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.

On September 16, 2022 Beyond Air, Inc. (NASDAQ: XAIR), a medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported that the Company is scheduled to participate in a fireside chat at the LifeSci Partners HealthTech Symposium being held virtually September 20-21, 2022 (Press release, Beyond Air, SEP 16, 2022, View Source [SID1234619629]). Additionally, Steve Lisi, Chairman and CEO of Beyond Air, will be presenting corporate overviews and participating in 1×1 meetings at the Ladenburg Thalmann Healthcare Conference being held Thursday, September 29, 2022 at the Sofitel Hotel New York and the Roth Inaugural Healthcare Opportunities Conference on October 6, 2022 in New York City.

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LifeSci Partners HealthTech Symposium – September 20-21, 2022
Title: Beyond Air (XAIR) Fireside Chat
Date & Time: Wednesday, September 21, 2022, at 12:00 – 12:25pm ET
Moderator: Corey Davis, Ph.D., LifeSci Advisors, LLC
Participant: Steve Lisi, Chairman & CEO, Beyond Air
Location: Virtual
Webcast Link: Link
Ladenburg Thalmann Healthcare Conference – September 29, 2022
Title: Beyond Air (XAIR) Company Presentation
Date & Time: Thursday, September 29, 2022, at 1:30pm – 1:55pm ET
Presenter: Steve Lisi, Chairman & CEO, Beyond Air
Location: Sofitel New York City
Webcast Link: Link
Roth Inaugural Healthcare Opportunities Conference – October 6, 2022
Title: Beyond Air (XAIR) Company Presentation
Date & Time: Thursday, October 6, 2022, (Time – TBD)
Presenter: Steve Lisi, Chairman & CEO, Beyond Air
Location: The Yale Club, New York City
Webcast Link: TBD
If you are interested in requesting a 1×1 meeting at one of the respective conferences, please contact your bank/conference representative. For more details, please see the Events section of Beyond Air’s corporate website.

On September 16, 2022 Marengo Therapeutics, a company pioneering novel therapeutics targeting the T cell receptor Vβ chain (TCR Vβ) to selectively activate the right T cell subsets to fight cancer, reported it is advancing its lead TCR activator, STAR0602, into the clinic following clearance of its investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA) (Press release, Marengo Therapeutics, SEP 16, 2022, View Source [SID1234619626]). STAR0602 is a bi-functional fusion antibody that deploys a novel mechanism of T cell activation that has demonstrated potent single agent activity in PD-1 refractory settings in preclinical studies. Marengo plans to initiate a Phase I/II clinical trial of STAR0602 as a single agent in advanced solid tumors in the fourth quarter of 2022.

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To conduct the clinical trial for STAR0602 and advance translational research via the company’s TCR Vβ targeted STAR platform, Marengo has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI)’s Center for Cancer Research (CCR) and its recently announced Center for Immuno-Oncology (CIO). The CIO is co-led by Dr. Jeffrey Schlom, Co-Director of CIO, and Dr. James Gulley, Co-Director of CIO, Deputy Director of the CCR, NCI, and acting Clinical Director, NCI. The NCI and its collaborators at Marengo Therapeutics, Inc. will conduct preclinical and clinical investigations of Marengo Therapeutics’ selective immune activation antibody repertoire in cancer and other T cell-related diseases. This is the first CRADA with the newly formed CIO team at the NCI, which is one of the Institutes of the National Institutes of Health (NIH).

"Advancing our lead asset into the clinic marks a key inflection point for Marengo as we begin to translate our novel discovery into life-saving medicines. The collaboration with NCI will help us accelerate enrollment for our clinical trial while ensuring that it is executed in accordance with the highest standards of ethics and quality," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo. "We are truly honored to be the CIO’s first CRADA partner and look forward to combining our expertise with that of Dr. Gulley, Dr. Schlom, and their teams to create paradigm-shifting immunotherapeutics for patients. The studies conducted as part of this CRADA will help us expand the opportunities for our lead asset and the STAR platform to address high unmet medical needs."

On September 16, 2022 EXUMA Biotech, Corp., a clinical-stage biotechnology company discovering and developing cell and gene immunotherapies for solid and hematological tumors, reported that pre-clinical data from its solid-tumor subcutaneous CAR therapy program will be presented at the virtual 2022 Cancer Immunology and Immunotherapy Conference: Discovery to Mainstream Oncology hosted by the Center of Excellence in Immunology of the National Cancer Institute from September 15 – 16, 2022 (Press release, EXUMA Biotechnology, SEP 16, 2022, View Source [SID1234619625]). Additionally, EXUMA will participate in the 7th Annual CAR-TCR Summit organized by Hanson Wade from September 19-22, 2022, in Boston.

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"We are encouraged by the progress of EXUMA’s novel cell and gene therapy platforms, which have the potential to address current challenges with cellular immunotherapies and provide for the next generation of CAR and TCR-based therapies. EXUMA is using advanced lentivectors designed to generate novel cellular therapeutics to treat cancer patients without the need for preparative, lymphodepleting chemotherapy. Our goal is to transform cellular immunotherapy by improving efficacy and safety while also reducing its time, cost, and complexity in order to bring these medicines broadly to patients with significant, unmet medical needs," said Sid Kerkar, M.D., VP, R&D, Oncology.

2022 Cancer Immunology and Immunotherapy Conference: Discovery to Mainstream Oncology
(ncifrederick.cancer.gov/events/conferences/NCIImmunology2022)
Thursday & Friday, September 15-16, 2022

Participation: Virtual poster presentation with video recording
Title: In vivo generation of tumor-metabolism-regulated HER-2-specific CAR+ cells eradicate established HER2+ gastric carcinomas with the novel subcutaneous route of administration of CD3-directed lentivector-loaded lymphocytes
Presenters: Dr. Fred Vigant and Dr. Sid Kerkar, Vice President, Research & Development, Oncology
Access: View Source

7th Annual CAR-TCR Summit, Engineering a Disease-Free World
(www.car-tcr-summit.com)