MEDICAL

Genelux and Newsoara Announce Collaboration and License Agreement for Oncolytic Immunotherapies

Genelux Corporation | September 29, 2021

Genelux Corporation, a clinical-stage immunotherapy company, and Newsoara BioPharma Co., Ltd., announced a collaboration and exclusive license for the development and commercialization of Olvi-Vec and other oncolytic viruses.

According to the terms of the agreement, Newsoara shall have exclusive rights in Greater China (mainland China, Hong Kong, Macau and Taiwan) to Olvi-Vec for which Genelux currently is planning a U.S. based Phase 3 registration trial in platinum resistant/refractory ovarian cancer. Newsoara also shall have exclusive rights in Greater China to Genelux's proprietary oncolytic virus platform, and the parties will collaborate on the development of novel oncolytic immunotherapeutics.

Newsoara, at its cost and expense, will be responsible for development and commercialization and will have the future right to manufacture licensed products in Greater China. The parties also will collaborate on a Phase 2 clinical trial for the intravenous delivery of Olvi-Vec in a new indication using clinical sites in China and the U.S. Newsoara will be responsible for all trial costs.

Under terms of the agreement, Genelux will receive up-front and near-term payments totaling $11 million and will be eligible to receive additional per-product payments of up to $160.5 million, contingent on certain development, regulatory and commercial milestones, plus tiered royalties on net sales ranging from mid-single-digit to mid-double-digit percentages. Genelux shall have an exclusive license outside of Greater China to oncolytic virus products derived by Newsoara and will pay Newsoara milestones and royalties on sales of any such products which Genelux elects to develop.

We are delighted to be working with Newsoara on developing Olvi-Vec, as well as on our broader collaboration. It is a dynamic organization with a commitment to advancing cutting-edge therapeutics, whose strength in research, development and manufacturing in China is a perfect complement to our focus on the discovery and clinical development of novel virotherapies. Together we look forward to accelerating the development of Olvi-Vec and to strengthening and broadening our pipeline of next-generation oncolytic viral immunotherapies.

- Thomas Zindrick, J.D., President and CEO of Genelux.

About Olvimulogene Nanivacirepvec (Olvi-Vec)
Olvi-Vec is a proprietary, non-pathogenic oncolytic vaccinia virus, modified to increase its safety, tumor selectivity and therapeutic potential. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer. Olvi-Vec has been administered to more than 150 patients in clinical studies. In these studies, Olvi-Vec was generally well tolerated and the data provided evidence of clinical benefit.

About Newsoara
Newsoara is a clinical-stage biopharmaceutical company with the mission to develop and commercialize life changing medicines for the treatment of patients with cancer, autoimmune, metabolic and other major diseases in China and around the world. With fully integrated drug discovery, CMC and clinical development capabilities, Newsoara has built a robust and broad pipeline for treating major diseases with unmet needs. Newsoara has assembled a world-class management team with extensive experience in novel drug development that is motivated to improve and impact human health worldwide.

About Genelux Corporation
Genelux is a clinical-stage biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. The Company's most advanced product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus (VACV), a stable DNA virus with a large engineering capacity. The core of Genelux's discovery and development efforts revolves around the company's proprietary CHOICE™ platform from which the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec.

Spotlight

Biotechnology is generally defined as “the application of science and technology to living organisms, as well parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services”1 . This definition is deliberately broad and covers all modern biotechnology but also many other traditional or borderline activities. Taken all together, these activities belong to what is commonly called “Life Sciences”.

Spotlight

Biotechnology is generally defined as “the application of science and technology to living organisms, as well parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services”1 . This definition is deliberately broad and covers all modern biotechnology but also many other traditional or borderline activities. Taken all together, these activities belong to what is commonly called “Life Sciences”.

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RESEARCH

Cedilla Therapeutics Expands Leadership Team with Key Appointments Across R&D And Finance

