Ono Shares Replay Information for 44th Annual J.P. Morgan Healthcare Conference Presentation

On January 15, 2026 Ono Pharmaceutical Co., Ltd. (TSE:4528), reported that Toichi Takino, President and COO, presented at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 11:15 a.m. PST / 2:15 p.m. EST.

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An audio recording of the event is available here and accessible until February 15, 2026.

(Press release, Ono, JAN 15, 2026, View Source [SID1234662064])

Agenus Announces Closing of $141M Strategic Collaboration with Zydus Lifesciences to Advance BOT+BAL and Strengthen U.S. Manufacturing Readiness

On January 15, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported the closing of its previously disclosed strategic collaboration with Zydus Lifesciences Ltd. The agreement is designed to accelerate global development and potential commercialization of Agenus’ botensilimab and balstilimab (BOT+BAL) immunotherapy combination program.

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The collaboration provides Agenus with strategic capital and committed, long-term biologics manufacturing capacity in the United States to support BOT+BAL clinical development, authorized early access pathways, and commercial supply preparation.

As part of the collaboration, Agenus has granted Zydus exclusive rights to develop and commercialize BOT and BAL in India and Sri Lanka, with Agenus eligible to receive royalties on net sales in those territories.

The collaboration, first announced on June 3, 2025, included the following key financial terms:

Upfront Consideration: $75 million cash payment to Agenus for transfer of biologics manufacturing facilities in Emeryville and Berkeley, California
Equity Investment: $16 million purchase by Zydus of Agenus (AGEN) common stock (~2.1 million shares at $7.50 per share)
Contingent Milestone Payments: Up to $50 million payable to Agenus, triggered by BOT+BAL production orders
Exclusive License: Zydus obtains exclusive rights to develop and commercialize BOT and BAL in India and Sri Lanka, with Agenus eligible to receive a 5% royalty on net sales in those territories
"Closing this collaboration with Zydus strengthens our balance sheet and, critically, secures dedicated U.S. manufacturing capacity at a pivotal moment for Agenus," said Dr. Garo Armen Ph.D., Chairman and Chief Executive Officer of Agenus. "With these foundations in place, our focus in 2026 is disciplined execution—advancing our Phase 3 program, broadening paid patient access through authorized pathways, and progressing toward regulatory submission supported by one of the most substantial clinical datasets generated in MSS colorectal cancer."

In 2025, the BOT+BAL combination demonstrated a two-year overall survival rate of 42% and a now-mature median overall survival of 21 months in an expanded cohort of 123 patients with third-line or later microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases. Building on these results, Agenus, in collaboration with Canadian Cancer Trials Group (CCTG) has initiated the global BATTMAN Phase 3 trial, with sites activated and prepared to enroll patients.

Following the closing, the Emeryville and Berkeley, California biologics manufacturing facilities will be transferred to Zydus and housed under a newly formed subsidiary named Zylidac Bio LLC. Agenus has secured committed manufacturing capacity at these U.S. sites to support BOT+BAL supply needs for their clinical trials, global access programs and future commercialization.

This transaction further positions Agenus to execute on its near- and long-term strategy as interest in BOT+BAL continues to grow globally.

Commenting on the finalization of the deal, Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited., stated, "With this deal, Zylidac Bio LLC will now provide biologicals manufacturing sites offering CDMO services to biopharmaceutical companies globally. This supports the evolving landscape of biological product manufacturing in the U.S., which prioritizes secure, domestic, and high-quality supply chains for advanced therapies. Zylidac Bio LLC offers a critical, compliant solution for global innovators and allows for a localized supply chain. It reinforces our ability to serve the international biopharmaceutical industry with reliability and innovation."

Advisors

As part of this effort, Agenus was advised by Porrima Ltd and Biotech Value Advisors (BVA), who provided guidance on partner selection, transaction structure, and negotiations.

