Verismo Therapeutics to Present at iMig 2025

On October 23, 2025 Verismo Therapeutics, a clinical-stage CAR T company developing a novel KIR-CAR platform technology, reported its participation and sponsorship of the International Mesothelioma Interest Group (iMig) 2025 Conference. The company will highlight STAR-101, an ongoing Phase 1 clinical trial of Verismo’s lead pipeline SynKIR-110 in patients with advanced mesothelin-expressing cancers, including mesothelioma.

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Mesothelioma is a rare, aggressive cancer, with more than 2,500 people diagnosed annually in the United States and 30,000 globally1. Despite recent therapeutic advances, prognosis remains poor and most patients face limited options for long-term treatment. SynKIR-110 targets mesothelin, a protein highly expressed on mesothelioma cells and a validated target for innovative immunotherapies, enabling it to recognize and attack the cancer cells. SynKIR-110 was granted Orphan Drug and Fast Track Designations by the Food and Drug Administration for treatment of mesothelioma in 2022 and 2023, respectively.

"Mesothelioma is one of the most difficult cancers to treat, and it has historically been underserved in terms of new treatment development," said Daniel Sterman, M.D., Thomas and Suzanne Murphy Professor of Pulmonary and Critical Care Medicine at the NYU Grossman School of Medicine, Director of Division of Pulmonary Medicine at the NYU Langone Medical Center and an organizer of iMig 2025. "By sponsoring iMig and presenting the STAR-101 trial design, Verismo is demonstrating its commitment to advancing the science, addressing the unmet medical need, and supporting the global mesothelioma community." Dr. Sterman serves as the Medical Monitor for Verismo’s STAR-101 clinical study.

STAR-101 (NCT05568680) is a multicenter, open-label, Phase 1 study designed to evaluate the safety, feasibility, and preliminary efficacy of SynKIR-110 in patients with advanced mesothelin-expressing tumors. The trial is the first to bring Verismo’s multi-chain KIR-CAR platform into the clinic for solid tumors.

Verismo’s sponsorship of iMig 2025 underscores its dedication not only to scientific innovation but also to supporting patients, clinicians, and advocates working to advance care in mesothelioma worldwide.

Presentation Details:

Title: SynKIR-CAR T Cell Advanced Research (STAR)-101 Phase 1 Clinical Trial for Patients with Advanced Mesothelin-expressing Mesothelioma, Ovarian Cancer, or Cholangiocarcinoma
Session: Novel Combinations and Applications of Immunotherapy; Salon E
Date/Time: Monday, October 27, 2025, 2:30 – 2:45 PM
Presenter: Jun Xu, Ph.D., Executive Director of Translational Science, Verismo Therapeutics

(Press release, Verismo Therapeutics, OCT 23, 2025, View Source [SID1234656965])

New Targeted Therapy, Ulixertinib, Shows Promise for Histiocytosis, a Rare Blood Cancer (issued by Memorial Sloan Kettering Cancer Center)

On October 23, 2025 Biomed Valley Discoveries reported the first time Joey Carlsen Martinez came to Memorial Sloan Kettering Cancer Center (MSK), he was in terrible shape. He had a rare blood cancer called Erdheim-Chester disease, and his symptoms included crushing fatigue, severe joint pain, and memory loss. He needed a wheelchair to get around.

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Three years later, thanks to an experimental targeted therapy drug treatment for Erdheim-Chester disease that he is receiving at MSK, his life is much improved.

"Today, I have a mostly normal life," says Joey, 34, a stay-at-home dad who homeschools his two young daughters. "I still get tired easily, but I go grocery shopping, I cook dinner, and I take care of my family. And because I know how bad things can get, I feel so grateful for everything that I have."

Ulixertinib for Erdheim-Chester Disease and Other Forms of Histiocytosis
Joey’s extraordinary turnaround is the result of a novel targeted drug called ulixertinib. His doctor, neuro-oncologist and early drug development specialist Eli Diamond, MD, is first author of a paper published October 23, in Cancer Cell that reports outcomes for Joey and four other patients — the first patients to receive ulixertinib for a family of diseases called histiocytosis. Erdheim-Chester disease is a type of histiocytosis.

The MSK study found four out of five patients with histiocytosis benefited from ulixertinib. Based on that work, ulixertinib is being tested in a bigger phase 2 clinical trial now open at MSK and two other hospitals.

