On December 16, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported clinical and translational findings supporting the development of pelareorep in second-line metastatic colorectal cancer ("mCRC"), specifically in patients with KRAS-mutant, microsatellite-stable ("MSS") disease. This represents one of the most difficult-to-treat and least responsive subgroups within colorectal cancer.

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In a previously completed clinical study evaluating pelareorep in combination with standard-of-care therapy, 33% of KRAS-mutant MSS patients achieved an objective response, compared to the well-established historical objective response rate ("ORR") of approximately 6–11% for Avastin (bevacizumab) + FOLFIRI in second-line mCRC.1, 2 In that same study, patients receiving the pelareorep, bevacizumab, and FOLFIRI treatment regimen more than doubled progression-free survival and overall survival compared to those receiving bevacizumab and FOLFIRI (click here for the PR).

In addition to the clinical activity, a separate translational analysis of paired tumor biopsies revealed that treatment with pelareorep led to a notable increase in KRAS-mutant–specific T-cell populations, indicating that pelareorep may directly enhance anti-tumor immune recognition in this genetically defined subgroup. These findings provide strong biological support for pursuing pelareorep as a precision immunotherapy capable of addressing a patient population that rarely benefits from checkpoint inhibitors or other immunotherapies. A complete analysis of the translational data will be presented at an upcoming medical meeting.

"Colorectal cancer is the core of our emerging GI tumor platform strategy for pelareorep, with a projected total addressable market of $20 billion by 2033,"3 said Jared Kelly, Chief Executive Officer of Oncolytics Biotech. "Pelareorep has clearly demonstrated the potential to become a transformational new treatment option in this underserved setting. With translational data supporting its unique activation of KRAS-specific T cells, pelareorep has delivered a 33 percent response rate in KRAS-mutant, MSS colorectal cancer."

Dr. Sanjay Goel, Professor of Medicine at Rutgers Cancer Institute of New Jersey and a leading investigator in GI oncology, commented: "These results are extremely encouraging. Achieving a 33% ORR in KRAS-mutant MSS colorectal cancer is highly unusual in this setting and warrants immediate further study. The translational findings strengthen the mechanistic rationale behind the clinical activity we’re observing. I am eager to move this program into a controlled study to validate the signal and help bring a much-needed therapeutic option to this patient population."

Together, the clinical and mechanistic data support advancing pelareorep into a controlled study in second-line KRAS-mutant MSS mCRC, which the company expects to initiate following consultation with key opinion leaders and regulatory authorities. The planned study is intended to confirm pelareorep’s potential to significantly outperform the current standard-of-care in a controlled setting and establish a new treatment paradigm for KRAS-mutant colorectal cancer. By sponsoring the study instead of pursuing an investigator-sponsored trial, Oncolytics will be able to provide an appropriate level of analytical rigor to support regulatory submissions that could lead to an approval in this indication. Additionally, the Company will have full control over data from the study and will be able to update investors, potential partners, and other stakeholders at its discretion. This change reflects the Company’s heightened interest in and focus on mCRC and pelareorep’s potential as a platform gastrointestinal immunotherapeutic agent.

(Press release, Oncolytics Biotech, DEC 16, 2025, View Source [SID1234661459])

On December 16, 2025 Tubulis reported that its CEO and Co-founder Dominik Schumacher will present a company overview and update at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco.

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The presentation will take place on Monday, January 12, 2026, at 3:00 pm PT in the Mission Bay Room (32nd Floor) at The Westin St. Francis.

(Press release, Tubulis, DEC 16, 2025, View Source [SID1234661475])

On December 16, 2025 Ratio Therapeutics Inc. (Ratio), a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment and monitoring, reported that dosing of the first cohort has been completed in the ATLAS trial, a Phase 1/2 open-label study evaluating the safety, tolerability, and efficacy of the company’s lead therapeutic radiopharmaceutical, [Ac-225]-RTX-2358, targeting fibroblast activation protein‑α (FAP) in patients with relapsed or refractory soft tissue sarcomas.

