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Viewpoint: Will King Charles abandon his kooky ideas about agriculture and help accelerate Britain’s embrace of sustainable biotechnology tools? -…

Posted: October 4, 2022 at 1:58 am

England is in crisis. They lost a beloved figurehead this month but for decades prior were losing scientific ground. If you look for the home of the modern organic food and anti-vaccine movements, you find their nexus in 1990s England.

The primary royal behind those beliefs is now King Charles III.

In order to manage the $28 billion he inherits (tax-free, paying taxes only applies to peasants in England)(1) he will have to give his $1.5 billion estate to his son, the new Prince of Wales, William (also tax free) but the Prince is not only taking over during a time when Brits are wondering why they still care about a throne that hasnt been relevant in hundreds of years, he is taking over at a time when being anti-science is no longer fashionable for progressive elites.

Though it was recently the darling of the intelligentsia, and Prince Charles longed to belong in that circle, anti-vaccine sentiments have become proletariat since COVID-19. The war on science when it comes to food harms a lot more people worldwide each year than the pandemic did. Hundreds of thousands of kids could stop going blind each year with Golden Rice but elites like King Charles III give money to groups that block its implementation.

Prince William could start to gain back some credibility for the family by jettisoning the organic food fetish of his father. Organic food, like the anti-vaccine movement, is a relic of 1990s England. Dr. Andrew Wakefield set off the modern anti-vaccine craze the same way that English environmental activists set off the Frankenfood one. Now supplements, wellness, and organic are all giant businesses based on exploitation of famous names who wanted to impress their elite friends

The world should have passed the anti-vaccine and anti-food movement by but they persist in large part because of the new British monarch and his quasi-American royalty of American Democrats counterpart, Robert F. Kennedy, Jr.(2)

Its easy to embrace science, especially in light of their history making changes when it was needed. They changed their name to Windsor from Saxe-Coburg and Gotha during World War I to help commoners forget the British royal family is German during a time that Germany was shooting at English men in Europe. Given that public relations success, they can certainly change their tune when it comes to science.

Perhaps due to an infusion of new blood outside the shockingly limited pool drawn from during the 19th and 20th centuries, Prince William seems to be a more genetically gifted thinker than his father. He can show it by embracing the modern world, where food and medicine are embraced.(3)

He doesnt actually have to divest from the farm, that is just me getting attention in a title. It is enough if he acknowledges that having peasants toil for his carrots only using specially labeled toxic pesticides is a pastime for the rich, and not a way to feed the world.

(1) The same way California Governor Gavin Newsom doesnt want people who make over $2 million each year to pay higher taxes to subsidize the electric cars the Governor insists Uber drivers need to buy. High taxes are for the middle class and the poor, not the donors he will need in order to fail running for President in 2024.

(2) Nothing looks more hypocritical than people on the left in England and the US suddenly endorsing vaccines when just two years ago they opposed them. It instead reeks of politics, and politics need to be a no-no for the new generation of British royals, lest they be relegated to the name recognition of the Queen of the Netherlands, whoever that is.

(3) and not just engage in publicity stunts about energy costs that are squarely the blame of the government his father now seeks to lead.

Hank Campbell founded Science 2.0 in 2006, and writes for USA Today, Wall Street Journal, CNN, and more. His first book,Science Left Behind,was the #1 bestseller on Amazon for environmental policy books. Follow Hank on Twitter@HankCampbell

A version of this article was originally posted atScience 2.0and is reposted here with permission. Science 2.0 can be found on Twitter@science2_0

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Ainos Announces Positive Results from Additional Preclinical Study of Its Low-dose Oral Interferon Formulation Against New Variant Virus – Omicron -…

Posted: October 4, 2022 at 1:57 am

VELDONA formulation showed significant stabilization of physical condition and complete recovery from lung inflammation throughout the course of treatment period.

By upregulation of immunomodulatory, Ainos' VELDONA formulation demonstrates efficacy against new variant virus based on clinical symptoms and lung inflammation.

SAN DIEGO, CA / ACCESSWIRE / September 30, 2022 / Ainos, Inc. (NASDAQ:AIMD, AIMDW) ("Ainos", or the "Company"), a diversified medtech company focused on the development of novel point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced the results from its antiviral efficacy study in hamsters against the Omicron variant of SARS-CoV-2 (the "Study"). The Company's results showed that its low-dose oral interferon alpha ("IFN-") formulation, VELDONA, had a therapeutic effect on lungs infected with the SARS-CoV-2 (the "Omicron variant") virus by regulating the immune response, thereby expediting recovery of infected animals. The Company has submitted the application documents for U.S. FDA Phase 2 clinical trials for evaluating the efficacy of VELDONA in patients with mild COVID-19. Further information regarding the Study can be found on Ainos' website (link).

The Study evaluated the effectiveness of VELDONA over a sixteen-day course (five-day pre-treatment, one-day during viral infection and ten-day treatment after infection) of Omicron-variant-infected hamsters. Compared with hamsters in the placebo group receiving solution without VELDONA (the "Placebo Group"), the hamsters in the group receiving solution with VELDONA (the "VELDONA Group") demonstrated resistance to body weight loss immediately after infection, then showed a better recovery trend in the following three days. The body weights of the hamsters in the VELDONA Group remained more stable than those of the hamsters in the Placebo Group during the treatment period.

Mean Body Weight Throughout the Treatment Period

Percentage of Body Weight Change

For pathological indicators, on the tenth day, no hamsters in the VELDONA Group showed mixed-cellular inflammation, peribronchial infiltration, and perivascular infiltration, compared to 50% of hamsters in the Placebo Group. Hamsters in the VELDONA Group in general showed promising results in treating indicators of new variant virus infection.

Lung Pathology Report

Mixed cellular inflammation, peribronchial infiltration, and perivascular infiltration.

Chun-Hsien Tsai, Ainos' Chairman of the Board, President, and Chief Executive Officer, commented, "Ainos has conducted three preclinical animal studies since March 2022 in our efforts to validate the effectiveness of our low-dose oral interferon to protect against symptoms associated with COVID-19 (Delta and Omicron variants). The studies have yielded consistent results, demonstrating VELDONA's efficacy in inducing systemic immunomodulatory to fight against SARS-COV-2. The results of the two-week study also showed that VELDONA is well-tolerated and safe in hamsters. In addition, this new study exhibited a preventative and therapeutic effect against new variant virus. Ainos believe that these results, in combination with the results of our previous two Phase 2 studies of VELDONA on prevention and treatment of influenza, demonstrate that VELDONA may become an important solution for the treatment of COVID-19 and other viral infections in the future. Furthermore, we would like to thank the Emerging Infectious Disease Core Facility Platform of the National Defense Medical Center in Taiwan for the support and professional technical services they provided for the Study."

