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])

On November 28, 2025 Pasithea Therapeutics Corp. ("Pasithea" or the "Company") (Nasdaq: KTTA; KTTAW), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), reported the pricing of a public offering of 80,000,000 shares of the Company’s common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.75 per share of common stock (or per pre-funded warrant in lieu thereof). The public offering was led by healthcare-dedicated investors, including Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners, and Squadron Capital Management.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The closing of the offering is expected to occur on or about December 1, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds to the Company from the offering are expected to be approximately $60 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes. The Company’s cash position following the closing will extend its cash runway through at least the first half of 2028. Such corporate purposes include, without limitation, ongoing research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in or acquiring companies that are synergistic with or complementary to the Company’s technologies, licensing activities related to its current and future product candidates, and to the development of emerging technologies, investing in or acquiring companies that are developing emerging technologies, licensing activities, or the acquisition of other businesses and working capital.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-291611) originally filed with the Securities and Exchange Commission ("SEC") on November 18, 2025, as amended on November 26, 2025, and declared effective on November 28, 2025. The offering is being made only by means of a prospectus, which is part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. When available, electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Pasithea Therapeutics, NOV 28, 2025, View Source [SID1234660995])

On November 27, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990) reported TROP2 ADC sacituzumab tirumotecan (sac-TMT) monotherapy for advanced or metastatic urothelial carcinoma (UC) patients has been published in the journal of Annals of Oncology (Impact Factor: 65.4). This study provides the first evidence of sac-TMT’s potential significant clinical benefit for patients with advanced UC.

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This publication is based on the efficacy and safety results of cohort 9 of a phase II MK-2870-001/KL264-01 study evaluating sac-TMT monotherapy in patients with advanced or metastatic UC and disease progression after chemotherapy and immune checkpoint inhibitors. Sac-TMT employs the only currently available irreversible conjugation technology, combined with the novel toxin – a topoisomerase I inhibitor KL610023 (T030). This enhances stability, ensuring greater release of the toxin T030 at tumor sites. It guarantees precise and potent tumor cell killing, achieving an effective balance between efficacy and safety. With its unique structural design, sac-TMT has demonstrated outstanding therapeutic potential in clinical studies.

The results showed that sac-TMT 5 mg/kg monotherapy every 2 weeks demonstrated promising antitumor activity in participants with heavily pretreated advanced or metastatic UC, with a manageable safety profile, warranting further evaluation of sac-TMT in this population.

As of data cutoff (February 17, 2025), 49 participants were treated with sac-TMT; 37 (76%) had received ≥2 prior lines of therapy. Median follow-up was 18.8 months. The confirmed ORR was 31% (sac-TMT as second-line therapy demonstrated a confirmed ORR of 50%) and the disease control rate was 71%. Median DOR was not reached, and the 12-month probability of sustained response was 53%. Median PFS was 5.5 months, with 12-month PFS rate was 29%. Safety with sac-TMT was manageable, the most frequent grade 3 or 4 treatment-related adverse events (AEs) (≥5%) were hematologic toxicities and stomatitis, with no febrile neutropenia events or grade 5 treatment-related AEs.

Professor Ye Dingwei, Vice President of Fudan University Shanghai Cancer Center, stated, "Traditional chemotherapy has limited efficacy for advanced or drug-resistant UC. The emergence of precision medicines like ADCs is breaking through treatment bottlenecks for patients with poor response to chemotherapy. We are delighted to observe the encouraging clinical outcomes achieved by the sac-TMT monotherapy regimen, particularly its outstanding efficacy even among heavily pretreated patients. This development injects new momentum into the treatment landscape for advanced UC and offers patients a more precise therapeutic option."

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as non-small cell lung cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, three indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting), EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy and EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy. Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. In addition, the sNDA for sac-TMT for the treatment of adult patients with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and was included in the priority review and approval process.

As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 15 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, NOV 27, 2025, View Source [SID1234660992])