Agreement-to-acquire-Labor-Dr.-Merk

On December 9, 2020 Boehringer Ingelheim reported the execution of the agreement on the acquisition of Labor Dr. Merk & Kollegen (Press release, Boehringer Ingelheim, DEC 9, 2020, View Source [SID1234572470]). The acquisition will enable Boehringer Ingelheim to further expand and accelerate its comprehensive program for the development of ATMP-based immuno-oncology therapies including the Vesicular Stomatitis Virus (VSV) with modified glycoprotein (GP) platform and cancer vaccines platforms. Labor Dr. Merk & Kollegen has outstanding experience in process development, manufacturing and analytical characterization in virology besides expertise in microbiology and cell culture. Labor Dr. Merk & Kollegen has already worked in close collaboration with Boehringer Ingelheim on viral-based therapy development since 2015.

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"The acquisition of Labor Dr. Merk & Kollegen is strengthening our promising pipeline with diverse potential first-in-class cancer immunology and cancer cell directed therapies for patients with hard-to-treat cancer," said Dr. Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit. "The trusting and highly effective collaboration between our scientists and the Labor Dr. Merk & Kollegen team has already contributed significantly to our progress in viral-based cancer therapies. We will welcome the Labor Dr. Merk & Kollegen team and look forward to jointly advancing our program in this area."

Boehringer Ingelheim is taking cancer on by strengthening its position in cancer immunology, with a focus on cancer vaccines, oncolytic viruses, T-cell engagers, stromal modulators and myeloid cell modulators by combining its world-class, in-house research and development with that of highly innovative external companies. The addition of Labor Dr. Merk & Kollegen’s site will enable Boehringer Ingelheim to further strengthen its oncolytic virus and cancer vaccine development capabilities and capacities by establishing an end-to-end fully integrated center of excellence for virus development and clinical manufacturing. It will add to a series of strategic acquisitions and collaborations over the past years, including the acquisition of ViraTherapeutics and AMAL Therapeutics, which are contributing assets that will be further developed at Labor Dr. Merk & Kollegen’s site.

Labor Dr. Merk & Kollegen is a privately-held company founded in 1971. It is headquartered in Ochsenhausen, Germany, close to Boehringer Ingelheim’s Biberach R&D site. As a center of excellence in virology, Labor Dr. Merk & Kollegen has a long track record in GLP and GMP certified biosafety testing. In recent years Labor Dr. Merk & Kollegen established its GMP-virus manufacturing facility. With around 130 highly qualified and specialized employees, the company has built considerable expertise in process development, manufacturing and analytical characterization of viral therapeutics and oncolytic viral therapeutics. Labor Dr. Merk & Kollegen will be integrated with all employees as a new unit into Boehringer Ingelheim’s Development organization and continue to operate at its Ochsenhausen site. A future expansion is planned.

"Following our successful strategic partnership, we are really excited to join forces with Boehringer Ingelheim," said Dr. Ingrid Rapp, CEO at Labor Dr. Merk & Kollegen. "Boehringer Ingelheim is a truly global pharmaceutical company with excellent R&D capacities. We look forward to taking our next development step in oncology as part of this outstanding team."

The companies did not disclose the financial terms of the deal. The transaction is subject to the approval of the competition authorities in Germany. Closing will follow thereafter.

Theratechnologies Announces New Findings For Its Lead Investigational Compound TH1902 For The Treatment Of Several Additional Cancers

On December 8, 2020 Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported new pre-clinical in vivo findings regarding the efficacy and tolerability of its novel investigational proprietary peptide-drug conjugate (PDC), TH1902, for the treatment of several cancer types expressing the sortilin receptor (SORT1+) as shown in the table below (Press release, Theratechnologies, DEC 8, 2020, View Source [SID1234574978]).

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New pre-clinical in vivo results in colorectal, pancreatic, melanoma and endometrial cancers are similar to those presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) last June, which confirmed, at the time, the effect of TH1902 in vivo in ovarian and triple-negative breast cancers (TNBC). The Company intends to present the detailed results at scientific meetings next year.