Cedilla Therapeutics | November 17, 2021

Cedilla Therapeutics, a biotechnology company bringing a new dimension to precision oncology, announced appointments across its research and development (R&D) and finance teams, including Joshua Murtie, Ph.D., as Vice President of Biology and Chris Lindblom as Vice President of Finance. These hires are part of an ongoing initiative to expand Cedilla’s leadership and enable future growth as the company progresses its lead programs, conditional inhibitors of TEAD and CDK2, toward the clinic and continues to develop a broad portfolio of small molecule medicines that target key oncogenic drivers. “We are delighted to expand our team with these key hires, who share our passion and commitment to developing targeted medicines that conditionally modulate proteins in their functional state. We look forward to Joshua and Chris’ many contributions as we continue to explore the power of our novel approach to access historically undruggable cancer drivers, advance our lead conditional inhibitor programs targeting TEAD and CDK2 into clinical development, and ultimately build Cedilla into a fully integrated organization and leader in precision medicine.” Alexandra Glucksmann, Ph.D., President and Chief Executive Officer of Cedilla Therapeutics Joshua Murtie, Ph.D., has been appointed Vice President of Biology. Dr. Murtie brings over ten years of industry experience to Cedilla. He worked most recently as Senior Director at Servier Pharmaceuticals, where he oversaw cancer biology, in vivo pharmacology and early-stage program management at the company’s U.S. research site. Earlier, he spent nearly seven years at Agios Pharmaceuticals in roles of increasing responsibility, ultimately serving as Senior Director and Head of Cancer Biology, with responsibility for the strategic oversight of the company’s cancer biology portfolio from early target discovery to translational research. Prior to Agios Pharmaceuticals, Dr. Murtie worked as an investigator at Sanofi and Novartis. He holds a Ph.D. in molecular and cell biology from the Uniformed Services University of the Health Sciences and completed his research fellowship at Harvard Medical School. “I am thrilled to join Cedilla, particularly as we prepare to advance our lead programs, targeting TEAD and CDK2, into investigational new drug application-enabling studies next year,” said Dr. Murtie. “Both TEAD and CDK2 are well-known yet elusive cancer targets, which, if drugged successfully, could benefit the lives of patients living with a broad range of solid tumors. I am incredibly impressed by the collaborative and innovative culture at Cedilla and look forward to working closely with the team to translate our research efforts into precision therapies for patients in need.” Chris Lindblom has been appointed Vice President of Finance. Over the course of his 19 years in the biotechnology industry, Mr. Lindblom has crafted long-range financial plans for public and private companies and played a key role in helping companies raise capital through private equity rounds, venture debt deals and public offerings. Prior to joining Cedilla, Mr. Lindblom served as Vice President of Finance at IFM Therapeutics, Cogen Immune Medicine (through its merger with Torque Therapeutics to form Repertoire Immune Medicines) and Warp Drive Bio (through its acquisition by Revolution Medicines). Earlier, Mr. Lindblom held various senior finance roles at Millennium Pharmaceuticals, including through the commercial launch of VELCADE®, and at Infinity Pharmaceuticals. He also served as Vice President of Finance at OvaScience and Senior Vice President of Finance and Administration at BIND Therapeutics. Mr. Lindblom holds an MBA from Boston College and a B.S. in accounting from Syracuse University. He is also a CPA. “Since its founding, Cedilla has attracted a strong team, including leading scientists and advisors and a robust investor syndicate, to support its mission to bring a new dimension to precision oncology and deliver medicines that can offer profound benefits to patients,” said Mr. Lindblom. “I am honored to take on this role and eager to partner with my new colleagues as we continue building Cedilla for its next phase of growth.” About Cedilla Therapeutics Cedilla Therapeutics is bringing a new dimension to precision oncology. We have discovered new ways to selectively inhibit oncogenic drivers with small molecules that conditionally modulate proteins in their functional state. Our conditional inhibitors are unlocking critical and elusive cancer targets including TEAD and CDK2. We are a driven and patient-focused team.

