Turning Point Therapeutics Announces New Preclinical Data for Three Drug Candidates

On April 9, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported new preclinical data supporting the ongoing development of three of its drug candidates, repotrectinib, TPX-0022 and TPX-0131 (Press release, Turning Point Therapeutics, APR 9, 2021, View Source [SID1234577798]). The findings will be presented this weekend at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, which is convening virtually through April 14.

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For lead drug candidate, repotrectinib, poster presentations will highlight new preclinical combination data with MEK and MEK/Raf inhibitors, as well as repotrectinib’s potency against wildtype and mutant TRKA/B/C as compared to approved TRK inhibitors. The preclinical studies found that repotrectinib combinations with approved MEK inhibitor, trametinib, or investigational MEK/Raf inhibitor, VS-6766, were more effective than single-agent treatment in patient-derived KRAS mutant G12D/V lung and G12D/V/R pancreatic cancer models. Based on the findings and additional preclinical support presented previously, Turning Point anticipates the first cohort of its planned Phase 1/2 TRIDENT-2 study will examine the safety, tolerability, pharmacokinetics, and any early signals of efficacy of repotrectinib in combination with trametinib in patients with KRAS mutant G12D advanced solid tumors.

"We are encouraged by the new preclinical data our research team has generated in support of our ongoing development of repotrectinib, TPX-0022 and TPX-0131," said Athena Countouriotis, M.D., president and CEO. "In particular, our preclinical models continue to suggest that the combination of repotrectinib with MEK inhibitors can suppress mutant KRAS signaling to achieve more potent and durable anti-tumor activity. We look forward to studying this further in the first cohort of our planned TRIDENT-2 combination study.

"In addition, preclinical studies show repotrectinib is highly potent against wild type TRK fusions and is less affected by NTRK resistance mutations than approved therapies, with strong potency in both in vitro and in vivo studies. We look forward to sharing additional clinical data from our TRIDENT-1 study of repotrectinib in the second half of the year."

TPX-0022, MET, SRC, CSF1R Inhibitor
For MET/SRC/CSF1R inhibitor TPX-0022, the company will present preclinical data demonstrating potential utility in combination with immune checkpoint inhibitors. In a syngeneic xenograft tumor model, TPX-0022 treatment downregulated immunosuppressive cytokines, increased anti-tumor M1 macrophages, and enriched levels of CD8+ cytotoxic T cells. TPX-0022 had single agent in vivo efficacy and enhanced the efficacy of an anti-PD-1 inhibitor. With the new data, Turning Point is evaluating a potential additional combination study of TPX-0022 and an anti-PD-1 checkpoint inhibitor. In the second half of 2021, the company plans to provide a clinical data update from the Phase 1 dose finding portion of its ongoing SHIELD-1 study and initiate its planned Phase 1b/2 SHIELD-2 clinical study of TPX-0022 in combination with an EGFR targeted therapy.

TPX-0131, ALK Inhibitor
For its ALK-inhibitor, TPX-0131, Turning Point will present preclinical data showing its potential to cross the blood-brain barrier and its potency against wild type ALK and a broad spectrum of acquired ALK resistance mutations, including the G1202R solvent front mutation, L1196M gatekeeper mutation, and the G1202R/L1196M and /L1198F compound mutations. Turning Point plans to initiate a Phase 1/2 study in patients with ALK-positive TKI-pretreated advanced non-small cell lung cancer in the second quarter of 2021.

AACR plans to make poster presentations available via its website on Saturday, April 10. The four posters to be presented are:

Title: Repotrectinib increases effectiveness of MEK inhibitors in KRAS mutant cancer models
Abstract Number: 1104

Title: Molecular characteristics of repotrectinib that enable potent inhibition of TRK fusion proteins and broad mutant selectivity
Abstract Number: 1119

Title: TPX-0022, a potent MET/SRC/CSF1R inhibitor that modulates the tumor immune microenvironment in preclinical models
Abstract Number: 1444

Title: TPX-0131, a potent inhibitor of wild type ALK and a broad spectrum of both single and compound ALK resistance mutations
Abstract Number: 1469

IntelGenx Announces Intention to Amend Convertible Unsecured Promissory Notes

On April 9, 2021 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQB:IGXT) ("IntelGenx"), a leader in pharmaceutical films, reported that it is proposing to amend the terms of its 6.0% convertible unsecured promissory notes due June 1, 2021, originally issued by private placement on May 8, 2018 (the "Notes"), to (i) extend the maturity date to October 31, 2024, (ii) change the conversion ratio for conversions at the option of the holders of the Notes from 6,250 fully paid and non-assessable shares of common stock for each U.S.$5,000 aggregate principal amount of the Notes then outstanding to 11,363 fully paid and non-assessable shares of common stock for each U.S.$5,000 aggregate principal amount of the Notes then outstanding, effectively representing a reduction of the conversion price from U.S.$0.80 to U.S.$0.44, and (iii) reduce the trigger price for a conversion at the option of IntelGenx from U.S.$1.40 or greater for 20 consecutive trading days to U.S.$0.88 or greater for 20 consecutive trading days (Press release, IntelGenx, APR 9, 2021, View Source(TSX%2DV%3AIGX),date%20to%20October%2031%2C%202024%2C [SID1234577797]). The proposed amendments are subject to approval of the TSX Venture Exchange and holders holding a majority of the aggregate outstanding principal amount of the Notes.

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An aggregate principal amount of U.S.$1,600,000 of Notes is outstanding as of the date hereof.

Moderna to Present at the 20th Annual Needham Virtual Healthcare Conference

On April 9, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported that David Meline, Chief Financial Officer, and Lavina Talukdar, Senior Vice President & Head of Investor Relations, will participate in a fireside chat at the 20th Annual Needham Virtual Healthcare Conference on April 15th, 2021 at 11:45 a.m. ET.

