1stOncology™: Cancer Intelligence Service – Page 66 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Eisai and Nuvation Bio Enter into Exclusive Licensing Agreement for Taletrectinib in Europe and Additional Countries Outside the U.S., China and Japan

On January 13, 2026 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), a human-centered global leading research-based pharmaceutical company working in the neurology and oncology therapeutic areas, and Nuvation Bio Inc. (NYSE: NUVB, Corporate Headquarters: New York, NY, CEO: David Hung, M.D., "Nuvation Bio"), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported an exclusive license and collaboration agreement that significantly expands the long-term global footprint of taletrectinib (generic name, marketed as IBTROZI in the U.S. and Japan). Taletrectinib is a highly selective, next-generation oral treatment currently approved for patients living with advanced ROS1- positive (ROS1+) non-small cell lung cancer (NSCLC) in the U.S., China, and Japan.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Eisai will now have exclusive development, registration and commercialization rights for taletrectinib for the treatment of ROS1+ NSCLC in Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and India. Nuvation Bio will continue to lead global development and retain full U.S. commercial rights, maintaining its strong focus on U.S. launch activities and ongoing pivotal studies of taletrectinib across early- and late-stage ROS1+ NSCLC.

"Our partnership with Eisai represents a major global expansion milestone for taletrectinib, strengthening the long-term potential of this clinically meaningful treatment option for even more patients living with ROS1+ NSCLC," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "With Eisai’s world-class infrastructure and track record of bringing innovative medicines to market in major regions, we believe the expanse of this collaboration illustrates the commercial potential of taletrectinib while accelerating the opportunity for providers and patients around the world to access this important treatment option."

Under the terms of the exclusive license and collaboration agreement, Eisai will pay EUR 50 million (approx. USD 60 million) upfront and up to EUR 145 million (approx. USD 170 million) in regulatory and commercial milestone payments, as well as double-digit tiered royalties up to the high-teens as a percentage of future net sales in the licensed territories. Following the upfront payment, Eisai will pay the first milestone payment of EUR 25 million (approx. USD 30 million) from this transaction upon achievement of EU regulatory approval (conditional or full) of taletrectinib. The USD amounts are approximated based on an exchange rate of EUR1= USD1.2. Eisai anticipates no changes to its consolidated financial forecast for the period ending March 31, 2026.

"With its efficacy and safety profile, we believe taletrectinib has the potential to become a standard of care for patients with ROS1+ NSCLC in the EU and beyond, as it is already becoming the standard of care in the U.S. just six months from approval," said Terushige Iike, Chief Business Officer of Eisai Co., Ltd. "We are thrilled to partner with Nuvation Bio and prioritize taletrectinib as our flagship oncology product in NSCLC, bringing this innovative medicine to patients as quickly as possible."

A Marketing Authorization Application (MAA) for the treatment of advanced ROS1+ NSCLC is expected to be filed in Europe in the first half of 2026. Additional filings are then planned for Canada and other regions.

In June 2025, the U.S. Food and Drug Administration (FDA) granted full approval to taletrectinib for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy, following a Priority Review and double Breakthrough Therapy designations. Taletrectinib is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON.

(Press release, Eisai, JAN 13, 2026, View Source [SID1234661947])

Oncolytics Biotech® Announces Updated Clinical Data from GOBLET Cohort 4 Demonstrating Activity of Pelareorep Plus Atezolizumab in Third-Line Anal Cancer

On January 12, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported updated clinical data from GOBLET Cohort 4 in patients with third-line metastatic squamous cell anal carcinoma ("SCAC"), a setting with no U.S. Food and Drug Administration ("FDA")-approved treatment options. Previous analysis from this cohort has focused on second-line or later SCAC patients.

Updated GOBLET Cohort 4 Third-Line Anal Cancer Data

As of the current data cut, four of 14 evaluable third-line patients receiving pelareorep and atezolizumab achieved objective responses, resulting in an objective response rate ("ORR") of approximately 29%. These responses included two complete responses and two partial responses. The median duration of response ("DOR") is approximately 17 months (67 weeks), indicating both depth and durability of clinical benefit in a heavily pretreated population.

Patients enrolled in this cohort had progressed following multiple prior systemic therapies and represent a highly refractory disease population. In historical third-line SCAC studies, objective response rates are typically approximately 10% or less, with limited durability.1, 2 There are currently no FDA-approved therapies for patients with third-line anal cancer.

