On October 7, 2026 MimiVax Inc., a clinical-stage biotechnology company dedicated to the development of innovative cancer immunotherapies, in collaboration with Roswell Park Comprehensive Cancer Center, reported results from the SURVIVE trial (NCT05163080), the Company’s Phase 2b randomized, double-blind, placebo-controlled clinical trial evaluating its novel cancer vaccine, SurVaxM, in patients with newly diagnosed glioblastoma.

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The data reflect the first reportable results from the fully enrolled clinical trial, which has been underway since 2022 at 11 U.S. cancer centers.

Across all 233 evaluable patients, SurVaxM improved median overall survival (OS), the primary endpoint, to 22.8 months versus 20.3 months for placebo (hazard ratio [HR] 0.75; 95% CI 0.54 to 1.03; log-rank p=0.076 adjusted for MGMT & KPS stratification), a clinically meaningful result that did not quite reach the traditional threshold for statistical significance (p=0.05).

Importantly, among a prespecified key subpopulation of patients aged 65 and under, SurVaxM demonstrated a statistically significant benefit, with median OS of 24.2 months versus 20.2 months (HR 0.64; 95% CI 0.44 to 0.93; p=0.019 adjusted for MGMT & KPS stratification). A significant benefit was seen in progression-free survival (PFS) in the same subgroup of patients 65 and under (HR 0.64; p=0.018), including improvement in progression-free survival at 12 months (44% SurVaxM vs 24% placebo).

"Every patient with glioblastoma is facing one of the hardest diagnoses in medicine. To see many of our study patients living longer, and several of them living years longer, is deeply meaningful to every one of us who has participated in the work to develop and study this new treatment approach," said Ajay Abad, M.D., study principal investigator and Assistant Professor of Oncology and Neurology in the Department of Neuro-Oncology at Roswell Park. "In a disease where we’ve had limited progress over the last 20 years, an improvement in survival of this magnitude is noteworthy."

Robert Fenstermaker M.D., co-principal investigator of the SURVIVE trial, Chair Emeritus of Neurosurgery at Roswell Park and Chief Medical Officer and Co-founder of MimiVax, added, "For patients 65 and under, this is one of the strongest signals we have seen in newly diagnosed glioblastoma in a long time. We designed the trial to provide a good comparison to our earlier Phase 2a study, while adding a placebo arm to account for improvements in standard of care that may have occurred over time. In a disease where progress has often been measured in weeks, results like these can be enormously meaningful."

Long-Term Survival

The new analysis also shows that approximately 42% of SurVaxM-treated patients 65 and under were alive through 30 months or longer, with no further deaths reported at 30 through 54 months. This durable, long-term survival represents a doubling of survival compared to placebo (42% SurVaxM vs. 18% Placebo). This level of long-term survival is uncommon in people with newly diagnosed glioblastoma and warrants continued follow-up and investigation.

"These initial results from the SURVIVE trial give us a clear and coherent picture. SurVaxM showed a consistent survival signal, with a substantial group of patients living well past what we typically see in this disease," said Michael Ciesielski, Ph.D., Chief Executive Officer and Co-Founder of MimiVax. "We believe these data make a compelling case for SurVaxM, and we look forward to discussing these robust findings with the FDA."

The Control Arm’s Strong Results

The placebo arm in SURVIVE outperformed the trial’s design assumptions, with a median overall survival of 20.3 months versus an expected 16-month historical benchmark. The contemporary standard of care performed better than historical references would have predicted, raising the bar against which SurVaxM was measured. The longer survival in the control arm made a statistically significant separation in the overall population more difficult to achieve and provides important context for interpreting the primary endpoint.

