On May 23, 2022 KaliVir Immunotherapeutics, Inc. reported a collaboration and global exclusive licensing agreement with Roche for the discovery, development and commercialization of novel oncolytic vaccinia viruses derived from KaliVir’s oncolytic immunotherapy VETTM platform (Press release, KaliVir Immunotherapeutics, MAY 23, 2022, View Source [SID1234614964]).

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KaliVir will work with Roche to leverage KaliVir’s proprietary technology platform based on genetically modified vaccinia virus to discover and develop novel oncolytic virus candidates. KaliVir’s VETTM platform can enhance the vaccinia viral backbone with a combination of proprietary genetic modifications to maximize tumor killing and systemic delivery and spread, and can be readily optimized to combine with a wide variety of therapeutic transgenes.

Under the terms of the agreement, KaliVir will generate oncolytic vaccinia virus product candidates derived from the company’s VETTM platform expressing Roche proprietary therapeutic transgenes. Roche will have exclusive license to discover, develop and commercialize the products worldwide. KaliVir will receive an upfront payment, and may be eligible to receive research, development and commercial milestone payments, as well as tiered royalties on commercial sales of products emerging from the collaboration.

"We are extremely excited to work with Roche and its excellent scientific team to identify and develop novel, innovative treatments for cancer patients worldwide," said KaliVir CEO Helena Chaye. "Our VETTM platform is a powerful engine for identifying novel, innovative oncolytic immunotherapies, and we look forward to further expanding its potential and our broader discovery research capabilities through this discovery collaboration."

"Roche has been discovering and developing breakthrough treatments in oncology for more than 50 years. Building on our strong internal pipeline, we are continually looking for partnerships to foster the discovery and development of innovation to fundamentally change how we deliver care for patients now and in the future," stated James Sabry, Global Head of Pharma Partnering at Roche. "KaliVir and its promising VETTM platform represent an excellent example of exciting, cutting-edge technologies that we believe could make a difference for cancer patients."

On May 23, 2022 Penn Medicine and Children’s Hospital of Philadelphia (CHOP), who together pioneered the research and development of the world’s first personalized cellular therapy for cancer — also known as CAR T cell therapy — reported that plans with Costa Rica’s CCSS, or the Caja Costarricense de Seguro Social (Social Security Program), to facilitate CAR T research in Costa Rica (Press release, Penn State College of Medicine, MAY 23, 2022, View Source [SID1234614963]). The effort is a step toward global equity in clinical research opportunities involving the use of CAR T cell therapies, which represent a leading-edge approach to cancer care not widely available across the world.

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Two Memoranda of Understanding, between CCSS and Penn and CCSS and CHOP, were announced during a ceremony attended by First Lady Jill Biden on Sunday at the National Children’s Hospital in San Jose, Costa Rica. Representatives from both Penn Medicine and CHOP attended the ceremony, along with U.S. Ambassador to Costa Rica Cynthia Telles, PhD, who was previously a Clinical Professor in the UCLA Department of Psychiatry at the UCLA David Geffen School of Medicine.

Penn scientists led research, development, and clinical trials of the world’s first approved CAR T therapy in collaboration with Novartis and Children’s Hospital of Philadelphia, and their research has demonstrated remissions stretching beyond 10 years among patients who received the treatment after running out of conventional options. There are now six FDA-approved CAR T cell therapies in the United States, for six different cancers, including forms of both pediatric and adult leukemia and several other blood cancers.

"At least 15,000 patients across the world have received CAR T cells, and dozens more clinical trials using this approach are in progress, for almost every major tumor type, but people in many parts of the globe still do not have access to treatment with these transformative therapies," said Carl H. June, MD, the Richard W. Vague Professor in Immunotherapy and director of the Center for Cellular Immunotherapies in Penn’s Perelman School of Medicine. "We are honored to work with our colleagues in Costa Rica in hopes of building a path for patients in underserved areas to have the opportunity to benefit from clinical research programs offering this personalized therapy."

"Equity in cancer care and research is a central goal of our mission at the Abramson Cancer Center," said Robert H. Vonderheide, MD, DPhil, director of Penn’s Abramson Cancer Center. "This new effort with Costa Rica exemplifies the longstanding work by Penn Medicine’s Center for Global Health to address disparities across the world."

Under the terms of the two Memoranda of Understanding, the three groups will explore the potential for adult and pediatric patients to come to Penn or CHOP for efforts to collect their immune cells for manufacturing into CAR T cells at Penn. Then, it is intended that CAR T cells made successfully would be sent to Costa Rica for infusion as part of a clinical trial protocol conducted there. The three groups may also elect to explore educational and training opportunities, drawn from Penn and CHOP’s experience treating patients in the United States, as Costa Rican health care providers develop protocols to treat patients on clinical trials using this technology.

