On March 7, 2024 CERo Therapeutics Holdings, Inc., (NASDAQ:CERO) ("CERo") an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms reported the publication in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), a paper titled "Therapeutic Targeting of TIM-4-L With Engineered T Cells for Acute Myeloid Leukemia (Press release, Cero Therapeutics, MAR 7, 2024, View Source [SID1234640951])." The paper details preclinical studies by CERo analyzing its lead clinical candidate CER-1236 in targeting Acute Myelogenous Leukemia (AML) tumor cells from human patients, and the candidate’s killing effects on these tumor cells. The results in the paper found that the target for CER-1236 is found in the large majority (83%) of leukemic cells extracted from the bone marrow from patients, and that more importantly CER-1236 effectively eliminated leukemic cells in the company’s experiments. Finally, the target for CER-1236 was found by CERo to be highly expressed and detectable across common AML genetic classification subtypes, including patient samples with adverse risk mutations in TP53, ASXL1 and RUNX1.

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"This new publication provides support for our plans to test CER-1236 in AML patients in our planned Phase I clinical trial, and moreover extends the scientific data we have produced showing the target for CER-1236 is present on tumor cells from diverse cancers, including ovarian, non-small cell lung cancer (NSCLC), and B cell malignancies," said Daniel Corey M.D, Ph.D, CERo’s Founder and Chief Technology Officer.

"We’re very pleased with this publication in Clinical Cancer Research supporting our near term plans to advance CER-1236 into the clinic. As we have previously reported, CERo plans to file an Investigational New Drug (IND) application in the first half of 2024, and is targeting initial treatment of AML patients as well as B Cell lymphoma patients before the end of the year," said Brian G Atwood, CERo’s Chairman and Chief Executive Officer.

On March 7, 2024 Synthekine Inc., an engineered cytokine therapeutics company, reported that data from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 taking place in San Diego, from April 5-10, 2024 (Press release, Synthekine, MAR 7, 2024, View Source [SID1234640950]). The company will also present new preclinical data for its orthogonal IL-2 (orthoIL-2) technology for cytokine-inducible cell therapies, currently being investigated in a Phase 1 study with the STK-009 + SYNCAR-001 combination therapy.

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"AACR marks the first time Synthekine will present clinical data from the ongoing trial of STK-012, our lead program and a novel approach to biasing IL-2," said Debanjan Ray, chief executive officer of Synthekine. "We are also excited to share new preclinical data with our orthoIL-2 technology comparing it head-to-head with other armoring approaches for CAR T-cell therapies. We look forward to sharing these results with the scientific community, while continuing our rapid progress to advance our broad pipeline of cytokine programs, including cytokine-inducible cell therapies, for the treatment of cancer, inflammatory and autoimmune diseases."

Details are as follows and available on the AACR (Free AACR Whitepaper) online itinerary planner:

Title: Initial results from a Phase 1a/1b study of STK-012, a first-in-class α/β IL-2 receptor biased partial agonist in advanced solid tumors (NCT05098132)
Session Title: First-in-Human Phase I Clinical Trials 2
Session Date & Time: Tuesday, Apr 9, 2024, 9:00 AM – 12:30 PM PT
Location: Poster Section 48
Poster Board Number: 11
Abstract Number: CT183

Title: Orthogonal IL-2/IL-2Rβ signaling selectively enhances and sustains a synthetic effector state via a novel mechanism and outperforms constitutive armoring approaches
Session Title: Adoptive Cellular Therapy 2
Session Date & Time: Tuesday, Apr 9, 2024, 1:30 PM – 5:00 PM PT
Location: Poster Section 40
Poster Board Number: 3
Abstract Number: 6312

Copies of the posters will be available on Synthekine’s website following presentation at the meeting.

On March 7, 2024 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that Clay Siegall, Ph.D., President and CEO of Immunome, will present at the Leerink Partners 2024 Global Biopharma Conference on Tuesday, March 12, 2024 at 4:20 p.m. ET (Press release, Immunome, MAR 7, 2024, View Source [SID1234640949]).

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Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

On March 7, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported its participation in the 36th Annual ROTH Conference being held March 17-19, 2024 in Dana Point, California (Press release, MAIA Biotechnology, MAR 7, 2024, View Source [SID1234640948]). Chief Executive Offer Vlad Vitoc, M.D. will host one-on-one meetings with institutional investors and analysts on Monday, March 18th and Tuesday, March 19th.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Conference Details:

Location:

The Ritz Carlton, Laguna Niguel in Dana Point, California.

Registration:

Available on the conference website.

1×1 meetings:

Investors may request a meeting by contacting a ROTH
representative at 800.678.9147 or by contacting MAIA investor Relations.