Safety

SurVaxM was well tolerated. Observed responses were predominantly Grade 1 or 2 injection-site reactions (injection-site reaction 48%, pain 41%, erythema 39%, pruritus 38%, swelling 29%) and influenza-like illness (13%). Rates of Grade 3 or higher adverse events were similar between arms (48% with SurVaxM versus 46% with placebo), as were overall serious adverse event rates (25% versus 21%). Adverse events led to treatment discontinuation in 4% of SurVaxM patients, with one discontinuation attributed to study treatment. There were no treatment-related deaths in either arm.

Regulatory Next Steps

MimiVax plans to request a meeting with the U.S. Food and Drug Administration in the coming months to review the SURVIVE data and align on the path forward for SurVaxM in newly diagnosed glioblastoma.

"We want to discuss Breakthrough Therapy Designation with the FDA, along with other expedited pathways, including accelerated approval," said Dr. Ciesielski. "The path to making SurVaxM available to patients will be determined in consultation with the agency."

A Serious Unmet Need

Glioblastoma is a deadly disease that strikes about 15,000 Americans every year. With few effective therapies and a standard of care that has not changed in more than 20 years, patients and families are desperate for new options.

About the SURVIVE Trial

SURVIVE (NCT05163080) is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating SurVaxM in combination with standard of care in patients with newly diagnosed glioblastoma. The fully enrolled trial included 233 evaluable patients at 11 leading U.S. cancer centers. The primary endpoint was overall survival (OS), with patients aged 65 and under prespecified as a key subpopulation for the primary endpoint. Secondary endpoints included progression-free survival (PFS), landmark survival, safety, and survivin-specific immune responses.

About SurVaxM

SurVaxM is a first-in-class, patented peptide-mimic immunotherapeutic vaccine that targets survivin, a cell-survival protein present in approximately 95% of glioblastomas and many other cancers. Delivered by subcutaneous injection, SurVaxM is designed to stimulate the patient’s own immune system to recognize and attack survivin-expressing cancer cells, with the goal of controlling tumor growth and preventing recurrence. SurVaxM holds FDA Orphan and Fast Track Designations for newly diagnosed glioblastoma and is being evaluated across multiple cancer indications, including glioblastoma, neuroendocrine tumors, multiple myeloma, and pediatric brain cancers. SurVaxM is for investigational use only and has not yet been approved by the FDA or any other regulatory authority for any indication.

The late-stage SURVIVE study for glioblastoma has completed enrollment and is no longer open to additional patients. There are no SurVaxM studies currently enrolling for glioblastoma.

(Press release, MimiVax, OCT 7, 2026, View Source [SID1234673263])

On October 7, 2026 AbbVie (NYSE: ABBV) reported that the U.S. Food and Drug Administration (FDA) has granted two Breakthrough Therapy Designations (BTDs) for telisotuzumab adizutecan (Temab-A; ABBV-400) in colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).

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Temab-A has received two BTDs: one in combination with bevacizumab for adults with refractory, metastatic CRC who have been previously treated with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF monoclonal antibody (mAb), and if indicated, anti-EGFR mAb therapy. The second designation is for Temab-A as a monotherapy for adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous NSCLC who have previously received treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody therapy. These designations were primarily based on results from the first-in-human study M21-404 (NCT05029882).

"These Breakthrough Therapy Designations reflect the growing clinical evidence supporting c-Met as a meaningful therapeutic target across multiple solid tumors," said Eleni Lagkadinou, M.D., Ph.D., vice president, oncology early development, AbbVie. "As one of the most advanced assets in our next-generation ADC portfolio, Temab-A has demonstrated potential across multiple tumor types, both as a monotherapy and in combinations. We believe these designations further support our strategy of advancing biomarker-driven therapies and underscore our commitment to developing transformative medicines for patients with difficult-to-treat cancers."

Colorectal and lung cancer together affect more than four million people worldwide each year and remain among the leading causes of cancer-related mortality.1,2 Despite advances in treatment, many patients with CRC and advanced NSCLC continue to experience disease progression, underscoring the need for new therapeutic approaches. The FDA’s BTD program is intended to expedite the development and review of investigational medicines with clinical evidence that may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Temab-A is an investigational asset and has not been approved for use by global regulatory authorities.

