Alpha Tau Reports Positive Data Demonstrating 100% Objective Response Rate and 18.2-Month Median Overall Survival with Alpha DaRT® in Combination with Pembrolizumab in Locally Advanced or Metastatic Head and Neck Cancer, Surpassing the Study’s Pre-Specified Threshold for Success

On July 21, 2026 Alpha Tau Medical Ltd. ("Alpha Tau" or the "Company") (Nasdaq: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported positive results from a clinical study evaluating Alpha DaRT in combination with pembrolizumab (Keytruda) in elderly patients with locally advanced and metastatic head and neck squamous cell carcinoma (HNSCC), in which the combination produced a 100% objective response rate and a median overall survival of 18.2 months among evaluable patients. The results are being presented in a podium presentation at the American Head and Neck Society ("AHNS") 12th International Conference on Head and Neck Cancer, held July 18-22, 2026, in Boston, Massachusetts.

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Head and neck cancer is among the most common cancers worldwide, with an estimated 890,000 new cases diagnosed globally each year, and with more than 60,000 new cases of HNSCC estimated in the United States in 2026 across the oral cavity, pharynx, and larynx. Despite treatment with curative intent, roughly half of patients with HNSCC will experience recurrence, and distant spread, when it occurs, most often involves the lung.

Since the Keytruda KEYNOTE-048 trial, pembrolizumab, with or without chemotherapy, has been the first-line standard of care for recurrent or metastatic HNSCC; however, as monotherapy in patients whose tumors express PD-L1 (Combined Positive Score, or CPS, ≥1), pembrolizumab was observed in the KEYNOTE-048 trial to produce a median overall survival of 12.3 months and an objective response rate of approximately 19%, leaving considerable room for improvement, particularly for elderly and frail patients who may not tolerate the addition of chemotherapy.

Alpha Tau’s study is a single-center, prospective, open-label, single-arm study evaluating Alpha DaRT in combination with pembrolizumab in up to 48 patients with recurrent unresectable or metastatic HNSCC and PD-L1 CPS ≥1, using a Simon two-stage adaptive design. Patients received a lead-in dose of pembrolizumab, followed by insertion of Alpha DaRT sources into a target lesion; the sources were removed ~14 days later, and patients continued on pembrolizumab per standard dosing. Tumor response was assessed systemically, i.e., in all tumors, both treated and untreated by Alpha DaRT, using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), and safety was graded using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Eleven patients (four female, seven male) were recruited in total, with a mean age of 72 years (range 52-96). Two patients died prior to response evaluation, leaving nine patients evaluable for response; one died before Alpha DaRT treatment, and the other died shortly after treatment from an unrelated cardiovascular issue. With every evaluable patient responding, the trial reached the efficacy threshold built into its two-stage adaptive design, under which the study was permitted to stop for success once more than six patients responded, and enrollment was concluded on that basis.

Efficacy Results

Note: Caution should be exercised in comparing results from unrelated clinical studies due to differences in study designs, patient populations and other relevant factors.

Response Rate

Among evaluable patients, treatment with Alpha DaRT plus pembrolizumab produced an objective response rate (i.e., systemic complete response plus partial response) of 100%, including four complete responses and five partial responses, for a complete response rate of 44%. By comparison, pembrolizumab monotherapy in the PD-L1 CPS ≥1 population of KEYNOTE-048 produced an objective response rate of approximately 19%.

Survival Data

Median overall survival was 18.2 months, and median progression-free survival was 5.4 months, with four patients remaining alive at the time of this analysis. By comparison, pembrolizumab monotherapy in a similar population in the KEYNOTE-048 trial achieved a median overall survival of 12.3 months and a median progression-free survival of approximately 3.2 months.

Safety Results

No Alpha DaRT-related serious adverse events were observed. Only two Alpha DaRT-related adverse events were reported across the treated cohort, both Grade 1 in severity.

