On June 29, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Korean Ministry of Intellectual Property (MOIP) has issued Patent Number 10-2960889 related to Anixa’s breast cancer vaccine technology. This composition-of-matter patent, exclusively licensed from Cleveland Clinic, protects the Company’s novel approach to breast cancer prevention and treatment in South Korea through 2040, addressing a disease for which no preventive vaccine is currently approved anywhere in the world.

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With this issued patent, Anixa continues to expand the international scope of its intellectual property portfolio, reinforcing its leadership in the field of cancer immunotherapy. The Korean patent complements Anixa’s existing patent portfolio in the United States and other key international markets, further strengthening the Company’s global intellectual property estate. The expanded patent protection enhances Anixa’s ability to pursue future regulatory approvals, strategic partnerships and commercialization opportunities.

"Each global patent we secure deepens the global foundation we are building for our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue clinical development in the U.S., our growing international patent estate further strengthens our ability to pursue global opportunities and potentially partner with larger pharmaceutical companies for worldwide commercialization. In our recently completed Phase 1 clinical trial conducted at Cleveland Clinic, the vaccine met all major primary endpoints, was safe and well tolerated, and generated immune responses in 74% of participants, supporting continued clinical development of this novel preventive approach."

Breast cancer remains the most commonly diagnosed cancer among women worldwide, and currently there is no approved vaccine to prevent it. While breast cancer survival rates are high in South Korea, the incidence rate has been increasing rapidly and, unlike in Western nations, the disease tends to occur earlier in life heightening the need for preventive options in the region.

Anixa’s vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer. This "retired" protein strategy, developed at Cleveland Clinic and licensed exclusively to Anixa, aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue, particularly in aggressive forms of the disease such as triple-negative breast cancer.

By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies. The Company’s broader vaccine platform also targets other high-incidence cancers and is designed to transform how the medical community approaches cancer prevention. If successful, the technology could represent one of the first preventive vaccine approaches targeting breast cancer, representing a potentially transformative advancement in cancer prevention.

(Press release, Anixa Biosciences, JUN 29, 2026, View Source [SID1234668998])

On June 29, 2026 AbbVie (NYSE: ABBV) reported topline results from the Phase 3 EPCORE DLBCL-4 trial evaluating the combination of epcoritamab, a T-cell engaging bispecific antibody, and lenalidomide, compared to rituximab plus gemcitabine plus oxaliplatin (R-GemOx) in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who received at least one prior line of therapy. Based on topline results from the prespecified primary analysis, the trial met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in progression-free survival (PFS). The risk of disease progression and death was reduced by 60% (HR 0.40 [95% CI 0.30, 0.55]; p-value <0.0001) and 56% (HR 0.44 [95% CI 0.33, 0.60]; p-value <0.0001), based on different censoring rules in the U.S. and outside the U.S., respectively.

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The safety profile of epcoritamab when administered in combination with lenalidomide was consistent with the known safety profiles of the individual agents (epcoritamab and lenalidomide).

"Despite recent advances, there remains a critical need for innovative therapies to improve outcomes for those battling DLBCL, an aggressive and often difficult-to-treat cancer," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "Today’s encouraging topline results highlight the potential of epcoritamab, a fixed-treatment therapy, in combination with lenalidomide, as a meaningful treatment option after initial disease progression."

AbbVie and Genmab will engage global regulatory authorities to discuss next steps. Data will be submitted for presentation at a future medical meeting.