How MSK Has Led the Development of Histiocytosis Treatments
Dr. Diamond is an internationally recognized leader in treating histiocytosis and led the development of the only two drugs approved by the U.S. Food and Drug Administration (FDA) for treating histiocytosis — vemurafenib (Zelboraf) and cobimetinib (Cotellic).

"The patients in this study were treated on what is called a single-patient investigational new drug (IND) application," Dr. Diamond explains. "We essentially write an individual clinical trial for each participant. For rare diseases like histiocytosis, this approach is a good way to evaluate potential new treatments on a small number of patients."

What Is Histiocytosis and What Symptoms Does It Cause?
Histiocytosis is a collection of rare diseases diagnosed in only a few hundred people in the United States every year and can affect patients of any age, including children.

Histiocytosis starts when the body makes too many histiocytes, a type of white blood cell, which can build up and form tumors in any part of the body and cause a broad range of symptoms, including:

Bone and joint pain
General symptoms such as fatigue and malaise
Rashes and other skin problems
Blurred vision and tumors in or around the eyes and sinuses
Problems with the brain including balance issues, memory loss, and hormone imbalances
Joey experienced all of these symptoms on and off for nearly a decade before he was diagnosed with Erdheim-Chester at age 29.

"I finally found out what was wrong with me two months after my wife found out she was pregnant with our first child," Joey says. "It was a crazy time, especially because nobody had ever heard of this disease."

Joey, who lives in Washington state, was fortunate to find a doctor in Seattle who was familiar with treating histiocytosis. He tried three different therapies, and while they helped with some of his symptoms, they caused severe side effects, especially nausea and vomiting. Joey was running out of options. That’s when he heard about Dr. Diamond and decided to make the trip to New York to visit MSK.

How New Discoveries About the ERK Gene and MEK Protein Led to a New Drug for Histiocytosis
Laboratory mouse models and other studies have revealed how histiocytosis is driven by mutations in a cell-signaling pathway driven by the protein MEK. The mutations lead to uncontrolled cell growth and, ultimately, cancer. MEK is implicated not only in histiocytosis but several other cancer types, especially melanoma.

The two previous drugs approved for histiocytosis act on genes within the MEK pathway to block histiocyte growth. The new drug, ulixertinib, also acts on this pathway, but on a different gene, called ERK.

"MSK has a very active program in histiocytosis, both in the lab and in the clinic," says MSK physician-scientist Omar Abdel-Wahab, MD, Chair of the Molecular Pharmacology Program in the Sloan Kettering Institute. Dr. Abdel-Wahab is co-senior author of the new paper, along with Benjamin Durham, MD, a former trainee and member of his lab who is now at the Rutgers Cancer Institute.

"Drugs that block ERK have been studied for a number of different cancers, but some patients have notable side effects at high doses," Dr. Diamond explains. "But with histiocytosis, ulixertinib works at very low doses, allowing patients to avoid most of these side effects."

Side Effects and Benefits of Ulixertinib for Erdheim-Chester Disease
For Joey, the only major side effect of ulixertinib has been an acne-like rash. He continues to take the drug daily. Early in his treatment, he had to make frequent trips to MSK, but now Dr. Diamond is able to coordinate with doctors in Seattle so that Joey can have scans and blood tests closer to home. He travels to MSK periodically, and Dr. Diamond partners with his Seattle oncologist to make adjustments to the dosage that Joey is taking, based on his levels of disease and the treatment’s side effects.

Joey and his wife recently celebrated their sixth wedding anniversary. He is still unable to work full-time but is thankful to be home with his daughters. "I can’t think of another situation in which I’d get to spend so much time with my girls every single day," he says. "That’s been the biggest blessing out of all of this."

Joey has joined support groups for patients with Erdheim-Chester and enjoys helping others with the disease, especially those who are newly diagnosed. "The whole Erdheim-Chester disease community is so amazing," he says. "I’m so grateful for them, and grateful for Dr. Diamond and the whole team at MSK."

MSK’s History of Leadership in Treating Rare Blood Cancers Like Histiocytosis
MSK’s leadership in developing treatments for histiocytosis is the result of a dedication to fundamental lab research. Fifteen years ago, Dr. Abdel-Wahab developed the first-ever mouse models for studying histiocytosis. These models have allowed researchers to learn much more about the genes and proteins that drive the disease, as well as to test experimental therapies that block them.

Patient samples sent to MSK by histiocytosis specialists from all over the world also have helped to build a better understanding of these rare diseases. Several of those specialists are co-authors on the Cancer Cell paper.

"Our work in histiocytosis and the ways this work has ultimately benefited patients all over the world is a great example of the importance of continuing to fund basic and translational lab research," Dr. Abdel-Wahab says.

