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ERYTECH CONFIRMS PLANS TO SUBMIT BLA FOR ERYASPASE IN HYPERSENSITIVE ALL PATIENTS

On July 21, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported its intention to move forward towards the submission of a BLA to the US Food and Drug Administration (FDA) for eryaspase in hypersensitive acute lymphoblastic leukemia (ALL) patients following feedback from the agency in a pre-BLA meeting (Press release, ERYtech Pharma, JUL 21, 2021, View Source [SID1234585095]).

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The purpose for the meeting was to discuss clinical, non-clinical and quality content and expectations for the Company’s potential BLA submission. Based on the discussion and the totality of the available information to the Company to date, ERYTECH believes its regulatory package can potentially support an approval of eryaspase in hypersensitive ALL patients. Pending successful completion of remaining steps, the Company anticipates submitting a BLA in the fourth quarter of 2021.

"We are encouraged by the interactive dialogue with the agency, and grateful for the feedback and guidance we received on a potential path to approval," said Gil Beyen, CEO of ERYTECH. "This is an important milestone for ERYTECH as it advances our lead product candidate eryaspase as an alternative treatment for ALL patients with hypersensitivity to PEG-asparaginase, while our Phase 3 trial in second line pancreatic cancer is nearing completion. If all goes well, we could be in a position to make this product candidate available to ALL and pancreatic cancer patients in the course of next year."

In December 2020, positive Phase 2 clinical results were presented by the Nordic Society of Pediatric Hematology and Oncology, at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting. Eryaspase, in combination with chemotherapy, administered every two weeks, provided a sustained asparaginase enzyme activity level, and was generally well tolerated with few hypersensitivity reactions.

About Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that is the most common type of cancer in children in the US and Europe. More than 13,000 cases are diagnosed in the US and Europe each year with the majority of patients diagnosed before age 20. Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment-limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with inferior event free survival highlighting the need for additional asparaginase based treatment options.

Mabworks Plans Hong Kong IPO to Support Antibody/Multi-Specifics Pipeline

On July 21, 2021 Beijing Mabworks Biotech reported that it has filed an application to IPO on the Hong Kong Exchange (Press release, Mabworks Biotech, JUL 21, 2021, View Source [SID1234585071]). The company is developing mAbs and multi-specific antibodies for oncology and autoimmune diseases. Its pipeline consists of six clinical-stage drug candidates and six preclinical candidates, plus an Avastin biosimilar that Mabworks out-licensed to Betta Pharma of Hangzhou. The company’s lead candidate is MIL62, a third-gen CD20 multi-specific that is slated to begin Phase III trials in lymphoma. Because the application was the first filing, no financial details of the IPO were included.

Sorrento Announces That Its Subsidiary Levena and Its Partner Escugen Have Received Clearance to Begin Clinical Trials With Anti-TROP-2 Antibody Drug Conjugate For Multiple Solid Tumors

On July 21, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported its partner Escugen Biotechnology Co, Ltd. ("Escugen") and Sorrento’s subsidiary Levena (Suzhou) Biopharma Co., Ltd. ("Levena") have received an approval letter from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its Application for Clinical Trial (Acceptance No. CXSL2101069) of Recombinant Humanized Anti-Trop2 Mab-SN38 Conjugate (Press release, Sorrento Therapeutics, JUL 21, 2021, View Source [SID1234585070]).

The TROP-2 ADC (ESG-401) was jointly developed by Shanghai-based Escugen and Levena, and the two companies jointly own the domestic and international patents for this ADC and share global rights for the product.

ESG-401 has potentially distinct differentiating advantages over its competitors in terms of safety, effectiveness and process robustness. Using an innovative, highly stable and cleavable linker, this ADC demonstrated in a series of preclinical studies that it releases very little free toxin during circulation, highly enriches in tumor tissues and rapidly endocytoses, thereby effectively killing tumor cells and inhibiting tumor growth. In the preclinical studies, ESG-401 demonstrated excellent safety, with no off-target or off-tumor toxicity observed in those high-dose, repetitively administered non-human primates. Additionally, ESG-401 showed significant antitumor activity in a variety of tumor models expressing TROP-2, with a low effective dosage and long inhibition time on tumor growth. ESG-401 potentially addresses a highly unmet need for the treatment of multiple solid tumors, including triple-negative breast cancer and urothelial carcinoma.

Sorrento intends to file a US IND for this ESG-401 before the end of the year.

ITI’s Academic Collaborator Dr. John Sampson Recognized as “World Expert” in Glioblastoma

On July 21, 2021 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported that its’ academic collaborator, Dr. John Sampson of Duke University’s Department of Neurosurgery, has been recognized as a World Expert in Glioblastoma by Expertscape, an online resource that identifies the world’s top experts in all medical fields (Press release, Immunomic Therapeutics, JUL 21, 2021, View Source [SID1234585069]). The publication recognized the top 0.1% of scholars writing about glioblastoma over the past ten years, a level they label as "World Expert". Dr. Sampson’s recognition as a World Expert in glioblastoma is part of Glioblastoma Awareness Day, which is being celebrated today, Wednesday, July 21, 2021.

"Dr. Sampson’s contributions to advancing the research in glioblastoma is widely known in our scientific community and we are excited that his significant impact is being recognized on a global level by Expertscape," commented Dr. William Hearl, CEO of ITI. "This recognition is especially important today, on Glioblastoma Awareness Day, where we honor the patients, families, and care givers who have faced this complex and deadly type of brain cancer. We look forward to continuing to collaborate with Dr. Sampson to advance our glioblastoma immunotherapy program, ITI-1000, through Phase 2 and toward patients in need."

TRACON Pharmaceuticals Increases Previously Announced Bought Deal Offering of Common Stock to $15.0 Million

On July 21, 2021 TRACON Pharmaceuticals (NASDAQ: TCON) ("TRACON" or the "Company"), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics, 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 3,926,702 shares of common stock of the Company at a price to the public of $3.82 per share, less underwriting discounts and commissions (Press release, Tracon Pharmaceuticals, JUL 21, 2021, View Source [SID1234585053]). In addition, the Company has granted the underwriter a 30-day option to purchase up to an additional 589,005 shares of common stock at the public offering price, less underwriting discounts and commissions. The closing of the public offering is expected to occur on or about July 26, 2021, subject to satisfaction of customary closing conditions.

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

The gross proceeds of the offering are expected to be approximately $15.0 million, prior to deducting underwriting discounts, commissions and estimated offering expenses and excluding the exercise of the underwriter’s option to purchase additional shares. The Company intends to use the net proceeds from this offering to support the continued clinical development of envafolimab, as well as for working capital and general corporate purposes.

The shares of common stock are being offered pursuant to an effective registration statement on Form S-3 (File No. 333-229990) that was filed with the U.S. Securities and Exchange Commission ("SEC") on March 1, 2019, as amended, and declared effective on October 8, 2019. The shares of common stock are offered only by means of a prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, and, when filed, the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, New York, NY 10022, by email at [email protected] or by phone at (646) 975-6996.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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.