On April 5, 2020, Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company") and Sanofi Biotechnology SAS ("Sanofi") reported that it has entered into the Third Amendment to Amended and Restated License and Collaboration Agreement (the "Third Amendment"), which amends the Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009, by and between the Company and Sanofi (as successor in interest to Aventis Pharmaceuticals Inc. and Sanofi-Aventis Amérique Du Nord), as amended (the "Antibody LCA") (Filing, 8-K, Regeneron, APR 5, 2020, View Source [SID1234556163]). The Antibody LCA provides for the development, manufacture, and commercialization of certain antibody products, including, prior to April 1, 2020 (and prior to giving effect to the Third Amendment), Praluent (alirocumab). On April 5, 2020, the Company and Sanofi also entered into the Praluent Cross License & Commercialization Agreement (the "Praluent Agreement" and, together with the Third Amendment, collectively, the "Agreements"). The Agreements are each effective from and after April 1, 2020. As described in greater detail below, the Agreements together effect the previously announced restructuring of the parties’ antibody collaboration in respect of Praluent.

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Third Amendment. Under the Third Amendment, Sanofi and the Company amended the Antibody LCA, among other things, to remove Praluent from the Antibody LCA such that (a) effective April 1, 2020, the Antibody LCA no longer governs the development, manufacture, or commercialization of Praluent and (b) the quarterly period ended March 31, 2020 is the last quarter for which Sanofi and the Company will share profits and losses for Praluent under the Antibody LCA. Notwithstanding the foregoing, net product sales of Praluent outside the United States will continue to be taken into account to determine (x) each party’s percentage share of profits and losses outside the United States from the products that continue, from and after April 1, 2020, to be governed by the Antibody LCA and (y) the milestones applicable to net product sales outside the United States under the Antibody LCA.

Praluent Agreement. Under the Praluent Agreement, effective April 1, 2020, the Company, at its sole cost, is solely responsible for the development and commercialization of Praluent in the United States, and Sanofi, at its sole cost, is solely responsible for the development and commercialization of Praluent outside of the United States. Each of the Company and Sanofi will obtain an exclusive license under certain intellectual property rights of the other party to commercialize Praluent in the United States and outside the United States, respectively. Because before April 1, 2020 Sanofi was, under the Antibody LCA, responsible for commercializing Praluent in the United States, Sanofi will transfer to the Company certain assets relating to the commercialization of Praluent in the United States.

Sanofi will pay the Company a 5% royalty on Sanofi’s net product sales of Praluent outside the United States until March 31, 2032. The Company will not owe Sanofi royalties on the Company’s net product sales of Praluent in the United States.

Although each party will be responsible for manufacturing Praluent for its respective territory, the parties have entered into definitive supply agreements under which, for a certain transitional period (a) the Company will continue to supply drug substance to Sanofi and (b) Sanofi will continue to supply finished product to Regeneron.

With respect to any intellectual property or product liability litigation relating to Praluent, the parties have agreed that, effective April 1, 2020, Regeneron and Sanofi each will be solely responsible for any such litigation (including damages and other costs and expenses thereof) in the United States and outside the United States, respectively, arising out of Praluent sales or other activities on or after April 1, 2020. The parties will each bear 50% of any damages arising out of Praluent sales or other activities prior to April 1, 2020. If Sanofi is obligated to pay any third-party royalties on Praluent sales outside the United States after April 1, 2020 as a result of certain patent litigation proceedings, then Sanofi will have the right to set off 50% of such third-party royalty payments against up to 50% of any Praluent royalty payment owed to Regeneron.

The foregoing description of the Third Amendment and the Praluent Agreement is qualified in its entirety by reference to the full text of the Third Amendment and the Praluent Agreement, respectively, a copy of each of which will be filed with the U.S. Securities and Exchange Commission as an exhibit to the Quarterly Report on Form 10-Q to be filed by the Company for the quarterly period ending June 30, 2020.

On April 5, 2020 Samsung Biologics (207940.KS) reported that it has entered into a strategic partnership with PharmAbcine for the development and manufacturing of PMC-402 pipeline, a next generation therapeutic antibody candidate to treat oncology and neovascular disorders (Press release, Samsung Bioepis, APR 5, 2020, View Source [SID1234556134]). Under this agreement, Samsung will provide the full scope of its CDO services from cell line development, process development, cGMP clinical manufacturing to IND filing support.

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PharmAbcine is a clinical-stage biotech company developing fully human therapeutic antibodies to treat cancer and neovascular disease. Olinvacimab, the company’s lead molecule, is currently in phase II clinical trials for a combination therapy to treat cancer with Merck’s Keytruda.

According to PharmAbcine, PMC-402 is expected to enhance the delivery of immune cells and cancer therapeutics to treat tumor cells via active normalization of leaky blood vessels. Attributable to its vessel normalization characteristics, PharmAbcine plans to expand the indication to eye diseases such as wAMD (wet age-related macular degeneration) and DR (diabetic retinopathy).

"The anti-cancer effect of PMC-402, both as a monotherapy and a combination therapy with immuno-cancer drugs, was confirmed through initial research. From this year, we will test the safety of PMC-402 and initiate phase I clinical trial by 2021 through collaboration with Samsung Biologics," said Jin-San Yoo, CEO of PharmAbcine.

