Charles River Laboratories Showcases End-to-End Oncology Capabilities at AACR 2023

On April 10, 2023 Charles River Laboratories International, Inc. (NYSE: CRL) reported that its team of oncology experts will attend the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, with 19 scientific posters and a spotlight presentation to highlight its enhanced oncology portfolio (Press release, Charles River Laboratories, APR 10, 2023, View Source [SID1234629928]). The meeting is taking place from April 14-19, 2023, at the Orange County Convention Center in Orlando, Florida, with Charles River at Booth #943.

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"Cancer is the second leading cause of death worldwide, and patients are relying on the research and development of new therapeutics. AACR (Free AACR Whitepaper) offers our researchers a unique opportunity to learn from leaders in the industry and share critically important knowledge to further innovation."

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Charles River’s team of industry-leading oncology experts have contributed to 84 percent of the cancer therapies approved by the Food and Drug Administration from 2018-2022. Additionally, Charles River has been named as co-inventors on 78 patents, and supported 16 clinical candidates and 11 FDA-approved cell and gene therapies. At the AACR (Free AACR Whitepaper) Annual Meeting, researchers will present recent work utilizing emerging tools and approaches for cancer research.

Navigating Cell Therapy Discovery and Development

Cell therapies continue to be a focus in the field of advanced therapies. During a Spotlight Session, scientific leaders from across disciplines will discuss cell therapy discovery and development, including insights into the discovery journey from materials, research models, and quality assessment, as well as considerations and capabilities to streamline research and mitigate self-inflicted risks.

Tuesday, April 18, 3:00-4:00 p.m., Theater A: Navigating Cell Therapy Discovery and Development, featuring:
Nicholas Ostrout, Senior Advisor Cell & Gene Therapy
Arif Khan, Senior Scientist Lead
Gemma Moiset, Group Leader Advanced Modalities
Steven Bronson, Scientific Product Manager
Utilizing Technology to Fuel Discovery Innovation

Mutation-targeting therapies have become a new paradigm for cancer treatment. In a joint poster presentation, Charles River and Cypre, Inc. will present the use of 3D in vitro tumor panels, that include a hydrogel matrix and fibroblasts to replicate the stromal compartment of the tumor microenvironment to test mutation-targeting therapies. The strategic partnership between Charles River and Cypre provides clients with access to Cypre’s proprietary 3D hydrogel patterning technology – Symphony and VersaGel – to predict therapeutic efficacy of targeted and immuno-oncology agents in a more representative and high throughput model of the tumor microenvironment. The models incorporate patient-derived xenografts (PDX) from Charles River’s Cancer Model Database, enabling a seamless transition to in vivo studies following indication and model selection.

Monday, April 17, 9:00 a.m.-12:30 p.m., Section 20: KRAS, BRAF, BRCA1 and EGFR Mutation-Specific Panels using Hydrogel-Based 3D in vitro Tumor Models
Identifying how to optimally combine immunotherapies with other available anti-cancer therapies is a major challenge in oncology. In February 2021, Charles River announced a strategic partnership with Kibur Medical to offer exclusive access to its implantable microdevice (IMD) for in vivo preclinical oncology studies. Now, in a joint poster presentation, Charles River and Kibur Medical highlight the use of an implantable microdevice that allows cassette microdosing and measurement of intratumor drug responses and anti-tumor immunity for up to 20 different agents in parallel.

Tuesday, April 18, 1:30-5:00 p.m., Section 21: Transcriptomic Analysis in a Renal Cancer PDX Model Enables the Deconvolution of Additive and Synergistic Effects of the Six Different Standard of Care Compounds with Anti-PD-1 Treatment
Lastly, the increased use of machine learning (ML) in drug discovery has allowed medicinal chemists to operate at a vastly different scale than traditional approaches by enabling them to search much larger universes of potential compounds. In 2022, Charles River and Valo Health launched LogicaTM, an artificial intelligence (AI) powered solution that directly translates clients’ biological insights into optimized preclinical assets. Experts from the Logica team will be available at the Charles River Booth #943 to discuss the unique risk-sharing model of Logica that ties costs to value generation points.

A full schedule of Charles River’s activities during AACR (Free AACR Whitepaper) 2023, as well was reprints of each poster, are available online. Charles River experts will be available for meetings to discuss how an integrated approach can support drug discovery and development programs from hit identification to IND (Investigational New Drug) filing.

Throughout the conference, Charles River will be providing live updates on the Eureka Blog, including reviews of scientific sessions and input on the research being presented.

Approved Quotes

"Cancer is the second leading cause of death worldwide, and patients are relying on the research and development of new therapeutics. AACR (Free AACR Whitepaper) offers our researchers a unique opportunity to learn from leaders in the industry and share critically important knowledge to further innovation." – Aidan Synnott, Corporate Vice President, Global Discovery Services, Charles River
"Logica integrates world-leading laboratory capabilities with best-in-class AI-driven molecular design. The offering is packaged in a unique, success-based pricing model that produces a development candidate that is ~50% less expensive than alternatives. Given the breadth of Logica’s capabilities, we are confident that the molecules we deliver will be considerably better than what can be provided by other offerings. It’s a win-win." –Guido Lanza, Senior Vice President, and Logica General Manager, Valo Health

"Kibur Medical provides drug developers with the unique ability to simultaneously profile in situ anti-tumor activity of up to 20 unique agents or combinations independently. This deep molecular insight into in vivo tumor-drug pharmacodynamics significantly accelerates and de-risks oncology drug development and precision medicine." – Professor Oliver Jonas, co-Founder, Kibur Medical Inc.

"Cypre 3D Tumor Panels offer PDX IC50 data in 30 days. Leveraging the Cypre hydrogel patterning technology, targeted- and immuno-therapeutic leads of various modalities (small molecules, antibodies, and cell therapy) are screened against proprietary 3D in vitro models of the tumor microenvironment using high content image analysis. We look forward to serving our clients with our pre-configured Cypre Tumor Panel Catalog." – Kolin C. Hribar, PhD, CEO & Founder, Cypre Inc.

New Phase 2 Data With Cretostimogene Grenadenorepvec (CG0070) in Combination with KEYTRUDA® (pembrolizumab) in BCG-Unresponsive NMIBC at the AUA 2023 Annual Meeting

On April 10, 2023 CG Oncology, Inc. reported acceptance of an oral presentation at the American Urological Association (AUA) 2023 Annual Meeting in Chicago, IL from April 28-May 1, 2023 (Press release, CG Oncology, APR 10, 2023, View Source [SID1234629927]). The updated data will be presented from the CORE-001 study, an ongoing Phase 2 clinical trial of cretostimogene grenadenorepvec (CG0070) in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details of the oral presentation are as follows:

CORE-001: Phase 2 Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non-Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin (BCG)
Abstract Number: 23-5631
Session: PD13: Bladder Cancer: Non-invasive II
Presenter: Roger Li, M.D., lead study investigator and Urologic Oncologist at Moffitt Cancer Center
Presentation Date & Time: Saturday, April 29, 2023, 8:10-8:20am Central Daylight Time
Location: McCormick Place, S404A

CG Oncology will also be exhibiting at the AUA annual meeting and can be found at booth 3963.

More information about the study, CORE-001 (NCT04387461), along with other studies sponsored by CG Oncology, can be found at www.clinicaltrials.gov or www.cgoncology.com.

CG Oncology has previously announced a clinical collaboration with Merck (known as MSD outside the US and Canada) relating to the investigation of cretostimogene grenadenorepvec used in combination with KEYTRUDA (pembrolizumab).

About Cretostimogene Grenadenorepvec

Cretostimogene grenadenorepvec (CG0070) is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. Cretostimogene grenadenorepvec is also in a Phase 2 study in combination with KEYTRUDA (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with cretostimogene grenadenorepvec in combination with OPDIVO (nivolumab).

MedGenome to Exhibit Proprietary Sequencing and Informatics Solutions at the American Association for Cancer Research Annual Meeting

On April 11, 2023 MedGenome, a global precision medicine company specializing in omics solutions, reported that it will be exhibiting at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 14 – 19, 2023 in Orlando, Florida (Press release, MedGenome, APR 10, 2023, View Source [SID1234629926]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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MedGenome will be at Booth #2074 to exhibit its advanced single cell sequencing and immune repertoire profiling solutions. MedGenome’s advanced analyses pipeline provides researchers with a comprehensive report which includes publication ready tables, plots and detailed metrics to visualize and interpret the results. MedGenome will also exhibit its end-to-end sequencing and informatics solutions to analyze T-cell receptor (TCR) and B-cell receptor (BCR) repertoires for antibody and diagnostics marker discovery projects.

Hiranjith GH, Site Head and VP of Research Services at MedGenome and his team will be at Booth #2074. For more information, or to schedule a meeting with the MedGenome team at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, reach out to the contact below.

MedGenome to Exhibit Proprietary Sequencing and Informatics Solutions at the American Association for Cancer Research Annual Meeting

On April 11, 2023 MedGenome, a global precision medicine company specializing in omics solutions, reported that it will be exhibiting at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 14 – 19, 2023 in Orlando, Florida.

MedGenome will be at Booth #2074 to exhibit its advanced single cell sequencing and immune repertoire profiling solutions. MedGenome’s advanced analyses pipeline provides researchers with a comprehensive report which includes publication ready tables, plots and detailed metrics to visualize and interpret the results. MedGenome will also exhibit its end-to-end sequencing and informatics solutions to analyze T-cell receptor (TCR) and B-cell receptor (BCR) repertoires for antibody and diagnostics marker discovery projects.

