On March 1, 2024 Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR-driven cancers, reported that long-term efficacy and safety results from its completed Phase 2 registrational AMPECT study of nab-sirolimus in malignant PEComa were published in the Journal of Clinical Oncology (JCO) (Press release, Aadi Bioscience, MAR 1, 2024, View Source [SID1234640705]). The manuscript, "A Phase 2 Trial of nab-Sirolimus in Patients with Advanced Malignant Perivascular Epithelioid Cell Tumors (AMPECT): Long-term Efficacy and Safety Update," authored by Andrew J. Wagner, MD, PhD and colleagues can be accessed online ahead of print here.

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"We are excited to report the final outcomes of this registrational trial after an additional 3 years of follow-up. Responses to nab-sirolimus in patients with advanced PEComa lasted a median of 39.7 months," commented Dr. Wagner, Senior Physician at the Dana-Farber Cancer Institute and Associate Professor of Medicine at Harvard Medical School. "The median survival outcomes were consistent with the primary analysis, and the confirmed overall response rate remained at 38.7% and included an additional patient with a complete response. The long-term, durable responses to nab-sirolimus with tolerable safety are great news for patients with this rare disease."

"The data published in JCO highlight the potential for nab-sirolimus to be an effective and highly differentiated treatment that may help patients suffering from this aggressive cancer achieve longer duration of responses and survival rates," said Loretta Itri, MD, Chief Medical Officer of Aadi. "We want to thank the principal investigators, study coordinators, and the patients who participated in AMPECT. We believe these results provide a significant contribution to sarcoma research and we look forward to continuing to advance nab-sirolimus."

The AMPECT trial (NCT02494570) evaluated the efficacy and safety of nab-sirolimus in patients with advanced malignant PEComa and was the first prospective registrational study in this setting. Data from this Phase 2, open-label, single-arm, multi-center study served as the basis for the FDA approval of FYARRO in advanced malignant PEComa regardless of mutational status.

Key updates reported:

Efficacy: At study completion, the confirmed ORR on the basis of independent radiographic review using RECIST v1.1 remained at 38.7% (95% CI, 21.8%-57.8%), with an additional converted confirmed complete response (CR) since the previously published analysis. The disease control rate (DCR) remained at 71% (95% CI, 52.0%–85.8%).

Durability: At the time of the primary analysis, the median duration of response (mDOR) had not been reached. At study completion, the mDOR was reached at 39.7 months (95% CI, 6.5 months to NR), median PFS remained the same at 10.6 months (95% CI, 5.5-41.2 months), and median OS was 53.1 months (95% CI, 22.2 months to NR).

Safety: The most common TRAEs were stomatitis (82.4%) and fatigue and rash (each 61.8%). No new or unexpected adverse events occurred, and no grade 4 or 5 TRAEs were reported.

On March 1, 2024 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company’s management will participate in the following investor conferences in March 2024 (Press release, MacroGenics, MAR 1, 2024, View Source [SID1234640704]):

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TD Cowen’s 44th Annual Health Care Conference (Boston). MacroGenics’ President & Chief Executive Officer, Scott Koenig, M.D., Ph.D., will participate in a Prostate Cancer Corporate Panel Discussion on Monday, March 4, 2024, at 10:30 am ET. MacroGenics’ management will also participate in one-on-one meetings.

Leerink Partners 2024 Global Biopharma Conference (Miami). Scott Koenig, M.D., Ph.D., will participate in a fireside chat on Tuesday, March 12, 2024, at 9:20 am ET. MacroGenics’ management will also participate in one-on-one meetings.

Barclays 26th Annual Global Healthcare Conference (Miami). Scott Koenig, M.D., Ph.D., will participate in a fireside chat on Wednesday, March 13, 2024, at 10:15 am ET. MacroGenics’ management will also participate in one-on-one meetings.

Webcasts of the above presentations may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain archived replays of these webcasts on its website for 30 days after each conference.

On March 1, 2024 Tvardi Therapeutics, Inc. ("Tvardi"), a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, reported that it will participate at the Cowen 44th Annual Health Care Conference with the management team holding one-on-one investor meetings on March 4, 2024 (Press release, Tvardi Therapeutics, MAR 1, 2024, View Source [SID1234640703]).

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Cowen’s 44th Annual Health Care Conference is taking place March 4 – 6, 2024, at the Marriott Copley Place in Boston, MA. The conference incorporates presentations, fireside chats, and innovative panel discussions hosted by members of the Cowen research team that focus on various aspects of the health care industry.

On March 1, 2024 Precision BioSciences, Inc. (Nasdaq: DTIL) ("Precision"), an advanced gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion, excision, and elimination, reported that it has agreed to sell to the public by way of an underwritten offering 2,500,000 shares of its common stock and accompanying warrants to purchase up to 2,500,000 shares of common stock at a combined offering price of $16.00 price per share, for total gross proceeds of $40.0 million, before deducting underwriting discounts and commissions (Press release, Precision Biosciences, MAR 1, 2024, View Source [SID1234640702]). The warrants have an exercise price of $20.00 per share and are exercisable immediately and will expire five years following the date of issuance. The financing consisted of participation from leading life sciences investors, including Perceptive Advisors, Janus Henderson Investors, Aquilo Capital Management, LLC and LYFE Capital.

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In addition, Precision BioSciences has granted the underwriter a 30-day option to purchase up to an additional 375,000 shares of its common stock and/or warrants to purchase up to 375,000 shares of common stock, at the combined public offering price and less underwriting discounts and commissions. The offering is expected to close on or about March 5, 2024, subject to customary closing conditions. All shares of common stock and accompanying warrants to be sold in the offering will be sold by Precision. Precision intends to use the net proceeds of the offering to help fund ongoing and planned research and development, and for working capital and general corporate purposes.

Guggenheim Securities, LLC is acting as sole book-running manager for the offering.

The securities described above were offered by means of a prospectus supplement dated March 1, 2024, and accompanying prospectus dated June 15, 2023, forming part of Precision’s effective shelf registration statement (File No. 333-272540). The prospectus supplement and accompanying prospectus relating to this offering will be filed with the U.S. Securities and Exchange Commission (the "SEC") and will be available on the SEC’s website located at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus may also be obtained, when available, by contacting: 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].

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

On March 1, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported that Virginia Oncology Associates, PC (Norfolk, Virginia) has been activated as the second clinical trial site in the Phase 1 Deltacel-01 trial evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with non-small cell lung cancer (NSCLC) (Press release, Kiromic, MAR 1, 2024, View Source [SID1234640701]).

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"Virginia Oncology Associates is known for its excellence in oncology-focused research and patient care, and we are delighted to add them as the second Deltacel-01 clinical trial site. With encouraging preliminary results from the first patient in Deltacel-01, we are proud to expand trial access to more sites with the goal of enhancing enrollment efficiency and data quality," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.

The site initiation process at Virginia Oncology Associates has been completed and patient enrollment is expected to begin in April, following receipt of preliminary results from the first three-patient cohort in Deltacel-01. Dr. Gary Simmons, D.O., MSHA, will serve as the principal investigator at this site, and brings to Deltacel-01 extensive experience in clinical studies focused on oncology and on CAR T-cell therapies.

Kiromic also announces that the third patient in Deltacel-01 completed treatment at the Beverly Hills Cancer Center on February 21. Kiromic expects to announce initial safety and tolerability data, as well as preliminary efficacy results, from this patient and from the trial’s second patient 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 lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.