Cure Genetics Raises $60 Million to Advance Universal CAR-T Products

On January 25, 2022 Cure Genetics of Suzhou reported that closed a $60 million Series B round to advance clinical development of its cell therapy candidates for hematological and solid tumors (Press release, CureGenetics, JAN 25, 2022, View Source [SID1234607390]). Cure was established by CRISPR pioneers in 2016 to develop therapies for difficult-to-treat cancers and genetic diseases. Its CRISPR-mediated single or multiplex gene editing platform is aimed at producing more effective or safer cell therapy products, including universal CAR-T candidates. The financing round was led by Advantech Capital and joined by Oriza Holdings, Blue Ocean Private Equity and Qiming Venture Capital

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Checkpoint Therapeutics to Participate in the B. Riley Securities’ Virtual Oncology Conference

On January 25, 2022 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that James Oliviero, President and Chief Executive Officer, will participate in a fireside chat hosted by Justin Walsh, Equity Research Analyst (Biotechnology), at the B. Riley Securities’ Virtual Oncology Conference, taking place on Thursday, January 27, 2022, at 11:00 a.m. EST (Press release, Checkpoint Therapeutics, JAN 25, 2022, View Source [SID1234607409]). Checkpoint management will also participate in one-on-one meetings during the conference.

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A live webcast of the fireside chat will be available on the IR Calendar page under News & Events, located within the Investors section of Checkpoint’s website, View Source, for approximately 30 days following the meeting.

IMX-110 + anti-PD-1 Combination Produced Extended Median Survival in Genetic Pancreatic Cancer Mouse Model, Bolstering Planned 2022 IMX-110 Combination Clinical Trial Rationale

On January 25, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases, reported data showing that IMX-110 + anti-PD-1 produced 63-day median survival in a genetic pancreatic cancer mouse model in which mice develop their own pancreatic cancer and have an intact immune system (Press release, Immix Biopharma, JAN 25, 2022, View Source [SID1234606772]). Historically, according to Winograd et al., 2015, 42-days is the median survival produced by a 4-drug combination: 2 chemotherapies (gemcitabine, nab-paclitaxel) and 2 immunotherapies (anti-PD-1, anti-CD40) in the same genetic pancreatic cancer mouse model.

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"This data highlights why we are excited to collaborate with BeiGene on our planned 2022 Phase 1b/2a combination clinical trial of IMX-110 + BeiGene anti-PD-1 tislelizumab in advanced solid tumors," said Ilya Rachman, MD PhD, CEO of ImmixBio. "We believe this upcoming combination clinical trial will allow us to rapidly expand into multiple oncology indications."

The U.S. Food and Drug Administration ("FDA") has approved orphan drug designation ("ODD") for IMX-110 for the treatment of soft tissue sarcoma. Additionally, the FDA has approved rare pediatric disease ("RPD") designation to IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize anti-PD-1 tislelizumab in North America, Europe, and Japan in exchange for an upfront payment by Novartis of US$650 million plus royalties and milestone payments.

As of January 2022, anti-PD-1 tisleizumab has been approved or granted conditional approval in 6 cancer indications in China, including non-squamous non-small cell lung cancer ("NSCLC"), squamous NSCLC, classical Hodgkin’s lymphoma, Hepatocellular Carcinoma, and urothelial carcinoma.

Sierra Oncology Announces Proposed Public Offering of Common Stock

On January 25, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported that it intends to offer and sell $100.0 million of shares of its common stock in an underwritten public offering (Press release, Sierra Oncology, JAN 25, 2022, View Source [SID1234606788]). The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the offering. In addition, Sierra Oncology intends to grant the underwriters a 30-day option to purchase up to $15.0 million of additional shares of its common stock. Sierra Oncology intends to use the net proceeds of the offering to prepare for potential commercialization of momelotinib, clinical development activities of its other product candidates, research, clinical and process development and manufacturing of its product candidates, working capital, and capital expenditures and other general corporate purposes.

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Jefferies and Cantor are acting as the joint book-running managers for the proposed offering. LifeSci Capital, Oppenheimer & Co. and H.C. Wainwright & Co. are acting as lead managers for the proposed offering.

