On December 10, 2025 Bantam Pharmaceutical, a clinical-stage company pioneering mitochondrial biology to develop first-in-class medicines for treating aggressive cancers, reported that the first patient was treated at The Princess Margaret Cancer Centre in Toronto, Canada in its Phase 1 clinical trial studying BTM-3566.

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This milestone is an important step as the company begins testing the safety, tolerability, and early signs of effectiveness of BTM-3566 in patients. BTM-3566 is a new type of medicine that targets aggressive cancers by modulating a stress pathway inside cells which may help patients whose cancer has worsened after other treatments.

This first-in-class small molecule works by activating the OMA1-ATF4 integrated stress response (ISR) pathway – a newly described mechanism that governs mitochondrial functions and how cells respond to stress. Instead of targeting an individual protein and its cancer-driver mutations, BTM-3566 specifically uses the machinery of the cancer cell to trigger cell death, making it an ideal treatment option for patients whose cancers no longer respond to standard therapies.

"Enrolling the first patient in our Phase 1 trial is a pivotal milestone in our clinical development efforts," said Michael Stocum, President & CEO of Bantam Pharmaceutical. "Princess Margaret Cancer Centre is an esteemed institution, and we are proud to collaborate with their expert investigators to advance this study for patients with limited treatment options."

Bantam’s Phase 1 program is active in both the U.S. and Canada to study BTM-3566 in lymphomas and solid tumors. The lymphoma cohort includes patients with relapsed/refractory mature B-cell lymphomas. The solid tumor cohort includes a broad range of cancers such as head and neck, lung, gastroesophageal/gastrointestinal, colorectal, sarcomas, uterine, renal and bladder, among others.

"Princess Margaret Cancer Centre is excited to be the first institution to enroll a patient in Bantam’s study of this novel therapeutic approach for those who no longer respond to standard treatments," said Dr. Albiruni Razak, Medical Oncology Lead, Sarcoma at the Princess Margaret Cancer Centre.

Bantam expects to have early information from the first patient available during J.P. Morgan Week in January 2026, along with a full summary of all non-clinical monotherapy and combination data underpinning its regulatory filings in the US and Canada.

For information about the ongoing U.S. trials, visit ClinicalTrials.gov and search NCT06792734 and NCT07266285. For information about the ongoing Canadian trial, visit ISRCTN.com and search ISRCTN15438979.

About BTM-3566

BTM-3566 is a first-in-class small molecule targeting aggressive cancers by activating the OMA1-ATF4 ISR pathway—a newly described mechanism that governs mitochondrial homeostasis and cell survival under stress. Unlike many therapies that target specific tumor mutations, this approach triggers intrinsic apoptotic pathways by modulating mitochondrial function, making it an ideal treatment option when patients progress.
In pre-clinical studies, BTM-3566 demonstrated potent anti-cancer activity, showing complete regressions in patient-derived xenograft (PDX) models of aggressive B-cell lymphomas, including double- and triple-hit DLBCL and in MCL PDX models from patient tumors that progressed on rituximab, BTK inhibitors and CAR-T therapies. BTM-3566 exhibits activity in solid tumors, including tumor regressions in multiple PDX models, where low FAM210B RNA expression is a potential biomarker for patient selection. BTM-3566 also exhibits strong synergy in combination with other drugs, including BH3 mimetics, hypomethylating agents and rituximab, enabling both monotherapy and combination development strategies.

(Press release, Bantam Pharmaceutical, DEC 10, 2025, View Source [SID1234661357])

On December 10, 2025 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported that the Company was selected for a Product Development Research Grant through The Cancer Prevention and Research Institute of Texas (CPRIT), an award valued at more than $7 million. The Company was selected for funding as one of nine awardees out of 164 applicants for its proposal titled ‘Advancing DOC1021: Phase 1/2 Refractory Melanoma Study,’ which aims to expand DOC1021 into early-stage clinical development in a third target indication.

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"We are honored to have CPRIT’s support as we bring DOC1021 into a new and critically underserved indication," said Jay Hartenbach, President and COO of Diakonos Oncology. "Across more than two dozen preclinical tumor models and multiple clinical indications, our personalized dendritic cell vaccine platform has shown a consistent pattern of potent immune activation and efficacy. With CPRIT’s support, we are now able to evaluate whether these same immune mechanisms can also benefit patients with refractory melanoma, a population with significant unmet medical need."

