On September 6, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the Company will host a virtual R&D Day, "Innovations in Oncology: The Science of Trilaciclib", on Thursday, September 15, 2022, from 9:00 a.m. to 11:00 a.m. ET (Press release, G1 Therapeutics, SEP 6, 2022, View Source [SID1234619019]).

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G1 will review the development and expansion strategy for trilaciclib, its innovative investigational therapy to improve the lives and outcomes of people living with cancer. The Company will also present new preclinical data supporting potential of trilaciclib to work synergistically with other anti-cancer therapies. Trilaciclib is currently in clinical trials assessing its myeloprotective and anti-tumor immunomodulatory effects in a range of tumor types and in combination with a variety of treatments, including ADCs and checkpoint inhibitors.

Additionally, the program will feature insights from leading clinicians on the differentiated and broadly applicable immune-based mechanism of action of trilaciclib; the importance of transient CDK4/6 inhibition; and the urgent need to improve treatment options for patients with colorectal cancer:

Shom Goel, B Med Sci, MBBS, FRACP, PhD, Peter MacCallum Cancer Centre, The University of Melbourne
Richard Goldberg, MD, Professor Emeritus and former Director, West Virginia University Cancer Institute (WVUCI)
A webcast of the event can be accessed on the Events & Presentations page of www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

On September 6, 2022 Synaffix B.V. (Synaffix) and Emergence Therapeutics AG ("Emergence") ("the Companies") reported that the Companies have entered into a licensing agreement of up to $360 million, providing Emergence access on a target-specific basis to Synaffix’s proprietary antibody drug conjugate (ADC) technologies comprising GlycoConnect, HydraSpace and SYNtecan E linker-payload (Press release, Synaffix, SEP 6, 2022, View Source [SID1234619018]).

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Under the terms of the agreement, Synaffix will be eligible to receive up to $360 million in upfront and milestone payments plus royalties on commercial sales. The first program will commence at signature, with the option to expand the collaboration to additional targets. The agreement is the result of positive proof of concept data following a successful initial discovery research collaboration between the companies.

Emergence will be responsible for the research, development, manufacturing and commercialization of the ADCs. Synaffix will be responsible for the manufacturing of components that are specifically related to its proprietary technologies.

Jack Elands, Chief Executive Officer of Emergence Therapeutics, commented: "This transaction demonstrates our commitment to the development of our pipeline of first-in-class and/or best-in-class ADCs. Beyond our lead program ETx-22, a next generation Nectin-4 ADC, we are actively advancing further programs to develop treatments for high unmet-need cancers. We are impressed with the Synaffix technology and are pleased to select it as a key component to accelerate our pipeline of ADCs."

Peter van de Sande, Chief Executive Officer of Synaffix, said: "This marks an important milestone for Synaffix as this is the 10th ADC developer who has licensed our innovative ADC technology to develop proprietary ADCs for their own pipeline. By consolidating all essential technologies within Synaffix, we have repeatedly enabled the development of best-in-class and first-in-class ADCs under a single technology license agreement. We are thrilled that Emergence has selected Synaffix as its long-term ADC technology partner and look forward to working closely with Emergence as they build out their portfolio of ADC candidates."

On September 6, 2022 Arsenal Biosciences, Inc. (ArsenalBio), a privately held programmable cell therapy company engineering advanced CAR T therapies for solid tumors, reported the close of a $220 million Series B financing round (Press release, Arsenal Bio, SEP 6, 2022, View Source [SID1234619017]). New investors Softbank Vision Fund 2, Bristol-Myers Squibb Company, Byers Capital, Emerson Collective Investments, Green Sands, Hitachi Ventures, Sixth Street, and others joined existing investors the Parker Institute for Cancer Immunotherapy (PICI), Westlake Village BioPartners, the University of California, San Francisco (UCSF) Foundation Investment Company, Euclidean Capital, Waycross Ventures, and Kleiner Perkins, in supporting the oversubscribed round.

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Proceeds from the financing will help the company expand its programmable cell therapy research activities and grow its pipeline of therapeutic candidates for solid tumor malignancies across a range of cancer indications. The fundraising comes as the company begins planning for clinical trials of its lead program AB-1015, an ovarian cancer candidate for which FDA IND clearance and first patient dosing are targeted for later this year. The company also has candidates in early development for kidney, prostate, and other cancer indications.

