On October 6, 2025 CREATE Medicines, Inc. (formerly Myeloid Therapeutics, Inc.) reported an expanded strategy to move beyond myeloid-focused in vivo programming toward multilineage immune programming, including T cells, myeloid cells, and NK cells, to deliver scalable, redosable, off-the-shelf therapies with greater clinical impact (Press release, Myeloid Therapeutics, OCT 6, 2025, View Source [SID1234656472]).

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CREATE is the most advanced clinical-stage company in RNA-based in vivo CAR therapeutics, with programs targeting HER2, TROP2, and GPC3-positive solid tumors and validated targets for in vivo CAR-T mediated B cell depletion. Building on this foundation, CREATE Medicines is pioneering a new era in multi-immune programming with an expanded platform designed to deliver transformative therapies across oncology, autoimmunity, and fibrosis.

"Our clinical work in more than 40 patients has proven that we can tolerably and repeatedly program immune cells inside the body," said Daniel Getts, Ph.D., Chief Executive Officer of CREATE Medicines. "We are now extending those capabilities to program multiple immune lineages for deeper, more durable responses, starting with MT-304, our HER2 multi-immune CAR in breast cancer. In parallel, we are advancing the first-ever RNA retrotransposon-based in vivo CAR-T for B-cell depletion in oncology and autoimmunity."

Clinical Validation

CREATE Medicines has generated one of the largest clinical datasets in the in vivo CAR field, with more than 40 patients treated across multiple Phase 1 studies. These trials provide not only proof-of-mechanism but also critical insights that de-risk next generation multi-cell programs.

Proof-of-mechanism: Paired biopsies confirmed CAR+ immune cells infiltrating tumors, with immune remodeling and CD8 T cell recruitment.
Safety and repeat dosing: Over 200 doses delivered with a consistent, manageable safety profile and no cumulative toxicities.
Evidence of activity: CAR expression detected in circulating immune cells, with stable disease in several patients and a confirmed partial response on treatment for 16 months.
These results validate CREATE’s ability to reprogram immune cells inside the body and provide the foundation for expansion into multi-lineage programming across T cells, myeloid cells, and NK cells.

CREATE is strongly supported by a syndicate of leading life science investors, including Newpath Partners, ARCH Venture Partners, 8VC, and Hatteras Venture Partners. These firms share the company’s vision to transform immunotherapy through in vivo multi-immune programming and remain highly committed to its continued success.

Pipeline Updates and Anticipated Milestones

MT-302 (TROP2; solid tumors): Dose escalation completed; tolerable safety profile.
MT-303 (GPC3; hepatocellular carcinoma): Dose escalation ongoing.
MT-304 (HER2; solid tumors): First patient expected Q4 2025; first-in-class multi-immune CAR engaging NK and myeloid cells.
Retrotransposon-based in vivo CAR-T: First all-RNA product candidate with permanent CAR integration for B-cell depletion.
Additional multi-lineage programs in preclinical development across oncology and immunology.
Platform Differentiation

At the core of CREATE’s platform is targeted, programmable cell engagement:

Selective activation: Cell-specific receptors and LNPs for precise T, myeloid, and NK cell programming.
Flexible durability: Transient or stable CAR expression, with permanent integration via RNA-based retrotransposon technology.
Industry-leading RNA: Up to 8+ days of linear mRNA expression with no reactogenicity.
Speed and scalability: Concept-to-clinic in <12 months with low-cost manufacturing.

On October 6, 2025 ESSA Pharma Inc. (NASDAQ: EPIX) ("ESSA" or the "Company") reported that its Securityholders (as defined below) have approved the acquisition of all of the issued and outstanding common shares of the Company (the "Common Shares" and the holders of such Common Shares, the "Shareholders") by XenoTherapeutics Inc. ("Xeno"), a non-profit biotechnology company, by way of a statutory plan of arrangement (the "Transaction" or the "Arrangement") at the special meeting of Securityholders held today (the "Meeting") (Press release, ESSA, OCT 6, 2025, View Source [SID1234656471]).

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The special resolution approving the Arrangement was approved by: (i) 99.83% of the votes cast by Shareholders present in person or represented by proxy at the Meeting, (ii) 99.85% of the votes cast by Shareholders, holders of options to purchase Common Shares of the Company, holders of pre-funded Common Share purchase warrants of the Company (collectively, the "Securityholders"), present in person or represented by proxy at the Meeting, voting together as a single class, and (iii) 99.48% of the votes cast by Shareholders, present in person or represented by proxy at the Meeting, excluding for this purpose the votes required to be excluded pursuant to Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions.

At the Meeting, Shareholders also approved: (a) on an advisory and non-binding basis, the compensation to be paid or become payable to the Company’s named executive officers that is based on or otherwise relates to the Arrangement by 99.51% of the votes cast by Shareholders present in person or represented by proxy at the Meeting; and (b) in the event the Arrangement is terminated, (1) the voluntary liquidation and dissolution of the Company by 99.77% of the votes cast by Shareholders present in person or represented by proxy at the Meeting and (2) the appointment of PricewaterhouseCoopers LLP or, in the alternative, another liquidator of nationally recognized experience, as the liquidator of the Company with authorization for the board of directors of the Company to set the remuneration of the liquidator by 99.79% of the votes cast by Shareholders present in person or represented by proxy at the Meeting.

The Arrangement is subject to the approval of the Supreme Court of British Columbia (the "Court") and other customary closing conditions. The Court hearing for the final order to approve the Arrangement is expected to take place on October 7, 2025, and the completion of the Arrangement is expected to occur on or about October 9, 2025.

On October 6, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in predictive computational target discovery, powered by AI/ML reported, that a trial in progress of the first in human clinical trial to assess the anti-IL18BP antibody, COM503 (GS-0321) in participants with advanced solid malignancies will be presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), taking place between November 7-9, 2025, in National Harbor, Maryland (Press release, Compugen, OCT 6, 2025, View Source [SID1234656470]).

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Poster presentation details:
Abstract Title: A First in human clinical trial to assess the anti-IL18BP antibody, COM503 (GS-0321) in Participants with Advanced Solid Malignancies
Abstract number: 589
Presenter: Dr. Manish Sharma, MD, Co-Director of Clinical Research, START Midwest, Grand Rapids
Date: Friday, November 7, 2025

On October 6, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS; "Atossa" or the "Company), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, reported an amendment to its Phase 2 EVANGELINE study of (Z)-endoxifen in premenopausal women with newly diagnosed early-stage ER+/HER2- breast cancer (Press release, Atossa Therapeutics, OCT 6, 2025, View Source [SID1234656469]). The amended, non-registrational design is expected to accelerate objective readouts while reducing projected future study costs, consistent with Atossa’s focus on extending operating runway and deploying capital where it is most impactful. In 2026, Atossa is concentrating its resources on near-term, NDA-enabling activities for investigational (Z)-endoxifen.

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"This amendment is about efficiency, focus, and financial discipline," said Steven Quay, M.D., Ph.D., Atossa’s Chairman and Chief Executive Officer. "By streamlining EVANGELINE, we are rationalizing study spending and concentrating our strong balance sheet on the NDA-enabling package we plan to advance in 2026, without changing our safety oversight or commitment to rigorous data."

Capital Allocation Highlights

Prioritizing runway and catalysts: The amended design is expected to reduce future EVANGELINE study costs and further focus on NDA-enabling work under Atossa’s 2025-2026 operating plan
Faster, objective decision points: Cohort A patients with an initial Ki-67 of > 10% employ a pre-specified two-stage futility rule using short-interval, objective endpoints (e.g., Week-4 Ki-67 ≤10%) to enable earlier go/no-go decisions. Cohort B will be for patients with initial Ki-67 of < 10%
Safety unchanged: There is no change to patient-safety data collection or Data Safety Monitoring Committee (DSMC) oversight with this amendment
Operational focus: A single-arm, open-label structure concentrates efforts on one regimen and the data elements most relevant to a future NDA
EVANGELINE Design Snapshot (As Amended)

Study type: Single-arm, open-label, non-registrational Phase 2 in premenopausal women with ER+/HER2– breast cancer in the pre-surgical setting
Cohort A (signal-seeking): Two-stage futility design assessing the Week-4 Ki-67 ≤10% rate to allow early stop if not promising
Cohort B (estimation): Week-24 objective response (RECIST 1.1, central review)
Rationale: Focus on objective, short-interval endpoints to inform development decisions efficiently while preserving patient safeguards
Study size change: The original EVANGELINE study design included 214 patients. This amendment reduces the patient total to 40-65 patients
Clinical context

EVANGELINE run-in data previously presented at the 2024 San Antonio Breast Cancer Symposium showed a Week-4 Ki-67 ≤10% rate of 86% across evaluated (Z)-endoxifen dose levels with/without Ovarian Function Suppression (OFS). In 2021, Atossa reported an 86% response rate of Ki-67 < 10% for women on low dose (4 mg/day) endoxifen in the same pre-surgery neoadjuvant setting. Published comparators in similar settings report a 41% response rate with tamoxifen and a 78% response rate with an aromatase inhibitor and OFS (Nitz UA, et al., J Clin Oncol. 2022 Aug 10;40(23):2557-2567). However, no efficacy conclusions can be drawn from the ongoing study at this point. There is no change to patient safety data collection or Data Safety Monitoring Committee oversight by this amendment.

ABOUT EVANGELINE

EVANGELINE is a single-arm, open-label, non-registrational Phase 2 study evaluating investigational (Z)-endoxifen in premenopausal women with ER+/HER2– breast cancer in the pre-surgical setting. The trial uses short-interval, objective endpoints with a pre-specified two-stage futility rule to enable faster, data-driven decisions.

Participating U.S. centers include: Mayo Clinic Rochester; Mayo Clinic Arizona; Mayo Clinic Florida; Washington University School of Medicine; St. Elizabeth Healthcare; Bon Secours Cancer Institute; Vanderbilt-Ingram Cancer Center; Henry Ford Cancer Institute; Fred Hutch; Dana-Farber Cancer Institute; Baylor University; University of Arizona; Northwestern University; Avera Cancer Institute; and California Research Institute. For current site activation status and updates, see ClinicalTrials.gov (NCT05607004).

ABOUT (Z)-ENDOXIFEN

(Z)-endoxifen is an investigational, active metabolite of tamoxifen being developed by Atossa for hormone receptor–positive breast-cancer settings. Its safety and efficacy have not been established.

On October 6, 2025 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875) (the "Company"), reported that Yuichi Iwaki, M.D., Ph.D., President and CEO, and David H. Crean, Ph.D., Chief Business Officer, will present a corporate overview at the LD Micro Main Event XIX Investor Conference (Press release, MediciNova, OCT 6, 2025, View Source [SID1234656468]). The conference is being held on October 19 – 22, 2025 at the Hotel Del Coronado in San Diego, CA.

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Presentation Date: Monday, October 20, 2025
Time: 1:30pm Pacific Time
Register to view presentation: Webcast Link

A live webcast of the presentation can be accessed on the investor relations section of the MediciNova website. A replay of the webcast will be archived and available following the event for 90 days.

Drs. Iwaki and Crean will be available for one-on-one meetings throughout the conference.