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CELL AND GENE THERAPY

Childhood Trauma and Genetics Linked to Increased Obesity Risk

DRI | March 10, 2022

New research from the Healthy Nevada Project® found associations between genetics, obesity, and childhood trauma, linking social health determinants, genetics, and disease. The study, which was published this week in Frontiers in Genetics, found that participants with specific genetic traits and who experience childhood traumas are more likely to suffer from adult obesity. In 2016, DRI and Renown Health launched the Healthy Nevada Project®, the nation’s first community-based, population health study, which now has more than 60,000 participants. The project is a collaboration with personal genomics company, Helix, and combines genetic, environmental, social, and clinical data to address individual and community health needs with the goal of improving health across the state and the nation. The new study focuses on Adverse Childhood Experiences (ACEs), which are traumatic and unsafe events that children endure by the age of 18. Over 16,000 participants in the Healthy Nevada Project® answered a mental health survey, and more than 65 percent of these individuals self-reported at least one ACE occurrence. These 16,000 participants were cross-referenced with their genetic makeup, and clinical Body Mass Index (BMI) measures. According to the research team’s findings, study participants who had experienced one or more types of ACE were 1.5 times more likely to become obese adults. Participants who experienced four or more ACEs were more than twice as likely to become severely obese. Our analysis showed a steady increase in BMI for each ACE a person experienced, which indicates a very strong and significant association between the number of adverse childhood experiences and adult obesity, More importantly, participants’ BMI reacted even more strongly to the occurrence of ACEs when paired with certain mutations in several genes, one of which is strongly associated with schizophrenia.” lead author Karen Schlauch, Ph.D., of DRI. We know that genetics affect disease in the Healthy Nevada Project®, and now we are recognizing that ACEs also affect disease, Our new study shows that the combination of genes and environmental factors like ACEs, as well as many social determinants of health, can lead to more serious health outcomes than either variable alone. More broadly, this new work emphasizes how important it is for population genetic studies to consider the impact of social determinants on health outcomes.” Healthy Nevada Project® Principal Investigator Joseph Grzymski, Ph.D., of DRI and Renown Health. The study team believes that it is important for clinical caregivers to understand the strong impact that negative childhood experiences such as ACEs can have on both child and adult health. The researchers hope the information from this study will encourage doctors and nurses to conduct simple screenings for ACEs and consider a patient’s social environment and history in combination with genetics when developing treatment plans for better patient health. According to the 2019 Youth Behavior Risk Survey (YRBS), 25.6 percent of Washoe County teenagers are overweight or obese. Obesity is a serious health concern for children and adolescents. According to the Centers for Disease Control and Prevention, obese children and adolescents are more likely to become obese as adults. Obese and overweight children and adolescents are at risk for multiple health problems during their youth, which are likely to be more severe as adults, Obese and overweight youth are more likely to have risk factors associated with cardiovascular diseases, such as high blood pressure, high cholesterol, and type 2 diabetes. Losing weight, in addition to a healthy diet, helps to prevent and control multiple chronic diseases and improves quality of life for a lifetime.” Max J. Coppes, MD, PhD, MBA, FAAP, Nell J Redfield Chair of Pediatrics at the University of Nevada Reno School of Medicine, Physician in Chief of Renown Children's Hospital. We’d like to thank all of the Healthy Nevada Project® participants who provided information to make our work possible, Our research illustrates that it’s not just genetics that cause disease, but that our environment and life experiences interact with our genes to impact our health in ways that we are only beginning to understand.” Robert Read, M.S., of DRI. About DRI The Desert Research Institute (DRI) is a recognized world leader in basic and applied environmental research. Committed to scientific excellence and integrity, DRI faculty, students who work alongside them, and staff have developed scientific knowledge and innovative technologies in research projects around the globe. Since 1959, DRI’s research has advanced scientific knowledge on topics ranging from humans’ impact on the environment to the environment’s impact on humans. DRI’s impactful science and inspiring solutions support Nevada’s diverse economy, provide science-based educational opportunities, and inform policymakers, business leaders, and community members. With campuses in Las Vegas and Reno, DRI serves as the non-profit research arm of the Nevada System of Higher Education.

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INDUSTRIAL IMPACT

Inhibrx Receives FDA Orphan-Drug Designation for INBRX-101 for the Treatment of Alpha-1 Antitrypsin Deficiency

Inhibrx, Inc. | March 04, 2022

Inhibrx, Inc. a biotechnology company with four clinical programs in development and a strong emerging pipeline, announced that the U.S. Food and Drug Administration, or FDA, has granted orphan-drug designation for INBRX-101 for the treatment of alpha-1 antitrypsin deficiency, or AATD. "We believe this designation from the FDA acknowledges the significant unmet need for novel therapeutic options in a patient community where the standard of care has not seen an improvement in many decades. We believe INBRX-101 can greatly improve the quality of life for AAT patients and look forward to working closely with regulators, key opinion leaders, patients and their families to achieve this." Inhibrx Chief Executive Officer, Mark Lappe The FDA's Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan-drug designation provides certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval. About AATD and INBRX-101 Alpha-1 antitrypsin deficiency, or AATD, is an inherited orphan disease affecting an estimated 100,000 patients in the United States. AATD is characterized by deficient levels of the AAT protein, which causes loss of lung tissue and function and decreased life expectancy. Plasma-derived AAT is the current standard of care but does not maintain patients in the normal AAT range, and requires frequent and inconvenient once-weekly IV dosing, while relying on plasma collection practices that might not be sustainable. INBRX-101 is a precisely engineered recombinant human AAT-Fc fusion protein designed to safely achieve and maintain levels of AAT found in healthy individuals with a favorable safety profile and the potential for once-monthly dosing. In October 2021, the Company announced interim functional PK data from 21 AATD patients in the Phase 1 study. Dose related increases in maximal and total INBRX-101 exposure occurred across the entirety of the tested single ascending dose range of 10 to 120 mg/kg. Data from the first multiple ascending dose cohort of INBRX-101 at 40 mg/kg IV every three weeks showed the expected accumulation of functional AAT levels with observed trough levels exceeding the goal of the current standard augmentation therapy with plasma-derived AAT. Interim safety data from 24 patients with AATD showed no drug-related severe or serious adverse events at doses up to and including 120 mg/kg single dose and 80 mg/kg multiple dose. Drug-related adverse events were predominantly mild with a few moderate events, and all were transient and reversible. No signs of neutralizing anti-drug antibodies have been observed. About Inhibrx, Inc. Inhibrx is a clinical-stage biotechnology company focused on developing a broad pipeline of novel biologic therapeutic candidates in oncology and orphan diseases. Inhibrx utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary sdAb platform. Inhibrx has collaborations with 2seventy bio Bristol-Myers Squibb and Chiesi, among others.

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