About Ainos, Inc.

Headquartered in San Diego, California, Ainos, Inc. (f/k/a Amarillo Biosciences, Inc.) is a diversified medtech company engaged in developing innovative medical technologies for point-of-care testing and safe and novel medical treatment for a broad range of disease indications. In addition to its proprietary therapeutics using low-dose non-injectable interferon, Ainos is committed to developing a comprehensive healthcare business portfolio encompassing medical devices and consumer healthcare products. While prioritizing the commercialization of medical devices as part of its diversification strategy, Ainos has also expanded its product portfolio to include Volatile Organic Compounds (VOC) and COVID-19 POCTs. Leveraging its patents related to VOC technologies and COVID-19 POCT products, the Company seeks to expedite the commercialization of its medical device pipeline, beginning with Ainos-branded COVID-19 POCT product candidates.

Forward-Looking Statements

This press release contains "forward-looking statements" about Ainos within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict," "project," "target," "future," "likely," "strategy," "foresee," "may," "guidance," "potential," "outlook," "forecast," "should," "will" or other similar words or phrases. Similarly, statements that describe the Company's objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company's current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. The Company's actual results may differ materially from those indicated in the forward-looking statements.

Important factors that could cause the Company's actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release include, among others, the cost of production and sales potential of the planned drug treatments announced in this press release; the Company's dependence on revenues from the sale of COVID-19 test kits; the Company's limited cash and history of losses; the Company's ability to achieve profitability; the Company's ability to raise additional capital to continue the Company's product development; the ability to accurately predict the future operating results of the Company; the ability to advance Ainos' current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates the Company develops; the ability to obtain and maintain regulatory approval of Ainos product candidates; delays in completing the development and commercialization of the Company's current and future product candidates, which could result in increased costs to the Company, delay or limit the ability to generate revenue and adversely affect the business, financial condition, results of operations and prospects of the Company; intense competition and rapidly advancing technology in the Company's industry that may outpace its technology; customer demand for the products and services the Company develops; the impact of competitive or alternative products, technologies and pricing; disruption in research and development facilities; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; potential cybersecurity attacks; increased requirements and costs related to cybersecurity; the Company's ability to realize the benefits of third party licensing agreements; the Company's ability to obtain and maintain intellectual property protection for Ainos product candidates; compliance with applicable laws, regulations and tariffs; and the Company's success in managing the growth. A more complete description of these risk factors and others is included in the "Risk Factors" section of Ainos' most recent Annual Report on Form 10-K/A and other reports filed with the U.S. Securities and Exchange Commission, many of which risks are beyond the Company's control. In addition to the risks described above and in the Company's Form 10-K/A, other unknown or unpredictable factors also could cause actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release.

The forward-looking statements made in this press release are expressly qualified in their entirety by the foregoing cautionary statements. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law.

Investor Relations Contact

ICR, LLCRobin YangTel: +1 646-224-6971Email: Ainos.IR@icrinc.com

SOURCE: Ainos, Inc.

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North Korea tells officials that 350,000 people died of diseases this year – Radio Free Asia

Posted: October 4, 2022 at 1:57 am

North Korean officials have been told that more than 350,000 people in the country died of illnesses over the past year, many likely related to COVID-19, sources told RFA, as authorities began a new vaccination campaign on the countrys border with China more than a month after declaring victory over the coronavirus.

Attendees of a training session for government officials were surprised by the number of suspected deaths from COVID, and also from diseases like the flu, tuberculosis and from waterborne pathogens, a government official from South Pyongan province, north of the capital Pyongyang, told RFAs Korean Service.

At the meeting, the issue of continuing the quarantine measures to prevent the spread of an infectious disease was repeatedly emphasized because deaths from COVID-19 are suspected to account for the majority of the 350,000 deaths, the source said, speaking on condition of anonymity for security reasons.

I can tell from my surrounding area that many people have died from sickness this year, he said. A friend of mine on the provincial People's Committee died a few days after suffering from a high fever and sore throat. Another friend's parents also died, and this friend assumes that his parents died of COVID-19.

RFA was not able to confirm the death total, but if it is accurate, the number of COVID-related deaths is far higher than the government has publicly stated. For the first two years of the pandemic, Pyongyang claimed to be completely virus free.

North Korea finally acknowledged the virus was spreading within its borders in May, when it declared a national maximum emergency due to a major outbreak of the disease that it traced back to a military parade the previous month.

North Korea reported during the emergency that 4.7 million people had developed so-called fever cases, with state media reporting 74 related deaths. The government declared an end to the emergency on Aug. 10.

These figures were never officially confirmed to be COVID-19 related, likely because of a lack of testing capabilities.

The actual death toll is probably between 100,000 and 170,000, according to a journal article penned by Shin Young-jeon, a South Korean preventative medicine expert at Hanyang University in Seoul.

Prior to the emergency, anyone who died of symptoms suspected to be related to COVID-19 were hastily cremated and buried, making a confirmation of the disease impossible, sources said.

Even as more information emerges about the number of North Koreans who died in the past year, authorities are still threatening to punish citizens who spread rumors about COVIDs impact, an official from Onsong county in the northeastern province of North Hamgyong told RFA on condition of anonymity to speak freely.

Last week the Central Committee [of the Korean Workers Party] delivered an emergency order to take measures to prevent the spread of words that disturb the public mind, said the second source. There have been stories circulating among residents that more than 350,000 people have died of sickness this year.

The State Security Department and the Social Security Department, as well as party and labor organizations, have stepped up their propaganda efforts and started cracking down on residents for believing or spreading false rumors, he said. But the citizens find it more believable that it is not a rumor and that the government actually did announce a high death toll during official meetings.

The second source said that publicly authorities still stick to the official line that only around 70 people died during the national emergency.

Many of the residents are devastated by the fact that hundreds of thousands of people may have actually died from COVID-19, he said.

Vaccine campaign

Although the COVID emergency has been officially over for more than a month, the country began to inoculate people in Ryanggang province last week, marking the first time that COVID vaccines have been made available to people living along the border with China, sources there told RFA.

In May, RFA reported that authorities had made a propaganda event out of vaccinating soldiers who were involved in a major national construction project in the capital Pyongyang, calling the Chinese-made vaccine an immortal potion of love, from leader Kim Jong Un.

Authorities later began vaccinating citizens of North Koreas capital, Pyongyang, in July, but now residents of the border city of Hyesan can also get the vaccine, a Ryanggang resident told RFA.

Authorities have already declared that the coronavirus has ended, so the people dont know why they are vaccinating us now, the third source said.