Uzi Sofer, CEO of Alpha Tau, stated: "These results reinforce two priorities at the heart of our strategy: establishing Alpha DaRT in localized, unresectable disease, and building the combination evidence to compete in the metastatic setting alongside blockbuster checkpoint inhibitors. Our interim data had already shown us that response rates with Alpha DaRT plus pembrolizumab were exceptionally high; what we were waiting for was the survival follow-up to confirm those responses would translate into real, lasting benefit. Now that the data have matured, the picture is even stronger. Combination trials like this one are central to how we intend to grow the platform. Showing that Alpha DaRT can be added to a systemic backbone safely, and with results like these, is exactly the kind of evidence we hope will define its role across our pipeline. And we won’t stop here: We are exploring, in ongoing discussion with the FDA, the possibility of a similar but larger study in the U.S."

Prof. Aron Popovtzer, MD, Director of the Sharett Institute of Oncology at Hadassah University Medical Center and the lead Principal Investigator in this clinical study at Hadassah, commented: "Elderly patients with recurrent or metastatic head and neck squamous cell carcinoma are among the most difficult we treat. Since KEYNOTE-048, pembrolizumab has been our first-line standard of care, but as a single agent it produces a response in fewer than one in five patients, and many are too frail to add chemotherapy. That unmet need is what led us to design the first study to combine Alpha DaRT with checkpoint inhibition, adding a localized, immune-activating alpha-emitting radiotherapy to the systemic treatment these patients are already receiving. After years of work, it is deeply gratifying to see the effort was worth it – the results are genuinely encouraging, and they exceeded our expectations. Every evaluable patient responded, including several complete responses, with improvements in both overall and progression-free survival relative to historic data on pembrolizumab alone and a safety profile that let patients stay on their standard treatment. To my knowledge, no other combination study with pembrolizumab has shown results like these in this patient population, and it is a real achievement to see a therapy add this much value on top of a checkpoint inhibitor. These are early data, and larger controlled studies are needed to confirm the benefit, but they make a compelling case for continuing to investigate Alpha DaRT with immunotherapy, both in head and neck cancer and across other solid tumors."

Robert Den, MD, Chief Medical Officer of Alpha Tau, added: "It’s worth reading these results against the bigger picture of where our global clinical trial pipeline is heading. We have strong preclinical data suggesting that Alpha DaRT may prime a systemic anti-tumor immune response, and we have clinical experience, including multiple studies in head and neck and skin cancer, showing that Alpha DaRT monotherapy carries a favorable safety profile in this population. What this study suggests is that combining Alpha DaRT with pembrolizumab can translate that immune-priming effect into a clinical survival benefit for patients with recurrent or metastatic head and neck cancer. These results reinforce our plan to validate the clinical benefit of Alpha DaRT in this patient population in larger studies, and they add another key data point to a pipeline that now spans head and neck, skin, pancreatic, prostate, and brain cancers, among others."

About the Study

The study builds on Alpha Tau’s foundation of Alpha DaRT monotherapy data in head and neck and skin cancer, including a first-in-human study in which Alpha DaRT achieved an objective response rate of 100% and a complete response rate of 78.6% among evaluable SCC lesions in a population that skewed toward elderly, heavily pre-treated and radioresistant patients. The current study pairs Alpha DaRT with pembrolizumab, the current first-line standard of care for CPS ≥1 recurrent or metastatic HNSCC, to evaluate whether adding a localized, immune-activating radiotherapeutic to systemic checkpoint inhibition can improve outcomes without the added toxicity associated with chemotherapy. The study was conducted at Hadassah University Medical Center in Jerusalem, Israel. For more information, please see View Source

(Press release, Alpha Tau Medical, JUL 21, 2026, View Source [SID1234669337])

Publication in Cancer Research Details Atebimetinib’s Broad, Durable Preclinical Activity and Favorable Tolerability Across RAS- and RAF-Mutant Tumors via Deep Cyclic Inhibition

On July 21, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported the publication of new findings in Cancer Research, a leading peer-reviewed journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), characterizing the differentiated mechanism and broad preclinical activity of atebimetinib.

