On January 7, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported the expansion of its gastrointestinal ("GI") Tumor Scientific Advisory Board ("SAB") with the appointment of Dr. Eileen O’Reilly, Dr. Neil Segal, and Dr. Van Morris, three globally recognized experts in gastrointestinal oncology. The GI SAB was recently established to support Oncolytics’ growing portfolio of clinical programs in pancreatic, colorectal, and anal cancers and to guide the Company’s strategy as it advances pelareorep as a platform immunotherapy across GI tumors.

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Dr. Eileen O’Reilly is the Winthrop Rockefeller Endowed Chair of Medical Oncology at Memorial Sloan Kettering Cancer Center ("MSK") and an internationally recognized leader in pancreatic cancer research and treatment.

"The data emerging with pelareorep across gastrointestinal cancers add to the growing evidence of immunotherapy’s potential in these diseases," said Dr. O’Reilly. "The opportunity to help guide a program that has demonstrated durable responses and encouraging survival signals across multiple tumor types is an important one."

Dr. Neil Segal is the Research Director of the Division of Gastrointestinal Oncology at MSK and an expert in translational oncology and biomarker-driven development.

"Pelareorep’s immunomodulatory potential across solid tumors warrants further evaluation as a potential therapeutic approach," said Dr. Segal. "I look forward to contributing scientific guidance as Oncolytics advances its clinical development program and explores collaborative opportunities."

Dr. Van Morris is an Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, TX, where he also serves as the Section Chief for Colorectal Cancer.

"I have a strong belief in the potential of immunotherapies like pelareorep to help patients in the gastrointestinal cancer setting," said Dr. Morris. "This drug candidate has shown very promising findings in early trials for patients with colorectal and anal cancers, which should be further studied as soon as possible. I look forward to shepherding pelareorep through these next steps of its development."

Jared Kelly, Chief Executive Officer of Oncolytics Biotech, commented: "We’re thrilled to welcome Drs. O’Reilly, Segal, and Morris to our GI SAB. Each brings deep clinical and strategic expertise that will be instrumental as we advance pelareorep through late-stage development. Our focus remains on moving forward with studies that aim to deliver new treatments for patients with difficult GI tumors—programs with total addressable markets so significant that large pharma should take notice. Pelareorep represents a rare example of a true immunotherapy platform with broad applicability across gastrointestinal cancers, and we are strategically positioned to maximize its impact."

With the addition of these distinguished members, Oncolytics’ GI SAB now includes six global experts representing leading academic and clinical institutions across North America and Europe. The inaugural three members include Sanjay Goel, M.D., M.S., FASCO, Professor of Medicine and Director of the Phase I Program at Rutgers Cancer Institute of New Jersey; Deva Mahalingam, M.D., Ph.D., Professor of Medicine, GI oncologist and Director of the Developmental Therapeutics Program, Lurie Cancer Center at Northwestern University; and Dirk Arnold, M.D., Ph.D., FESMO, Principal Investigator of the GOBLET study, Professor of Medicine, and Director of Asklepios Tumorzentrum Hamburg, Germany. The GI SAB will continue to provide guidance on study design, clinical strategy, and translational initiatives as the Company advances its pancreatic, anal, and colorectal cancer programs toward registration-enabling trials.

Review of clinical data for pelareorep in GI cancers

In first-line pancreatic ductal adenocarcinoma, an aggregated analysis of pelareorep’s efficacy across multiple clinical studies and over 100 patients showed the two-year overall survival ("OS") rate was ~22.0% for pelareorep-based treatment regimens compared to a historical benchmark of ~9.0% (link to the PR).

The current approved standard of care for second-line or later squamous cell anal carcinoma patients is a checkpoint inhibitor monotherapy that recorded an objective response rate ("ORR") of 13.8%, whereas the combination of pelareorep and a checkpoint inhibitor generated an ORR of 30% (link to the PR).

Second-line KRAS-mutant metastatic colorectal patients who received pelareorep and FOLFIRI + bevacizumab recorded 16.6 months progression-free survival compared to 5.7 months for the historical control of FOLFIRI + bevacizumab, and 27.0 months compared to 11.2 months for OS (link to the PR). Further analysis of data from this study resulted in an ORR of 33% for patients receiving the pelareorep-based combination regimen compared to 6-11% for the historical benchmark (link to the PR).

Oncolytics is planning pivotal studies in all three of these indications and will continue to engage the U.S. Food and Drug Administration ("FDA") where needed while simultaneously moving each indication forward.