(Press release, Agenus, JAN 15, 2026, View Source [SID1234662065])

Saudi FDA Grants Accelerated Approval to ImmunityBio’s ANKTIVA® for Non-Muscle Invasive Bladder Cancer with Carcinoma In-Situ

On January 14, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported that the Saudi Food and Drug Authority (SFDA) has granted approval of ANKTIVA (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary disease. This regulatory action by the SFDA adds to the existing approvals in the United States and United Kingdom, as well as conditional approval in the European Union.

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"We are pleased to bring ANKTIVA to Saudi patients with NMIBC, who otherwise have no viable options but life-altering surgery," said Rich Adcock, Chief Executive Officer, ImmunityBio. "At ImmunityBio, we’re committed to using our innovative science to improve the health of people around the world, and we continue investing in research and clinical trials that we believe are essential to fulfilling that mission."

ImmunityBio plans to open a regional office in the Kingdom of Saudi Arabia to support physicians and health systems across the Middle East and North Africa. The company will collaborate with Biopharma Cigalah as its commercial and distribution partner in the region. Founded in 2007, BioPharma Cigalah provides the commercial infrastructure and capabilities needed to support therapies for serious diseases and expand patient access throughout the Middle East and North Africa.

"The incidence of bladder and other cancers in the Middle East and North Africa is large and growing, demonstrating a significant unmet need for the kind of innovative treatments ImmunityBio is developing," added Mr. Adcock. "We are pursuing approvals across the region to fill that need, as well as investing in a regional office in Saudi Arabia in order to support our expansion into these growing markets."

The randomized QUILT-2.005 trial in BCG-naïve patients comparing BCG alone to BCG plus ANKTIVA is ongoing, and enrollment has exceeded expectations. Enrollment is on track to be completed by Q2 2026, with a potential BLA submission by year-end.

About ANKTIVA (nogapendekin alfa inbakicept)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the Company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, JAN 14, 2026, View Source [SID1234662051])

Fresenius Kabi, TQ Therapeutics Announce Cell Therapy Technology Agreement

On January 14, 2026 Fresenius Kabi, an operating company of Fresenius, and TQ Therapeutics, reported they have entered into a strategic-development agreement under which Fresenius Kabi has an exclusive license to develop, manufacture, and distribute products that incorporate TQ Therapeutics’ proprietary cell selection technology. The goal of the agreement is to advance cell and gene therapy accessibility by enabling scalable and efficient cell therapy manufacturing.

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Fresenius Kabi is a leading provider of essential medicines and medical technologies. TQ Therapeutics specializes in proprietary cell selection technology and following therapeutic applications. Under the agreement, TQ Therapeutics’ affinity and column-based cell isolation technology will be integrated into Fresenius Kabi’s Cue Cell Processing System. By combining these technologies, the companies aim to create an automated and robust system that can isolate T cells from whole blood and apheresis products in less than two hours for cell and gene therapy manufacturing applications. The goal is to quickly, easily and consistently produce high purity T cells, helping therapeutic developers work more efficiently and potentially bring treatments to patients faster.

"With this collaboration, we are reinforcing our commitment to innovation in cell and gene therapy technology," said Saurabh Bhasin, Head of Portfolio, Cell Therapies & Contract Manufacturing Operations at Fresenius Kabi. "By integrating TQ Therapeutics’ novel selection technology into our Cue system, our aim is to improve manufacturing success and scalability—key steps toward supporting the advancement of cell and gene therapies."

TQ Therapeutics’ goal is to leverage the Cue system and its integrated cell selection column technology to develop extracorporeal, ultra-short cell and gene therapy processes for clinical applications creating faster steps that can be performed closer to the point of care to help simplify and accelerate treatment workflows.

