nelson, director of Hopkins Sidney Kimmel Comprehensive Cancer Center, said institutions have long shared their work to make advances.

Daily

Get your morning news in your e-mail inbox. Get all the top news and sports from the baltimoresun.com.

In the 1970s, researchers looked at what could kill cancer in a lab dish and determined how much of that stuff we could get into a person without too much collateral damage, Nelson said.

It cured some cancer but also damaged other organs, made hair fall out and made people feel sick, he said.

Today doctors have and are developing new tools: They can inventory gene defects in cancer patients, target specific gene defects with therapies, improve the technology to better diagnose cancer and determine which drugs will or wont work on specific patients. And thats on top of new immunotherapies.

Nelson said Hopkins, Maryland and other institutions need to figure out how to seize opportunities like government moonshot and private dollars to build on progress. Collaboration is one big way.

Hopkins scientists recently announced they were awarded $8 million for novel cancer research. Its part of a $50 million award from the Break Through Cancer research foundation to five top cancer centers that will work together on cures for pancreatic, ovarian and brain cancers.

They hope to accelerate research like scientists did with the mRNA vaccines against COVID-19 in less than a year. Then they need to ensure any new treatments are delivered as comfortably and equitably as possible.

Take a disease like breast cancer. You never need to be in the hospital overnight, for a mammogram, biopsy, lumpectomy, chemo, hormonal therapy, Nelson said. People have lives to live. Go get in, get seen and get back to work or home. Thats the future.

See the original post:
University of Maryland Medical Center hopes new Baltimore cancer center will advance treatment, care - Baltimore Sun

Topline readout of Phase 2 AML trial Group 2 active disease anticipated in Q2 2022

Company plans to file INDs in lymphoma and pancreatic cancer by year end, with clinical trials to be initiated in 2023

HOUSTON, May 13, 2022 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc.(Nasdaq: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today provided a corporate update and reported financial results for the first quarter ended March 31, 2022.

2022 has already been an exciting year for Marker as we reported encouraging initial results from the six-patient safety lead-in portion of our Phase 2 AML trialincluding elimination of MRD in one MRD positive patientand announced plans for Company-sponsored trials of our second cell therapy product candidate, MT-601, in pancreatic cancer and lymphoma, saidPeter L. Hoang, Markers President and Chief Executive Officer. We also implemented a new MultiTAA-specific T cell therapy manufacturing process, details of which were presented at the 2022 International Society for Cell & Gene Therapy (ISCT) annual meeting. After completing enrollment of the first 20 patients in the Phase 2 AML trial last year, we anticipate reporting topline data from the active disease group in the main phase of the trial next quarter.

PROGRAM UPDATES AND EXPECTED MILESTONES

Acute Myeloid Leukemia (MT-401)

Additional Clinical Programs (MT-601)

BUSINESS UPDATES

FIRST QUARTER 2022 FINANCIAL RESULTS

Cash Position and Guidance: At March 31, 2022, Marker had cash, cash equivalents and restricted cash of $28.8 million.

R&D Expenses: Research and development expenses were $7.0 million for the quarter ended March 31, 2022, compared to $5.6 million for the quarter ended March 31, 2021.

G&A Expenses: General and administrative expenses were $3.7 million for the quarter ended March 31, 2022, compared to $3.1 million for the quarter ended March 31, 2021.

Net Loss: Marker reported a net loss of $9.9 million for the quarter ended March 31, 2022, compared to a net loss of $8.8 million for the quarter ended March 31, 2021.

About Marker Therapeutics, Inc.Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Markers cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patients immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cell therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

To receive future press releases via email, please visit: https://www.markertherapeutics.com/email-alerts.

Forward-Looking StatementsThis release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Companys expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; the timing, conduct and success of our clinical trials, including the Phase 2 trial of MT-401; our ability to use our manufacturing facilities to support clinical and commercial demand; the timing and use of the CPRIT award; and our future operating expenses and capital expenditure requirements. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Companys most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at http://www.sec.gov. Such risks and uncertainties may be amplified by the COVID-19 pandemic and its impact on our business and the global economy. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Investors and Media Contacts

Marker Therapeutics:

Neda SafarzadehVice President/Head of Investor Relations, PR & Marketing(713) 400-6451Investor.Relations@markertherapeutics.com

Solebury Trout:

MediaAmy BonannoAbonanno@soleburytrout.com

Read more here:
Marker Therapeutics Reports Q1 2022 Operating and Financial Results - BioSpace

Dr. Sara Vasconcelos in the laboratory at Toronto General Hospital on May 11.Christopher Katsarov/The Globe and Mail

When Sara Vasconcelos talks about her work, it sounds as if shes in the restoration business. But instead of repairing damaged buildings, the researcher at Torontos University Health Network wants to fix damaged hearts by using stem cells to rebuild cardiovascular tissue.

Now, Dr. Vasconcelos is one step closer to achieving that goal with a $3-million grant from the Stem Cell Network, a Canadian research funding organization. Her effort is one of 32 projects across the country that rose to the top in a competition for in the largest outlay of federal funding for regenerative medicine in 20 years.

