Alentis Therapeutics Names Roberto Iacone CEO

On July 29, 2020 Alentis Therapeutics, the Swiss biotech developing breakthrough treatments for fibrotic diseases, reported that Dr. Roberto Iacone has been named Chief Executive Officer (Press release, Alentis Therapeutics, JUL 29, 2020, View Source [SID1234562520]).

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Dr. Iacone is a physician-scientist, a serial entrepreneur and brings more than 15 years life science industry experience to Alentis. Most recently while at Versant Ventures, he co-founded Bright Peak Therapeutics and Ridgeline Therapeutics, and was part of the leadership team that built the precision oncology company Black Diamond Therapeutics from inception through to its NASDAQ IPO in three years. Prior to Versant, Roberto was Roche’s Global Head of Rare Diseases Research, where he established numerous collaborations with academic and biotech partners, which included large and small molecule as well as gene therapy programs.

Welcoming Dr. Iacone to the company, Neil Goldsmith, Chairman of the Board of Alentis Therapeutics, said: "Alentis has developed significantly in our first year, with excellent progress in our understanding of the role of Claudin-1 as a novel therapeutic target in fibrosis and hepatobiliary cancers. We have taken major strides in Chemistry and Manufacturing Control (CMC) for our first product, and its safety profile appears very encouraging from the pilot studies conducted to date. We are delighted that Roberto has decided to join our cause, and look forward to further great strides from him and the team. We also would like to thank former CEO Markus Ewert for his fantastic work building the company, portfolio and team."

"We’re very excited that Roberto has joined us to lead the team as the company moves to the next level in its development," said Thomas F. Baumert MD, founder and board member of Alentis Therapeutics, Professor of Medicine and Head of the Inserm Research Institute for Viral and Liver Diseases at the University of Strasbourg. "His entrepreneurial thinking and leadership experience will rapidly advance the Alentis portfolio into the clinic addressing key unmet medical needs to improve patients’ lives and outcomes."

"The recent advances in science enable novel therapies to treat and reverse fibrosis, which is central to multiple diseases as well as several life-threatening cancers such as hepatocellular carcinoma and cholangiocarcinoma," said Dr. Iacone. "Alentis has developed a tremendous portfolio and platform to develop breakthrough treatments for fibrotic diseases."

He added that following the foundation of the company one year ago, the development of Alentis’ lead compound has markedly advanced with completed preclinical in vivo proof-of-concept studies for liver and kidney fibrosis, fibrosis-driven hepatobiliary cancer and extensive safety studies.

"As we now transition towards a clinical-stage company, I look forward to working with the team and board, our collaborators, and the investors, to realise the potential benefit for patients," said Dr. Iacone.

"Roberto’s expertise in developing drugs in biotech, pharma and VC will be most valuable in effectively translating Alentis Therapeutics’ most promising research and its assets into clinical benefit for patients as well as commercial value," said Dr. A. Wallnöfer, General Partner at BioMed Partners VC and former Head of Clinical Research & Exploratory Development at F. Hoffmann-La Roche.

Roberto holds an M.D. from the University of Naples, and a PhD from the Max Planck Research School for Molecular Cell Biology and Genetics.

Deciphera Pharmaceuticals, Inc. to Announce Second Quarter 2020 Financial Results and Host Conference Call and Webcast on August 4, 2020

On July 29, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported that it will report its second quarter 2020 financial results on Tuesday, August 4, 2020 (Press release, Deciphera Pharmaceuticals, JUL 29, 2020, View Source [SID1234562519]).

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In connection with the earnings release, Deciphera’s management team will host a live conference call and webcast at 4:30 PM ET on Tuesday, August 4, 2020, to discuss the Company’s financial results and provide a corporate update.

