On September 22, 2021 KSQ Therapeutics, a biotechnology company developing drugs to treat cancer and autoimmune diseases using its proprietary, integrated discovery platform to systematically screen the whole genome in cancer and immune cells, reported that Qasim Rizvi, Chief Executive Officer of KSQ, will present at the 2021 Cantor Virtual Global Healthcare Conference on Wednesday, September 29, 2021 at 4:40 PM (ET) (Press release, KSQ Therapeutics, SEP 22, 2021, View Source [SID1234590141]). The conference is being held September 27-30, 2021.

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On September 22, 2021 CG Oncology, Inc. reported that it has entered into a clinical trial collaboration agreement to evaluate the combination of CG Oncology’s investigational oncolytic immunotherapy CG0070, with Roche’s atezolizumab, an anti-PD-L1 (programmed death-ligand 1) therapy (Press release, CG Oncology, SEP 22, 2021, View Source [SID1234590140]).

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The Phase 1/2 clinical trial will evaluate the safety and efficacy of this novel immunotherapy combination in patients with various advanced solid tumors yet to be disclosed. CG Oncology will sponsor the study and Roche will provide atezolizumab.

CG0070, CG Oncology’s lead immuno-oncology candidate, is in an ongoing Phase 3 monotherapy study and has been administered in over 100 patients to date for the treatment of high-risk, non-muscle invasive bladder cancer (NMIBC). CG0070 is based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroying various cancer cells, including bladder tumor cells, through their defective retinoblastoma (Rb) pathway.

"We are pleased to enter into this collaboration agreement with Roche," said Arthur Kuan, CEO of CG Oncology. "We are excited to initiate this important clinical trial with our lead oncolytic immunotherapy, CG0070, in combination with atezolizumab to evaluate the potential synergy of these two immunotherapies in cancer."

Additional details of the collaboration were not disclosed.

On September 22, 2021 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in aggressive cancers, reported plans to present at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), held virtually from October 7-10, 2021 (Press release, Boundless Bio, SEP 22, 2021, View Source [SID1234590139]).

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Boundless Bio, in collaboration with the Dana Farber Cancer Institute and Mirati Therapeutics, will share in vivo results from a colorectal cancer xenograft model revealing ecDNA as a key mediator of resistance to adagrasib and sotorasib, clinical-stage and FDA approved KRASG12C inhibitors respectively. These findings support previous Boundless Bio published work that ecDNA is an important underlying cause of cancer resistance and reinforces the critical need for novel therapeutic strategies to address ecDNA enabled cancers. The poster presentation will be available on-demand throughout the conference, details are below:

Title: Detection of KRAS amplification on extrachromosomal DNA (ecDNA) upon acquired resistance to KRASG12C inhibitors
Presenter: Ryan J. Hansen, Ph.D.
Poster Number: LBA005

About ecDNA

Extrachromosomal DNA, or ecDNA, are distinct circular units of DNA lacking centromeres but containing functional genes, including oncogenes, that are separated from tumor cell chromosomes. ecDNA replicate within cancer cells and can be passed to daughter cells asymmetrically during cell division, thereby constituting a primary driver of focal gene amplification and copy number heterogeneity in cancer. By leveraging the plasticity afforded by ecDNA, cancer has the ability to increase or decrease copy number of select oncogenes located on ecDNA to enable survival under selective pressures, including chemotherapy, targeted therapy, immunotherapy, or radiation, making ecDNA one of cancer cells’ primary mechanisms of recurrence and treatment resistance. ecDNA are not found in healthy cells but are present in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.

On September 22, 2021 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported the appointment of Louis J. Denis, M.D., as Chief Medical Officer (Press release, Verastem, SEP 22, 2021, View Source [SID1234590138]). Dr. Denis brings more than 25 years of clinical development and oncology expertise to Verastem.

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"Louis’ proven track record in drug development, including targeting the RAS pathway for treatment of cancer, and his background as a medical oncologist will be invaluable as we advance our registration-directed trials of VS-6766 and defactinib through the clinic," said Brian Stuglik, CEO of Verastem Oncology.

