On October 5, 2026 Orion Corporation (Orion Pharma) reported that the first patient has been dosed in the BICIDES Phase 1/2 clinical trial evaluating the safety, pharmacokinetics and preliminary anti-tumor activity of ODM-216, an investigational bispecific antibody simultaneously targeting PVRIG and PD-L1 in patients with advanced solid tumors. ODM-216 is Orion Pharma’s first biologic candidate and first immuno-oncology treatment to enter clinical testing in humans. ODM-216 is a key component of Orion Pharma’s immuno-oncology portfolio, including several assets in the pre-clinical pipeline.

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"Treating the first patient in the ODM-216 BICIDES study is a significant achievement for Orion Pharma and an important moment in the evolution of our long-term global R&D strategy to expand our capabilities beyond small molecules and into biologics," said Professor Outi Vaarala, M.D., Ph.D., Executive Vice President, Research & Development at Orion Pharma. "As both our first biologic and first immuno-oncology candidate to reach clinical stage, ODM-216 reflects our team’s commitment to discovering and advancing innovative new treatment approaches that further strengthen our foundation for a diversified future oncology pipeline. We look forward to evaluating ODM-216 in the clinic as we continue our mission for people living with difficult-to-treat cancers."

ODM-216’s advancement is fueled by Orion Pharma’s internal research & development efforts across its global R&D organization located in Finland, the UK and the US, including the company’s Biologics Research & Development Centre in Cambridge, UK, which was established in 2025 to strengthen Orion Pharma’s biologics capabilities.

The Phase 1/2 trial is known as BICIDES and more information can be found on ClinicalTrials.gov using identifier: NCT07805252.

About ODM-216
ODM-216 is an investigational anticancer medicine being developed by Orion Pharma. Designed to activate anti-tumor immune responses, ODM-216 is a bispecific antibody simultaneously targeting PVRIG and PD-L1, two immune-regulatory pathways involved in cancer growth and progression.

(Press release, Orion, OCT 5, 2026, View Source [SID1234673186])

On October 5, 2026 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported that the United States Patent and Trademark Office has issued U.S. Patent No. 12,734,168 entitled, "Delta Opioid Receptor Antagonists Reprogram Immunosuppresive Microenvironment to Boost Immunotherapy." The patent is directed to, among other things, administration of DOR antagonists to subjects having cancer associated with DOR expressing Myeloid Derived Suppressor Cells (MDSCs). It is further directed to uses of a variety of DOR antagonist combination therapies in treating, inhibiting, reducing, ameliorating, and/or preventing cancer and/or metastasis.

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"We are the first company to identify both the presence of and central role the DOR plays in modulating the ability of MDSCs to allow cancers to survive in an immunologic sanctuary. Inhibiting the DOR on MDSCs may allow cancer immunotherapies to work better and allow them to keep on working by removing their immunosuppressive shield thereby preventing cancer fighting T cells becoming exhausted. T cell exhaustion remains a major obstacle for cancer immunotherapies," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. "Further, we are pleased the patent covers uses of our DOR technology beyond ADCs and its potential application to other important classes of cancer immunotherapies, such as adoptive cellular immunotherapies like CAR-T, T Tregs , or TIL cell therapies. Utilizing our patented DOR technology, we are excited about our progress in advancing our novel class of bi-functional, bi-specific immune modulating ADCs targeting the DOR on MDSCs toward proof-of-concept in preclinical models of blood-related cancers like AML and MDS."

The patent, issued on September 15, 2026, covers administering a DOR antagonist to cancer subjects and mediating immunosuppressive myelopoiesis. Additionally, the patent discloses applications of DOR antagonists not only with bi-specific or bi-functional ADC technology, but also in the context of autologous or allogeneic adoptive cellular immunotherapies such as CAR-T, Treg or TIL cellular therapies. The patent term runs through 2043 before any patent term extension.

(Press release, TuHURA Biosciences, OCT 5, 2026, View Source [SID1234673184])

On October 5, 2026 Imugene Limited (ASX: IMU), a clinical-stage cellular therapy company, reported updated patient data from the BTK inhibitor (BTKi) combination cohort of its ongoing Phase 1b basket study of azer-cel (azercabtagene zapreleucel).

