On January 19, 2021 Aclaris Therapeutics, Inc. (Nasdaq: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that it intends to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering (Press release, Aclaris Therapeutics, JAN 19, 2021, View Source [SID1234574101]). All of the shares of common stock to be sold in the offering will be offered by Aclaris. Aclaris also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering on the same terms and conditions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cantor Fitzgerald & Co. and William Blair & Company, L.L.C. are acting as joint book-running managers for the offering. H.C. Wainwright & Co., LLC is acting as lead manager for the offering.

A shelf registration statement relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on March 13, 2020 and declared effective by the SEC on April 29, 2020. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687 or by email at [email protected].

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

On January 19, 2021 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported the closing of its previously-announced bought-deal public offering (the "Offering") pursuant to which the Company issued 16,727,900 units of the Company (the "Units") at a price of US$2.75 per Unit (equivalent to approximately C$3.51 per Unit) (the "Offering Price") for aggregate gross proceeds to the Company of US$46,001,725 (equivalent to approximately C$58,714,929), including the full exercise of the over-allotment option to purchase an additional 2,181,900 Units at the Offering Price (Press release, Theratechnologies, JAN 19, 2021, View Source [SID1234574100]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Each Unit is comprised of one common share of the Company (a "Common Share") and one-half of one Common Share purchase warrant of the Company (each whole warrant, a "Warrant"). Each Warrant entitles the holder thereof to purchase one Common Share at an exercise price of US$3.18 (equivalent to approximately C$4.06) at any time until January 19, 2024.

The net proceeds from the Offering will be used primarily to fund research and development activities, commercialisation initiatives, general and administrative expenses, working capital needs and other general corporate purposes.

This press release is not an offer to sell or the solicitation of an offer to buy the securities in the United States or in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from U.S. registration requirements and applicable U.S. state securities laws.

On January 19, 2021 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported its corporate partners, Alphamab Oncology and 3D Medicines, received notification that the New Drug Application (NDA) for envafolimab was granted priority review by the Center for Drug Evaluation of the National Medical Products Administration (NMPA) in the indication of MSI-H/dMMR cancer (Press release, Tracon Pharmaceuticals, JAN 19, 2021, View Source [SID1234574099]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We congratulate our partners on the acceptance of the initial regulatory submission for envafolimab in China for priority review, which marks another important milestone in the development and potential commercialization of this promising program," said Charles Theuer, M.D., Ph.D., TRACON Chief Executive Officer. "In addition to the registration trial in MSI-H/dMMR advanced solid tumors in China, envafolimab is being studied in two other registration trials, a randomized Phase 3 trial in biliary tract cancer in China being conducted by Alphamab and 3D Medicines, and our ENVASARC trial in sarcoma in the U.S., which has now dosed multiple patients."

About Priority Review by the NMPA

Priority review is a procedure established to encourage the research and development of new drugs and accelerate the review and approval of new drugs with obvious clinical value and urgent clinical needs. According to the new "Drug Registration Rules" (SAMR Order No.27) and Working Procedures for Priority Review and Approval of Drug Marketing Authorization (Interim) (No. 82 of 2020) implemented on July 1, and July 7, 2020, respectively, once granted Priority Review, the NMPA will prioritize the review process and resources for applications with expected shorter review timelines.

About Envafolimab (KN035)

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registration trials. Envafolimab is currently being studied in the ENVASARC Phase 2 registration trial in the U.S. sponsored by TRACON, as well as in a Phase 2 registration trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. In the Phase 2 registration trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.

About ENVASARC (NCT04480502)

The ENVASARC registration trial is a multi-center, open-label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

On January 19, 2021 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," "MTEM" or "the Company"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for MT-6402, a next-generation ETB targeting PD-L1 that is enabled with MTEM’s antigen seeding technology (AST) (Press release, Molecular Templates, JAN 19, 2021, View Source [SID1234574098]). ETBs enabled with AST have dual mechanisms of action that include the enzymatic destruction of ribosomes and the delivery of viral class I antigens into the targeted tumor to be processed and presented on its cell surface to induce an antigen specific immune response. MTEM expects to start dosing enrolled subjects in a first-in-human Phase 1 study in relapsed/refractory patients with PD-L1-positive solid tumors in 2Q21.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 1 study is planned as a multi-center, open-label, dose escalation and dose expansion trial in the United States and outside of the United States. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment will be eligible to screen for enrollment in the clinical trial. Following determination of the maximum tolerated dose (MTD) or recommended Phase 2 dose, expansion cohorts are planned to study MT-6402 as a monotherapy in tumor-specific and tumor-agnostic cohorts.

"We are excited to be advancing MT-6402, a third generation ETB, into the clinic for the treatment of patients with PD-L1-positive cancers. MT-6402 utilizes both our proprietary de-immunized toxin scaffold and antigen seeding technology," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "The PD-1/PD-L1 axis is central to many tumors and targeting that axis with a new mechanism of action has an opportunity to provide meaningful benefit to patients. We look forward to providing an update on the Phase 1 study by year-end 2021."

About MT-6402

MT-6402 is an ETB consisting of a single chain variable fragment (scFv) with affinity for PD-L1, fused to the enzymatically active de-immunized Shiga-like toxin-A subunit (SLTA) and a class I antigen derived from the human cytomegalovirus (HCMV) pp65 protein. MT-6402 was designed to induce potent anti-tumor effects via PD-L1 targeting through multiple mechanisms that may overcome the limitations of the PD-L1 antibodies. In MTEM’s preclinical studies, MT-6402 was found to specifically bind and kill both tumor and immune PD-L1 expressing cells in a manner consistent with SLTA mediated cellular cytotoxicity through ribosomal inactivation, independent of checkpoint inhibition. Additionally, MT-6402 alters the immunophenotype of targeted cells by delivering foreign class I antigen from CMV for presentation in complex with MHC class I, which may provoke a CMV-specific immune response against the targeted cells. Third, MT-6402 may rehabilitate the tumor microenvironment (TME) and allow for immune recognition of tumors by destroying PD-L1-expressing immune cells in the TME through ribosomal inactivation.

On January 19, 2021 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported that the U.S. Food and Drug Administration (FDA) has lifted the previously announced partial clinical hold on the phase 1 studies of PRS-343 (Press release, Pieris Pharmaceuticals, JAN 19, 2021, View Source [SID1234574097]). As previously guided, the Company intends to move into a proof-of-concept study of PRS-343 in gastroesophageal cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"It has been rewarding to see the impact of PRS-343 on the lives of patients in these studies. Data continue to be encouraging, and the clinical benefit linked to single-agent activity that we have seen attests to the potential of this therapy and, more broadly, our localized 4-1BB agonism approach," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "We are excited to advance this program into the proof-of-concept phase and look forward to sharing more details about the study later this quarter."