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ConcertAI Announces Strategic Agreement with Bayer to Accelerate Clinical Development in Precision Oncology

On April 22, 2025 ConcertAI reported a multi-year agreement with Bayer to leverage ConcertAI’s Translational360 — powered by Guardant Health liquid biopsy genomic data — and AI SaaS solutions, which use artificial intelligence and machine learning (AI/ML)-derived insights to accelerate clinical development in precision oncology (Press release, Bayer, APR 22, 2025, View Source [SID1234652029]).

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The agreement will fully leverage ConcertAI’s newly launched Translational360, an integrated research-grade longitudinal clinical molecular database that taps into the CancerLinQ network of de-identified cancer patient data from over 9 million records coming from all 50 states in the U.S.

Translational360 combines clinical, genomic, transcriptomic, and whole-slide imaging (WSI) from comprehensive molecular testing for deep phenotypical and genomic insights. Transcriptomics is increasingly a foundation of biopharma translational sciences, allowing researchers to understand disease molecular mechanisms, basis of patient response, and inter-patient variability that’s essential for developing new therapeutics. Too often, clinical trial results in early phases are ambiguous with idiosyncratic positive and negative responses. The integrated data solutions and advanced AI enable selection of programs with the highest likelihood of success and design trials informed by multi-modal, multi-genomic, and transcriptomic data and AI.

"This partnership furthers causal biological inferences, where multi-modal and multi-molecular data can be integrated with AI/ML-based approaches across discovery, translation, and development, accelerating oncology pipelines, allowing our biopharma partners to deliver better medicines faster," said Jeff Elton, Ph.D., CEO of ConcertAI. "This partnership builds on a multi-year history of working together and is unique in offering both tissue and liquid biopsy molecular data, allowing insights into patterns of treatment response, acquisition of resistance, AI modeling of likely success and benefit, informing program priority and clinical study design."

"Data play a critical role in providing a multi-dimensional understanding of a tumor, the clinical environment, and the patient’s response to therapy," said Helmy Eltoukhy, Chairman and co-CEO of Guardant Health. "The real-world data can provide access to unprecedented insights into a patient’s cancer journey, including a tumor’s complex systemic interactions, to help users navigate critical decision points as they develop novel targeted therapies."

"As cancer rates continue to rise, we’re committed to advancing next-generation solutions that can speed up drug discovery and clinical development, enabling us to bring precision oncology treatments to patients faster," said Sai Jasti, Head of Data Science and AI for Pharma R&D at Bayer. "By combining ConcertAI’s powerful data solutions with Bayer’s scientific and AI expertise, we aim to enhance the use of real-world data and cutting-edge AI to boost R&D productivity and ultimately deliver transformative precision therapies to those who need them."

"More AI-designed new molecular entities are progressing faster in first-in-human trials, which is a great milestone," said Claudio D’Ambrosio, Ph.D., Chief Revenue Officer of ConcertAI. "Our entire R&D process has been historically built on studying controlled cell lines and animal models that don’t reflect the interspecies differences, the physiology, and the different biological barriers we have in humans. We are flipping this paradigm on its head. We need to start with human cancer genomes and phenotypes and ‘reverse translate.’ Unlike only a few years ago, we now have powerful human data."

Debiopharm to Reveal Insights From Their ADC, DDR Inhibitor, and Antibody Conjugation Technology Research at the 2025 AACR Conference in Chicago

On April 22, 2025 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases and develop new antibody linker technologies, reported it will release promising new data for two of its pipeline products at the 2025 Annual American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting in Chicago, Illinois (Press release, Debiopharm, APR 22, 2025, View Source [SID1234652027]). Furthermore, a joint poster presentation with Oncodesign Services (www.oncodesign-services.com) will highlight the applicability of its antibody conjugation technology, AbYlink, in the preparation of conjugates for use in non-invasive preclinical imaging.

Comprehensive preclinical results will be presented for Debio 1562M, a next-generation Antibody-Drug Conjugate (ADC) targeting the cell surface glycoprotein CD37 soon to undergo first-in-human evaluation. Two preclinical data releases will be included in the poster display sessions for Debio 0123, a selective WEE1 kinase inhibitor disrupting the DNA-damage response (DDR) of cancer cells. The first data release shows how Debio 0123 can be used in combination with the PKMYT1 inhibitor lunresertib as a promising therapeutic strategy in ovarian and breast cancer. The company will also unveil new impactful findings stemming from its collaboration with Genialis, showing how machine learning has the potential to enhance the ability to predict responders to Debio 0123, thus further advancing the understanding and application of WEE1 biology and response to inhibitors.