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A live webcast will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for 30 days following the presentation.

aTyr Pharma Presents Preclinical Research Showing Effects of ATYR2810 in Lung and Breast Cancer at the 2021 AACR Virtual Annual Meeting

On April 9, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported two poster presentations at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which is being held virtually April 10 – 15 and May 17 – 21, 2021 (Press release, aTyr Pharma, APR 9, 2021, View Source [SID1234577795]). The full text of the corresponding abstracts is available on the AACR (Free AACR Whitepaper) website. The posters will be available for browsing on the AACR (Free AACR Whitepaper) website starting Saturday April 10 at 8:30 a.m. ET through Monday June 21. The posters will also be available on the aTyr website.

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The posters present findings from preclinical studies, conducted in collaboration with Dr. Arthur M. Mercurio and his lab at the University of Massachusetts Medical School, demonstrating effects of ATYR2810, aTyr’s anti-human Neuropilin-2 (NRP2) / VEGF blocking monoclonal antibody, in solid tumors. In animal models of non-small cell lung cancer, ATYR2810 administered therapeutically as a single agent significantly inhibited tumor growth. When administered in combination with chemotherapy, including either 5-FU or cisplatin, ATYR2810 inhibited tumor growth to a greater extent compared to either chemotherapeutic agent alone. In models of triple-negative breast cancer (TNBC), ATYR2810 administered in combination with widely used anti-cancer therapeutics, including the chemotherapeutic agent cisplatin or the targeted VEGF therapy bevacizumab, increased the anti-tumor effects of each agent. ATYR2810 also down-regulated epithelial-mesenchymal transition genes, which may be a mechanism that mediates its anti-tumor effects.

"The data presented in these posters affirm the therapeutic potential of ATYR2810 for aggressive cancer and provide a compelling rationale for evaluating the efficacy of ATYR2810 in patients," said Dr. Arthur M. Mercurio, Professor and Vice Chair of the Department of Molecular, Cell and Cancer Biology at the University of Massachusetts Medical School and co-author of the posters. "Notably, the ability of this antibody to promote the differentiation of TNBC cells and render them more susceptible to chemotherapy has the potential to be a significant advancement because therapy resistance, which is associated with tumor recurrence and metastasis, is a major challenge for patients with TNBC and other aggressive cancers."

"These findings build upon our preclinical work related to ATYR2810 and strengthen our understanding of blocking VEGF-mediated NRP2 signaling as a potential approach to inhibiting tumor growth," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "Whether as a monotherapy or in combination with other widely used anti-cancer treatments, including chemotherapy or a targeted therapy such as bevacizumab, these findings suggest that ATYR2810 has potential as a therapeutic agent in certain tumors where NRP2 is implicated. We look forward to continuing IND-enabling activities for ATYR2810 to support advancement to clinical trials in cancer in the future."

Details of posters and corresponding abstracts are as follows:

Title: The Neuropilin-2 targeting antibody ATYR2810 inhibits non-small cell lung cancer tumor growth in monotherapy and combination therapy
Authors: Alison G. Barber, Zhiwen Xu, Justin Rahman, Hira Lal Goel, Arthur M. Mercurio, Christoph Burkart, Leslie A. Nangle. aTyr Pharma, San Diego, CA, UMass Medical School, Boston, MA.
Abstract Number: 5247
Session Category: Tumor Biology
Session Title: Human-in-Mouse Models of Human Cancer
Poster Number: LB234
Permanent Abstract Number: LB234
Date and Time: April 10 at 8:30 a.m. ET

Title: A domain-specific antibody to NRP2 down-regulated epithelial-mesenchymal transition genes and enhanced efficacy of standard-of-care therapeutics for aggressive breast cancer
Authors: Zhiwen Xu, Christoph Burkart, Hira Lal Goel, Justin Rahman, Clara Polizzi, Matt Seikkula, Luke Burman, Arthur M. Mercurio, Leslie A. Nangle. aTyr Pharma, San Diego, CA, UMass Medical School, Boston, MA.
Abstract Number: 5316
Session Category: Experimental and Molecular Therapeutics
Session Title: Biological Therapeutic Agents
Poster Number: LB095
Permanent Abstract Number: LB095
Date and Time: April 10 at 8:30 a.m. ET

About ATYR2810

aTyr is developing ATYR2810 as a potential therapeutic for certain aggressive tumors where Neuropilin-2 (NRP2) is implicated. ATYR2810 is a fully humanized monoclonal antibody that is designed to specifically and functionally block the interaction between NRP2 and one of its primary ligands, VEGF. ATYR2810 is the first Investigational New Drug (IND) candidate to arise from aTyr’s in-house research program designing monoclonal antibodies to selectively target the NRP2 receptor and its associated signaling pathways. NRP2 is a cell surface receptor that is highly expressed in certain tumors, in the lymphatic system and on key immune cells implicated in cancer progression. Increased NRP2 expression is associated with worse outcomes in many cancers. Preclinical data suggest that ATYR2810 could be effective against certain types of solid tumors. ATYR2810 is currently undergoing IND-enabling studies.

BIOGEN TO REPORT FIRST QUARTER 2021 FINANCIAL RESULTS APRIL 22, 2021

On April 9, 2021 Biogen Inc. (Nasdaq:BIIB) reported it will report first quarter 2021 financial results Thursday, April 22, 2021, before the financial markets open (Press release, Biogen, APR 9, 2021, View Source [SID1234577794]).

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Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m. ET. To access the live webcast, please go to the investors section of Biogen’s website at View Source Following the live webcast, an archived version of the call will be available on the website.