Melanoma is a serious and often aggressive form of skin cancer that arises from melanocytes, the pigment-producing cells in the skin. While many cases can be treated effectively when detected early, some patients experience disease progression despite available therapies such as immune checkpoint inhibitors or targeted therapies. In the case of refractory melanoma, the disease no longer responds to immune checkpoint inhibitors, resulting in limited options and poor clinical outcomes. Diakonos’ planned Phase 1/2 study will evaluate the safety and preliminary efficacy of DOC1021, along with ctDNA and immune biomarker responses, in this particularly high-need patient population.

"Despite the remarkable progress made with targeted therapies and immune checkpoint inhibitors, patients with refractory melanoma still have very limited options," said Ryan J. Sullivan, MD, Director of the Cutaneous Medical Oncology Program at Massachusetts General Brigham Cancer Institute. "DOC1021’s personalized dendritic cell approach, which presents each patient’s own tumor antigens in a viral-mimicking context, offers a compelling new way to re-engage the immune system against tumors that have escaped standard therapies. This trial will allow us to rigorously evaluate whether that biology can translate into meaningful benefit for this high-risk patient population."

Enrollment in the Phase 1 clinical study of DOC1021 for patients with refractory melanoma is expected to begin in January 2026, representing an important step forward in the Company’s efforts to advance this investigational therapy into early-stage clinical development.

About DOC1021

DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy that uniquely combines tumor lysate and amplified tumor-derived mRNA. The immunotherapy is made with a patient’s dendritic cells combined with mRNA and proteins prepared from freshly obtained patient tumor specimens.

The unique double-loading approach, which mimics a viral infection, unlocks a synergistic and exponentially more powerful tumor killing TH1 response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen pool. Moreover, the approach does not require any molecular modification of the patient’s immune cells for manufacturing and does not require preconditioning chemotherapy or high dose IL-2 for administration. DOC1021 allows for simple administration in the outpatient setting and broad reach via community cancer centers.

Diakonos currently has two active clinical trials with DOC102, a Phase 1 pancreatic cancer study (NCT04157127) and a Phase 2 glioblastoma (GBM) study (NCT06805305). Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs, in October 2023 and May 2024, respectively. The company also received Orphan Drug Designation for the GBM program in January 2024. The refractory melanoma Phase 1/2 study with DOC1021 will be initiated with the facilitation and support of the Cancer Prevention and Research Institute of Texas (CPRIT).

(Press release, Diakonos Oncology, DEC 10, 2025, View Source [SID1234661356])

On December 10, 2025 at the San Antonio Breast Cancer Symposium (SABCS), researchers reported the initial findings from a major multi-year collaboration between the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and Caris Life Sciences (Caris) focused on transforming recurrence risk assessment in early-stage breast cancer through artificial intelligence (AI). The public-private partnership pairs ECOG-ACRIN’s extensive clinical trial expertise and biorepository resources with Caris’ comprehensive MI Cancer Seek whole exome and whole transcriptome profiling, whole slide imaging, and advanced machine learning platforms.

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The research teams developed multimodal models to more precisely stratify recurrence risk in early-stage breast cancer. The models integrate histopathologic imaging, clinical, and molecular data generated from TAILORx, one of the world’s largest and most rigorously annotated breast cancer research repositories. This level of multimodal integration is unprecedented at this scale in early breast cancer prognostication.

Early-stage breast cancer represents a large and heterogeneous patient population in which treatment decisions frequently hinge on uncertain recurrence risk. Of the approximately 310,720 new cases diagnosed in the United States each year, an estimated 60% are early-stage (American Cancer Society), underscoring the broad application and clinical relevance of more accurate and individualized risk assessment.

"Realized through collaboration between ECOG-ACRIN, NCI, and Caris Life Sciences, this public-private partnership represents a methodological, logistical, and collaborative integration of datasets from the historically impactful TAILORx trial to further extend the benefits for breast cancer patients," said ECOG-ACRIN Group Co-Chair Peter J. O’Dwyer, MD. "The advance in personalized medicine afforded in this work, in turn, helps to advance the potential of AI to refine treatment and improve outcomes."