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The article, "Dual-MEK Inhibitor Atebimetinib Displays Broad Activity in RAS- and RAF-Mutant Tumors via Deep Cyclic Inhibition and Resisting RAF-Bypass," (Kolitz et al., Cancer Research, doi.org/10.1158/0008-5472.CAN-25-4907) reports that atebimetinib demonstrated broad antitumor activity across RAS- and RAF-mutant models while resisting RAF-mediated bypass signaling, a key mechanism associated with resistance to other MEK inhibitors. Because the activity observed spanned a range of KRAS, NRAS, and BRAF alterations, the findings support the potential of atebimetinib to address RAS- and RAF-mutant cancers broadly — including the majority of RAS-mutant tumors that are not addressed by currently available mutation-selective inhibitors.

"Atebimetinib was deliberately designed to overcome the historical limitations of MEK inhibition, including the toxicity that comes with chronic MAPK pathway suppression, and the RAF-mediated pathway reactivation that has limited the durability of pathway suppression, particularly in RAS-mutant disease," said Brett Hall, Ph.D., Chief Scientific Officer of Immuneering. "The new findings noted in the Cancer Research article underscore the scientific basis for our Deep Cyclic Inhibitor technology and the broad, mutation-agnostic, durable activity we observed across RAS- and RAF-mutant models, reinforcing atebimetinib’s position as a differentiated, modern MEK inhibitor."

The article describes how atebimetinib combines a novel dual-MEK mechanism with a short half-life designed to achieve Deep Cyclic Inhibition (DCI) of the MAPK pathway. Unlike other MEK inhibitors that chronically suppress signaling and are prone to RAF-mediated bypass, atebimetinib was shown to produce profound but transient inhibition of MAPK signaling followed by recovery periods that allow normal tissue to rest between doses – an approach designed to improve tolerability while maintaining antitumor activity.

Key findings include:

Atebimetinib demonstrated potent inhibition of both pERK and pMEK across multiple KRAS-, NRAS-, and BRAF-mutant tumor models, including colorectal, lung, and melanoma models.
Whereas other MEK inhibitors reduced pERK but allowed pMEK to accumulate — the molecular signature of RAF-mediated pathway reactivation — atebimetinib reduced both pERK and pMEK, reflecting its resistance to CRAF-mediated bypass.
Atebimetinib’s short half-life enabled deep cyclic inhibition of the MAPK pathway, characterized by deep suppression during peak exposure followed by recovery toward physiologic baseline signaling between doses.
In multiple head-to-head in vivo studies, atebimetinib demonstrated greater depth and durability of tumor growth inhibition than the FDA-approved MEK inhibitor binimetinib across KRAS-, NRAS-, and BRAF-mutant tumor models while remaining well tolerated.
In the Colon-26 model, a syngeneic colon-carcinoma model widely used to study cancer cachexia, atebimetinib-treated animals maintained body weight near baseline (within approximately 5%) through roughly two weeks of dosing, while untreated control animals lost a median of more than 20% of body weight by approximately day 14. Across the in vivo models more broadly, atebimetinib-treated mice maintained body weight within a median of 3-5% over up to four weeks of chronic dosing.

Immuneering is currently recruiting patients in MAPKeeper 301 (NCT07562152), a global randomized Phase 3 pivotal trial evaluating atebimetinib plus mGnP versus standard-of-care gemcitabine/nab-paclitaxel in first-line metastatic pancreatic cancer. In the second half of the year, the company expects to dose the first patient in a Phase 2 trial of atebimetinib plus Libtayo (cemiplimab) in patients with first-line RAS-mutant non-small cell lung cancer.

(Press release, Immuneering, JUL 21, 2026, View Source [SID1234669353])

Enterome Phase 2 data show EO2463-induced CD8 T-cell expansion correlates with progression-free survival in patients with indolent non-Hodgkin lymphoma in the watch-and-wait setting

On July 21, 2026 Enterome SA, a clinical-stage company pioneering OncoMimics, a new class of off-the-shelf, multi-targeted in vivo immune therapies, reported new positive interim data from the ongoing open-label Phase 1/2 SIDNEY trial of OncoMimics EO2463 to treat indolent Non-Hodgkin Lymphoma (iNHL). The data show EO2463 continues to have an effect, now showing a statistically significant correlation with progression-free survival (PFS) as a monotherapy in the watch-and-wait setting, and an additive effect, associated with complete response rates, when used in a triple combination, together with the standard of care, lenalidomide and rituximab (R2).

