On October 1, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently develop improved antibody drug conjugate (ADC) cancer treatments, reported the presentation of two real-world analyses supporting mucin 16 (MUC16) as a durable therapeutic target and potential prognostic biomarker in ovarian cancer. These data will be presented at the International Gynecologic Cancer Society (IGCS) Annual Global Meeting taking place October 1-3, 2026, in Montreal, Canada.

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In tumor samples from patients with ovarian cancer, MUC16 expression remained high and largely stable following standard-of-care (SoC) treatments, including platinum and non-platinum chemotherapy, bevacizumab-containing regimens, PARP inhibitors and mirvetuximab soravtansine. Treatment-associated changes in MUC16 expression were consistently small, and MUC16 demonstrated less treatment-associated variation than several other ADC targets, including FRα, TROP2 and NaPi2b. These findings suggest MUC16 is a durable therapeutic target for ADCs across multiple lines of therapy, and support development strategies that include both combination approaches and treatment in relapsed disease.

"For an ADC target to have broad clinical utility in ovarian cancer, it’s important that it remains consistently expressed as patients move through multiple lines of therapy," said Margaret Dugan, MD, Chief Medical Officer of Whitehawk Therapeutics. "These findings suggest MUC16 is durable throughout the treatment continuum and support the exploration of HWK-016 both in combination with established therapies and in patients whose disease has progressed following prior treatment."

In a separate analysis of patients with high-grade serous ovarian carcinoma (HGSOC) – the most common histologic subtype accounting for approximately 70% of cases – high tumor MUC16 expression was prognostically associated with poor real-world overall survival (rwOS). This association remained statistically significant after adjustment for key clinical and molecular covariates and was also observed among patients who were treatment-naïve at first metastatic diagnosis.

"Ovarian cancer continues to be a difficult-to-treat disease with new therapeutic approaches urgently needed," said Robert L. Coleman, MD, Texas Oncology. "The observation that high MUC16 expression was independently associated with poorer real-world overall survival indicates it is an important marker of more aggressive disease biology, and supports the continued investigation of MUC16-directed ADCs in this disease."

Poster Details:

Title: Durable and Treatment-Agnostic MUC16 Expression in Ovarian Cancer Supports Targeted Antibody-Drug Conjugate Development
Poster: 950
Presenter: Kathleen N. Moore, MD, University of Nebraska Medical Center, Omaha, Nebraska
Date & Time: E-Poster

Key Findings:

MUC16 expression remained largely stable following platinum and non-platinum chemotherapy, bevacizumab-containing regimens, PARP inhibitors and mirvetuximab soravtansine.
Findings suggest that the target may be suitable for MUC16-directed therapy after prior SoC treatment and in combination with standard early-line platinum-based treatment.
Stable MUC16 expression is also observed in paired tumor samples.
MUC16 demonstrated less treatment-associated variation than several late-stage ADC targets, including FRα, TROP2 and NaPi2b.
Title: High MUC16 Expression Is Associated With Poor Real-World Overall Survival in Patients With High-Grade Serous Ovarian Carcinoma
Poster: 519
Presenter: Robert L. Coleman, MD, Texas Oncology, The Woodlands, Texas
Date & Time: October 1, 2026, 2:35-2:40 ET

Key Findings:

MUC16 expression at metastatic diagnosis was prognostically associated with poor rwOS.
Results were similar in the treatment-naïve subpopulation.
Eastern Cooperative Oncology Group performance status, BRCA mutation status and age at diagnosis were also independent prognostic factors of rwOS.
High circulating CA125 was also associated with poor prognosis in patients with heavily pretreated HGSOC.
HWK‑016 is a MUC16-directed, next-generation ADC targeting the non-shed extracellular domain that is being evaluated in an ongoing Phase 1 clinical trial in patients with advanced ovarian and endometrial cancers (NCT07470853).

These analyses were conducted as part of a previously announced collaboration between Whitehawk and Tempus AI. The posters will be accessible on the Presentations page of the Investors & News section of the Company’s website at www.whitehawktx.com.

(Press release, Whitehawk Therapeutics, OCT 1, 2026, View Source [SID1234671227])

On October 1, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the second patient has been treated in the fifth cohort of its ongoing Phase 1, dose-escalating, clinical trial (ClinicalTrials.gov NCT05316129) evaluating its novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer. The study is being conducted at Moffitt Cancer Center ("Moffitt").

