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."

On September 16, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and IDT Biologika reported they have agreed to terminate their collaboration following the delivery of inactivated COVID-19 bulk vaccine to Valneva, and considering the current order levels and existing inventories (Press release, Valneva, SEP 16, 2022, View Source [SID1234619692]).

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As per the commercial manufacturing services agreement signed in November 20211, IDT Biologika produced VLA2001 bulk vaccine at its Biosafety Level 3 facilities in Germany, and Valneva bought the batches that were manufactured so far by IDT. In light of the reduced European Commission order2, Valneva has suspended manufacturing of the vaccine and, as compensation, will pay IDT up to €36.2 million in cash and the equivalent of €4.5 million in kind, in the form of specified equipment purchased by Valneva.

Valneva has started to deliver doses of VLA2001 to the European Member States who ordered the vaccine and is retaining inventory for potential additional supply to these Member States should demand increase. In parallel, the Company is continuing discussions with various other governments around the world, with the aim to deploy approximately eight to ten million doses of remaining inventory into international markets in the next six to twelve months.

About VLA2001
VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B vaccine. VLA2001’s manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).
VLA2001 is the first COVID-19 vaccine to receive a standard marketing authorization in Europe3 and the only whole virus, inactivated, adjuvanted COVID-19 vaccine to receive marketing authorization in Europe for use as primary vaccination in people from 18 to 50 years of age. The vaccine was also granted conditional marketing authorization in the United Kingdom4 and emergency use authorization in the United Arab Emirates5 and Kingdom of Bahrain6. Valneva currently has agreements to supply VLA2001 to certain EU Member States7 and the Kingdom of Bahrain8. In August 2022, the World Health Organization (WHO) issued recommendations for use of VLA20019.

On September 16, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development and global access to life-changing radiopharmaceuticals, reported the closing of its previously announced underwritten public offering of 13,900,000 shares of Common Stock at a public offering price of $9.00 per share (Press release, Point Biopharma, SEP 16, 2022, View Source [SID1234619630]). The gross proceeds to the Company from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, were approximately $125 million.

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Piper Sandler and Guggenheim Securities, LLC acted as joint book-running managers for the offering. Oppenheimer & Co. acted as lead manager for the offering.

POINT intends to use the net proceeds from the proposed offering, together with its existing cash, cash equivalents and investments, to fund clinical and preclinical research and development programs, pre-commercialization activities, and for working capital and other general corporate purposes.

The securities are being offered by POINT pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission ("SEC"). A prospectus supplement and accompanying prospectus relating to the proposed offering has been filed with the SEC and is available for free on the SEC’s website at View Source Copies of the prospectus supplement and the accompanying prospectus relating to these securities may also be obtained for free from:

Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected].

Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544 or by email at [email protected].

Oppenheimer & Co., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8055, or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities of POINT, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.