Applied BioMath, LLC Announces Collaboration with Verseau Therapeutics for System Pharmacology Modeling in Oncology

On August 3, 2020 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported their collaboration with Verseau Therapeutics for the development and delivery of a systems pharmacology model that will be used for efficacious dose prediction for the treatment of cancer (Press release, Applied BioMath, AUG 3, 2020, View Source [SID1234562730]).

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"We previously collaborated with Applied BioMath to evaluate the therapeutic feasibility of a series of assets," said Dr. Tatiana Novobrantseva, Co-founder and Chief Scientific Officer of Verseau Therapeutics. "We look forward to extending this collaboration to predict an efficacious dose for one of our lead macrophage checkpoint inhibitor programs. The intersections between mathematical models and experimental drug development will yield more translatable experiments and better-informed clinical trials."

Applied BioMath employs a rigorous fit-for-purpose model development process which aims to quantitatively integrate knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "The mechanistic nature of our systems modeling is ideal for using available data to evaluate Pharmacokinetic (PK)/Pharmacodynamic (PD) relationships when predicting efficacious dose," said Dr. John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "This allows project teams to make more informed decisions as they head into IND."

Melanoma Research Alliance Hails FDA’s First ‘Triplet’ Combination Approval for Melanoma

On August 3, 2020 The Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research worldwide, reported that welcomes the decision by the U.S. Food and Drug Administration (FDA) approving Genentech’s Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients (Press release, Melanoma Research Alliance, AUG 3, 2020, View Source [SID1234562729]).

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The newly approved triplet treatment is the first FDA-approved combination for metastatic melanoma that brings together immunotherapy with targeted therapies. Tecentriq, an immunotherapy, works by releasing the brakes on the immune system allowing it to attack cancerous cells. Cotellic and Zelboraf are targeted therapies that shut down specific pathways used by cancer to grow. Mutated copies of the BRAF V600 protein are found in about half of all melanomas.

"The approval of Tecentriq + Cotellic and Zelboraf marks the 13th new treatment approach approved for melanoma since 2011 and the first that combines checkpoint immunotherapy with BRAF/MEK inhibition," said Michael Kaplan, MRA President and CEO. "This is a huge step forward for patients with BRAF-mutant melanoma and provides even more options to treat their disease."

The FDA approval for Tecentriq + Cotellic and Zelboraf is based on results from the Phase 3 IMSpire 150 study. In the study, the triplet combination of Tecentriq + Cotellic and Zelboraf was compared to placebo + Cotellic and Zelboraf among patients with advanced BRAF-mutant melanoma. In data published June 13, 2020 by The Lancet, the triplet combination helped people live longer without their disease worsening (median PFS 15.1 months versus 10.6 months respectively). Rates of treatment related adverse events were similar between the two groups.

"This approval demonstrates the innovative spirit within the melanoma research community," says Dr. Marc Hurlbert, MRA Chief Science Officer. "It is the first of numerous combinations being studied that bring together checkpoint immunotherapy with targeted kinase therapies in the melanoma field’s pursuit to improve patient outcomes."

Melanoma is the deadliest form of skin cancer and rates have increased over the last three decades. More than 100,000 people in the United States will be diagnosed with melanoma this year alone. Despite incredible advances in melanoma research over the last decade that have supported the approval of 13 new treatment approaches, further advances are needed to fully eliminate suffering and death related to the disease.

Eagle Pharmaceuticals to Discuss Second Quarter 2020 Financial Results on August 10, 2020

On August 3, 2020 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported that the Company will release its 2020 second quarter financial results on Monday, August 10, 2020, before the market opens (Press release, Eagle Pharmaceuticals, AUG 3, 2020, View Source [SID1234562728]).

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Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a conference call to discuss the results as follows:

Date

Monday, August 10, 2020

Time

8:30 a.m. ET

Toll free (U.S.)

877-876-9173

International

785-424-1667

Webcast (live and replay)

www.eagleus.com, under the "Investor Relations" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-4014 (US) or 402-220-2983 (International) and entering conference call ID EGRXQ220. The webcast will be archived for 30 days at the aforementioned URL.

Kezar Life Sciences to Participate in Two Upcoming Virtual Investor Conferences

On August 3, 2020 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing novel small molecule therapeutics to treat unmet needs in autoimmunity and cancer, reported members of the executive team will present during upcoming virtual investor conferences (Press release, Kezar Life Sciences, AUG 3, 2020, View Source [SID1234562727]). The details of the presentations are as follows:

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William Blair Virtual BioTech Conference
Panel Session: Advancements in Renal Disease: Thursday, August 6, 2020 at 3:00pm EDT
Presenter: Noreen Henig, MD, Chief Medical Officer

BTIG Virtual Biotechnology Conference 2020
Presentation: Tuesday, August 11, 2020 at 1:30pm EDT
Presenter: John Fowler, Chief Executive Officer

The panel and presentation will be webcast live and may be accessed on the "Events & Presentations" section of the Company’s website at View Source Kezar Life Sciences will maintain an archived replay of the webcasts on its website for 90 days after the conference.

AngioDynamics to Participate in a Virtual Fireside Chat at the Canaccord Genuity Growth Conference

On August 3, 2020 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that Jim Clemmer, President and Chief Executive Officer, will participate in a virtual fireside chat at the 40th Annual Canaccord Genuity Growth Conference at 1:30 p.m. ET on Wednesday, August 12, 2020 (Press release, AngioDynamics, AUG 3, 2020, View Source [SID1234562726]).

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A live webcast of the fireside chat will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.