About the EPCORE DLBCL-4 Trial
EPCORE DLBCL-4 (NCT06508658) is a global Phase 3 open label, multi-center, randomized trial to evaluate the efficacy of epcoritamab (GEN3013, DuoBody-CD3xCD20) in combination with lenalidomide compared to chemoimmunotherapy, rituximab plus gemcitabine plus oxaliplatin (R-GemOx), in adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including patients with diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), high-grade B-Cell lymphoma (HGBL) with MYC and B-cell/lymphoma 2 (BCL2) and/or BCL6 rearrangements, follicular lymphoma grade 3B (FL3B), T-cell/histiocyte-rich large B-Cell lymphoma (TCHR LBLC), and Epstein-Barr Virus-positive diffuse large B-cell lymphoma (EBV+ DLBCL). Patients in the trial were previously treated with at least one line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy, and failed or relapsed after, or were not a candidate for autologous stem cell transplantation (ASCT) and ineligible for or unable to receive CAR-T since DLBCL diagnosis. Patients received subcutaneous epcoritamab (cycles 1–3, once weekly; cycles 4–12, once every 4 weeks) and oral lenalidomide (25 mg/day on days 1–21) for a total of twelve 28-day cycles or intravenously infused R-GemOx for up to four cycles (each cycle lasting 28 days). The trial started on August 13, 2024, and is ongoing.

More information on this trial can be found at www.clinicaltrials.gov. (NCT06508658).

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.1

Epcoritamab (approved under the brand name EPKINLY in countries including the U.S. and Japan, and TEPKINLY in the European Union) has received regulatory approval in certain lymphoma indications in more than 65 countries and territories. Epcoritamab is being co-developed by AbbVie and Genmab 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 filings for the investigational relapsed or refractory diffuse large B-cell lymphoma (DLBCL) study.

AbbVie and Genmab continue to evaluate the use of epcoritamab as monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

USE & IMPORTANT SAFETY INFORMATION for EPKINLY (epcoritamab-bysp) in U.S.

What is EPKINLY?
EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory) after 2 or more treatments. EPKINLY for the treatment of DLBCL is approved based on patient response data. A study is ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Important Warnings—EPKINLY can cause serious side effects, including:

Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or lead to death. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule.
Neurologic problems that can be serious, and can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY.
People with DLBCL or high-grade B-cell lymphoma may be hospitalized after receiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the risk of CRS and neurologic problems.

Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away.

EPKINLY can cause other serious side effects, including:

Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or generally unwell, or confusion.
Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia and lymphopenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems.
Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.

Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.

The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma include CRS, injection site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal) pain. The most common severe abnormal laboratory test results include decreased white blood cells, decreased red blood cells, and decreased platelets.

These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).

Please see Full Prescribing Information and Medication Guide, including Important Warnings.

(Press release, AbbVie, JUN 29, 2026, View Source [SID1234668997])

On June 29, 2026 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB: OTLC) and Sapu Nano reported the publication of a peer-reviewed scientific manuscript validating its proprietary Deciparticle nanoparticle platform through the successful development of Sapu003, the Company’s investigational intravenous everolimus formulation currently being evaluated in an ongoing Phase 1b clinical trial.

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The publication, "Intravenous Everolimus Formulation (Sapu003) for Clinical Trials," has been published in the International Journal of Molecular Sciences and provides the first comprehensive description of the Deciparticle platform, including formulation design, scalable cGMP manufacturing, product characterization, stability, and preclinical evaluation.

Publication Citation

Min SH, Forero K, Putnam W, Anderson J, Hoff R, Lopp J, Trieu V, Ho K, Lee C. Intravenous Everolimus Formulation (Sapu003) for Clinical Trials. International Journal of Molecular Sciences. 2026;27(13):5775. doi:10.3390/ijms27135775.

Everolimus is a well-established inhibitor of the mammalian target of rapamycin (mTOR) approved for the treatment of multiple cancers. However, because of its poor aqueous solubility and limited oral bioavailability, clinical use has historically been restricted to oral administration. Sapu003 was developed using the Deciparticle platform to enable intravenous delivery through a stable nanoparticle formulation.

The publication reports several significant achievements, including:

Development of a stable intravenous everolimus formulation with mean particle sizes below 20 nanometers.
A robust, scalable cGMP manufacturing process capable of producing clinical-grade material with high batch-to-batch reproducibility.
Favorable product stability following lyophilization and refrigerated storage.
Successful formulation of multiple hydrophobic therapeutic compounds, demonstrating the broader applicability of the Deciparticle platform beyond everolimus.
Potent preclinical antitumor activity supporting continued clinical development of Sapu003.