On Thursday, the Ottawa-based network announced a total of $19.5-million in awards, which together with matching funds from various partners, will translate into $42-million for research and clinical trials over the next three years. The funding will enable the work of more than 400 scientists, clinicians and trainees, the organization said.

Its a big step, said Dr. Vasconcelos, who said she will use her award to build on preliminary findings obtained using rats. She will next work with pig hearts, which offer a much closer analogue to the human organ.

While doing so, she also hopes to overcome a barrier that has stood in the path of those who are trying to repair hearts using cardiomyocytes heart tissue cells that are grown from embryonic stem cells. The problem is that the replacement cells wither away if they are not nourished and kept alive by blood vessels.

As part of her project Dr. Vasconcelos aims to use a technique in which small sections of microscopic blood vessels are harvested from human fat and implanted along with the heart cells.

The microvessels that are like Lego pieces, she said. You can put a whole bunch of them in with the stem cell-derived cardiomyocytes and they will connect to each other and connect to the host vessels that carry blood.

With her grant secured, Dr. Vasconcelos said she is assembling the team that will test the method on pig hearts later this year. Ultimately, her goal is to develop the technique into a therapy that can restore cardiac function in human patients following a heart attack, she said.

Among the other projects to win funding are some that are already heading for clinical studies. That includes a large study led by Guy Sauvageau, a hematologist at Maisonneuve-Rosemont Hospital in Montreal, that involves developing engineered blood stem cells to treat leukemia.

Working with a group of clinical sites in the U.S., Dr. Sauvageau and his team have already had success at treating patients with leukemia who relapse. The new project will involve introducing genetical engineered stem cells into people who are better able to withstand cancer treatment and facilitate recovery.

Between 10,000 and 20,000 patients a year would benefit from this kind of therapy, Dr. Sauvageau said.

In the future, he added, the study could open the door to teaching the body to continually produce and replenish its own cancer-killing immune cells rather than having those cells created externally and infused in a form of treatment know as CAR T-cell therapy.

As part of another of the funded projects, David Thompson at the Vancouver Coastal Health Research Institute will conduct clinical trials for one of the worlds first genetically engineered cell replacement therapies for type 1 diabetes.

Dr. Sara Vasconcelos points to an image of vascular tissue in the laboratory at Toronto General Hospital where they engineer cell and tissue regeneration.Christopher Katsarov/The Globe and Mail

The diversity of the projects highlights the increasing prominence of stem cells in multiple domains of health research, an area where Canada has a long track record of success ever since University of Toronto researchers James Till and Ernest McCullough established the existence of stem cells cells which can differentiate into more specialized types in bone marrow in 1961.

Tania Bubela, dean of health sciences at Simon Fraser University in Burnaby, B.C., said the kind of funding the Stem Cell Network provides helps bridge a crucial gap between fundamental laboratory research and proven therapies for patients.

What weve realized over time is that where you get public sector investments to close the funding gap is exactly in that translational space from preclinical into early stage clinical trials, Dr. Bubela said. Once you have that proof that things are going to work and that they can be taken up by the health system, thats when venture capital starts to get interested.

Our Morning Update and Evening Update newsletters are written by Globe editors, giving you a concise summary of the days most important headlines. Sign up today.

See the original post here:
Heart, cancer and diabetes projects among winners of funding boost for stem cell therapies - The Globe and Mail

Investigators identified that in pivotal clinical trials supporting FDA approvals of CAR T-cell therapies for patients with hematologic cancer, Black patients were significantly underrepresented.

Notable disparities with regard to Black patients have been observed in CAR T-cell therapy clinical trials that have led to FDA approvals in hematologic cancers, according to findings from a study published in JAMA Network Open.1

Between studies, about 2% to 5% of Black patients were enrolled in clinical trials, received CAR T therapies, and reported efficacy. Using an adjusted prevalence measure, investigators reported that the lowest participation to prevalence ratio was 0.2 for multiple myeloma and 0.6 for large B-cell lymphoma (LBCL). The lowest number of Black patients was observed in the clinical trial that led to the approval of brexucabtagene autoleucel (Tecartus) in mantle cell lymphoma, with only 1 Black patient included.

The findings of this study suggest that low enrollment of Black persons exists in trials for CAR T therapy and that the disparity is substantial and ongoing, especially for therapies to treat [multiple myeloma]. Efforts should be made to understand and overcome barriers that lead to decreased enrollment of Black participants in clinical trials that include novel, potentially beneficial, and/or curative CAR T therapies in difficult-to-treat hematological malignant neoplasms with otherwise limited treatment options, Samer Al Hadidi, MD, assistant professor of medicine at the University of Arkansas for Medical Sciences, said in a press release.2

Between August 2017 and March 2021, 5 CAR T products were approved across 7 indications. A total of 1057 patients were enrolled, 746 of whom received CAR T-cell therapies and 729 reported efficacy.