The observed response rate and emerging durability in GOBLET Cohort 4 compare favorably with historical outcomes and highlight the potential clinical relevance of pelareorep plus atezolizumab in this setting of significant unmet medical need.

"As we continue to analyze the Goblet data, we are finding important trends that are helping to shape our clinical development strategy," said Jared Kelly, Chief Executive Officer of Oncolytics. "When you isolate to anal cancer patients with two prior lines of treatment and see a strong signal like this, it points the arrow in a direct line to a registration study in an indication where there are no FDA-approved therapies. We already had good data here, but looking closer, it becomes clearer that we can make an immediate impact on patients’ lives who have no options."

In the second-line setting, pelareorep and atezolizumab achieved a 30% ORR, more than doubling the 13.8% ORR that was approved by the FDA for the current standard of care therapy. Additionally, the median duration of response is 15.5 months for pelareorep and atezolizumab compared to 9.5 months (link to the PR).

Planned Registration Strategy and Accelerated Approval Pathway

If the objective response rate and duration of response observed in GOBLET Cohort 4 are reproduced in the planned registration study, Oncolytics believes the resulting dataset would be sufficient to support accelerated approval in this indication, consistent with regulatory precedent in rare cancers with no available therapies. After initial encouraging feedback from KOLS and the FDA, Oncolytics is planning to have a Type C meeting with the FDA in Q1 2026 to discuss and receive guidance on this development plan.

(Press release, Oncolytics Biotech, JAN 12, 2026, https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-announces-updated-clinical-data-from-goblet-cohort-4-demonstrating-activity-of-pelareorep-plus-atezolizumab-in-third-line-anal-cancer/ [SID1234662101])

Atara Biotherapeutics Provides Regulatory and Business Update on EBVALLO™ (tabelecleucel)

On January 12, 2026 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the EBVALLO (tabelecleucel) Biologics License Application (BLA) as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), who have received at least one prior therapy including an anti-CD20 containing regimen.

The CRL indicates that the FDA is unable to approve the EBVALLO BLA in its present form. The BLA was resubmitted in 2025 after reaching alignment with the FDA on the acceptability of the resubmission criteria and fulfilment of the conditions as identified in the first Complete Response Letter dated 15 January 2025 (First CRL). As we previously disclosed, in the First CRL, the FDA identified a single deficiency regarding Good Manufacturing Practice (GMP) compliance and did not raise any concerns with respect to the safety, efficacy or trial design.

In the current CRL, received after market close on 9 January 2026, the FDA confirmed that the GMP compliance issues had been satisfactorily resolved, and importantly, no safety issues were raised. However, in a complete reversal of position by the FDA, the CRL claims that the single arm ALLELE trial, which was previously confirmed by the FDA as adequate to support the BLA filing, is no longer considered to be adequate to provide evidence of effectiveness for accelerated approval. Furthermore, the FDA stated that the trial’s interpretability is confounded due to trial study design, conduct, and analysis.

The FDA’s new position is contrary to the FDA’s prior guidance to Atara, the FDA’s alignment with Atara on the clinical trial data set, and the acceptance of the trial design as a single arm study as relevant for this patient population at BLA submission. This prior alignment had been reached by Atara and the FDA through multiple, documented meetings held over the past five plus years.

In November 2025, Atara transferred the BLA to Pierre Fabre Pharmaceuticals (PFP), Inc., the U.S. pharmaceutical subsidiary of Pierre Fabre Laboratories. As a first step towards resolution, PFP intends to request a Type A meeting and expects it to be granted within 45 days. PFP and Atara plan to urgently interact with the FDA to find a path forward for the timely accelerated approval of EBVALLO without which patients with EBV+ PTLD have extremely limited treatment options and a life expectancy often measured in weeks to months.

"We are surprised and disappointed by this FDA decision for EBV+ PTLD patients who have a significant unmet need, highlighted by tabelecleucel’s Orphan Drug designation and by the granting of Breakthrough status at the time we submitted the ALLELE primary data," said Cokey Nguyen, President and Chief Executive Officer of Atara. "The issues highlighted in the CRL were issues Atara and the FDA aligned on in previous reviews or communications. We had aligned with the agency to accept an Accelerated Approval and to perform a post marketing confirmatory study to support full approval. We proceeded with the BLA submission on this basis and continued all remediation efforts after the resubmission in 2025, in full reliance of the confirmation provided by the FDA. We strongly believe that tabelecleucel can bring substantial benefit to post-transplant lymphoproliferative disease patients, and look forward to addressing the concerns of the FDA clinical review team newly in place alongside our partners."

