On March 21, 2019 BioInvent International AB (OMXS: BINV), focused on the discovery and development of novel and first-in-class immuno-regulatory antibody-based medicines generated by its proprietary platforms, reported a comprehensive program to target TNFR2 for therapy of cancer (Press release, BioInvent, MAR 21, 2019, View Source [SID1234534525]). Using the n-CoDeR & F.I.R.S.T. platforms, the company has generated a broad panel of highly specific anti-TNFR2 antibodies, including the lead candidate antibody BI-1808, that may have broad utility in the treatment of solid cancers. BI-1808 is currently in preclinical development, and expected to enter clinical trials in the first half of 2020.

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Tumor necrosis factor 2 (TNFR2) is viewed as a highly promising receptor to target to overcome immune resistance in the tumor microenvironment. TNFR2 is found predominantly on regulatory T cells (Treg cells) in tumor tissue and has in several studies been associated with the most suppressive Treg cells. TNFR2 is known to play an important role both in the proliferation and function, as well as phenotypic stability of Treg cells. TNFR2 is also strongly associated with so called myeloid derived suppressor cells (MDSCs) in the tumor milieu and has been shown to both drive their accumulation and suppressive function. Its relatively selective expression together with its important function in the overall immune suppressive tumor microenvironment make TNFR2 a very compelling immune oncology target. Supporting preclinical data are expected to be submitted for publication in a peer-reviewed journal late 2019.

Björn Frendéus, CSO of BioInvent, said, "We believe targeting TNFR2 for cancer therapy holds great promise. Thanks to our proprietary n-CoDeR & F.I.R.S.T. platforms we have been able to generate first-in class anti-TNRF2 antibodies that are highly specific. We are pushing our first lead candidate BI-1808 towards the clinic, and are on track to commence clinical development in the first half of 2020."

On March 21, 2019 CStone Pharmaceuticals ("CStone"; HKEX: 2616) reported that China’s National Medical Products Administration (NMPA) has approved the clinical trial application to begin a Phase 1 trial in China for BLU-667 (CS3009), a highly selective and potent RET inhibitor discovered by CStone’s partner Blueprint Medicines (Press release, CStone Pharmaceauticals, MAR 21, 2019, View Source [SID1234534561]). The study is part of Blueprint Medicines’ ongoing, global Phase 1 ARROW clinical trial for patients with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other advanced solid tumors. Trial objectives include overall clinical response, duration of response, pharmacokinetics, pharmacodynamics and safety.

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In June 2018, CStone and Blueprint Medicines entered into a license and collaboration agreement in which Blueprint Medicines granted CStone exclusive rights to develop and commercialize BLU-667 and two other drug candidates in Mainland China, Hong Kong, Macau and Taiwan.

Recently, BLU-667 was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of RET-mutation-positive MTC that requires systemic treatment and for which there are no acceptable alternative treatments.

Based on the early clinical data and regulatory feedback, Blueprint Medicines has announced plans to submit a New Drug Application (NDA) to the U.S. FDA for BLU-667 in the first half of 2020.

"BLU-667 has already demonstrated its potential to produce clinical responses in several RET-altered tumor types, and there are currently no selective RET inhibitors approved globally," noted CStone Chairman and CEO Dr. Frank Jiang. "If the data generated in Chinese patients are consistent with global results, we plan to use the global and China data from the ARROW study to support NDA filings in China."

CStone’s Chief Medical Officer Dr. Jason Yang commented: "Currently available data show that non-small cell lung cancer and medullary thyroid cancer patients with RET altered tumors may benefit from BLU-667, with the potential to advance standards of care in these genetically defined populations. We will move forward on development of BLU-667 in China and hope to make this drug candidate available to Chinese patients as quickly as possible."

About BLU-667

BLU-667 is an investigational, once-daily oral precision therapy specifically designed for highly potent and selective targeting of oncogenic RET alterations. In preclinical studies, BLU-667 consistently demonstrated sub-nanomolar potency against the most common RET fusions, activating mutations and predicted resistance mutations. In addition, BLU-667 demonstrated markedly improved selectivity for RET compared to approved multi-kinase inhibitors, including more than 80-fold improved potency for RET versus VEGFR2. By suppressing primary and secondary mutants, BLU-667 has the potential to overcome and prevent the emergence of clinical resistance. This approach is expected to enable durable clinical responses across the range of RET alterations, with a favorable safety profile.

BLU-667 was designed by Blueprint Medicines’ research team, leveraging the company’s proprietary compound library. Blueprint Medicines is developing BLU-667 for the treatment of people with RET-altered NSCLC, MTC and other solid tumors. The U.S. FDA has granted Breakthrough Therapy Designation to BLU-667 for the treatment of RET-mutation-positive MTC.

On March 21, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported the pricing of its previously announced underwritten public offering of 16,666,668 shares of common stock, short-term warrants to purchase up to 8,333,334 shares of common stock, and long-term warrants to purchase up to 8,333,334 shares of common stock, at a price to the public of $0.75 per share and accompanying warrants (Press release, Oragenics, MAR 21, 2019, View Source [SID1234534524]). Oragenics expects to receive gross proceeds of approximately $12.5 million from the offering. The offering is expected to close on or about March 25, 2019, subject to customary closing conditions.