In the study that led to the approval of tisagenlecleucel (Kymriah) in acute lymphoblastic leukemia, patients who were Black were put in a racial category designated as other, otherwise, their enrollment was specified mainly in the demographic subgroups information available under the FDA product labeling information.

Investigators noted that most of the studies included in FDA approvals did not report the proportions of racial and ethnic groups. Eighteen Black patients with diffuse LBCL who were treated with CAR T-cell therapy reported efficacy per disease category. Additionally, in one CAR T-cell therapy approval study for multiple myeloma, only 6 Black patients participated, comprising 6% of the total patient population.

The incidence of [multiple myeloma] is more than 2 times higher among Black persons than among non-Hispanic White persons, the investigators wrote. Black patients with [multiple myeloma] face multiple disparities, including lower use of hematopoietic stem cell transplantation, palliative care, and novel therapeutics, which may result in worse outcomes. Lack of access to novel therapies that disproportionately affect Black persons may result in further widening of the existing established disparities.

On April 13, 2022, the FDA initiated a plan to increase clinical trial diversity by employing the Race and Ethnic Diversity Plan.3 This has gone into effect for companies submitting applications for investigational new drugs, biologics license application, or investigation device exemption. This new plan recommends that companies define their enrollment goals for underrepresented populations so that they may be a part of pre-specified protocol objectives.

Read more:
Dearth of Participation From Black Patients Noted in CAR T Clinical Trials Supporting FDA Approvals - Cancer Network

Investigators of the phase 1/2 IMAGINE study (NCT05138458), evaluating MT-101 in patients with refractory or relapsed peripheral T-cell lymphoma (PTCL), have dosed its first patient, according to Myeloid Therapeutics Inc.

MT-101 is made with myeloid cells collected from the patient's blood which are then modified and later infused back into the patients veins. The modified myeloid cells are able to recognize the tumor cells and are designed to target and kill them.

The agent targeting the surface receptor, CD5, is the first mRNA engineered chimeric antigen receptor (CAR) monocyte (CAR-M) created by the company's proprietary ATAK platform. The ATAK CAR is designed to specifically promote broad anti-tumor activity.

"We are pleased to announce the initiation of dosing in the IMAGINE clinical trial, which represents a major milestone in our efforts to provide treatment with CD5 ATAK cells for patients with relapsed or refractory PTCL," said Michele Gerber, MD, MPH, chief medical officer of Myeloid, in a press release. "Currently, we are continuing through the dose-escalation cohorts of IMAGINE, which [are] designed to assess the safety and tolerability, optimal dose regimen, tumor penetration and preliminary efficacy of MT-101 in patients with PTCL. Following the conclusion of phase 1, we expect to expand quickly into the phase 2 portion of this study, which we designed to support registration of MT-101."

This open-label, first-in-human, multiple-ascending dose, multicenter, phase 1/2 study looks to test the safety, tolerability, and efficacy of MT-101 in patients with PTCL.

The research study is divided into 2 parts with the first looking to determine the safety and tolerability of the study drug product. Throughout this portion of the study, 3 groups of study patients will be examined with the first group receiving a low dose of cells, the second group receiving a higher dose of cells, and the third group receiving the higher dose of cells and lymphodepleting chemotherapy in order to reduce the number of T cells that are in the blood. The second part of the study will then administer cells with or without chemotherapy based on results of part 1. Safety, tolerability, and efficacy of MT-101 will be assessed within this portion of the study, and all patient groups will receive 6 doses of drug product over 3 weeks.

Enrollment is open to adults aged 18 and older with refractory or relapsed pathologically confirmed PTCL. Patients must have a CD5-expressing tumor by IHC or flow cytometry of tumor biopsy within 3 months of or at the time of screening, an ECOG performance status of 2 or less, and adequate organ function.

The primary end point is examining the safety and tolerability of MT-101, with secondary end points including MT-101 cell kinetics in blood and objective response rate. Other outcome measures of the trial consist of duration of response, progression-free survival, and overall survival.

According to the press release, at day 28, which is the primary end point for safety and tolerability, the dosed patient showed no dose-limiting toxicities, no cytokine release syndrome, and no immune effector cell-associated neurotoxicity syndrome. Additionally, the company achieved a reduced vein-to-vein time of 8 days with the dosing of this patient.

Currently, the dose-escalation portion of this study is open and enrolling patients. When the recommended phase 2 dose is found, a phase 2 trial will be initiated to support registration in this patient population.

"MT-101, Myeloid's leading mRNA-engineered monocyte, was advanced from conception and preclinical proof of concept to our first dose in humans in just 18 months. Importantly, this is the first instance of an engineered monocyte cell product delivered to a patient with a significantly reduced vein-to-vein time of just 8 days," stated Daniel Getts, PhD, chief executive officer of Myeloid, in the release. "Overall, this achievement highlights Myeloid's ability to produce scalable cell therapy products in an efficient manner, and we are optimistic about the impact this program can provide to PTCL patients and their families going forward."