The vaccine is distributed through neighborhood watch units and schools, another resident of the province told RFA.

Residents, who were terrified of dying from colds or pneumonia, feel fortunate that they can get vaccinated even if it's this late in the game, the fourth source said. When I asked the medical staff, they said the vaccine was made in China.

In July, Pyongyang citizens were vaccinated. This must have been a measure to prevent the spread of the coronavirus in advance of major national events such as the National Conference of War Veterans, held on the Day of Victory in the Great Fatherland Liberation War on July 27, the fourth source said, using the North Korean term to describe the anniversary of the armistice agreement that ended hostilities in the 1950-53 Korean War, in what most historians consider to be a stalemate.

South Koreas National Intelligence Service on Tuesday reported to the National Assembly that North Korea started a large-scale vaccination campaign in the border area.

Translated by Claire Shinyoung Oh Lee and Leejin J. Chung.

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Sierra Space, UC San Diego Partner to Develop the First Stem Cell Research Institute in Space – Business Wire

Posted: October 4, 2022 at 1:54 am

LOUISVILLE, Colo.--(BUSINESS WIRE)--Sierra Space, a leading commercial space company at the forefront of building the future of space transportation and infrastructure for low-Earth orbit (LEO) commercialization, and University of California San Diego, one of the worlds top 15 research universities and a leader in microgravity research, have formed a new agreement with the goal of defining the future of human health care research in space.

In a new Memorandum of Understanding (MOU) between the two organizations, Sierra Space and UC San Diego agreed to collaborate on Orbital Reef, the first commercial space station in LEO, to expand the universitys Integrated Space Stem Cell Orbital Research (ISSCOR) program, which is currently operational on the International Space Station (ISS). Together they will help define and shape the future of biotech and biopharma research and development in microgravity.

This agreement with UC San Diego is a major breakthrough in human health care research conducted in space and signals the beginning of a new era of discovery, said Tom Vice, Sierra Space CEO. Through our collaboration, the highly impactful work that researchers are already doing on the International Space Station today can expand and deliver even greater impact for humanity. As the ISS completes its time in service, UC San Diego will now have a place to grow and expand its vital research in biotech and biopharma with full, on-orbit biomanufacturing and biofabrication centers to foster breakthrough advancements and products in medical science that will benefit all life on Earth.

Microgravity and radiation exposure in low-Earth orbit offers a unique opportunity to study stem cell aging and pre-cancer development in a compressed time frame in a manner that is unavailable on Earth, said Catriona Jamieson, MD, PhD, a stem cell biologist, hematologist and director of the new UC San Diego Sanford Stem Cell Institute, funded with a $150 million gift from philanthropist T. Denny Sanford.

In collaboration with NASA, our Integrated Space Stem Cell Orbital Research team has launched six missions carrying stem cells and stem cell-derived organoids into LEO. We are learning things that we never could under normal gravity; knowledge that can elevate the search for new pre-cancer diagnostics and therapeutics that eradicate cancer at its earliest stages into addition to a broad array of degenerative diseases that arise as a result of stem cell dysfunction.

UC San Diego will provide input to Sierra Space on the design and concept of operations for providing new, state-of-the-art biomanufacturing, biofabrication and related in-space laboratory capabilities and services to industry, academia and government researchers. The university will also participate in a Sierra Space-led in-space biomanufacturing research consortium of industry, academia, philanthropic and government researchers that will focus on R&D objectives, priorities and technical requirements.

Sierra Space will lead the development, launch and deployment of space habitats to establish the necessary infrastructure for UC San Diego and other partners to conduct microgravity research and in-space manufacturing. The companys Dream Chaser spacecraft, the worlds only winged commercial spaceplane, will provide transportation to LEO, while its Large Integrated Flexible Environment (LIFE) modules will offer ample habitable spaces in which to live and work on orbit.

Sierra Space recently made two key appointments to lead development of research capabilities for future LEO commercialization. Dr. Jonathan Volk, Senior Manager of In-Space Manufacturing and Advanced Materials joined the company from Space Commerce Matters where he was the Director of Commercialization Strategies. Prior to this role, Volk was the Commercial Innovation Manager for Physical and Materials Science at the Center for the Advancement of Science in Space (CASIS), which managed the U.S. National Laboratory on the ISS. Dr. Marc Giulianotti takes on the role of Senior Manager, In-Space Biomanufacturing, joining Sierra Space from his role as Director of Science and Technology with the ISS U.S. National Laboratory. Dr. Giulianotti also has more than 20 years working in early drug discovery efforts at the Torrey Pines Institute for Molecular Studies. Both Volk and Giulianotti will focus on advancing the transformative research and technologies in the commercial space destinations of the future.

About Sierra Space

Sierra Space (www.sierraspace.com) is a leading commercial space company at the forefront of innovation and the commercialization of space. Sierra Space is building platforms in space to benefit life on Earth. The company is in the latter stages of doubling its headcount, with large presences in Colorado, Florida and Wisconsin. Significant investors in Sierra Space include General Atlantic, Coatue, and Moore Strategic Ventures.

With more than 30 years and 500 missions of space flight heritage, Sierra Space is enabling the future of space transportation with Dream Chaser, the worlds only winged commercial spaceplane. Under construction at its Colorado headquarters and expected to launch in 2023 on the first of a series of NASA missions to the International Space Station, Dream Chaser can safely carry cargo - and eventually crew - to on-orbit destinations, returning to land on compatible commercial airport runways worldwide. Sierra Space is also building an array of in-space destinations for low-Earth orbit (LEO) commercialization including the LIFE (Large Integrated Flexible Environment) habitat at the Kennedy Space Center in Florida, a three-story commercial habitation and science platform designed for LEO. Both Dream Chaser and LIFE are central components to Orbital Reef, a mixed-use business park in LEO being developed by principal partners Sierra Space and Blue Origin, which is expected to be operational by 2027.

About UC San Diegos Sanford Stem Cell Clinical Center

Sanford Stem Cell Clinical Center (Sanford Center) is among the Universitys most highly visible and top priority interdisciplinary and multi-institutional programs. Sanford Center provides essential physical and human resources needed to leverage stem cell research currently being conducted at UC San Diego. Due to the complexity of regenerative medicine projects and substantial institutional investment, on a daily basis Sanford Center personnel works with a large variety of departments in Health Sciences, Health System, and the school of engineering.

As part of UC San Diego Health, Sanford Center motivates University-wide change and sustainability, focusing on creating the structure under which various innovative regenerative medicine units and initiatives are developed. Sanford Center has led several successful and highly visible interdisciplinary faculty recruitments, committing to over $48M towards faculty start-up, retention, and research funds for over 25 faculty members. Sanford Center also played a pivotal role in securing over $77M of grants from California Institute of Regenerative Medicine (CIRM), awarded respectively to dept. of Bioengineering, Pediatrics, Cellular & Molecular Medicine, Medicine, Neurosciences, and Sanford Center.