Additionally, in the framework of a licensing agreement and a collaborative endeavor to support innovative research, Debiopharm and Oncodesign Services will present promising new data illustrating how AbYlink conjugation technology can facilitate the production of conjugates for use in preclinical research in cancer treatment.

"The pre-clinical results to be released during the AACR (Free AACR Whitepaper) are laying a solid foundation for future research," explained Angela Zubel, Chief Development Officer, Debiopharm. "The two drug research approaches of ADCs and DDR inhibition are harnessing novel modalities and targets with the potential to outsmart hard-to-treat liquid and solid tumors, revolutionizing patient outcomes. Our AbYlink technology demonstrates great potential in the context of antibody radio conjugates against cancer and shows promise for broader use and wider applications."

Session Title: Antibody-Based Cancer Therapeutic Agents
AACR 2025
Oral Presentation

Debiopharm compound

Title

Presenter

-Sun, April 27th

-Mini symposium: 3:35-3:50pm

-Abstract Presentation #: 1160

Debio 1562M

Debio 1562M, a 2nd generation ADC targeting CD37, shows high potency against AML and MDS and safe toxicological profile for future clinical development

Lisa Ivanschitz, Associate Principal Scientist, Debiopharm

Poster Session Title: DNA Damage Response and Modulation of DNA Repair 1
AACR 2025
Poster Presentation

Debiopharm compound

Title

Presenter

-Mon, April 28th

-Poster display: 2:00-5:00pm

-Abstract #2914

-Poster Section: 16

-Poster Board #: 21

Debio 0123

The WEE1 inhibitor Debio 0123 is synergistic with the PKMYT1 inhibitor lunresertib in preclinical models of ovarian and breast cancer

Luke Piggott, Principal Scientist, Debiopharm

Poster Session Title: Artificial Intelligence and Machine Learning for Therapeutic Election and Discovery
AACR 2025
Poster Presentation

Debiopharm compound

Title

Presenter

-Mon, April 28th

-Poster display: 2:00-5:00pm

-Abstract #3659

-Poster Section: 45

-Poster Board #: 21

Debio 0123

Biology-driven, machine learning-based development of a biomarker to predict response to WEE1 inhibitor Debio 0123

Kristian Urh, Genialis

Poster Session Title: Radiation Treatment Combinations for Tumors, Normal Tissue
AACR 2025
Poster Presentation

Debiopharm technology

Title

Presenter

-Mon, April 28th

-Poster display: 9:00am-12:00pm

-Abstract #1825

-Poster Section: 24

-Poster Board #: 11

AbYlink

Pharmacological evaluation of bioconjugated Trastuzumab using the AbYlink regio-selective conjugation technology in gastric cancer expressing HER2+

Eftychia Koumarianou, Head of pharmaco-imaging and molecular radiotherapy, Oncodesign Services

About DNA-Damage Repair (DDR)

When cells have damaged DNA, they need to undergo a repair process called DDR to be able to survive. Cancer cells rely a lot on DDR as they divide and grow uncontrollably. Inhibition of DDR, particularly in combination with other anticancer agents, prevents cancer cells from repairing their DNA, which ultimately activates a self-destruction program in cancer cells. DDR inhibitors such as Debio 0123, a WEE1 inhibitor from Debiopharm, are being tested in clinical and preclinical studies.

Natera To Present Data from 8 Studies at 2025 AACR Annual Meeting

On April 22, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported that data from 8 studies will be shared at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting that will take place April 25 – 30, 2025 in Chicago, IL (Press release, Natera, APR 22, 2025, View Source [SID1234652026]).