Read more from the original source:
First Patient Dosed in IMAGINE Trial Evaluating MT-101 in Patients With PTCL - Targeted Oncology

With the recent FDA approvals of belantamab mafodotin (BLENREP), ciltacabtaene autoleucel (cilta-cel; Carvykti), and idecabtagene vicleucel (ide-cel; Abecma), the multiple myeloma treatment landscape is hub for BCMA-directed therapies.

Each of the FDA-approved BCMA-directed therapies, and targets are being explored in ongoing studies examining response rates in patients with or without prior BCMA-directed CAR T-cell therapy.

The BCMA CAR products currently approved for patients with myeloma are specifically for those who have had at least 4 prior lines of therapy, including a proteasome inhibitor image and a CD38 antibody. While there is no age limit, patients should be in good enough condition to withstand cytokine release syndrome and are typically those without advanced heart failure, uncontrolled cardiac conditions, oxygen independence, or other severe pulmonary conditions.

During the 3rd Summit of the Americas on Immunotherapies for Hematologic Malignancies, Adam Cohen, MD, director, Myeloma Immunotherapy, and associate professor of Medicine at the Hospital of the University of Pennsylvania, presented clinical data supporting the approved agents. He noted the positive findings of the exciting new immunotherapies for myeloma which have shown high response rates, even in patients who have had prior BCMA-directed CAR T cells.

In an interview with Targeted OncologyTM, Cohen further discussed the recent updates and advancements in BCMA-directed therapies for multiple myeloma.

TARGETED ONCOLOGY: Can you discuss your presentation on the topic of BCMA-directed therapies for patients with multiple myeloma?

Cohen: The bulk of my talk is presenting the clinical data that supports the use of both belantamab mafodotin, as well as ide-cel, and cilta-cel, which are FDA approved products. I also go through some of the exciting data coming out with the bispecific antibodies and other immune therapy that's showing a lot of promise in myeloma as well as in other cancers.

I reviewed some of the most mature data from the BCMA-targeted bispecifics as well as from 2 bispecifics hitting other targets, 1 called GPRC5D and 1 [called] FCRH5. So, there's really a lot of exciting new immunotherapies for myeloma, and these are showing high response rates, even in patients who have already had prior CAR T cells or prior BCMA-directed therapy in some cases.

Then, I finished up with a little bit of discussion of correlative analysis trying to understand mechanisms of resistance, which patients might be likely to respond, and which patients might not. I think that's going to hopefully help frame the next generation of trials if we really understand why some patients are not going to respond to these current products that are either better products that we can use, or can we combine these currently available therapies with some of our other therapies in myeloma to really start getting deeper and more durable remissions for more patients and maybe even eventually get to a cure? That's really what we're all hoping [for].

What survival response rates are being seen with other therapies for this disease?

Unfortunately, once patients had become refractory to some of our standard upfront treatments, proteasome inhibitors, IMiDs and CD-38 antibodies, we know that relapse in that relapsed refractory population, that response rates, PFS, and survivals are fairly poor. There was a large study called the MAMMOTH study that was a retrospective look back at multiple different regimens from multiple centers. Regardless of the regimen, the response rates were somewhere in the order of 30%, the PFS was only 3 to 4 months, and survival was generally in the order of 6 to 8 months. It really was an area of unmet need, and fortunately, the BCMA targeted therapies are trying to fill that niche.

Can you discuss some of the FDA approved agents? What was exciting about the study supporting these approvals?

The first BCMA-targeted drug that was approved was called belantamab mafodotin. This is an anti-BCMA antibody drug conjugate. It's a monoclonal antibody that has a microtubule poison on the end of it called MMAF, and it's given as an IV infusion every 3 weeks. It was approved based on the DREAMM-2 study which looked at 2 different doses of the drug and found that the 2.5 milligram per kilogram dose was sort of the optimal one going forward, and that's the one that got approved.

The response rate, again in that heavily refractory population of a median 6-7 prior lines of therapy was around 32%. Median PFS was only about 3 months, but the median duration of response was 11 months, meaning if you did get a response, those responses tended to be fairly durable. We've had patients on this drug going on more than 2 and a half years. So that's the first one that got approved in 2020.

The next one that was approved was ide-cel, which is a CAR T-cell product targeting BCMA, which was approved in the summer of 2021. This was based on the KARMA study, which was a multi-institution, single-arm, phase 2 study giving these BCMA-targeted CAR T cells to patients with heavily refractory myeloma. In that study, the overall response rate was 73%, with almost 40% of patients getting a CR [complete response]. The median progression-free survival for all patients was around 9 months, but in the group that got the highest dose of 450 million cells, which is the target dose approved by the FDA, median PFS was close to 12 months. This was unprecedented activity in this heavily pretreated population of patients.

The final product, that just got approved at the end of February 2022, is cilta-cel. This is another CAR T-cell product targeting BCMA. It has a distinct CAR construct compared with ide-cel cell and was also tested in a multi-institution. phase 2 study in the United States called CARTITUDE-1. In this study at 97 patients, the overall response rate was 98% with over 80% of patients achieving a complete remission. Median progression-free survival has not yet been reached with about 2 years of follow up. There are remarkable response rates, depth of response, and PFS with these CAR T-cell products in particular. I think that's what's generating a lot of excitement in the field right now, and now we have 2 different CAR products that are approved and available for our patients, which is great.