A shelf registration statement on Form S-3 relating to the common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on November 5, 2021 and declared effective by the SEC on November 12, 2021. A preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this proposed offering may also be obtained, when available, by contacting 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]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, New York, New York 10022, or by email at [email protected].

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

Merus Appoints Shannon Campbell as Chief Commercial Officer and Regains Worldwide Rights to MCLA-145

On January 25, 2022 – Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the appointment of Shannon Campbell as Executive Vice President & Chief Commercial Officer (Press release, Merus, JAN 25, 2022, View Source [SID1234607410]). Ms. Campbell is an accomplished healthcare leader with demonstrated success leading commercial businesses across a range of specialty markets, including oncology.

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"Shannon will be instrumental in advancing Merus’ mission to become a commercial-stage company, further advancing the strategy for our lead clinical program, zenocutuzumab for neuregulin 1 fusion cancer and developing our commercial approach for our pipeline of innovative multispecific antibody product candidates," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "Her leadership and depth of experience in launching products, managing partnerships, and delivering sustained performance in highly competitive oncology markets will be a great asset to our organization."

Ms. Campbell will join Merus as Executive Vice President & Chief Commercial Officer in February to lead the commercial strategy for the most advanced clinical candidate, zenocutuzumab (Zeno), as well as Merus’ robust pipeline of multispecific product candidates in development. This includes petosemtamab (MCLA-158), currently under investigation in second-line head and neck squamous cell carcinoma; MCLA-145, under investigation for solid tumors; and MCLA-129, under investigation for patients with lung and other solid tumors, particularly those that do not respond to EGFR inhibitors. Merus holds global rights to all four clinical candidates, apart from MCLA-129, for which Merus licensed to Betta Pharmaceuticals the exclusive right to develop and commercialize in China.

Ms. Campbell brings over 25 years of pharmaceutical commercialization experience and joins Merus from Novartis Pharmaceuticals, where she led Novartis’s U.S. Oncology Solid Tumor Franchise and was responsible for a broad portfolio of therapies in oncology and rare diseases. Prior to Novartis, Ms. Campbell was with Bayer HealthCare Pharmaceuticals, where she was instrumental in helping to build, launch and lead Bayer’s U.S. Oncology business.

"I am excited to join Merus at this pivotal time," said Ms. Campbell. "The Merus pipeline of clinical-stage assets has the potential to offer meaningful benefit to patients, and I look forward to building and leading the commercial strategy for these programs."

Merus also announced today that Incyte (Nasdaq: INCY) has elected to opt-out of its ex-U.S. development of MCLA-145, restoring full global rights to Merus. MCLA-145 is currently enrolling a global, phase 1, open-label, single-agent clinical trial evaluating MCLA-145 in patients with solid tumors. The trial consists of a dose escalation phase, followed by a planned dose expansion phase. Merus is also planning to evaluate the combination of MCLA-145 with a PD-1 blocking antibody.

"Regaining worldwide rights to MCLA-145 opens up new possibilities for Merus," said Dr. Lundberg. "We remain committed to continuing the development of MCLA-145 to explore the potential of this compound as monotherapy, as well as in combination, to address the high unmet medical need for patients with solid tumors. We look forward to the further progress and continued success of our other joint projects in research and development with Incyte under this collaboration."

Under the terms of a 2017 Collaboration and License Agreement ("Agreement") between Merus and Incyte, Incyte received ex-U.S. rights to MCLA-145. Incyte’s opt-out of ex-U.S. rights to MCLA-145 provides Merus the exclusive right to develop and commercialize potential MCLA-145 products globally. As part of the Agreement, Incyte will continue to support the program for a limited time while ex-U.S. activities are transitioned to Merus, and Incyte will also retain a right to a residual royalty of up to 4% on sales of future commercialization of MCLA-145, if approved.

Additionally, per the Agreement, the parties will continue to collaborate on the development and commercialization of up to ten bispecific or monospecific antibody programs. Merus also has the option to co-fund development of product candidates arising from two programs. For any program for which Merus exercises its co-development option, Merus would be responsible for 35 percent of global development costs in exchange for a 50 percent share of U.S. profits and losses and tiered royalties ranging from 6 to 10 percent on ex-U.S. sales by Incyte for these programs. Merus also has the right to elect to provide up to 50 percent of detailing activities for product candidates arising from one of these programs in the U.S.