"Offering full range of services in development, manufacturing, and laboratory testing from our state-of-the-art facilities, Samsung Biologics works intimately with our clients to reach IND and market Faster & Better," said Tae-Han Kim, CEO of Samsung Biologics. He added, "Through partnership with Samsung Biologics, biotech companies can not only benefit from fast timeline and high-quality products, but also concentrate on discovery activity, a core aspect of their business."

Samsung Biologics has played a significant role in the global biopharma landscape by establishing a global scale bio-ecosystem for biotech companies. With the announced opening of its US CDO R&D center in San Francisco later this year, Samsung expects to support more clients around the globe with maximum client satisfaction.

On April 3, 2020, Inovio Pharmaceuticals, Inc. (the "Company") reported that it has entered into an At-The-Market Equity Offering Sales Agreement (the "Sales Agreement") with Stifel, Nicolaus & Company, Incorporated ("Stifel") under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.001 per share (the "Common Stock"), through Stifel as its sales agent (Filing, 8-K, Inovio, APR 3, 2020, View Source [SID1234556124]). The Company has filed a prospectus supplement pursuant to the Sales Agreement for the offer and sale of its Common Stock having an aggregate offering price of up to $150,000,000.

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Pursuant to the Sales Agreement, sales of the Common Stock, if any, will be made under the Company’s previously filed and effective Registration Statement on Form S-3 (File No. 333-237172) and an applicable prospectus supplement, by any method that is deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended. Subject to the terms and conditions of the Sales Agreement, Stifel may sell the Common Stock by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended. Stifel will use commercially reasonable efforts to sell the Common Stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay Stifel a commission of up to three percent (3.0%) of the gross sales proceeds of any Common Stock sold through Stifel under the Sales Agreement, and also has provided Stifel with certain indemnification rights.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed herewith as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On April 3, 2020 Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell & gene therapy company, is reported that China National Medical Products Administration (NMPA) has accepted Gracell’s Investigational New Drug (IND) application for GC007g, a donor-derived anti-CD19 chimeric antigen receptor (CAR-T) cell therapy (Press release, Gracell Biotechnologies, APR 3, 2020, View Source [SID1234556125]).

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GC007g is an allogenic CAR-T therapy under development for B-ALL patients who relapsed or refractory from prior treatment. The therapy utilizes healthy T cells from human leukocyte antigens (HLA) matching donors, with potentially better T cell fitness, and possibly higher efficacy compared to the use of patient’s own T cells. The company plans to initiate a phase 1 clinical study in patients with CD19 positive relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) in Q2, 2020.

"The IND approval for GC007g marks a significant milestone for Gracell." said Dr. William CAO, founder and CEO of Gracell, "We are delighted that this first-of-its-kind CAR-T program will soon be evaluated in IND approved clinical trials. We expect donor-derived CAR-T therapy, GC007g may become a good alternative solution to the r/r B-ALL patients who may not be eligible for autologous CAR-T therapy due to infections and other conditions, to those who do not respond to autologous CAR-T therapy, or to those whose CAR-T cells fail to be manufactured successfully".

About GC007g
GC007g is an investigational CD19-targeted CAR-T cell therapy, where HLA matching donors’ T cells were employed to redirected to eradicate CD19 positive leukemia cells.

About B-ALL
B-ALL, a major form of acute lymphoblastic leukemia (ALL), is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 501. In 2015, ALL affected around 837,000 people globally and resulted in 110,000 deaths worldwide2. It is also the most common cause of cancer and death from cancer among children. First onset ALL is typically treated with long term chemotherapy. In case of relapsed or refractory disease immunotherapy monoclonal antibodies may be an option in certain subtypes while CART therapy may be an option for patients 25 and younger.

On April 3, 2020 Dilon Technologies Inc., a world class global leader in breast cancer treatment and diagnosis and owner of the Navigator Gamma Probes reported that it has acquired substantially all the assets of Dune Medical, including Marginprobe’s "MarginProbe" (Press release, Dune Medical Devices, APR 3, 2020, View Source [SID1234560783]).

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"With the acquisition of the MarginProbe, Dilon will now offer the only FDA approved device for identifying positive margins during breast conservation surgery. MarginProbe’s patented RF technology differentiates cancerous versus healthy tissue in real-time. This allows surgeons to immediately remove additional tissue, helping to reduce avoidable surgeries" said Dilon’s Chairman, Bob Moussa, who continued, "The synergy between Dilon’s Navigator Gamma Probes and the MarginProbe will help patients and physicians answer the question, "did we get it all?" when that answer is most needed. In addition to the advantages to the patients, the reduction in re-excision rate will provide major savings to health care systems."

As a global provider of breast cancer solutions, Dilon’s Navigator Gamma Probes are used for radio-guided lymphatic mapping and tumor localization world-wide. "The combination of Dilon’s class leading Navigator Gamma Probes with the MarginProbe is a natural fit. Dilon’s already strong sales network is synergistic and well suited to expand the MarginProbe’s potential as the products are literally used side by side by the same physician; now they will be sold that way as well. The market in the United States alone exceeds $150m annually, and as a US based company, Dilon has a home field advantage in the MarginProbe’s biggest market. Luminaries and thought leaders have already adopted MarginProbe as their standard of care in the US. Our goal is to make MarginProbe the standard of care worldwide."