Are there currently any concerns with using BCMA-directed therapies?

Each of these approaches have their own toxicities that we need to watch out for. Belantamab, which is the antibody drug conjugate, shows one of the primary toxicities is corneal toxicity, keratopathy. The MMAF chemotherapy agent can lead to epithelial damage in the cornea that can cause blurred vision or dry eye. This is reversible, if you hold the drug and let it wash out, it does resolve and there's no permanent visual loss. It does require co-management with an eye care specialist, either an ophthalmologist or optometrist, to do eye exams and does require some dose modifications and dose holds in order to get patients through this. That's the one thing for the belantamab to keep an eye out for.

The main risks with the CAR T-cell products are similar to CAR T cells for other diseases, namely cytokine release syndrome and neurotoxicity. This tends to occur within the first week of treatment. Patients are typically hospitalized either during the CAR infusion, or shortly thereafter for monitoring for this. We've learned how to really manage these with aggressive, supportive care, and in some cases, tocilizumab or steroids to try to minimize the risk of these becoming severe. That's something we definitely need to keep an eye out for, with the CAR T-cell products, at least in the immediate post treatment period.

I think the key thing that we're learning is that these certainly can be very immune suppressive. Targeting BCMA can lead to hypogammaglobulinemia and increased risk of infections that can persist for months. These patients often need IVIG replacement, they need to be monitored closely with prophylactic antimicrobials as needed, and prompt treatment of any signs of infection.

Who is the ideal candidate for this type of treatment? What advice do you have for oncologists whose patient may not be the ideal candidate?

Right now, both BCMA CAR products in myeloma are approved for patients who have had at least 4 prior lines of therapy, which must include a proteasome inhibitor image and a CD38 antibody. There's no real upper age limit for CAR T-cell therapy. We've treated patients in their early 80s, but they do need to be robust to be able to withstand cytokine release syndrome. Typically, we would exclude patients with advanced heart failure or uncontrolled cardiac conditions, oxygen independence, COPD, or other severe pulmonary conditions or very poor performance status. We don't think renal failure necessarily is an exclusion, they were excluded from the trials, but we have been able to treat patients with commercial products even with profound renal dysfunction, just modifying the lymphodepleting chemotherapy.

I think the time to think about sending your patient into the CAR T-cell center should be when they're progressing on their third line therapy and you're thinking about starting a fourth line treatment. It would be helpful if you're thinking there would be a CAR T-cell candidate to get them into the center so we can assess them at the same time and add them to the waitlist for CAR T cells. Unfortunately, there's still limited manufacturing slots for these, so there can be a several month waitlist. That way, that patient is already in the system and if they don't respond to fourth-line treatment, or even if they are responding well but it's not a deep response, we may be able to take them to CAR T cells while they're under good disease control.

We're learning that patients who are really progressing rapidly while we're trying to collect T cells and then manage them with bridging therapy during the manufacturing process has been challenging. Some of those patients unfortunately never make it to their CAR T cells because their disease just takes off. I think it's better to send them in while they're still under some control and while we have good bridging options.

See the rest here:
Increasing Use of BCMA-Directed Therapies in Multiple Myeloma - Targeted Oncology

- AUTO4: oral presentation on initial clinical experience in peripheral T cell lymphoma- AUTO1/22: oral presentation on initial experience in r/r pediatric B-cell acute lymphoblastic leukemia- obe-cel: poster presentation in r/r primary CNS lymphoma- obe-cel: poster presentation in r/r B-non-Hodgkins lymphoma and chronic lymphoblastic leukemia- Conference call to be held on June 13, 2022 at 7:30 am EST/12:30 pm BST

LONDON, May 12, 2022 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc(Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces the online publication of four abstracts submitted to the European Hematology Association (EHA) Congress to be held June 9-12, 2022. Autolus plans to present more detail on these programs and the next steps in a conference call following the EHA presentations, on June 13, 2022, details below.

We are delighted to be presenting encouraging early clinical data from four of our pipeline programs, including important additive safety and efficacy data from our lead asset obe-cel in indications beyond adult r/r B-ALL. These data demonstrate the inherent value in both our pipeline and our technology base from which it originates, said Dr. Christian Itin, Chief Executive Officer of Autolus. With oral presentations on the early safety, tolerability, feasibility and preliminary efficacy of AUTO4 and AUTO1/22, were in a great place to evaluate the next strategic steps for these candidates and further build on the data presented here.

Abstracts to be presented:

Conference Call

Management will host a conference call and webcast on June 13, 2022 at7:30 am ET/12:30 pm BST to discuss the EHA data. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus website.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID: 6594553. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID: 6594553.

About Autolus Therapeutics plcAutolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the Company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information, please visit http://www.autolus.com.

