On January 16, 2026 ImmunityBio, Inc. (NASDAQ: IBRX) reported an update on the status of enrollment in its randomized registrational trial in BCG-naïve non-muscle-invasive bladder cancer (NMIBC), QUILT-2.005. Enrollment has exceeded internal expectations and is now over 85% complete, with full enrollment of the planned study population anticipated by Q2 2026. Based on the current enrollment trajectory, ImmunityBio anticipates submitting a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) by year end 2026.

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In 2023, to determine the contribution of effect of ANKTIVA (nogapendekin alfa inbakicept), the FDA requested that an interim analysis of this randomized controlled trial be performed to assess complete response rate and duration of complete response in subjects treated with ANKTIVA plus BCG compared with BCG alone. These data were submitted to the Agency and publicly presented at the American Urological Association (AUA) Annual Meeting in 2024.

The interim analysis demonstrated that ANKTIVA significantly prolonged the duration of complete response when combined with BCG compared to BCG alone in the BCG-naïve NMIBC setting. At six months, 85% of patients receiving ANKTIVA plus BCG maintained a complete response, compared with 57% of patients receiving BCG alone. At nine months, 84% of subjects in the experimental arm maintained a complete response, while subjects receiving BCG alone demonstrated a complete response rate of 52%. Despite the limited sample size of this interim analysis, the difference in duration of complete response at nine months reached statistical significance (p=0.0455).1.

"We look forward to the final accrual of this important registrational randomized trial in patients with BCG-naïve non-muscle-invasive bladder cancer, which represents a substantial proportion of newly diagnosed bladder cancer cases," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman, and Global Chief Medical and Scientific Officer of ImmunityBio. "The interim analysis is encouraging and consistent with findings in the approved BCG-unresponsive setting, where the duration of complete response has exceeded 47 months."

Recognizing the ongoing shortage of TICE BCG, ImmunityBio’s Expanded Access Program of recombinant BCG continues to progress and support patient access. The Company has requested consultation with the FDA to address the use of recombinant BCG as an alternative supply source in anticipation of continued clinical need, including patients with BCG-naïve disease.

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 16, 2026, View Source [SID1234662069])

On January 16, 2026 Genmab A/S (Nasdaq: GMAB) reported topline results from the Phase 3 EPCORE DLBCL-1 trial evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, which demonstrated an improvement in progression-free survival (PFS) (HR: 0.74 [95% CI 0.60 to 0.92])* in patients treated with epcoritamab monotherapy. Additionally, improvements were observed in the complete response rate, duration of response, and time to next treatment among patients treated with epcoritamab monotherapy. EPCORE DLBCL-1 is the first Phase 3 study to demonstrate an improvement in PFS in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who were treated with a CD3xCD20 T-cell engaging bispecific monotherapy. The study demonstrated an overall survival (OS) of HR: 0.96 [95% CI 0.77 to 1.20], which did not reach statistical significance.

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The global study enrolled 483 patients with R/R DLBCL with at least one prior line of therapy (73% had received two or more prior lines) who were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The study evaluated the safety and efficacy of epcoritamab monotherapy compared to investigator’s choice of either rituximab plus gemcitabine and oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR).

The adverse events observed in this study appear consistent with the known safety profile of epcoritamab. Further analysis of the results is ongoing, including the potential impact of various factors, such as the COVID-19 pandemic and increasing availability of novel anti-lymphoma therapies. The full trial results will be submitted for presentation at a future medical meeting. Genmab and AbbVie will engage with global regulatory authorities to discuss next steps.

Data is anticipated in 2026 from two Phase 3 trials evaluating fixed duration epcoritamab in patients with DLBCL, including EPCORE DLBCL-2, a front-line study evaluating epcoritamab in combination with standard-of-care rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP), and EPCORE DLBCL-4, evaluating epcoritamab in combination with lenalidomide versus chemo-immunotherapy in patients with relapsed or refractory DLBCL.

"The EPCORE DLBCL-1 trial is the first Phase 3 study evaluating a bispecific antibody monotherapy to demonstrate improvements in progression-free survival in patients with relapsed or refractory DLBCL," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "The results from this global trial contribute to the growing body of evidence supporting epcoritamab and build upon the robust foundation established by epcoritamab, which has been used to treat thousands of patients in need of additional therapeutic options. Together with our partner, AbbVie, we remain deeply committed to advancing the development of epcoritamab as a potential core therapy across a broad range of B-cell malignancies."

Epcoritamab (approved under the brand name EPKINLY in countries including the U.S. and Japan, and as TEPKINLY in the European Union) has received regulatory approval in certain lymphoma indications in more than 65 countries. Genmab and AbbVie remain committed to advancing the potential of epcoritamab, with ongoing clinical programs evaluating the therapy as a monotherapy and in combination regimens across treatment lines and a broad range of hematologic malignancies.

About Diffuse Large B-Cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases.i,ii In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year.iii DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.iv,v DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.iv,vi

About the EPCORE DLBCL-1 Trial
EPCORE DLBCL-1 (NCT04628494) is a global Phase 3 open label, multi-center, randomized trial to evaluate the efficacy of epcoritamab (GEN3013, DuoBody-CD3xCD20) compared to investigator’s choice of chemotherapy, either rituximab plus gemcitabine plus and oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR), in patients with relapsed or refractory DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The trial started on January 13, 2021, and is ongoing.

More information on this trial can be found at View Source

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.vii

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Where approved, epcoritamab is a readily accessible therapy. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes three ongoing Phase 3, open-label, randomized trials, among them a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

(Press release, Genmab, JAN 16, 2026, View Source [SID1234662068])

On January 16, 2026 EORTC, together with the European Medicines Agency (EMA), and in collaboration with key stakeholders reported to have published a multistakeholder roadmap outlining strategic actions to advance treatment optimisation research in oncology. The recommendations were developed within the Cancer Medicines Forum (CMF)1 and are presented in a new article titled "Accelerating cancer treatment optimisation: a multistakeholder roadmap from the Cancer Medicines Forum" published in the Journal of Cancer Policy.

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Treatment optimisation research focuses on determining how anticancer therapies can be used most effectively in clinical practice, addressing questions related to dose, duration, schedule, sequence, and combinations. While current regulatory trials support marketing authorisation, many of these questions remain unanswered at approval, creating challenges for clinicians, patients, and healthcare systems.

The roadmap is based on a multidisciplinary workshop held in April 2024 within the CMF, which brought together multiple international stakeholders, including regulators, health technology assessment bodies, clinicians, patient representatives, academic researchers, industry, public health organisations. The discussions align with ongoing EORTC initiatives to support treatment optimisation, including a recent event held in the European Parliament focused on the challenges and opportunities in this area. Participants identified key barriers, including limited incentives, funding constraints, regulatory hurdles, and challenges in implementing optimisation findings, and proposed coordinated solutions.

"Recognising treatment optimisation as a public health priority is essential to ensuring that cancer therapies are used as effectively and sustainably as possible," said Dr Denis Lacombe, EORTC CEO. "Strengthening collaboration and creating the right conditions for pragmatic clinical trials will be key to making this happen."

The roadmap also emphasises the importance of aligning evidence requirements across regulators and HTA bodies to ensure that optimisation results can inform regulatory approvals, clinical practice and reimbursement decisions.

EORTC remains committed to supporting independent, practice-informing research and to strengthening evidence generation throughout the lifecycle of cancer medicines.

(Press release, EORTC, JAN 16, 2026, View Source [SID1234662067])

On January 15, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported the closing of its previously announced best-efforts public offering of 5,366,726 units. Each unit consists of one common share (or one pre-funded warrant ("Pre-Funded Warrant") in lieu thereof) and one warrant (the "Warrants"). Each unit was sold to the public at a price of US$5.59 per unit (inclusive of the Pre-Funded Warrant exercise price) for gross proceeds of approximately US$30 million, before deducting placement agent fees and offering expenses. The Warrants included in the units have been approved for listing on the Nasdaq Capital Market and commenced trading under the symbol "BCTXL" on January 14, 2026. Each Warrant is immediately exercisable, entitles the holder to purchase one common share at an exercise price of US$6.93 per share and expires five years from the date of issuance. The common shares (or Pre-Funded Warrants) and Warrants were purchased together in the offering but were issued separately.

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The Company relied upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

The Company intends to use the net proceeds from the offering to fund working capital requirements, general corporate purposes and the advancement of the Company’s business objectives.

ThinkEquity acted as the sole placement agent for the offering.

A registration statement on Form S-1 (File No. 333-292388) relating to the securities was filed with the Securities and Exchange Commission ("SEC") on December 23, 2025, and became effective on January 13, 2026, and a related registration statement was filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, on January 13, 2026. This offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus has been filed with the SEC and is available on the SEC’s website located at View Source

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, BriaCell Therapeutics, JAN 15, 2026, View Source [SID1234662207])

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])