On November 19, 2025 KaliVir Immunotherapeutics, Inc., a clinical-stage biotechnology company developing cutting-edge, multi-mechanistic oncolytic immunotherapies, reported a clinical trial collaboration and supply agreement with Roche to evaluate VET3-TGI, a novel oncolytic immunotherapy developed using KaliVir’s proprietary Vaccinia Enhanced Template (VET) platform, in combination with Roche’s atezolizumab (Tecentriq).

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The collaboration will support the expansion of KaliVir’s ongoing STEALTH-001 (NCT06444815) Phase 1a/1b clinical study evaluating VET3-TGI in patients with advanced or metastatic solid tumors. Under the terms of the agreement, Roche will supply atezolizumab for use in combination with VET3-TGI across multiple dosing cohorts.

VET3-TGI is KaliVir’s lead oncolytic immunotherapy candidate, designed to directly destroy tumor cells while activating a potent immune response through a proprietary payload that includes interleukin-12 (IL-12) and a TGF-β inhibitor. Combining VET3-TGI with atezolizumab aims to amplify immune activation and reshape the tumor microenvironment, with the goal of broadening and deepening clinical benefit for patients with a range of solid tumors.

"This clinical collaboration with Roche allows us to build on the promising clinical and preclinical data by expanding the evaluation of VET3-TGI beyond monotherapy into combination therapy with an established checkpoint inhibitor," said Helena Chaye, CEO of KaliVir Immunotherapeutics. "Partnering with Roche, a global leader in oncology, represents an important step toward advancing innovative therapeutic strategies and exploring the full potential of this novel combination for patients with advanced solid tumors."

About VET3-TGI and the STEALTH-001 Study

VET3-TGI is a novel oncolytic virus developed using KaliVir’s proprietary VET platform, designed to selectively replicate in tumor cells, stimulate local immune responses and remodel the immunosuppressive tumor microenvironment through the expression of IL-12 and a TGFβ inhibitor. The STEALTH-001 study is a first-in-human, open-label, dose escalation and expansion Phase 1a/1b trial assessing both intratumoral and intravenous administration of VET3-TGI. The STEALTH-001 trial is a dose escalation and expansion study evaluating VET3-TGI administered through direct IT injection and IV infusion. The trial is evaluating VET3-TGI as a monotherapy and in combination with a checkpoint inhibitor in patients with pathologically confirmed, advanced, unresectable or metastatic solid tumors. The study continues to progress as planned through its dose escalation phase.

(Press release, KaliVir Immunotherapeutics, NOV 19, 2025, View Source [SID1234660103])

On November 19, 2025 Purdue Pharma L.P. ("Purdue") reported positive preliminary results from a Phase 1 study of tinostamustine in MGMT promoter-unmethylated (uMGMT) glioblastoma (GBM), a form of aggressive brain cancer with a subset of patients that do not respond or respond poorly to standard-of-care therapy. Tinostamustine was shown to be tolerable at doses of 80 to 100 mg/m², with side effects similar to other anti-neoplastic agents and preliminary signs of efficacy. The results will be shared as a poster at the 2025 Neuro-Oncology Societies Meeting on November 22 in Honolulu, Hawaii. The results were also presented in October at the 2025 European Association for Neuro-Oncology (EANO) meeting.

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Glioblastoma is a fast-growing cancer that occurs in the brain. It is very challenging to treat and there is no cure.1 Most treatments seek to remove or shrink the tumor to help reduce symptoms and prolong survival.1 As many as 15,000 people in the U.S. are diagnosed with glioblastoma each year,2 and nearly 60% of those patients have uMGMT GBM.3

Tinostamustine is an investigational, potential first-in-class, new chemical entity that combines two potentially synergistic mechanisms of action, bifunctional alkylating activity and pan histone deacetylase inhibition (or HDAC inhibition). Tinostamustine has the potential to be a first-line treatment for GBM.

