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.

On March 7, 2024 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported the publication of the manuscript, "Multi-omic Profiling of Follicular Lymphoma Reveals Changes in Tissue Architecture and Enhanced Stromal Remodeling in High-Risk Patients" in Cancer Cell, a premier peer-reviewed scientific journal that publishes high-impact results in cancer research and oncology (Press release, BostonGene, MAR 7, 2024, View Source [SID1234640946]).

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Follicular lymphoma (FL), an often incurable malignancy, stems from developmentally blocked germinal center B cells. Throughout its progression, FL tumor B cells undergo significant genetic changes and extensively remodel the lymphoid microenvironment to promote survival and immune evasion. The dynamic interaction between tumor B cells and the tumor microenvironment are thought to influence the diverse clinical behaviors observed among FL patients, ranging from an indolent disease to a more aggressive clinical course characterized by progression after therapy, histologic transformation, and premature death from lymphoma. Despite the urgent need, current clinical tools inadequately predict disease behavior, underscoring the necessity for risk stratification methods, particularly for early relapsers.

The study, led by researchers at the National Institute of Allergy and Infectious Diseases and National Cancer Institute in collaboration with BostonGene, employed a multi-modal approach to comprehensively examine cell-intrinsic and -extrinsic factors governing disease progression and therapeutic outcomes in FL patients enrolled in a prospective clinical trial. Utilizing BostonGene’s advanced end-to-end bioinformatics and proprietary software, the researchers identified several tumor-specific features and microenvironmental patterns associated with early relapse, the most high-risk subgroup of FL patients.

The research’s key findings included identifying unique histological patterns such as stromal desmoplasia and follicular growth pattern alterations observed before first progression and relapse in FL patients. Additional results provide a comprehensive characterization of the genomic and transcriptomic landscapes of tumor B cells, uncovering diverse genetic lesions and alterations in pathways associated with immune escape, apoptosis resistance, and extracellular matrix remodeling. Utilizing single-cell resolution profiling, the research revealed distinct populations of B cells, T cells, myeloid cells, and stromal cells within FL lymph nodes, shedding light on their spatial distribution within the tumor microenvironment. Moreover, the researchers established a correlation between gene signatures linked to poor prognosis and extracellular matrix remodeling with cellular communities identified in FL lymph nodes, offering potential therapeutic targets for high-risk patients.

"The insights garnered from this study signal a pivotal moment in refining treatment strategies for follicular lymphoma patients," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "By unraveling the intricate molecular and cellular dynamics steering disease progression, we advance toward implementing precision medicine paradigms that can reshape the standard of care."

Research reported in this press release was supported by the National Institute of Allergy and Infectious Diseases and National Cancer Institute, parts of the National Institutes of Health, under award numbers Z01 AI000545, ZIA BC011914, Z01 SC004024, and Z01 BC011006. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.