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The Phase 1 study is evaluating a novel CAR-T therapy targeting follicle stimulating hormone receptor (FSHR), which is expressed on ovarian cancer cells but has limited expression in healthy tissues. The trial is designed to assess safety, tolerability, and preliminary signs of efficacy across escalating dose levels.

The patients in the fifth cohort receive a dose of 1×10⁷ CAR-positive cells per kilogram of body weight following lymphodepletion, representing the highest dose level evaluated to date in the study. To date, no dose-limiting toxicities have been observed across any cohort up to and including the first patient treated in the fifth cohort.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "Ovarian cancer remains one of the deadliest cancers affecting women, and patients with recurrent disease face limited treatment options and poor outcomes. While this Phase 1 study is primarily designed to evaluate safety, we are highly encouraged that multiple patients have surpassed one year of survival following treatment, with one patient having survived beyond two years. Typically, these highly pre-treated patients survive a matter of weeks. We look forward to further evaluating this novel solid tumor-specific CAR-T therapy as enrollment progresses."

As of the date of this release, four patients in the study have surpassed one year of survival following treatment, with individual patients surviving approximately 28, 19, 17, and 17 months post-treatment, respectively. The Company believes these outcomes are notable in a highly pre-treated, recurrent ovarian cancer population that has progressed after multiple prior lines of therapy and limited treatment options and poor prognosis.

Anixa’s CAR-T technology was developed by Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. The Phase 1 clinical trial is being conducted at Moffitt, under the direction of Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt. Anixa holds an exclusive world-wide license to the technology from The Wistar Institute.

(Press release, Anixa Biosciences, OCT 1, 2026, View Source [SID1234671226])

On October 1, 2026 Xspray Pharma AB (publ) reported an update on the regulatory status for its two lead product candidates, Dasynoc and Nilopki. The Company reiterates its plan to resubmit the New Drug Applications, NDAs, for both product candidates to the U.S. Food and Drug Administration, FDA, in the fourth quarter of 2026.

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Preparations for the resubmission of both NDAs are progressing as expected. Following dialogue with the FDA, Xspray has confirmation that both Nilopki and Dasynoc resubmissions may occur independent of the cGMP status of NerPharMa.

For both Dasynoc and Nilopki, the required additional consecutive commercial-scale batches and related analytics have commenced. For Nilopki, Xspray continues to prepare the necessary documentation to establish dose correspondence with Tasigna at a dose level relevant only to a patient sub-population with the 96mg.

Xspray’s assessment is that the remaining Xspray-controlled activities required for resubmission of both NDAs can be completed in time to support resubmission in the fourth quarter of 2026.

With respect to both NDAs, the cGMP status of Xspray’s third-party manufacturing facility, NerPharMa, remains an important part of FDA’s approvability assessment. Final facility clearance remains necessary before approval can be granted. NerPharMa has informed FDA that it considers the facility inspection-ready since June 2026. They have completed the CAPA plan agreed with the FDA and communicated this accordingly. What remains is the FDA’s assessment. The timing and nature of FDA’s next step remain outside of Xspray’s control.

"Xspray remains focused on completing the remaining regulatory steps for both Dasynoc and Nilopki as efficiently and comprehensively as possible," says Blake Leitch, CEO of Xspray Pharma. ""The corrective work at the manufacturing site has been carried out and reported to FDA, and what remains there is FDA’s assessment of it. We continue to target resubmission of both NDAs in the fourth quarter of 2026, while maintaining launch readiness and financial discipline."

Xspray will hold a live-streamed Investor Update in Gothenburg on 2 October 2026, starting 12.30-14.00 CET. Link to follow the Investor Update live.

(Press release, Xspray, OCT 1, 2026, View Source [SID1234671223])

On October 1, 2026 Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that TUDRIQEV (vusolimogene oderparepvec-wtpg) is now commercially available in the United States. TUDRIQEV is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.

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This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

TUDRIQEV received accelerated approval from the U.S. Food and Drug Administration in early August. Beginning today, healthcare providers can order TUDRIQEV for next day delivery.

"With TUDRIQEV now available, we have reached a critical milestone in bringing this therapy to patients with advanced melanoma who have been waiting for a new option," said Sushil Patel, Ph.D., Chief Executive Officer of Replimune. "I’m deeply proud of our team, who moved with urgency to put the infrastructure and comprehensive patient support services in place so that healthcare providers can access this therapy with next day delivery when their patients need it."

