On July 12, 2021 ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric and orphan drugs and Clinigen Group plc (AIM: CLIN, ‘Clinigen’), the global pharmaceutical Products and Services company, reported that they have signed an exclusive agreement to manage the supply and distribution of Kigabeq into unlicensed markets (Press release, ORPHELIA Pharma, JUL 21, 2021, View Source [SID1234585002]).

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Kigabeq was granted a European Paediatric Use Marketing Authorization (PUMA) in September 2018 and is currently approved for the treatment of infantile spasms (West Syndrome) and pharmaco-resistant focal-onset seizures (partial seizures).

Under the terms of the agreement, Clinigen will provide access to Kigabeq 500 mg and 100 mg soluble tablets into markets where Kigabeq is not commercially available. Clinigen will manage all elements of the supply including healthcare practitioner enquiry management, regulatory oversight, logistics and access management. The agreement currently covers all global territories except for USA, China, EU, UK and Bangladesh.

Sam Herbert, Chief Operating Officer and Head of Products Division, Clinigen, said: "We are pleased to be partnering with ORPHELIA Pharma and to be supplying Kigabeq through our product lifecycle platform. This agreement will offer healthcare professionals another option to treat difficult-to-manage types of epilepsy. This is a great example of how Clinigen’s lifecycle platform can help patients source medicines which are not otherwise available."

Hugues Bienaymé, General Manager of ORPHELIA Pharma added: "We are delighted to have entered into this collaboration with Clinigen. With this agreement, our ambition to make Kigabeq available worldwide, will be fulfilled."

Healthcare professionals can obtain details about the products by calling the Clinigen customer service team at +44 (0) 1932 824100, emailing [email protected] or going online at www.clinigendirect.com.

Patients seeking medical information should contact their physician.

On July 21, 2021 Exscientia, an AI-driven pharmatech company with a mission to revolutionise how drugs are discovered, and GT Apeiron Therapeutics （Apeiron）, a Shanghai based company focused on novel oncology drugs, reported a strategic research and development collaboration agreement (Press release, Exscientia, JUL 21, 2021, View Source [SID1234585035]). The collaboration will leverage the patient-centric AI-first capabilities of Exscientia to accelerate the discovery of multiple small molecule therapeutic drug candidates designed to selectively treat aberrant cell cycle driven cancers and build a pipeline of CDK novel therapies. All pipeline products will be equally owned and Exscientia holds an equity stake in Apeiron.

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This expanded collaboration follows the successful design of multiple selective CDK7 compounds. The potent, highly selective, non-covalent CDK7 compounds have demonstrated consistent tumour responses in xenograft models as well as exceptional pharmacokinetics. In addition, using live primary tissue samples from ovarian cancer patients, the CDK7 inhibitors showed both enhanced tumour cell cytotoxicity as well as selectivity over immune cells in the same microenvironment.

"Based on what they have already achieved, Exscientia is clearly the leader in AI-driven drug discovery, and we have witnessed this first-hand in our collaboration so far," stated Dr. Mingxi Li, President of GT Apeiron Therapeutics. "We have been incredibly impressed by the combined power of the AI design and use of patient data to optimize and select molecules that are more likely to give positive effects in the clinic. This joint venture is a significant step in building GT Apeiron’s valuable and robust pipeline of CDK inhibitor drugs and substantially accelerates our early-stage output and progression towards being a clinical stage biotech company."

"We are driven to bring drugs to market that make a difference for patients," says Andrew Hopkins, chief executive officer of Exscientia. "Apeiron bring a focus and an expertise on the biological basis of multiple cancers and helps us to create better drugs for better outcomes in the clinic and beyond. This collaboration has already proven to be capable of delivering potential drug candidates with promising patient-relevant data, and we look forward to extending that into a portfolio of multiple clinical assets."

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]).

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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.

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 it has entered into an underwriting agreement with H.C. Wainwright & Co. under which the underwriter has agreed to purchase on a firm commitment basis 2,617,802 shares of the Company’s common stock at a public offering price of $3.82 per share, less underwriting discounts and commissions (Press release, Tracon Pharmaceuticals, JUL 21, 2021, View Source [SID1234585019]). In addition, the Company has granted the underwriter a 30-day option to purchase up to an additional 392,670 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about July 26, 2021, subject to satisfaction of customary closing conditions.

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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 $10 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 will be filed with the SEC and will be 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 the final prospectus supplement and accompanying prospectus relating to the offering, when filed, 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.

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.

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