(Press release, Oncolytics Biotech, JAN 7, 2026, View Source [SID1234661806])

On January 7, 2026 Arbele, a biotechnology company focused on developing innovative targeted cancer therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ARB1002, its investigational antibody-drug conjugate (ADC) for the treatment of pancreatic cancer.

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ARB1002 is composed of an anti-CDH17 monoclonal antibody chemically linked to a potent cytotoxic agent. The ADC is designed to selectively bind CDH17, a cell-surface adhesion molecule overexpressed in pancreatic cancer, enabling targeted delivery of the cytotoxic payload to tumor cells while limiting off-target exposure.

"Orphan Drug Designation for ARB1002 marks a significant regulatory milestone for Arbele and reflects the critical need for new treatment options for patients with pancreatic cancer," said Dr Linda Wu, Chief Development Officer of Arbele. "This designation reinforces our confidence in the therapeutic potential of ARB1002 and supports its continued advancement through clinical development."

Pancreatic cancer is among the deadliest solid tumors, with limited effective therapies and poor long-term survival outcomes. The FDA’s Orphan Drug Designation program is intended to incentivize the development of therapies for rare diseases affecting fewer than 200,000 patients in the United States, offering benefits that may include tax credits for qualified clinical development expenses, exemption from certain FDA user fees, and seven years of market exclusivity following regulatory approval.

ARB1002 is planned to enter a Phase 1 clinical trial this year, with Arbele completing IND-enabling studies to support its clinical evaluation in pancreatic cancer.

"This designation highlights CDH17 as a promising target in pancreatic cancer and validates Arbele’s ADC development strategy," added Dr Tony Wong, Chief Technology Officer. "We look forward to continued engagement with the FDA as we progress ARB1002."

(Press release, ARBELE, JAN 7, 2026, View Source [SID1234661821])

On January 7, 2026 Ottimo Pharma ("Ottimo"), an innovative, clinical-stage biotech company developing one-of-a-kind PD-1/VEGFR2 dual-paratopic antibodies to extend the lives of patients living with cancer, reported the US Food and Drug Administration clearance of the investigational new drug (IND) application for its lead candidate OTP-01. The first patient has been dosed and recruitment is well underway. All manufacturing of OTP-01 is occurring solely in the US.

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"I am proud of our Ottimo team for their remarkable speed in bringing OTP-01 into the clinic since coming out of stealth," said David Epstein, Chair and Chief Executive Officer of Ottimo Pharma. "We are developing this unique, first-in-class antibody to be the ideal backbone therapy to combine with Antibody Drug Conjugates or chemotherapy, with the aim of creating a new standard of care across a wide range of solid tumors."

The broad Phase I/IIA, open-label, multicenter study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of OTP-01. The study is enrolling patients in the US and Australia and will expand to approximately 20 centers globally.

"Our aim is to fully assess the potential of this distinctive antibody by generating comprehensive clinical and translational data to inform both dose selection and combination strategies, and to ​set the stage for broad development across multiple tumor types," said Dr. Mehdi Shahidi, Head of Development and Chief Medical Officer of Ottimo.

About OTP-01
OTP-01 is a first-in-class, investigational Fc-null, IgG1 monoclonal antibody featuring a unique dual-paratopic design that enables simultaneous engagement of the PD-1 immune checkpoint and the VEGFR-2 angiogenic pathway. As a single agent, OTP-01 maintains conventional IgG architecture, supporting optimal manufacturability and stability. Preclinical data supports the potential of OTP-01 to provide potent PD-1 inhibition combined with uniquely engineered allosteric VEGFR2 receptor inhibition (targeting ligands A/C/D) and modulates multiple immune subsets while optimally promoting tumor vascular normalization. This integrated dual-target engagement is designed to drive tumor microenvironment-biased distribution and enhance intratumoral immune activation. In addition, pre-clinical studies have demonstrated significantly improved anti-tumor efficacy and intratumoral CD8+ T cell infiltration compared to PD-1 inhibition alone. As a one-of-a-kind, next-generation investigative therapy for solid tumors, OTP-01 aims to offer a wider therapeutic window for patients, with the potential to improve outcomes across multiple indications. The antibody is produced with high manufacturing efficiency in the U.S.

(Press release, Ottimo Pharma, JAN 7, 2026, View Source [SID1234661807])

On January 7, 2026 Rakuten Medical, Inc., a global biotechnology company developing and commercializing its proprietary Alluminox platform-based photoimmunotherapy, reported the closing of a $100 million Series F financing round. This includes $70 million in new capital and the conversion of $30 million in convertible promissory notes with accrued interest.