Highlights from AACR (Free AACR Whitepaper) include:

An oral presentation titled "Large-scale Genomic Profiling of Colorectal Cancer" from an exploratory analysis examining the characteristics of the mutational landscape of CRC and patterns across clinical and molecular subgroups. The study was performed using Natera’s proprietary real-world database (RWD) that comprises de-identified clinical and genomic data from over 73,000 patients who underwent commercial Signatera testing.
Poster presentations exploring the genomic landscape in over 30,000 breast cancer patients and over 8,000 gynecologic cancer patients, revealing distinct genomic patterns, and underscoring the research value of Natera’s RWD.
Data that integrates Natera’s clinical and genomic information, demonstrating how its real-world evidence database can enhance immunotherapy response prediction by improving neoantigen identification.
Further datasets in esophageal cancer, sarcoma, and CRC, adding to the evidence base of Signatera’s clinical validity and utility.
"We are pleased to share such a broad set of data showcasing our breadth of capabilities in oncology," said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer. "In addition to presenting Signatera data in several types of cancer, we look forward to presentations that leverage the use of our multi-modal database of real-world evidence, which can provide valuable insights to strengthen drug discoveries and potentially accelerate therapeutic breakthroughs."

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.

Onward Therapeutics Announces IMPD Approval for Its Subsidiary Emercell to Start Clinical Investigation of Allogeneic NK Cell Therapy OT-C001 in Combination with Rituximab

On April 22, 2025 Onward Therapeutics SA, a biotechnology company dedicated to advancing innovative cancer immunotherapies, reported that its subsidiary, Emercell SAS, has received Investigational Medicinal Product Dossier (IMPD) approval from the European Medicines Agency (EMA) to initiate a Phase 1 clinical trial of OT-C001, an allogeneic natural killer (NK) cell therapy, in combination with an anti-CD20 monoclonal antibody, Rituximab (Press release, Onward Therapeutics, APR 22, 2025, View Source [SID1234652024]).

The upcoming phase 1 study (C00101 study) will enroll patients with diffuse large B-cell lymphoma (DLBCL), who have relapsed after, or are refractory to CAR-T cell therapy, or ineligible for CAR-T cell infusion. OT-C001 will be evaluated with Rituximab across various dose levels. The trial will also examine cellular kinetics and biomarkers to characterize the specific mechanism associated with therapeutic responses.

"We are delighted to have reached an important milestone of entering clinical development of OT-C001 following our strategic investments in Emercell since 2021," said Dr. C. Grace Yeh, Chairman and CEO of Onward Therapeutics,"This Phase 1 trial may validate Emercell’s patented platform technology for meaningful clinical outcomes. Along with the continued optimization of industrial manufacturing, these efforts will strengthen our ability to form strategic partnerships and advance this promising therapy."

"OT-C001 sets itself apart by utilizing a pool of multiple umbilical cord blood (UCB) samples, offering both diversity in the product and consistency across GMP batches," said Dr. Patrick Henno, Founder and ex-President of Emercell, "unlike the complex manufacturing processes of many engineered cell therapy products, OT-C001 provides a safe and scalable solution to unmet medical needs in targeted indications."

"We are excited to initiate this multicenter phase 1 trial in one of the most common and aggressive forms of non-Hodgkin lymphoma," said Dr. Alain Herrera, President of Emercell and CMO of Onward Therapeutics, "despite challenges in the cell therapy market, this achievement advances our mission to provide novel treatments for DLBCL patients in need of new therapeutic options. OT-C001 has the versatility to act as a universal platform through combinations with various monoclonal antibodies or targeted therapies; it may benefit patients across multiple indications beyond DLBCL."

About OT-C001

OT-C001 is an allogeneic cell therapy of highly activated and expanded NK cells from UCB, manufactured using a patented expansion and activation process. It targets tumor cells through direct and indirect cytotoxicity, when combined with a monoclonal antibody targeting tumor specific antigens. OT-C001 is being evaluated as a potential new treatment for advanced hematologic malignancies with monoclonal antibodies. In non-clinical in vitro, in vivo models, and toxicology studies, it was well tolerated and displayed promising anti-tumor activities.

Tagworks Pharmaceuticals Announces FDA Clearance of IND Application and Initiation of Phase 1 Clinical Trial for TGW101 and Appoints Keith Orford, MD, PhD, as Chief Medical Officer

On April 22, 2025 Tagworks Pharmaceuticals BV ("Tagworks"), a clinical-stage precision oncology company using its proprietary Click-to-Release treatment platform to develop a new standard of care for patients suffering from solid tumors, reported the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for a Phase 1 clinical trial evaluating TGW101, a first-in-class antibody drug-conjugate (ADC) targeting tumor associated glycoprotein 72 (TAG-72) with an monomethyl auristatin E (MMAE) payload, in patients with advanced solid tumors (Press release, Tagworks Pharmaceuticals, APR 22, 2025, View Source [SID1234652023]). The Company also announced the appointment of Keith Orford, MD, PhD, as Chief Medical Officer (CMO).