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

Each short-term warrant will have an exercise price of $0.75 per share of common stock, will be immediately exercisable, and will expire on the earlier of (1) the eighteen month anniversary of the date of issuance and (2) twenty-one trading days following the Company’s release of top-line data related to its Phase 2 double blind, placebo controlled clinical trial of AG013. Each long-term warrant will have an exercise price of $0.90 per share of common stock, will be immediately exercisable and will expire five years following the date of issuance.

The Company has granted the underwriter a 30-day option to purchase up to 2,500,000 additional shares of common stock and/or short-term warrants to purchase 1,250,000 shares of common stock and long-term warrants to purchase 1,250,000 shares of common stock of the Company at the public offering price, less underwriting discounts and commissions.

The Company intends to use the net proceeds of the offering to fund its AG013 research, clinical trials, pre-clinical development of the lantibiotics program, and for working capital and general corporate purposes.

The securities described above are being offered pursuant to a shelf registration statement (File No. 333-213321), which was declared effective by the United States Securities and Exchange Commission ("SEC") on September 7, 2016. A preliminary prospectus supplement relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, 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] or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the Company’s 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 March 21, 2019 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that its partner in cancer immunotherapy, Xiangxue Life Sciences (XLifeSc), a wholly-owned subsidiary of Xiangxue Pharmaceutical Co., Ltd. (Shenzhen Exchange: 300147), has received an allowance by China’s National Medical Products Administration (NMPA, formerly known as the China Food and Drug Administration) of its company-sponsored Investigational New Drug (IND) application to initiate registrational related clinical studies in China of T-cell receptor Affinity Enhanced Specific T-cell (TAEST) therapy in patients with solid tumors that are HLA-A*02:01 positive and NY-ESO-1 positive (Press release, Athenex, MAR 21, 2019, View Source;p=RssLanding&cat=news&id=2391974 [SID1234534543]). The cancer immunotherapy product, named TAEST16001 injection, is based on TAEST technology generated T-cells, with enhanced binding affinity, against the antigen NY-ESO-1 and is HLA-A*02:01 restricted.

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On October 15, 2018, Athenex and XLifeSc announced preliminary results of investigator-initiated pilot studies in China of patients receiving TAEST therapy which showed encouraging positive clinical safety and efficacy signals. Among six patients that received TAEST therapy after the standard lymphodepletion protocol, two patients showed partial response and four patients showed stable disease, with two of the stable disease patients showing significant tumor necrosis. In addition, the safety profile is believed to be within the range for cancer immunotherapy, with no CNS adverse events observed. Importantly, it was observed that TAEST technology generated T-cells persisted for several months in these patients, highlighting the potential long-term effects of this treatment. An abstract with more detailed data has been submitted for presentation to an international scientific meeting.

In July 2018, Athenex and XLifeSc entered into an agreement to establish a new joint venture named Axis Therapeutics Limited, which owns the global rights to the TAEST technology, excluding China (XLifeSc retains the mainland China rights), and in this territory Axis Therapeutics is leading the research, development and commercialization efforts of T-cell receptor-engineered T cells (TCR-T, including the TAEST technology), a form of cancer immunotherapy.

Mr. YongHui Wang, Chairman and Chief Executive Officer of Xiangxue Pharmaceutical and Chief Executive Officer of XLifeSc, commented, "We are excited with the quick allowance by China’s NMPA of our IND for TAEST16001 and are ready to initiate registrational related clinical studies. Athenex has been a great collaborative partner and the joint development team established will allow our joint venture to move forward with the development of TAEST16001 in other geographic regions."

Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex and Chief Executive Officer of Axis Therapeutics, said, "We congratulate our partner, XLifeSc, and its parent company, Xiangxue Pharmaceutical, for obtaining the allowance of this company-sponsored IND to initiate their registrational related clinical studies. We are impressed by their scientific approach and pre-clinical data, and excited by the encouraging preliminary safety and efficacy results from the investigator-initiated pilot studies in China. Axis Therapeutics is also preparing an IND application to the U.S. Food and Drug Administration and we look forward to starting clinical studies in the U.S. in the near future. Our collaboration with XLifeSc and Xiangxue Pharmaceuticals has been extremely rewarding. Exploring the combination of this exciting approach in conjunction with select Athenex pipeline products may lead to the development of more effective therapies for cancer patients."

On March 21, 2019 Cellular Biomedicine Group, Inc. (Nasdaq: CBMG) (CBMG or the Company), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported the pricing of an underwritten public offering of 1,029,412 shares of its common stock at a public offering price of $17.00 per share (Press release, Cellular Biomedicine Group, MAR 21, 2019, View Source [SID1234534562]). In addition, the underwriters have been granted a 30-day option to purchase up to 154,411 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. Closing of the offering is expected to occur on or about March 25, 2019, subject to customary closing conditions. The gross proceeds to CBMG from this offering are expected to be approximately $17.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by CBMG. CBMG intends to use the net proceeds from this offering for preclinical studies, clinical trials, continued technology platform development, as well as for working capital and other general corporate purposes.

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Cantor Fitzgerald & Co. and Robert W. Baird & Co. Incorporated are acting as joint book-running managers for the offering.

The shares of common stock described above are being offered by CBMG pursuant to its shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (or SEC) and declared effective by the SEC on June 17, 2016. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, by sending a request to: Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at [email protected]; or Robert W. Baird & Co. Incorporated, Attention: Syndicate Department, 777 East Wisconsin Ave., Milwaukee, Wisconsin 53202, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of CBMG, nor will 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 registration or qualification under the securities laws of any such state or jurisdiction.