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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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).

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

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.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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

On April 10, 2023 Ultima Genomics, Inc. and Genome Insight, Inc. have signed an agreement to collaborate to bring affordable whole genome sequencing solutions to cancer patients (Press release, Ultima Genomics, APR 10, 2023, https://www.prnewswire.com/news-releases/ultima-genomics-and-genome-insight-collaborate-to-bring-affordable-whole-genome-sequencing-to-cancer-patients-301792800.html [SID1234629924]). As part of the agreement, Genome Insight will join the early access program for Ultima’s high-throughput NGS instrument platform, the UG 100, and develop an optimized version of its whole genome bioinformatics solution for Ultima’s sequencing technology. The combination of Genome Insight’s proprietary bioinformatics with Ultima’s low-cost sequencing will make whole genome sequencing an affordable reality for cancer patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Although cancer is a disease caused by alterations to the genome, conventional NGS approaches typically use targeted panels that examine only a small fraction of this information. Insights into the whole genome can expand the understanding of cancer biology and provide important information for physicians in formulating a treatment strategy for each patient. Genome Insight’s proprietary bioinformatics platform translates a cancer patient’s genome into medically meaningful insights. Optimizing this platform for Ultima’s high-throughput, low-cost sequencing architecture will enable delivery of curated whole genome sequencing reports to patients and physicians at a very low cost – even cheaper than conventional NGS panels.

"We are excited to partner with Ultima to bring affordable whole genome sequencing to cancer patients," said Young Seok Ju, CEO of Genome Insight. "The ability to analyze the entire genome at a low cost is a game-changer in cancer treatment, and we are proud to be at the forefront of this revolution. This collaboration is an important step towards our vision of using whole genome sequencing to improve patient outcomes."

"We founded Ultima Genomics to help overcome the tradeoffs scientists and clinicians are forced to make between the breadth, depth and frequency with which they use genomic information," said Gilad Almogy, CEO of Ultima Genomics. "Genome Insight’s focus on whole genome sequencing is a perfect example of this, and we are excited to collaborate on this development."