Across analytic evaluations, the multimodal AI models demonstrated enhanced prognostic performance compared to existing recurrence-risk assessment methods, highlighting their potential to support more personalized treatment decision-making in early-stage breast cancer.

"By integrating imaging, clinical data, and molecular profiling, we are advancing beyond single-dimension diagnostics to deliver a more precise and comprehensive understanding of recurrence risk in breast cancer," said Caris EVP and Chief Medical Officer George W. Sledge, Jr., MD. "The development of these models underscores the transformative power of multimodal AI and machine learning in precision oncology."

Both AI models-including development approaches, integrated biomarker features, and demonstrated prognostic improvements- were presented in today’s SABCS sessions.

Multimodal Artificial Intelligence (AI) Models Integrating Image, Clinical, and Molecular Data for Predicting Early and Late Breast Cancer Recurrence in TAILORx, presented by Joseph A. Sparano, MD (Mount Sinai Tisch Cancer Center). Late-Breaking Abstract GS1-08 was presented during SABCS General Session 1.

In this project, researchers developed and prospectively validated a multimodal model integrating pathomic imaging (I), clinical (C), and expanded molecular (M+) data from 4,462 TAILORx tumor specimens. The expanded M+ gene expression panel includes 42 tumor genes associated with breast cancer recurrence derived from five commercially available gene assays, including the Oncotype DX (ODX) 21-gene recurrence score and a set of highly variable genes. Based on the results of the TAILORx trial, ODX is widely used in clinical practice for its prognostic information on recurrence and predictive information on chemotherapy benefit; however, its ability to forecast recurrence beyond the 5-year mark is limited.

The findings from this study will ultimately provide crucial support for the development of a new diagnostic test for women with HR-positive, HER2-negative, node-negative breast cancer that more accurately estimates recurrence risk, especially late recurrence 5 or more years after diagnosis.

"Although the TAILORx trial was the first randomized trial to establish the role of the 21-gene recurrence score to guide chemotherapy use in early breast cancer, our goal was to take one step further in personalizing cancer therapy by developing a new diagnostic test using tumor specimens derived from the trial," said Dr. Sparano.

Dr. Sparano noted that the team developed an AI model that evaluates not only tumor gene expression but also uses deep learning of digitized H&E slides used for routine pathologic assessment to provide better prognostic information about cancer recurrence risk.

"We found that the expanded gene panel was a strong predictor of early recurrence within 5 years after diagnosis, the pathomic imaging was a strong predictor of late recurrence after 5 years, and when combined, a test which added both features to the prognostic information provided by clinicopathologic factors was the strongest predictor of distant recurrence out to 15 years," he said.

A Multimodal-Multitask Deep Learning Model Trained in NSABP B-42 and Validated in TAILORx for Late Distant Recurrence Risk in HR+ Early Breast Cancer, presented by Eleftherios (Terry) Mamounas, MD, MPH (NSABP Foundation, Inc. and AdventHealth Cancer Institute). Abstract RF3-07 was presented during SABCS Rapid Fire Session 3.

Patients with early-stage, hormone receptor–positive (HR+) breast cancer are at risk for distant recurrence several years after diagnosis and initial treatment, making long-term risk assessment critical. Assessment of clinical factors alone (tumor size, grade, node status) is insufficient for precise risk stratification. Furthermore, there is a lack of personalized tools to guide decisions about the use of extended endocrine therapy (EET) beyond the standard 5 years.

Dr. Mamounas presented a multimodal–multitask deep learning algorithm designed to estimate late distant recurrence (DR) risk and help identify patients most likely to benefit from EET. Originally developed and validated in the NSABP B-42 randomized phase 3 trial, the model demonstrated strong prognostic performance, identifying those with minimal recurrence risk after a standard 5-year course of adjuvant endocrine therapy who could be spared additional treatment.

The ECOG-ACRIN/Caris research team conducted a new external validation study of the model in 4,300 patients from the TAILORx trial. In TAILORx, the model demonstrated robust late distant recurrence prognostication independent of other known prognostic factors, supporting its potential clinical utility as a scalable, cost-effective alternative to genomic assays using routine H&E and clinical data.

