Revolution Medicines Announces Dosing of First Patient in Phase 1/1b Clinical Study of RMC-5552 in Patients with Advanced Solid Tumors

On April 21, 2021 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage precision oncology company focused on developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, reported dosing of the first patient in a multicenter Phase 1/1b clinical trial evaluating RMC-5552, the company’s investigational first-in-class bi-steric mTORC1 inhibitor as a monotherapy (Press release, Revolution Medicines, APR 21, 2021, View Source [SID1234578301]). The trial is an open-label dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of RMC-5552 in patients with advanced relapsed/refractory solid tumors. Results from this study will inform Revolution Medicines’ identification of the maximum tolerated dose (MTD) and selection of recommended Phase 2 dose and schedule (RP2DS) for further evaluation of the compound.

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RMC-5552 is a potent and selective inhibitor of mTORC1 that is being developed as an anticancer therapeutic for patients with solid tumors that have hyperactivation of the mTOR pathway, including certain RAS-addicted cancers. The compound is designed to inhibit mTORC1 and preserve the natural tumor suppressive activity of 4EBP1, without the undesired inhibition of mTORC2. RMC-5552 has demonstrated antitumor activity in a wide variety of preclinical models. Revolution Medicines has also reported in vivo data demonstrating that RMC-5552 may increase antitumor activity in combination with KRASG12C inhibitors in lung and colon cancers harboring KRAS mutations and co-mutations in the mTOR signaling pathway that can cause resistance to single agent RAS inhibition.

"The initiation of the RMC-5552 clinical program is the first step in the evaluation of our first-in-class, bi-steric mTORC1 inhibitor as a RAS Companion Inhibitor for the treatment of tumors driven by co-occurring RAS mutations and genomic activation of the mTORC1 pathway, which account for a significant proportion of RAS-addicted cancers," said Steve Kelsey, M.D., president, research and development at Revolution Medicines. "These co-occurring mutations may contribute to resistance to single-agent RAS inhibitors, and the potential to add RMC-5552 to RAS-directed therapies aligns nicely with our strategy of developing rational, biomarker-driven drug combinations that can achieve maximum clinical benefit in patients with RAS-driven cancers. We also look forward to evaluating RMC-5552 in selected indications where mTORC1 is activated independently of RAS."

New Patent Issuance for RMC-5552 and Related Compounds

In additional news regarding the RMC-5552 program, Revolution Medicines reported that the United States Patent and Trademark Office has issued U.S. Patent No. 10,980,889. This patent provides, in part, composition of matter protection for RMC-5552, as well as related compounds in the company’s proprietary series of selective mTORC1 inhibitors.

About mTORC1

The mTOR Complex 1 (mTORC1) is a central node within the mTOR signaling pathway and a critical regulator of metabolism, growth and proliferation in cancer cells. Oncogenic mutations of genes upstream of mTOR, including PI3 kinase, PTEN, and STK11, can drive abnormal activation of mTORC1 and subsequent inactivation of the tumor suppressor 4EBP1. Selective inhibition of mTORC1 to reactivate 4EBP1 is a potential therapeutic strategy for patients with tumors bearing such mutations. These mutations are often co-occurring with RAS mutations in RAS-addicted tumors and combinations of mTORC1 and RAS-targeted inhibitors may be of particular benefit in this context.

Clovis Oncology to Announce First Quarter 2021 Financial Results and Host Webcast Conference Call on May 5

On April 21, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that its first quarter 2021 financial results on Wednesday, May 5, 2021, before the open of the US financial markets (Press release, Clovis Oncology, APR 21, 2021, View Source [SID1234578300]). Clovis’ senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the Company’s results in greater detail.

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The conference call will be simultaneously webcast on the Clovis Oncology website www.clovisoncology.com, and a replay of the webcast will be available for 30 days.

Dial-in numbers for the conference call are as follows: US participants 877.698.7048 International participants 647.689.5448, conference ID: 3219208.

Biovaxys Assigned BVAXF By Finra As New Us OTC Trading Symbol

On April 21, 2021 BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB, OTC:BVAXF) ("BioVaxys"), the world leader in haptenized antigen vaccines for antiviral and cancer applications, reported that effective today it has been assigned a new US OTC trading symbol of BVAXF (Press release, BioVaxys Technology, APR 21, 2021, View Source [SID1234578298]). This replaces the prior US OTC trading symbol of LMNGF.

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BioVaxys has also applied for a OTCQB listing and anticipates approval in the upcoming weeks. The OTCQB is the mid-tier OTC equity market, which lists primarily early-stage and developing companies in the U.S. and international markets. OTCQB companies must meet certain minimum reporting standards, pass a bid test, and undergo annual verification.

Vaccibody 2020 Annual Report

On April 21, 2021 Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported that the Board of Directors has approved the Company’s financial statements for 2020 (Press release, Vaccibody, APR 21, 2021, View Source [SID1234578297]).

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The Company’s annual accounts for the financial year 2020, including the financial statements and annual report, are together with the auditor’s report attached to this announcement. Vaccibody’s annual report 2020 contains the first annual accounts where the financial statements have been prepared in accordance with IFRS (International Financial Reporting Standards). The financial statements are presented in United States dollar (USD). The annual report 2020 is also available at the Company’s website, View Source

Nissan Chemical and Modulus Discovery Jointly Announce Signing of Strategic Drug Discovery Collaboration Agreement

On April 21, 2021 Nissan Chemical Corporation (Head Office: Chuo-ku, Tokyo Japan; President: Shinsuke Yagi, "Nissan Chemical"), and Modulus Discovery, Inc. (Head Office: Chiyoda-ku, Tokyo Japan; CEO: S. Roy Kimura, Ph.D., "Modulus"), an early stage global biopharmaceutical company, reported the signing of a strategic drug discovery collaboration agreement (Press release, Modulus Discovery, APR 21, 2021, View Source [SID1234578296]). Under this agreement, the companies will collaboratively accelerate the development of novel small molecule drug candidates derived from Modulus’ pipeline of R&D programs leveraging each party’s drug discovery platform and expertise.

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Nissan Chemical has been developing novel medicines through proprietary drug discovery research and drug substance development functions, and has built a track record of multiple drug candidate out-licensing deals and market approvals of innovative medicines. Modulus is a preclinical-stage technology-driven drug discovery firm leveraging its cutting-edge computational technology, accumulated disease biology insights, and a networked operational platform that enables accelerated and efficient identification of small molecule drug candidates. Modulus’ proprietary pipeline of programs are focused on chronic inflammatory diseases, oncology, immune disorders, and rare genetic conditions.

This strategic collaboration aims to accelerate several of Modulus’ late-stage discovery programs toward entry into clinical trials through Nissan Chemical’s technology and know-how on drug substance development and manufacturing and sharing of development costs. Nissan Chemical will receive a portion of the profits that Modulus obtains from future licensing deals for these programs.