"The publication of this work represents an important milestone for Sapu Bioscience," said Vuong Trieu, Ph.D., CEO and Chairman of Oncotelic. "Independent peer review validates not only the scientific foundation supporting Sapu003, but also the broader Deciparticle platform. We believe this technology has the potential to address one of the longstanding challenges in drug development-enabling intravenous delivery of poorly water-soluble therapeutic compounds through a scalable and reproducible manufacturing process."

Unlike many formulation technologies developed for a single product, the published research demonstrates that the Deciparticle platform is compatible with wide range of hydrophobic molecules, including rapalogs, macrocyclic compounds, immunosuppressants, and selected peptide therapeutics. The Company believes this broad formulation capability may support future pipeline expansion and collaborative development opportunities.

Sapu003 is currently being evaluated in an ongoing Phase 1b open-label dose-escalation study in patients with advanced mTOR-sensitive solid tumors. The study is assessing the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of weekly intravenous Sapu003 administered in combination with exemestane.

"The publication marks the successful translation of the Deciparticle platform from laboratory research to clinical-stage manufacturing," added Dr. Trieu. "As our Phase 1b clinical study progresses, we look forward to further evaluating the potential of Sapu003 while continuing to expand the application of the Deciparticle platform to additional therapeutic programs."

About Sapu003

Sapu003 is an investigational intravenous formulation of everolimus developed using Sapu Bioscience’s proprietary Deciparticle nanoparticle platform. The program is designed to overcome the formulation limitations associated with oral everolimus while enabling predictable intravenous administration for the treatment of patients with advanced cancers.

About Deciparticle

Deciparticle is Sapu Bioscience’s proprietary nanoparticle formulation platform designed to enable intravenous delivery of poorly water-soluble therapeutic compounds. The technology combines amphiphilic polymer design with scalable cGMP manufacturing to generate stable nanoparticle formulations suitable for clinical development. The platform has demonstrated compatibility across multiple classes of hydrophobic therapeutic agents and is being evaluated for broader pharmaceutical applications.

(Press release, Oncotelic, JUN 29, 2026, View Source [SID1234668995])

On June 29, 2026 Zelluna (OSE: ZLNA), a company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported that The Royal Marsden NHS Foundation Trust has been activated as the second clinical site in the ZIMA-101 Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna’s lead TCR-NK product candidate.

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The Royal Marsden is one of Europe’s leading cancer centres with a strong track record in execution of early-stage clinical trials in oncology, and Dr. Andrew Furness serves as the principal investigator at the site. The activation of this second clinical site further expands the Company’s clinical execution capabilities and patient recruitment capacity as ZIMA-101 progresses through its early stages. The site, will soon be in a position to actively identify and screen patients with suitable tumour types, characteristics (including expression of the MAGE-A4 antigen and HLA-A*02 positivity) and disease stage for potential enrolment.

The activation of The Royal Marsden follows the activation of the first clinical site, The Christie NHS Foundation Trust, where Professor Fiona Thistlethwaite serves as Chief Investigator for the study. With both sites now activated, the ZIMA-101 programme has full clinical execution capability across two of the UK’s leading cancer centres.

ZIMA-101 is a first-in-human Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna’s lead TCR-NK product candidate and the world’s first MAGE-A4-targeting TCR-NK therapy in clinical development. The study marks the first clinical evaluation of Zelluna’s proprietary TCR-NK platform.

"This is another important milestone for Zelluna as we continue to advance the execution of the ZIMA-101 study," said Namir Hassan, Chief Executive Officer of Zelluna. "The activation of The Royal Marsden expands our ability to identify and enrol eligible patients and reflects the continued progress being made across the programme. We remain focused on advancing the study with discipline and urgency and are grateful to the investigators, clinical teams and patients who are making this important work possible."

Zelluna remains on track for initial clinical data from the ZIMA-101 study to emerge from mid-2026.

(Press release, Zelluna Immunotherapy, JUN 29, 2026, View Source [SID1234668994])

On June 29, 2026 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported financial results for the fiscal fourth quarter and year ended March 31, 2026 and provided a business update.

