On April 21, 2025 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and Alzheimer’s disease (AD) through the inhibition of Semaphorin 4D (SEMA4D), reported that it will present exciting new data characterizing the unique mechanism of pepinemab to enhance immune responses to checkpoint therapies, corresponding with improved survival benefit in patients with melanoma and head and neck cancer at the 2025 Annual Meeting of American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Chicago on April 29, 2025 (Press release, Vaccinex, APR 21, 2025, View Source [SID1234651995]). Elizabeth Evans, PhD, Senior VP Discovery and Translational Medicine, will present results of these studies in two presentations.

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AACR Conference Information:

Date: Tuesday, April 29, 2025
Presentation title: Regulating dendritic cells to promote mature tertiary lymphoid structures and enhance anti-tumor immunity. Presentation #3975
Time: 9-12 AM CDT/10 AM – 1 PM EDT.
Session Title: The Tumor Immune Interplay as a Driver of Progression

Presentation title: Neoadjuvant pepinemab enhances DC function associated with mature tertiary lymphoid structures and activity of immune checkpoint blockade in patients with metastatic melanoma. Presentation #6007
Time: 2-5 PM CDT/ 3-6 PM EDT.
Session Title: Therapeutic Antibodies, Including Engineered Antibodies 2
Access: Posters will be presented in-person on Tuesday, April 29 at McCormick Place Convention Center, Chicago, Illinois, and on AACR (Free AACR Whitepaper) 2025 virtual meeting platform at 1:00 PM ET on Friday, April 25, 2025.

Previously reported data from these two clinical studies suggest a crucial role of pepinemab to facilitate immune cell interactions within highly organized and robust centers of immunity, called tertiary lymphoid structures, or TLS. By blocking the SEMA4D inhibitory signal to Dendritic Cells (DC), pepinemab allows productive, coordinated interactions between SEMA4D+ T cells, key effector cells capable of eradicating tumors, and DC, regulatory cells that promote immune cell interactions within TLS so as to amplify mature T cell responses. New data will characterize clinical outcomes, biomarkers, and mechanisms of these interactions in patients treated with pepinemab in combination with immune checkpoint therapy.

Boosting TLS within tumors is an area of growing excitement because the presence of TLS has been shown to correlate with clinical benefit and positive response to immune checkpoint therapy. A limitation in the field has been identification of safe and effective therapies that can induce formation and harness the potential of TLS to enable durable benefit to patients. Pepinemab may represent a solution to this problem, as our data demonstrate the potential of pepinemab to turn immunologically cold tumors, such as HPV-negative and PD-L1-low head and neck cancer, into hot immune centers by inducing robust and mature TLS.

Neoadjuvant immunotherapy has emerged as a promising approach in the treatment of various cancers, showing improved immune and clinical benefit in the preoperative setting compared to standard post surgery adjuvant treatments. Despite these advances, many patients who initially benefit from antibodies that block inhibitory checkpoint molecules (e.g. PD-1, CTLA 4) will progress. More effective combination therapies are needed. Neoadjuvant treatment with pepinemab enhanced TLS maturity and correlated with longer recurrence-free survival when combined with immune checkpoint inhibitors in patients with metastatic melanoma. Evaluation of pepinemab in the neoadjuvant setting for patients with head and neck cancer is ongoing and will be reported at upcoming scientific meeting this Spring.

About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can otherwise bind to plexin-B1 receptors to trigger collapse of the actin cytoskeleton in cells and lead to loss of homeostatic functions of dendritic cells in immune tissue and of astrocytes and other glial cells in the brain. Pepinemab appears to be well-tolerated with a favorable safety profile in multiple clinical trials in different cancer and neurological indications.

On April 18, 2025 SparX Biopharmaceutical Corp. reported that it will present clinical updates on its lead asset, SPX-303, a first-in-class anti-LILRB2/PD-L1 bispecific antibody, during the Trial-in-Progress poster session at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 28, from 2:00 PM to 5:00 PM (Press release, Sparx Therapeutics, APR 18, 2025, View Source [SID1234651986]). The presentation marks the one-year anniversary of the first patient dosing of this novel bispecific antibody in its ongoing Phase 1 clinical trial.

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A more comprehensive overview of SPX-303’s dual mechanism, which targets both myeloid and T-cell immune checkpoints, will be featured at a Satellite Symposium themed "Harnessing Super Immunotherapy and ADCs to Redefine the Standard of Care." Co-hosted by the University of Illinois at Chicago Cancer Center and Yao Yuan—Academy for Pharma Innovation, the symposium will convene expert clinicians, academic investigators, and industry leaders to discuss how next-generation immuno-oncology, known as "Super IO," can be synergized with antibody-drug conjugates (ADCs). This innovative approach combines the tumor-targeting precision of ADCs with the immune-activating power of checkpoint inhibitors, aiming to deliver deeper and more durable anti-tumor responses.