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Second-Line BCL Treatment Landscape Shifts From ASCT to CAR T-Cell Therapy – Targeted Oncology

Posted: October 4, 2022 at 1:54 am

Hematologic malignancies have been impacted heavily by the introduction of chimeric antigen receptor (CAR) T-cell therapy, which has demonstrated long remission in major clinical trials and received approvals by the FDA. CAR T-cell therapy provides a new option for patients with relapsed/refractory B-cell lymphoma (BCL).

The current treatment landscape for patients with relapsed/refractory [BCL] looks extremely promising, thanks to the positive results from clinical trials and thus the subsequent FDA approvals of these therapeutics, Manali Kamdar, MD, associate professor of medicine-hematology and clinical director of lymphoma services at the University of Colorado Medicine in Aurora, said in an interview with the SOHO Daily News beforethe 10th Annual Meeting of the Society of Hematologic Oncology (SOHO 2022).

Kamdars presentation on September 30, 2022, at 1:40 pm during the conference concerns the question of when to use CAR T-cell therapy vs autologous stem cell transplant (ASCT) in patients with relapsed/refractory aggressive BCL. She says the 3 phase 3 studies of CAR T-cell products that were presented at the 2021 American Society of Hematology Annual Meeting and Exposition (ASH 2021) have made a major difference in answering this question for high-risk patients.

Patients with diffuse large BCL who relapse within 12 months of frontline chemoimmunotherapy with R-CHOP (rituximab [Rituxan], cyclophosphamide, doxorubicin, vincristine [Oncovin], prednisone) are considered primary refractory, and these patients have very poor outcomes. In the past, they would receive salvage chemotherapy followed by an ASCT. Kamdar says only a quarter of these high-risk patients would achieve long-term remission following ASCT.

This led to an urgent need for CAR T-cell therapy in the second line for these patients. CAR T cells had shown efficacy for R/R BCL, leading to the approval of these therapies in patients with at least 2 prior lines of treatment, the first being axicabtagene ciloleucel (axi-cel; Yescarta) in 2017.1,2

The results of 3 pivotal phase 3 trials of CAR T-cell products were first presented at ASH 2021, comparing them with salvage chemotherapy and ASCT in patients with aggressive non-Hodgkin BCL who relapsed within 12 months of frontline chemoimmunotherapy. The ZUMA-7 trial (NCT03391466) that evaluated axi-cel and the TRANSFORM trial (NCT03575351) that evaluated lisocabtagene maraleucel (liso-cel; Breyanzi) showed significantly higher event-free survival (EFS) rates in patients who received CAR T-cell therapy vs ASCT, but the BELINDA trial (NCT03570892) that evaluated tisagenlecleucel (tisa-cel; Kymriah) failed to show improved EFS over standard-of-care second-line therapy.3-5 Kamdar plans to discuss the possible reasons for the different outcomes of these trials in greater detail in her presentation.

With axi-cel and liso-cel receiving FDA approvals as second-line therapy, CAR T-cell therapy stands to replace ASCT in this stage of sequencing.6,7 Within this high-risk R/R large BCL subset, I will have to say I no longer recommend an ASCT based on these 2 positive studies, and that we take patients to CAR T-cell therapy, Kamdar said.

Kamdars presentation will focus on the outcomes demonstrated by these trials, including the statistically significant EFS, progression-free survival, and complete response rate of CAR T-cell therapy. Additionally, she will discuss the manageable levels of toxicity seen in the 2 positive trials, with no grade 4 or 5 cytokine release syndrome or neurotoxicity being reported. Longer follow-up is needed to observe overall survival outcomes and other long-term impacts of these therapies.

Despite these results, CAR T-cell therapy is not an option for those who are chemotherapy-sensitive who relapsed more than 12 months after frontline therapy. Currently, ASCT remains the standard of care, Kamdar said. But itd be nice to see [whether] there is something else that can actually be better.

Additionally, the role of CAR T-cell therapy is being investigated in patients who are transplant-ineligible in the phase 2 TRANSCEND-PILOT 017006 study (NCT03483103) that evaluates liso-cel. Durable responses to liso-cel were reported in the primary analysis presented at the 2022 American Society of Clinical Oncology Annual Meeting.8

For patients with high-risk R/R BCL, Kamdar says its crucial to start referring patients for CAR T-cell therapy as soon as they are determined to be primary refractory. CAR T-cell therapy is certainly a process that takes time, because manufacturing of the cells requires a minimum of 17 to 34 days based on the construct you choose, she said. Additionally, insurance approvals and logistical concerns can cause further delays to starting therapy. CAR T-cell production time and accessibility may be improved by new approaches that are being investigated, including allogeneic CAR T cells that do not require patients to undergo leukapheresis.

One rising area of need is therapies for patients who fail CAR T-cell therapy, who may have limited treatment options if they are CD19 negative. Kamdar anticipates that novel therapies, including bispecific antibodies, bispecific T-cell engagers, and natural killer T cells, could fill this unmet need in patients with R/R BCL. [Approximately] 20% of patients [in recent trials of bispecific agents] may have actually received prior CAR T-[cell therapy], and they are showing a response in patients who have failed prior CAR T-cell therapy, she said.

She suggests novel time-limited bispecific therapies will not only benefit those who relapsed or who cannot receive CAR T-cell therapy, but they are also valuable for physicians who want to treat patients while waiting to start CAR T-cell therapy.

Kamdar is looking forward to discussing the shift from ASCT to CAR T-cell therapy in second-line therapy in greater detail at SOHO 2022. Im very excited to see all my colleagues after so long, Kamdar said. Im thrilled to be able to connect in person with everyone. Its been too long.

REFERENCES:

1. Schuster SJ, Svoboda J, Chong EA, et al. Chimeric antigen receptor T cells in refractory B-cell lymphomas.N Engl J Med. 2017;377(26):2545-2554. doi:10.1056/NEJMoa1708566

2. FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma. News release. FDA; October 18, 2017. Updated March 21, 2018. Accessed August 25, 2022. https://bit.ly/3ANA0k5

3. Locke FL, Miklos DB, Jacobson CA, et al. Axicabtagene ciloleucel as second-line therapy for large B-cell lymphoma.N Engl J Med. 2022;386(7):640-654. doi:10.1056/NEJMoa2116133

4. Kamdar M, Solomon SR, Arnason J, et al. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial. Lancet. 2022;399(10343):2294-2308. Published correction appears in Lancet. 2022;400(10347):160.

