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Immunome Announces U.S. FDA Acceptance of New Drug Application for Varegacestat for the Treatment of Adults with Desmoid Tumors

On July 8, 2026 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, reported the U.S. Food and Drug Administration (FDA or the Agency) has accepted its New Drug Application (NDA) for varegacestat, an investigational, oral, once-daily gamma secretase inhibitor (GSI), for the treatment of adults with desmoid tumors. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 28, 2027.

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"The FDA’s acceptance of our NDA for varegacestat is an important milestone for Immunome and for patients living with desmoid tumors," said Clay Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We believe varegacestat has the potential to provide an important oral treatment option, supported by robust clinical data across all key efficacy endpoints. We look forward to working closely with the FDA throughout the review."

RINGSIDE Phase 3 Trial Results

The NDA is based on results from the Phase 3 RINGSIDE trial evaluating varegacestat in patients with progressing desmoid tumors. Key findings include:

The registrational trial met its primary endpoint of improving progression-free survival vs. placebo, with a statistically significant and clinically meaningful 84% reduction in the risk of disease progression or death (hazard ratio = 0.16, p<0.0001).
The trial also met all key secondary endpoints, including achieving an objective response rate of 56% vs. 9% with placebo (p<0.0001), as assessed by blinded independent central review.
Varegacestat demonstrated statistically significant improvement in worst pain intensity at week 12, with a clinically significant difference observed as early as the first evaluation at week 4.
In an exploratory analysis, varegacestat showed a median best change in tumor volume of -83% vs. +11% with placebo, as assessed by blinded independent central review.
Varegacestat was generally well tolerated with a manageable safety profile, consistent with the gamma secretase inhibitor class. The most common adverse events for participants in the treatment arm were diarrhea (82%), fatigue (44%), rash (43%), nausea (35%) and cough (34%). Most (95%) events were grade 1 or 2.
The results were presented in an oral abstract session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

About the RINGSIDE Trial

The global, randomized, double-blind, placebo-controlled Phase 3 RINGSIDE trial (ClinicalTrials.gov Identifier: NCT04871282) evaluated the efficacy and safety of varegacestat in patients with progressing desmoid tumors. A total of 156 patients were randomized to receive varegacestat 1.2 mg daily or placebo until disease progression or death, representing the largest randomized study in this population. The primary endpoint of the trial was progression-free survival as assessed by blinded independent central review. Statistically controlled secondary endpoints were confirmed ORR using RECIST v1.1 and change in tumor volume at week 24, both determined by blinded independent central review, as well as change in pain intensity at week 12 as determined using a patient-reported outcome instrument. Additional secondary endpoints included duration of response, best reduction in tumor volume, patient-reported outcomes, and safety and tolerability. RINGSIDE includes an open-label extension phase, which is ongoing.

About Desmoid Tumors

Desmoid tumors (also known as aggressive fibromatosis or desmoid-type fibromatosis) are aggressive non-metastatic soft tissue tumors that are prone to recurrence. Approximately 1,000-1,650 people are diagnosed with desmoid tumors each year in the United States, and there are approximately 10,000-11,000 actively managed patients. Those affected face debilitating pain, deformity and, in some cases, life-threatening organ damage. The chronic pain and physical limitations associated with desmoid tumors lead to a high clinical burden and impaired quality of life. Although desmoid tumors are not considered cancerous, they often require systemic treatment to prevent permanent disability and alleviate disease burden.

About Varegacestat

Varegacestat (formerly AL102) is an investigational, oral, once-daily gamma secretase inhibitor. In December 2025, Immunome reported positive topline results for the Phase 3 RINGSIDE trial of varegacestat in adults with progressing desmoid tumors. Immunome’s NDA for varegacestat was accepted by the FDA in July 2026 (PDUFA target action date of April 28, 2027) and the Company plans to submit a Marketing Authorization Application to the European Medicines Agency for varegacestat by the end of 2026.

