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argenx to Report Third Quarter 2022 Financial Results and Business Update on October 27, 2022

On October 20, 2022 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported that it will host a conference call and audio webcast on Thursday, October 27, 2022 at 2:30 pm CET (8:30 am ET) to discuss its third quarter 2022 financial results and provide a business update (Press release, argenx, OCT 20, 2022, View Source [SID1234622232]).

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A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately one year following the presentation.

Neuren receives US$10 million milestone payment

On October 20, 2022 Neuren Pharmaceuticals (ASX: NEU) reported that it has now received the milestone payment of US$10 million from its US partner Acadia Pharmaceuticals (Nasdaq: ACAD) (Press release, Neuren, OCT 20, 2022, View Source;[email protected] [SID1234622231]). The payment was due following the US Food and Drug Administration (FDA) acceptance for review of Acadia’s New Drug Application (NDA) of trofinetide for the treatment of Rett syndrome. The FDA granted a Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) action date of 12 March 2023.

Acadia has exclusive rights to develop and commercialize trofinetide in North America. Neuren retains all rights to trofinetide for all countries outside North America and has a fully paid-up, irrevocable licence for use in those countries to all data generated by Acadia. The development and commercialisation of trofinetide in North America is fully funded by Acadia.

If the NDA is approved by the FDA, the next potential milestone payment to Neuren would be US$40 million (A$62 million at an assumed exchange rate of 0.65), payable following the first commercial sale of trofinetide in the United States. Subsequently, Neuren is eligible to receive double-digit percentage royalties on net sales of trofinetide in North America, plus milestone payments of up to US$350 million (A$538 million) on achievement of a series of four thresholds of total annual net sales, plus one third of the market value of a Rare Pediatric Disease Priority Review Voucher if awarded by the FDA upon approval of the NDA, with the one third share estimated by Neuren as US$33 million (A$51 million).

Cerus Corporation to Release Third Quarter 2022 Financial Results on November 3, 2022

On October 20, 2022 Cerus Corporation (Nasdaq: CERS) reported that its third quarter 2022 financial results will be released on Thursday, November 3, 2022, after the close of the stock market (Press release, Cerus, OCT 20, 2022, View Source [SID1234622230]). The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Participants may register for the call here. While not required, interested participants are encouraged to join 10 minutes prior to the start of the event.

A replay will be available on Cerus’ website and will be available approximately three hours after the call through November 17, 2022.

Ashvattha Therapeutics Announces the Appointment of Steve Maricich, M.D., Ph.D. as Chief Medical Officer

On October 20, 2022 Ashvattha Therapeutics ("Ashvattha"), a clinical-stage company developing novel hydroxyl dendrimer therapeutics (HDTs), reported that Steve Maricich, M.D., Ph.D., joined the company as chief medical officer (Press release, Ashvattha Therapeutics, OCT 20, 2022, View Source [SID1234622229]). Dr. Maricich joins Ashvattha as a seasoned clinical development physician and translational scientist with more than 15 years of industry and academic experience that includes working with small molecules, biologics, cell and gene therapies across multiple therapeutic areas including cancer, GI disease, hematology, neurology, and rare disease.

"We are thrilled to welcome Dr. Maricich to our senior management team," said Jeff Cleland, Ph.D., chairman and CEO of Ashvattha. "He joins at a pivotal time for the company as we prepare to initiate clinical trials of our neurology hydroxyl dendrimer candidates next year. His neurology background and expertise advancing preclinical programs to clinical development will be a major asset to our team and the growth of the company."

Dr. Maricich added, "I am excited to join Ashvattha, and I look forward to working with the team to unlock the full potential of the hydroxyl dendrimer platform. To date, attempts to deliver drugs to the brain via systemic administration have not translated to the clinic. I believe that HDTs represent a new precision medicine approach that transcends tissue barriers and possesses the ability to change the standard of care across a number of disease indications."

