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Actym Therapeutics Will Present Data at the 2018 Society for Immunotherapy of Cancer (SITC) Annual Meeting

On November 8, 2018 Actym Therapeutics, a privately held biotechnology company focused on therapeutic targeting of intractable immune pathways in the tumor microenvironment, reported that it will be presenting data at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in Washington, D.C. from November 9-11, 2018 (Press release, Actym Therapeutics, NOV 8, 2018, View Source [SID1234530898]). The presentation is titled "STACT-TREX1: A novel tumor-targeting systemically-delivered STING pathway agonist demonstrates robust anti-tumor efficacy in multiple murine cancer models."

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"We look forward to sharing data demonstrating the potent anti-tumor activity of our first-in-class STING pathway agonist therapy, STACT-TREX1, in preclinical models. We are encouraged by the data showing that single-agent treatment with STACT-TREX1 generates tumor antigen-specific CD8+ T cell responses, suggesting induction of adaptive anti-tumor immunity after intravenous administration in mice. We believe this mechanism for activating the STING pathway in the tumor microenvironment represents a novel and superior approach for the treatment of cancer," said Dr. Christopher Thanos, President and CEO of Actym Therapeutics.

Details of the presentation are as follows:

Abstract

P235:

STACT-TREX1: A novel tumor-targeting systemically-delivered STING pathway agonist demonstrates robust anti-tumor efficacy in multiple murine cancer models

Date:

November 9, 2018

Location:

Hall E, Walter E. Washington Convention Center

For those unable to attend the conference who would like a copy of the presentation, please send an email request to [email protected]. Please include your name, company, title and phone number. The presentation will be emailed to those making proper requests after November 10, 2018.

Inventiva Announces Poster Presentation on Its YAP/TEAD Inhibitor Program at the EORTC-NCI-AACR Symposium in Dublin

On November 7, 2018 Inventiva reported that it will be presenting a poster on its YAP/TEAD pre-clinical program at the upcoming EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Therapeutics Symposium being held on November 13-16, 2018 in Dublin, Ireland (Press release, Inventiva Pharma, NOV 7, 2018, View Source [SID1234625407]).

The poster to be presented, entitled "Discovery of promising anti-cancer drug combination using YAP-TEAD inhibitors with standard of care treatment in mesothelioma and NSCLC cells", illustrates some of the recent data observed by Inventiva in pre-clinical studies, which suggest that the YAP/TEAD inhibitor molecules being investigated by the Company may have potential as a therapy in the treatment of mesothelioma, Non-Small Cell Lung Cancer (NSCLC) and other cancers.

Inventiva’s YAP/TEAD approach aims at disrupting the formation of the transcriptional complex formed by YAP and TEAD, which are believed to be key players in the oncogenic process as well as in fibrogenesis.

Inventiva has observed that its lead YAP/TEAD inhibitor molecules have prevented the formation of the YAP/TEAD transcriptional complex in vitro and are associated with a reduction of YAP/TEAD target genes expression and anti-proliferative effects in cancer cell lines where proliferation is under the control of the Hippo pathway. The Company has also observed in xenograft and patient-derived xenograft (PDX) mice models that its YAP/TEAD inhibitor molecules exhibited activity both as a stand-alone treatment or in combination with standard of care.

Based on these promising results, the Company plans to finalize the toxicological studies necessary to advance its YAP/TEAD program into Phase I/II clinical development in 2019.

"We have made significant progress in our understanding of the Hippo pathway, which offers exciting potential for the treatment of rare and prevalent cancers," stated Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva. "We have observed that our patented small molecules exhibited activity both as a stand-alone treatment and in combination with standard of care in pre-clinical models. In addition, molecules that inhibit the YAP/TEAD interaction have already shown a potential to overcome drug resistance and tumor escape mechanisms, which makes this pathway particularly interesting. Our program is advancing well and we are looking forward to see it progressing into Investigational New Drug (IND) enabling studies."

The event details for the presentations are as follows:

Poster Title: "Discovery of promising anti-cancer drug combination using YAP-TEAD inhibitors with standard of care treatment in mesothelioma and NSCLC cells"
Session Title: Drug Resistance and Modifiers
Date: Tuesday, November 13th
Time: 10am to 2pm
Location: The Convention Centre, Spencer Dock, North Wall Quay, Dublin, Ireland

Tocagen to Participate in Investor Conferences in November

On November 7, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported that Marty Duvall, chief executive officer, reported that it will present at the following upcoming investor conferences (Press release, Tocagen, NOV 7, 2018, View Source;p=RssLanding&cat=news&id=2375950 [SID1234531165]):

Wednesday, November 14, 11:00-11:40 a.m. ET in New York City
Stifel Nicolaus Healthcare Conference

Tuesday, November 27, 4:35-4:55 p.m. ET in Boston
Evercore ISI Biopharma Catalyst/Deep Dive Conference

The live audio webcasts from the conferences and subsequent replay may be accessed by visiting the "Events & Presentations" page in the investors section of Tocagen’s website. The webcasts will be available shortly after conclusion of the presentation and archived on the company’s website for 90 days following the presentation.