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These new findings confirm previous data suggesting specific CD8 T cell expansion caused by EO2463 could be developed as a predictive biomarker and represent a compelling rationale for further study to confirm that EO2463 increases PFS in patients with iNHL.

Enterome presented the data today at the Pan Pacific Lymphoma Conference (PPLC) at the Fairmont Orchid, Kohala Coast (Big Island) in Hawaii. Copy of the poster is available here.

"The correlation between the robust CD8 T cell expansion induced by EO2463 and PFS is a landmark finding that creates an imperative for further study and offers new hope for patients suffering from iNHL. It suggests that EO2463, which has been well-tolerated to date, may effectively extend PFS as a standalone therapy without hurting quality of life in this generally older and fragile patient population. We want to prioritize patients classified for watch-and-wait, an observational protocol, because they currently receive no active treatment, despite having to live with the grave psychological impact of their cancer diagnosis," said Pierre Belichard, Chief Executive Officer of Enterome. "Based on these and other data, we believe EO2463 is ready to start the final stage of registrational clinical development as a first-in-class therapeutic for patients with iNHL in a watch-and-wait setting. We are in active discussions with potential investors and partners to find the best way to bring this product to patients."

SIDNEY (NCT04669171) is an ongoing open-label Phase 1/2 study evaluating the safety, tolerability, immunogenicity and preliminary efficacy of EO2463 as monotherapy and in combination regimens patients with follicular lymphoma and marginal zone lymphoma. The trial includes a dedicated watch-and-wait monotherapy cohort, a first-line low-tumor-burden combination cohort with rituximab, and relapsed/refractory cohorts treated with EO2463+R2. Interim data continue to support further evaluation of EO2463 both as a standalone treatment and in combination with established anti-lymphoma therapies.

More recently, as SIDNEY progresses, data have begun to show the impact of EO2463 on clinical efficacy. Enterome reported at ASH (Free ASH Whitepaper) in late 2025 that EO2463 caused a higher-than-expected complete recovery (CR) rate with the triple combination therapy, EO2463 and R2, compared to the combination of only lenalidomide and rituximab (or "R2"). Data reported at ASH (Free ASH Whitepaper) in late 2024 showed that EO2463 monotherapy generated a 46% objective response rate in watch-and-wait patients.

Last month, at EHA (Free EHA Whitepaper) 2026, Enterome presented data showing that EO2463-induced CD8 T cell expansions were significantly associated with clinical outcomes in each of the monotherapy, rituximab ("R1"), and R2 cohorts, suggesting that EO2463-induced CD8 T-cell expansion can be used as a predictive biomarker. Today, Enterome announced that new analyses extend this finding to progression-free survival in the monotherapy cohort.

Key data presented at PPLC:

In the EO2463 monotherapy cohort (Cohort 2, watch-and-wait), higher CD8 T cell expansion was significantly associated with longer progression-free survival (HR=0.18, 95% CI 0.03–0.82; log-rank p=0.020).
In the EO2463 plus lenalidomide/rituximab combination cohort (Cohort 1+4, relapsed/refractory disease), higher CD8 T cell expansion was significantly associated with complete response (p=0.0073)
EO2463 is an off-the-shelf OncoMimics active immunotherapy composed of four synthetic microbial-derived peptides designed to mimic the B-cell lineage markers CD20, CD22, CD37 and CD268 (BAFF receptor), plus the helper peptide UCP2. This multi-target approach is intended to expand pre-existing memory CD8 T cells, selectively target malignant B cells, broaden target coverage and obviate antigen escape. In May 2026, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to EO2463 for treatment of patients with follicular lymphoma.

Upcoming presentation at ESMO (Free ESMO Whitepaper) Congress 2026

Enterome will also present data on its solid-tumor OncoMimics candidate EO4010 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place 23–27 October 2026 in Madrid, Spain.

