On October 29, 2019, Intrexon Corporation ("Intrexon") and TS AquaCulture LLC ("TS AquaCulture"), a Virginia limited liability company that is managed by Third Security, LLC ("Third Security"), reported that it has entered into a stock purchase agreement (the "Purchase Agreement"), pursuant to which, upon the terms set forth therein, TS AquaCulture purchased from Intrexon 8,239,199 shares of common stock, par value $0.001 per share, of AquaBounty Technologies, Inc., a Delaware corporation ("AquaBounty"), for an aggregate purchase price of $21,586,701.38 and Intrexon assigned to TS AquaCulture all of Intrexon’s rights, and TS AquaCulture accepted and assumed all of such rights and obligations, under the Relationship Agreement, dated as of December 5, 2012, by and between Intrexon and AquaBounty (Filing, 8-K, Intrexon, OCT 29, 2019, View Source [SID1234552291]).

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Randal J. Kirk and shareholders affiliated with him beneficially own approximately 46.2% of Intrexon’s voting stock. Mr. Kirk is Intrexon’s Chief Executive Officer and Chairman of Intrexon’s board of directors (the "Board") and currently serves as the Senior Managing Director and Chief Executive Officer of Third Security and owns 100% of the equity interests of Third Security. Third Security directly owns shares of Intrexon common stock and is also the manager of certain entities that directly own shares of Intrexon common stock, and therefore may be deemed to beneficially own approximately 34.7% of Intrexon’s common stock.

The Purchase Agreement was unanimously approved by the independent members of Intrexon’s Board of Directors, with the recommendation of the Audit Committee and an independent special committee of the Board.

The foregoing is a summary description of certain terms of the Purchase Agreement and, by its nature, is incomplete. A copy of the Purchase Agreement is filed herewith as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference. Intrexon encourages all readers to read the entire text of the Purchase Agreement.

On October 29, 2019 Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited off-the-shelf CAR T-cells (UCART), reported the Company has dosed the first patient in its UCARTCS1 clinical trial, MELANI-01, the first allogeneic off-the-shelf CAR-T product candidate the U.S. Food and Drug Administration (FDA) has cleared to enter into clinical development for relapsed/refractory multiple myeloma (R/R MM) (Press release, Cellectis, OCT 29, 2019, View Source [SID1234549963]). The UCARTCS1 clinical trial is a Phase 1 dose-escalation study to evaluate the safety, expansion, persistence and clinical activity of UCARTCS1 cells in R/R MM patients.

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"This first patient dosing for our MELANI-01 clinical trial is an important advancement, as our team has worked tirelessly to develop and take the CS1 target from the lab to the clinic," said Dr. André Choulika, Chairman and CEO, Cellectis. "In taking this next clinical step, we look forward to deepening our understanding of UCARTCS1 as a potential new treatment option for relapsed/refractory multiple myeloma patients in the future."

The MELANI-01 clinical trial is currently open at MD Anderson Cancer Center in Houston, Texas, under the supervision of Dr. Krina Patel, Principal Investigator, Study Coordinating Investigator, Assistant Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine at MD Anderson Cancer Center, as well as Hackensack Meridian in New Jersey under the supervision of Dr. David Siegel, Director of the Multiple Myeloma Institute at John Theurer Cancer Center (JTCC) at Hackensack University Medical Center. Another site is planned to open at Weill Cornell Medicine in New York under the leadership of Dr. Adriana Rossi, Associate Clinical Director, Myeloma Center and Assistant Professor of Medicine, Division of Hematology and Medical Oncology.

About Multiple Myeloma (MM)
Multiple myeloma is a cancer that affects a type of white blood cells called plasma cells that are specialized mature B cells, which secrete antibodies to combat infections. Multiple myeloma is characterized by the uncontrolled proliferation of neoplastic plasma cells in the bone marrow, where they overcrowd healthy blood cells. Although MM is a chronic disease and an exact cause has not yet been identified, researchers have made significant progress over the years in managing the disease through better understanding MM’s pathophysiology. The progress in finding a cure needs to be continued as The American Cancer Society estimates that 32,110 new cases of MM will be diagnosed, and 12,960 deaths are expected to occur in 2019 in the U.S. alone.

About UCARTCS1
UCARTCS1 is an allogeneic, off-the-shelf, gene-edited T-cell product candidate designed for the treatment of multiple myeloma. CS1 (SLAMF7) is highly expressed on MM tumor cells and is an attractive target. The limitation so far has been the presence of the CS1 target on the surface of T-cells, which has hindered the access to CAR-Ts. For example, the introduction of a CAR construct in T-cells induces cross T-cell reactivity and leads to destruction of the CS1+ T-cell population during manufacturing. Cellectis solved this issue by using TALEN gene editing to knock out the CS1 gene from T-cells before introducing the CS1 CAR construct.