"Newly diagnosed patients with GBM, especially those with uMGMT, experience limited if any survival benefit from current pharmacologic treatment approaches," said Julie Ducharme, Vice President and Chief Scientific Officer, Purdue. "These Phase 1 findings show that tinostamustine can be administered safely following standard chemoradiation. We are encouraged by these results and look forward to advancing tinostamustine through the Phase 2/3 GBM AGILE trial (Glioblastoma Adaptive Global Innovative Learning Environment – NCT03970447), a global adaptive clinical trial for glioblastoma patients led by the Global Coalition for Adaptive Research (GCAR)."

In September 2025, Purdue entered into an agreement to include tinostamustine in GBM AGILE, a pioneering, international adaptive platform trial designed to streamline the clinical trial process and accelerate the evaluation of treatments for glioblastoma. It is led by GCAR, a non-profit corporation and is supported by a global network of clinicians, researchers, biostatisticians, and patient advocacy organizations.

In the current study, the Phase 1, open-label, multicenter dose-escalation trial (NCT05432375) evaluated the safety, tolerability, and preliminary efficacy of tinostamustine following chemoradiation with temozolomide (RT/TMZ), the standard-of-care chemotherapy for GBM. Eligible patients were adults with confirmed uMGMT GBM who had completed RT/TMZ in the past 5 weeks and without disease progression. Tinostamustine was administered as a one-hour intravenous infusion on Day 1 of each 21-day cycle, beginning at 80 mg/m² and escalating to 100 mg/m² using a standard 3+3 design.

Ten patients were enrolled, nine of whom were evaluable for safety and efficacy. The median patient age was 63 years, and most were male. Three patients received tinostamustine at 80 mg/m² without experiencing dose-limiting toxicities (DLTs). Among the six patients treated at 100 mg/m², one experienced a DLT of prolonged low-grade thrombocytopenia. Grade ≥3 treatment-related adverse events were reported in both cohorts, including anemia and hematologic toxicities. Overall, tinostamustine’s side effect profile was considered manageable, and 100 mg/m² was established as the maximum tolerated dose (MTD) per the study protocol.

"Glioblastoma is one of the most devastating cancers, and patients with uMGMT GBM face especially limited treatment options," said Craig Landau, MD, President and CEO, Purdue. "The data generated to date are encouraging and represent a meaningful step forward for tinostamustine, that if successfully developed and ultimately approved by FDA, would provide hope and potential benefit for affected patients and their families. We are encouraged by these preliminary results and committed to advancing innovative science that can transform lives. Tinostamustine reflects the kind of bold innovation we strive for across our pipeline, and we look forward to continuing this important work with urgency and purpose."

While not designed to demonstrate efficacy, exploratory analyses of progression-free and overall survival outcomes showed encouraging signals of clinical activity. Details of these findings will be presented at the scientific meeting. The forthcoming evaluation in the GBM AGILE trial will advance the understanding of tinostamustine’s potential in treating glioblastoma.

This press release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that tinostamustine will successfully complete development or gain FDA approval.

(Press release, Purdue Pharma, NOV 19, 2025, View Source [SID1234660102])

On November 19, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for zidesamtinib, an investigational ROS1-selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI). The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026.

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Nuvalent’s NDA submission is based on results for TKI pre-treated patients with advanced ROS1-positive NSCLC enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial. These data were reported along with preliminary data from the ongoing Phase 2 TKI-naïve cohort of ARROS-1, and presented as part of the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer in September 2025.

About Zidesamtinib and the ARROS-1 Phase 1/2 Clinical Trial
Zidesamtinib is an investigational, novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC.

Zidesamtinib is currently being investigated in the ARROS-1 trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ROS1-positive NSCLC patients who previously received at least one ROS1 TKI, or patients with other ROS1-positive solid tumors who had been previously treated. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of zidesamtinib, with additional objectives including determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The ongoing global, single arm, open label Phase 2 portion is designed with registrational intent for TKI-naïve and TKI pre-treated patients with advanced ROS1-positive NSCLC.

