AIM ImmunoTech Announces Pricing of $1.26 Million Registered Direct Offering

On September 30, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that it has entered into a securities purchase agreement with a single institutional investor to purchase 4,653,036 shares of common stock in a registered direct offering at a purchase price of $0.27 per share (Press release, AIM ImmunoTech, SEP 30, 2024, View Source [SID1234646920]). In a concurrent private placement, the Company also agreed to issue unregistered Class C warrants to purchase up to an aggregate of 4,653,036 shares of common stock and, unregistered Class D warrants to purchase up to an aggregate of 4,653,036 shares of common stock. The Class C and Class D warrants will each have an exercise price of $0.28, will be exercisable six months from the date of issuance and, in the case of the Class C warrants, will expire on the eighteen-month anniversary from the initial exercise date, and in the case of the Class D warrants, will expire on the five-year anniversary from the initial exercise date.

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The gross proceeds to the Company from the registered direct offering and concurrent private placement are estimated to be approximately $1.26 million before deducting the placement agent’s fees and other estimated offering expenses payable by the Company.

Maxim Group LLC is acting as the sole placement agent in connection with the offering.

The shares of common stock are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-262280), which was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on February 4, 2022. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement relating to the shares of common stock will be filed by the Company with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, at (212) 895-3745.

The warrants to be issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws. Accordingly, the warrants and the shares of common stock underlying the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

Adicet Bio to Present at the American Society of Gene & Cell Therapy’s (ASGCT) 2024 Advancing Gene + Cell Therapies for Cancer Conference

On September 30, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported acceptance of an oral presentation at the upcoming American Society of Gene & Cell Therapy’s (ASGCT) (Free ASGCT Whitepaper) 2024 Advancing Gene and Cell Therapies for Cancer conference, taking place October 16 – 17, 2024, in Philadelphia, PA (Press release, Adicet Bio, SEP 30, 2024, View Source [SID1234646954]).

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Details of the oral presentation are as follows:

Title: ADI-270: An Armored Allogeneic Anti-CD70 CAR γδ T cell Therapy Designed for Enhanced Potency and Persistence Against Multiple Oncology Indications
Session Name: Novel Targets and Effector Cells
Abstract Number: 8
Presenting Author: Shon Green, Ph.D.
Date and Time: October 17, 2024; 11:15 a.m. – 11:30 a.m. ET

Allogene Therapeutics Announces Participation in the Goldman Sachs Cell Therapy Day Conference

On September 30, 2024 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that it will participate in panel focused on innovations in the allogeneic cell therapy landscape during the Goldman Sachs Cell Therapy Day on October 1, 2024 in New York (Press release, Allogene, SEP 30, 2024, View Source [SID1234646921]).

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Goldman Sachs Cell Therapy Day
Tuesday, October 1, 2024
Panel Discussion: 10:00AM PT/1:00PM ET

A webcast of this panel discussion will be posted to the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following a live webcast, a replay will be available on the Company’s website for approximately 30 days.

Repare Therapeutics Announces Phase 1 Data Highlighting Camonsertib in Combination with Radiotherapy Treatment Presented at the ASTRO Annual Meeting

On September 30, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported data highlighting the clinical benefits of camonsertib, a potential best-in-class oral small molecule ATR inhibitor, combined with palliative radiation for the treatment of metastatic tumors harboring an ataxia-telangiectasia-mutated (ATM) mutation (Press release, Repare Therapeutics, SEP 30, 2024, View Source [SID1234646955]).

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These data from a clinical trial conducted in collaboration with investigators at Memorial-Sloan Kettering Cancer Center were presented at the American Society for Radiation Oncology (ASTRO) annual meeting in Washington, DC by Nancy Lee, MD, FASTRO, Radiation Oncologist & Early Drug Development Specialist, Memorial Sloan Kettering Cancer Center and titled, "Genotypically-Selected Pan Cancer Trial of Camonsertib with Palliative Radiation in the Treatment of Metastatic Tumors Harboring an Ataxia-Telangiectasia Mutated (ATM) Mutation."

"These encouraging early Phase 1 data build further support for the broad clinical potential of camonsertib," said Maria Koehler, MD, PhD, Executive Vice President and Chief Medical Officer of Repare. "This first-in-human study combining camonsertib, an ATR inhibitor, with palliative radiation provides early clinical data showing that the combination has the potential to radiosensitize for higher clinical benefit in patients with tumors harboring pathogenic ATM mutations versus those with variants of unknown significance. We are highly encouraged by this early look at the response rate and safety profile of this combination in the Phase 1 setting."

Key Study Findings

Seventeen (17) patients with metastatic tumors harboring ATM mutations were enrolled in the trial; of which 12 had pathogenic ATM mutations and 5 had ATM mutations with variants of unknown significance (VUS).
Primary cancer histology included gastrointestinal (n=5), pancreas (n=5), breast (n=2), lung (n=2), bladder (n=2), and thyroid (n=1).
The recommended phase 2 dose for camonsertib was determined to be 160 mg given once-daily prior to radiation (4Gy) on days 1-5.
Interim response information was available for 16 patients at submission:
At 2-months, there were 2 complete responses (CR), 5 partial responses (PR), and 4 stable disease (SD) in the pathogenic ATM mutation group versus 1 PR and 4 SD in the VUS group.
At 6-months, in 9 evaluable patients, 2 CR, 4 PR, and 1 SD were reported in the pathogenic group versus 1 SD and 1 progressive disease (PD) in the VUS group.

Anixa Biosciences Announces Submission of Protocol Amendment for CAR-T Trial

On September 30, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it and partner Moffitt Cancer Center ("Moffitt") have submitted an amendment to the current protocol that governs its ongoing clinical trial utilizing a CAR-T therapy to treat ovarian cancer (NCT05316129) (Press release, Anixa Biosciences, SEP 30, 2024, https://ir.anixa.com/news/detail/1052/anixa-biosciences-announces-submission-of-protocol-amendment-for-car-t-trial [SID1234646922]).

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A key change in the protocol provides a second dose of the therapy to patients who might benefit from an additional dose. Previously, Anixa and Moffitt sought and received approval of a single patient IND application to enable a second dose for a single patient who, upon examination of tumor obtained from a biopsy, exhibited cellular infiltration and necrosis, indicating biologic activity of the CAR-T. This amendment will permit all potential patients to receive another leukapheresis and a second dose of CAR-T, without submitting individual INDs for each patient.

Dr. Robert Wenham, Chair of the Gynecologic Oncology Department at Moffitt, and the principal investigator of the trial, stated, "In initial Phase 1 clinical trials, it is customary to begin with low, often subtherapeutic cell doses to verify safety, before increasing the dose levels. In our study, the patient approved for a second dose by the individual IND received the starting, lowest dose. While initially meeting the criteria for progression due to size of her predominate tumor, her cancer has since remained relatively stable and she has not received additional therapy since her first infusion. We are hoping a second, higher dose may improve her overall response and outcome. In general, we anticipate that higher cell doses will lead to efficacy, but for solid tumors, a second dose may be needed in a subset of patients to improve the rate and durability of responses."

"We hope to get approval from regulatory agencies shortly, to enable second doses for the appropriate patients. We are clearly enthusiastic about the progress of this trial and are looking forward to treating additional patients," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences.