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Myosin Therapeutics Receives FDA Fast Track Designation for MT-125 in Glioblastoma

On October 22, 2025 Myosin Therapeutics, Inc., a clinical-stage biotechnology company developing first-in-class therapies that modulate molecular motor proteins, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to MT-125 for the treatment of glioblastoma (GBM).

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Fast Track is an FDA program designed to facilitate development and expedite review of drugs that treat serious conditions and address unmet medical needs. This designation benefits patients and drug sponsors by enabling more frequent interactions with the FDA and providing eligibility for rolling review of a marketing application.

"Receiving Fast Track designation validates our conviction that MT-125 has the potential to offer an entirely novel treatment approach to patients with even the most aggressive forms of glioblastoma," said Dr. Courtney Miller, Chief Executive Officer of Myosin Therapeutics. "We are energized by the open communication with the FDA that the Fast Track offers because it will ensure we advance MT-125 as quickly as possible with our patient-centered approach."

MT-125 is a first-in-class dual inhibitor of non-muscle myosin IIA and IIB (NMIIA/IIB). It brings a completely new mechanism of action to a disease where decades of limited progress has built anticipation for genuine therapeutic innovation. By leveraging years of GBM biology research focused on targeting the cellular nanomotor proteins driving tumor cells, MT-125 enables simultaneous tackling of the proliferative and invasive phenotypes of this aggressive primary brain tumor, while improving the efficacy of radiation. A Phase 1/2 trial evaluating safety, pharmacokinetics, and preliminary activity is cleared to proceed (ClinicalTrials.gov: NCT07185880). FDA previously granted Orphan Drug Designation to MT-125 for malignant gliomas, including GBM.

(Press release, Myosin Therapeutics, OCT 22, 2025, View Source [SID1234656905])

Inhibrx To Host Webcast Presentation of Topline Results from its Registrational Trial of Ozekibart (INBRX-109) in Chondrosarcoma and to Provide Updates on Colorectal Cancer and Ewing Sarcoma Expansion Cohorts

On October 22, 2025 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology and rare diseases, reported that it will host a live webcast presentation on Thursday, October 23, 2025 at 1:30 p.m. Pacific Time to provide topline results from the registrational ChonDRAgon study investigating ozekibart (INBRX-109) as a single agent versus placebo in patients with advanced or metastatic, unresectable chondrosarcoma. The Company will also provide an update on the ongoing expansion trials investigating ozekibart in combination with FOLFIRI in late-line colorectal cancer and in combination with irinotecan and temozolomide in refractory Ewing sarcoma.

Investors may join via the web: View Source or may listen to the call by dialing (1-888-880-3330). Please refer to Inhibrx Biosciences, Inc. or the conference ID 9577647 when calling in. Following the webcast, the presentation may be accessed through a link on the investors section of Inhibrx’s website at View Source The webcast will be available for 60 days following the event. Following the presentation, Inhibrx will update its corporate presentation within the "Investors" section of its website at www.inhibrx.com.

About ozekibart (INBRX-109)
Ozekibart is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation. In January 2021, the FDA granted Fast Track designation to ozekibart for the treatment of patients with metastatic or unresectable conventional chondrosarcoma, and, in November 2021, the FDA granted orphan drug designation to ozekibart for chondrosarcoma.

In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, registration-enabling Phase 2 trial of ozekibart in metastatic, unresectable conventional chondrosarcoma.

Additionally, in Phase 1/2 trials, Inhibrx is investigating ozekibart in colorectal cancer in combination with FOLFIRI and Ewing sarcoma in combination with irinotecan/temozolomide, as well as other tumor types.

(Press release, Inhibrx, OCT 22, 2025, View Source [SID1234656904])

Harbour BioMed Announces Positive Phase II Results for HBM4003 and Tislelizumab Combination in MSS mCRC

On October 22, 2025 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, reported positive Phase II clinical data for porustobart (HBM4003), a next-generation, fully human heavy-chain-only anti-CTLA-4 antibody, in combination with tislelizumab, in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC).

The multicenter, open-label Phase II study (NCT05167071) enrolled 24 heavily pretreated patients with non-liver-metastatic (NLM) MSS mCRC. Patients received HBM4003 (0.3 mg/kg) plus tislelizumab (200 mg) every 21 days. The primary efficacy endpoint was objective response rate (ORR) per RECIST 1.1 criteria. The findings showed promising antitumor activity and a manageable safety profile for the combination therapy in this difficult-to-treat population.

