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Natera and Aveta Biomics Announce Strategic Partnership Supporting Global Phase 3 Registrational Trial of APG-157 in Head and Neck Cancer

On June 29, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, and Aveta Biomics, Inc., a clinical-stage immuno-oncology company advancing first-in-class oral immunotherapies for solid tumors, reported a strategic partnership supporting AVTA 30-01, Aveta’s global Phase 3 registrational clinical trial evaluating APG-157 in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) (NCT07667296).

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APG-157 is Aveta’s first-in-class oral immunotherapy intended to expand the benefits of immunotherapy to both immune-cold and immune-hot tumors in patients with LA-HNSCC. APG-157 has received FDA Fast Track and Orphan Drug Designations for this indication.

AVTA 30-01 builds upon previously reported Phase 2 clinical data of APG-157 monotherapy in demonstrating favorable safety, evidence of tumor-control, deep molecular responses, and encouraging event-free survival outcomes. The trial will incorporate serial Signatera testing to assess molecular residual disease (MRD) and treatment response throughout therapy and follow-up. Circulating tumor DNA (ctDNA) has emerged as one of the most promising approaches for detecting MRD and identifying recurrence earlier than conventional imaging alone.

Approximately 826 patients are expected to be enrolled across North America, Europe, Asia-Pacific, and Australia. The study includes separate randomized cohorts for resectable and unresectable locally advanced disease, each with treatment and control arms, and Signatera will be a secondary endpoint. The trial is expected to begin enrollment in 2H’26.

Global annual incidence of head and neck cancer is approximately 950,000,1 and disease recurrence remains a major cause of mortality despite advances in surgery, radiation therapy, and immunotherapy.

"Patients with locally advanced head and neck cancer continue to face substantial risks of recurrence despite aggressive treatment," said Parag Mehta, Ph.D., founder and chief executive officer of Aveta Biomics. "We believe APG-157 has the potential to transform treatment by activating anti-tumor immunity in both immune-cold and immune-hot tumors. Incorporating serial Signatera testing into AVTA 30-01 will allow us to further validate the ctDNA findings observed in Phase 2 while generating molecular response data that will advance the understanding of treatment benefits for patients and strengthen the regulatory submission."

This study adds to the evidence Natera continues to generate in head and neck cancer. The company recently announced a successful readout of the prospective Phase 2 SINERGY trial, supporting Signatera MRD-guided treatment in this histology.

"Growing evidence continues to demonstrate the value of Signatera MRD detection in head and neck cancer," said Eric Matthews, general manager, biopharma, Natera. "We’re pleased to partner with Aveta on AVTA 30-01 to demonstrate how Signatera has the potential to advance the field and improve care for patients."

(Press release, Aveta Biomics, JUN 29, 2026, View Source [SID1234669001])

Excalipoint Therapeutics Announces Clinical Trial Collaboration with Roche to Evaluate EXP011 in DLL3‑Expressing Solid Tumors

On June 29, 2026 Excalipoint Therapeutics, a clinical-stage biotechnology company advancing novel T-cell engager (TCE) therapies for solid tumors and autoimmune disorders, reported a clinical collaboration with Roche to explore the combination of Excalipoint’s lead product candidate EXP011 (CTM012), a tri-specific T-cell engager targeting DLL3, CD3, and 4-1BB and Roche’s atezolizumab in patients with DLL3-expressing solid tumors.

Roche will supply atezolizumab for use in the planned clinical studies. The clinical studies under the collaboration are designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of EXP011 combined with atezolizumab in small cell lung cancer (SCLC), with potential extension into other tumor types such as neuroendocrine tumors (NET).

"We are pleased to partner with Roche to explore the combination potential of EXP011 and atezolizumab for patients with SCLC and other hard-to-treat solid tumors." said Lei Fang, Ph.D., Co-Founder, Chairman and Chief Executive Officer, Excalipoint Therapeutics. "This collaboration enables us to evaluate a differentiated immuno-oncology combination strategy to address the limitations of current treatment regimens and deliver better clinical benefits for patients."

