On December 1, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the publication of a peer-reviewed article in Nature communications, reporting data from the REACtiVe-2 clinical trial. REACtiVe-2 is a Phase 1 dose-escalation study evaluating the safety, tolerability and immunological effects of mitazalimab in combination with the dendritic cell-based vaccine MesoPher, developed by Amphera, in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) following standard of care chemotherapy. The study, conducted at Erasmus Medical Center in Rotterdam, underscores mitazalimab’s ability to activate anti-tumor immunity and support its proposed mode of action, including a reduction of tumor fibrosis, as well as increased T-cell infiltration and activation in the tumor.

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Key findings:

The combination therapy significantly decreased intratumoral collagen content, likely through mitazalimab-mediated macrophage activation and stromal degradation.
Treated tumors showed a clear rise in intratumoral T cells, indicating improved recruitment and immune access to the tumor.
The treatment activated central memory CD4+ T cells and triggered immune pathways related to antigen presentation.
Patients with stable disease after prior chemotherapy achieved a median OS of 12.1 months and a 1-year survival rate of 50%.
"These compelling translational data provide further support for the therapeutic potential of mitazalimab in reshaping the immunosuppressive microenvironment characteristic of pancreatic cancer," said Søren Bregenholt, CEO of Alligator Bioscience. "Furthermore, the data validates the immunological basis behind mitazalimab’s mechanism of action, thereby reinforcing it’s rational in mPDAC and other solid tumors, in combination with other treatment modalities.
The REACtiVe-2 study has been a part of Alligator’s broader clinical strategy to establish mitazalimab as a immunotherapy in hard-to-treat cancers such as mPDAC. The findings further highlight the synergistic potential of mitazalimab when combined with vaccines and chemotherapy.

(Press release, Alligator Bioscience, DEC 1, 2025, View Source [SID1234661015])

On December 1, 2025 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, reported that management will participate in a fireside chat at the Bank of America CNS Therapeutics Conference, being held virtually on Monday, December 8, 2025, at 2:25 pm ET.

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A webcast of the fireside chat will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 90 days following the event.

(Press release, Alector, DEC 1, 2025, View Source [SID1234661014])

On December 1, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported further encouraging efficacy data from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), an aggressive form of blood cancer.

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In September 2025, Imugene announced that a total of thirteen out of sixteen patients had achieved an ORR of 81%, defined as either Complete Response, (the disappearance of signs of cancer in response to treatment) or Partial Response, (defined as cancer reduction by at least 50%). Since then, an additional patient has become evaluable, achieving a Partial Response at Day 28 scan evaluation increasing the best ORR to 82% with fourteen out of seventeen patients showing response to treatment. The Complete Response (CR) rate continues to evolve as enrollment progresses and patients transition from partial to complete response, with an average time to best response seen in one to three months. The durability of response is also deepening in patients treated with azer-cel in combination with interleukin-2 (IL-2).

Azer-cel is being developed as a potential allogeneic, off-the-shelf, CAR T-cell therapy, addressing key limitations of approved autologous CAR T drugs, including geographical access to treatment centres, manufacturing complexity and time to receive treatment (on-demand).

Imugene is actively enrolling patients to the Phase 1b azer-cel trial at ten US sites with up to six sites in Australia planned, after the first Australian patient was dosed in January 2025 at Royal Prince Alfred Hospital in Sydney, resulting in a Complete Response.

About the Phase 1b azer-cel trial
The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients with DLBCL. The study has recently expanded to include and treat CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including primary central nervous system lymphoma (PCNSL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM) and follicular lymphoma (FL). Treatment with azer-cel, lymphodepletion (LD) and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated.

About diffuse large B cell lymphoma (DLBCL)
DLBCL is an aggressive and fast-growing type of non-Hodgkin’s lymphoma (NHL), a type of blood cancer. DLBCL is the most common type of NHL, with approximately 160,0001 global cases per year and approximately 30,000 new cases per year in the U.S. Relapsed/refractory DLBCL has a high unmet medical need; ~60% of patients treated with approved autologous CD19 CAR T relapse.

About primary central nervous system lymphoma (PCNSL)
PCNSL is a rare and aggressive form of non-Hodgkin lymphoma (NHL), a type of blood cancer that originates in the brain, spinal cord, leptomeninges, or eyes, usually without evidence of systemic disease. In the U.S., there are approximately 1,500 to 1,800 new cases per year with limited approved treatment options and is a high unmet need. Currently, there are no CAR T-cell products approved for the treatment of PCNSL providing a unique opportunity for azer-cel to treat CART naïve patients.