On October 29, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) reported topline results from the primary analysis of the retrospective observational matched control cohort (Re-MIND) (Press release, MorphoSys, OCT 29, 2019, View Source [SID1234549979]). This study was designed to compare the effectiveness of lenalidomide monotherapy based on real-world patient data with the efficacy outcomes of the tafasitamab/lenalidomide combination, as investigated in MorphoSys’s L-MIND trial.

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Re-MIND collected outcome data from 490 non-transplant eligible patients with relapsed/ refractory diffuse large B cell lymphoma (r/r DLBCL) who had received lenalidomide monotherapy in the U.S. and the EU in a real-world setting. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible Re-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective response rates (ORR) were validated based on this subset of 76 patients in Re-MIND and L-MIND, respectively.

The primary endpoint of Re-MIND has been met and shows a statistically significant superior best ORR of the tafasitamab/lenalidomide combination compared to lenalidomide monotherapy. ORR was 67.1% (95% confidence interval (CI): 55.4-77.5) for the tafasitamab/ lenalidomide combination, compared to 34.2% (CI: 23.7-46.0) for the lenalidomide monotherapy (p<0.0001). Superiority was consistently observed across all secondary endpoints, including complete response (CR) rate (tafasitamab/lenalidomide combination 39.5%; CI: 28.4-51.4 versus lenalidomide monotherapy 11.8%; CI: 5.6-21.3; p<0.0001), as well as in pre-specified statistical sensitivity analyses. In addition, there was a significant difference observed in overall survival, which was not reached in the tafasitamab/lenalidomide combination as compared to 9.3 months in the lenalidomide monotherapy (hazard ratio 0.47; CI: 0.30-0.73; p<0.0008).

"Encouraged by the results we achieved with the real-world data approach, we re-affirm our plans to pursue advancement of tafasitamab to market in combination with lenalidomide as a potential, chemo-free treatment option for patients with r/r DLBCL, subject to FDA approval. The data announced today complement the previously published data of the single-arm
L-MIND study and MorphoSys has started the rolling submission of our BLA to the FDA, which we plan to complete by end of this year," commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG.

"I’m very excited about this real-world data approach of the Re-MIND trial to isolate a single-agent contribution of tafasitamab in combination with lenalidomide in a matched patient population in r/r DLBCL. This study further strengthens the synergistic effect of tafasitamab and lenalidomide, as already observed in the L-MIND trial," said Pier Luigi Zinzani, M.D., Ph.D., Professor of Hematology, Head of Lymphoma Group, Institute of Hematology,
"L. e A. Seràgnoli", University of Bologna, Bologna, Italy, and one of the lead investigators in MorphoSys’s Re-MIND study.

Details of the L-MIND primary analysis were published on June 22, 2019, and can be found here.

About L-MIND
L-MIND is a single arm, open-label phase 2 study, investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) after up to two prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy and subsequent autologous stem cell transplantation. The study’s primary endpoint is objective response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). In May 2019, the study reached its primary completion. Primary analysis data with a cut-off date of November 30, 2018 included 80 patients enrolled into the trial who had received tafasitamab and lenalidomide and had been followed-up as per protocol for at least one year. Efficacy results in this update were based on response rates assessed by an independent review committee for all 80 patients. Based on earlier reported interim data from L-MIND, in October 2017 the U.S. FDA granted Breakthrough Therapy Designation for tafasitamab plus lenalidomide in this patient population. MorphoSys is working towards completion of a BLA submission to the U.S. FDA based on L-MIND by end of 2019.

About Re-MIND
Re-MIND, an observational retrospective study, was designed to isolate the contribution of tafasitamab in the combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory DLBCL who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys’s L-MIND trial. Re-MIND collected the efficacy data from 490 r/r DLBCL patients in the U.S. and EU. Eligible patients were matched 1:1 to the L-MIND study population based on important baseline characteristics, such as relevant prognostic factors, laboratory characteristics and patient demographics.

On October 29, 2019 Danaher Corporation (NYSE: DHR) ("Danaher") reported that its wholly owned subsidiary, DH Europe Finance II S.à r.l. ("Danaher International II"), has priced an offering of (Press release, Danaher, OCT 29, 2019, View Source [SID1234549995]):