5. Bishop MR, Dickinson M, Purtill D, et al. Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma.N Engl J Med. 2022;386(7):629-639. doi:10.1056/NEJMoa2116596

6. FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma. FDA. April 1, 2022. Accessed August 25, 2022. https://bit.ly/3ANmZab

7. FDA approves lisocabtagene maraleucel for second-line treatment of large B-cell lymphoma. FDA. June 24, 2022. Accessed August 25, 2022. https://bit.ly/3Q52NVT

8. Seghal A, Hoda D, Riedell PA, et al. Lisocabtagene maraleucel (liso-cel) as second-line (2L) therapy for R/R large B-cell lymphoma (LBCL) in patients (pt) not intended for hematopoietic stem cell transplantation (HSCT): primary analysis from the phase 2 PILOT study. J Clin Oncol. 2022;40(suppl 16):7062. doi:10.1200/JCO.2022.40.16_suppl.7062

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Robocop at 35: why the satirical action movie still holds up today – Digital Trends

Posted: October 4, 2022 at 1:47 am

Robocop begins with a lovely establishing shot of futuristic Old Detroit at twilight. The camera soars across a body of water (presumably the Detroit River) and pushes in towards the city. The buildings are clean-lined and elegant. The sky is a deep cerulean. This place seems pretty nice, we think.

Ah, but its an ironic joke one of many at the expense of the citys people who yearn for a livable urban environment amongst the industrial ruin because nothing else in the movie will be beautiful, at least not in conventional terms. Any beauty is seen through the eyes of rapacious men who can only appreciate the lethal curves and angles of militarized steel, the vertiginous skyscrapers of wealth and privilege, and the shimmering aura of money in all its forms. When a crime boss chews out a subordinate for accidentally scorching the cash from a robbery, he seems almost as aghast at the desecration of the pristine greenbacks as the fact that the gang wont be able to spend them.

Robocop is a movie about these evil men, the venal institutions over which they preside, and the flickers of human decency that keep them from enveloping what good is left of the human spirit. Among the many reasons why the movie remains so popular after 35 years (rousing sci-fi action, scathing wit, seamless world-building, first-rate filmmaking) is this insistence that the good among us can still rise from the (sometimes radioactive) muck that threatens to overwhelm us.

A lot of bad movies were made in the 1980s, and many of them were in traditionally disreputable genres like science fiction and horror. This was partially due to the massive popularity of the new home video market that was desperate for products to fill the shelves. Any old straight-to-video geek show would do as long as it contained some splatter gore and a little T&A and maybe had a sense of humor about itself.

Robocop has plenty of all of that, but the acclaimed Dutch director Paul Verhoeven who was making only his second film in America after Flesh + Blood signals that he is a serious filmmaker by employing bravura filmmaking early on. Even as the angry Black police sergeant yells scumbag repeatedly (could anything be more 80s?), Verhoeven establishes the station and the new recruit, Alex Murphy (Peter Weller), with some complexly choreographed long takes and a moving camera. Its as though he wants to put the viewer on notice that, while Robocop may go on the video store shelf next to The Toxic Avenger, it will hardly be some tossed-off exploitation quickie.

A gnarly toxic avenger of sorts does appear late in the movie thanks to that ubiquitous 80s movie feature, a vat of acid, but the looming threat in that early scene is that the police officers might strike, thus leaving the populace unprotected. But like the lovely opening shot, its another bit of misdirection by Verhoeven. While labor unions were a public enemy for many in the conservative 80s, Robocop is radically, subversively leftist and firmly on the side of besieged workers. The institutions facilitating run-amok capitalism whether political, corporate, or military-industrial are the real threats to public safety and well-being in the movie.

Verhoeven and writers Edward Neumeier and Michael Miner waste no time in identifying the bad guys in the first of the movies famous satirical future news reports. The talking heads (Entertainment Tonights fizzy reporter Leeza Gibbons was an inspired casting choice) cheerfully recount the legacy of European colonialism in Africa, now in the threatening form of a French neutron bomb, along with the bumbling inadequacy of the US president, who floats around helplessly during his visit to the Star Wars Orbiting Peace Platform. The point is quickly made: Modern Western leadership is mired in the past, potentially deadly, and ineffectual. As the movie will soon dramatize, governments could never hope to match the ruthless efficiency and undiluted purpose of global corporations.

Sure enough, the first speech by the corporate Big Bad, Dick Jones (Ronny Cox), is about how the privatization of public endeavors such as hospitals, space exploration, and the military have enriched Omni Consumer Products (OCP). Their next goal is to privatize policing, a ripe target given its low level of public trust (thanks mostly to poor funding). Jones solution is to roll out robots/tanks designated ED-209s to keep the peace. But Verhoeven savagely lampoons the idea of a machine doing the delicate human work of policing in the now infamous sequence in which the ED-209 prototype shreds a junior executive into bloody hamburger without ever understanding what its doing (the machine keeps on pumping the corpse full of lead long after the man is beyond dead).

The fact that the robot (who is programmed for urban pacification) is rendered in quaint stop-motion animation is a sly joke about how out of touch it is. In another subtle jab, the name of the scientist who heads the program is Dr. McNamara, as in Robert McNamara, one of the architects of the Vietnam War and the warmongering scourge of Errol Morris Oscar-Winning documentary, The Fog of War. That the bloody corpse ends up flattened on top of the diorama of Delta City, OCPs gentrification model for Detroit, is less subtle, but the point is that none of the cold-hearted executives are in a position where they need to even pretend to care. Delta City could be an ocean of carnage and they would only see the next profit opportunity from their executive boardroom in the sky.

In a parallel jab, the criminals on the ground are equally aspirational, making small talk about capital investment and free enterprise between robberies and murders. These ground-level criminals are led by the psychopathic Clarence Boddicker, played with sneering bemusement by Kurtwood Smith. Ive written about this before, but it bears repeating: Smith and Cox play two of the all-time great movie bad guys here. Miguel Ferrer as an aggressively ambitious young executive also does slimily stellar work. The fact that theyre all here together is another reason why Robocop is considered a highlight of the genre.

Speaking of genre, the movie has also become considered a classic because it artfully fuses many classic sci-fi preoccupations: dystopian futurism, transhumanism, artificial intelligence, robotics, and the nature of human identity. These all coalesce around the character of Murphy, the neophyte officer who Boddickers gang violently dispatches, leaving just enough warm meat (and handsome chin) to refashion into the titanium-encased super cop.