About obe-cel(AUTO1)Obe-cel is a CD19 CAR T cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies.Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, obe-cel may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the ability of the programmed T cells to engage in serial killing of target cancer cells. In collaboration with Autolus academic partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical trials for B-NHL. Autolus has progressed obe-cel to the FELIX trial, a potential pivotal trial for adult ALL.

About obe-cel FELIX clinical trialAutolus Phase 1b/2 clinical trial of obe-cel is enrolling adult patients with relapsed / refractory B-precursor ALL. The trial had a Phase 1b component prior to proceeding to the single arm, Phase 2 clinical trial. The primary endpoint is overall response rate, and the secondary endpoints include duration of response, MRD negative CR rate and safety. The trial is designed to enroll approximately 100 patients across 30 of the leading academic and non-academic centers in the United States,United KingdomandEurope. [NCT04404660]

About AUTO1/22AUTO1/22 is a novel dual targeting CAR T cell based therapy candidate based on obe-cel. It is designed to combine the enhanced safety, robust expansion & persistence seen with the fast off rate CD19 CAR from obe-cel with a high sensitivity CD22 CAR to reduce antigen negative relapses. This product candidate is currently in a Phase 1 clinical trial called CARPALL for patients with r/r pediatric ALL. [NCT02443831]

About AUTO4AUTO4 is a programmed T cell product candidate in clinical development for T cell lymphoma, a setting where there are currently no approved programmed T cell therapies. AUTO4 is specifically designed to target TRBC1 derived cancers, which account for approximately 40% of T cell lymphomas, and is a complement to the AUTO5 T cell product candidate, which is in pre-clinical development. AUTO4 has been tested in a Phase 1 clinical trial, LibRA1 for patients with peripheral T cell Lymphoma.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding Autolus development of the obe-cel program; the future clinical development, efficacy, safety and therapeutic potential of its product candidates, including progress, expectations as to the reporting of data, conduct and timing and potential future clinical activity and milestones; expectations regarding the initiation, design and reporting of data from clinical trials; expectations regarding regulatory approval process for any product candidates; the collaboration between Autolus and Blackstone; the discovery, development and potential commercialization of potential product candidates including obe-cel using Autolus technology and under the collaboration agreement; the therapeutic potential for Autolus in next generation product developments of obe-cel in B-cell malignancies; the potential and timing to receive milestone payments and pay royalties under the strategic collaboration; and the Companys anticipated cash runway. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; and the impact of the ongoing COVID-19 pandemic on Autolus business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2022, as well as discussions of potential risks, uncertainties, and other important factors in Autolus' subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Contact:

Olivia Manser+44 (0) 7780 471568o.manser@autolus.com

Julia Wilson+44 (0) 7818 430877j.wilson@autolus.com

Susan A. NoonanS.A. Noonan Communications+1-917-513-5303susan@sanoonan.com

Original post:
Autolus Therapeutics to Present Four Clinical Data Updates at the European Hematology Association Congress - GlobeNewswire

The treatment landscape continues to expand across nonsmall cell lung cancer (NSCLC), with the FDA approvals of multiple agents, including targeted therapies such as sotorasib (Lumakras) and lorlatinib (Lorbrena), according to faculty from an OncLive State of the Science Summit on lung cancer.

The event, chaired by Christine Bestvina, MD, assistant professor of medicine, hematology and oncology (cancer), University of Chicago Medicine Comprehensive Cancer Center, highlighted updates across the lung cancer landscape, including the use of frontline immunotherapy in NSCLC, plus the role CTLA-4 inhibitors could play in this patient population.

Bestvina was joined by her colleagues:

Below, Fidler, Weinberg, Bestvina, Feldman, and Vokes summarize the main messages from their presentations.

Fidler: Comprehensive next-generation sequencing [NGS] is essential for [patients with] stage IV adenocarcinoma. [NGS] should include RNA sequencing and circulating tumor DNA [ctDNA] assays, [which] can maximally capture targeted alterations. We saw that with a [2018 report by Charu Aggarwal, MD, MPH, of Penn Medicine,] where some of the alterations were only captured in the ctDNA assays.

Perioperative PD-L1 [testing] could be useful to guide multimodality therapy, and EGFR testing should be performed on resectable patients that may pursue a neoadjuvant chemotherapy [plus] immunotherapy approach, given the overwhelming disease-free survival benefit with osimertinib [Tagrisso] for [patients with EGFR mutations].

Weinberg: Sotorasib received [FDA] approval in May 2021 for patients with KRAS G12C[mutated] metastatic NSCLC in the second-line setting or later. Adagrasib is a KRAS G12C inhibitor, but it is not yet approved.

In general, [KRAS G12C inhibitors] are tolerated well. Gastrointestinal [adverse] effects [AEs] and liver abnormalities are the largest treatment-related AEs. There is emerging data in studies that we should keep an eye on in terms of combination treatment thats ongoing.

Lorlatinib was approved in March 2021 for the treatment of patients with ALK fusionpositive metastatic NSCLC. Alectinib [Alecensa], for most [clinicians], is still our go-to first-line [treatment] for patients with ALK fusionpositive metastatic NSCLC. But I would consider lorlatinib in the first line if the patient has significant central nervous system metastasis. [It is important to] be aware of the unique [AE] profile of lorlatinib.