Administration
TUDRIQEV is administered by direct intratumor injection into superficial, deep, and/or visceral lesions, with imaging guidance used for deep or visceral lesions. It is given once every two weeks for eight consecutive doses, with the dose based on tumor size; a lower concentration is used for the first dose and a higher concentration for subsequent doses. Nivolumab is administered intravenously beginning at week three. Please see the full Prescribing Information for complete dosing, preparation, handling, and administration instructions.

Clinical Data Supporting Approval
The accelerated approval was based on the registrational anti-PD-1-failed melanoma cohort of the IGNYTE trial, which enrolled 140 patients. Among the 91 efficacy-evaluable patients with at least one non-injected lesion, TUDRIQEV plus nivolumab achieved an objective response rate of 24.2% (95% CI: 15.8, 34.3) with a median duration of response of 14.1 months (95% CI: 10.7, not reached).

A confirmatory Phase 3 trial, IGNYTE-3 (NCT06264180), is ongoing.

ReplimuneConnect Plus Patient Support Program
Replimune is committed to helping eligible patients in the U.S. access treatment with TUDRIQEV. ReplimuneConnect Plus is a comprehensive program that provides information and support on access, reimbursement, and financial assistance for eligible patients who are prescribed TUDRIQEV, including benefits investigation, co-pay assistance for eligible commercially insured patients, referrals to independent foundations, and case manager support.

Patients, caregivers, and healthcare providers can learn more and enroll at replimuneconnectplus.com or by calling 1-833-775-7587, Monday through Friday from 8 AM to 8 PM ET.

About Melanoma
Melanoma is the fifth most common cancer, with approximately 105,000 new cases estimated in the U.S. in 2025, and the most lethal form of skin cancer, accounting for nearly 8,500 deaths annually. Standard of care includes immune checkpoint blockade, to which approximately half of patients will not respond or will progress after treatment. For patients who progress following anti-PD-1 therapy, treatment options are limited.

About TUDRIQEV (vusolimogene oderparepvec-wtpg)
TUDRIQEV is a genetically modified herpes simplex virus type 1 (HSV-1) oncolytic viral therapy that encodes a fusogenic glycoprotein derived from gibbon ape leukemia virus with the R sequence deleted (GALV-GP-R–) and human granulocyte macrophage colony-stimulating factor (GM-CSF). The genes encoding the HSV-1 neurovirulence factor ICP34.5 and the ICP47 inhibitor of antigen presentation are deleted. TUDRIQEV preferentially replicates within tumors, leading to tumor lysis and release of tumor and viral antigens. In combination with nivolumab, TUDRIQEV may promote an anti-tumor immune response in the anti-PD-1-resistant setting. For more information, visit Tudriqev.com.

INDICATION
TUDRIQEV (vusolimogene oderparepvec-wtpg) is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.
This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Warnings and Precautions
Accidental Exposure to TUDRIQEV: Healthcare providers, caregivers, close contacts, pregnant women, newborns, and patients should avoid direct contact with injected tumors, dressings, or bodily fluids of patients. Should accidental exposure occur, clean the affected area.

Herpetic Infection or Reactivation: Assess and treat suspected herpetic lesions as clinically warranted.

Visceral Injury: Monitor patients for signs and symptoms of visceral injury during and after TUDRIQEV administration and manage accordingly.

Adverse Reactions
Serious adverse reactions occurred in 35% of 140 patients who received TUDRIQEV in combination with nivolumab, including 2 patients each with arthralgia, hypophysitis, immune-mediated enterocolitis, and pyrexia. Adverse reactions leading to permanent discontinuation of TUDRIQEV occurred in 2.9% of 140 patients and were 1 each of amylase increased, lipase increased, myocarditis, and pneumonitis.

The most common non-laboratory adverse reactions (incidence >10%) are fatigue, pyrexia, chills, musculoskeletal pain, nausea, diarrhea/colitis, injection site reaction, headache, cough, influenza-like illness, vomiting, pruritus, arthralgia, asthenia, constipation, decreased appetite, dizziness, skin/superficial infection, and dyspnea.

Drug Interactions
Antivirals: Delay TUDRIQEV administration for 72 hours.

Use in Specific Populations
Females and Males of Reproductive Potential: Advise females of reproductive potential, and males with a female partner of reproductive potential, to use effective contraception during TUDRIQEV treatment and for 90 days after the last dose.

Please report any adverse event or product quality complaint related to a Replimune product by calling 1-877-375-0095. You may also contact the FDA directly at www.fda.gov/medwatch or 1-800-FDA-1088.