Key Takeaways
Memorial Sloan Kettering Cancer Center is a leader in lab and clinical research on different forms of histiocytosis, including Erdheim-Chester disease.
Scientists at MSK, led by physician-scientist Omar Abdel-Wahab, MD, have collected histiocytosis patient samples from all over the world and developed mouse models to study this family of rare blood cancers.
Based on a single-patient investigational new drug application study from neuro-oncologist and early drug development specialist Eli Diamond, MD, ulixertinib for histiocytosis was found to be beneficial in four out of five people (80%) and is now being studied in a phase 2 clinical trial.
Ulixertinib for histiocytosis works by controlling histiocyte cell growth caused by a mutation in the MEK signaling pathway via the ERK gene.
Histiocytosis happens when the body makes too many histiocytes, a type of white blood cell, which can build up and form tumors in any part of the body and cause a broad range of symptoms like fatigue, bone pain, trouble with speech and balance, skin rashes, and more.
Dr. Abdel-Wahab holds the Evnin Family Chair in Molecular Pharmacology at MSK.
Additional Authors, Funding, and Disclosures
Biomed Valley Discoveries, the company that makes ulixertinib, provided the drug through an extended access program for the single-patient studies reported in the article. The company is providing funding support for the current clinical trial.

Dr. Diamond is supported by the Frame Family Fund, the Joy Family West Foundation, and Applebaum Foundation. Dr. Diamond and Dr. Abdel-Wahab are together supported by National Institutes of Health (NIH) grant R37CA259260, Cycle for Survival, and the Marie-Josée and Henry R. Kravis Center for Molecular Oncology. Dr. Abdel-Wahab is also supported by NIH grants R01 CA251138, R01 CA283364, R01 HL128239, R01 CA242020, and P50 CA254838-01, as well as the Edward P. Evans Foundation and Blood Cancer United. Dr. Durham has been and is supported by NIH grant K08 CA218901 and the American Society of Hematology (ASH) (Free ASH Whitepaper) Fellow Scholar Award in Basic/Translational Research and a Junior Faculty Scholar Award in Basic/Translational Research.

(Press release, BioMed Valley Discoveries, OCT 23, 2025, View Source [SID1234666000])

CDR-Life Presents Early Clinical Data Demonstrating Pharmacodynamic Activity of CDR404, a Novel Antibody-Derived T Cell Engager Targeting MAGE-A4+ Solid Tumors

On October 23, 2025 CDR-Life, Inc., a biotechnology company developing highly selective T cell engagers (TCEs) to treat cancer and autoimmune diseases, reported the first clinical data showing that CDR404, the company’s lead M-gager TCE, achieved all four canonical pharmacodynamic (PD) hallmarks of TCE activity in patients with MAGE-A4+ solid tumors. The data, presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), in Boston, Massachusetts, highlights CDR404’s robust immune activation and early signals of clinical activity, including tumor stabilization and biomarker improvements in patients with ovarian cancers and synovial sarcomas.

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CDR404 is an antibody-based TCE designed to target intracellular tumor antigens presented on HLA molecules. It engages MAGE-A4 peptides displayed by HLA-A*02:01 on cancer cells and redirects CD3+ T cells for targeted tumor cell killing. The ongoing Phase 1 CDR404 trial (NCT06402201) is being conducted at leading cancer centers across the United States and Europe. Unlike conventional approaches utilizing T cell receptors, the proprietary M-gager platform leverages antibody-derived binding domains that combine exceptional specificity with strong potency, excellent developability and ease of manufacturing.

At initial dose levels of 100–200 μg, CDR404 triggered the full cascade of immune activation associated with effective TCE therapy, including CD8+ T cell activation and expansion, reprogramming to a memory phenotype and recruitment of lymphocytes into tumors. Notably, repeated dosing did not induce PD-1–mediated T cell exhaustion, suggesting sustained biological activity. In one patient, a transient tumor flare followed by stabilization was observed, which is consistent with tumor infiltration by cytotoxic T cells.

"These early data demonstrate that our M-gager platform can extend the precision and power of antibody-based T cell engagers to intracellular antigens, an area long thought to be accessible only to TCR-based modalities," said Christian Leisner, PhD, Chief Executive Officer of CDR-Life. "Seeing all four pharmacodynamic hallmarks of activity in patients even at low doses underscores the potential of this approach to redefine how we target solid tumors."