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Four further patients in Cohort 3 reached their Day 28 assessment. Two of the four responded: one Complete Response (CR) in a patient with Mantle Cell Lymphoma (MCL) and one Partial Response (PR) in a patient with Chronic Lymphocytic Leukemia (CLL). Of the other two patients, one with Richter’s Transformation (Diffuse Large B-Cell Lymphoma / Richter’s Transformation, DLBCL/RT) had Stable Disease (SD), and one with Mantle Cell Lymphoma (MCL) had Progressive Disease (PD).

CLL and MCL are high-risk B-cell malignancies where progression on standard BTKi therapies poses a critical clinical challenge. Patients who relapse on or become refractory to BTKi regimens face limited subsequent treatment options and poor overall survival outcomes.

All patients enrolled in this combination cohort have relapsed on or are refractory to prior BTKi therapy. The trial is evaluating whether concurrent administration of azer-cel with a BTKi can enhance antitumor activity in B-cell malignancies. The global BTKi market reached over US$12.0 billion in 2025.

Executive Chairman, Paul Hopper, said: " Observing additional responses in our BTKi combination cohort provides compelling further validation of this strategy. The key here is that we are treating patients who have all progressed on BTK inhibitors and who have high unmet need hematologic cancer with few therapeutic options. With the combination of azer-cel and continuation of the BTK inhibitor, we are seeing a high response rate including in challenging tumor types like MCL and CLL."

Cohort 3 adds to the azer-cel Phase 1b study data. Across the Phase 1b study, azer-cel has now demonstrated a 75% Overall Response Rate (ORR) across a total evaluated population of 55 patients. This includes a 68% ORR in CAR T-relapsed/refractory DLBCL (Cohort 1, n=22), a 81% ORR in CAR T-naïve patients (Cohort 2, n=26), and a 71% ORR in the BTKi combination cohort (Cohort 3, n=7). These pooled results reinforce the consistent therapeutic potential of azer-cel across diverse, difficult-to-treat patient populations. Further clinical updates will be reported as patient enrolment continues and data matures.

Azer-cel is an off-the-shelf, allogeneic CAR T cell therapy targeting CD19 for the treatment of blood cancers. Derived from healthy donor T cells, azer-cel is available for administration within days, bypassing the three-to-six-week manufacturing delay characteristic of autologous CAR T products.

About the Phase 1b azer-cel trial

The ongoing, open-label Phase 1b trial of azer-cel in the U.S. and Australia evaluates three main patient populations: CAR T-relapsed patients, CAR T-naïve patients, and BTKi combination cohort of patients with B-cell malignancies who previously progressed on BTKi therapy. Across a broad range of non-Hodgkin lymphomas (including FL, CLL/SLL, MZL, WM, and MCL), treatment with azer-cel, lymphodepletion, and IL-2 has yielded meaningful clinical activity including multiple complete responses in the BTKi cohort, with a manageable safety and tolerability profile.

(Press release, Imugene, OCT 5, 2026, View Source [SID1234673182])

On October 5, 2026 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported it will present a poster highlighting preclinical data with PoxSTG-EEV, a novel enveloped oncolytic virus designed for systemic delivery, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting.

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SITC 2026 will take place November 4 – 8, 2026, in Phoenix, Arizona (USA).

Poster details

Title: "PoxSTG-EEV: a Novel Enveloped Virion–Based Formulation of a Chimeric Oncolytic PoxVirus Adapted for Systemic Delivery"

• Abstract number: 1050
• Date: November 7, 2026
• Authors: Johann Foloppe, Juliette Kempf, Michèle Klein, Julie Hortelano, Baptiste Moreau, Laurine Gault, Isabelle Farine, Philippe Erbs

The abstract will be available on the SITC (Free SITC Whitepaper) website on November 3, 2026, at 9 a.m. ET

(Press release, Transgene, OCT 5, 2026, View Source [SID1234673180])

On October 5, 2026 Iovance Biotherapeutics presented its corporate presentation.

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(Presentation, Iovance Biotherapeutics, OCT 5, 2026, View Source [SID1234673177])