(Press release, Immunome, JUL 8, 2026, View Source [SID1234669112])

Tsingke Highlights AI-Driven CLDN18.2 Antibody Discovery at AIS 2026

On July 8, 2026 Tsingke, a provider of integrated life science research solutions, participated in the Antibody Industrial Symposium (AIS) 2026, one of Europe’s leading conferences dedicated to therapeutic antibodies and biotherapeutics. At the event, the company presented its latest advances in AI-assisted therapeutic antibody discovery and showcased its comprehensive antibody development platform at Booth #44.

AI-Enabled Discovery of Highly Selective CLDN18.2 Antibodies

As part of the scientific program, Tsingke presented an AI-enabled workflow for discovering therapeutic antibodies targeting Claudin 18.2 (CLDN18.2), an emerging target for gastric cancer and other solid tumors.

The presentation demonstrated how AI-assisted sequence analysis and a proprietary screening strategy improve target specificity by reducing potential cross-reactivity with the closely related CLDN18.1 protein, a longstanding challenge in CLDN18.2 antibody development.

The resulting antibody candidates showed strong specificity and favorable developability, highlighting the potential of integrating AI with experimental validation to accelerate therapeutic antibody and antibody-drug conjugate (ADC) development.

End-to-End Antibody Development Capabilities

In addition to its scientific presentation, Tsingke showcased its integrated antibody development platform, covering multiple stages of biologics discovery and development, including:

Antibody Discovery using hybridoma, single B-cell, and phage display technologies for the identification of high-affinity and highly specific antibodies.
Antibody Engineering including antibody humanization, affinity maturation, and synthetic antibody library construction to accelerate therapeutic antibody optimization.
Protein Expression supported by six expression systems and a rapid gene-to-protein workflow for applications including monoclonal antibodies, ADCs, AOCs, and in vitro diagnostics (IVD).
"AIS 2026 provided an excellent opportunity to share our latest work in AI-enabled antibody discovery and connect with researchers across the antibody community," said Chuanting Tan, Senior R&D Engineer at Tsingke. "As therapeutic antibody development becomes increasingly complex, integrating computational approaches with experimental validation can help researchers identify and optimize promising candidates more efficiently. We will continue to enhance our discovery and development capabilities to support innovation in biologics research."

Building on these efforts, Tsingke will continue expanding its AI-enabled discovery platform and integrated biologics capabilities to help researchers accelerate projects from early target discovery through protein expression and characterization.

(Press release, Tsingke Biotech, JUL 8, 2026, View Source;302820198.html [SID1234669111])

Northwest Biotherapeutics Presents Updated Survival Data from Phase III Trial of DCVax®-L For Glioblastoma Using Individual Patient Level Data in Multiple Independent Analyses

On July 8, 2026 Northwest Biotherapeutics (OTCQB:NWBO) (the "Company" or "NWBio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that the Company’s Chief Technical Officer, Dr. Marnix Bosch, presented updated survival data from the Phase III trial of DCVax-L for glioblastoma (GBM) at the 2026 Annual Meeting of the British Neuro-Oncology Society (BNOS). The updated data included results of multiple different statistical analyses conducted by independent statisticians, using individual patient-level data (IPD), and demonstrated that the survival extension with DCVax-L was likely underestimated in the original analysis of the trial results.

The original analysis of the DCVax-L trial results used cohort-level data to compare the results in DCVax-L patients vs. controls, as the Company only had access to cohort-level data for the controls. More recently, the Company obtained individual patient data (IPD) from several major randomized controlled trials (RCTs) in newly diagnosed glioblastoma (ndGBM), which enabled more precise matching of the DCVax-L patients and the controls. Notably, the Statistical Analysis Plan (SAP) for the DCVax-L trial had envisioned that IPD-based analyses would be undertaken when access to IPD could be obtained.