Title: EO4010 (EO) multi-target peptide immunotherapy: tumor directed CD8 T cell expansion kinetics and association to survival in patients (pts) with treated mismatch repair proficient (pMMR) metastatic colorectal carcinoma (mCRC)
Presentation number: 859P

Presentation time: Sun, October 25, 2026 – Time: 12:00 – 12:45

OncoMimics consist of bacteria-derived peptide antigens that closely mimic tumor-associated antigens (TAAs) of solid tumors, or lineage markers (e.g. as observed in B cell lymphomas). These peptides induce a fast and potent in vivo expansion of effector-memory CD8 T-cells, naturally primed by gut bacteria, and cross-reactive with TAAs/B cell markers, thereby eliciting cytotoxic responses against tumor cells. Because they are recognized as foreign entities by the immune system, OncoMimics help overcome the self-tolerance that limits the ability of many cancer immunotherapies to trigger rapid, potent, and durable endogenous immune responses. The synthetically produced OncoMimics peptides are selected and designed in silico by mining Enterome’s proprietary database of 23 million commensal bacteria genes. Each product combines multiple highly immunogenic peptides specifically designed to broaden target coverage, mitigate tumor heterogeneity and obviate the cancer’s ability to escape the therapeutic intervention.

(Press release, Enterome, JUL 21, 2026, View Source [SID1234669338])

Nurix Therapeutics Announces HSR Clearance of Global Collaboration with Roche to Co-Develop and Co-Commercialize Potential Best-in-Class BTK Degrader Bexobrutideg Across Malignant Hematology, Immunology and Neurology

On July 21, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported the closing of its previously announced global collaboration agreement with Roche to co-develop and co-commercialize bexobrutideg, following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

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Summary of Business Terms
Under the terms of the agreement, Nurix will receive an upfront cash payment of $700 million and is eligible to receive development, regulatory and sales milestones for potential total payments of up to $2.3 billion. Development costs will be shared 40% by Nurix and 60% by Roche. The parties will equally split the profits and losses from U.S. commercialization. Nurix and Roche will co-commercialize bexobrutideg in the United States across all indications. Outside of the United States, Roche will be responsible for commercialization, with Nurix eligible to receive royalties ranging from the low- to high-teens. Nurix and Roche will jointly advance a broad clinical development program for bexobrutideg, including ongoing and planned studies in chronic lymphocytic leukemia (CLL), additional B-cell malignancies, multiple sclerosis (MS) and chronic spontaneous urticaria (CSU).

"This global collaboration marks a transformational moment for Nurix and the field of targeted protein degradation," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "With Roche as our partner, we are uniquely positioned to realize the full potential of bexobrutideg across oncology, immunology and neurology. Roche’s global development and commercial capabilities, combined with Nurix’s leadership in targeted protein degradation, provide the resources, expertise and shared commitment needed to rapidly advance bexobrutideg for patients who continue to face significant unmet medical needs. We are excited to begin this next chapter and to execute on what we believe is one of the most ambitious development programs ever undertaken for a degrader medicine."

About Bexobrutideg (NX-5948)
Bexobrutideg (NX-5948) is an investigational, orally bioavailable, brain-penetrant, highly selective small-molecule degrader of Bruton’s tyrosine kinase (BTK) being developed by Nurix and Roche as a potential best-in-class therapy across oncology, immunology and neurology.

​​​Bexobrutideg is currently being evaluated in the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study in patients with relapsed/refractory CLL, and in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed/refractory B-cell malignancies. Additional trials are planned, including the DAYBreak CLL-306 clinical trial (NCT07516093), a randomized Phase 3 trial comparing bexobrutideg to pirtobrutinib in patients with relapsed/refractory CLL, and the NX-5948-203 Phase 1/2 clinical trial (NCT07520006), assessing the combination of bexobrutideg with venetoclax with or without an anti-CD20 antibody in patients with relapsed/refractory CLL and treatment naïve CLL. A new tablet formulation of bexobrutideg is being evaluated in a first-in-human single-ascending-dose and multiple-ascending-dose study in healthy volunteers (NCT06717269) to support future development in immunology and neurology indications. Additional information about these clinical trials can be found at clinicaltrials.gov.

(Press release, Nurix Therapeutics, JUL 21, 2026, View Source [SID1234669354])

Condensed Interim Financial Report

On July 21, 2026 Novartis reported Second Quarter and Half Year 2026.

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(Presentation, Novartis, JUL 21, 2026, View Source [SID1234669426])