"This clinical collaboration with Roche will further crystallize the clinical value of EXP011 in solid tumors and accelerate the global development of this highly differentiated asset," said Jielun Zhu, Co-Founder, CFO & CBO, Excalipoint Therapeutics. "This partnership is also a strong endorsement of the potential of EXP011 in overcoming treatment barriers of existing therapies to drive more durable response and improve patient outcomes."

EXP011 is Excalipoint’s lead tri-specific T-cell engager from its proprietary co-stimulatory EXCOPIA Platform (formerly known as TOPABody) designed to selectively target DLL3, a tumor-specific antigen highly expressed in SCLC and neuroendocrine tumors, while engaging CD3 and 4-1BB to achieve potent, controlled and synergistic T-cell activation and anti-tumor activity.

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

(Press release, Excalipoint Therapeutics, JUN 29, 2026, View Source [SID1234669000])

Nuvation Bio Announces Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer Validated in the United Kingdom

On June 29, 2026 Nuvation Bio (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) has validated the Marketing Authorisation Application (MAA) submitted by its partner Eisai Co, Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The application was submitted through the International Recognition Procedure, which takes into account approvals from trusted regulatory partners and supports expedited access to medicines in the U.K. The application will now be evaluated by the MHRA to decide whether to approve or reject the application.

In January 2026, Eisai and Nuvation Bio announced they had entered into an exclusive licensing and collaboration agreement in Europe and additional countries* outside the U.S., China and Japan to extend the global reach of taletrectinib. Taletrectinib is an oral treatment for patients living with advanced ROS1+ NSCLC (marketed as IBTROZI in the U.S. and Japan). In March 2026, the European Medicines Agency validated the MAA for taletrectinib. Additional filings are planned for Canada and other regions included in Eisai’s licensed territories.

Within the U.K., there are around 50,200 new lung cancer cases every year. Around 80 to 85% of all lung cancers are NSCLC, of which approximately 2% of patients harbor the ROS1+ mutation.

The application is based on data from the two pivotal Phase 2 clinical studies, TRUST-I and TRUST-II, evaluating taletrectinib in patients globally. Results from a pooled analysis of the TRUST clinical program were originally published in the Journal of Clinical Oncology in April 2025, and updated data reflecting longer patient follow-up were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2026, further building the efficacy and safety profile observed to date. Updated results from the TRUST-I study were also simultaneously published in April 2026 in the Journal of Clinical Oncology.

"We are pleased to see taletrectinib advance into the regulatory review process in the U.K. following the recent progress with the EMA," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "Having seen the meaningful impact taletrectinib has already brought to patients in the U.S., China and Japan, we are excited about this important step in expanding access to this medicine. This validation brings us closer to delivering taletrectinib to patients in the U.K. and reinforces our commitment to making it available to patients around the world."

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.

* Eisai’s licensed territories: Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and India

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About Taletrectinib
Taletrectinib is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com.

About the TRUST Clinical Program
The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of taletrectinib. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating taletrectinib for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating taletrectinib for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating taletrectinib versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.

About the International Recognition Procedure (IRP) in the United Kingdom
IRP is a regulatory pathway established by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) that allows the agency to take into account the expertise and decision-making of trusted international reference regulators, such as the European Medicines Agency (EMA) and FDA.

Under IRP, MHRA conducts a targeted assessment based on existing regulatory evaluations, with the aim of supporting patients in the U.K. with expedited access to safe and effective medicines.

(Press release, Nuvation Bio, JUN 29, 2026, View Source [SID1234668999])

Anixa Biosciences Granted First Korean Patent for its Breast Cancer Vaccine, Extending Global Protection Through 2040

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.

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])

AbbVie Announces Positive Phase 3 Results for Epcoritamab Plus Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

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.

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])