(Press release, Nuvalent, NOV 19, 2025, View Source [SID1234660101])

On November 19, 2025 Dialectic Therapeutics, Inc., a clinical-stage biotechnology company developing innovative anti-cancer drugs, reported that patient dosing is underway in a clinical trial led by the renowned Drs. Elizabeth Stover, Joyce Liu, and Ursula Matulonis from the Dana-Farber Cancer Institute. Dr. Matulonis previously served as the Principal Investigator for the study that led to a recent FDA approval in platinum-resistant ovarian cancer (PROC).

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Dr. Stover, the principal investigator and IND-holder of the study, has recruited the first two patients, with more now being considered for eligibility in this extraordinarily exciting trial. For more information about the trial, including eligibility criteria, call 877-338-7425 or visit: View Source

"The advance of DT2216 to this Phase 1b/2 trial represents a critical milestone, driven by compelling data from our Phase 1a and preclinical studies. We have a remarkable opportunity to impact patients’ lives and are grateful for the leadership of our world-class collaborators at Harvard and Dana-Farber," said John D. Harkey Jr., Executive Chairman of Dialectic Therapeutics, Inc.

"New therapeutic options are very much needed for our patients with platinum-resistant ovarian cancer. The preclinical data is extremely compelling in terms of the likelihood of translating to the clinical setting, and we are very excited to test weekly paclitaxel and DT2216 for ovarian cancer," stated Dr. Ursula Matulonis, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute and professor of Medicine at Harvard Medical School.

Dr. Stover’s trial builds on the Phase 1a clinical data and the preclinical results, generated by Dialectic and Harvard School of Public Health, which demonstrate complete tumor eradication in both in vivo and in vitro ovarian cancer models.

"The preclinical efficacy observed with DT2216 and paclitaxel is among the strongest results we have seen in preclinical models of high-grade serous ovarian cancer. It’s exciting to be able to bring a new potential treatment option to the clinic for our patients," said Dr. Elizabeth Stover, Assistant Professor of Medicine at Harvard Medical School and a medical oncologist in the Division of Gynecologic Oncology.

DT2216 is a novel therapeutic designed to potently and selectively degrade BCL-XL, a key protein used by cancer cells to evade death.

The company’s completed Phase 1a trial enrolled and treated 20 patients across six dose-escalating cohorts. This study established a recommended Phase 2 dose (RP2D) demonstrating a favorable safety and tolerability profile. Biomarkers from patients receiving the RP2D showed that DT2216 degraded the intended BCL-XL target protein in all patients within this dosing cohort, demonstrating powerful and precise target engagement.

In collaboration with Dr. Kristopher Sarosiek at Harvard School of Public Health, the effects of DT2216 were evaluated in cancer cell line and patient-derived xenograft (PDX) models of high-grade serous ovarian carcinoma (HGSOC), including OVCAR3 and the highly chemo-resistant DF83 PDX model. The combination of paclitaxel and DT2216 induced rapid tumor regressions and eradicated the tumors completely. Notably, tumors showed no evidence of regrowth after DT2216 treatment was discontinued.

"As a lab that investigates how tumor cells commit to cell death, we’re encouraged by how cleanly the biology matches the pharmacology. DT2216 selectively engages the target – BCL-XL – and potently initiates tumor cell death in combination with paclitaxel. It’s exactly the trajectory we hope to replicate in patients," stated Dr. Sarosiek, Director of the Cell Death Laboratory at Harvard School of Public Health. "We’ve long sought to develop innovative therapies that directly target the proteins responsible for making tumor cells resistant to treatment, and DT2216 offers us the opportunity to finally achieve this in patients."

(Press release, Dialectic Therapeutics, NOV 19, 2025, View Source [SID1234660100])

On November 19, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercialising first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, reported that at the R&D Day taking place today, it will present the latest data and future plans for three mid/late-stage clinical programs, including ATG-022 (CLDN18.2 antibody-drug conjugate [ADC]), ATG-037 (oral CD73 small molecule inhibitor), and ATG-101 (PD-L1/4-1BB bispecific antibody). The company will also share the latest progress on ATG-125 (B7H3 x PD-L1 bispecific ADC): A B7H3 x PD-L1 targeted therapy featuring "IO + ADC" dual-effect molecules for the treatment of solid tumors and its AnTenGager T-cell engager (TCE) technology platform which incorporates steric hindrance masking, along with updates on several key preclinical programs. In addition, guest expert Prof. Xin Wang, Chief Physician, Drug Clinical Trial Center, National Cancer Center / Cancer Hospital of the Chinese Academy of Medical Sciences, will deliver a keynote session sharing her insights on ATG-022.