"This agreement with Fresenius Kabi allows us to bring our proprietary technology to a broader audience with the goal of accelerating the development of next-generation cell therapies," said Christian Eckert, chief executive officer of TQ Therapeutics. "With Fresenius Kabi’s expertise in cell and gene therapy device technologies development and commercialization, and TQ Therapeutics’ focus on developing ultra-short processes for clinical cell therapies from manufacturing to in vivo applications, we are creating a novel value proposition for scaling and enabling the supply of cell therapies for broader patient populations."

Cell and gene therapy is an emerging segment of medicine that has shown promise in treating certain cancers and other conditions.

Phacilitate Advanced Therapies Week 2026

Fresenius Kabi and TQ Therapeutics will debut the Cue Cell Processing System and the in-development cell selection module at Booth #623 on February 10-12 during Phacilitate ATW 2026 in San Diego, CA. Attendees are invited to visit the booth to learn more about the technology and its development.

(Press release, Fresenius, JAN 14, 2026, View Source [SID1234662052])

C4 Therapeutics Outlines Strategic Milestones to Advance Cemsidomide as a Potential Best-in-Class IKZF1/3 Degrader and Discovery Strategy Focused on Novel Targets in Clinically Validated Pathways

On January 14, 2026 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported milestones through 2028 and highlighted recent achievements.

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"We begin 2026 with compelling opportunities ahead, anchored by cemsidomide’s path to become a foundational medicine for multiple myeloma by reaching patients across multiple lines of therapy. As we prepare to initiate two cemsidomide trials in the coming months, we believe the emerging data exploring the class in combination with BiTE therapies derisks our strategy to rapidly advance cemsidomide through registrational development," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "We are equally excited about our new discovery strategy that leverages a decade of learnings in the TPD field as well as the strengths of our platform to address unmet needs for inflammation, neuro-inflammation and neuro-degenerative diseases by degrading novel targets that modulate validated inflammatory pathways. Our strong balance sheet provides cash runway through key inflection points, keeping us positioned to advance our portfolio and create transformative medicines for patients."

Anticipated Key Strategic Milestones
C4T’s vision is to become a fully integrated biopharmaceutical company leveraging the benefits of targeted protein degradation across drug discovery, clinical development and commercialization to create and deliver breakthrough therapies for patients. To achieve this vision, C4T’s strategy centers around rapidly advancing cemsidomide to become the IKZF1/3 degrader of choice across lines of therapy and progressing its early portfolio of high-value degraders pursuing novel targets. The following anticipated key strategic milestones through 2028 support this strategy.

Cemsidomide
Relapsed/Refractory Multiple Myeloma: Fourth Line or Later

In Q1 2026, initiate the Phase 2 MOMENTUM trial of cemsidomide and dexamethasone and complete enrollment within 12 months.
In mid-2026, present further analysis of the data from the ongoing Phase 1 trial of cemsidomide and dexamethasone.
In 2H 2027, present initial overall response rate (ORR) data for the MOMENTUM trial.
In mid-2028, present efficacy and safety for the MOMENTUM trial.
By year-end 2028, submit new drug application evaluating cemsidomide and dexamethasone for potential accelerated approval in fourth line or later.
Relapsed/Refractory Multiple Myeloma: Second Line or Later

In Q2 2026, initiate the Phase 1b trial of cemsidomide in combination with elranatamab and provide incremental updates throughout dose escalation.
In mid-2026, share the plan to initiate an additional Phase 1b trial to evaluate cemsidomide in combination with other anti-myeloma agents.
In mid-2027, present Phase 1b data from all cohorts evaluating cemsidomide in combination with elranatamab.
By early 2028, initiate the Phase 3 trial evaluating cemsidomide in combination with a BCMA BiTE.
Early Portfolio: CFT8919

In Q1 2026, utilize data from the Phase 1 dose escalation trial to inform ex-China clinical development.
Early Portfolio: Internal Discovery Projects Focused on Inflammation, Neuro-inflammation and Neuro-degenerative Diseases

By year-end 2028, deliver up to three investigational new drug applications.
Early Portfolio: Discovery Collaborations

Earn additional research milestones and potential licensing fees from collaborations with Merck KGaA, Darmstadt, Germany, Roche and Biogen.
By year-end 2026, deliver at least one development candidate to a collaboration partner.
By year-end 2026, advance existing collaborations toward key milestones.
2025 Achievements
Cemsidomide

Completed enrollment in the Phase 1 trial of cemsidomide and dexamethasone and presented data demonstrating that the two highest dose levels (75 µg and 100 µg) achieved a 40% and 53% ORR, respectively. This compelling anti-myeloma activity in a heavily pretreated patient population reinforces cemsidomide’s potential best-in-class profile.
Developed a regulatory path incorporating FDA feedback that positions cemsidomide to potentially receive two distinct accelerated approvals in (1) fourth line or later for cemsidomide and dexamethasone, and (2) second line or later for cemsidomide in combination with a BCMA BiTE.
Selected 100 µg dose for the MOMENTUM trial as the recommended Phase 2 dose after discussions with FDA.
CFT8919

Advanced the Phase 1 dose escalation trial in China with partner Betta Pharmaceuticals to generate data that will inform C4T’s next steps.
Internal Discovery Pipeline

Implemented new discovery strategy focused on developing degrader medicines for five novel targets that modulate three clinically validated pathways for inflammation, neuro-inflammation and neuro-degenerative diseases to potentially deliver new therapies with enhanced efficacy for patients with unmet needs. This strategy leverages C4T’s expertise in developing highly catalytic orally bioavailable degraders that penetrate the blood brain barrier to achieve high central nervous system exposures and compelling efficacy in central nervous system models as well as C4T’s ability to control targeted protein levels through finely tuned degrader kinetics.
Extended capabilities to identify molecular glue degraders for targets with and without G- and RT-loops by utilizing DNA-encoded library (DEL) technology.
About Cemsidomide
Cemsidomide is an investigational, orally bioavailable molecular glue degrader of IKZF1/3, transcription factors that drive multiple myeloma. Data from the Phase 1 trial, which has completed enrollment, show cemsidomide’s differentiated safety and tolerability profile and potentially class-leading anti-myeloma activity that support the potential for durable outcomes.

About the MOMENTUM Trial
MOMENTUM (Multi-center trial Of cemsidoMidE iN relapsed/refracTory mUltiple Myeloma) is a Phase 2, open-label, single-arm study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of cemsidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma. Data from the Phase 1 trial identified 100 µg as the recommended Phase 2 dose. The primary endpoint is overall response rate per International Myeloma Working Group response criteria, as assessed by an independent review committee. Approximately 100 patients who have received at least three prior anti-myeloma regimens that must have included an IKZF1/3 degrader, a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager or CAR-T therapy will be enrolled in the trial. More information is available at clinicaltrials.gov (NCT07284758).

About Cemsidomide in Combination With Elranatamab (ELREXFIO)
The Phase 1b trial is designed to evaluate the safety, tolerability and preliminary efficacy of cemsidomide in combination with elranatamab, an FDA-approved B-cell maturation antigen CD3 targeted bispecific antibody. The study will evaluate different cemsidomide dose levels (beginning with 75 µg, with the opportunity to simultaneously explore 50 µg and 100 µg) in patients who have received one to four prior lines of therapy, which must have consisted of at least one IKZF1/3 degrader. Exclusion criteria for patients include those who have received prior treatment with a BCMA-directed T-cell engager or BCMA-directed CAR-T therapy. More information is available at clinicaltrials.gov (NCT07280013).

About Multiple Myeloma
Multiple myeloma (MM) is a rare blood cancer affecting plasma cells. Approximately 36,000 people in the United States are diagnosed with MM each year. Despite advances in treatment, MM remains incurable. Treatment combinations include IKZF1/3 degraders, which are established backbone therapies, across lines of therapy.

(Press release, C4 Therapeutics, JAN 14, 2026, View Source [SID1234662035])