But something stirs in the consciousness or soul or whatever metaphysical designation you want to give it, and that something is the essence of Murphy, who will struggle to understand and assert selfhood throughout the film. The cast and filmmakers do great work imbuing Murphy/Robocop with affecting pathos, especially since we dont really get to know him before his transformation and only see his family in flashback snippets. When his former partner, Officer Lewis (Nancy Allen), tells him that his family moved on after what they assumed was his death, we genuinely feel for the crestfallen tin can.

Of course, this is after we are already on his side, having witnessed his acts of reckless superheroism protecting the community. Another of the movies jokes is that Robocop is effective, but not very efficient. He tends to cause a great deal of collateral damage whenever he foils a crime or saves a victim (hes really no better than ED-209 in this regard). Nobody seems to care though, either because the city is already such a shambles that it doesnt matter or because people are so happy to see something working on their behalf that the destruction is worth it.

In terms of genre, Robocop is also one of the rare sci-fi films that predicted a real-world future that more or less came to pass. Like Blade Runner (starring Verhoevens frequent collaborator, Rutger Hauer) it features big cities that are simultaneously crumbling and gentrifying, a rising gap between rich and poor, an evisceration of social services, global corporations that control all the wealth and have monopolies on the best technology and research and development, and all of it teeters on the edge of environmental catastrophe.

Unlike Blade Runner, with its perpetual rainy night and empty streets, the urban environment depicted in Robocop still looks like the decaying industrialism in some big cities today. If you wandered around parts of the real Detroit, Im guessing you couldnt tell much of a difference.

Despite rooting around in dystopian sludge (at times literally), Robocop is not a nihilistic movie or even a cynical one. Though its primary form is scathing satire, it is profoundly humanist. Verhoeven was a child in the Netherlands during World War II and he witnessed the carnage and the chaos firsthand. While it probably seemed like the forces of darkness were extinguishing the light of civilization, that light survived amidst profound acts of courage and heroism. The movie dramatizes a similarly optimistic scenario with conviction.

Verhoeven has also said that, from a boys point of view, the war felt like a spectacle or adventure, which may account for both the fun and the briskness of the film (and some of his other films as well, such as Total Recall and the World War II action-drama Black Book). A good satire has to move, lest it gets bogged down in either depressiveness or preaching (one of the great satirists in the English language was named Jonathan Swift, after all). Verhoeven and the writersknow when to get in and out of the story, and indeed the movie sports one of the tidiest conclusions in all of cinema: the hero dispatches the villain and reclaims his human identity all in one stroke. Cut to black, cue the music.

Robocop is a Hollywood film made within the studio system by a foreign director during a blatantly commercial era of American moviemaking. It eviscerates capitalism and suggests that democracy is nothing more than a civics textbook fairy tale in a world run by authoritarian tycoons. This version of the world is pretty well accepted now that were all just a little bit wiser about the way things work (thanks Internet!).

But in 1987, when President Reagan, virtually nestled among amber waves of grain, was delivering speeches about American exceptionalism, such notions were little more than pinko hippie-speak. The fact that Verhoevens punk treatise was made at all in that environment is a miracle. That it has become one of the enduring indictments of its era while still being relevant to our contemporary moment and a helluva lot of fun makes it a special film indeed.

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Hurricane Ian Preparation Considerations for South Carolina Fruit and …

Posted: October 4, 2022 at 1:45 am

Hurricane Ian is approaching the Southeast and is expected to bring significant amounts of rain and heavy winds to South Carolina over the weekend. The latest forecasts show Ian traveling northeast towards the Atlantic, then northward through western South Carolina.

Clemson Extension agents advise specialty crop growers in The South Carolina Grower to be prepared to experience damaging winds, excessive rainfall and power outages. After the wind and rain have passed and it is safe to do so, take lots of photos of any damage experienced on your farm for insurance purposes.

Structural and Land Considerations

Be sure to anchor down or put anything away that may blow away in a stiff wind. Numerous high tunnels were damaged or took flight in Hurricane Matthew in 2016. If possible, it wouldnt be a bad idea to remove the plastic from the frame to protect its structural integrity in the wind. If that is not possible, cutting the plastic will work if the winds get strong enough to warrant it (but wait until the last minute to make this decision). Make sure ditches are clear around production areas so excess water will be able to drain unimpeded. If there is enough time, digging drainage furrows in areas prone to holding water may be helpful as well.

Disease Considerations

Winds and rain from Hurricane Ian may bring fungal spores or bacterial cells into fields in South Carolina. Before the rain starts on Thursday, cucumber, cantaloupe, pumpkin, and watermelon crops should be sprayed with a fungicide to protect them from downy mildew. Ranman is suggested. The extended periods of leaf wetness will promote the development of gummy stem blight and anthracnose. Systemic fungicides are needed now because they will move into the leaf and provide residual control after the residue on the leaf surface is washed off due to excessive rains. Quadris Top is one of the few fungicides that will protect against both gummy stem blight and anthracnose. Other systemic products include Inspire Super or Miravis Prime for gummy stem blight and Topsin M for anthracnose.

Black rot on brassica crops is typically seen after a hurricane because the wind-driven rain spreads the bacterium. Since black rot is already present in several areas, it is likely to be much worse after the hurricane. No chemicals are effective enough to provide useful protection before a hurricane. Growers should consider harvesting early if the crop is close enough to maturity.

Food Safety Considerations

Flood waters resulting from a natural disaster present a food safety risk to food crops. Flooding, as defined by the Food and Drug Administration (FDA), is the flowing or overflowing of a field with water outside a growers control. Pooled water resulting from rainfall or irrigation systems does not pose the same risks as flood water. Flood water can contain hazards from runoff or sewage. These hazards may be biological (bacteria, viruses, parasites) and/or chemical (petroleum, heavy metals, chemicals, etc.). If present, they may cause illness or injury to consumers.

Also, be aware that produce in cold storage can degrade rapidly if power is lost. If backup generators are available, make sure they are in good working order.

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Understanding the Epigenetics of Childhood Trauma – Psych Central

Posted: October 4, 2022 at 1:43 am

Childhood trauma affects your mind, body, and well-being. The study of epigenetics suggests it may also affect your genes.

Intergenerational and historical trauma centers around the idea that the trauma a person experiences can have ripple effects on the next generation.

Examples of trauma that could be intergenerational include ongoing sexual abuse, war, and systemic trauma like racism.

Trauma doesnt just impact the individual who endured it, but it impacts future generations as well, and is, in a sense, inherited, says Saba Harouni Lurie, LMFT and founder of Take Root Therapy in Los Angeles.

Research on exactly how and to what extent trauma affects your DNA is ongoing, but recent studies suggest theres a connection between trauma and genetics.

The genetic makeup that youre born with plays a role in whether you will develop certain mental or physical health conditions, but thats only one piece of the puzzle. The study of epigenetics shows us how your lived experiences and environment can actually change how your DNA and genetic traits are expressed in situations.