Selpercatinib [Retevmo] was FDA approved in May 2020 [for the treatment of patients with RET alterationpositive NSCLC]. Pralsetinib [Gavreto] was approved in September 2020 for the first-line treatment of patients with metastatic NSCLC with RET fusions. [Notably], selpercatinib has less myelosuppressive [AEs].

Larotrectinib [Vitrakvi] was approved in November 2018 [for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment]. Entrectinib [Rozlytrek] was approved in August 2019 for the first-line treatment of solid tumors harboring NTRK fusions without resistance mutations. [Additionally], there are emerging second-generation inhibitors to overcome on-target resistance.

Bestvina: Immune monotherapy is whats preferred for patients [with NSCLC] who have high PD-L1 [expression], although chemotherapy [plus] immunotherapy may be preferred in never smokers or patient [who present with more aggressive disease]. Chemotherapy [plus] immunotherapy is whats recommended to for [patients with] a [PD-L1 tumor proportion score of] less than 50%.

The addition of a CTLA-4 [inhibitor] may be helpful for certain patient subgroups. But stay tuned, because lots of combination trials [are expected] to read out soon.

Feldman: In the paradigm of treatment for extensive-stage SCLC, we want to consider clinical trials. In the first-line setting, [treatment options include] etoposide [and] platinum [chemotherapy combined with] either atezolizumab [Tecentriq] or durvalumab [Imfinzi]. In the second-line setting, we have an FDA approval for topotecan and lurbinectedin [Zepzelca]. Many investigators prefer [liposomal] irinotecan instead of topotecan, although that is an off-label usage.

In the third-line setting for patients who havent had a checkpoint inhibitor, one can consider pembrolizumab [Keytruda] or nivolumab [Opdivo]. Otherwise, we still have agents such as paclitaxel and temozolomide [Temodar] to consider in the third-line setting.

Vokes: Survival [rates] in resectable lung cancer are still too low. Although we should be happy with the [current] results, we shouldnt be content and say we dont have to look any further. Targeted therapies and immune checkpoint inhibitors have significantly improved treatment outcomes, and resection is the key. [Treatment can be given before or after surgery], but the key is to cut [the disease] out, [if possible].

[The use of] adjuvant and neoadjuvant chemotherapies are evidence based. Osimertinib is [FDA] approved [as an adjuvant treatment following tumor resection in EGFR-mutated NSCLC], and atezolizumab [is approved for use as an adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA NSCLC with a PD-L1 expression on 1% or moreof tumor cells]. Moreover, neoadjuvant nivolumab and [platinum-doublet chemotherapy was recently approved for adult patients with resectable NSCLC].

Continued here:
Targeted Therapies Continue to Expand the Treatment Paradigm in NSCLC - OncLive

Company Logo

Global Microcarrier Market

Global Microcarrier Market

Dublin, May 11, 2022 (GLOBE NEWSWIRE) -- The "Global Microcarrier Market, Size, Share, Forecast 2022-2027, Industry Trends, Growth, Impact of COVID-19, Opportunity Company Analysis" report has been added to ResearchAndMarkets.com's offering.

This report provides a detailed analysis of Microcarriers Industry. The global microcarrier market is estimated to reach US$ 2.24 Billion by 2027, from S$ 1.48 Billion in 2021.

Globally, a microcarrier is a non-toxic finely particulate material used to grow cells in a suspension or a support matrix, which facilitates the growth of adherent cells in a bioreactor. Recently, microcarrier-based cell culture has attracted significant attention from scientists and technologists worldwide. Besides, microcarrier technology has advantages for producing significant numbers of functional cells and maintaining their unique phenotypes as a powerful source of cell therapy and tissue engineering. With improved microcarrier materials, especially purely natural-material microcarriers, tissue engineering has a bright future.

Global Microcarrier Is Expected to Expand at a CAGR of 7.1% During 2021-2027:

Over the years, factors such as the increasing incidence of diseases demanding cell therapy and boosting R&D funding by research institutes and biopharmaceutical companies have played a critical role in market expansion. Further, the rising demand for monoclonal antibodies for the targeted treatment of cancer and other chronic disorders is expected to create significant opportunities for market growth during the forecast period. In addition, the increasing prevalence of cancer cases is playing an essential role in developing the microcarrier market. Also, the growing demand for cell-based vaccines is fuelling the market's growth over the forecast period.

COVID-19 Is Anticipated to Have a Noteworthy Impact On the Microcarrier Market:

In our report, we have closely observed the impact of COVID-19 on the global microcarrier market. After WHO officially announced COVID-19 as a pandemic, several renowned pharmaceutical companies, research institutes, and start-ups geared their R&D efforts to devise drugs and vaccines for infectious diseases. Further, due to advanced R&D activities and funding, the need for cell culture products, including microcarrier products, is anticipated to grow over the subsequent years. This will provide a significant stimulus to the global market for microcarriers. As per this research report, Global Microcarrier Market was US$ 1.48 Billion in 2021.

