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Celyad Oncology Announces FDA Lifts Clinical Hold of CYAD-101-002 Phase 1b Trial

On August 1, 2022 Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the CYAD-101-002 (KEYNOTE-B79) Phase 1b trial after the Company made changes to the eligibility criteria for the trial (Press release, Celyad, AUG 1, 2022, View Source [SID1234617176]).

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"We are pleased that the FDA lifted the clinical hold on this trial. We remain confident in the potential development of not only the candidate itself, but the continued development with our proprietary TIM technology. CYAD-101 is currently our only clinical candidate co-expressing NKG2D and TIM, and we hope to continue to showcase our expertise with our non-gene edited technologies and explore additional opportunities to utilize NKG2D in allogeneic CAR T," said Dr. Charles Morris, Chief Medical Officer of Celyad Oncology.

As previously disclosed, on February 28, 2022, the Company announced that it was voluntarily pausing the CYAD-101-002 trial to investigate reports of two fatalities in the study. The trial was subsequently put on clinical hold in March 2022 by the FDA.

The CYAD-101-002 Phase 1b trial evaluates the TCR Inhibitory Molecule (TIM)-based allogeneic NKG2D CAR T cell investigational therapy CYAD-101 with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with refractory metastatic colorectal cancer (mCRC) with microsatellite stable (MSS) / mismatch-repair proficient disease.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Transactions in connection with share buy-back program

On August 1, 2022 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, AUG 1, 2022, View Source [SID1234617175]).

The share buy-back program is expected to be completed no later than August 31, 2022 and comprises up to 370,000 shares.

The following transactions were executed under the program from July 25, 2022 to July 29, 2022:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 437,483 shares as treasury shares, corresponding to 0.67% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 22 dated June 17, 2022.

Navidea Biopharmaceuticals Reminds Investors of Today’s Deadline to be a Shareholder of Record for the Previously Announced Rights Offering

On August 1, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported a reminder to shareholders that the record date of its proposed rights offering is Wednesday, August 3, 2022 ("Record Date") (Press release, Navidea Biopharmaceuticals, AUG 1, 2022, View Source [SID1234617174]). To be a shareholder of record on the Record Date, ownership of Navidea stock must occur by market close on Monday, August 1, 2022 to account for settlement. Holders of certain of our outstanding warrants, Series D preferred stock and Series F preferred stock are also entitled to participate in the rights offering.

The subscription rights will be non-transferable and may only be exercised during the anticipated subscription period of August 4, 2022 through 5:00 PM ET on August 17, 2022, unless extended by Navidea.

The expected calendar for the rights offering is as follows:

August 1, 2022: Ownership Day — in order to be considered a stockholder of record on August 3, shares should be acquired by this date.
August 3, 2022: Record Date
August 4, 2022: Distribution Date; Subscription Period Begins
August 17, 2022: Subscription Period Ends 5:00 PM ET (unless extended at Navidea’s sole discretion)
Holders who exercise their subscription rights in full will be entitled, if available, to subscribe for additional units that are not purchased by other stockholders, on a pro rata basis and subject to ownership limitations.

Navidea has engaged Maxim Group LLC as dealer-manager for the proposed rights offering. Questions about the rights offering or requests for copies of the preliminary and final prospectuses, when available, may be directed to Maxim Group LLC at 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

A registration statement (Registration No. 333-262691) relating to these securities has been filed with the Securities and Exchange Commission ("SEC") but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. The rights offering, which is expected to commence following the effectiveness of the registration statement, is being made only by means of a written prospectus. A preliminary prospectus relating to and describing the proposed terms of the rights offering has been filed with the SEC as a part of the registration statement and is available on the SEC’s website at View Source Copies of the preliminary and final prospectuses for the rights offering may be obtained, when available, from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, email: [email protected] or telephone (212) 895-3745.

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

Lantern Pharma to Report Second Quarter 2022 Operating & Financial Results on August 8th, 2022 at 4:30 p.m. ET

On August 1, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence (A.I.) and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that it will host its second quarter 2022 financial results webcast on Monday, August 8th, 2022 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time (Press release, Lantern Pharma, AUG 1, 2022, View Source [SID1234617173]).

Management intends to discuss the operating and financial results for the second quarter ended June 30, 2022 and provide guidance on upcoming milestones. Panna Sharma, President and Chief Executive Officer of Lantern Pharma, will lead the call and will be joined by other members of the management team.

A replay of the webinar will be available after the call on the investor relations section of the Company’s website: ir.lanternpharma.com.

Aclaris Therapeutics Expands Leadership Team

On August 1, 2022 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported the appointment of Douglas Manion, M.D., FRCP (C), as President and Chief Operating Officer (Press release, Aclaris Therapeutics, AUG 1, 2022, View Source [SID1234617172]). Dr. Manion will be responsible for overseeing day-to-day operations, continuing to develop Aclaris’ infrastructure and helping Aclaris develop its vision and overall strategic direction alongside Neal Walker, Aclaris’ CEO, and Aclaris’ board of directors.

"We are excited to strengthen our leadership team by welcoming Dr. Manion to Aclaris," said Dr. Neal Walker, CEO of Aclaris. "Doug’s significant experience across the business, strong background in drug development, and track record of leading organizations, building teams and creating value for both large and small organizations will be extremely valuable as we continue to advance our drug development pipeline."

Dr. Manion brings over 25 years of pharmaceutical industry experience in both large and small companies. Most recently, he served as Executive Vice President of Research and Development at Arena Pharmaceuticals, Inc., where he oversaw all research and development activities until its acquisition by Pfizer Inc. Prior to that, Dr. Manion was the Chief Executive Officer of Kleo Pharmaceuticals, Inc., an immuno-oncology company, until its acquisition by Biohaven Pharmaceutical Holding Company Ltd. Dr. Manion’s previous biopharmaceutical experience included leadership roles at Bristol-Myers Squibb, GlaxoSmithKline, DuPont Pharmaceuticals and DuPont Merck Pharmaceuticals.

"Aclaris is at an exciting stage in its life, and I am thrilled to join the organization," said Dr. Manion. "I look forward to leveraging my strengths in helping Aclaris grow and execute on its strategy."

Dr. Manion’s appointment is effective August 1, 2022. In connection with his appointment, Dr. Walker will no longer serve as the President, but will continue to serve as Aclaris’ Chief Executive Officer.