Two widely recognized and rigorous statistical methods were applied by the independent statisticians for the IPD-based analyses: propensity score matching (PSM) and inverse probability weighting (IPW). The PSM analyses of two large RCTs in ndGBM found that the median survival advantage with DCVax-L treatment was 4.9 to 6.3 months, and PSM analysis of a third RCT in ndGBM found 3.4 to 3.7 months survival advantage with DCVax-L. The Hazard Ratios (HRs) ranged from 0.69 to 0.77, and the p values ranged from 0.004 to 0.027. All of these results are substantially greater than the results of the original trial analysis, which found that the median survival advantage with DCVax-L was 2.8 months based on cohort-level data.

The IPW analyses, taking a different approach than the PSM analyses, delivered similar findings: median survival advantage with DCVax-L of 3.4 to 4.3 months.

In addition to conducting the PSM and IPW analyses of known prognostic factors, the statisticians also conducted two forms of sensitivity analyses to check for potential unknown factors which could have confounded or biased the results: E Values and Rosenbaum’s Gamma measures. The results of these sensitivity analyses demonstrated that the observed treatment effect with DCVax-L is not attributable to a hidden imbalance between the DCVax-L patients and the controls.

For further information, please see the presentation slide deck on the Company’s website (www.nwbio.com)

"These new PSM and IPW analyses, together with the E Value and Rosenbaum’s Gamma sensitivity analyses, provide strong evidence and reinforcement of the survival benefit with DCVax-L treatment, based on my review of the statisticians’ analyses," commented Dr. Marnix Bosch. "The key is that all of these analyses, which have taken multiple different approaches and have applied them to multiple ndGBM RCTs, have produced results that are all directionally consistent and all in the same range of magnitude. The statisticians’ findings indicate that the median survival benefit reported from the original analysis of the DCVax-L Phase III trial, based on cohort-level data, was likely substantially underestimated."

(Press release, Northwest Biotherapeutics, JUL 8, 2026, View Source [SID1234669110])

HanchorBio Tests Broader Ambitions for HCB101 Through InxMed Partnership

On July 8, 2026 HanchorBio, Inc. (TWSE: 7827) reported step to broaden the development path for HCB101, its lead oncology asset, through a new partnership with InxMed.

The Taiwan-listed clinical-stage biotech announced that its subsidiary, FBD Biologics Limited, has signed a strategic memorandum of understanding (MOU) with InxMed (Shanghai) Co., Ltd., a late-stage biotechnology company focused on cancer drug resistance and tumor microenvironment biology.

Under the MOU, the two companies will conduct preclinical and translational research evaluating HCB101 in combination with InxMed’s investigational assets, including IN10018/ifebemtinib, a FAK inhibitor, and OMTX705, a FAP-targeted antibody-drug conjugate.

For investors, the agreement is not a near-term revenue event. No licensing economics, upfront payment, or clinical trial commitment has been disclosed. The significance is strategic: HanchorBio is testing whether HCB101 can move beyond its current clinical anchors and become a broader combination asset for difficult-to-treat solid tumors.

HCB101 is a clinical-stage SIRPα-Fc fusion protein targeting the CD47/SIRPα pathway, designed to enhance macrophage-mediated anti-tumor activity. HanchorBio has been developing the asset with gastric cancer as an important clinical anchor, while also exploring other solid tumors, including head and neck cancer and colorectal cancer.

InxMed brings a complementary profile. Its lead asset, IN10018/ifebemtinib, has advanced into late-stage clinical development, including a Phase III trial in China for platinum-resistant recurrent ovarian cancer, and has received Fast Track designation from the U.S. FDA. Its pipeline focuses on tumor defense mechanisms, including FAK signaling, cancer-associated fibroblasts, and stromal barriers.

The collaboration gives HanchorBio a way to test whether HCB101’s macrophage-centered immune activation can be paired with drugs targeting the tumor’s physical and biological defenses, including fibrosis, stromal barriers, and immune exclusion.

That fits HanchorBio’s broader "anchor-and-expand" strategy: use defined tumor settings, such as gastric cancer, to establish clinical value, then evaluate whether the same mechanism can be extended to other biologically selected solid tumors.

