On October 12, 2021 CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, reported that acceptance of an oral presentation and a poster presentation at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, held virtually and in-person in Washington, DC, November 10-14, 2021 (Press release, CG Oncology, OCT 12, 2021, View Source [SID1234591115]).

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CG Oncology will present preliminary safety and efficacy data from CORE1, an ongoing Phase 2 clinical trial of CG0070 in combination with KEYTRUDA (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

Under a previously announced clinical collaboration with Merck relating to the investigation of CG0070 used in combination with pembrolizumab, the goal of CORE1, which will enroll up to 35 patients, is to evaluate the safety and efficacy of CG0070 plus KEYTRUDA for the treatment of NMIBC unresponsive to BCG.

More information about the study can be found at www.clinicaltrials.gov (NCT04387461).

Details of the oral presentation are as follows:

CORE1: Phase 2, Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
Abstract Number: 955
Presenter: Roger Li, M.D., Moffitt Cancer Center
Session Date & Time: Saturday, November 13, 2021 from 12:15-12:30pm EST
Category: Late-Breaking Oral Abstract Session

In addition, CG Oncology will present an overview of trial design and methodology of BOND3, an ongoing global Phase 3 trial with CG0070 as a monotherapy for the treatment of patients with NMIBC unresponsive to BCG. The goal of BOND3, which will enroll 110 patients, is to evaluate the safety and efficacy of CG0070 as a monotherapy for the treatment of NMIBC unresponsive to BCG.

More information about the study can be found at www.clinicaltrials.gov (NCT04452591).

Details of the poster presentation are as follows:

A phase 3, single-arm study of CG0070 in subjects with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG)
Abstract Number: 426
Presenter: Edward Uchio, M.D., UC Irvine Health, Department of Urology
Session Date & Time: Friday, November 12, 2021 and Saturday, November 13, 2021 from 7:00am-8:30pm EST
Category: Poster Abstract Session

Full abstracts of both presentations will be available on the SITC (Free SITC Whitepaper) website on November 10, 2021.

On October 12, 2021 4D pharma plc (AIM: DDDD, NASDAQ, LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported that 4D management will present at the Jefferies Virtual Next Generation IBD Therapeutics Summit being held on October 19, 2021 (Press release, 4d Pharma, OCT 12, 2021, View Source [SID1234591114]).

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A webcast of the presentation will be available on the ‘Events’ section of the 4D pharma website at www.4dpharmaplc.com beginning Tuesday, October 19, 2021 at 8:00 a.m. ET (1:00 p.m. BST).

On October 12, 2021 Biognosys, a leader in next-generation proteomics solutions for drug discovery and development, reported that it is supporting Cancer Scout as Proteomics provider (Press release, Biognosys, OCT 12, 2021, View Source [SID1234591113]).

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Cancer Scout is a large-scale joint research project led by University Medical Center Göttingen and Siemens Healthineers. The project received funding of EUR 10 million by the German Federal Ministry of Education and Research (BMBF)1.

The objective of Cancer Scout is to provide a new Artificial Intelligence tool for precision medicine in the fight against cancer. The research project will analyze and combine genomics, proteomics, and pathology data through Artificial Intelligence to generate a "digital biopsy" of molecular changes in tumors. Identifying these molecular changes can support early and accurate cancer diagnosis and predict personalized therapies for a patient’s tumor.

Oliver Rinner, PhD, CEO and founder of Biognosys states: "We are excited to be part of this visionary multi-omics research project and contribute to the development of more personalized clinical diagnostics and therapies for cancer with our proteomics solutions."

Biognosys was selected as the provider for the Proteomics data analysis in Cancer Scout, based on its unique technologies and workflows for large-scale proteomics, comprehensive quality standards for clinical research, and extensive expertise in precision oncology.

Biognosys’ discovery proteomics platform utilizes proprietary, patented Hyper Reaction Monitoring (HRM) mass spectrometry technology to quantify complete proteomes with unmatched precision, depth, and reproducibility. This solution can be applied with high throughput in large-scale studies involving thousands of samples from a broad range of clinical sample types.

Professor Philipp Ströbel, Director of Pathology at the University Hospital Göttingen, comments: "Combining digital pathology with proteomics and other omics data is essential to identify the full spectrum of molecular changes in tumors and enable truly personalized cancer care."

Christian Wolfrum, Head of New Business Development and Planning at Siemens Healthineers, adds: "We are excited to work with Biognosys to generate novel scientific insights in Cancer Scout and translate these into personalized cancer care solutions for clinical practice."

On October 12, 2021 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported it will host a webcast and conference call to discuss corporate updates and financial results for its second fiscal quarter 2021, ended September 30, 2021 (Press release, Myovant Sciences, OCT 12, 2021, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-host-second-fiscal-quarter-2021-earnings [SID1234591112]). The webcast and conference call will be held at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time on October 26, 2021.

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Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S.

A replay of the webcast, along with the earnings press release and presentation materials, will be archived on Myovant’s investor relations website.

On October 12, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported it has triggered the first development milestone payment under its global licensing agreement with Bristol Myers Squibb for AGEN1777, an Fc-enhanced bispecific anti-TIGIT antibody (Press release, Agenus, OCT 12, 2021, View Source [SID1234591111]). Agenus will receive a $20 million cash payment with the dosing of the first patient.

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"AGEN1777 represents Agenus’ latest innovation to activate the immune system against cancer and combat therapeutic resistance, as well as our fifth pharmaceutical collaboration to reach clinical development," said Steven O’Day, MD, Chief Medical Officer of Agenus. "With AGEN1777’s unique mechanism of action and Bristol Myers Squibb’s immuno-oncology expertise, our goal is to efficiently evaluate AGEN1777’s benefit in difficult to treat tumors."

This Phase 1 dose escalation study is designed to evaluate the safety, tolerability, and preliminary clinical activity of AGEN1777 as a single agent and in combination with a PD-1 inhibitor in patients with advanced solid tumors. The first patient was treated at Providence Cancer Institute by Dr. Rachel Sanborn. The trial will follow a standard dose-escalation design and will be used to establish the recommended Phase 2 dose (RP2D).

Bristol Myers Squibb intends to advance the research and development of AGEN1777 in immuno-oncology for high priority tumor indications including non-small cell lung cancer.

The global license agreement with Bristol Myers Squibb included a $200 million upfront payment paid in July 2021, and up to $1.36 billion in development, regulatory and commercial milestones in addition to tiered double-digit royalties on net product sales. Bristol Myers Squibb is solely responsible for the development and commercialization of AGEN1777 and its related products worldwide. Agenus retains options to conduct clinical studies under the development plan, to conduct combination studies with certain other Agenus pipeline assets, to co-fund global development for increased US royalties, and to co-promote AGEN1777 in the US upon commercialization.

About AGEN1777
AGEN1777 is a potentially first-in-class bispecific anti-TIGIT antibody engineered with an enhanced Fc region for high binding affinity and improved T and NK cell activation.