On June 25, 2020 GNS Healthcare, an AI-driven precision medicine company, reported the launch of GeminiTM, the in silico multiple myeloma patient (Press release, GNS Healthcare, JUN 25, 2020, View Source [SID1234561492]). The in silico patient is a highly accurate computer model of disease progression and drug response at the individual patient level. Clinical development applications include discovering markers of response/nonresponse for clinical trial design, predicting optimal combination therapies, and running head-to-head in silico trials. Market access applications include generating evidence for line of therapy switching and optimizing treatment sequencing.

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Drawing from large quantities of molecular, genomic, and clinical data, this in silico patient represents a culmination of almost a decade of research and development in collaboration with several biopharmaceutical companies, academic medical centers, and the Multiple Myeloma Research Foundation (MMRF). GNS and MMRF recently announced a five-year collaboration which seeks to answer key questions for multiple myeloma patients. GeminiTM includes the drug mechanisms most commonly used to treat multiple myeloma – such as proteasome inhibitors, IMIDs, corticosteroids, alkylating agents, anti-SLAMF7, anti-CD38, and others, connecting the impact of these drugs to clinical endpoints including progression free survival (PFS) and overall survival (OS). Previous results from the in silico multiple myeloma patient have been presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and recently published in Leukemia.

"Over the past decade there have been a dozen treatments approved for multiple myeloma but there is still a lack of evidence to ensure patients receive optimal treatments in first line and subsequent lines of therapy," said GNS Chairman and CEO, Colin Hill. "Creating Gemini, the in silico patient, allows us to break the bottleneck of understanding what treatments work for which patients, driving better clinical trial design, generating real-world evidence for market positioning and ultimately creating better outcomes for patients."

"We are reaching a tipping point where patient data is becoming rich and multi-layered enough to power AI models that can help predict patient response at the individual level. This announcement represents a true step forward in personalizing cancer treatment," said Dr. Ravi Parikh, an Oncologist and instructor of Medical Ethics and Health Policy in the Perelman School of Medicine at the University of Pennsylvania.

To support the future formation of in silico patients, GNS recently convened an in silico patient advisory board to guide development and commercialization strategy. The in silico patient for multiple myeloma represents the first of several poised to expand the world’s understanding of causal response to therapeutics across a range of diseases within oncology, immunology, and neurology.

On June 25, 2020 Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the closing of an additional 3,375,000 shares of common stock pursuant to the full exercise of the underwriters’ option to purchase additional shares from Leap’s previously announced public offering (Press release, Leap Therapeutics, JUN 25, 2020, View Source [SID1234561476]). After giving effect to the full exercise of the option, the aggregate gross proceeds to Leap from this offering were approximately $51.75 million, before deducting underwriting discounts and commissions and other offering expenses payable by Leap.

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Piper Sandler & Co. and Raymond James & Associates, Inc. acted as book-running managers for the offering. Robert W. Baird & Co. Incorporated acted as the lead manager. H.C. Wainwright & Co. and Ladenburg Thalmann & Co. Inc. acted as co-managers.

The securities were offered and sold pursuant to an effective shelf registration statement on Form S-3 (File No. 333-223419) that was previously filed by Leap with the Securities and Exchange Commission (the "SEC") on March 2, 2018 and was declared effective by the SEC on March 16, 2018. A preliminary prospectus supplement and the related prospectus has been filed with the SEC and will be available for free on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN, 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected] or Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, or by telephone at (800) 248-8863, or e-mail at [email protected].

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 June 25, 2020 Nurix Therapeutics, Inc., a company developing targeted protein modulation drugs, reported the formation of a new adoptive cell therapy company, DeCART Therapeutics, which has been initially formed as a wholly owned subsidiary of Nurix (Press release, Nurix Therapeutics, JUN 25, 2020, View Source [SID1234561493]). DeCART plans to combine the use of Nurix’s proprietary targeted protein modulation drugs with the latest T cell genetic engineering technologies to create a drug-enhanced chimeric antigen receptor T cell (CAR T) process for cancer. DeCART has been founded by Nurix in partnership with Carl June, M.D., the Richard W. Vague Professor in Immunotherapy and director of the Center for Cellular Immunotherapies in the Abramson Cancer Center of the University of Pennsylvania,. Dr. June will lead the DeCART founding team and also serve as the chairman of DeCART’s scientific advisory board.

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"On behalf of the founding team, we are very excited to launch DeCART and begin implementing our first drug-enhanced CAR T process with a goal of rapidly advancing towards clinical development," said Dr. June, "We are encouraged by the preclinical results using CBL-B inhibitors to improve T cell phenotype in a manner that is consistent with delivering anti-tumor activity."

DeCART’s first program is expected to use Nurix’s small molecule CBL-B inhibitor, NX-0255, for ex vivo enhancement of T cell biology throughout the processing and engineering of CAR T cells. CBL-B is an E3 ligase target that functions as an intracellular immune checkpoint that regulates T cell activation and immune response. DeCART will explore development and commercialization of CAR T cell therapies for both hematologic and solid tumors.

"We are very pleased to work with leaders from the powerful research, clinical, and management team that have made history at the University of Pennsylvania with the first regulatory approval and commercialization of CART19 therapy," said Arthur T. Sands, M.D., Ph.D., chief executive officer of Nurix. "Together with DeCART, we plan to introduce a new generation of drug-enhanced CAR T products for patients by integrating pharmacologic control of protein levels within T cells."

DeCART Therapeutics plans to establish operations in Cellicon Valley in the Philadelphia area and will be managed by Ms. Dana Hammill as its chief operating officer. Ms. Hammill is the former director of strategy and business development at the Center for Cellular Immunotherapies at the Perelman School of Medicine at the University of Pennsylvania where she co-managed Penn-Novartis alliance for commercialization of CART19. Dr. Sands will serve as chairman of the board of directors of DeCART.

On June 25, 2020 Hutchison China MediTech Limited ("Chi-Med" or the "Company") (Nasdaq/AIM: HCM) reported that it has entered into a definitive agreement for the sale of US$100 million of shares at a price equivalent to US$25.00 per American Depositary Share ("ADS") via a private placement to General Atlantic, a leading global growth equity firm (Press release, Hutchison China MediTech, JUN 25, 2020, https://www.chi-med.com/us100-million-equity-investment-by-general-atlantic/ [SID1234561459]). This fundraise could increase to US$200 million, through a warrant granted with a term of 18 months for a further US$100 million in Chi-Med shares exercisable at a price per share equivalent to US$30.00 per ADS, a 32.5% premium to the 30-day VWAP.

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Chi-Med is delivering on its strategic intention to become a global oncology business. In 2020, there has been significant progress in building an innovative, global, science-focused biopharmaceutical company including three U.S. Food and Drug Administration (FDA) Fast Track Designations for fruquintinib in metastatic colorectal cancer and surufatinib for two forms of advanced neuroendocrine tumors. The submission of a New Drug Application (NDA) for surufatinib in the United States is also planned for later this year.

Chi-Med will receive all proceeds from this private placement, which will fund ongoing research and clinical development and support the further growth of its commercialization capabilities both in China and globally.

This financing also highlights the strong commitment General Atlantic is making to Chi-Med. General Atlantic has 40 years’ experience in investing in global growth equity companies, with a demonstrated history in the biopharma sector, and has approximately US$34 billion of assets under management. It has a broad portfolio of life science company investments with whom they constructively partner to support further growth.

Mr. Christian Hogg, Chief Executive Officer of Chi-Med, said, "Over the last few months, we have made significant development, regulatory and commercial progress in several oncology programs intended for the global market. We are delighted therefore to welcome General Atlantic to our existing shareholder base and to further strengthen our balance sheet. We are confident that in this phase of material progress for Chi-Med we can deliver innovative cancer therapies to patients internationally."

Mr. David Hodgson, Vice Chairman of General Atlantic, said, "General Atlantic is committed to supporting innovation in the global life sciences industry. Chi-Med has built a deep pipeline of assets powered by its robust research and development engine. We endorse Chi-Med’s strategy to become a leading biopharma innovator and will leverage our global organization in support of Chi-Med’s mission to deliver safe and effective therapeutics to cancer patients in need around the world."

Mr. Lefei Sun, Managing Director and Head of Healthcare for China at General Atlantic, continued, "We believe Chi-Med is a pioneer of the Chinese biotech market in bringing advanced oncology therapies to the world. We are delighted to partner with Chi-Med to help unlock future value."

Chi-Med has agreed to issue the equivalent of 4,000,000 ADSs in a private placement to General Atlantic at a price equivalent to US$25.00 per ADS, resulting in aggregate gross proceeds of US$100 million to Chi-Med. The purchase price represents a 10.4% premium to the 30-day VWAP. The Company has also granted a warrant to General Atlantic to purchase up to an additional equivalent of 3,333,334 ADSs, at an exercise price equivalent to US$30.00 per ADS, and a term of 18 months.

Description of Share Capital and Securities Regulation
Each ADS represents five ordinary shares, par value US$0.10 each (the "Shares"). The new Shares to be issued by Chi-Med including shares issuable upon exercise of the warrant, pursuant to the private placement will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing ordinary shares of Chi-Med.

The securities to be sold in the private placement will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Subject to certain conditions, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the Shares sold in the private placement and the Shares issuable upon exercise of the warrant to facilitate future resales by General Atlantic. Any offering of the securities under the resale registration statement will only be made by means of a prospectus. General Atlantic has the right to appoint an observer or a representative director to the board of directors of the Company upon achieving certain ownership thresholds in the future.

This announcement, including any information included or incorporated by reference in this announcement, is for information purposes only and shall not constitute nor form part of, and should not be construed as, an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. No public offering of the securities referred to in this announcement is being made in the United States or elsewhere.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.

Admission to the London Stock Exchange AIM market and Shares Outstanding After Completion
The private placement of 20,000,000 Shares (equivalent to 4,000,000 ADSs) to General Atlantic will comprise the issuance of 18,700,000 Shares ("First Tranche Shares") and the issuance of 1,300,000 Shares ("Second Tranche Shares"). Application will be made to the London Stock Exchange for the First Tranche Shares and the Second Tranche Shares to be admitted to the AIM market operated by the London Stock Exchange ("Admission"). It is expected that admission of the First Tranche Shares will become effective at 8:00 a.m. British Summer Time on July 3, 2020 and admission of the Second Tranche Shares will become effective at 8:00 a.m. British Summer Time on July 6, 2020.

Following admission of the First Tranche Shares to trading on AIM, the issued share capital of Chi-Med will consist of 709,274,765 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. Following admission of the Second Tranche Shares to trading on AIM, the issued share capital of Chi-Med will consist of 710,574,765 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. The figure of 709,274,765 (following admission of the First Tranche Shares but prior to admission of the Second Tranche Shares) and the figure of 710,574,765 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, Chi-Med under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

For illustrative purposes only, if the 710,574,765 ordinary shares were converted in their entirety, they would be equivalent to 142,114,953 Nasdaq-traded ADSs (each equating to five ordinary shares).

In addition, the Company will apply for the block listing of up to 16,666,670 new ordinary shares in accordance with the block listing process under Rule 29 of the AIM Rules for Companies to cover the potential exercise of the warrant. The new ordinary shares subject to the block admission will not be allotted immediately, but rather will be issued and allotted on exercise of the warrant from time to time. The Company will make six-monthly announcements of the utilization of the block listing, in line with its obligations under Rule 29 of the AIM Rules for Companies. The expected effective date of admission of these securities to AIM is on July 6, 2020.

About General Atlantic
General Atlantic is a leading global growth equity firm providing capital and strategic support for growth companies. Established in 1980, General Atlantic combines a collaborative global approach, sector specific expertise, a long-term investment horizon and a deep understanding of growth drivers to partner with great entrepreneurs and management teams to build exceptional businesses worldwide. The firm’s global Life Sciences portfolio includes Adagene, CANbridge, Ginkgo Bioworks, Immunocore, Motif FoodWorks, Ocumension, PathAI, and Royalty Pharma. General Atlantic has more than 150 investment professionals based in New York, Amsterdam, Beijing, Greenwich, Hong Kong, Jakarta, London, Mexico City, Mumbai, Munich, Palo Alto, São Paulo, Shanghai, and Singapore. For more information on General Atlantic, please visit the website: www.generalatlantic.com.

On June 25, 2020 Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported the publication of a new research paper released today in Frontiers in Bioengineering and Biotechnology (Press release, Cellectis, JUN 25, 2020, View Source [SID1234561477]). This article describes an innovative and easy-to-implement procedure which will streamline the manufacturing of allogeneic ‘off-the-shelf’ CAR T-cell therapies.

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The methodology described in this article defines a novel non-mechanical purification strategy to generate TCRαβ negative (allogeneic) cells for CAR T-cell therapies. With an early and transient expression of an anti-CD3 CAR in the engineered donor T-cells, Cellectis programed these cells to self-eliminate the remaining TCR+ cell population and obtained an ultrapure TCRαβ(-) population (up to 99.9%) at the end of the CAR-T production.

"We propose a novel, modular and broadly implementable methodology that can efficiently eliminate residual TCRαβ+ cells during the early steps of the allogeneic CAR T-cell generation process without altering key characteristics (T-cell differentiation, exhaustion markers, proliferative capacity and target cell killing capacity)", said Alexandre Juillerat, Ph.D., Team Leader, Innovation Department and NY Laboratory Head, Cellectis. "This study provides a proof of concept to produce the next generation of allogeneic ‘off-the-shelf’ CAR T-cell therapies," he added.

Using Cellectis’ proprietary technologies, TALEN gene editing together with our PulseAgile cell electroporation device, the innovation team developed a new strategy to achieve purification levels compatible with manufacturing and clinical requirements, including the prevention of GvHD. This new method offers optimal outcome for potential future applications in both liquid and solid tumor development programs.

Alexandre Juillerat, Ph.D., Team Leader, Innovation Department and NY Laboratory Head, Cellectis

Alexandre Juillerat, Ph.D., graduated in Chemistry from the University of Lausanne, Switzerland. After receiving his Ph.D. in 2006 in protein engineering from the École Polytechnique Fédérale de Lausanne (EPFL, Switzerland), he moved to the laboratory of Structural Immunology at the Institut Pasteur in Paris, France. In 2010, he joined the R&D department of Cellectis in Paris, France, working on the development and implementation of sequence specific designer nucleases including the transcription activator-like effector nucleases (TALEN). He then joined the Cellectis facility based in New York, NY, leading projects associated with the development of the T-cell chimeric antigen receptor (CAR) technology. Cellectis’ New-York-based innovation team is constantly at the forefront of pioneered research, inventing and generating robust, first-in-class allogeneic CAR T-cell product candidates that address multiple unmet cancer needs.