On September 18, 2022 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") reported that it has set a record date of September 26, 2022 (the "Record Date") for the previously announced spin-off by Biohaven of its Biohaven Ltd. ("SpinCo") subsidiary, which will own the Kv7 ion channel activators, glutamate modulation, myeloperoxidase inhibition and myostatin inhibition platforms, preclinical product candidates, and certain corporate infrastructure currently owned by Biohaven (Press release, Biohaven Pharmaceutical, SEP 18, 2022, View Source [SID1234619639]). The completion of the spin-off remains subject to closing conditions noted in Biohaven’s Proxy Statement filed on August 30, 2022, including receipt of shareholder approval at Biohaven’s special meeting of shareholders to be held on September 29, 2022.

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On the date of the distribution (the "Distribution Date"), each holder of Biohaven common shares will receive one common share of SpinCo for every two common shares of Biohaven held as of the Record Date. No action or payment is required by Biohaven shareholders to receive shares of SpinCo.

Beginning on September 23, 2022, and continuing until the occurrence of the distribution on the Distribution Date, Biohaven common shares will trade with an entitlement to the distribution under the symbol "BHVN". Any holders of Biohaven common shares who sell shares on or before the Distribution Date will also be selling their right to receive SpinCo common shares. Investors are encouraged to consult with their financial advisors regarding the specific implications of buying or selling Biohaven common shares on or before the Distribution Date.

Beginning on September 23, 2022, SpinCo common shares are expected to begin trading on a "when-issued" basis on the New York Stock Exchange under the symbol "BHVN WI" and under "Biohaven Ltd." When-issued trading of SpinCo common shares will continue until the distribution occurs. SpinCo common shares are expected to begin "regular-way" trading on the NYSE under the symbol "BHVN" on the first trading day following the Distribution Date.

On September 18, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, reported that ATG-101, the company’s in-house developed novel PD-L1/4-1BB bispecific antibody, has been granted an Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer (Press release, Antengene, SEP 18, 2022, View Source [SID1234619631]). This ODD will help Antengene facilitate regulatory communication with the FDA, accelerate the clinical development and the future registration of ATG-101.

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At present, no PD-L1/4-1BB bispecific antibody has been approved for the treatment of pancreatic cancer worldwide.

Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. Orphan Drug Designations by the U.S. FDA are meant to support the development of drug candidates that could potentially bring substantial therapeutic benefits to patients with rare diseases (a condition with a prevalence of less than 200,000 in the U.S.), and to provide incentives to the subsequent development, registration and commercialization to designated drugs. Those incentives include tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, and 7-year market exclusivity in the U.S. regardless of the patent status of the designated drug.

Pancreatic cancer is a highly malignant type of gastrointestinal cancer. According to the statistics by the World Health Organization (WHO), pancreatic cancer was ranked 13th and 7th globally by its incidence and mortality rates in 2012. In 2018, the U.S. reported over 55,000 newly- diagnosed pancreatic cancer cases and 44,330 related deaths. Whereas still defined as an orphan disease currently, it is projected that by 2030, pancreatic cancer will become the second most common cause of cancer-related deaths.

ATG-101 is a novel PD-L1/4-1BB bispecific antibody that was designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile. In preclinical studies, ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that had progressed on anti-PD-1/L1 treatment. Furthermore, ATG-101 has also shown an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies. ATG-101 is the first PD-L1/4-1BB bispecific antibody entering clinical development in Australia and is currently being evaluated in clinical studies in Australia, China, and the U.S.

Dr. Bo Shan, Antengene’s Chief Scientific Officer, said, "We are very encouraged by this Orphan Drug Designation from the U.S. FDA and are hopeful that ATG-101 will offer a novel therapeutic to patients with pancreatic cancer. As Antengene’s first in-house developed asset with global rights, ATG-101 has already entered clinical development in Australia, China, and the U.S. We will strive to accelerate the global clinical development of ATG-101 in efforts to provide a new treatment option to patients around the world."