About Telisotuzumab Adizutecan (Temab-A)

Telisotuzumab adizutecan (Temab-A) is a next-generation, c-Met protein-targeting antibody-drug conjugate (ADC) with a topoisomerase 1 inhibitor (Top1i) payload being investigated in advanced solid tumors including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). The c-Met protein (also known as MET protein), with increased expression in many solid tumors, may contribute to disease progression and treatment resistance, reinforcing its potential as a promising therapeutic target.

Developed using AbbVie’s adizutecan platform, Temab-A combines a validated, humanized bivalent IgG1 monoclonal antibody that binds with high affinity to the c-Met protein with the Top1i payload through a cleavable valine-alanine linker and stable bromoacetamide attachment. This design is intended to support targeted delivery while minimizing systemic payload release.

In addition to CRC and NSCLC, Temab-A is being evaluated across other multiple advanced solid tumors, including head and neck squamous cell carcinoma (HNSCC), gastroesophageal adenocarcinoma (GEA), pancreatic ductal adenocarcinoma (PDAC), and ovarian cancer (OC). The clinical development program includes multiple Phase 3 and Phase 2/3 studies evaluating Temab-A as both a monotherapy and in combination with other therapies across a range of treatment settings. Additional information about ongoing Temab-A clinical trials can be found on clinicaltrials.gov.

(Press release, AbbVie, OCT 7, 2026, View Source [SID1234673262])

On October 7, 2026 10x Genomics, Inc. (Nasdaq: TXG), the life science technology leader focused on accelerating science and advancing human health, reported a multi-project research collaboration with Fred Hutchinson Cancer Center (Fred Hutch), one of the nation’s leading cancer research institutions, to advance the use of single cell and spatial technologies in both solid tumor and hematologic malignancies.

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The collaboration marks 10x’s first clinical research initiative to extend beyond solid tumors into blood cancers, and builds on 10x’s work to generate evidence for the clinical potential of its single cell and spatial products in oncology diagnostics.

The first project intends to use 10x’s Flex Apex and Xenium platforms, with plans to expand to the Atera platform, to investigate tumor samples from patients with advanced bladder cancer treated with antibody-drug conjugates, immune checkpoint inhibitors and other therapies. The goal is to correlate drug target expression and tumor microenvironment features with treatment response and clinical outcomes. From there, the 10x and Fred Hutch teams will explore biomarkers that could one day help inform therapy selection for oncologists and their patients.

The second project intends to use the Flex Apex platform to investigate residual disease detection in acute myeloid leukemia (AML). Monitoring for residual leukemic cells after treatment is a critical part of guiding care for patients with AML, but today, it relies on a patchwork of separate technologies. 10x and Fred Hutch plan to investigate whether single cell analysis can improve and expand upon the current gold-standard methods.

Lawrence Fong, MD, will lead the collaboration for Fred Hutch. "This project will help us better characterize the cellular and molecular responses to cancer treatments. We look forward to seeing how the results of this research could help guide treatment decisions for people with cancer," said Fong, who is the scientific director of Fred Hutch’s Integrated Immunotherapy Research Center and cares for patients with prostate, bladder and kidney cancers. Fong is also the Bezos Family Distinguished Scholar in Immunotherapy at Fred Hutch.

"Across cancer care, we have more effective therapies than ever, and too little insight into which patient will actually benefit from which one," said Serge Saxonov, Co-founder and CEO of 10x Genomics. "Single cell and spatial biology let us look directly at the biology that drives treatment response, whether it’s in a tumor or in the blood, and we believe that’s the missing foundation for precision oncology. We’re excited to work with Fred Hutch on this research."

