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.

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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, 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.

On March 3, 2021 TrakCel, a leading supplier of cellular orchestration solutions supporting the cell and gene therapy industry, reported that it has closed its latest funding round led by AmerisourceBergen and Labcorp (NYSE: LH) (Press release, TrakCel, MAR 3, 2021, View Source [SID1234576025]). These strategic investments enable further transformation of TrakCel’s cellular therapy orchestration solution, growth of its existing partner ecosystem, and continued global expansion.

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The company will use both the investment and the combined expertise gained from collaborations with the investors to further augment its offering to both clinical and commercial-stage cell and gene therapy developers as part of its drive toward industry standardization and future innovation.

TrakCel has developed the broadest portfolio of live deployments in the industry across a range of therapies, from autologous and allogeneic therapies, personalized cancer vaccines and CRISPR, to tumor and marrow infiltrating lymphocyte therapies.

"The close of this funding delivers a unique opportunity to propel the improvement and evolution of our product and services portfolio in order to exceed expectations across the quickly evolving cell and gene therapy space," said Ravi Nalliah, Chief Strategy Officer and Co-Founder, TrakCel. "In addition, this investment enhances our already considerable digital ecosystem of partners. Now, TrakCel has the funding and the partnership support to take advantage of our market and industry experience gained as the first orchestration solution to the cell and gene therapy marketplace."

Augmenting and aligning its digital ecosystem with AmerisourceBergen in the future will allow TrakCel to significantly expand its reach. This will also enable the two companies to offer services that drive them toward further standardization of the delivery of cell and gene therapies.

"The advanced therapy sector is producing major advances in treatment that will revolutionize healthcare and the treatment of diseases with currently limited therapeutic options. It is essential that partners to manufacturers find ways to innovate on behalf of the patient and provider to enhance the treatment experience," said Doug Cook, EVP, President of Commercialization and Animal Health at AmerisourceBergen. "By working with TrakCel, we’ll unlock new ideas and generate new value for all therapy participants, truly living our purpose of creating healthier futures."

Labcorp, a leading global life sciences company, provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Labcorp’s mission to improve health and improve lives will be complemented and supported by TrakCel’s cell, gene and immunotherapy therapy software platform.

"The tools and technologies developed by TrakCel to support the critical needs of advanced therapy logistics are a good complement to the services that we supply for cell and gene therapies," said Steve Anderson, PhD, Chief Scientific Officer, Labcorp Drug Development. "The ability to more effectively orchestrate those activities, paired with Labcorp’s deep scientific and clinical expertise, makes our collaboration an important aspect for the successful delivery and commercialization of advanced therapies. Our investment in TrakCel also further demonstrates our commitment to the area of precision medicine."

On March 3, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that it will report financial results for the full year ended December 31, 2020 before the market opens on Monday, March 29, 2021, and host a conference call to discuss the results and provide a corporate update at 8:00 a.m. ET (Press release, I-Mab Biopharma, MAR 3, 2021, View Source [SID1234576043]).

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Conference Call and Webcast Information

I-Mab will host a live conference call and webcast on March 29, 2021 at 8:00 a.m. ET. Participants must register in advance of the conference call. Details are as follows:

Registration Link:

View Source

Conference ID:

4848159

Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call.

A webcast replay will be archived on the Company’s website for one year after the conclusion of the call at View Source

A telephone replay will be available approximately two hours after the conclusion of the call. To access the replay, please call +1-855-452-5696 (U.S.), +61-2-8199-0299 (International), 400-632-2162 (Mainland China), or 800-963-117 (Hong Kong). The conference ID number for the replay is 4848159.

On March 3, 2021 Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer, reported that company executives will participate in three investor conferences in March 2021 (Press release, Sierra Oncology, MAR 3, 2021, View Source [SID1234575987]). Stephen Dilly, MBBS, PhD, Chief Executive Officer of Sierra will provide a company update at the HC Wainwright Life Sciences Conference and the Oppenheimer Healthcare Conference; Barbara Klencke, MD, Chief Development Officer will participate in a panel discussion at the 33rd Annual Roth Conference.

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Presentation Details:

Conference:

HC Wainwright Global Life Sciences Conference

Presenter:

Stephen Dilly, MBBS, PhD, Chief Executive Officer

Date:

Tuesday, March 9, 2021

Time:

On Demand Viewing starting at 7:00 am ET

Conference:

Virtual 33rd Annual Roth Conference

Presenter:

Barbara Klencke, MD, Chief Development Officer

Session:

Large Market Opportunities in RARE Hematologic & Inflammatory Disease

Date:

Monday, March 15, 2021

Time:

10:00 am – 11:00 am ET

Conference:

Oppenheimer 31st Annual Healthcare Conference

Presenter:

Stephen Dilly, MBBS, PhD, Chief Executive Officer

Date:

Wednesday, March 17, 2021

Time:

1:50 pm – 2:20 pm ET

All three presentations will be webcast and available at the times noted above on the Investors section of Sierra’s corporate website in the Events & Webcast tab.

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.