The conference call may be accessed by dialing (866) 930-5479 (domestic) or (409) 216-0603 (international) and referring to conference ID 3769662. A webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source The archived webcast will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

Repare Therapeutics Announces Dosing of First Patient in Phase 1/2 Clinical Trial of RP-3500

On July 29, 2020 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported the first patient has been dosed in the Phase 1/2 clinical trial of RP-3500, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of solid tumors with specific genome instability-related genomic alterations including those in ATM gene (ataxia teleangectasia mutated kinase) (Press release, Repare Therapeutics, JUL 29, 2020, View Source [SID1234562518]). The multi-center trial will enroll patients with advanced solid tumors of any histology that harbor gene alterations that suggest sensitivity to ATR inhibition as discovered by Repare’s proprietary SNIPRx platform. Dosing follows acceptance by the U.S. Food and Drug Administration (FDA) of the Company’s investigational new drug (IND) application earlier this month.

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"The TRESR (Treatment Enabled by SNIPRx) study of RP-3500 as a monotherapy or in combination with talazoparib is a promising targeted approach for a range of difficult-to-treat cancers in patients with tumors harboring genetic alterations we have identified and we believe could predict response," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "The RP-3500 development plan reflects our strategy to develop differentiated oncology treatments in highly targeted tumors."

The Phase 1/2 clinical trial is a multi-center, open-label, dose-escalation and expansion trial that is expected to enroll approximately 230 patients with advanced solid tumors of any histology that harbor gene alterations determined pre-clinically to suggest sensitivity to RP-3500 alone or in combination with the PARP inhibitor, talazoparib. The primary outcome measure in the Phase 1 part of the study will be an assessment of safety and tolerability and determination of a dose for the Phase 2 portion of the trial. The Phase 2 monotherapy portion of the trial is expected to further evaluate the efficacy of RP-3500 in biomarker-selected tumors. Additional objectives include assessments of anti-tumor activity, pharmacokinetics (PK), pharmacodynamics (PD) and confirmation of the predictive biomarkers. The first patient dosing took place at The University of Texas MD Anderson Cancer Center ("MDACC") under the direction of the principal investigator Timothy Yap, M.D., Ph.D., Associate Professor in the Department of Investigational Cancer Therapeutics at MDACC. Additional centers in the United States, Canada, and Europe are anticipated to be opened in the near-term for patient recruitment.

RP-3500 has shown substantial anti-tumor activity in multiple preclinical models of solid tumors at doses below the maximum tolerated dose. In preclinical studies, sustained responses were associated with the presence of specific molecular alterations that will be tested in clinical studies. RP-3500 has also shown pre-clinical anti-tumor activity in combination with several PARP inhibitors in the presence of specifically identified genetic alterations. Repare selected talazoparib to test in combination with RP-3500 in collaboration with Pfizer. Talazoparib is being provided by Pfizer to Repare for the purposes of the clinical trial.

About Repare’s SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those patients most likely to achieve clinical benefit from resulting product candidates.

MannKind Corporation to Hold 2020 Second Quarter Financial Results Conference Call on August 5, 2020

On July 29, 2020 MannKind Corporation (NASDAQ:MNKD) reported that it will release its 2020 second quarter financial results and its management will host a conference call to discuss the financial results and corporate updates at 5:00 PM (Eastern Time) on Wednesday, August 5, 2020 (Press release, Mannkind, JUL 29, 2020, View Source [SID1234562517]).

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Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder.

Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under News & Events.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 7888638#. A replay will also be available on MannKind’s website for 14 days.

Salarius Announces Proposed Public Offering of Common Stock

On July 29, 2020 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting cancers caused by dysregulated gene expression, reported that it has commenced an underwritten public offering of shares of its common stock (Press release, Salarius Pharmaceuticals, JUL 29, 2020, View Source [SID1234562515]). All of the shares are being offered by Salarius. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Ladenburg Thalmann & Co. Inc. is acting as sole book-running manager in connection with the public offering.

A shelf registration statement on Form S-3 (File No. 333-231010) relating to the shares was filed with the Securities and Exchange Commission (the "SEC") and was declared effective by the SEC on May 17, 2019. A copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained be obtained at the SEC’s website at www.sec.gov or from Ladenburg Thalmann & Co. Inc., Attn: Prospectus Department, 277 Park Avenue, 26th Floor, New York, New York 10172, by calling (212) 409-2000.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.