About other types of B Cell Lymphoma
Other subtypes of non-Hodgkin lymphoma (NHL) include chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), the most common slow growing leukemia that can become resistant to therapy; marginal zone lymphoma (MZL), a slow-growing B-cell lymphoma that arises in lymphoid tissues associated with mucosal sites like the stomach and lung; Waldenström macroglobulinemia (WM), a rare slow-growing lymphoma characterised by excess IgM production, which can cause multiple complications; andfollicular lymphoma (FL), a common slow-growing NHL that can become more aggressive. While several targeted therapies and monoclonal antibodies are available for these types of B Cell Lymphoma, relapsed or refractory disease remains an ongoing challenge, highlighting the ongoing need for continued innovation and new and better treatments.

About Interleukin 2 (IL-2)
IL-2 is a cytokine (a protein that affects what happens between cells in the immune system) that helps T-cells (which are part of the immune system that help fight cancer) grow and survive. IL-2 has been shown to help T cells live longer and to enhance the cancer killing functions of CAR T cells, making them more effective at targeting and killing cancer cells.

(Press release, Imugene, DEC 1, 2025, View Source [SID1234661000])

On November 28, 2025 A new collaborative study from Pusan National University and Yonsei University reported that the FOLFIRINOX regimen showed numerically improved survival outcomes compared to current standards such as FOLFOX, FOLFIRI, and nal-IRI/FL, while maintaining manageable toxicity levels. These findings suggest that FOLFIRINOX could serve as a promising second-line treatment option for patients with advanced BTC following first-line chemotherapy failure, warranting further validation through prospective clinical studies.

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Researchers determined FOLFIRINOX may extend survival in advanced biliary tract cancer as a second-line therapy with manageable toxicity
Researchers determined FOLFIRINOX may extend survival in advanced biliary tract cancer as a second-line therapy with manageable toxicity
Biliary tract cancers, including intrahepatic, perihilar, and extrahepatic cholangiocarcinoma and gallbladder cancer, are among the most aggressive gastrointestinal malignancies. Treatment options remain limited once the disease progresses, after first-line chemotherapy, and survival rarely exceeds one year.

To address this, the team of researchers led by Professor Yun Hak Kim from Pusan National University analyzed 12 years of clinical data from 54 patients treated at Yonsei Severance Hospital and combined the results with a systematic review and meta-analysis of 21 studies from around the world. This paper was made available online on 05 September 2025 in the journal International Journal of Surgery.

The combined evidence suggests that FOLFIRINOX may provide better progression-free and overall survival than currently recommended regimens such as FOLFOX, FOLFIRI, or nal-IRI/FL.

"We conducted a meta-analysis integrating 12 years of real-world data on the use of FOLFIRINOX or mFOLFIRINOX as salvage treatment in patients with advanced BTC treated at the Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, along with all available published studies on second-line chemotherapy regimens for advanced BTC," said Prof. Kim.

In this study, patients receiving FOLFIRINOX achieved a median progression-free survival of 4.2 months and an overall survival of 11.4 months. In the accompanying meta-analysis of 21 studies, FOLFIRINOX demonstrated numerically longer progression-free and overall survival compared with currently used second-line regimens such as FOLFOX, FOLFIRI, and nal-IRI/FL.

Still, the authors caution that toxicity remains significant. Nearly 40 percent of patients developed severe neutropenia, requiring dose adjustments or additional medical support. The team emphasizes that FOLFIRINOX should be reserved for fit patients under close supervision until further prospective trials confirm its broader safety.

Beyond short-term survival, the study highlights the potential to integrate biomarker-based selection and supportive strategies such as granulocyte colony-stimulating factor to mitigate toxicity. Future research may also explore pairing FOLFIRINOX with immunotherapies or molecular-targeted drugs. "Our findings suggest that FOLFIRINOX may offer a potential benefit as a second-line treatment option for BTC following progression on first-line chemotherapy," concluded Prof. Kim.

This paper provides an evidence-based foundation for clinicians considering treatment options after first-line chemotherapy failure and may guide updates to future BTC management guidelines.

(Press release, Pusan National University, NOV 28, 2025, View Source [SID1234660998])

On November 28, 2025 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in the 8th Annual Evercore Healthcare Conference, which is taking place from December 2 – 4, 2025. The fireside chat is scheduled to take place on Tuesday, December 2, 2025, at 12:30 PM ET.

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A live webcast of the fireside chat will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

(Press release, TG Therapeutics, NOV 28, 2025, View Source [SID1234660996])