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The event will be held today at 14:00 (Beijing Time), both in-person at the Antengene Shanghai office and online via webcast. For further information on how to join the event, please refer to: View Source

1. Building a pipeline of first/best-in-class innovative therapies with strategic focus on four areas

To address major unmet medical needs in the APAC region and globally amid the rapidly evolving innovative drug landscape, Antengene has adopted a forward-looking strategy to build a diverse portfolio covering four major areas – ADCs, immuno-oncology (IO), autoimmune diseases, and TCEs.

ADCs: ATG-022 (CLDN18.2 ADC) is advancing smoothly through clinical development and has generated a steady stream of promising data. In addition, two "IO + ADC" dual-mechanism candidates targeting B7-H3 x PD-L1 and CD24 are progressing well in preclinical development.
IO: ATG-037 (oral CD73 small molecule inhibitor) and ATG-101 (PD-L1/4-1BB bispecific antibody) are progressing smoothly through clinical studies.
Autoimmune diseases: ATG-201 (CD19×CD3 TCE), which is advancing toward clinical studies for the treatment of autoimmune diseases, can mediate complete B cell depletion with reduced risk of cytokine release syndrome (CRS). ATG-207 (undisclosed bifunctional biologics), is a first-in-class preclinical program being developed for T-cell driven autoimmune diseases.
TCEs: Antengene has built a robust portfolio of first/best-in-class programs targeting CD19×CD3, CDH6×CD3, ALPPL2×CD3, LY6G6D×CD3, GPRC5D×CD3, LILRB4×CD3, and FLT3×CD3, offering a wide therapeutic window for addressing unmet clinical needs across autoimmune diseases, solid tumors, and hematologic malignancies.
2. Encouraging data set a solid foundation for further advancement in clinical development

▶ ATG-022 (CLDN18.2 ADC)

Latest data from the Phase I/II CLINCH study: As of November 10, 2025, in patients with moderate to high CLDN18.2 expression (IHC 2+ > 20%), the 2.4 mg/kg dose cohort achieved an objective response rate (ORR) of 40% (12/30), a disease control rate (DCR) of 90% (27/30), and a median overall survival (mOS) of 14.72 months; while the 1.8 mg/kg dose cohort achieved an ORR of 40% (12/30), a DCR of 86.7% (26/30), and a median progression-free survival (mPFS) of 5.45 months. Among patients with low/ultra-low CLDN18.2 expression (IHC 2+ ≤ 20%), those treated at the efficacious dose range of 1.8-2.4 mg/kg achieved an ORR of 28.6% (6/21) and a DCR of 52.4% (11/21). In these results, ATG-022 demonstrated potent antitumor activity in patients with a broad range of CLDN18.2 expression levels.
Broad combinatory potential for front-line treatment: the 1.8 mg/kg cohort demonstrated promising efficacy with only 16.1% of patients experienced grade 3 or higher treatment-related adverse events (TRAEs). This differentiated safety profile uniquely positions ATG-022 as an ADC with best-in-class safety profile and potential to transform first-line standard of care in combination with both immune checkpoint inhibitors (CPIs) and chemotherapy.
Three clinical development pathways: To fully realize the therapeutic potential of its CLDN18.2-targeted therapy ATG-022, Antengene has outlined a clear clinical development roadmap designed to achieve regulatory approval, maximize therapeutic reach, and broaden tumor-type coverage. The strategy includes a near-term approval path through a pivotal Phase III in third and later line gastric cancer patients with moderate to high CLDN18.2 expression; a front-line proof-of-concept Phase II study evaluating ATG-022 in combination with a CPI and the CAPOX regimen, which, if supported by positive results, is expected to advance into a Phase III trial; and A broad indication-expansion effort through the ongoing Phase II study that builds on encouraging activity signals, extending beyond gynecologic tumors to further assess ATG-022 across a wider range of solid tumor types.
▶ ATG-037 (oral CD73 small molecule inhibitor)