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This upsized financing doubles Rakuten Medical’s initial target, underscoring strong investor confidence in its execution capabilities and the potential of the investigational Alluminox platform-based photoimmunotherapy, an innovative cancer treatment modality.

Toward U.S. Approval of ASP-1929
Rakuten Medical will utilize the Series F proceeds to advance its top priority: securing U.S. regulatory approval for ASP-1929, Rakuten Medical’s designation for its first investigational photoimmunotherapy drug. The company is currently enrolling patients into its global Phase 3 trial (ASP-1929-381, NCT06699212), evaluating ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line therapy for recurrent head and neck cancer. The proceeds will allow Rakuten Medical to strengthen its operational capabilities to accelerate enrollment in the U.S., Taiwan, Japan, Ukraine and Poland. Based on trial results, Rakuten Medical aims to submit a Biologics License Application (BLA) to the U.S. FDA in 2028.

Global Expansion and Broader Clinical Development
Rakuten Medical is leveraging the regulatory dossier submitted in Japan for its approved drug Akalux (ASP-1929) and the BioBlade Laser System device, along with post-market real-world data, to supplement its efforts in seeking approvals in additional countries. With support from strategic partners who have deep expertise in regional regulatory environments, the company aims to accelerate these efforts.

Disclaimer: Rakuten Medical’s Alluminox platform-based photoimmunotherapy is investigational outside Japan.

In parallel, Rakuten Medical is expanding development beyond head and neck cancer through internal programs and support for investigator-initiated trials (IITs). These studies will utilize grants and other funding sources to ensure efficient progress. Additionally, the company will continue driving commercial growth of ASP-1929 photoimmunotherapy for head and neck cancer in Japan, both to expand profitability for the Japan entity and to establish a reliable funding engine to fuel global expansion.

Development Program Beyond Head and Neck Cancer

Solid tumors (including malignant skin tumors): Initiate Phase 1 trial of RM-0256 photoimmunotherapy in Japan in Q2 2026, supported by AMED1 grant funding.
Esophageal and gynecologic cancers: Support two ongoing IITs of ASP-1929 photoimmunotherapy in Japan; the gynecologic cancer IIT is supported by AMED funding.
Pancreatic and non-small cell lung cancers: Support two planned IITs of ASP-1929 photoimmunotherapy in the U.S., potentially supported by external grants
International Composition of Investors
The Series F round was led by TaiAx Life Science Fund L.P. (TaiAx), an international life science venture capital fund. TaiAx was jointly established by Taiwania Capital Management, based in Taipei, Taiwan, and Axil Capital Group, based in Tokyo, Japan.

The round included the largest institutional investor group in company history, including major Japanese financial institutions—Daiwa Securities, Mitsui Sumitomo Insurance, Sumitomo Mitsui Banking—and Taiwanese venture firms ABIES Capital and Nexus CVC. Strategic partner OEP Group also joined, along with existing investors, including SBI Group, Rakuten Group, Inc. and Mickey Mikitani, Rakuten Group Chairman and CEO and Rakuten Medical CEO.

This round creates an exceptionally diverse investor base for Rakuten Medical, anchored in key global markets: the U.S., Japan and Taiwan.

Mickey Mikitani, CEO of Rakuten Medical, commented:
"Securing significant investment from leading life science investors underscores the strength of our technology and the excellence of our team. The Alluminox platform underlines a new treatment modality that requires advanced expertise in both drug development and medical device technology. Rakuten Medical is tightly focused and mission driven, having successfully developed, received approval for and commercialized an innovative therapy in 15 years. This financing will enable us to accelerate clinical development, expand our global reach and prepare for the next phase of growth."

Michael Huang, Managing Partner of Taiwania Capital Management, commented:
"This oversubscribed Series F financing reflects our strong conviction in Rakuten Medical’s differentiated technology and its ability to address profound unmet medical needs. We are thrilled to lead this round and to form a strong, like-minded global syndicate united by a shared vision to advance the future of cancer care."

(Press release, Rakuten Medical, JAN 7, 2026, View Source [SID1234661822])

On January 7, 2026 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that management will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 3:45 pm PT in San Francisco.

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A live webcast of the presentation can be accessed by visiting the Events and Presentations section of the Company’s website: View Source The webcast will be archived for a limited time following the presentation.

(Press release, Protara Therapeutics, JAN 7, 2026, View Source [SID1234661808])