On February 18, 2025 Foundation Medicine, Inc., a genomics company committed to transforming cancer care, reported a collaboration with Sumitomo Pharma America, Inc. (SMPA) to develop the FoundationOneHeme platform as a companion diagnostic to identify patients with acute leukemia with a KMT2A rearrangement, also known as mixed lineage leukemia (MLL) rearrangement, or NPM1 mutations for potential treatment with SMPA’s enzomenib (DSP-5336), an investigational menin inhibitor (Press release, Foundation Medicine, FEB 18, 2025, View Source [SID1234650356]).

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Acute leukemia requires immediate treatment as the blood cells multiply rapidly, leading to a sudden onset of symptoms.1 Approximately 30% of acute myeloid leukemia (AML) patients have NPM1 mutations, 2 and 5-10% of AML patients have KMT2A (MLL) rearrangements.3

Menin inhibitors are emerging as a promising targeted therapy option for acute leukemia with KMT2A (MLL) rearrangements or NPM1 mutations.4 Menin is a protein that interacts with the KMT2A gene, playing a crucial role in regulating gene expression and protein interactions involved in hematopoiesis.5 Menin inhibitors are designed to disrupt this interaction, inhibiting the proliferation of leukemic cells.4

"Thanks to advancements in comprehensive genomic profiling, we have seen an increased focus on developing new targeted therapies for patients with hematological malignancies, which may help bring the promise of precision medicine to more patients," said Foundation Medicine’s Chief Biopharma Officer Troy Schurr. "We’re excited to work with Sumitomo to advance our FoundationOne Heme platform as a companion diagnostic as they advance investigation of this promising potential treatment option for acute leukemia patients with a KMT2A rearrangement and NPM1 mutations."

Foundation Medicine’s portfolio of tests offers physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. Foundation Medicine is the global leader in companion diagnostic approvals, with more than 50% of all approved companion diagnostic indications for next-generation sequencing (NGS) testing in the United States and Japan.

On February 18, 2025 Incyte (Nasdaq:INCY) reported that it will present at the following investor conferences during the month of March (Press release, Incyte, FEB 18, 2025, View Source [SID1234650355]):

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Cowen 45th Annual Health Care Conference on Monday, March 3, 2025 at 11:10 am (EST)
Leerink Partners 2025 Global Healthcare Conference on Tuesday, March 11, 2025 at 9:20 am (EST)

The presentations will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.

On February 18, 2025 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company, reported that through its academic partnership with Cedars-Sinai Medical Center, Cedars-Sinai has received $600,000 in funding from the Department of Defense Lung Cancer Research Program to advance the development of ENV205, a groundbreaking new drug to treat chemotherapy drug resistance and cachexia (Press release, Kairos Pharma, FEB 18, 2025, View Source [SID1234650354]).

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This funding will accelerate the Company’s research efforts to develop ENV205, a first-in-class therapy designed to reverse chemotherapy drug resistance, counteract muscle loss, improve strength, and enhance the effectiveness of existing cancer treatments. By targeting key pathways that drive cachexia, Kairos seeks to develop ENV205 to provide a much-needed solution to help patients maintain their health and resilience throughout cancer therapy. The Company has long been partnering with Cedars-Sinai in its research and development of ENV205.

Neil Bhowmick, Kairos Pharma’s Chief Scientific Officer, stated, "We are grateful to our supporters and collaborators who share our vision of improving outcomes for cancer patients worldwide. We look forward to collaborating with the Department of Defense to advance this promising new therapy toward clinical trials."

Dr. John Yu, Kairos Pharma’s Chief Executive Officer, added, "Developing our therapeutics through non-dilutive federal funding has been a hallmark of Kairos’s success in drug development and underscores the excellence of our scientific team."

Cachexia is a severe muscle-wasting condition that affects over half of cancer patients and significantly impacts quality of life, treatment tolerance, and survival. It is a complex metabolic syndrome characterized by involuntary weight loss, muscle atrophy, and systemic inflammation, which currently lacks effective treatment options.

On February 18, 2025 CEL-SCI Corporation (NYSE American: CVM) reported financial results for three months ended December 31, 2024, as well as key recent clinical and corporate developments (Press release, Cel-Sci, FEB 18, 2025, View Source [SID1234650353]).