(Press release, ECOG-ACRIN, DEC 10, 2025, View Source [SID1234661355])

On December 10, 2025 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company developing first-in-class therapies for difficult-to-treat cancers, reported a clinical supply agreement with BeOne Medicines, a global oncology company. This agreement will supply a global, multi-center Phase 1b/2a clinical trial to evaluate Senhwa’s lead compound Pidnarulex (CX-5461) in combination with BeOne’s tislelizumab, a PD-1 inhibitor, in patients with advanced solid tumors, including pancreatic ductal adenocarcinoma (PDAC) and immune checkpoint inhibitor (ICI)-refractory melanoma.

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This agreement represents a significant milestone for Senhwa as CX-5461 enters the immuno-oncology field, and it also underscores the company’s commitment to advancing strategic combination therapies that break through the limitations of immunotherapy —bringing new hope to cancer patients worldwide.

Senhwa Biosciences: Driving a New Era in Immuno-Oncology

"This agreement represents a major step forward for Senhwa as we expand into the heart of immuno-oncology," said Benny T. Hu, Chairman of Senhwa Biosciences. "By leveraging the unique mechanism of action of CX-5461 in modulating the tumor microenvironment, we hope to discover and confirm new treatment options for patients who do not currently benefit from existing treatment options, while increasing international recognition and building long-term strategic value for the company," added by Chairman Hu.

Under the terms of the agreement, BeOne Medicines will provide tislelizumab for the combination study, while Senhwa will supply CX-5461 and lead clinical and regulatory operations. The study will enroll patients at multiple sites in the United States and Taiwan, assessing safety, tolerability, and preliminary efficacy of the CX-5461 plus tislelizumab combination.

By modulating the tumor microenvironment, CX-5461 breaks through the barriers of immunotherapy, opening new possibilities for cancer treatment

Discovered and developed by Senhwa, CX-5461 is the world’s first G-quadruplex stabilizer with significant clinical data—a novel therapeutic class designed to selectively disrupt genomic stability in tumor cells through replication stress induction.

Recent preclinical and clinical findings suggest that CX-5461 not only exerts direct cytotoxic activity but also modulates the tumor microenvironment, enhancing immune recognition and response.

By converting immunologically "cold" tumors into "hot" ones, CX-5461 may sensitize previously resistant tumors to checkpoint blockade and broaden the clinical utility of immunotherapy.

The "cold-to-hot" tumor concept represents one of the most promising frontiers in cancer immunology. CX-5461’s differentiated mechanism positions Senhwa to play a leading role in improving the efficacy of the immune checkpoint inhibitors approved by FDA with only 20-30% response rates.

Global Immunotherapy Market: Expanding Horizons

According to Precedence Research, the global cancer immunotherapy market is expected to grow from USD 136.4 billion in 2025 to USD 338.4 billion by 2034, representing a compound annual growth rate (CAGR) of 10.65%. Similarly, Grand View Research projects that the broader immunotherapy market will exceed USD 486 billion by 2030.

As major pharmaceutical companies approach a looming patent cliff—most notably with the immune checkpoint inhibitor blockbuster KEYTRUDA, which is expected to lose its exclusivity in 2028—the industry is ramping up efforts to secure next-generation immuno-oncology assets through strategic partnerships, mergers, and acquisitions.

With its differentiated pipeline, established collaboration with the U.S. National Cancer Institute (NCI), and now entering the supply agreement with BeOne Medicines, Senhwa Biosciences is uniquely positioned at the intersection of scientific innovation and global capital markets. The company aims to play a pivotal role in the next wave of expansion and innovation in precision medicine and immuno-oncology by partnering with global pharmaceutical companies and to drive sustainable growth and long-term value creation for its stakeholders.

(Press release, Senhwa Biosciences, DEC 10, 2025, View Source [SID1234661354])

On December 10, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported it will present data on potential treatments for pancreatic and gastric/gastroesophageal junction (G/GEJ) cancer at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium taking place January 8-10, 2026 in San Francisco, California. Highlights include a late-breaking oral presentation of cohort results from the Phase 2 ILUSTRO study of first-line zolbetuximab in combination with chemotherapy and immunotherapy in claudin 18.2-positive, HER2-negative, locally advanced or metastatic G/GEJ cancer, as well as new Phase 1 data from ASP3082 (setidegrasib), an investigational KRAS G12D targeted protein degrader, in pancreatic cancer.