The study’s first-in-human dose was guided by quantitative systems pharmacology modeling, enabling detection of pharmacodynamic effects more quickly than traditional approaches. Based on these encouraging signals, the trial will begin to focus on patients with MAGE-A4–positive ovarian cancers, a population with high unmet need.

Additional analyses, including integrated pharmacokinetic-pharmacodynamic and circulating tumor DNA (ctDNA) data, are ongoing.

Presentation Details:

Title: Hallmarks of pharmacodynamic activity of CDR404, a new antibody-
derived T cell engager (TCE) targeted against MAGE-A4+ solid tumors in
HLA-A02:01+ patients
Presenter: Melissa Vrohlings, Head of Translational Science, CDR-Life
Date and Time: October 23, 2025 | 12:30 – 4 pm ET
Location: Poster Session A
Level 2, Exhibit Hall D

In addition to the poster presentation on CDR404, CDR-Life is also presenting a poster on CDR609, the company’s newest T cell engager clinical candidate that targets LGR5, a highly cancer-specific cell surface antigen widely expressed on common solid tumors.

Presentation Details:

Title: CDR609: A First-in-Class LGR5-targeted T Cell Engager for treatment of
Colorectal Cancer and other solid tumors
Presenter: Sophie Barsin, Project Leader, CDR-Life
Date and Time: October 23, 2025 | 12:30 – 4 pm ET
Location: Poster Session A
Level 2, Exhibit Hall D

(Press release, CDR-Life, OCT 23, 2025, View Source [SID1234666504])

ALX Oncology Announces Preclinical Data and Phase 1 Trial-in-Progress Presentations of ALX2004, a Novel EGFR-Targeted ADC, at 2025 AACR-NCI-EORTC Conference

On October 23, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported preclinical data and the trial design for the ongoing Phase 1 clinical trial for its ADC candidate, ALX2004, in two poster presentations at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), taking place October 22 – 26, 2025 in Boston, Massachusetts. ALX2004-01 is a first-in-human study to evaluate the safety, tolerability, and preliminary efficacy of ALX2004 in patients with advanced or metastatic solid tumors that are known to express EGFR.

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"Our preclinical findings have shown potent anti-tumor activity and a favorable toxicity profile supporting our advancement of ALX2004 into the clinic," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "Given that toxicity challenges of earlier generation ADCs have limited the therapeutic window in the treatment of EGFR-expressing solid tumors; we are encouraged by our preclinical data that this unique molecule, ALX2004 could potentially overcome these limitations. Enrollment in this trial began in August and continues to be on track to allow us to deliver initial safety data in the first half of next year. We are pleased to present extensive preclinical data supporting ALX2004’s potential to break new ground in ADC innovation in the EGFR-targeting class at the AACR (Free AACR Whitepaper)-NCI-EORTC Conference."

The Company’s first ADC, ALX2004, is the result of a rigorous internal drug design process. Developed in house by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is designed to optimize all mechanisms of ADC cancer killing while maximizing the therapeutic window. ALX2004 uses a matuzumab-derived EGFR antibody selected to minimize off tumor skin toxicity and maximize therapeutic window, with a binding epitope distinct from U.S. Food and Drug Administration approved EGFR antibodies. Additionally, ALX2004 has a proprietary linker-payload and Top1i payload engineered to offer improved linker stability for on-target delivery of payload and enhanced bystander effect.

ALX2004 is currently being evaluated in a first-in-human, open-label multicenter study in participants with advanced or metastatic select EGFR-expressing solid tumors. The design of this Phase 1 clinical trial (NCT07085091) will also be presented at the meeting.

Details for ALX Oncology’s poster presentations are as follows:

Title: ALX2004, A Novel Anti-EGFR Topoisomerase I Inhibitor Antibody-Drug Conjugate for the Treatment of EGFR-Expressing Solid Tumors
Presenter: Marja Vrljic, Ph.D., Vice President, Antibody Technologies, ALX Oncology
Abstract: #A119
Date and Time: Thursday, October 23, 12:30-4:00 p.m. ET
Session: Poster Session A
Location: Hynes Convention Center, Level 2, Exhibit Hall D

Title: A Phase 1, First-in-Human, Open-Label Multicenter Study to Evaluate ALX2004, Antibody-Drug Conjugate Targeting EGFR, in Patients With Advanced or Metastatic Select Solid Tumors (ALX2004-01)
Abstract: LB-A004
Date and Time: Thursday, October 23, 12:30-4:00 p.m. ET
Session: Poster Session A
Location: Hynes Convention Center, Level 2, Exhibit Hall D

(Press release, ALX Oncology, OCT 23, 2025, View Source [SID1234656933])

FDA Grants Priority Review for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each in Combination with Padcev® (enfortumab vedotin-ejfv), for Certain Patients with Muscle-Invasive Bladder Cancer

On October 23, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the U.S. Food and Drug Administration (FDA) has granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of April 7, 2026, marking the first concurrent review of both KEYTRUDA and KEYTRUDA QLEX for the same novel indication.

