On December 9, 2020 IGM Biosciences, Inc. (NASDAQ: IGMS) (IGM) reported the pricing of its upsized underwritten public offering of shares of its common stock at a price to the public of $90.00 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase shares of its common stock at a purchase price of $89.99 per each pre-funded warrant, which represents the per share public offering price of common stock less the $0.01 per share exercise price for each such pre-funded warrant (Press release, IGM Biosciences, DEC 9, 2020, View Source [SID1234572479]). IGM expects to receive total gross proceeds of approximately $200 million from this offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by IGM. In addition, IGM has granted the underwriters a 30-day option to purchase up to an additional $30.0 million of shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock and pre-funded warrants in the offering will be sold by IGM. The offering is expected to close on or about December 11, 2020, subject to satisfaction of customary closing conditions.

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Jefferies, Stifel, Guggenheim Securities and RBC Capital Markets are acting as joint book-running managers for the offering. Baird and Truist Securities are acting as the lead managers for the offering.

The securities in the offering will be offered by IGM pursuant to a Registration Statement on Form S-3, filed with the Securities and Exchange Commission (SEC) on November 5, 2020 and declared effective on November 12, 2020. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be accessed for free through the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658 or by email at [email protected]; or RBC Capital Markets, LLC, 200 Vesey Street, 8th Floor, New York, NY 10281-8098; Attention: Equity Syndicate; by telephone at (877) 822-4089 or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

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.

On December 8, 2020 ImmunoGenesis, Inc., a clinical-stage biotechnology company developing therapeutics to catalyze effective immune responses in immunologically cold cancers such as prostate, colorectal and pancreatic cancer, reported that it has acquired the rights to the hypoxia-reducing agent evofosfamide. The company plans to initiate a Phase 2 clinical trial in 2021 investigating evofosfamide in combination with both CTLA-4 and PD-1 blockade in patients with castration-resistant prostate cancer (CRPC), pancreatic ductal adenocarcinoma (PDAC) and HPV-negative head and neck cancer (HNSCC) (Press release, ImmunoGenesis, DEC 8, 2020, View Source [SID1234651021]).

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Evofosfamide, a 2-nitroimidazole prodrug of the cytotoxin bromo-isophosphoramide mustard (Br-IPM), was originally developed as a hypoxia-activated prodrug. Dr. Michael A. Curran, founder of ImmunoGenesis, discovered that evofosfamide can reduce hypoxia in solid tumors. Dr. Curran demonstrated in pre-clinical models that evofosfamide could restore T cell function and synergize with checkpoint inhibition.

Based on Dr. Curran’s work as Associate Professor of Immunology at The University of Texas MD Anderson Cancer Center, ImmunoGenesis is developing evofosfamide as a hypoxia-reversal agent (HRA) which could synergize with checkpoint blockade to drive efficacy in tumor types where checkpoint blockade monotherapy is ineffective. Dr. Curran’s financial relationship with ImmunoGenesis is managed and monitored by the MD Anderson Conflict of Interest Committee.

The planned Phase 2 trial is supported by data from a Phase 1 trial, both led by David S. Hong, M.D., Professor of Investigational Cancer Therapeutics at MD Anderson. The Phase 1 study investigated evofosfamide in combination with the CTLA-4 inhibitor, ipilimumab, in four tumor types where hypoxia is believed to be a major source of immune resistance. The combination treatment drove an overall response rate of 17 percent and a disease control rate of 83 percent across four different dose levels in 21 heavily pre-treated patients.

"Overcoming resistance to immunotherapy in immunologically cold tumors will likely require a multi-faceted approach to address diverse mechanisms of host immune suppression," said Dr. Curran, "Evofosfamide is the first drug to demonstrate success in reversing hostile tumor metabolism through reduction of hypoxia. Restoration of tumor oxygen supply facilitates T cell infiltration and persistence allowing these otherwise poorly immune checkpoint sensitive cancers to become therapeutically sensitized."

In addition to the clinical efficacy demonstrated in the Phase 1 trial, a clear biomarker picture has emerged. Pre-existing immune gene signatures predicted response to therapy, while hypermetabolic tumors predicted progression. Responders also showed improved cellular signatures of anti-tumor immunity.

"Our vision at ImmunoGenesis is to develop a pipeline of drugs that synergize to address the critical ingredients necessary for effective immunity against the particularly difficult-to-treat cold tumors, including the generation of sufficient anti-tumor T cells, the protection and expansion of those cells in the tumor, and finally the reduction in hostile tumor metabolism" said James Barlow, ImmunoGenesis President and CEO. "Coupled with the PD-L1/PD-L2 dual specific antibody and STING agonist the company previously licensed from Dr. Curran’s lab, the addition of evofosfamide creates an integrated suite of molecules with extraordinary potential to address the unmet therapeutic need in cold 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.

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.