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Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas
"At Astellas, we are harnessing next-generation treatment modalities and a precision biomarker-driven approach to deliver treatments that make a meaningful difference for patients with gastrointestinal cancers. We’re excited to share data at ASCO (Free ASCO Whitepaper) GI from our growing portfolio of assets in GI cancers – which showcase our commitment to better understanding how to treat these diseases – including emerging data from zolbetuximab as well as progress on ASP3082 (setidegrasib), our investigational KRAS G12D targeted protein degrader. Together with the passionate GI cancer community of patients, physicians, and advocates, we are working to transform outcomes for patients and pave the future of cancer care."

Astellas Presentations at ASCO (Free ASCO Whitepaper) GI 2026

Zolbetuximab

Presentation Title

Presenter

Presentation Details

Phase 2 ILUSTRO trial of first-line
zolbetuximab plus mFOLFOX6 and
nivolumab in patients with claudin
18 isoform 2-positive, human
epidermal growth factor receptor 2-
negative, locally advanced or
metastatic gastric or
gastroesophageal junction
adenocarcinoma

K. Shitara

Type: Oral presentation

Abstract Number: LBA284

Date: January 8, 2026,
8:47 a.m. – 8:57 a.m. PST

Determinants of biomarker testing
and treatment selection by
oncologists caring for patients with
gastric or gastroesophageal
junction adenocarcinoma

R. Fuldeore

Type: Poster

Abstract Number: 453

Date: January 8, 2026,
11:30 a.m. – 1:00 p.m.;
6:00 p.m. – 7:00 p.m. PST

Zolbetuximab + pembrolizumab
and chemotherapy as first-line
treatment for patients with
CLDN18.2-positive, HER2-
negative, PD-L1-positive locally
advanced unresectable or
metastatic G/GEJ
adenocarcinoma: Phase 3, double-
blind, randomized trial (LUCERNA)

K. Shitara

Type: Poster

Abstract Number: TPS473

Date: January 8, 2026,
11:30 a.m. – 1:00 p.m.;
6:00 p.m. – 7:00 p.m. PST

Assessment of the impact of proton
pump inhibitor exposure on
survival outcomes in patients with
gastric or gastroesophageal
junction adenocarcinoma treated
with zolbetuximab plus
chemotherapy

A. Yamada

Type: Poster

Abstract Number: 349

Date: January 8, 2026,
11:30 a.m. – 1:00 p.m.;
6:00 p.m. – 7:00 p.m. PST

A real-world study of claudin 18.2
association with molecular
subtypes, mutations/biomarkers,
immune landscapes, and gene
signatures and prognostic value in
pancreatic ductal adenocarcinoma

G. Zhang

Type: Poster

Abstract Number: 744

Date: January 9, 2026,
11:30 a.m. – 1:00 p.m.;
5:00 p.m. – 6:00 p.m. PST

Treatment patterns and outcomes
of patients diagnosed with
metastatic pancreatic
adenocarcinoma

R. Fuldeore

Type: Poster

Abstract Number: 685

Date: January 9, 2026,
11:30 a.m. – 1:00 p.m.;
5:00 p.m. – 6:00 p.m. PST

ASP3082 (setidegrasib)

Presentation Title

Presenter

Presentation Details

Efficacy and safety of setidegrasib
(ASP3082) monotherapy or in
combination with mFOLFIRINOX in
patients with pancreatic ductal
adenocarcinoma

A. Kasi

Type: Poster

Abstract Number: 704

Date: January 9, 2026,
11:30 a.m. – 1:00 p.m.;
5:00 p.m. – 6:00 p.m. PST

Phase 1 evaluation of setidegrasib
(ASP3082), a first-in-class selective
protein degrader, in patients with
KRAS G12D-mutant pancreatic
ductal adenocarcinoma:
Pharmacokinetics and biomarker
insights

W. Park

Type: Poster

Abstract Number: 775

Date: January 9, 2026,
11:30 a.m. – 1:00 p.m.;
5:00 p.m. – 6:00 p.m. PST

(Press release, Astellas, DEC 10, 2025, View Source [SID1234661353])