On March 19, 2024 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported that it will present new in vitro data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, taking place on April 5-10 in San Diego, California (Press release, MaaT Pharma, MAR 19, 2024, View Source [SID1234641268]).

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MaaT034, a ground-breaking full ecosystem synthetic microbiota product, is the first candidate coming​ from the​ Company’s MET-C platform. Produced using a co-culturing technology and for large scale manufacturing, MaaT034 is being developed to improve responses to immunotherapy for patients with solid tumors in combination with an ICI (Immune Checkpoint Inhibitors) treatment. The first-in-human study is planned for 2025, with clinical batches currently being produced in 2024.

The Company will detail the new preclinical data in a press release on Monday, April 8th, 2024.

AACR Poster Presentation details:

Title: Evaluation of a new co-cultured microbiome ecosystem therapy candidate (MaaT034) for clinical testing as adjuvant/neoadjuvant to immune checkpoint inhibitors in solid tumors
Session Category:Immunology
Session Title: Microbiome, Inflammation, and Cancer
Session Date and Time: Wednesday Apr 10, 2024, 9:00 AM – 12:30 PM
Location:Poster Section 2
Poster Board Number:18
Published Abstract Number:6687

On March 19, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported early efficacy results showing primary lung tumor stabilization and the complete disappearance of brain metastases in the second patient in the Company’s Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, MAR 19, 2024, View Source [SID1234641267]). Deltacel-01 is evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC).

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Preliminary results obtained six weeks from the beginning of treatment show Deltacel’s efficacy in controlling tumor growth, as well as favorable safety and tolerability. Stable disease status was confirmed by CT scan. An MRI scan of the patient’s brain performed before treatment began noted new onset metastatic disease, which completely resolved on repeat MRI imaging performed six weeks from the beginning of treatment. This patient is being treated at the Beverly Hills Cancer Center (BHCC).

"These six-week results in the second patient enrolled in Deltacel-01 are extremely promising. Along with preliminary results from the first patient we previously reported, they strengthen the candidacy of Deltacel as a potential treatment for patients with advanced disease. The complete eradication of this patient’s preexisting brain metastases supports a growing body of evidence for the benefit of our therapy and could also support Deltacel-01 crossing the blood-brain barrier," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.

"These preliminary results, especially the CT and MRI scan findings and the absence of dose-limiting toxicities, underscore the promise of Deltacel as a potentially efficacious therapy. We are cautiously optimistic given we have achieved a stable disease status for this patient. This aligns with our center’s commitment to bringing pioneering care for patients with few or no available treatment options," commented Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director, and Principal Investigator at BHCC.

Kiromic expects to announce initial safety, tolerability, and preliminary efficacy results from the third patient enrolled in Deltacel-01 by the end of March.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On March 19, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that members of its executive team are scheduled to participate in the upcoming investor conference, detailed below (Press release, Innate Pharma, MAR 19, 2024, View Source [SID1234641266]). Participants will be Sonia Quaratino, Executive Vice President, Chief Medical Officer, Yannis Morel, Executive Vice President, Chief Operating Officer and Arvind Sood, Executive Vice President, President of US Operations.

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• 2nd Annual H.C. Wainwright Cell Therapy Virtual Conference
Event Date: March 26, 2024 | virtual event

On March 19, 2024 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported the pricing of an underwritten offering consisting of 41,999,998 shares of its common stock at a price of $3.00 per share and pre-funded warrants to purchase 8,002,668 shares of its common stock (Press release, Geron, MAR 19, 2024, View Source [SID1234641265]). The pre-funded warrants are being sold at a price of $2.999 per pre-funded warrant. All of the securities in the offering are to be sold by Geron. The offering included participation from RA Capital Management, Fairmount, OrbiMed, Farallon Capital Management, Adage Capital Partners, L.P., Boxer Capital, Vivo Capital, Deep Track Capital, and multiple large investment management firms, in addition to other new and existing investors. The offering is expected to close on or about March 21, 2024, subject to the satisfaction of customary closing conditions.

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The gross proceeds to Geron from this underwritten offering, before deducting the underwriting discount and other estimated offering expenses, are expected to be approximately $150.0 million. Geron currently intends to use the net proceeds from this offering, together with its existing cash, cash equivalents, and current and noncurrent marketable securities, to fund the potential commercialization of imetelstat in low or intermediate-1 risk myelodysplastic syndromes in the U.S, and potential launch and commercialization of imetelstat in low or intermediate-1 risk myelodysplastic syndromes in the EU, subject to receipt of regulatory approvals, as well as continued development and potential regulatory submissions for imetelstat in relapsed/refractory myelofibrosis. Geron intends to use the remaining proceeds, if any, for working capital and general corporate purposes.

TD Cowen, Stifel and Barclays are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as co-manager for the offering.

An automatically effective shelf registration statement on Form S-3 relating to the offering of the shares of common stock and pre-funded warrants described above was filed with the Securities and Exchange Commission (SEC) on January 4, 2023. A prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by email at [email protected] or by telephone at (833) 297-2926; and Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

On March 19, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that it has entered into definitive agreements for the sale and issuance of 1,542,112 shares of common stock (or prefunded warrants in lieu thereof) of the Company and warrants to purchase up to 1,542,112 shares of common stock at a combined offering price of $4.215 per share of common stock (or per prefunded warrant in lieu thereof) and accompanying warrant, in a registered direct offering priced at-the-market under the Nasdaq rules (Press release, Genprex, MAR 19, 2024, View Source [SID1234641264]). The warrants have an exercise price of $4.09 per share, will be exercisable on the date of issuance, and will expire five years following the date of issuance. The closing of the offering is expected to occur on or about March 21, 2024, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to Genprex from this offering are expected to be approximately $6.5 million, before deducting the placement agent’s fees and other offering expenses. Genprex intends to use the net proceeds from this offering for working capital and general corporate purposes.

A "shelf" registration statement (File Number 333-271386) relating to the offered securities was filed with the Securities and Exchange Commission ("SEC") on April 21, 2023 and was declared effective on June 9, 2023. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. A prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC. Electronic copies of the prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The Company also has agreed to amend certain existing warrants to purchase up to an aggregate of 194,248 shares of the Company’s common stock that were previously issued to investors in March 2023 and July 2023, with exercise prices of $44.00 and $35.40 per share and expiration dates of March 1, 2028 and July 21, 2028 for $0.125 per amended warrant, effective upon the closing of the offering, such that the amended warrants will have a reduced exercise price of $4.09 per share and an expiration date of five years from the closing of the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or 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.