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BigHat Biosciences and Lilly Collaborate to Advance AI-Driven Antibody Therapeutics

On April 17, 2025 BigHat Biosciences ("BigHat"), a biotechnology company with a machine learning (ML)-guided antibody discovery and development platform, reported a strategic collaboration with Eli Lilly and Company ("Lilly") (Press release, BigHat Biosciences, APR 17, 2025, View Source [SID1234651981]). In this collaboration, BigHat will deploy its Milliner platform, a suite of state-of-the-art ML technologies integrated with a synthetic biology-based high-speed wet lab, to design and engineer therapeutic antibodies with superior functionality.

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BigHat and Lilly will collaborate to design and discover next-generation antibodies for up to two antibody therapeutic programs. This partnership aims to design, engineer, and develop antibodies with enhanced functionality and improved biophysical properties to create therapeutics that will benefit patients with chronic disease.

"Partnering with Lilly represents an exciting opportunity to harness the full potential of AI-driven biologic design. By combining Lilly’s deep expertise in drug discovery and development with BigHat’s machine learning-powered Milliner platform, we can accelerate the advancement of truly differentiated, next-generation protein therapeutics," said Peyton Greenside, CEO and Co-founder of BigHat.

This collaboration builds on BigHat’s strategy to engage in value-generating strategic partnerships balanced with an exciting internal pipeline of proprietary therapeutics in the areas of oncology and immunology. BigHat’s ML-powered platform is designed to tackle molecular engineering challenges and unlock the development of novel therapeutics for the improvement of patient outcomes. In addition to supporting the development of its partners’ therapeutic programs, BigHat has built and advanced a pipeline of next-gen antibody-drug conjugates (ADCs) and functionally differentiated T-cell engagers (TCEs) across indications in both oncology and immunology. BigHat is advancing a next-generation ADC for GI cancers into the clinic in 2026. Lilly Catalyze360 will provide support, while BigHat retains full global rights and control to the program.

In addition to the antibody discovery collaboration and support for BigHat’s ADC for GI cancers, Lilly will also make an equity investment in BigHat. This collaboration is part of the Lilly Catalyze360 model, which is a comprehensive approach to empower early-stage biotech startups across all therapeutic areas by providing access to funding as well as world-class lab space and/or drug development talent and resources through its three pillars: Lilly Ventures, Lilly Gateway Labs, and Lilly ExploR&D.

City of Hope Research on Artificial Intelligence (AI), Precision Medicine, Immunotherapies and Other Topics to be Presented at American Association of Cancer Research (AACR) Annual Meeting 2025

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]).

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)

Endevica Bio Announces First Patient Dosing in Phase 2 Trial in Patients with Stage 4 Metastatic Colorectal Cancer

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]).

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.

nference and BeiGene Collaborate to Drive New B-Cell Cancer Research

On April 17, 2025 nference, a company dedicated to transforming healthcare by making biomedical data computable, reported a collaboration with BeiGene, Ltd, a global oncology company that intends to change its name to BeOne Medicines Ltd., to unlock new insights in treating B-cell cancers (Press release, BeiGene, APR 17, 2025, View Source [SID1234651978]). The collaboration will leverage nference’s proprietary Agentic AI platform to deepen understanding of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) treatment patterns.

B-cell cancers, including CLL and SLL, are a group of malignancies affecting lymphocytes, a type of white blood cell crucial to immune function. These cancers impact thousands, with CLL being the most common adult leukemia in the U.S. This retrospective descriptive analysis will review more than 700 patient charts to identify real-world treatment patterns.

"Through this collaboration with BeiGene, we aim to uncover valuable real-world insights into treatment patterns and outcomes, helping refine clinical practices," said Dr. Venky Soundararajan, Co-founder and Chief Scientific Officer at inference. "Our goal is to generate a comprehensive view of real-world outcomes that enhances clinical decisions, leading to more effective, personalized care for patients with CLL, SLL, and other B-cell malignancies."

Hoth Therapeutics Announces Granted Japanese Patent for Novel RNA-Based Cancer Therapy Targeting KIT Gene – Expands Global IP in Precision Oncology Platform

On April 17, 2025 Hoth Therapeutics, Inc.(NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing next-generation RNA-targeted precision therapies, reported it has been granted a key patent by the Japan Patent Office (JPO), expanding its global intellectual property portfolio in RNA-based cancer therapeutics (Press release, Hoth Therapeutics, APR 17, 2025, View Source;expands-global-ip-in-precision-oncology-platform-302431170.html [SID1234651977]).

The newly issued patent secures broad claims covering antisense oligomers that target the KIT gene — a clinically validated oncogene associated with gastrointestinal stromal tumors (GIST), leukemia, mastocytosis, and other cancers. These oligomers are designed to alter pre-mRNA splicing or reduce KIT protein expression, offering a highly targeted therapeutic mechanism.

"This patent significantly strengthens Hoth’s position in the RNA therapeutics space and marks a major milestone in our global strategy," said Robb Knie, CEO of Hoth Therapeutics. "Targeting the KIT pathway with antisense technology represents a precision-driven approach that holds immense potential in oncology and beyond. This grant provides strong validation and global momentum as we continue advancing our RNA platform toward the clinic."

The patent includes coverage for:

Antisense RNA molecules comprising 10–50 nucleotides targeting KIT pre-mRNA splicing sequences
Morpholino and chemically modified antisense variants
Pharmaceutical compositions and expression vectors
Applications in both human and veterinary medicine
Why It Matters:
The KIT gene is implicated in aggressive and difficult-to-treat cancers. By leveraging antisense oligonucleotides (ASOs) to modulate KIT expression, Hoth is pioneering a novel RNA-based strategy that could bypass traditional small molecule resistance mechanisms. With this patent, Hoth now holds exclusive rights to develop, partner, and commercialize ASO-based therapies targeting KIT — a critical asset in the precision oncology space.

Key Highlights:

Patent grant accelerates Hoth’s global IP expansion in RNA-targeted therapies
Targets validated oncogene KIT, widely implicated in cancer progression and resistance
Supports pipeline momentum in oncology, immunology, and rare diseases
Creates licensing and partnership opportunities in high-growth therapeutic areas