CTI BioPharma to Present at The JMP Securities Hematology Summit on Tuesday, Dec. 15

On December 8, 2020 CTI BioPharma Corp. (NASDAQ: CTIC) reported that management will provide a corporate overview at The JMP Securities Hematology Summit at 3:00 p.m. EST (Press release, CTI BioPharma, DEC 8, 2020, View Source [SID1234574977]). The conference will be held in a virtual meeting format.

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Presentation details:

Event: The JMP Securities Hematology Summit
Date: Tuesday, Dec. 15
Time: 3:00 p.m. EST

The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma’s website at www.ctibiopharma.com.

Atara Biotherapeutics Announces Pricing of $175.0 Million Public Offering

On December 8, 2020 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T- cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases, reported the pricing of an underwritten public offering of 5,102,041 shares of its common stock at a price to the public of $24.50 per share and, to certain investors, pre-funded warrants to purchase 2,040,816 shares of its common stock at a purchase price of $24.4999 per pre-funded warrant share, which represents the per share public offering price for the common stock, minus the $0.0001 per share exercise price of each such pre-funded warrant share (Press release, Atara Biotherapeutics, DEC 8, 2020, View Source [SID1234574479]). The aggregate gross proceeds from the offering are expected to be approximately $175.0 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Atara Biotherapeutics. The offering is expected to close on or about December 11, 2020, subject to customary closing conditions. In connection with the offering, Atara Biotherapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,071,428 shares of its common stock at the public offering price, less the underwriting discounts and commissions.

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Citigroup, Evercore ISI and Mizuho Securities are acting as joint book-running managers for the offering. Canaccord Genuity is acting as lead manager and Roth Capital Partners is acting as manager for the offering.

The securities described above are being offered by Atara Biotherapeutics pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Atara Biotherapeutics with the Securities and Exchange Commission (the "SEC") and that became automatically effective on February 27, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC, and a final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 800-831-9146; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at [email protected]; or Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY 10020, by telephone 212-205-7600, or by email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Cerecor Announces FDA Acceptance of Investigational New Drug Application for CERC-007 for Treatment of Relapsed or Refractory Multiple Myeloma

On December 8, 2020 Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, reported that its Investigational New Drug Application (IND) to study the use of CERC-007 to treat relapsed or refractory multiple myeloma (MM) has been accepted by the United States Food and Drug Administration (FDA) and is now open (Press release, Cerecor, DEC 8, 2020, View Source [SID1234573112]). The first study will be a U.S. multicenter Phase 1b clinical trial. Initial data is expected in the first quarter of 2021.

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"Elevated levels of IL-18 are correlated with poor survival in patients with multiple myeloma1," said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor. "Targeting and reducing IL-18 using CERC-007 may substantially benefit relapsed or refractory multiple myeloma patients. Our first study under this new IND will give us important information about the pharmacokinetics, pharmacodynamics, dose, safety and preliminary efficacy that should illuminate the path forward. We look forward to sharing the data with the scientific and medical communities in the first quarter of 2021."

The planned Phase 1b clinical trial is a U.S. multicenter, open-label, dose-escalation, sequential group study of CERC-007 as a monotherapy in approximately 30 patients with relapsed or refractory MM. The primary objectives of the study will be to determine the safety and tolerability of CERC-007, the recommended Phase 2 dose, and preliminary efficacy as measured by response rate in accordance with International Myeloma Working Group (IMWG) criteria.

About Multiple Myeloma
Multiple myeloma is the second most common blood cancer, with approximately 140,000 patients in the United States.2 Multiple myeloma is characterized by an excess proliferation of plasma cells. Despite increased availability of new agents, the disease is characterized by a pattern of recurrent relapses and remains incurable for the majority of patients, with a 5-year survival rate of approximately 50%.2

About CERC-007
CERC-007 is a fully human monoclonal antibody targeting the proinflammatory cytokine IL-18. It is in development for multiple auto-immune diseases, including Still’s disease (adult onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM).