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])

AVEO Oncology, an LG Chem company, Announces First Patient Dosed in Front-Line AML Combination Study of Ficlatuzumab

On January 14, 2026 AVEO Oncology, an LG Chem company, (AVEO) reported that the first patient has been successfully dosed in a Phase 1b/2 clinical trial evaluating ficlatuzumab in combination with azacitidine and venetoclax in patients that are 60 years of age or older with untreated acute myeloid leukemia (AML) through a Master Clinical Trial Collaboration Agreement with Blood Cancer United, formerly the Leukemia & Lymphoma Society.

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As part of this strategic collaboration with Blood Cancer United, a global nonprofit focused on blood cancer patient support, research, and advocacy, Blood Cancer United will be sponsoring the clinical trial as a sub-study in their Beat AML Master Clinical Trial, the first collaborative precision medicine clinical trial in a blood cancer, which tests multiple therapies in multiple study arms simultaneously.

The Phase 1b/2 clinical trial is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the combination as a potential treatment for AML. Ficlatuzumab is AVEO’s investigational humanized IgG1 monoclonal antibody that is designed to bind to the hepatocyte growth factor (HGF) ligand and prevent it from signaling via the c-Met receptor. Early phase clinical trials evaluating ficlatuzumab in combination with cytarabine in AML reported a favorable safety profile with promising clinical activity, supporting ficlatuzumab for further study in AML patients, particularly in those who are considered unfit for standard intensive first-line therapy.

"This is a significant milestone for AVEO and Blood Cancer United, who are both dedicated to improving patient outcomes through novel clinical research," said Michael P. Bailey, President and CEO of AVEO. "We welcome this partnership and are excited to collaborate on this important clinical trial as we continue to expand our efforts to address high unmet medical needs with our novel clinical stage portfolio of therapies."

"The Beat AML Master Clinical Trial seeks to change the paradigm for how this deadly cancer is treated, using an innovative precision medicine protocol and implementing strategic partnerships," said Lore Gruenbaum, Ph.D, Chief Scientific Officer of Blood Cancer United. "Our collaboration with AVEO is a key next step for the trial and transforming patient care for adults with AML."

(Press release, AVEO, JAN 14, 2026, View Source [SID1234662048])

GT Medical Technologies Announces First Patients Treated with GammaTile in the BRIDGES Trial for Newly Diagnosed Glioblastoma

On January 14, 2026 GT Medical Technologies, a company focused on improving the lives of patients with brain tumors, reported that the first patients have been enrolled in the Beginning Radiation Immediately with GammaTile at Glioblastoma Excision versus Standard of Care (BRIDGES) U.S. clinical trial for newly diagnosed glioblastoma (GBM). The BRIDGES trial is an innovative randomized study evaluating whether implanting GammaTile at the time of surgery can improve the survival outcomes for patients with newly diagnosed GBM.

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Per Langoe, CEO of GT Medical Technologies, stated "GT Medical Technologies is proud to announce that the first patients have been enrolled in the BRIDGES trial, a groundbreaking study that will examine the ability of GammaTile to increase survivability for patients with newly diagnosed GBM. Patients who are newly diagnosed with GBM face an unacceptably poor prognosis, demonstrating a significant need for disruptive therapies that can improve the standard of care. With the recent completion of our ROADS trial for newly diagnosed brain metastases, we are very encouraged going into the BRIDGES trial."

The first BRIDGES patient enrollment was achieved at Westchester Medical Center in Valhalla, NY, by neurosurgeon Dr. Simon Hanft. "All of us at Westchester Medical Center are excited about giving our patients access to the BRIDGES trial and what it could mean for our patients suffering from GBM," stated Dr. Hanft. "We have utilized GammaTile successfully for a number of years, and we look forward to a significant contribution to the BRIDGES trial in an effort to lead the exploration of new advancements in care for patients with GBM."

Dr. Clark C. Chen, Professor and Director of the Brain Tumor Program, Brown University Health, Providence, RI, explained "Although glioblastoma remains a challenging disease, meaningful progress is underway. The BRIDGES trial exemplifies this momentum, offering patients access to the most advanced therapies available in modern neuro-oncology. At Brown Health, we are proud to make this trial available to our patients."

"GammaTile therapy is designed to be implanted at the time of GBM tumor resection, enabling radiation treatment to begin immediately rather than weeks after surgery," said Dr. Michael Garcia, Chief Medical Officer at GT Medical Technologies. "This represents a fundamental shift from the traditional care paradigm, where time between surgery and radiation allows for the tumor to start growing back. By delivering radiation from day one—when tumor burden is at its lowest—GammaTile offers a new way to rethink postoperative radiation. This approach underpins the promise of the BRIDGES trial and its potential to transform how GBM is treated."

(Press release, GT Medical Technologies, JAN 14, 2026, View Source [SID1234662049])

Samsung Epis Holdings Delivers Business Updates at the 44th J.P. Morgan Healthcare Conference

On January 14, 2026 Samsung Epis Holdings (KRX: 0126Z0) reported corporate progress and updates at the 44th J.P. Morgan Healthcare Conference.

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"2026 is a monumental year for us, as we enter into a new chapter for our company. Today, we are announcing six additional candidates in our biosimilar pipeline, including vedolizumab and dupilumab. We are making great progress to secure 20 biosimilars in our portfolio by 2030," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. "We also received the investigational new drug application (IND) clearance for the first novel therapeutic candidate developed by Samsung Bioepis, and plan to advance our clinical program this year. As we broaden our portfolio beyond biosimilars, we will continue our development efforts in antibody-drug conjugates (ADCs), leveraging our innovative research and development platform to expand viable treatment options for patients with unmet needs."

Samsung Bioepis Biosimilar Updates

Samsung Bioepis currently has 11 biosimilars for 10 unique biological molecules approved and launched in more than 40 countries.1 The company has pembrolizumab biosimilar undergoing Phase 1 and 3 clinical studies, and plans to secure 20 biosimilars in its portfolio by 2030.
The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab.
Novel Therapeutics Updates

In December 2025, the FDA has cleared the IND Application for SBE303. SBE303 is Samsung Bioepis’ first novel ADC engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer.2 The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year.
Samsung Bioepis plans to have one novel therapeutic candidate enter into clinical study every year.
Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform.
Samsung Bioepis Biosimilars Portfolio

Code Name (Brand Name3)

Non-proprietary Name

Reference Product

Status4

SB5

(IMRALDI, HADLIMA, ADALLOCE)

Adalimumab

Humira

Launch

SB4

(BENEPALI, BRENZYS, ETOLOCE)

Etanercept

Enbrel

Launch

SB2

(FLIXABI, RENFLEXIS, REMALOCE)

Infliximab

Remicade

Launch

SB3

(ONTRUZANT, SAMFENET)

Trastuzumab

Herceptin

Launch

SB8

(AYBINTIO)

Bevacizumab

Avastin

Launch

SB11

(BYOOVIZ, AMELIVU)

Ranibizumab

Lucentis

Launch

SB12

(EPYSQLI)

Eculizumab

Soliris

Launch

SB15

(OPUVIZ, AFILIVU)

Aflibercept

Eylea

Launch

SB16

(OBODENCE, OSPOMYV)

Denosumab

Prolia

Launch

SB16

(XBRYK)

Denosumab

Xgeva

Launch

SB17

(PYZCHIVA, EPYZTEK)

Ustekinumab

Stelara

Launch

SB27

Pembrolizumab

Keytruda

Phase 1 and 3

Samsung Bioepis Biosimilar Candidates in Early Stage Development

Non-proprietary Name

Reference Product

Dupilumab

Dupixent

Guselkumab

Tremfya

Ixekizumab

Taltz

Vedolizumab

Entyvio

Ocrelizumab

Ocrevus

Fam-trastuzumab deruxtecan-nxki

Enhertu

(Press release, Samsung Epis Holdings, JAN 14, 2026, View Source [SID1234662050])