Consumables Segment Is Expected to Gain Traction by Grappling Market:

Story continues

By Product, the global microcarrier market is segmented into equipment and consumables. The consumables segment is expected to gain market share by grappling the market through 2021, and the trend is likely to persist during the forecast period. As per our analysis, the blossoming of this segment can be attributed to the rising adoption of microcarrier beads, media, and reagents for various applications, including cell culture procedures.

A Surge in Usage in Research Institutes as End-Users:

Over the past decades, microcarriers of a broad range with various physicochemical properties have been utilized and commercialized amongst end-users. As per our analysis, Pharmaceutical and Biotechnology Companies, Research Institutes, and CROs are the major end-user segments of the microcarriers market. As per our analysis, microcarriers are utilized in various research institutes to help manage patient health. Innovation, discovery, and development in the microcarriers segment, which are helping in making patient management more efficient, are creating a demand for microcarriers.

By Application, Cell and Gene Therapy Show Fastest Growth over the Forecast Period:

Microcarriers are helping in cost-effective cell and gene therapy, i.e., they reduce fixed and variable costs during large-scale manufacturing. The current scenario has changed with technological advancements, and the significance of microcarriers in cell therapy has increased. Along with the statements mentioned above, another factor liable for the expansion of cell therapy applications of microcarriers is that companies are presently focusing on the requirement of microcarriers that donate to large-scale and cost-effective production.

North America is Envisioned to Dominate the Market Over the Forecast Period:

As per our analysis, the North American region is believed to have the largest share in the microcarrier market. The rising gene and cell therapy analysis in the area and the associations sponsoring this research are the major factors supporting its growth. For instance, the American Society of Gene and Cell Therapy are liable for funding the research; this society is compelling the biopharmaceutical and biotech companies to improve their R&D. Besides, the United States is also glimpsing high and rapid augmentation in the biologics and biosimilar Industry. It is one of the influential factors propelling the microcarrier market in the North American region.

Competitive Landscape:

The Microcarrier market is primarily inclusive of the global players, and few companies that are currently dominating the market. The companies working in the sector are Thermo Fisher Scientific, Merck KGaA, Eppendorf AG, Danaher Corporation, Sartorius AG, Lonza Group, Getinge AB Series B, GE Healthcare, Corning Inc and Becton, Dickinson, and Company.

The competition in the market is anticipated to increase as new companies are also coming up in the market. These companies prioritize diverse stages of organic development, such as brand releases, patents, product approvals, and research and development activities. Acquisitions, alliances, and agreements are all considered inorganic growth strategies in this sector.

Key Topics Covered:

1. Introduction

2. Research & Methodology

3. Executive Summary

4. Market Dynamics4.1 Growth Drivers4.2 Challenges4.3 Opportunities

5. Global Microcarriers Market

6. Market Share - Global Microcarriers Analysis6.1 By Product Type6.2 By Application6.3 By End Use6.4 By Region

7. Product - Global Microcarriers Market7.1 Equipment7.2 Consumables

8. Application - Global Microcarriers Market8.1 Biopharmaceutical Production8.2 Cell and Gene Therapy8.3 Tissue Engineering and Regenerative Medicine8.4 Other Applications

9. End Use - Global Microcarriers Market9.1 Pharmaceutical & Biotechnology Companies9.2 Contract Research Organizations & Contract Manufacturing Organizations9.3 Academic and Research Institutes

10. Region - Global Microcarriers Market10.1 North America10.2 Europe10.3 Asia-Pacific10.4 Rest of World

11. Merger and Acquisitions

12. Value Chain Analysis

13. Porters Five Forces

14. Key Players14.1 Thermo Fisher Scientific14.1.1 Overview14.1.2 Recent Development14.1.3 Revenue14.2 Merck KGaA14.2.1 Overview14.2.2 Recent Development14.2.3 Revenue14.3 Eppendorf AG14.3.1 Overview14.3.2 Recent Development14.3.3 Revenue14.4 Danaher Corporation14.4.1 Overview14.4.2 Recent Development14.4.3 Revenue14.5 Sartorius AG14.5.1 Overview14.5.2 Recent Development14.5.3 Revenue14.6 Lonza Group14.6.1 Overview14.6.2 Recent Development14.6.3 Revenue14.7 Getinge AB Series B14.7.1 Overview14.7.2 Recent Development14.7.3 Revenue14.8 GE Healthcare14.8.1 Overview14.8.2 Recent Development14.8.3 Revenue14.9 Corning Inc14.9.1 Overview14.9.2 Recent Development14.9.3 Revenue14.10 Becton, Dickinson and Company14.10.1 Overview14.10.2 Recent Development14.10.3 Revenue

For more information about this report visit https://www.researchandmarkets.com/r/g5q6nl

Attachment

Follow this link:
$2+ Billion Worldwide Microcarrier Industry to 2027 - Rising Demand for Monoclonal Antibodies for Targeted Treatment of Cancer is Expected to Create...