This collaboration builds on 10x’s announced collaborations with leading hospitals and institutes, and, together with 10x’s planned CLIA-certified laboratory, builds the scientific and operational foundation for potential future diagnostic applications in oncology and autoimmune disease. As part of this effort, 10x and Fred Hutch also plan to build a framework for future clinical reporting, defining how single cell and spatial features could support treatment planning in patients with cancer.

(Press release, Fred Hutchinson Cancer Research Center, OCT 7, 2026, View Source [SID1234673261])

On October 7, 2026 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage, AI-driven precision oncology company, reported that it has received regulatory and IRB approvals in Taiwan to open the next stage (Part 2) of its Phase 2 HARMONIC trial of LP-300. The Taiwan Food and Drug Administration (TFDA) approved the amended protocol earlier in September, and the lead Taiwan site received local Institutional Review Board (IRB) approval on September 29, 2026. The lead site is now open to accrual and actively screening patients. The approval also allows additional Taiwan sites to proceed with their own IRB reviews. Lantern anticipates IRB approval in an additional two sites during Q4.

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In the United States, a central IRB has approved the amended protocol, and academic clinical sites have begun identifying patients whose tumors carry the EGFR exon 21 L858R mutation. Patients enrolled under the amended protocol will be eligible for up to eight cycles of LP-300, which is an increase from the prior limit of up to six cycles.

The increase to eight cycles is supported by two key findings:

Longer progression-free survival in patients completing more cycles – In the ongoing Phase 2 trial, L858R patients who completed six cycles of LP-300 had a median progression-free survival (mPFS) of 8.9 months (n=9; three had not yet progressed), compared with 8.3 months for all L858R patients (n=16). These data are exploratory and need to be confirmed in additional patients.
Comparable safety with longer treatment – In HARMONIC , the safety profile of patients who received six cycles was comparable to that of patients who received four. Additionally, in prior clinical trials with LP-300, up to eight cycles at the current dose did not alter LP-300’s safety profile.
Taiwan: High Patient Population & Need

Lung cancer has been the leading cause of cancer death in Taiwan for decades, and more than half of lung cancer patients there have never smoked.1,2 According to Taiwan’s 2025 national lung cancer treatment guidelines, 55% of Taiwanese patients with advanced lung adenocarcinoma harbor EGFR mutations, predominantly exon 19 deletions and exon 21 L858R substitutions.1

Taiwan’s health system is also set up to find these patients. National Health Insurance reimburses next-generation sequencing at the time of drug resistance, so patients progressing on EGFR-targeted therapy can be profiled at the point where they would become eligible for HARMONIC. Lantern plans to open additional sites in Taiwan and expects this combination of high mutation prevalence and available molecular testing to support efficient enrollment in Part 2.

East Asia: A Consistent Pattern of Patient Need

Approximately one third of lung cancer patients in East Asia are never-smokers (39.7% in China, 38% in South Korea and 32.8% in Japan),3 compared with approximately 15% of NSCLC diagnoses in the United States.4 EGFR mutations are present in roughly half of advanced lung adenocarcinomas in Asian patients.5 By comparison, a pooled analysis of 456 studies put EGFR mutation prevalence in NSCLC at approximately 14% in Europe and 24% in the United States.6 The L858R mutation is also more common in Asia: a worldwide meta-analysis found that L858R accounts for approximately 41% of EGFR mutations in Asian patients with advanced NSCLC, compared with approximately 30% in European patients.7 Among East Asian never-smokers with lung adenocarcinoma, EGFR mutations are the most common driver, found in 60 to 78% of cases.3

Lantern has now enrolled or opened HARMONIC in two East Asian regions, having completed targeted enrollment in Japan across five clinical centers in 2025. The Company believes that data generated in Taiwan and Japan will be relevant to the broader East Asian patient population and will support discussions regarding partnering and regional co-development of LP-300 with Asia-focused biopharma companies.

