On February 3, 2021 Eucure Biopharma, a biopharmaceutical company dedicated to developing immuno-oncology antibody drugs, reported that its investigational anti-CD40 antibody drug (YH003), when combined with Junshi Biosciences’ anti-PD-1 antibody Toripalimab (TUOYI), demonstrated encouraging anti-tumor activity in an ongoing Phase I/II clinical trial in Australia (Press release, Eucure, FEB 3, 2021, View Source [SID1234574586]). The trial is a multicenter, open label study, with an initial multiple-dose-escalation phase designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of YH003 in combination with Toripalimab in subjects with advanced solid tumors. The second phase is a cohort extension phase to assess the safety and preliminary efficacy of YH003/Toripalimab with or without chemotherapy in PD-1 refractory, advanced unresectable/metastatic melanoma and pancreatic ductal adenocarcinoma.

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A 68-year-old female subject with ocular melanoma and liver metastases who failed prior immunotherapy, including first-line Nivolumab (an anti-PD-1 antibody) and second-line Nivolumab/Ipilimumab (an anti-CTLA-4 antibody) combination therapy, was enrolled in the 0.1 mg/kg cohort. The subject received a single three-week cycle of YH003 monotherapy, followed by three cycles of YH003/Toripalimab combination therapy over a total of 12 weeks. Imaging assessments indicated a partial response at week 10 post-treatment, with a 38.5% reduction in the total diameter of all target lesions. No dose-limiting toxicity (DLT) was observed in the study, and the drug was well tolerated in the first two cohorts and in the ongoing third cohort.

In response, Dr. Yuelei Shen, Chairman of Biocytogen and CEO of Eucure Biopharma, commented, "We are pleased to see a patient experiencing partial remission in this first YH003 trial, which is going fast and smoothly in Australia. This result further assured us that our anti-CD40 compound YH003 has great potential to be developed into an oncology therapy in this post PD-1 era. We will take advantage of expedited regulatory programs to hopefully put this product on the market as soon as possible. Then, we will explore the full potential of this compound in a broad spectrum of indications."

About YH003

YH003 is a humanized agonistic antibody that promotes CD40 activation on antigen-presenting cells, and thus stimulates the effector activity of anti-tumor T cells. Whether used alone or in combination with anti-PD-1 antibodies, YH003 demonstrated potent anti-tumor effects in Biocytogen’s CD40 humanized mice, and significantly increased the proportion of anti-tumor T cells. YH003 demonstrated an excellent safety profile at very high doses, both in mice and primates.

About Toripalimab (TUOYI)

Toripalimab is the first anti-PD-1 monoclonal antibody to obtain a marketing approval in China. So far, more than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On December 17, 2018, Toripalimab obtained a conditional approval from the NMPA for the second-line treatment of patients with unresectable or metastatic melanoma. Supplemental NDAs of Toripalimab for the third-line treatment of recurrent/metastatic nasopharyngeal carcinoma and second-line treatment of metastatic urothelial carcinoma were accepted by the NMPA in April and May 2020, respectively. Both supplemental NDAs received priority review designations from the NMPA in July 2020. In December 2020, Toripalimab was included in the National Reimbursement Drug List (NRDL) for the treatment of melanoma by the China National Healthcare Security Administration (NHSA).

In the United States, the FDA has granted Toripalimab breakthrough therapy designation for the treatment of recurrent/metastatic nasopharyngeal carcinoma, Fast Track designation for mucosal melanoma, and orphan drug designation for the treatment of nasopharyngeal carcinoma, mucosal melanoma and soft tissue sarcoma.

On February 3, 2021 DURECT Corporation (Nasdaq: DRRX) ("DURECT"), a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program, reported that it is commencing an underwritten public offering of its common stock (the "Offering") (Press release, DURECT, FEB 3, 2021, https://www.prnewswire.com/news-releases/durect-corporation-announces-proposed-offering-of-common-stock-301221648.html [SID1234574585]). All of the shares to be sold in the Offering will be sold by DURECT, subject to customary closing conditions. In addition, DURECT intends to grant the underwriter for the Offering a 30-day option to purchase up to an additional 15% of the number of shares of its common stock offered in the public offering.

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Cantor Fitzgerald & Co. is acting as the sole book running manager for the Offering.