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"Advancing [Ac-225]-RTX-2358 into the clinic represents a major milestone for our company and reflects years of dedicated and innovative work by our team," said John Babich, Ph.D., President and Chief Scientific Officer of Ratio. "The preclinical and early human experience point to a strong therapeutic profile for our drug in sarcoma, with encouraging signs of activity in additional FAP-expressing cancers. Initiation of this trial marks the entry of our first therapeutic into the clinic and underscores our commitment to developing innovative radiotherapies that can bring new treatment options to cancer patients."

"This study represents an important step in exploring a novel therapeutic approach for patients with relapsed or refractory sarcoma, a population with limited treatment options," said Dr. Sandra D’Angelo, MD, a Medical Oncologist specializing in the care of patients with sarcoma at Memorial Sloan Kettering Cancer Center. "Radiopharmaceuticals are transforming cancer treatment by delivering radiation directly to tumors with far greater precision and decreased side effects. Ratio’s technology is designed to further enhance these benefits, and we look forward to exploring the potential of [Ac-225]-RTX-2358 to provide a meaningful impact for patients suffering from this challenging disease."

About the ATLAS Trial

The ATLAS trial is a Phase 1/2 open-label clinical trial (clinicaltrials.gov identifier, NCT07156565) designed to assess the safety, tolerability, dosimetry, biodistribution, pharmacokinetics, and preliminary anti-tumor activity of [Ac-225]-RTX-2358, a highly selective, FAP targeted radiotherapeutic labeled with Actinium 225, in patients with relapsed or refractory soft tissue sarcomas that express FAP.

The study consists of two phases: an ascending administered activity phase (Phase 1) and an expansion phase (Phase 2). For patients to be eligible to receive treatment, FAP expression will be assessed using a [Cu-64]-LNTH-1363S PET scan. In the Phase 1 portion, patients with FAP positive sarcomas will receive intravenous injections of [Ac-225]-RTX-2358 once every eight weeks, for up to six treatment cycles over a 12-month period. Using a standard 3+3 dose escalation design, participants will be assigned to one of three groups, each receiving an increasing dose level to determine the maximum tolerated dose and establish a recommended dose for the expansion phase. Cohort expansion will be allowed to a max of 10 patients per cohort, enabling up to 26 patients to be treated and evaluated during the Phase 1 portion of the trial. This will allow better characterization of safety and tolerability as well as the assessment of preliminary efficacy. Safety data from each group will be reviewed by an independent Safety Review Committee before dose escalation proceeds. The Phase 2 portion of the study will evaluate the efficacy and safety of [Ac-225]-RTX-2358 in up to 50 patients. [Ac-225]-RTX-2358 is being manufactured by Pharmalogic. [Cu-64]-LNTH-1363S is being provided by Lantheus and manufactured by PharmaLogic.

Dr. D’Angelo provides consulting and advisory services to Ratio Therapeutics.

(Press release, Ratio Therapeutics, DEC 16, 2025, https://ratiotx.com/2025/12/16/ratio-therapeutics-has-successfully-dosed-the-first-cohort-in-its-phase-1-2-study-evaluating-a-novel-fap-targeted-radiopharmaceutical-in-patients-with-late-stage-aggressive-sarcomas/ [SID1234661461])

On December 16, 2025 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, reported a multi-year, global strategic collaboration and license agreement with Bristol Myers Squibb to discover and develop next-generation multi-specific antibodies.

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Under the terms of the agreement, Harbour BioMed will collaborate with Bristol Myers Squibb to advance and accelerate multi-specific antibody discovery programs. In return, Harbour BioMed could receive payments totaling $90 million, as well as development and commercial milestones of up to $1.035 billion, along with tiered royalties should Bristol Myers Squibb elect to advance all potential programs.