Part 2 Clinical Trial Design

Part 2 implements the protocol amendments to which the FDA had no objections and that were announced by Lantern in May 2026:

Enrollment is limited to patients with the EGFR exon 21 L858R mutation who have progressed after tyrosine kinase inhibitor treatment.
LP-300 may be given for up to eight cycles, increased from six, in combination with carboplatin and pemetrexed.
"Never-smoker lung cancer is most common in East Asia. In Taiwan, more than half of lung cancer occurs in never-smokers, and a meaningful share of those patients carry the L858R mutation, where outcomes on current targeted therapies have lagged those of other EGFR-mutant patients. What we see in Taiwan is what clinicians see across the region. With these approvals, the next stage of HARMONIC opens where the need is high and where we expect enrollment to be efficient. That matters for how quickly we can get to a clear answer on LP-300."
— Panna Sharma, President and Chief Executive Officer, Lantern Pharma Inc.

Rationale

Preliminary analyses from HARMONIC suggested that patients with L858R-mutant disease may derive greater benefit from the LP-300 combination than other EGFR-mutant subgroups, with a previously reported median progression-free survival of 8.3 months in this group (n=16).

The increase to eight cycles is supported by two findings. In the ongoing Phase 2 trial, L858R patients who completed six cycles of LP-300 had a median progression-free survival of 8.9 months (n=9; three had not yet progressed), with a safety profile comparable to that of patients who received four cycles. In addition, prior clinical experience showed that up to eight cycles at the current dose did not alter LP-300’s safety profile.

These data are preliminary, exploratory and based on small patient numbers. Lantern expects to gather additional supporting data in the next stage of the Harmonic clinical trial.

Market Opportunity and Regional Partnering Strategy

Lung cancer is the most commonly diagnosed cancer worldwide, with approximately 2.5 million new cases in 2022. China and Japan together accounted for approximately 1.2 million of those cases, nearly half of the global total.8

Approximately 350,000 new cases of EGFR-mutant NSCLC are diagnosed worldwide each year, and Lantern estimates that 90,000 to 100,000 of those patients carry the EGFR exon 21 L858R mutation. Lantern estimates that the treatment of never-smokers with NSCLC represents an annual market opportunity of $4 billion or more.

No therapy has been developed or labeled specifically for never-smoker NSCLC. Lantern is exploring regional licensing, partnering and co-development opportunities for LP-300 to accelerate its development and realize its commercial potential in the geographies where patient need is greatest.

About LP-300 and the HARMONIC Trial

LP-300 is an investigational small molecule being evaluated in Lantern Pharma’s Phase 2 HARMONIC trial in combination with carboplatin and pemetrexed in never-smokers with advanced NSCLC adenocarcinoma who have progressed following treatment with EGFR tyrosine kinase inhibitors. Part 2 of HARMONIC is a single-arm study enrolling patients with EGFR exon 21 L858R mutations, with LP-300 dosing of up to eight cycles. The trial is registered on ClinicalTrials.gov under identifier NCT05456256. LP-300 has not received FDA marketing approval for any indication. All clinical data referenced in this press release are preliminary.

(Press release, Lantern Pharma, OCT 7, 2026, View Source [SID1234673260])

On October 7, 2026 Affibody Medical AB ("Affibody"), a clinical stage biotechnology company developing next generation radiopharmaceuticals, reported that management will participate in the 6th Annual Needham Private Biotech & Medtech Company Virtual 1×1 Forum, taking place October 13–14, 2026. Affibody will be represented by David Bejker, Chief Executive Officer, and Peter Zerhouni, Chief Financial Officer and Chief Business Officer.

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During the forum, management will be available for one-on-one meetings with investors and will discuss Affibody’s precision radioligand therapy platform, including the ongoing clinical development of its lead HER2-targeted candidate, ABY-271, and its emerging pipeline of RLT programs for solid tumors.

(Press release, Affibody, OCT 7, 2026, View Source;1-forum/ [SID1234673259])