Key findings include:

Baseline: All patients (N=24) had received ≥2 prior lines of therapy; 16/24 (66.7%) had lung metastases.
Efficacy: Among the 23 evaluable patients, the combination therapy achieved:
Objective Response Rate (ORR): 34.8% (8 partial responses)
Disease Control Rate (DCR): 60.9% (8 partial responses + 6 stable diseases)
Median Progression-Free Survival (mPFS): 4.2 months
Safety: The regimen was well-tolerated, with no Grade 4 or fatal treatment-emergent adverse events (TEAEs) observed.
TRAEs were reported in 87.5% (21/24) of patients, most commonly (incidence ≥20%) liver function test abnormalities, hematological abnormalities, and pyrexia (mostly Grade 1-2).
Treatment-related serious adverse events (SAEs) occurred in 37.5% (9/24) of patients.
Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed commented: "The 2025 Nobel Prize in Physiology or Medicine was awarded to three immunologists for their groundbreaking discoveries in regulatory T cells (Treg cells) and their role in controlling the immune system. HBM4003, a next-generation anti-CTLA-4 antibody discovered through our HCAb Harbour Mice platform, is a direct clinical application arising from this foundational research. The positive results from this Phase II clinical study mark an important milestone for Harbour BioMed and underscore the therapeutic potential of HBM4003. We will continue to advance HBM4003 with the goal of delivering transformative immuno-oncology therapies to patients worldwide."

About Porustobart (HBM4003)

Porustobart (HBM4003) is a next-generation, fully human heavy-chain-only anti-CTLA-4 antibody discovered and developed using the HCAb Harbour Mice platform. It is also the first fully human heavy-chain-only antibody which entered clinical development globally. Compared with conventional CTLA-4 antibodies, porustobart has unique, favourable properties, including significant Treg cell depletion and optimized pharmacokinetics for improved safety. Additionally, by enhancing antibody-dependent cellular cytotoxicity (ADCC), porustobart increases the potential to selectively deplete intratumoral Treg cells, helping to overcome the efficacy and toxicity bottleneck of current CTLA-4 therapies. The Company has implemented a global development plan for multiple types of solid tumors with an adaptive treatment design for porustobart. Positive efficacy and safety data have been observed in the monotherapy trial targeting advanced solid tumors, as well as in combination trials with PD-1 inhibitors for melanoma, CRC, NEN and HCC. Final data from the study of HBM4003 in combination with toripalimab for advanced HCC were published in Clinical Cancer Research in August 2025.

(Press release, Harbour BioMed, OCT 22, 2025, View Source [SID1234656903])

Revolution Medicines to Present Updated Elironrasib Safety and Efficacy Data in Patients with KRAS G12C Non-Small Cell Lung Cancer Following Treatment with a KRAS(OFF) G12C Inhibitor

On October 22, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported updated clinical data for elironrasib, a RAS(ON) G12C-selective inhibitor, in previously treated patients with KRAS G12C non-small cell lung cancer (NSCLC) who had received a prior KRAS(OFF) G12C inhibitor. These results will be highlighted in an oral presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics in Boston, October 23-25.

"The compelling clinical activity, durable response and acceptable tolerability profile seen with elironrasib underscore the potential of this differentiated RAS(ON) G12C-selective inhibitor, including in patients who have progressed on G12C(OFF) inhibitors," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "These findings reinforce the promise of our RAS(ON) inhibitor platform to deliver a range of therapies that target the active, GTP-bound state of RAS proteins with the potential to create new global standards of care."

As of the August 4, 2025 data cutoff date, patients with KRAS G12C NSCLC, who had received prior therapy with a KRAS(OFF) G12C inhibitor, were treated with elironrasib at the recommended Phase 2 dose of 200 mg orally twice daily (BID) and were evaluated on key safety and antitumor activity endpoints. These patients (n=24) were heavily pretreated, with a median of three prior lines of therapy (range 2-6), with 92% (22 out of 24 patients) having progressed on a prior KRAS(OFF) G12C inhibitor. Elironrasib demonstrated compelling antitumor activity, with a confirmed objective response rate of 42% (95% CI: 22-63) and a disease control rate of 79% (95% CI: 58-93). The median duration of response was 11.2 months (95% CI: 5.9-not estimable), and the median progression-free survival was 6.2 months (95% CI: 4.0-10.3). The median overall survival (OS) was not yet reached and 12-month OS rate was 62% (95% CI: 40-78).