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"New options for muscle-invasive bladder cancer are vital — patients who are ineligible for chemotherapy have not seen a treatment advance beyond surgery in decades," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "With the FDA’s priority review, we are one step closer to offering KEYTRUDA or KEYTRUDA QLEX plus Padcev as a potential treatment option to these patients with MIBC who are ineligible for cisplatin-containing chemotherapy and have such high unmet medical need."

The sBLAs are based on data from the Phase 3 KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with Pfizer and Astellas. Results, which were presented at the recent European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, showed that after a median follow-up of 25.6 months, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), the trial’s primary endpoint, reducing the risk of EFS events by 60% (HR=0.40 [95% CI, 0.28-0.57]; p<0.0001) versus surgery (radical cystectomy) alone in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy. Median EFS was not reached [NR] (95% CI, 37.3-NR) for the KEYTRUDA plus Padcev regimen versus 15.7 months (95% CI, 10.3-20.5) for surgery alone.

KEYTRUDA plus Padcev also demonstrated a statistically significant and clinically meaningful improvement in key secondary endpoints of overall survival (OS) and pathologic complete response (pCR) rate. KEYTRUDA plus Padcev reduced the risk of death by 50% (HR=0.50 [95% CI, 0.33-0.74]; p=0.0002) versus surgery. The pCR rate increased from 8.6% in patients treated with surgery alone (n=15/174) to 57.1% in patients treated with perioperative KEYTRUDA plus Padcev (n=97/170), an estimated increase of 48.3 percentage points (95% CI, 39.5-56.5; p<0.000001).

KEYTRUDA plus Padcev is currently approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in the U.S., the European Union (EU), Japan and several other countries around the world based on results from the Phase 3 KEYNOTE-A39 trial, also known as EV-302. KEYTRUDA as a monotherapy is also approved in the U.S., EU, Japan and other countries for the treatment of certain patients with la/mUC or a type of non-muscle-invasive bladder cancer (NMIBC).

Four additional Phase 3 studies are currently evaluating KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive and metastatic disease. Three of these studies are in MIBC including KEYNOTE-B15 (NCT04700124), which is also known as EV-304 and is being conducted in collaboration with Pfizer and Astellas, KEYNOTE-866 (NCT03924856) and KEYNOTE-992 (NCT04241185). KEYTRUDA is also being evaluated in combination with Bacillus Calmette-Guerin (BCG) in patients with NMIBC in the Phase 3 KEYNOTE-676 (NCT03711032) trial.

About KEYNOTE-905/EV-303
KEYNOTE-905, also known as EV-303, is an open-label, randomized, multi-arm, controlled Phase 3 trial (ClinicalTrials.gov, NCT03924895) evaluating perioperative KEYTRUDA, with or without Padcev, versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy. The trial enrolled 595 patients who were randomized to receive either:

Arm A: Three cycles of neoadjuvant KEYTRUDA, followed by surgery to remove the bladder (radical cystectomy), followed by 14 cycles of adjuvant KEYTRUDA;
Arm B: Surgery alone;
Arm C: Three cycles of neoadjuvant KEYTRUDA plus enfortumab vedotin, followed by surgery to remove the bladder (radical cystectomy), followed adjuvantly by six cycles of KEYTRUDA plus enfortumab vedotin and then eight cycles of KEYTRUDA alone.
The primary objective of this trial is to compare EFS between arm C and arm B, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy or death due to any cause. The key secondary objectives are to compare OS and the difference in pCR rate between arm C and arm B, as well as EFS, OS and the difference in pCR rate between arm A and arm B. The study remains ongoing to test hypotheses between arm A and arm B.

About bladder cancer
Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 patients each year globally. Muscle-invasive bladder cancer represents approximately 30% of all bladder cancer cases. The standard of care for patients with MIBC has been neoadjuvant cisplatin-based chemotherapy followed by surgery, which is shown to prolong survival. However, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery alone.

(Press release, Merck & Co, OCT 23, 2025, View Source [SID1234656949])