MAIA’s lead candidate is THIO, a small molecule telomere-targeting anticancer agent that acts by producing direct telomeric DNA damage and inducing cancer-specific immune responses. THIO’s efficacy in non-small cell lung cancer (NSCLC) is being evaluated in THIO-101, a Phase 2 go-to-market clinical trial nearing completion, which is expected to be the first completed clinical study of a telomere-targeting agent in the field of cancer drug discovery and treatment. MAIA plans to pursue the FDA’s accelerated approval program for THIO.

Recent news from MAIA’s THIO-101 trial includes:

Early completion of enrollment; trial nears completion with topline data expected in second half of 2024; (press release, February 22, 2024)
Strong response rate of 38% in third-line treatment efficacy data; (press release, March 6, 2024).
Multiple paths to potential commercial approval of THIO under consideration; MAIA anticipates a final FDA decision on THIO in 2026; (MAIA Shareholder Letter 2024).

On March 7, 2024 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, reported the first patient dosed in the expansion of its open-label, non-randomized, multicenter Phase 1 study evaluating Debio 0123, an oral, potent, highly selective and brain-penetrant WEE1 inhibitor, as a monotherapy in patients with recurrent or progressive solid tumors (Press release, Debiopharm, MAR 7, 2024, View Source [SID1234640947]). The expansion of this Phase 1 study, NCT05109975, is to characterize the safety, tolerability, and initial signs of antitumor activity of Debio 0123 when administered as monotherapy. Two out of the three expansion arms of the study will be using biomarkers to pre-select patients with different solid tumors while the third arm will be treating patients with recurrent serous endometrial carcinoma. Currently, sites are open for enrollment in the United States, Spain, and Switzerland.

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"Part of our strategy of utilizing OMICs* approaches to identify specific biomarkers and identify patient populations that will respond to Debio 0123 due to synthetic lethality will allow us to enroll patients who are most likely to benefit from treatment, thereby taking a truly precision medicine approach" expressed Dr. Victor Rodriguez-Freixinos, Medical Director, Debiopharm.

Uterine serous carcinoma (USC) is an uncommon, but aggressive subtype of endometrial cancer. It represents approximately 10% of all endometrial cases, which translates to more than 6,000 newly diagnosed patients each year in the United States 1-2. Despite representing a small proportion of endometrial cancer cases, uterine serous carcinoma accounts for an alarming 39% of endometrial cancer-related deaths. Features highlighting the gravity of USC include the high rates of deep myometrial invasion, as well as metastatic spread to lymph nodes and peritoneal surfaces 1. These features largely affect the 5-year overall survival but compared with more common endometrial cancer, the prognosis for USC is generally poor and the risk of relapse is high 3. Similar to USC, epithelial ovarian cancer (EOC) is known for its poor prognosis due to the aggressive clinical course and the tendency to metastasize. However, EOC accounts for about 90% of all ovarian cancers and affects more than 17,000 American women each year, of which about 30% survive for 5 years after diagnosis 4-5.

"This study’s population is mainly female, burdened by fatal malignancies like Uterine Serous Carcinoma, Epithelial Ovarian Cancer and fallopian tube cancer which are well-known hard-to-treat cancers. These patients need new treatment options, as the current standard of care is insufficient in assuring long-term progression free survival." Dr. Manish R. Sharma, Principal Investigator at the START Midwest, Michigan.

The Debio 0123 program originates from a growing awareness of DDR inhibition in fighting life-threatening cancers. Maximizing efficacy, while preserving safety are key elements that Debiopharm is eager to assess throughout the clinical development of Debio 0123. With the successful realization of these requirements, Debio 0123 could become the first choice WEE1 inhibitor.

About Debio 0123

Debio 0123 is a brain-penetrant, highly selective WEE1 kinase inhibitor. WEE1 is a key regulator of the G2/M and S phase checkpoints, activated in response to DNA damage, allowing cells to repair their DNA before resuming their cell cycle. WEE1 inhibition, particularly in combination with DNA damaging agents, induces an overload of DNA breaks. In conjunction with abrogation of other checkpoints such as G1, the compound pushes the cells through cycle without DNA repair, promoting mitotic catastrophe and inducing apoptosis of cancer cells. Currently in research for solid tumors in monotherapy and combination, Debio 0123 is being developed to respond to high unmet needs of patients living with the burden of difficult-to-treat cancers.

About DNA-Damage Response (DDR)

When cells have damaged DNA, they need to undergo a repair process called DDR to be able to survive. Cancer cells use their hyperactive DDR response to divide and grow uncontrollably, which promotes cancer expansion. Inhibition of DDR, particularly in combination with other anticancer agents, induces an overall arrest in the uncontrollable cancer cell cycle. This ultimately activates a self-destruction program in cancer cells. DDR inhibitors such as Debiopharm’s WEE1 and USP1 inhibitors, are being tested in either clinical or preclinical studies.