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"CEL-SCI is very uniquely positioned at this moment as an immuno-oncology company with a vast amount of data from the largest Phase 3 head and neck cancer study ever performed, with statistically significant evidence that our drug can successfully fight cancer and extend lives in head and neck cancer," stated CEL-SCI CEO, Geert Kersten. "We hope to deliver a new standard of care to patients while substantially transforming our company’s valuation to reflect what we believe to be the intrinsic value of our cancer drug. The statistical analysis shows that our very soon to be initiated small confirmatory Registration Study has a very high chance of success and we will have indications of efficacy as early as 2026. Should the pre-surgical tumor responses mirror what we saw in the Phase 3 data, we believe we will be on the path for accelerated and/or conditional approval for Multikine next year."

Corporate and Clinical Developments include:

The U.S. FDA concurred with CEL-SCI’s plan to use of PD-L1 as a biomarker to select patients for a Phase 3 confirmatory trial. The study is designed to confirm the observation in our previous head and neck cancer Phase 3 trial that patients with low PD-L1 expression are most likely to have favorable outcomes from Multikine therapy. These patients, when treated with Multikine in the completed Phase 3 study, had a 5-year survival of 73% vs. 45% in the control group with a p-value of 0.0015. PD-L1 is a widely used biomarker for cancer patient selection for checkpoint inhibitors, which appear to work best for patients with high PD-L1 expression. Since Multikine has been shown to be more effective in patients with low PD-L1 expression, Multikine is uniquely positioned to benefit an estimated 70% of head and neck patients who have low PD-L1 expression.
The strong data from our completed Phase 3 study and the biological rationale for the use of Multikine in the treatment of head and neck cancer suggest a high likelihood of success for the confirmatory Registration Study. These data and rationale include:
Multikine shows pre-surgical tumor regression in head and neck cancer in just 3 weeks – confirmed by pathology at surgery:
Multikine led to significant rates of tumor regression prior to surgery.
There was no tumor regression observed in the control group that did not receive Multikine.
Pre-surgical tumor regressions confirmed at surgery forecast survival benefit.
The patient population for the Registration Study is likely to show significant survival prolongation.
Phase 3 Registration Study patient population selection is based on:
Strong statistical significance with respect to overall survival vs controls in 114 patients in the Phase 3 study.
Analysis of the patients in this group was pre-defined in the statistical analysis plan (SAP).
Strong biological rationale for the results seen in these patients based on Multikine’s mechanism of action (MOA) which brings about a strong and sustainable immune response and does not require overcoming PD-L1 blockade.
Ergomed, a clinical research organization (CRO) with a strong track record of fast enrollment and high-quality study delivery, is selected as the CRO for CEL-SCI’s confirmatory Registration Study. Ergomed has been a strategic partner and collaborator with CEL-SCI for over 10 years and was instrumental in successfully completing the prior Phase 3 study.
Financial Results

During the three months ended December 31, 2024, research and development expenses were $4.4 million, approximately the same as the three months ended December 31, 2023. General and administrative expenses for the first quarter of fiscal 2025 were $2.5 million compared to $2.1 million in the first quarter of fiscal 2023. Net loss was $7.1 million for three months ended December 31, 2024 compared to $6.7 million in the prior year period. Cash spent during the quarter was $5.1 million. Net loss per common share narrowed by 21% to $0.11 for the three months ended December 31, 2024, compared to $0.14 for the three months ended December 31, 2023.

On February 18, 2025 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,810,000 shares of common stock at a purchase price of $1.50 per share, in a private placement to accredited investors and certain Company directors (Press release, MAIA Biotechnology, FEB 18, 2025, View Source [SID1234650352]). Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.87 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing one year following issuance and have a term of six years from the initial issuance date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about February 20, 2025, subject to the satisfaction of customary closing conditions.

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The gross proceeds from the offering are expected to be $2,715,000, prior to offering expenses payable by the Company. The Company intends to use the net proceeds received from the private placement to fund the starting cost for Part C of the Phase II trial THIO -101 and for working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock 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 Securities 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 these securities, 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.