The Offering is being made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226518) previously filed by DURECT with the Securities and Exchange Commission (the "SEC") on September 28, 2019 and declared effective by the SEC on October 9, 2018. The Offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement relating to, and describing the terms of, the Offering will be filed with the SEC. Before you invest, you should read the registration statement, the preliminary prospectus, the documents that DURECT has filed with the SEC that are incorporated by reference into the registration statement, and the other documents DURECT has filed with the SEC for more complete information about DURECT and the offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering can be obtained, when available, from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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 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 February 3, 2021 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA) a leader in full-service, therapeutic antibody discovery and development, reported that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 1,616,293 common shares of the Company (the "Common Shares"), at a price to the public of $13.45 per Common Share, less underwriting discounts and commissions, for gross proceeds to the Company of approximately $21.7 million (Press release, ImmunoPrecise Antibodies, FEB 3, 2021, View Source [SID1234574581]). The closing of the offering is expected to occur on or about February 8, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as sole book-running manager for the Offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 242,443 Common Shares at the public offering price, less underwriting discounts and commissions. The Company intends to use the net proceeds from the Offering for (i) pursuing the Company’s objective of expanding its operations into Good Laboratory Practice and Good Manufacturing Practice-certified; (ii) the development and commercialization of Talem Therapeutics, LLC’s, a wholly owned subsidiary of the Company, internal and partnered therapeutic discovery programs; (iii) investments in employees, partnerships, cloud computing, data curation and analysis to enable further work toward the development of custom algorithms, cloud computing, large-scale sequence data analysis, and expanded access to next-generation sequencing technologies; (iv) the development of its PolyTopeTM approach to the development of innovative therapeutics and vaccines against the COVID-19; and (v) general corporate and working capital purposes.

In connection with the Offering, the Company filed with the securities regulatory authorities in each of the provinces of Canada (except Quebec), a short form base shelf prospectus dated December 11, 2020. The short form base shelf prospectus was filed on Form F-10 with the U.S. Securities and Exchange Commission (SEC). The Company also filed a preliminary prospectus supplement to the short form base shelf prospectus with the securities regulatory authority in the Province of British Columbia as well as with the SEC as part of a registration statement on Form F-10 under the U.S.-Canada multijurisdictional disclosure system (MJDS). The Common Shares will only be offered and sold in the United States either directly or through duly registered U.S. broker dealers. No Common Shares will be offered or sold to Canadian purchasers.

The Offering is being made in the United States only by means of the registration statement, including the base shelf prospectus and applicable prospectus supplement. Such documents contain important information about the offering. A short form base shelf prospectus and accompanying preliminary prospectus supplement have been filed with the SEC and are available for free on the SEC’s website at www.sec.gov and on the SEDAR website at www.sedar.com. Copies of the short form base shelf prospectus and accompanying final prospectus supplement will be filed with the SEC and will be available for free on the SEC’s website at www.sec.gov and on the SEDAR website at www.sedar.com. Electronic copies of the final prospectus supplement and registration statement, when available, may also be obtained from H.C. Wainwright & Co. LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected].

Prospective investors should read the base shelf prospectus and the prospectus supplement as well as the registration statement before making an investment decision.

No securities regulatory authority has either approved or disapproved the contents of this news release. This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

On February 3, 2021 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, reported the first subject dosed in clinical trial of pan-FGFR inhibitor ICP-192 in the United States (Press release, InnoCare Pharma, FEB 3, 2021, View Source [SID1234574580]).

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ICP-192 is a highly selective small-molecule pan-FGFR inhibitor for the treatment of various solid tumors with FGFR aberrations. Currently it is in Phase I/II clinical studies in China and the United States.

The Phase II trial in China is a multi-center, open-label clinical trial designed to evaluate the safety and efficacy of ICP-192 in patients with advanced cholangiocarcinoma and urothelial cancer that have FGFR aberrations. The phase II clinical trials have enrolled nearly 20 patients, and cases of partial response and complete response have been observed in patients of FGFR gene alterations.

"We will continue to advance ICP-192 in clinical studies for the treatment of advanced solid tumors with FGFR aberrations in China and global," said Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare. "ICP-192 is an excellent drug candidate for the treatment of solid tumors with FGFR aberrations. We will work together with top clinical experts to rapidly advance the trials to explore the potential usage of ICP-192 in a variety of solid tumors. We hope to provide patients with better treatment options."

ICP-192 is the second innovative drug candidate discovered by InnoCare, which was approved for the initiation of clinical trials in the U.S.

On February 3, 2021 Quanterix Corporation (Nasdaq: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported that it has commenced an underwritten public offering of $200.0 million of its common stock (Press release, Quanterix, FEB 3, 2021, View Source [SID1234574579]). In connection with the offering, Quanterix intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock at the public offering price less the underwriting discounts and commissions. All of the shares in the offering will be sold by Quanterix. 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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Goldman Sachs & Co. LLC, SVB Leerink LLC and Cowen and Company, LLC are acting as joint bookrunning managers for the offering. Canaccord Genuity LLC is acting as lead manager for the offering.

The public offering will be made pursuant to a shelf registration statement on Form S-3ASR (File No. 333-249925) previously filed with the Securities and Exchange Commission ("SEC") on November 6, 2020, which automatically became effective upon filing. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at View Source The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained, when available, from Goldman Sachs & Co. LLC, 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526 or by e-mail at [email protected], from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at (800) 808-7525, ext. 6105 or by e-mail at [email protected], or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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