Corporate and Financial Updates

In December 2025, Atara amended the commercialization agreement with Pierre Fabre Medicament (PFM) to, among other things, mitigate the impact of the cost of rebuilding commercial inventory in the United States. Under the terms of the amendment, Atara agreed to reduce the milestone payment due upon BLA approval to $31 million in exchange for the right to receive an additional $15 million potential milestone payment upon achieving a certain commercial milestone.

Cash, cash equivalents and short-term investments as of December 31, 2025, totaled approximately $8.5 million.

In 2025, Atara implemented significant operational efficiencies, including an approximately 90% reduction in headcount year over year, and transitioned substantially all tab-cel activities and associated costs to Pierre Fabre Laboratories including all regulatory, clinical and CMC responsibilities.

Additionally, in November 2025, we amended our Atara Research Center (ARC) lease agreement reducing our square footage and remaining lease liability by approximately 65%.

This estimate of our cash, cash equivalents, short-term investments and accounts receivable as of December 31, 2025, is preliminary, and has not been audited and is subject to change upon completion of our financial statement closing procedures. Our independent registered public accounting firm has not audited or performed any procedures with respect to this estimate. Additional information and disclosure would be required for a more complete understanding of our financial position and results of operations as of December 31, 2025.

(Press release, Atara Biotherapeutics, JAN 12, 2026, View Source [SID1234662053])

Oncovita announces a strategic partnership with Infinitusbio.AI to explore the design and optimize the development of new therapeutic candidates from its Measovir® platform

On January 12, 2026 Infinitusbio.AI, a U.S.-based Pharmatech company and creator of the proprietary Simulative AI Digital Cell Clone platform, and Oncovita, a Paris-based biotechnology company spun out of the Institut Pasteur and specialized in in situ cancer immuno-oncolytic virotherapy, announce a strategic partnership aimed at accelerating the development of next-generation cancer immunotherapies while creating long-term value for both companies. The partnership follows infinitusbio.AI’s successful Digital Cell Clone simulations using Oncovita’s vaccine candidates, which confirmed the wet‑lab results generated by Oncovita.

On the J.P. Morgan Healthcare Conference, held in San Francisco from January 12 to 15, Stéphane Altaba, CEO, and Patrick Spies, CFO of Oncovita, will present the company and this new partnership with infinitusbio.AI during a SimulativeBio session hosted at PricewaterhouseCoopers LLP on Wednesday, January 14, from 3:30 p.m. to 7:00 p.m. (PST). The session will explore the theme: "Cells, Machines, and the Future of Pharma: The case for simulative AI as the viable approach to modeling complex biological systems at scale."

In addition, Oncovita will present its strategy and latest developments at the RESI Conference on Tuesday, January 13 at 4:00 p.m. (PST) at the Marriott Marquis Hotel, San Francisco.

A strategic partnership to optimize the development of new therapeutics candidates from its Measovir platform.
This collaboration combines infinitusbio.AI’s unique Simulative AI Digital Cell Clone platform with Oncovita’s deep expertise in developing new cancer treatments based on genetically modified Measles vaccine virus, creating a powerful engine for faster, more cost‑efficient advancement of new oncology therapies.
The partnership will leverage infinitusbio.AI’s Digital Cell Clone platform, which can directly incorporate real‑world patient data to strengthen the IND‑enabling process by integrating it with animal testing results.
Oncovita’s Measovir proprietary platform enables the creation of customized therapeutic candidates based on the safe and lifelong protective measle vaccine to target solid tumor cancers. infinitusbio.AI will support Oncovita in selecting additional cancer indications for its current candidate MVdeltaC and suitable payloads for its future candidates, enabling efficient expansion of Oncovita’s drug pipeline and enhancing the company’s overall value.

« We’re delighted to enter this collaboration and advance our next generation immunotherapy programs with the support of infinitusbio.AI’s Digital Cell Clone platform. The partnership follows infinitusbio.AI’s successful Digital Cell Clone simulations using Oncovita’s vaccine candidates, which confirmed the wet‑lab results generated by Oncovita. Integrating infinitusbio.AI’s unique capabilities into our research aligns perfectly with our commitment to adopting smarter, more efficient R&D practices. This partnership will help us broaden the applicability of our Measovir platform to address additional cancer types, design new payloaded-engineered candidates and significantly shorten the time needed to deliver new therapies to patients.", said Stephane Altaba, CEO of Oncovita.