Jingsong Wang, MD, PhD, Founder, Chairman, and CEO of Harbour BioMed, commented: "We are delighted to collaborate with Bristol Myers Squibb to advance next-generation multi-specific antibody discovery and development. This collaboration leverages our Harbour Mice fully human antibody technology platform, which facilitates the efficient discovery and development of innovative biologics with enhanced therapeutic potential. Furthermore, the collaboration offers the possibility to utilize our established development capabilities to accelerate programs by conducting early clinical trials in China. By uniting the strengths of our platform with Bristol Myers Squibb’s expertise in drug discovery and development, we look forward to progressing these programs and delivering transformative therapies to patients worldwide."

(Press release, Harbour BioMed, DEC 16, 2025, View Source [SID1234661463])

On December 16, 2025 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology reported an update on the INBRX-106 Phase 2/3 clinical trial in combination with Keytruda (pembrolizumab) as a first-line treatment for patients with locally advanced unresectable or metastatic head and neck squamous cell carcinoma (HNSCC) and the Phase 1/2 trial evaluating patients with checkpoint inhibitor refractory or relapsed non-small cell lung cancer (NSCLC) in combination with Keytruda. The Company also provided a brief progress update on the expansion cohorts investigating ozekibart in combination with FOLFIRI in late-line colorectal cancer and in combination with irinotecan and temozolomide in refractory Ewing sarcoma.

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INBRX-106

Inhibrx has recruited 46 of the 60 patients in the randomized Phase 2 portion of the Phase 2/3 clinical trial evaluating INBRX-106 in combination with Keytruda versus Keytruda as a first-line treatment for patients with unresectable or metastatic HNSCC. Inhibrx expects to complete enrollment in the Phase 2 portion of the trial during the first quarter of 2026. This trial is recruiting patients who have not received prior systemic therapy for unresectable or metastatic HNSCC and have tumor PD-L1 CPS expression equal to or greater than 20. Patients are randomized one to one to either INBRX-106 in combination with Keytruda or Keytruda. The primary endpoint of the Phase 2 portion of this trial is overall response rate, supported by secondary endpoints of duration of response, progression free survival and safety.

In November 2025, Inhibrx completed enrollment of the Phase 1/2 trial evaluating 34 patients in checkpoint inhibitor refractory or relapsed NSCLC in combination with Keytruda. Primary endpoints for this cohort are objective response rate, disease control rate, duration of response and safety.

The current datasets for both HNSCC and NSCLC lack sufficient maturity to support an interpretation and conclusion on the viability of this program. Inhibrx expects that in the second half of 2026, the data should be mature enough to inform whether INBRX-106, in combination with Keytruda, demonstrates superior efficacy and sustained clinical benefit relative to the current standard of care.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp.

Ozekibart (INBRX-109)

In late October 2025, Inhibrx completed enrollment of 44 patients in the expansion cohort of the Phase 1/2 trial evaluating ozekibart in combination with FOLFIRI in heavily pretreated (third and fourth line) advanced or metastatic, unresectable colorectal cancer. As previously reported, ozekibart in combination with FOLFIRI was well tolerated, with durable responses and a high rate of disease control. The progression free survival data should be mature in the second quarter of 2026, and we plan to provide an update at that time.

Inhibrx expects to complete enrollment in the Phase 1/2 trial of ozekibart in combination with irinotecan and temozolomide (IRI/TMZ) for advanced or metastatic, unresectable, relapsed, or refractory Ewing sarcoma in the second quarter of 2026. If the current response and duration trends observed continue, Inhibrx plans to meet with the FDA in the second half of 2026 to discuss an accelerated approval pathway for this indication.

About INBRX-106

INBRX-106 is a precisely engineered hexavalent sdAb-based therapeutic candidate targeting OX40, designed to be an optimized agonist of this co-stimulatory receptor. It is currently being investigated in combination with Keytruda in patients with locally advanced or metastatic solid tumors, specifically HNSCC and NSCLC.

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. Inhibrx read out a successful single agent registration study in chondrosarcoma and a BLA filing is expected in early Q2 of 2026. Additionally, Inhibrx is evaluating ozekibart in patients diagnosed with colorectal cancer and Ewing sarcoma.

(Press release, Inhibrx, DEC 16, 2025, View Source [SID1234661464])