"Our program has been privileged to be part of the safe rollout of CAR T therapy around the world, but as with many of these cutting edge therapies, availability has been limited in middle income countries," said Stephan A. Grupp, MD, PhD, section chief of the Cellular Therapy and Transplant Section and inaugural director of the Susan S. and Stephen P. Kelly Center for Cancer Immunotherapy at Children’s Hospital of Philadelphia. "Given the importance of equity and access, our work with Costa Rica may provide a template for further expanding the safe use of CAR T globally. Costa Rica has an outstanding universal health system with a strong commitment to accessible medical care, and we look forward to continuing this collaboration."

"Thanks to this collaboration, our children and adults who are fighting cancer will have a new hope for a next-generation treatment developed by world leaders in this field," said Dr. Álvaro Ramos Chaves, CCSS executive president.

On May 23, 2022 Genuv Inc., a clinical-stage biotechnology company focused on innovative drug discovery for degenerative central nervous system diseases and advanced immuno-oncology therapeutics, reported it will release new preclinical data at two major medical conferences in June (Press release, Genuv, MAY 23, 2022, View Source [SID1234614962]).

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"We are excited to share new preclinical data for our two drug candidates, SNR1611 and GNUV201," said Heung-rok Park, Ph.D., chief technology officer of Genuv.

Details of the presentations are shown below.

Keystone Symposium: Neurodegeneration: The Biological Pathways Driving the Future of Therapeutic Development, June 5-9, Keystone, CO

Poster number: 1023
Title: Trametinib rescues neurodegeneration by TFEB-mediated activation of autophagic lysosomal function in Alzheimer’s Disease model mice
Session: Poster session 1 on June 6, 2022
Presenter: Jenny Choih, K.M.D., Ph.D.

Poster number: 2022
Title: Trametinib activates endogenous neurogenesis and recovers Alzheimer’s disease phenotype of 5XFAD
Session: Poster session 2 on June 7, 2022
Presenter: Jenny Choih, K.M.D., Ph.D.

Keystone Symposia abstracts are available at View Source

ASCO 2022 Annual Meeting, June 3-7, McCormick Place, Chicago, IL

Abstract number: e14509
Title: GNUV201, a novel human and mouse cross-reactive PD-1 monoclonal antibody for cancer immunotherapy
Session: Online publication

The abstract will be released by ASCO (Free ASCO Whitepaper) on May 26, 2022, at 5:00 p.m. EDT on ASCO (Free ASCO Whitepaper).org/abstracts.

On May 23, 2022 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company developing innovative therapies for the treatment of immune-mediated diseases, reported that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra, will participate in a fireside chat at the H.C. Wainwright Global Investment Conference (Press release, Aldeyra Therapeutics, MAY 23, 2022, View Source [SID1234614961]).

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Dr. Brady’s conversation with Matthew Caufield, Vice President, Equity Research for H.C. Wainwright, will be available on demand beginning at 7:00 a.m. ET Tuesday, May 24, 2022. To view the webcast, log in to the Investors & Media section of the Aldeyra Therapeutics website at View Source The event will remain archived on the website for 90 days.

On May 23, 2022 Xcovery Holdings, Inc., an oncology focused bio-pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has accepted its investigational New Drug application (IND) of BPI-442096 , a small molecule Src homology region 2 domain-containing phosphatase 2 (SHP2) inhibitor, in solid tumors. Xcovery will initiate a phase I clinical trial in the United States to assess the tolerability, safety, and efficacy of BPI-442096 (Press release, Xcovery, MAY 23, 2022, View Source [SID1234614960]).

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BPI-442096 is a new molecular entity developed by Betta Pharmaceuticals in China. In preclinical studies, BPI-442096 demonstrated significant activity against a variety of cancer cells, including those with KRAS G12C mutation, KRAS G12D mutation, KRAS G12V mutation, KRAS G12A mutation, BRAF Class III mutation, NF1 LOF mutation, RTK mutation.

"I am very pleased to see BPI-442096 IND’s US approval," said Dr. Liu Fuqiang, Vice President of CMC at Betta Pharmaceuticals and at Xcovery. "Currently, there’s no SHP2 inhibitor drug on the market and we can fill the unmet need by bringing this compound to patients. With the earlier approved IND of BPI-361175, a 4th generation EGFR inhibitor, Betta and Xcovery are co-developing two very exciting assets in the US."

Giovanni Selvaggi, M.D., Xcovery’s CEO and CMO, commented, "The FDA’s acceptance of our INDs is an important validation of both Betta and Xcovery’s global capabilities in pre-clinical and clinical development in oncology. Together with BPI-361175, we can now establish our own small molecules pipeline against solid tumors."