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$700,000,000 principal amount of 2.050% senior notes due 2022 at an offering price of 99.994% of the principal amount;
$700,000,000 principal amount of 2.200% senior notes due 2024 at an offering price of 99.952% of the principal amount;
$800,000,000 principal amount of 2.600% senior notes due 2029 at an offering price of 99.903% of the principal amount;
$900,000,000 principal amount of 3.250% senior notes due 2039 at an offering price of 99.809% of the principal amount; and
$900,000,000 principal amount of 3.400% senior notes due 2049 at an offering price of 99.756% of the principal amount (collectively, the "senior notes").
Danaher estimates that the net proceeds from the sale of the senior notes in this offering will be approximately $3.97 billion, after deducting the underwriting discounts and estimated offering expenses payable by Danaher. Danaher anticipates using the net proceeds to fund a portion of the cash consideration payable for, and certain costs associated with, its acquisition of the Biopharma Business of GE Life Sciences (the "GE Biopharma Acquisition"). Pending completion of the GE Biopharma Acquisition, Danaher may invest the net proceeds of the offering in short-term bank deposits or invest them in interest-bearing, investment-grade securities. The senior notes will be fully and unconditionally guaranteed on a senior unsecured basis by Danaher. The offering is expected to close on November 7, 2019, subject to customary closing conditions.

The offering is being made pursuant to an effective shelf registration statement on file with the U.S. Securities and Exchange Commission.

The offering of senior notes may be made only by means of a prospectus and prospectus supplement. A copy of the prospectus and prospectus supplement relating to the securities can be obtained by calling BofA Securities, Inc., toll-free at 1-800-294-1322, Mizuho Securities USA LLC, toll-free at 1-866-271-7403, MUFG Securities Americas Inc., toll-free at 1-877-649-6848, U.S. Bancorp Investments, Inc., toll-free at 1-877-558-2607, or Wells Fargo Securities, LLC, toll-free at 1-800-645-3751.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, the senior notes or any other securities, nor shall there be any offer, solicitation or sale of any security mentioned in this press release 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 October 29, 2019, SELLAS Life Sciences Group, Inc., a Delaware corporation (the "Company"), reported that it entered into an Equity Distribution Agreement (the "Distribution Agreement") with Maxim Group LLC ("Maxim"), as sales agent, in connection with an "at the market offering" under which the Company from time to time may offer and sell shares of its common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $5,000,000 (the "Shares") (Filing, 8-K, Sellas Life Sciences, OCT 29, 2019, View Source [SID1234550094]). Shares sold under the Distribution Agreement will be offered and sold pursuant to the Company’s previously filed and effective Registration Statement on Form S-3 (Registration No. 333- 233869) (the "Registration Statement") and a prospectus supplement and accompanying base prospectus that the Company filed with the Securities and Exchange Commission (the "SEC") relating to the Shares on October 29, 2019.

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Subject to the terms and conditions of the Distribution Agreement, Maxim will use its commercially reasonable efforts consistent with its normal trading and sales practices to sell the Shares from time to time, based upon the Company’s instructions, including any price, time or size limits specified by the Company. The Company has provided Maxim with customary indemnification rights, and Maxim will be entitled to a commission at a fixed commission rate equal to 3.0% of the gross sales price of all Shares sold. In addition, pursuant to the terms of the Distribution Agreement, the Company has agreed to reimburse Maxim for the documented fees and costs of its legal counsel reasonably incurred in connection with (i) entering into the transactions contemplated by the Distribution Agreement in an amount not to exceed $40,000 in the aggregate (inclusive of an advance of $20,000 payable to Maxim upon entrance into the Distribution Agreement) and (ii) Maxim’s ongoing due diligence, drafting and other filing requirements arising from the transactions contemplated by the Distribution Agreement in an amount not to exceed $5,000 in the aggregate per calendar quarter. Sales of the Shares, if any, under the Distribution Agreement may be made in transactions that are deemed to be "at the market offerings" as defined in Rule 415 under the Securities Act of 1933, as amended (the "Securities Act"). The Company has no obligation to sell any of the Shares, and may at any time suspend sales under the Distribution Agreement or terminate the Distribution Agreement. The Distribution Agreement will terminate upon the sale of all of the Shares under the Distribution Agreement unless terminated earlier by either party as permitted under the Distribution Agreement.

The Company currently intends to use the net proceeds from the offering, if any, for working capital, capital expenditures and other general purposes, including research and development of our product candidates (including clinical trial activities), and general and administrative expenses.

The foregoing description of the Distribution Agreement does not purport to be complete and is qualified in its entirety by reference to the Distribution Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and 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 Shares, nor shall there be any offer, solicitation or sale of the Shares in any state or country in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or country.

The legal opinion of the Company’s counsel regarding the validity of the Shares is filed as Exhibit 5.1 to this Current Report on Form 8-K. The Company cautions you that statements included in this Current Report on Form 8-K that are not a description of historical facts are forward-looking statements. These forward-looking statements include statements regarding the Company’s ability to sell Shares pursuant to the Distribution Agreement. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of these statements, results or sales will be achieved or completed due in part to risks and uncertainties inherent in the Company’s business, including those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, filed with the SEC on March 22, 2019 and August 14, 2019, respectively. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.