Please see full Prescribing Information, including Patient Information, at www.replimune.com/medicines. Please also refer to the full Prescribing Information for nivolumab.

(Press release, Replimune, OCT 1, 2026, View Source [SID1234671222])

On October 1, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, reported the publication of final phase 2a clinical trial results (NCT04495153) of aglatimagene besadenovec (aglatimagene) plus valacyclovir in patients with stage III/IV NSCLC who had shown inadequate response to ICI. The trial demonstrated a median overall survival (mOS) of 24.5 months in the evaluable population, substantially exceeding historical benchmarks for standard-of-care docetaxel chemotherapy in this patient population.

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The data is published in the Journal for ImmunoTherapy of Cancer, a leading peer-reviewed oncology journal, providing independent validation of the clinical significance of aglatimagene in patients with advanced NSCLC with an inadequate response to ICI.

Patients with unresectable stage III/IV NSCLC who progress on ICI face limited treatment options and poor survival outcomes. Current standard of care with docetaxel chemotherapy yields a median overall survival of only 9.8 to 11.8 months in this population.1,2 The phase 2a trial enrolled 46 evaluable patients receiving two courses of aglatimagene plus valacyclovir in combination with continued ICI therapy (per protocol population). Among patients with progressive disease at baseline despite ICI treatment (cohort 2, n=41), mOS was 21.5 months. Notably, 37% of patients with progressive disease on ICI remained alive beyond 24 months at the time of data cutoff, demonstrating a prolonged survival tail not typically observed in this setting.

Non-squamous NSCLC has also emerged as a key predictor of enhanced clinical benefit. In the evaluable population of patients with non-squamous histology and progressive disease on ICI (n=33), mOS reached 25.4 months, with 14 of 15 patients surviving beyond 24 months and 9 of 9 patients surviving beyond 30 months having non-squamous disease. Exploratory analysis in the intention-to-treat cohort of non-squamous patients showed mOS of 16.7 months, still longer than the 12.3-month benchmark reported with docetaxel in this setting in published trials.

Mechanistic studies revealed systemic immune activation following treatment. Among evaluable patients with >1 lesion (n=35), 69% exhibited systemic clinical response with reduction of uninjected lesions, indicating an abscopal response. Biomarker analysis demonstrated increased cytotoxic T cell infiltration in tumor tissue, expansion of activated CD8+ effector and central memory T cells in peripheral blood, and elevated serum levels of granzymes after the second aglatimagene injection, with changes most pronounced following the second administration. Multi-omics factor analysis identified coordinated immune activation patterns associated with improved survival. Patients who survived beyond 24 months exhibited significantly higher levels of key immune markers, including granzyme B and granzyme H, compared to those who died earlier.

Treatment with aglatimagene plus valacyclovir was generally well tolerated, with the most common adverse events being mild flu-like symptoms (fatigue, nausea, pyrexia) that were predominantly grade 1 and 2. Grade 3 treatment-related adverse events were reported in 13.7% of patients. No dose-limiting toxicities or unexpected safety signals were identified during extended follow-up.

"These peer-reviewed results confirm that aglatimagene has the potential to extend survival for patients with advanced non-small cell lung cancer who have limited options after immune checkpoint inhibitors fail to control their cancer," said Charu Aggarwal, MD, MPH, Leslye Heisler Professor of Medicine at the University of Pennsylvania’s Perelman School of Medicine and lead investigator of the trial. "The magnitude of benefit observed, particularly in patients with non-squamous disease, is striking, and represents an important potential advance for this patient population."

Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel commented, "Aglatimagene’s ability to reinvigorate anti-tumor immunity in checkpoint-refractory patients through a systemic immune response, combined with its favorable safety profile, positions this approach as a potentially transformative option for patients with limited therapeutic alternatives. These results support the advancement of our pivotal phase 3 AURORA trial, which is enrolling patients globally."

The global phase 3 AURORA trial is enrolling patients across approximately 150 sites worldwide. The trial is evaluating aglatimagene plus valacyclovir in combination with continued pembrolizumab versus standard-of-care docetaxel in patients with metastatic stage IV non-squamous NSCLC who have experienced disease progression despite prior pembrolizumab and platinum-based chemotherapy.

About aglatimagene besadenovec

Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several nonclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority for any use.

(Press release, Candel Therapeutics, OCT 1, 2026, View Source [SID1234671221])