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Clinical stage biopharmaceutical company: Replimune Group (REPL)

Replimune Group, Inc. (NASDAQ:REPL) was founded in March 2015, formerly known as Replimune Limited, headquartered in Woburn, Massachusetts, with 44 full-time employees (7/9/2018). It is a clinical stage biopharmaceutical company. Committed to using the company’s leading expertise in the field of oncolytic immunotherapy to change the lives of cancer patients.

Replimune Group

Replimune Group (REPL):

Replimune Limited was established in March 2015 under the laws of England and Wales. Replimune Group, Inc. was founded in July 2017 as the parent company of Replimune Limited. All Replimune Limited assets were injected into Replimune Group, Inc., and the former became a wholly-owned subsidiary of the latter. the company.

Replimune Group, Inc. uses its proprietary Immulytic platform to design and develop candidate products that are designed to maximize the activation of the immune system against solid tumors. The foundation of the platform includes a proprietary, engineered strain of herpes simplex virus 1 (HSV-1), which has been “armed” with a fusion therapeutic protein designed to significantly increase anti-tumor activity. The Replimune Group’s platform enables it to design a variety of candidate products, which contain various other genes whose expression is designed to enhance the inherent properties of HSV-1, directly destroy tumor cells and induce anti-tumor immune responses.

Replimune Group, Inc.’s lead product candidate, RP1, is currently undergoing a phase I/II clinical trial on approximately 150 patients with a series of solid tumors. The company has reached a cooperation agreement with Bristol-Myers Squibb Company (BMS) , according to which Bristol-Myers Squibb granted Replimune a non-exclusive royalty-free license and provided its anti-PD-1 therapy nivolumab for free in this clinical trial in combination with RP1 use. The first part of the clinical trial is being carried out in the UK, and the company is planning to conduct the second part of the clinical trial. The trial will recruit patients with 4 types of solid tumors in the UK. The product’s investigational new drug application (IND) in the United States is currently pending approval .

In addition, Replimune Group, Inc. has also signed a cooperation agreement with Regeneron Pharmaceuticals, Inc. , under which the company plans to jointly develop RP1 with Regeneron’s anti-PD-1 therapy, cemiplimab. For each clinical trial conducted under this cooperation, Regeneron will fund half of the clinical trial cost, provide cemiplimab free of charge, and grant a non-exclusive, royalty-free license for the Replimune cemiplimab product for use in clinical trials. The first planned clinical trial under this collaboration will be conducted in the first half of 2019. It is a randomized, controlled phase II clinical trial. It will be used in combination with RP1 and cemiplimab and compared with cemiplimab alone. It will be used in approximately 240 cases of skin Carried out in patients with squamous cell carcinoma (CSCC). If convincing clinical data is produced to prove the benefits of the combination therapy, the company believes that the data from the trial can support the submission of an application to regulatory agencies to obtain marketing approval.

In addition, Replimune Group, Inc. also plans to start clinical trials of its second product candidate RP2 in the first half of 2019.

Oncolytic immunotherapy is an emerging cancer treatment method that utilizes the ability of certain viruses to selectively replicate and directly kill tumors, and to induce effective, patient-specific anti-tumor immune responses. Although it has clinical activity alone, oncolytic immunotherapy can have a synergistic effect with certain other treatments, especially with immune checkpoint blocking therapy. Recently, immune checkpoint blockade therapy has been established for the treatment of cancer, but only for patients with sustained anti-tumor immune response, that is, their tumors are immunologically “hot”. Replimune Group’s product candidates are designed to induce a strong immune response against cancers in patients, including new antigens uniquely present in tumors. The goal is to improve the immune response to “hot” tumors and make immune “cold” tumors “hot”. “And enable patients to respond to immune checkpoint block therapy.

Replimune Group (REPL) investment:

Replimune Group, Inc. (NASDAQ: REPL) submitted its IPO prospectus on 6/22/2018 and listed on Nasdaq on 7/19/2018 with an issue price of US$15.00. It issued 6.7 million shares and raised US$105 million. Joint underwriting by JP Morgan / Leerink Partners/ BMO Capital Markets .

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