Latest data from the Phase I/Ib STAMINA-01 study: As of October 24, 2025, in the subgroup of patients with CPI-resistant melanoma who received the combination regimen (12 patients), the ORR was 33.3%, the DCR was 100%, including 1 complete response (CR) and 3 partial responses (PRs). One of these patients had maintained CR and reported no safety issues despite having been on the treatment for more than two years. In the subgroup of patients with CPI-resistant non-small cell lung cancer (14 patients), the ORR was 21.4%, the DCR was 71.4%, including 3 PRs. These findings suggest that ATG-037 has clinically meaningful therapeutic potential in multiple tumor types, particularly in patients who are CPI-resistant.
Clinical development pathways: existing data show that ATG-037 holds enormous therapeutic potential for the treatment of first-line or CPI-resistant melanoma, with promising potential for expansion into other tumor types. Antengene’s clinical development roadmap for ATG-037 has four main components: 1. combination with CPI for the treatment of CPI-resistant unresectable and metastatic melanoma (second-line treatment); 2. combination with CPI for the first-line treatment of unresectable or metastatic melanoma; 3. active expansion into other tumor types supported by the encouraging proof-of-concept data in CPI-resistant non-small cell lung cancer; 4. explore potential combinations with next-generation CPIs such as PD-1×VEGF bispecific antibody.
▶ ATG-101 (PD-L1/4-1BB bispecific antibody): dose-escalation study of ATG-101 is currently underway in China, the U.S., and Australia, and has already observed favorable safety in varies dosing regimens, thus laying a solid foundation for the future clinical development. One study evaluating ATG-101 in extrapulmonary neuroendocrine carcinoma (EP-NEC) patients will be initiated soon.

3. AnTenGager technology platform: a key driver of innovation

▶ A TCE platform featuring steric hindrance masking: AnTenGager is a proprietary "2+1" second-generation TCE technology platform featuring "2+1" bivalent binding for low-expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize CRS and enhance efficacy. These characteristics support the platform’s broad applicability across autoimmune diseases, solid tumors and hematological malignancies indications. Leveraging this platform, Antengene has discovered multiple investigational programs:

ATG-201 (CD19 x CD3 TCE): ATG-201 is a novel "2+1" CD19-targeted T-cell engager developed on the AnTenGagerTM TCE platform for the treatment of B cell related autoimmune diseases. Preclinical data presented at the 2025 American College of Rheumatology (ACR) Annual Meeting showed that in non-human primate (NHP) models, the monkey surrogate of ATG-201 achieved deep and durable depletion of naïve B cells with a favorable safety profile, characterized by only a very mild and transient increase in cytokine levels. The IND-enabling study of ATG-201 has been completed and the IND-submission is under preparation.
ATG-106 (CDH6 x CD3 TCE): A global first-in-class CDH6 x CD3 targeted TCE being developed for the treatment of ovarian cancer and kidney cancer.
ATG-110（LY6G6D x CD3 TCE): A potential global best-in-class LY6G6D x CD3 targeted TCE being developed for the treatment of microsatellite stable colorectal cancer.
ATG-112 (ALPPL2 x CD3 TCE): A global first-in-class ALPPL2 x CD3 targeted TCE being developed for the treatment of gynecologic tumors and lung cancer.
ATG-125 (B7H3 x PD-L1 bispecific ADC): A B7H3 x PD-L1 targeted therapy featuring "IO + ADC" dual-effect molecules for the treatment of solid tumors.
ATG-207 (undisclosed bifunctional biologics): a global first-in-class bifunctional biologic agent being developed for the treatment of T-cell driven autoimmune diseases, a therapeutic area representing a huge unmet clinical need.
Antengene will strive to further accelerate these highly promising clinical and preclinical programs. The company plans to report additional progress of these innovative programs and update the medical community, patients, and investors on future developmental milestones at a series of upcoming top international conferences.

(Press release, Antengene, NOV 19, 2025, View Source [SID1234660099])