On July 19, 2018 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a Fortress Biotech (NASDAQ: FBIO)
Company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor
engineered T cell (CAR T) technology, reported that it has completed a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for MB-102 (CD123 CAR T) (Press release, Mustang Bio, JUL 19, 2018, View Source [SID1234527786]). MB-102 is a CAR T therapy in development for the treatment of acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN) and high-risk myelodysplastic syndrome (MDS). Mustang will continue its efforts on its IND filing to the FDA for MB-102.

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are pleased with the FDA’s feedback on our development plan and expect to submit an IND filing for MB-102 in the fourth quarter as planned. We anticipate that our manufacturing facility will be ready to process patient cells in the next few months, which will help enable initiation of our Phase 1/2 clinical trial of MB-102 in AML, BPDCN and MDS to begin in 2019, after approval of Mustang’s first IND."

About MB-102 (CD123 CAR T)
MB-102 (CD123 CAR T) is a CAR T cell therapy that is produced by engineering patient T cells to recognize and eliminate CD123-expressing tumors. CD123 is widely expressed on bone marrow cells of patients with MDS, as well as in hematologic malignancies including AML, B cell acute lymphoblastic leukemia, hairy cell leukemia, BPDCN, chronic myeloid leukemia and Hodgkin’s lymphoma.

In the first-in-human clinical trial at City of Hope (NCT02159495), MB-102 has demonstrated complete responses at low doses in AML and BPDCN without dose-limiting toxicities, as reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2017. Dose escalation continues at City of Hope in both indications.

On July 19, 2018 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that the company has submitted a clinical trial authorization (CTA) application to the relevant regulatory authorities to start a phase I study of its wholly-owned bispecific drug candidate ATOR-1015 (Press release, Alligator Bioscience, JUL 19, 2018, View Source [SID1234527787]).

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The upcoming phase I study with ATOR-1015 is a first-in-human dose escalation study in patients with advanced solid cancer. The study will be conducted at five sites in Sweden and Denmark and will enroll up to 50 patients. The primary aim of the study is to investigate the safety and tolerability of ATOR-1015 and establish the recommended dose for the subsequent phase II studies. ATOR-1015 is intended to be the first CTLA-4 and OX40-binding bispecific antibody to achieve a strong anti-tumor effect, either as a monotherapy or in combination with currently established immunotherapies such as PD-1 and PD-L1 blockers. It is expected to be suitable for treating a large number of different forms of cancer.

"We are very pleased to announce the CTA submission and look forward to starting patient recruitment as fast as possible after regulatory approval. Based on a strong preclinical data package demonstrating that ATOR-1015 localizes to the tumor and selectively activates the immune system in the tumor area, we have high expectations of this first-in-class drug candidate," said Per Norlén CEO of Alligator Bioscience.

As previously communicated, Alligator has appointed Theradex Oncology, a global contract research organization with extensive expertise in oncology clinical development, to conduct the phase I study.

For further information, please contact:

Cecilia Hofvander, Director Investor Relations & Communications

Phone +46 46 286 44 95

E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 4:10 p.m. CEST on July 19, 2018.

About ATOR-1015

ATOR-1015 is a next generation CTLA-4 bispecific antibody developed for tumor-directed immunotherapy with increased capability of regulatory T-cell depletion. It is wholly-owned by Alligator. ATOR-1015 binds to two different immune receptors: the checkpoint receptor CTLA-4 and the co-stimulatory receptor OX40. The immune activation is increased in areas where both target molecules are expressed at high levels, notably in the tumor microenvironment, which is believed to reduce adverse immune reactions.

On July 19, 2018 Acorda Therapeutics, Inc. (Nasdaq:ACOR) reported that it will host a conference call and webcast to report its second quarter 2018 update and financial results on Thursday, August 2 at 8:30 a.m. ET (Press release, Acorda Therapeutics, JUL 19, 2018, View Source [SID1234527776]).

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To participate in the conference call, please dial (866) 393-4306 (domestic) or (734) 385-2616 (international) and reference the access code 4898766. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 11:30 a.m. ET on August 2, 2018 until 11:59 p.m. ET on September 1, 2018. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international); reference code 4898766. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

On July 19, 2018 Yisheng Biopharma Co., Ltd. ("Yisheng Biopharma"), a biopharmaceutical company focusing on research, development, manufacturing, sales and marketing of immunological biologics and vaccines, reported the grand opening of Anderson Biotech Company Limited and Royal OncoCare Hospitality as two wholly owned subsidiaries of Yisheng Biopharma in Cambodia (Press release, Yisheng US Biopharma, JUL 19, 2018, View Source [SID1234528627]). The two divisions represent the first expansion of Yisheng Biopharma business and product sales operations into an ASEAN member country.

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"The opening of these two divisions is an important milestone in company history," commented Zhang Yi, Founder and Chairman of Yisheng Biopharma. "Our product YivykaTM is approved in Cambodia for the treatment of advanced solid tumors, including lung, breast, liver, colorectal and stomach cancers. We are pleased to be in a position to expand access to the benefits that this product will bring to cancer patients and are grateful for the support we have received from the Ministry of Health of the Kingdom of Cambodia."

"ASEAN countries have witnessed a significant economic boom over the last decade and represent one of the fastest growing markets for the biopharmaceutical industry," added David Shao, Ph.D., President and CEO of Yisheng Biopharma. "With a population of over 600 million under-served individuals in these countries, we are committed to expanding and deepening our presence in this region of southeast Asia. We are conducting drug development in this region, with programs in immuno-oncology, rabies and hepatitis B infection, and are well positioned to introduce a series of innovative products into this region."

YivykaTM is an innovative immuno-oncology drug recently granted a drug registration license by the Ministry of Health of the Kingdom of Cambodia. YivykaTM is the first biological product introduced into the Cambodia market by Yisheng Biopharma.

About Yisheng Biopharma Co., Ltd.

Yisheng Biopharma is a global biopharmaceutical company discovering, developing and commercializing innovative immunological biologics. With approximately 700 employees worldwide and operations in China, the United States, Singapore and certain Southeast Asian countries.

On July 19, 2018 Replimune Group, Inc., a biotechnology company developing oncolytic immunotherapies derived from its Immulytic platform, reported the pricing of its initial public offering of 6,700,000 shares of common stock at a public offering price of $15.00 per share for gross proceeds of $100.5 million, before underwriting discounts and commissions and other offering expenses payable by Replimune (Press release, Replimune, JUL 19, 2018, View Source [SID1234530184]). In addition, Replimune has granted the underwriters a 30-day option to purchase up to 1,005,000 additional shares of its common stock at the initial public offering price, less underwriting discounts and commissions. All of the shares are being offered by Replimune. Replimune’s common stock has been approved for listing on the Nasdaq Global Select Market and is expected to begin trading under the ticker symbol "REPL" on July 20, 2018. The offering is expected to close on July 24, 2018, subject to customary closing conditions.

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J.P. Morgan, Leerink Partners and BMO Capital Markets are acting as joint book-running managers for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission (the "SEC") on July 19, 2018. The offering will be made only by means of a prospectus. Copies of the final prospectus related to the offering will be filed with the SEC and may be obtained, when available, by visiting EDGAR on the SEC website at www.sec.gov or from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by e-mail at [email protected]; or Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by e-mail at [email protected]; or BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, by telephone at (800) 414-3627, or by e-mail at [email protected].

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 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 jurisdiction.