These results are from RMC-6291-001, an ongoing multicenter, Phase 1 trial designed to evaluate elironrasib (RMC‑6291) monotherapy in patients with advanced KRAS G12C solid tumors.

Elironrasib is an innovative, mutant-selective inhibitor that binds selectively and covalently to the oncogenic RAS(ON) form of the RAS G12C variant that drives approximately 12% of cases of NSCLC. Revolution Medicines is exploring elironrasib monotherapy and combinations in various treatment settings and continues work to prioritize among multiple options for advancing its development. In July 2025, elironrasib was granted Breakthrough Therapy Designation for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor.

NSCLC accounts for 80%-85% of all lung cancers, and most patients have advanced or metastatic disease at initial diagnosis.1,2 KRAS mutations are found in nearly 30% of NSCLC cases, among which KRAS G12C is the most common.

Advancing RAS(ON) Inhibitor Platform Across Tumor Types
Jan Smith, Ph. D., chief scientific officer of Revolution Medicines will also highlight encouraging preclinical data supporting the RAS(ON) inhibitor doublet of zoldonrasib and daraxonrasib during a plenary session at the start of the AACR (Free AACR Whitepaper)-NCI-EORTC Symposium.

Several other presentations to be featured at the meeting demonstrate continued progress across Revolution Medicines’ RAS(ON) inhibitor portfolio, including:

"Targeting the Oncogenic State of RAS with Tri-Complex Inhibitors"
"RAS(ON) Inhibitor In-Pathway Combinations Maximize RAS Pathway Suppression in KRAS Mutant CRC Models"
"Resistance Mechanisms to Monotherapy Daraxonrasib (RMC-6236) in RAS Mutant PDAC"
"RASolve 301: A Phase 3 Study of Daraxonrasib (RMC-6236) vs. Docetaxel in RAS-Mutant NSCLC"
Further details and information on presentations can found on the AACR (Free AACR Whitepaper)-NCI-EORTC Symposium website.

About Non-Small Cell Lung Cancer
More than 197,000 people are diagnosed with non-small cell lung cancer (NSCLC) in the U.S. each year.3 Despite treatment advancements, NSCLC remains a leading cause of cancer-related mortality worldwide, primarily due to its late-stage diagnosis and limited response to conventional therapies.

(Press release, Revolution Medicines, OCT 22, 2025, View Source [SID1234656902])

Nurix Therapeutics Announces $250.0 Million Registered Offering of Common Stock

On October 22, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines in oncology and autoimmune disease, reported the pricing of its underwritten registered offering of 24,485,799 shares of its common stock at a price of $10.21 per share. The gross proceeds to Nurix from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Nurix, are expected to be $250.0 million. The offering is expected to close on or about October 23, 2025, subject to the satisfaction of customary closing conditions. All of the securities are being offered by Nurix.

The offering includes participation from both new and existing investors including General Atlantic, Redmile Group, Braidwell LP, Deep Track Capital, Perceptive Advisors, Trails Edge Capital Partners and Vestal Point Capital, as well as other healthcare-dedicated funds.

J.P. Morgan Securities LLC, Jefferies LLC and Stifel, Nicolaus & Company, Incorporated are acting as joint book-running managers for the offering. Oppenheimer & Co. Inc. and Robert W. Baird & Co. Incorporated are acting as lead managers for the offering.

Nurix currently intends to use any net proceeds from this offering primarily to fund clinical development of its drug candidates, including the clinical development of bexobrutideg (NX-5948) in chronic lymphocytic leukemia (CLL) and for the exploration of potential autoimmune indications, to fund research and development activities to expand its pipeline and for working capital and general corporate purposes.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-280117) that was previously filed by Nurix with the Securities and Exchange Commission ("SEC") and declared effective on June 11, 2024. A prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. A copy of the prospectus supplement relating to the offering, when available, may be obtained from: J.P. Morgan, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at (877) 821-7388, or via email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or via email at [email protected].

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

(Press release, Nurix Therapeutics, OCT 22, 2025, View Source [SID1234656901])