Experiencing trauma might alter your genetic makeup and those changes could be passed down to future generations. In this way, a child might inherit trauma responses from a parent, such as a tendency to react to threats with a fight, flight, freeze, or fawn response.

Epigenetics could also influence what someone is afraid of, what someone is sensitive to, and how their body functions and develops, says Lurie.

A 2018 study in mice suggests that epigenetic changes can continue to show effects for generations, supporting the idea of intergenerational trauma.

The researchers found that starving a group of mice caused them to engage in aggressive behavior toward their food. They gave the next generation ample food to eat but despite having plenty of food, the offspring of the starved mice also showed aggressiveness toward their food.

Epigeneticists also look at how the genes you inherit dont manifest. Things that run in your family might stay inactive or even be reversible, including trauma.

Methylation is a natural, biochemical process. When methyl groups are added to DNA, it can impact how those genes are expressed. Some researchers believe that experiencing trauma can affect your genes through methylation.

If trauma affects your genes, it can have effects on:

According to an older research paper from 2003, a lack of methyl groups or disruption of a methylation cycle can lead to immune system complications.

One 2018 Swedish study suggests a link between certain mental health conditions like post-traumatic stress disorder (PTSD) and autoimmune disorders.

An adverse childhood experience (ACE) score is a measure of childhood trauma a person has lived through, such as abuse or neglect from a caregiver or having a parent who has experienced incarceration.

According to the Centers for Disease Control and Prevention (CDC), experts have linked ACE scores to mental and physical health conditions. A higher score may increase the likelihood of developing:

Having a higher ACE score reflects the trauma youve experienced. It may mean youre more likely to have trouble:

If you have a higher ACE score, you might be more likely to experience health issues. Health issues can crop up because of a weakened stress response due to the lifelong effects of trauma exposure, says Lurie.

Sharnell Myles, PsyD, a certified clinical trauma professional and Vice President of Embark Behavioral Health, explains that Black people, particularly children, are subject to racial bias regarding their trauma responses.

Theres a common stereotype that Black people are excessively angry when really what theyre experiencing is strong emotions. But we know defensiveness can be a response to trauma, and expressiveness is part of Black culture, says Myles.

Myles adds that underlying factors can account for overblown reactions in people who have experienced trauma, especially in marginalized people.

Its also important to recognize that excessive anger stereotypically ascribed to Black people has been shown to be inaccurate, resulting from racial bias and power dynamics. So excessive anger may be perceived by other individuals, but not actually accurate.

One of the ways that these trauma-induced epigenetic modifications can occur is via stress response genes. By altering how the genes that respond to stressors function, an individual might develop lowered resilience to any additional trauma faced later in life, says Lurie.

Experts believe the link between epigenetics and trauma might serve as potential biomarkers for mental and physical health conditions.

This might help provide better support to folks whove experienced trauma. It could also help researchers find ways to potentially alter these genetic changes.

Know that while your parents trauma may have impacts on how you were parented and on how you experience the world, there are also ways to recover from trauma and adverse childhood experiences, says Lurie.

Whether youre navigating childhood trauma or trauma from being parented by someone with their own trauma, dealing with the effects can be challenging. But its possible to heal.

A 2019 clinical trial involving 39 English-speaking adults and a 6-week expressive writing program suggests creative expression, meditation, and mindfulness might help reduce depression symptoms and increase resilience in people with a history of trauma.

Creating supportive social environments can be challenging, especially if youve experienced trauma. But you might find it helpful to lean on others for support. Consider:

Connecting with a trauma specialist is also an option. There are various therapies for trauma.

You might also find it helpful to look for a therapist who regularly works with people from your specific cultural background or gender identity.

Psychotherapy can be very effective in treating mental health challenges, including those that may be caused or exacerbated by adverse childhood experiences. There is hope, and there is help, says Lurie.

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Epigenetic therapy promotes spinal cord regeneration in mice following injury – RegMedNet

Posted: October 4, 2022 at 1:43 am

Presently, there are no effective therapies for spinal cord damage. Physical therapy can help patients regain some movement, but the outcomes are heavily limited in severe cases due to the inability of spinal neurons to repair organically after injury.

However, in a study published in the journal PLOS Biology, Simone Di Giovanni and his research team at Imperial College London (United Kingdom) have looked to change this roadblock. The team displayed how weekly treatments that contain an epigenetic activator can help the regeneration of motor and sensory neurons in the spinal cord, when administered to mice 12 weeks after a serious injury.

Using a small molecule known asTTK21, theresearchers were able to trigger genetic programming that stimulates axon regeneration in neurons. TTK21 affects gene epigenetics via activating the CBP/p300 family of coactivator proteins.

TTK21 therapy was investigated in micemodels where the specimen had experiencedsevere spinal cord damage. The mice were raised in an enriching environment that allowed them to be physically active, as is recommended for human patients.

The treatment started 12 weeks after the severe spinal cord damage and lasted 10 weeks. Researchers discovered numerous improvements following TTK21 therapy when compared to the control treatment. Increased neuron sprouting in the spinal cord was the most noticeable effect. The researchers additionally found that motor axon retraction above the site of injury stopped and sensory axon development sharply increased. These changes were most likely caused by the observed increase in gene expression associated with regeneration. The next stage will be to further increase these effects to stimulate the regenerated axons to reconnect with the rest of the nervous system, so that the mice regain the capability to may move freely again.

Di Giovanni goes on to emphasize, This work shows that a drug called TTK21 that is administered systemically once/week after a chronic spinal cord injury in animals can promote neuronal regrowth and an increase in synapses that are needed for neuronal transmission. This is important because chronic spinal cord injury is a condition without a cure where neuronal regrowth and repair fail. We are now exploring the combination of this drug with strategies that bridge the spinal cord gap such as biomaterials as possible avenues to improve disability in spinal cord injury patients.

Press release:https://www.eurekalert.org/news-releases/964425

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ORYZON to Give Updates on Corporate Progress in October – Yahoo Finance

Posted: October 4, 2022 at 1:43 am

Oryzon Genomics, S.A.

MADRID, Spain and BOSTON, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that its management will give an update on corporate progress at several international events in October.

Oryzon will participate at the Chardan's 6th Annual Genetic Medicines Conference, which will be held on October 3-4 in New York (USA). The company will hold one-to-one meetings with pharmaceutical companies and global investors. Click on link for more info about the Chardan's 6th Annual Genetic Medicines Conference

Oryzon will participate at the MSD European Business Development Outreach, which will be held on October 5 in Zurich (Switzerland). The company will hold one-to-one meetings with pharmaceutical companies and global investors.