"We are very pleased to begin this strategic partnership with Oncovita, an exceptionally innovative French biotech company. We believe the combination of infinitusbio.AI’s Digital Cell Clones Lab platform and Oncovita’s deep expertise in immune-onco virotherapy will clearly demonstrate the transformative power of Simulative AI—from accelerating disease‑target discovery to optimizing clinical trial design. As we look ahead to an exciting 2026, we are confident this collaboration will drive meaningful progress in Oncovita’s next generation immunotherapy treatment development for the benefit of patients," explains Khai Pham, Founder & CEO of infinitusbio.AI.

Oncovita’s development strategy includes combination‑therapy to enhance efficacy in specific clinical settings. infinitusbio.AI’s platform can accelerate this exploration without requiring a dedicated training dataset, using its Human Cell Intelligent Model that can auto‑differentiate into any digital cell clone within minutes to infer potential outcomes.
infinitusbio.AI’s mechanistic digital cell clones will play a key role in validating the mechanism of action of Oncovita’s next generation immunotherapy, providing deeper insights into its biological efficacy. infinitusbio.AI’s digital cell clones will enable comparative analyses, helping Oncovita evaluate its cancer immunotherapy against existing cancer therapies.
The collaboration will also support Oncovita in identifying predictive biomarkers that can guide patient selection and improve clinical success.

(Press release, Oncovita, JAN 12, 2026, View Source [SID1234662042])

Bio-Sourcing and Zerion Pharma Join Forces to Develop First HER2 Oral Monoclonal Antibody Against Breast Cancer

On January 12, 2026 Bio‑Sourcing and Zerion Pharma A/S reported that their joint project to develop an oral formulation of Trastuzumab, the pioneer monoclonal antibody used to treat breast cancer, has been awarded funding under EUREKA Eurostars. This is Bio‑Sourcing’s second Eurostars success and, together with Zerion’s breakthrough Dispersome technology, it will support the development of an oral formulation of an anti‑HER2 antibody for the treatment of HER2‑positive breast cancer.

The program brings together Bio‑Sourcing’s disruptive BioMilk platform—which leverages natural milk components to protect and transport biologics through the gastrointestinal tract and has already been used to produce TrastuzOral —and Zerion’s solid oral‑dosage capabilities using its protein‑based Dispersome technology. Over 36 months, the consortium will optimize an orally deliverable trastuzumab biobetter produced in goat’s milk and progress it through preclinical validation, with the ambition to prepare for entry into Phase I clinical studies around 2030. The total project budget is €1.3 million, with Bio‑Sourcing as lead and Zerion as partner.

An effective oral therapy for HER2 breast cancer has the potential to move care beyond infusion centers, improving patient convenience and adherence while reducing pressure on healthcare resources. The differentiated oral route offers a compelling value proposition in a mature trastuzumab market and creates a platform opportunity to expand oral delivery to other biologics. With the global trastuzumab market estimated at $4.1 billion by 2030, an orally delivered formulation offers clear differentiation and the potential to both capture a significant share of this demand as well as increase overall market size.

Bertrand Mérot, CEO of Bio‑Sourcing: "We are delighted and very proud of Eurostars’ confirmation of the relevance of our unique strategy for oral administration of monoclonal antibodies. I am confident that our partnership with Zerion will further accelerate the development and commercialization of this disruptive formulation for breast cancer. Bio-Sourcing is thus continuing its strategy of developing oral administration of monoclonal antibodies, which has already led to the production of OralimuMab and TrastuzOral in a synergistic partnership with Zerion to further enhance this paradigm shift. The development of this breakthrough in the systemic oral administration of monoclonal antibodies will not only greatly improve patient comfort but also increase access to these innovative treatments, thereby significantly expanding the biopharmaceutical markets."

Ole Wiborg, CEO of Zerion Pharma A/S: "We are excited and very pleased to obtain this Eurostar grant together with Bio-Sourcing. I believe that our joint project holds a significant promise for improving the treatment of breast cancer patients and will further open up a plethora of additional opportunities for switching injectables to orally administered drugs. This blue stamping from EUREKA is also another recognition of our Dispersome technology and our excellent team of scientists that has relentlessly transformed great academic science into a commercially successful technology. I am grateful for that."

Eurostars forms part of the Horizon Europe framework and supports innovative SMEs and project partners—including universities and research organizations—through funding for international collaborative R&D and innovation projects. It is managed by EUREKA, an intergovernmental network covering 37 countries.

(Press release, Zerion, JAN 12, 2026, View Source [SID1234662004])