"ArsenalBio’s programmable cell therapy technology has shown great promise in preclinical development, giving us confidence that our approach may help address the unmet medical needs of cancer patients, ultimately helping alleviate human suffering," said Ken Drazan, M.D., ArsenalBio’s founder and Chief Executive Officer. "We look forward to entering the clinic so we can more fully understand the promise of our technology in treating ovarian and ultimately other devastating cancers."

Valentin (Vali) Barsan, M.D., investor for SoftBank Investment Advisers and attending pediatric oncology physician at Stanford University School of Medicine, has joined the ArsenalBio Board of Directors. He holds a medical degree from the Baylor College of Medicine and has clinical experience with the use of both FDA-approved as well as investigational CAR T cell therapies in pediatric and adult liquid and solid tumors. In addition to ArsenalBio, he serves on the Board of Directors for Neuron23 and Umoja Biopharma.

"Whereas CAR T-cell therapy has shown remarkable success in hematological malignancies, solid tumors have proven more challenging. Advances in genome engineering technologies such as CRISPR-Cas enable us to perceive mechanisms and develop tools that address T-cell exhaustion and improve memory, retain stemness, and enable persistence. I look forward to working closely with the ArsenalBio team to improve cancer immunotherapy through synthetic and computational biology techniques that will advance our ability to apply these cutting-edge therapies in patient care," said Dr. Barsan.

On September 6, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its highly productive bacterial Mimicry drug discovery platform, reported that it will present two posters on its OncoMimics pipeline at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, which will be held September 9-13 in Paris, France (Press release, Enterome, SEP 6, 2022, View Source [SID1234619016]). The posters will focus on two clinical trials evaluating EO2401 to treat patients with recurrent glioblastoma (ROSALIE) and adrenocortical carcinoma (ACC) and malignant pheochromocytoma/paraganglioma (MPP) (SPENCER).

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Details on Enterome’s poster presentations

ROSALIE study

Title: EO2401 (EO) therapeutic vaccine for patient (pts) with recurrent glioblastoma (GB):

phase 1/2 ROSALIE study

Authors: D. Reardon et al

Abstract number: 1223

Category: CNS tumours

Date: Saturday September 10th , 2022

Key highlights :

EO2401 is safe and well tolerated and generated immune responses in most evaluable patients.
ROSALIE (EOGBM1-18) proof-of-concept data has already shown strong immune responses in combination with an immune checkpoint inhibitor (nivolumab, Opdivo) and an anti-VEGF therapy (bevacizumab, Avastin), for the treatment of patients with first progression/recurrence of glioblastoma.
The addition of standard bevacizumab to the combination of EO2401 plus nivolumab led to an improvement in objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS)
The results of the second part of the study will be presented at ESMO (Free ESMO Whitepaper) Congress.

SPENCER study

Title: EO2401 (EO) therapeutic vaccine for patient (pts) with adrenocortical carcinoma (ACC) and malignant pheochromocytoma/paraganglioma (MPP): phase 1/2 SPENCER study

Authors: E. Baudin et al

Abstract number: 3149

Category: Adrenal cancer

Presenter: Dr. Eric Baudin, Associate Professor and Head of the Endocrine Oncology Unit at Gustave Roussy (Villejuif, France)

Date/Time: Oral Presentation- Monday September 12th, 2022 at 9.40 am CEST

Key highlights:

EO2401 in combination with nivolumab has demonstrated strong immune responses and clinical efficacy in patients with ACC, which was defined retrospectively using a set of clinical parameters.
A randomized Phase 2 trial with an expanded subpopulation of patients with ACC is planned to start in the coming months.
An update on the ongoing expanded study for treatment of patients with MPP will be presented at ESMO (Free ESMO Whitepaper) Congress.

On September 6, 2022 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that management will participate in the H.C. Wainwright 24th Annual Global Investment Conference taking place September 12-14, 2022 (Press release, CymaBay Therapeutics, SEP 6, 2022, https://ir.cymabay.com/news/detail/541/cymabay-therapeutics-to-present-at-the-h-c-wainwright-24th-annual-global-investment-conference [SID1234619015]).

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H.C. Wainwright 24th Annual Global Investment Conference