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Exicure Granted Orphan Drug Designation by the U.S. Food and Drug Administration for Cavrotolimod

On March 3, 2021 Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its clinical product candidate, cavrotolimod (AST-008), for the treatment of patients with Merkel cell carcinoma (MCC) (Press release, Exicure, MAR 3, 2021, View Source [SID1234576008]).

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"We are excited to have been granted Orphan Drug Designation by the FDA for cavrotolimod for MCC," said Dr. Douglas Feltner, Chief Medical Officer of Exicure. "This designation marks significant progress toward our goal of fulfilling the unmet medical need and finding a treatment for Merkel cell carcinoma patients."

Exicure previously announced that the FDA granted two Fast Track designations for cavrotolimod (AST-008) for MCC and cutaneous squamous cell carcinoma (CSCC), both in the advanced/metastatic setting after progression on anti-PD-1/PD-L1 antibodies.

About Orphan Drug Designation

Orphan Drug Designation is a designation granted by the FDA which provides orphan status to drugs or biologics which are intended to treat rare diseases or disorders that affect fewer than 200,000 people in the United States. This designation provides the sponsor of the drug certain incentives, including tax credits for qualified clinical trials and fee waivers. Orphan Drug Designation confers eligibility for seven years of market exclusivity to an orphan drug post-approval, subject to a receipt by the FDA of marketing approval.

About Cavrotolimod (AST-008)

Cavrotolimod (AST-008) is an SNA consisting of toll-like receptor 9 agonists designed for immuno-oncology applications. In December 2019, Exicure announced preliminary results from the Phase 1b stage of the clinical trial including potential signs of anti-tumor activity with cavrotolimod in combination with pembrolizumab in cancer patients, including those with MCC. To date, 20 patients in the Phase 1b stage of the clinical trial have been dosed, and no cavrotolimod-related serious adverse event or dose-limiting toxicity has been reported. The most commonly reported adverse events were injection site reactions and flu-like symptoms. In the second quarter of 2020, Exicure initiated Phase 2 dose expansion cohorts of intratumoral cavrotolimod in combination with approved checkpoint inhibitors to treat two cohorts of patients with advanced or metastatic MCC or CSCC. Each cohort is expected to enroll up to 29 patients whose tumors have progressed on anti-PD-1/PD-L1, or programmed cell death protein 1/programmed death-ligand 1, antibody monotherapy.

Salarius Announces Proposed Public Offering of Common Stock

On March 3, 2021 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with pediatric cancers, solid tumors, and other cancers, reported that it has commenced an underwritten public offering of shares of its common stock (Press release, Salarius Pharmaceuticals, MAR 3, 2021, View Source [SID1234576007]). 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.

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, 640 Fifth Avenue, New York, NY 10019 or by email at [email protected].

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.

PMV Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Corporate Highlights

On March 3, 2021 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, reported financial results for the fourth quarter and full year ended December 31, 2020 and provided corporate highlights (Press release, PMV Pharma, MAR 3, 2021, View Source [SID1234576006]).

"2020 was a transformative year for PMV Pharma, marked by our entry into the clinic, a strengthened management team and successful completion of our Nasdaq initial public offering," said David Mack, Ph.D., President and Chief Executive Officer. "The treatment of the first patient with PC14586, our tumor agnostic small molecule targeting the p53 Y220C mutant, was an important step forward in precision oncology. Our strong leadership and balance sheet position us to further advance our discovery pipeline of small molecule, tumor-agnostic precision medicine products that specifically target p53 mutants."

Corporate Highlights:

Initiated Phase 1/2 study of PC14586 in patients with advanced solid tumors that have a p53 Y220C mutation. The Phase 1/2 study will enroll up to 130 patients with a p53 Y220C mutation as determined by next generation sequencing. Phase 1 dose escalation will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of PC14586. Phase 2 will assess the overall response rate and duration of response at the PC14586 dose identified in Phase 1.
For information on the Phase 1/2 trial, please visit www.clinicaltrials.gov (NCT study identifier NCT04585750).
In October, the FDA granted PMV Pharma Fast Track designation to PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.
Appointment of Deepika Jalota, Pharm. D. to Chief Regulatory and Quality Officer, who joined PMV Pharma in June 2019 as Senior Vice President, Head of Regulatory Affairs and Quality Assurance. Dr. Jalota will continue to lead global regulatory strategy and execution as well as the quality assurance function. Dr. Jalota is a strategic regulatory leader with more than 20 years of regulatory affairs and drug development experience in oncology and other therapeutic areas. Prior to joining PMV Pharma, she served as Vice President, Global Regulatory Strategy, Oncology at Bayer HealthCare Pharmaceuticals where she was responsible for driving the development of global regulatory strategies for multiple early and late-stage oncology projects, including Xofigo, Vitrakvii and Nubeqa.
Expanded Scientific Advisory Board with the appointment of p53 pioneer Dr. Guillermina (Gigi) Lozano, Professor and Chair, Department of Genetics, MD Anderson Cancer Center.
Fourth Quarter 2020 Financial Results

PMV Pharma ended the fourth quarter with $361.4 million in cash, cash equivalents, and marketable securities, compared to $101.5 million as of December 31, 2019. Net cash used in operations was $32.7 million for the twelve months ended December 31, 2020 compared to $22.1 million for the twelve months ended December 31, 2019.
Net loss for the year ended December 31, 2020 was $34.4 million compared to $25.4 million for the year ended December 31, 2019.
Research and development (R&D) expenses were $23.9 million for the year ended December 31, 2020 compared to $20.8 million for the year ended December 31, 2019. The increase in R&D expenses was primarily related to increased headcount and clinical expenses related to advancing research on PC14586, the Company’s lead drug candidate.
General and administrative (G&A) expenses were $11.0 million for the year ended December 31, 2020, compared to $5.9 million for the year ended December 31, 2019. The increase in G&A expenses was primarily due to expanding the infrastructure necessary for operating as a public company.
About p53

p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.

About PC14586

PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice created by the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.

Avid Bioservices Declares Quarterly Dividend on Its Series E Convertible Preferred Stock

On March 3, 2021 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that its Board of Directors has declared a quarterly cash dividend payment on the Company’s 10.50% Series E Convertible Preferred Stock (the "Series E Preferred Stock") (Press release, Avid Bioservices, MAR 3, 2021, View Source [SID1234576005]).

The quarterly dividend on the Series E Preferred Stock is payable on April 1, 2021 to holders of record at the close of business on March 15, 2021.

The quarterly dividend payment on the Series E Preferred Stock will be $0.65625 per share, which is equivalent to an annualized 10.50% per share, based on the $25.00 per share stated liquidation preference, accruing from January 1, 2021 through March 31, 2021. The Series E Preferred Stock is listed on the NASDAQ Capital Market and trades under the ticker symbol "CDMOP".

Amgen Announces 2021 Second Quarter Dividend

On March 3, 2021 Amgen (NASDAQ:AMGN) reported that its Board of Directors declared a $1.76 per share dividend for the second quarter of 2021 (Press release, Amgen, MAR 3, 2021, View Source [SID1234576004]). The dividend will be paid on June 8, 2021, to all stockholders of record as of the close of business on May 17, 2021.