Tagworks initiated first-in-human Phase 1 clinical development of TGW101 in a multicenter, open-label, dose-escalation trial in patients with advanced solid tumors. The primary objectives of the study are to evaluate the safety and tolerability of TGW101 and identify the maximum tolerated dose, recommended dose, and regiment for cohort expansion. The study is currently recruiting in the U.S. and plans to enroll up to 50 patients.

"TAG-72 is a validated target with overexpression in many high unmet need solid tumors. However, due to its non-internalizing nature, this target has remained unreachable by current ADCs and other therapies which require uptake by tumor cells to activate their anti-tumor activity. TGW101’s highly differentiated profile enables controlled MMAE payload release and activation in the tumor microenvironment without internalization by tumor cells. This controlled drug release is achieved through a click reaction of the ADC linker with a trigger molecule, which is administered in a second step," said Marc Robillard, Chief Scientific Officer and Co-Founder of Tagworks. "TGW101 has demonstrated a favorable safety profile as well as effective and durable responses in preclinical solid tumor models. The IND clearance and initiation of our Phase 1 clinical trial is a significant milestone for our lead program and Tagworks, the pioneer of Click-to-Release chemistry."

Anthony Tolcher, MD, FRCPC, CEO, Founder, and Director of Clinical Research of NEXT Oncology San Antonio and the TGW101 Phase 1 Primary Investigator commented, "TGW101 represents an attractive new potential treatment option in advanced solid tumors with high unmet need, overcoming certain challenges and limitations of other ADC therapies. TGW101 has the potential to offer an improved anti-tumor effect and safety profile which may lead to better clinical outcomes. I am excited to collaborate with Tagworks’ team to evaluate TGW101 in patients with advanced solid tumors in the Phase 1 clinical trial."

In addition, Tagworks further strengthened its management team with the appointment of Keith Orford, MD, PhD, as CMO. Dr. Orford’s proven track record as a physician, scientist, and executive leader at several biotechnology companies will support Tagworks’ position as a leader and innovator in cancer drug development.

"We are pleased to welcome Keith and look forward to his contributions to the clinical development of our pipeline of innovative ADCs and targeted radiopharmaceuticals," said Ken Mills, Chief Executive Officer of Tagworks. "As we enter into clinical development, Keith’s development expertise, strategic insights, and leadership in the oncology community will be critical in positioning Tagworks for long-term success."

"I am thrilled to join the experienced team at Tagworks to develop and expand on the transformative potential of the Click-to-Release technology with the clear goal of providing safe and efficacious new therapies for patients with cancer," said Keith Orford, MD, PhD, CMO of Tagworks. "I look forward to immediately working closely with all of our investigators to evaluate the therapeutic utility of TGW101 in multiple advanced solid tumor indications."

Dr. Orford brings extensive experience in leadership and oncology development, having served as CMO at public and private cancer biotechnology companies. Most recently, he was CMO, Executive Vice President, Clinical and Translational Science at Parabilis Medicines (formerly Fog Pharma), where he oversaw translational medicine and clinical development. Prior to Parabilis, he held a series of clinical development roles of increasing responsibility, including CMO of Calithera Biosciences, Clinical Development Lead and Clinical Head of Immuno-Oncology and Combinations DPU at GlaxoSmithKline, and Associate Director of Clinical Pharmacology and Experimental Medicine and Oncology at Merck. Before joining industry, he held various roles as a Research Fellow and Instructor at Massachusetts General Hospital and Harvard Medical School, where he trained in internal medicine and completed a postdoctoral fellowship. He received his BS, MD, and PhD from Georgetown University.

About TGW101
TGW101 is an antibody-drug conjugate (ADC) targeting TAG-72, a non-internalizing marker found on the surface of many solid tumor cells. TGW101 consists of a TAG-72-binding diabody conjugated with monomethyl auristatin E (MMAE) toxin. TGW101 is administered intravenous (IV) first and allowed to bind to TAG-72 in the tumor. Then a small molecule trigger is administered IV, resulting in selective chemical cleavage of the linker of the tumor-bound TGW101, release of the MMAE in the extracellular tumor microenvironment and diffusion into surrounding tumor cells. TGW101 is being studied in an open-label, multicenter, Phase 1 dose-escalation clinical trial designed to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors.