Cellectis Wins Patent Challenge in Europe for a Method Using CRISPR-Cas9 for Gene Editing in T-Cells

On November 20, 2019 Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported that European Patent EP3004337, which claims a method of preparing T-cells for immunotherapy using the CRISPR-Cas9 system, initially granted on August 2, 2017, has been upheld by the European Patent Office (EPO) following an opposition procedure initiated in May 2018 (Press release, Cellectis, NOV 20, 2019, View Source [SID1234551531]).

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European Patent EP3004337 claims a method of genetically modifying T-cells by introduction into the cells and/or expression in the cells of an RNA-guided endonuclease, and a specific guide RNA that directs an endonuclease to at least one targeted locus in the T-cell genome, where it is expressed from transfected mRNA and guide RNA is expressed in the cells as a transcript from a DNA vector. The patent also covers the expansion phase of the resulting cells in vitro.

The inventors of this patent are Dr. André Choulika, Chairman and CEO, Cellectis, Dr. Philippe Duchateau, Chief Scientific Officer, Cellectis and Dr. Laurent Poirot, VP, Immunology Department, Cellectis.

Celgene Announces Plans to Transfer Listing of Celgene’s Contingent Value Rights Following Closing of Acquisition by Bristol-Myers Squibb

On November 20, 2019 Celgene Corporation (NASDAQ: CELG) reported that following the completion of Celgene’s acquisition by Bristol-Myers Squibb Company (NYSE: BMY), Bristol-Myers Squibb and Celgene plan to transfer the listing of Celgene’s contingent value rights (NASDAQ: CELGZ) ("Celgene CVRs") that are related to Celgene’s ABRAXANE product from the NASDAQ Global Market to the New York Stock Exchange ("NYSE") (Press release, Celgene, NOV 20, 2019, View Source [SID1234551530]). As a result, Celgene notified the NASDAQ Global Market today of its intent to initiate the voluntary delisting of the Celgene CVRs. The Celgene CVRs are expected to begin trading on the NYSE under the symbol "CELGRT" following their official delisting from the NASDAQ Global Market, which is expected to occur on December 2, 2019.

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Bristol-Myers Squibb Completes Acquisition of Celgene, Creating a Leading Biopharma Company

On November 20, 2019 Bristol-Myers Squibb Company (NYSE:BMY) reported that it has completed its acquisition of Celgene Corporation (NASDAQ:CELG) following the receipt of regulatory approval from all government authorities required by the merger agreement and, as announced on April 12, 2019, approval by Bristol-Myers Squibb and Celgene stockholders (Press release, Bristol-Myers Squibb, NOV 20, 2019, View Source [SID1234551529]).

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Upon completion of the acquisition, pursuant to the terms of the merger agreement, Celgene became a wholly owned subsidiary of Bristol-Myers Squibb Company. Under the terms of the merger, Celgene shareholders received for each share, 1.00 share of Bristol-Myers Squibb common stock, $50.00 in cash without interest and one tradeable Contingent Value Right (CVR), which will entitle the holder to receive a payment of $9.00 in cash if certain future regulatory milestones are achieved. Celgene common stock ceased trading as of the close of trading today. On November 21, 2019, newly issued Bristol-Myers Squibb shares and CVRs will commence trading on the New York Stock Exchange, with the CVRs trading under the symbol "BMYRT."

"This is an exciting day for Bristol-Myers Squibb as we bring together the leading science, innovative medicines and incredible talent of Bristol-Myers Squibb and Celgene to create a leading biopharma company," said Giovanni Caforio, M.D., Chairman and Chief Executive Officer of Bristol-Myers Squibb. "With our leading franchises in oncology, hematology, immunology and cardiovascular disease, and one of the most diverse and promising pipelines in the industry, I know we will deliver on our vision of transforming patients’ lives through science. I am excited about the opportunities for our current employees and the new colleagues that we welcome to the Company as we work together to deliver innovative medicines to patients."

Since announcing the transaction on January 3, 2019, there have been a number of tangible advancements toward delivering on the key value drivers for the merger, including: further progress relating to the patent estate for REVLIMID, the U.S. Food and Drug Administration (FDA) approval of INREBIC (fedratinib) for the treatment of certain forms of myelofibrosis, the U.S. FDA approval of REBLOZYL (luspatercept-aamt) for the treatment of anemia in certain adult patients with beta thalassemia, and regulatory filings of luspatercept and ozanimod in the U.S. and Europe. The Company has also made substantial progress toward the planning of a successful integration. For an overview of the combined company and the milestones achieved while the transaction was pending, visit www.bestofbiopharma.com.

OTEZLA Divestiture Update

As announced on August 26, 2019, in connection with the regulatory approval process for the transaction, Celgene entered into an agreement to divest the global rights to OTEZLA (apremilast) to Amgen (NASDAQ:AMGN) for $13.4 billion in cash following the closing of the merger with Bristol-Myers Squibb. On November 15, 2019, Bristol-Myers Squibb announced that the U.S. Federal Trade Commission (FTC) accepted the proposed consent order in connection with the pending merger of Bristol-Myers Squibb and Celgene, thereby permitting the parties to close the merger. Bristol-Myers Squibb expects the OTEZLA divestiture to be completed promptly following the closing of the merger and plans to prioritize the use of proceeds for debt reduction.

Accelerated Share Repurchase Program

Bristol-Myers Squibb also announced that its Board of Directors has authorized the repurchase of $7 billion of Bristol-Myers Squibb common stock.

In connection with this authorization, Bristol-Myers Squibb has entered into accelerated share repurchase (ASR) agreements with Morgan Stanley & Co. LLC and Barclays Bank PLC to repurchase, in aggregate, $7 billion of Bristol-Myers Squibb common stock. Bristol-Myers Squibb expects to fund the repurchase with cash on-hand. Approximately 80 percent of the shares to be repurchased under the transaction will be received by Bristol-Myers Squibb on November 27, 2019. The total number of shares ultimately repurchased under the program will be determined upon final settlement and will be based on a discount to the volume-weighted average price of Bristol-Myers Squibb’s common stock during the ASR period. Bristol-Myers Squibb anticipates that all repurchases under the ASR will be completed by the end of the second quarter of 2020.

Board Appointments

As previously announced, in connection with the closing of the transaction, Michael Bonney, Dr. Julia A. Haller and Phyllis Yale have joined the Bristol-Myers Squibb Board of Directors, expanding the size of the Board from 11 to 14. Mr. Bonney and Dr. Haller served on Celgene’s Board of Directors until the closing of the transaction. All three new directors bring valuable skill sets and significant experience relevant to Bristol-Myers Squibb’s business.

Advisors

Morgan Stanley & Co. LLC is serving as lead financial advisor to Bristol-Myers Squibb, and Evercore and Dyal Co. LLC are serving as financial advisors to Bristol-Myers Squibb. Kirkland & Ellis LLP is serving as Bristol-Myers Squibb’s legal counsel. J.P. Morgan Securities LLC is serving as lead financial advisor and Citi is acting as financial advisor to Celgene. Wachtell, Lipton, Rosen & Katz is serving as legal counsel to Celgene.

Pfenex to Present at the Piper Jaffray 31st Annual Healthcare Conference

On November 20, 2019 Pfenex Inc. (NYSE American: PFNX) is a development and licensing biotechnology company reported on leveraging its Pfēnex Expression Technology to develop and improve protein therapies for unmet patient needs (Press release, Pfenex, NOV 20, 2019, View Source [SID1234551528]). Using the patented Pfēnex Expression Technology platform, the Company has developed the FDA-approved PF708 product indicated for the treatment of osteoporosis in certain patients at high risk of fracture and created an advanced pipeline of therapeutic equivalents, biologics and vaccines. The Company announced today that Eef Schimmelpennink, President and Chief Executive Officer, will be presenting at the Piper Jaffray 31st Annual Healthcare Conference on Wednesday, December 4th, taking place at the Lotte New York Palace in New York.

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Piper Jaffray 31st Annual Healthcare Conference
Date: Wednesday, December 4, 2019
Time: 10:00 a.m. Eastern Time

Interested parties can access the live audio webcast and archive from the Investors Section of Pfenex’s website at www.pfenex.com.

Neon Therapeutics Reports Announces New Strategic Focus on Novel T Cell Programs

On November 20, 2019 Neon Therapeutics, Inc. (Nasdaq: NTGN) reported its new strategic focus on the development of its novel neoantigen-based T cell programs, in conjunction with a corporate restructuring (Press release, Neon Therapeutics, NOV 20, 2019, View Source [SID1234551527]). Neon will focus its efforts on the advancement of both personal and precision neoantigen-targeted T cell therapy candidates. Neon’s most advanced program is NEO-PTC-01, its personal neoantigen-targeted T cell therapy candidate consisting of multiple T cell populations targeting the most therapeutically relevant neoantigens from each patient’s tumor. Neon expects to file a Clinical Trial Application (CTA) in Europe by the end of 2019 to evaluate NEO-PTC-01 in patients with metastatic melanoma who are refractory to checkpoint inhibitors.

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"Prioritizing development of novel T cell therapies will leverage our years of expertise and learnings in pioneering neoantigen science, while positioning Neon to best deliver new therapies that could potentially improve patient outcomes and bring value to shareholders. The strategic restructuring will enable us to focus resources to execute on this vision. We acknowledge this decision impacts many talented employees who helped build Neon into a leader in neoantigen-based-therapies and we are grateful for their many contributions," said Hugh O’Dowd, Neon’s Chief Executive Officer.

NEO-PTC-01 leverages Neon’s neoantigen platforms, including RECON, its machine-learning bioinformatics platform, and NEO-STIM, its proprietary process to directly prime, activate and expand neoantigen-targeting T cells ex vivo. Neon believes that this approach will allow NEO-PTC-01, a non-engineered product that leverages peripheral blood mononuclear cells (PBMCs) as starting material, to specifically target each patient’s individual tumor with T cells that can drive a robust and persistent anti-tumor response.

The initial clinical development of NEO-PTC-01 will be focused on demonstrating monotherapy activity targeting metastatic solid tumors that are refractory to checkpoint inhibitor therapy. Following the planned submission of a CTA by the end of 2019, the company plans to initiate a Phase 1 dose escalation clinical trial in second-line metastatic melanoma in collaboration with the Netherlands Cancer Institute. The second planned indication for NEO-PTC-01 is second-line metastatic ovarian cancer, with potential to expand to other solid tumor types and potential development in the United States.

"NEO-PTC-01 has the potential to unlock the potency of cell therapy in solid tumors with several key advantages that overcome the challenges of other cell therapy approaches. In pre-clinical development and in several patient samples, we have demonstrated the ability to produce multiple enriched neoantigen-specific CD8+ and CD4+ T cell populations, including both memory and de novo T cell responses, that killed patient-specific tumors by targeting their tumor neoantigens. We believe that neoantigen targets will provide the tumor specificity required to develop safe, effective and durable T cell therapies for the treatment of solid tumors," said Richard Gaynor, M.D., Neon’s President of Research and Development.

Neon is also advancing a precision T cell therapy program targeting shared neoantigens in genetically defined patient populations. This process utilizes off-the-shelf targets with a patient’s own PBMCs to develop a novel cell-based immunotherapy enabling rapid deployment for each patient. The lead program from this approach, NEO-STC-01, is a T cell therapy candidate targeting shared RAS neoantigens initially in pancreatic cancer and is currently in preclinical development.

Corporate Restructuring

As part of this new strategic focus, Neon is reducing its workforce by approximately 24% of its current headcount. At this time, Neon will cease undertaking new additional spending commitments related to its cancer vaccine programs, NEO-PV-01 and NEO-SV-01. The company will continue to conduct follow-up from its NT-002 clinical trial of NEO-PV-01 in first-line patients with untreated advanced or metastatic non-small cell lung cancer, with plans to report clinical data from this trial in the third quarter of 2020. Neon also plans to cease future enrollment in its NT-003 trial in metastatic melanoma. Neon believes these actions will improve its potential to bring value to patients, employees and shareholders. As part of these cost reduction efforts, Neon intends to explore strategic options.

Neon expects that the restructuring and other cost-saving efforts will result in approximately $35 million in annualized cost savings. Neon estimates that it will incur approximately $1.5 million of pre-tax charges for severance and other costs related to the restructuring in 2019. With this restructuring, Neon now expects that its cash, cash equivalents and marketable securities will enable it to fund its operating expenses and capital expenditure requirements into the third quarter of 2020.

There can be no assurance that Neon’s restructuring and other cost-saving efforts will be sufficient to continue the development of NEO-PTC-01 or its other programs through completion of the planned or ongoing clinical trials, nor that Neon’s exploration of strategic alternatives will result in any transaction being entered into or consummated. Neon has not set a timetable for completion of this strategic review process and Neon does not intend to comment further unless or until its board of directors has approved a definitive course of action, the review process is concluded, or it determines that disclosure is required or appropriate.