SPX-303, a first-in-class bispecific antibody targeting LILRB2 and PD-L1, is currently enrolling patients with resistant or refractory solid tumors at a dose level of 20 mg/kg. "This innovative program represents a significant advancement in macrophage checkpoint blockade and T cell co-engagement strategies," said Dr. Gui-Dong Zhu, CEO of SparX. "It holds promise as a potential next-generation immuno-oncology therapy—or ‘Super IO’ booster—for patients with limited treatment options."

The SPX-303 poster will be presented at Poster #CT116-11 in the Phase I Clinical Trials in Progress session at McCormick Place, Chicago, on April 28, from 2:00 to 5:00 PM. The Satellite Symposium will be held at the Trump International Hotel & Tower Chicago (401 N Wabash Ave, Chicago, IL 60611). SparX welcomes attendees to visit its exhibition booth during the symposium and strongly encourages early registration via the [registration portal] to secure a seat.

About SPX-303

SPX-303 is a first-in-its-class bispecific antibody therapy designed to simultaneously inhibit LILRB2 and PD-L1, two critical immune checkpoint proteins often hijacked by cancer cells. The program represents a novel immunotherapy approach aimed at activating both myeloid and lymphoid immune responses.

On April 18, 2025 Ymmunobio AG (YB), a Swiss-based global biotech company dedicated to the development of new cancer therapeutics, reported that its two-antibody drug conjugate (ADC) assets, YB-800ADC1 and YB-800ADC2, have completed the preclinical proof of concept studies (Press release, Ymmunobio, APR 18, 2025, View Source [SID1234651987]). Both in vivo and in vitro studies have reached this important milestone by demonstrating the anti-tumor efficacy of both ADCs.

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The ADCs are derived from YB’s lead antibody YB-800 which targets a novel and first in class tumor marker. They utilize established payloads and a third-generation linker, demonstrating a tumor growth inhibition of 90%.

"These excellent results allow YB to move forward swiftly to prepare for the pivotal toxicology studies. This is a major step towards the clinical development of our ADCs in solid tumors and demonstrates the potential for YB’s ADCs to address unmet needs for cancer patients expressing the new novel tumor marker. In addition, the proof-of-concept data support the preclinical development of the two YB-800 based radiopharmaceuticals developed in collaboration with the Paul Scherer Institute," said Peter Schiemann, CEO.

On April 17, 2025 Endevica Bio, a privately held company developing first-in-class peptide drug candidates, reported the dose administration for the first patient in a Phase 2 trial for its experimental drug TCMCB07 (B07) to prevent weight loss in cancer patients undergoing chemotherapy (Press release, Endevica Bio, APR 17, 2025, View Source [SID1234651979]).

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The trial, being conducted in partnership with WuXi Clinical, will include 20 sites and 100 patients who are diagnosed with stage 4 metastatic colorectal cancer.

In the trial, patients are dosed with B07 as they begin chemotherapy and during the first several rounds of chemotherapy. The primary endpoint is preventing weight loss, which can lead to a debilitating condition called cachexia, a life-threatening wasting syndrome associated with chronic diseases, including cancer.

"This marks an important milestone in our commitment in developing a potentially life changing treatment for cachexia," said Russell Potterfield, Chief Executive Officer and Executive Chair of Endevica. "Each trial brings us closer to offering a viable solution for this debilitating disease, and we remain dedicated to making a lasting impact on the lives of those affected."

"We are incredibly excited to have our first patient dosed with B07 in individuals diagnosed with metastatic colorectal cancer who are undergoing chemotherapy," said Dr. Daniel Marks, Chief Medical and Scientific Officer of Endevica Bio. "Since there is no FDA approved therapeutic for cancer cachexia, this trial is a crucial step to provide a therapy for an area of huge unmet clinical need, and we look forward to the results."

In 2024, Endevica Bio completed its Phase 1 clinical trial with preliminary findings supporting its strong safety and efficacy. Last November, the Journal of Clinical Investigation, showed that B07 improved the appetite and preserved lean mass and fat mass in rodent models of cancer and its associated combination chemotherapy. This same study showed the strong potential of B07 to alleviate chemotherapy-induced anorexia and weight loss for millions of patients worldwide.