"I am delighted to join Verastem at such an exciting time. The encouraging results from the Phase 1/2 FRAME study presented at ESMO (Free ESMO Whitepaper), along with the recent FDA breakthrough therapy designation in recurrent low-grade serous ovarian cancer and the clinical partnership with Amgen in KRAS G12C-mutant non-small cell lung cancer sets the Company up for its next stages of growth," said Dr. Denis. "I look forward to working alongside Verastem’s experienced leadership team and scientific advisory board to advance its development programs and deliver new treatment options to cancer patients."

Prior to joining Verastem, Dr. Denis was the Chief Medical Officer of Asana BioSciences, where he provided strategic direction as well as medical and safety oversight to Asana’s portfolio of oncology and immunology assets. Previously, Dr. Denis held various leadership roles in Oncology clinical development and medical affairs at Boehringer Ingelheim and Pfizer. Dr. Denis received his M.D. from Vrije Universiteit Brussel Medical School, Belgium, and did his post-doctoral fellowships in Internal Medicine/Medical Oncology at Middelheim Hospital, Antwerp; the Rotterdam Cancer Institute, The Netherlands; and the Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, Texas.

About the VS-6766/Defactinib Combination

The combination of VS-6766 and defactinib has been found to be clinically active in patients with KRAS mutant tumors. In an ongoing investigator-initiated Phase 1/2 FRAME study, the combination of VS-6766 and defactinib is being evaluated in patients with low-grade serous ovarian cancer (LGSOC), KRAS mutant NSCLC and colorectal cancer (CRC). The FRAME study was expanded to include new cohorts in pancreatic cancer, KRAS mutant endometrioid cancer and KRAS-G12V NSCLC. Verastem Oncology is also supporting an investigator-initiated Phase 2 trial evaluating VS-6766 with defactinib in patients with metastatic uveal melanoma. Verastem Oncology has initiated Phase 2 registration-directed trials of VS-6766 with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS-G12V mutant NSCLC as part of its RAMP (Raf And Mek Program).

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766, with defactinib, its focal adhesion kinase (FAK) inhibitor, for the treatment of all patients with recurrent LGSOC regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

On September 22, 2021 OncoNano Medicine, Inc., a clinical-stage company utilizing the principles of molecular cooperativity in drug design to exploit universal tumor and immune targets to diagnose and treat cancer, reported a multi-year collaboration with The University of Texas Southwestern Medical Center (UTSW) to discover and conduct translational research of novel cancer therapeutics that leverage OncoNano’s core nanotechnology platform (Press release, OncoNano Medicine, SEP 22, 2021, View Source [SID1234590137]). OncoNano will sponsor research efforts in the laboratory of Professor Jinming Gao of UTSW with the objective of uncovering new cancer therapies that can benefit from OncoNano’s ultra pH-sensitive polymeric micelles. OncoNano will have an exclusive option to license new technology arising from the research conducted under this agreement.

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"We are excited to expand our research collaboration with the UT Southwestern Medical Center and the prominent UTSW laboratory led by Dr. Jinming Gao," said Martin Driscoll, Chief Executive Officer of OncoNano Medicine, Inc. "UTSW’s rich scientific discovery environment combined with world-class translational research capabilities presents a wonderful opportunity for our scientists to engage in a multi-year cooperative research effort to leverage our core technology platform and advance more novel cancer therapeutics into clinical development."

Dr. Gao and his team at UTSW invented the ultra pH-sensitive nanoparticle technology that represents the core of OncoNano’s differentiated oncology research platform. OncoNano is currently advancing two development programs that utilize the ultra pH-sensitive nanoparticle technology. Pegsitacianine, a fluorescent nanoprobe for real-time surgical imaging, is currently in Phase 2 clinical trials for multiple tumor types, and ONM-501, a novel dual-activating polyvalent STING agonist for immuno-oncology applications, is advancing toward a first in human study planned for early 2023.

"OncoNano’s multi-year support for basic research will broaden our capability to harness molecular cooperativity design that incorporates pathophysiological responses into the development of tumor-activatable compounds with increased therapeutic windows," said Jinming Gao, Professor of Oncology, Pharmacology and Cell Biology in the Harold C. Simmons Comprehensive Cancer Center at UTSW and Chief Scientific Officer of OncoNano. "We are working to expand the micelle technology platform developed at UTSW so it can be used to deliver additional payloads, including protein therapeutics such as cytokines, checkpoint inhibitors and bispecific antibodies. We look forward to this research collaboration with OncoNano Medicine to continuously translate lab discoveries into potentially important clinical applications."