Oryzon will participate at the Iberian Digital Forum on October 6-7, where the company will hold one-to-one meetings with national investors.

Oryzon will participate at the AACR Special Conference: Cancer Epigenomics in Washington (USA) on October 6-8, where the company will present a poster communication entitled: ASCL1 and SOX2 expression levels predict sensitivity to LSD1 inhibition with iadademstat in small cell lung cancer on October 7 at 18:00 ET. Click on link for more info about the AACR Special Conference: Cancer Epigenomics

Oryzon has been invited to the European Brain Council (EBC)s annual European congress, Brain Innovation Days, which will be held on October 11-12 in Brussels (Belgium). The company will take part in a panel discussion entitled Innovative Funding Models, taking place on October 12 at 14:35 CEST. Click on link for more info about the Brain Innovation Days

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Oryzon has been invited to the HealthTech Innovation Days, which will be held on October 13-14 in Paris (France). The company will participate at a round table devoted to age-related diseases on October 13 at 11:00 CEST. Click on link for more info about the HealthTech Innovation Days

Oryzon will attend BIO-Europe 2022, which will be held in Leipzig (Germany) and virtually on October 24-26, where the company will provide a corporate update and will also hold one-to-one meetings with pharmaceutical companies and global investors. Click on link for more info about BIO-Europe 2022

Finally, Oryzon will participate at the 34th EORTC-NCI-AACR Symposium, which will be held on October 26-28 in Barcelona (Spain). The company will present two poster communications entitled Iadademstat effects on neuroendocrine, inflamed and mesenchymal gene expression patterns in small cell lung cancer subtypesand Iadademstat and gilteritinib synergistically abrogate viability of both treatment-nave and drug-resistant AML cellson October 27. Click on link for more info about the 34th EORTC-NCI-AACR Symposium

About OryzonFounded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European leader in epigenetics. Oryzon has one of the strongest portfolios in the field, with two LSD1 inhibitors, iadademstat and vafidemstat, in Phase II clinical trials, and other pipeline assets directed against other epigenetic targets. In addition, Oryzon has a strong platform for biomarker identification and target validation for a variety of malignant and neurological diseases. For more information, visit http://www.oryzon.com

About Iadademstat Iadademstat (ORY-1001) is a small oral molecule, which acts as a highly selective inhibitor of the epigenetic enzyme LSD1 and has a powerful differentiating effect in hematologic cancers (see Maes et al., Cancer Cell 2018 Mar 12; 33 (3): 495-511.e12.doi: 10.1016 / j.ccell.2018.02.002.). A FiM Phase I/IIa clinical trial with iadademstat in R/R AML patients demonstrated the safety and good tolerability of the drug and preliminary signs of antileukemic activity, including a CRi (see Salamero et al, J Clin Oncol, 2020, 38(36): 4260-4273. doi: 10.1200/JCO.19.03250). In an ongoing, fully-accrued Phase IIa trial in elder 1L-AML patients (ALICE trial), iadademstat has shown encouraging safety and efficacy data in combination with azacitidine (see Salamero et al., EHA 2022 poster). The company has obtained approval from the U.S. FDA for its IND for FRIDA, a Phase Ib trial of iadademstat plus gilteritinib in patients with relapsed/refractory AML with FLT3 mutations. Beyond hematological cancers, the inhibition of LSD1 has been proposed as a valid therapeutic approach in some solid tumors such as small cell lung cancer (SCLC), neuroendocrine tumors (NET), medulloblastoma and others. In a Phase IIa trial in combination with platinum/etoposide in second line ED-SCLC patients (CLEPSIDRA trial), preliminary activity and safety results have been reported (see Navarro et al., ESMO 2018 poster). New trials in combination in SCLC and NET are under preparation. Oryzon has recently entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI) to collaborate on potential further clinical development of iadademstat in different types of solid and hematological cancers. In total iadademstat has been dosed so far to more than 100 cancer patients in four clinical trials. Iadademstat has orphan drug designation for SCLC in the US and for AML in the US and EU.

About Vafidemstat Vafidemstat (ORY-2001) is an oral, CNS optimized LSD1 inhibitor. The molecule acts on several levels: it reduces cognitive impairment, including memory loss and neuroinflammation, and at the same time has neuroprotective effects. In animal studies vafidemstat not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimers disease (AD), to normal levels and also reduces social avoidance and enhances sociability in murine models. In addition, vafidemstat exhibits fast, strong and durable efficacy in several preclinical models of multiple sclerosis (MS). Oryzon has performed two Phase IIa clinical trials in aggressiveness in patients with different psychiatric disorders (REIMAGINE) and in aggressive/agitated patients with moderate or severe AD (REIMAGINE-AD), with positive clinical results reported in both. Additional finalized Phase IIa clinical trials with vafidemstat include the ETHERAL trial in patients with Mild to Moderate AD, where a significant reduction of the inflammatory biomarker YKL40 has been observed after 6 and 12 months of treatment, and the pilot, small scale SATEEN trial in Relapse-Remitting and Secondary Progressive MS, where antiinflammatory activity has also been observed. Vafidemstat has also been tested in a Phase II in severe Covid-19 patients (ESCAPE) assessing the capability of the drug to prevent ARDS, one of the most severe complications of the viral infection, where it showed significant anti-inflammatory effects in severe Covid-19 patients. Currently, vafidemstat is in two Phase IIb trials in borderline personality disorder (PORTICO) and in schizophrenia patients (EVOLUTION). The company is also deploying a CNS precision medicine approach with vafidemstat in genetically-defined patient subpopulations of certain CNS disorders and is preparing a clinical trial in Kabuki Syndrome patients. The company is also exploring the clinical development of vafidemstat in other neurodevelopmental syndromes.

FORWARD-LOOKING STATEMENTS This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words expects, anticipates, believes, intends, estimates and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisin Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forwardlooking statements, whether as a result of new information, future events or otherwise. This press release is not an offer of securities for sale in the United States or any other jurisdiction. Oryzons securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of Oryzons securities to be made in the United States will be made by means of a prospectus that may be obtained from Oryzon or the selling security holder, as applicable, that will contain detailed information about Oryzon and management, as well as financial statements.

IR, US

IR & Media, Europe

Spain

Oryzon

Ashley R. Robinson

Sandya von der Weid

Patricia Cobo

Saikat Nandi

LifeSci Advisors, LLC

LifeSci Advisors, LLC

/ Carlos C. Ungra

Chief Business Officer

+1 617 430 7577

+41 78 680 05 38

+34 91 564 07 25

+1 917 208 8293

arr@lifesciadvisors.com

svonderweid@lifesciadvisors.com

pcobo@atrevia.comcungria@atrevia.com

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