On September 18, 2022 Dr. Gregory Fiore, Co-Founder, President and CEO of Exacis Biotherapeutics reported that will join an expert panel of biotechnology leaders to discuss "Placing Patients at the Center" during the Longwood Healthcare Leaders Fall webconference (Press release, Exacis Biotherapeutics, SEP 18, 2022, View Source [SID1234619628]). As a physician and CEO of Exacis, Dr. Fiore’s passion is to ensure that the field of cell therapy maintains its focus on improving the outcomes and experiences of oncology patients while increasing affordability and access to care.

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"I am honored to join this panel of thoughtful experts bringing a variety of perspectives related to patient-centricity," said Dr. Fiore. "Helping patients is what drives each of us and I am excited to learn from the co-panelists experiences about ideas we can build into our activities at Exacis."

The panel will take place at 3:20 pm ET on Thursday, September 22.

The Longwood Healthcare Leaders Fall webconference will be held September 21-22, 2022. Hosted by the Longwood Fund, an early-stage life science venture firm, the conference will bring together leading biopharma CEOs, heads of R&D, top academic researchers, and healthcare investors for an off-the-record forum focused on accelerating the translation of discoveries into medicines to help patients.

On September 18, 2022 Dr. Gregory Fiore, Co-Founder, President and CEO of Exacis Biotherapeutics reported that it will present "Leveraging mRNA Based Gene Editing to Optimize Advancement of Safe and Cost-Effective IPSC Products" as part of the focus track on Innovations in Gene Engineering and Editing at the 7th Annual CAR-TCR Summit in Boston on September 19, 2022 (Press release, Exacis Biotherapeutics, SEP 18, 2022, View Source [SID1234619627]). As the leader of Exacis, Dr. Fiore has direct experience in the use of mRNA to reprogram somatic cells to iPSCs and using a proprietary mRNA-based gene editing platform to engineer the cells into NK and T cells for treatment of cancer.

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"The advances we are making in genetic engineering for cell-based therapies are remarkable," said Dr. Fiore. "Translating this research into developing off the shelf iPSC-derived cell therapies that are safe and effective will have a significant impact on the future of medical care."

Topics covered in Dr. Fiore’s presentation will include:

Engineering stealthing edits and performance enhancements to iPSCs with mRNA-based gene edited tools for enhanced persistence and potency
Avoiding viral and DNA vectoring approaches and using a fusogenic lipid delivery system to transfect cells
Expanding iPSCs during differentiation to yield large numbers of allogeneic NK cell therapies using an innovative and capital efficient manufacturing approach
The presentation will take place at 2:00 pm ET on Monday, September 19.

The 7th Annual CAR-TCR Summit will be held September 19-22, 2022, in Boston, MA. The comprehensive forum focuses on the goal of engineering a disease-free world. Meeting attendees will explore discovery through to commercialization to deliver safe, effective, and commercially viable CAR and TCR therapies.

On September 17, 2022 KYAN Therapeutics reported that MYC is a transcription factor that is dysregulated in over 70% of human cancers, making it an important target that unfortunately, has been deemed "undruggable" for many years (Press release, KYAN Therapeutics, SEP 17, 2022, View Source [SID1234632300]). Although synthetic lethality has offered a promising parallel approach that targets MYC-dependent vulnerabilities in cancer, there is still no targeted synthetic lethality therapy against MYC-driven cancers that has been approved for clinical use. A major challenge to getting MYC synthetic lethality targets into clinical settings is the need to prioritize targets by therapeutic potential for each MYC-driven cancer type due to the dissimilarities of tumors in each type.

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Taking into account the need for target prioritization and an increase in the exploration of combination therapies against MYC-driven cancers, the researchers in this study used KYAN’s experimental–analytical hybrid platform to find MYC synthetic lethal targets with the greatest therapeutic potential and compared their therapeutic value to current standard-of-care drugs in MYC-driven hepatocellular carcinoma (HCC). The researchers further utilized technology from KYAN and the Agency of Science, Technology & Research (A*STAR)’s Institute of Molecular and Cell Biology (IMCB) to identify a two-drug combination of novel splice-switch oligonucleotides (SSOs) as promising therapeutic candidates for MYC-driven HCC.

"We are thrilled that our collaboration with IMCB is already generating such exciting results," said Hugo Saavedra, CEO of KYAN Therapeutics. "Being able to aid drug discovery is yet another valuable tool that helps us to build solutions for better cancer care."