Dr. Maricich joins Ashvattha from Calibr and Scripps BioVentures, where he served as the chief medical officer. There, he oversaw the development of clinical-stage oncology and GI programs and designed clinical paths for preclinical programs across a wide range of indications. Dr. Maricich’s previous experience includes the CMO role at Allievex, a rare disease start-up company that he helped spin out of BioMarin Pharmaceuticals. Over the course of his career, Dr. Maricich has secured more than $2M in grant funding from the NIH and other privately operated organizations. Dr. Maricich earned his M.D. and Ph.D. degrees in neuroscience from Case Western Reserve University. He is a board-certified child neurologist with experience as a primary investigator while serving as pediatrics and child neurology faculty at Baylor College of Medicine/Texas Children’s Hospital, Case Western Reserve University/Rainbow Babies and Children’s Hospital, and the University of Pittsburgh/UPMC Children’s Hospital of Pittsburgh.

Erasca Announces Clinical Trial Collaboration and Supply Agreement with Pfizer to Evaluate ERAS-007 and Palbociclib Combination

On October 20, 2022 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported a clinical trial collaboration and supply agreement (CTCSA) with Pfizer Inc. (NYSE: PFE) for the CDK4/6 inhibitor palbociclib (IBRANCE) (Press release, Erasca, OCT 20, 2022, View Source [SID1234622228]).

This agreement will support a clinical proof-of-concept study evaluating ERAS-007, an oral ERK1/2 inhibitor, in combination with palbociclib for the treatment of patients with KRAS- and NRAS-mutant colorectal cancer (CRC) and KRAS-mutant pancreatic ductal adenocarcinoma (PDAC). The combination is currently being investigated as part of the ongoing Phase 1b/2 HERKULES-3 master protocol clinical trial in patients with gastrointestinal (GI) malignancies. Erasca is sponsoring the study, and Pfizer is supplying palbociclib at no cost.

"We are excited to expand our existing relationship with Pfizer to explore ERAS-007 in combination with palbociclib in RAS-mutated GI malignancies as part of our HERKULES-3 program," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Preclinical evidence supports synergistic anti-tumor effects when downstream RAS/MAPK pathway inhibition is combined with cell cycle inhibition in CRC and PDAC. ERAS-007 blocks RAS/MAPK pathway signaling at the terminal node with robust inhibitory activity across RAS mutations, while data support palbociclib inhibition of CDK4/6 leading to cell cycle arrest. Based on their respective mechanisms of action, ERAS-007 and palbociclib offer a promising combination to overcome adaptive resistance in patients with these highly prevalent oncogenic drivers."

Worldwide, approximately 1.8 million cases of CRC are diagnosed annually, with about 50% of patients harboring KRAS or NRAS mutations. PDAC accounts for an estimated 0.5 million new cases diagnosed annually, with over 90% harboring a KRAS mutation. Lack of effective treatment availability and emergence of compensatory mechanisms of resistance continue to challenge the ability to achieve and maintain responses in these GI malignancies. Erasca is exploring whether inhibiting ERK1/2, the terminal node of the RAS/MAPK signaling pathway, in combination with palbociclib can limit the development of treatment resistance and further improve therapeutic benefits.

About ERAS-007
ERAS-007 is a potential best-in-class ERK1/2 inhibitor being investigated alone or in combination with different inhibitors targeting upstream nodes of the RAS/MAPK pathway as part of Erasca’s MAPKlamp strategy. The extracellular signal-regulated kinases (ERK), ERK1 and ERK2, belong to a family of serine-threonine kinases that regulate cellular signaling and comprise the terminal node of the RAS/MAPK pathway. ERAS-007 is being investigated across a series of HERKULES clinical trials that span multiple tumor types and include both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, RAF, and/or cell cycle inhibitors. HERKULES-1 is a Phase 1b/2 clinical trial for ERAS-007 as a single agent and in combination with the SHP2 inhibitor ERAS-601 (together, Erasca’s first MAPKlamp) in advanced solid tumors. HERKULES-2 is a Phase 1b/2 master protocol clinical trial for ERAS-007 in combination with various agents in patients with non-small cell lung cancer (NSCLC). HERKULES-3 is a Phase 1b/2 master protocol clinical trial for ERAS-007 in combination with various agents in patients with GI cancers.