The next key question is whether the collaboration can generate translational data strong enough to support additional development decisions. If it does, the MOU could help HanchorBio strengthen HCB101’s positioning as a potential combination backbone and reinforce the value of its FBDB platform.

For now, the InxMed partnership should be viewed as a measured strategic expansion move — not a financial milestone, but a test of how far HCB101’s value can extend beyond its initial clinical path.

(Press release, Hanchor Bio, JUL 8, 2026, View Source [SID1234669109])

Study of Ensartinib as Postoperative Adjuvant Therapy Published in The New England Journal of Medicine

On July 8, 2026 Betta Pharmaceuticals reported ensartinib as postoperative adjuvant therapy for patients with stage IB–IIIB (T3N2M0) ALK-positive non-small cell lung cancer (NSCLC), known as the ELEVATE study, was published online in full in The New England Journal of Medicine (NEJM; Impact Factor 84.5), a world-leading medical journal. The study provides important evidence for adjuvant therapy of ALK-positive NSCLC worldwide and has the potential to change current clinical practice.

Lung cancer is the most common and deadliest malignancy both globally and in China. According to the statistical report issued by the National Cancer Center, in 2022, there were an estimated 1.06 million new cases of lung cancer and 733,300 related deaths in China. Of patients with lung cancer, NSCLC accounts for up to 85%. Approximately 5-7% of patients with NSCLC have ALK-positive disease. Although some patients with ALK-positive NSCLC are diagnosed at an early or intermediate stage amenable to surgical resection, they still face high risks of recurrence and death, and traditional postoperative adjuvant chemotherapy offers modest benefits. Therefore, reducing the risk of recurrence and prolonging survival after surgery remains an urgent unmet clinical need.

The ELEVATE study directly addresses this unmet need. In the ELEVATE study, a total of 274 patients from 56 medical centers across China were randomly assigned at a 1:1 ratio to receive oral ensartinib or placebo following complete surgical resection and any planned adjuvant chemotherapy. It is a phase 3, multicenter, randomized, placebo-controlled, double-blind registration study in the field of ALK-TKI adjuvant therapy for ALK-positive lung cancer. The results showed a 2-year disease-free survival rate of 86.4% in the ensartinib group compared with 53.5% in the placebo group, with a hazard ratio of 0.20 (95% CI: 0.11 to 0.38) in patients with stage II to IIIB NSCLC. This means that two years of adjuvant treatment with ensartinib reduces the risk of disease recurrence or death by 80%. A significant reduction in this risk was also observed in stage IB to IIIB population, with a hazard ratio of 0.20 (95% CI: 0.10 to 0.37).

Dr. Ding Lieming, Chairman and CEO of Betta Pharmaceuticals, stated: "The publication of the ELEVATE study in NEJM represents high recognition from the international medical community of the scientific value and clinical significance of this research. It is not only an important milestone for Betta but also a landmark achievement showcasing Chinese clinical oncology research on the global academic stage, with the potential to change postoperative adjuvant treatment strategies for patients with ALK-positive lung cancer. The marketing application for the adjuvant indication of ensartinib has already been accepted in China. Moving forward, we will continue to focus on unmet clinical needs, deepen independent innovation, and accelerate the development of more innovative products with core competitiveness and global impact, benefiting more patients."

It is known that ensartinib is a novel, potent, and highly selective next-generation ALK inhibitor. It is an innovative drug developed independently and wholly owned by Betta Pharmaceuticals and its subsidiary Xcovery. Its first-line and second-line indications have already been approved in China, offering good accessibility and a favorable safety profile, and it has received the First Prize for Scientific and Technological Progress in Zhejiang Province. In December 2024, ensartinib was approved for marketing in the United States and subsequently included in the NCCN Guidelines for Non-Small Cell Lung Cancer. Marketing authorization applications in other overseas markets, including the European Union, are progressing.

(Press release, Betta Pharmaceuticals, JUL 8, 2026, View Source [SID1234669108])