Hiranjith GH, Site Head and VP of Research Services at MedGenome and his team will be at Booth #2074. For more information, or to schedule a meeting with the MedGenome team at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, reach out to the contact below.

Totus Medicines Announces Presentations at the Upcoming American Association for Cancer Research (AACR) Annual Meeting

On April 10, 2023 Totus Medicines, a clinical stage biotechnology company fueled by its breakthrough Accel platform, reported it will be presenting four posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, regarding its lead program, TOS-358, the first highly specific, covalent PI3Kα inhibitor (Press release, Totus Medicines, APR 10, 2023, View Source [SID1234629925]). Totus has created the Accel Platform that, for the first time ever, can search, map, and decode billions of drug molecules across multiple cellular targets in a single experiment. This has allowed Totus to identify candidate molecules in months, not years, and rapidly advance these molecules toward the clinic. Notably, the Accel Platform enabled discovery of TOS-358 at an unprecedented pace. TOS-358 was discovered in under 4 months and received IND approval in ~2 years from original screening.

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TOS-358 represents the first highly specific covalent inhibitor of PI3Kα, which is mutated in ~15% of all cancers (Breast, Colorectal, Lung, Bladder, etc.). However, the therapeutic benefit of current molecules is limited by two key problems. Firstly, current non-covalent PI3Kα inhibitors cannot achieve continuous >95% target pathway inhibition, which is required for anti-tumor efficacy. Secondly, high doses of current non-covalent PI3Kα inhibitors are non-specific and inhibit other PI3K isoforms at effective doses. This leads to toxicity such as hyperglycemia and GI toxicity. TOS-358 represents the first ever highly specific covalent molecule targeting PI3Kα that can achieve durable, near 100% inhibition of PI3Kα activity and avoid these safety issues in preclinical studies.

Totus will outline three key points at AACR (Free AACR Whitepaper) to support TOS-358 as the best-in-class PI3Kα inhibitor:

Despite claims indicating 80% inhibition is sufficient, PI3Kα-mutant tumors consistently require >95% inhibition to induce significant anti-tumor effects, and TOS-358 can uniquely achieve this level of inhibition.

Common pathway feedback mechanisms re-activate PI3Kα in most cell lines and render non-covalent approaches ineffective. TOS-358 can uniquely block these feedback mechanisms and retain >95% inhibition over time.

PI3Kα-WT inhibition alone does not induce significant hyperglycemia or metabolic dysfunction. Previous non-covalent molecules (Alpelisib) inhibit both PI3Kα and other off-target (PI3Kβ) leading to significant toxicities. TOS-358 does not cause significant metabolic dysfunction due to its highly specific ability to target PI3Kα.
Based on these studies, we outline the best-in-class status of TOS-358 due to its unique ability to achieve >95% inhibition of PI3Kα with limited side effects leading to unprecedented monotherapy efficacy in preclinical models.

"We’re thrilled to be presenting several posters at AACR (Free AACR Whitepaper) that demonstrate the preclinical efficacy, safety, and differentiation of TOS-358, the world’s first covalent inhibitor of PI3Kα in clinical development," said Neil Dhawan, CEO and co-founder of Totus Medicines. "We’ve come a long way, fast, and are looking forward to sharing our findings with the broader cancer research community, which we believe will redefine the cancer community’s understanding of PI3Kα targeting."

The poster presentations are listed below and the full abstracts will be available on the AACR (Free AACR Whitepaper) and Totus Website.

A study to evaluate the safety and tolerability of the covalent phosphoinositide-3-kinase (PI3K)-alpha Inhibitor, TOS-358, in adult subjects with select solid tumors
Abstract number: CT249
Date and Time: Tuesday April 18 at 1:30 PM – 5:00 PM ET

Development and validation of a pharmacodynamic (PD) assay for TOS-358, the first covalent inhibitor of PI3Kα in clinical development
Abstract number: 2249
Date and Time: Monday, April 17 at 9:00 AM – 12:30 PM ET

Inhibition of wild-type PI3Kα signaling is required for durable efficacy in PI3Kα mutant cancer cells due to robust re-activation of wild-type PI3Kα signaling
Abstract number: 4946
Date and Time: Tuesday, April 18 at 1:30 PM – 5:00 PM ET

TOS-358, a first-in-class covalent PI3Kα inhibitor, demonstrates superior efficacy and does not induce significant hyperglycemia at efficacious doses in multiple animal models
Abstract number: 4945
Date and Time: Tuesday, April 18 at 1:30 PM – 5:00 PM ET