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The Company recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The FDA considers this a complete, class 1 response with a goal date of August 2, 2026, and has notified the company to expect an advisory committee meeting in late July.

"The FDA’s acceptance of our RP1 BLA resubmission marks a pivotal milestone in our mission to bring this important therapy to patients facing advanced melanoma, where the need for durable, effective treatment options remains significant," said Sushil Patel, Ph.D., CEO of Replimune. "We are working hard to ensure we can provide access to RP1 as soon as possible pending an approval. We are equally pleased by the momentum across our clinical programs including continued strong enrollment in our IGNYTE-3 trial of RP1 in advanced melanoma and our REVEAL trial of RP2 in metastatic uveal melanoma."

Program Highlights & Milestones

RP1 (vusolimogene oderparepvec)

• IGNYTE Trial (RP1 + Nivolumab) – 3-Year Overall Survival Analysis: In an oral presentation at the ASCO (Free ASCO Whitepaper) 2026 annual meeting, RP1 plus nivolumab demonstrated exceptional durability in anti-PD-1-failed melanoma patients, with 47.8% of all treated patients alive at 3 years and a median overall survival of 32.9 months – including an 83.5% 3-year survival rate among responders – representing a rare and meaningful long-term benefit in a patient population with historically limited treatment options (Presentation).
• IGNYTE-3 Confirmatory Study: The global Phase 3 trial assessing RP1 in combination with nivolumab versus physician’s choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment is actively enrolling. The primary endpoint of this trial is overall survival, and key secondary endpoints are progression free survival and overall response rate.

RP2

• Phase 1 First-in-Human Trial (RP2) – Final Data: In an oral presentation at the ASCO (Free ASCO Whitepaper) 2026 annual meeting, RP2 monotherapy and in combination with nivolumab demonstrated promising efficacy across multiple advanced solid tumor types, achieving a 19% objective response rate in both arms with durable responses (median duration not reached for monotherapy), while translational analyses confirmed the intended mechanism of transforming immunologically "cold" tumors into immune-inflamed environments with systemic T-cell activation, supporting advancement to a randomized Phase 2/3 trial in metastatic uveal melanoma (Presentation).
• REVEAL Study: The registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. The trial is evaluating RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in approximately 280 patients. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. Phase 2/3 transition is expected in Q1 2027.

Financial Highlights

• Cash Position: As of March 31, 2026, cash, cash equivalents and short-term investments were $268.9 million, as compared to $483.8 million as of fiscal year ended March 31, 2025. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans.

Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments will enable us to fund operations into the first quarter of calendar 2027, which includes scale up for the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.

• R&D Expenses: Research and development expenses were $52.3 million for the fiscal fourth quarter and $221.2 million for the fiscal year ended March 31, 2026, as compared to $54.0 million for the fiscal fourth quarter and $189.4 million for the fiscal year ended March 31, 2025. This year over year increase was primarily due to an increase in personnel-related costs as we scaled operations in preparation for commercial launch of RP1, as well as consulting and facility-related costs. Research and development expenses included $4.1 million in stock-based compensation expenses for the fiscal fourth quarter and $16.7 million for the fiscal year ended March 31, 2026.

• S,G&A Expenses: Selling, general and administrative expenses were $21.0 million for the fiscal fourth quarter and $98.7 million for the fiscal year ended March 31, 2026, as compared to $25.4 million for the fiscal fourth quarter and $72.2 million for the fiscal year ended March 31, 2025. Selling, general and administrative expenses included $4.1 million in stock-based compensation expenses for the fiscal fourth quarter and $15.5 million for the fiscal year ended March 31, 2026.

• Net Loss: Net loss was $73.7 million for the fiscal fourth quarter and $313.9 million for the fiscal year ended March 31, 2026, as compared to a net loss of $74.1 million for the fiscal fourth quarter and $247.3 million for the fiscal year ended March 31, 2025.

About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2

RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.

(Press release, Replimune, JUN 29, 2026, View Source [SID1234668993])