About TCMCB07
TCMCB07 is a melanocortin‐3/4 antagonist peptide candidate in clinical development for the treatment of cachexia. It is designed to be a first-in-class peptide drug with the ability to cross the blood-brain barrier and act on previously inaccessible target receptors to modulate the body’s behavioral and metabolic response to chronic illness. Pre-clinical animal trial results show significant lean muscle mass retention (e.g., a reversal of the cachectic condition) during administration of the drug. The results are consistent in cachexia arising from many different types of chronic disease.

On April 17, 2025 Researchers with City of Hope, one of the largest and most advanced cancer research and treatment organizations in the U.S. with its National Medical Center named top 5 in the nation for cancer by U.S. News & World Report, reported it will present the latest cancer research at the AACR (Free AACR Whitepaper) Annual Meeting 2025, which will take place April 25 to 30 in Chicago (Press release, City of Hope, APR 17, 2025, View Source [SID1234651980]).

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City of Hope experts will present more than 74 chaired, plenary, educational, minisymposium, poster and other sessions on the use of artificial intelligence (AI), multiomics and other emerging technologies in cancer research, advances in the clinical application of natural killer cells, new clinical trial results, translating research into policy through community engagement and much more.

"The extensive breadth and depth of research being presented at AACR (Free AACR Whitepaper) by City of Hope’s researchers exemplifies our commitment to making hope a reality for all cancer patients," said John D. Carpten, Ph.D., City of Hope’s chief scientific officer, Irell & Manella Cancer Center Director’s Distinguished Chair and Morgan & Helen Chu Director’s Chair of the Beckman Research Institute "We are proud to share our dedication to developing innovative technologies and treatments for improved care through a combination of scientific discovery, clinical ingenuity and compassion."

Chaired sessions

David W. Craig, Ph.D., professor and founding chair of the Department of Integrative Translational Sciences within Beckman Research Institute of City of Hope, is chairing the final plenary session of the conference, "Opportunities in Predicative Oncology." He will deliver opening and closing remarks for the session focused on exploring emerging computational, biological and clinical approaches to learn more about tumors at multiple levels and improve precision medicine. "Opportunities in Predictive Oncology," plenary session PL05, will take place on Wednesday, April 30, 2025, 8 to 10 a.m.

"This session will explore how researchers are working at the forefront of our field and pushing the boundaries of cancer care by using leading-edge technologies to improve how we can target disease on an individual basis," Dr. Craig said. "Combining multifaceted sets of data allows us to better understand treatment resistance, build stronger predictive models and enhance outcomes using precision medicine."

Dr. Craig is also chair of an educational session on integrating AI and data science to gain deeper insights into the causes of cancer and how it progresses. He will present on using a biological analysis approach called multiomics to investigate the unique genetic makeup of different cell populations in solid tumors.

"Accelerating Cancer Research with AI and Data Science: Multi-scale Multi-Modal Integration for Deeper Insights," educational session ED04, is on Friday, April 25, 2025, 4:45 to 6:15 p.m. Dr. Craig’s presentation, "Resolving spatial subclonal genomic heterogeneity using the integration of multi-omic genomic approaches in solid tumors," is the first of the session.

In addition, Nina (Jiarong) Song, a graduate student in Dr. Craig’s lab, will present new data from a team of researchers that highlights the use of AI to integrate digital pathology, genomics and spatial transcriptomics to gain new insights into glioblastoma, triple-negative breast cancer and colorectal cancer progression. Part of the minisymposium MS.BCS01.01 "Artificial Intelligence and Machine Learning for Basic and Translational Research," held on Sunday, April 27, 2025, 3 to 5 p.m., Song’s presentation, "Decoding tumor microenvironment with deep learning: merging spatial transcriptomics and histopathology," is the first talk of the minisymposium.

Michael A. Caligiuri, M.D., former president of City of Hope National Medical Center and professor in the Department of Hematology & Hematopoietic Cell Transplantation, is the chair of two educational sessions. He will introduce a session on advances in the application of natural killer (NK) cells — a type of white blood cell that destroys cancer and can be harnessed as a therapeutic intervention, which is being researched at City of Hope — and present on "Innate immune lymphocytes, including NK cells." The educational session ED57, "Natural Killer Cells: Advances in Basic Biology and Clinical Applications," is on Saturday, April 26, 2025, 10 to 11:30 a.m. Dr. Caligiuri’s presentation is the first of the session.

Dr. Caligiuri is also chair of ED54, "Academic Entrepreneurship: Getting Your Discovery to Patients, Part 1—Liftoff," on Saturday, April 26, 2025, 8 to 9:30 a.m., which will help define the steps required for translating research from the bench to the bedside.