SpringWorks Therapeutics Receives FDA Fast Track Designation for Nirogacestat for the Treatment of Adult Patients with Desmoid Tumors

On November 7, 2018 SpringWorks Therapeutics, a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for nirogacestat, an investigational, oral, small molecule, selective gamma-secretase inhibitor, for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis (Press release, SpringWorks Therapeutics, NOV 7, 2018, View Source [SID1234538851]).

Desmoid tumors are rare and debilitating soft-tissue tumors that can occur in both children and adults. Depending on their size and location, desmoid tumors can cause severe morbidities such as pain, internal bleeding, disfigurement, and limited range-of-motion. In some cases, desmoid tumors can be fatal if they impact vital organs.1 It is estimated that 900 to 1,500 new cases of desmoid tumors are diagnosed each year in the United States.2

"The Fast Track designation recognizes that desmoid tumors have a substantial impact on the lives of patients, and that nirogacestat has the potential to address the significant needs faced by this community who currently do not have an FDA-approved treatment," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. "We look forward to continuing to work closely with the FDA throughout our development program with the hope of ultimately bringing this important medicine to patients."

The FDA’s Fast Track program is designed to expedite the development and review of drugs with the potential to treat serious or life-threatening conditions, and with nonclinical or clinical data that demonstrate the potential to address unmet medical needs. Fast Track designation enables a company to have frequent communication with the FDA throughout the drug development and review process.3

In June 2018, the U.S. FDA granted Orphan Drug designation for nirogacestat for the treatment of desmoid tumors. SpringWorks expects to initiate the DeFi Study, a global Phase 3, double-blind, randomized, placebo-controlled, trial in patients with desmoid tumors in the first half of 2019.

About Desmoid Tumors
Desmoid tumors (also referred to as aggressive fibromatosis or desmoid-type fibromatosis) are rare, non-metastatic tumors of connective tissue cells that can arise in any part of the body, with the most common sites being the upper and lower extremities, abdominal walls, thoracic areas, and the head and neck. The severity of desmoid tumors and associated symptoms varies based on their size and location. Desmoid tumors can cause severe morbidities such as pain, internal bleeding, disfigurement, limited range of motion, and in some cases, fatality if they impact vital organs. While they can affect children and adults, desmoid tumors are more commonly diagnosed in young adults between 20-30 years of age, with a two-to-three-fold predominance in females. 1,4 It is estimated that desmoid tumors affect 2 to 4 per million people worldwide, and that there are 900 to 1,500 new cases diagnosed per year in the United States.2 Historically, desmoid tumors were treated with surgical resection or in severe cases, amputation, but even with these interventions, high rates of tumor regrowth have been observed.5 There are currently no FDA-approved therapies for the treatment of desmoid tumors.

About Nirogacestat
Nirogacestat is an investigational, oral, small molecule, selective gamma-secretase inhibitor. Gamma secretase is an integral membrane protein that cleaves multiple different transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth. Nirogacestat has been investigated in 24 patients with desmoid tumors across Phase 1 and Phase 2 clinical trials.

Alligator Bioscience to receive million-dollar payments – AbClon partner exercises option

On November 7, 2018 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that it will receive payments of more than USD 3.5 million under its collaboration agreement with the South Korean company AbClon Inc. ("AbClon") (Press release, Alligator Bioscience, NOV 7, 2018, View Source [SID1234538674]). This is following the exercising of an option by a third party, Shanghai Henlius Biotech, Inc. ("Henlius"), to expand from a regional to a global agreement.

In October 2016, Henlius signed a license agreement with AbClon, encompassing the intellectual property and commercial rights of the monoclonal HER2 antibody AC101 in China (including Taiwan, Hong Kong and Macao). The two parties have now signed an amendment to the agreement in which Henlius will exercise its option to secure the right to develop and commercialize AC101 globally.

The exercising of this option triggers a payment of USD 10 million (approx. SEK 90 million) from Henlius to AbClon. As Alligator holds an ownership interest in this project, this entitles Alligator to 35 percent of AbClon’s income from the agreement with Henlius. The payment of USD 3.5 million (before foreign tax) to Alligator will be made in two parts, the first half due in 2018 and the second half in H1 2019.