Select presentations by City of Hope scientists and physicians include:

"Managing and predicting toxicities from new and emerging ADCs"

As part of a session on advances in diagnostics and therapeutics, Hope Rugo, M.D., who recently joined City of Hope as director of its Women’s Cancers Program, will talk about new findings in managing toxicities from antibody-drug conjugates. (Advances in Diagnostics and Therapeutics session ADT04: Monday, April 28, 2025, 1:25 to 1:45 p.m.)

Dr. Rugo will also serve as a discussant at the Clinical Trials Plenary Session on Biologics and T-cell Engagers on Tuesday, April 29, 10:15 a.m. to 12:15 p.m.

"Multi-omics analysis of MYC gene and WNT signaling pathway alterations in early-onset colorectal cancer in Hispanic/Latino patients, enhanced with spatial transcriptomics approaches"

Francisco (Paco) Carranza, a postdoctoral scientist in the lab of Enrique Velazquez Villarreal, M.D., Ph.D., M.P.H., M.S., assistant professor in the Department of Integrative Translational Sciences, will present on the investigation of early-onset colorectal cancer in young Hispanic/Latino populations using multi-omics analysis to improve precision medicine in underrepresented populations. (Minisymposium session 3742: Monday, April 28, 2025, 2:35 to 2:50 p.m.)

"PM-AI agent: A conversational artificial intelligence system for precision medicine and advancing health equity through integrative clinical, genomic and social determinants of health data analysis"

Dr. Velazquez Villarreal will also present a poster on the development of a new precision medicine AI tool that addresses key challenges in the integration of clinical, genomic, population-specific variables and social determinants of health to promote better equity in cancer research. (Poster presentation 1115/1: Sunday, April 27, 2025, 2 to 5 p.m.)

"Penpulimab versus placebo in combination with chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: A global, multicenter, randomized, double-blind, phase 3 trial (AK105-304)"

Medical oncologist Aditya Shreenivas, M.D., M.S. will present new data from phase 3 of a clinical trial testing Penpulimab, a humanized anti-PD-1 monoclonal antibody, in patients with advanced nasopharyngaeal carcinoma. (Clinical trials minisymposium session CT011: Sunday, April 27, 2025, 3:50 to 4 p.m.)

"Overcoming intrinsic mechanisms of cell cycle inhibitor resistance in estrogen receptor-positive (ER+) breast cancer"

Kimya Karimi, a postdoctoral scholar in the lab of Andrea Bild, Ph.D., professor in the Department of Medical Oncology & Therapeutics Research, will present new data from a City of Hope study exploring a combination treatment to overcome primary endocrine therapy resistance in estrogen receptor-positive breast cancer. (Minisymposium session 6383: Tuesday, April 29, 2025, 3:05 to 3:20 p.m.)

"The science and art of community engagement for translating research into cancer-related policy and implementation"

Kimlin Tam Ashing, Ph.D., professor and founding director of the Center of Community Alliance for Research & Education at City of Hope will present during an educational session on building community outreach and engagement partnerships for improved health outcomes. (Educational session ED39: Friday, April 25, 2025, 3:30 to 3:50 p.m.)

Highlighted poster sessions

Jing Qian, a senior research associate in the lab of Dr. Carpten is first author on "Spatial transcriptomics reveals differences in the tumor and immune microenvironment of high-grade serous ovarian cancers with differing responses to immune checkpoint inhibitors." (Late breaking poster session LB076/12: Sunday, April 27, 2025, 2 to 5 p.m.)

Peter Zang, M.D., a hematology and oncology fellow is first author on "Digital spatial profling with GeoMx to identify differential protein expression in Non-Hispanic/Latino and Hispanic/Latino Patients with metastatic hormone sensitive prostate cancer," a poster abstract that outlines work from the lab of senior author Tanya Barauskas Dorff, M.D., professor in the Department of Medical Oncology & Therapeutics Research on the complex interplay between ethnicity and disease biology in prostate cancer. (Poster session 5103/8: Tuesday, April 29, 2025, 2 to 5 p.m.)

A poster presentation by Sydney Grant, a postdoctoral fellow, and Aritro Nath, Ph.D., assistant professor in the Department of Medical Oncology & Therapeutics Research, "Integrating multimodal data with survival-based variational autoencoders to predict recurrence-free survival in breast cancer," highlights a new model the team developed to predict recurrence-free survival in breast cancer patients. (Poster session 5011/15: Tuesday, April 29, 2025, 9 a.m. to noon)