On January 19, 2021 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the National Medical Products Administration (NMPA) in China has approved an investigational new drug (IND) application to study GC019F, a FasTCAR-enabled chimeric antigen receptor (CAR)-T therapy in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia (B-ALL) (Press release, Gracell Biotechnologies, JAN 19, 2021, View Source [SID1234574116]).

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GC019F is an autologous CAR-T therapy currently in development for adult B-ALL patients who are relapsed from or refractory to prior therapies. With the therapy, a patient’s own T cells are genetically modified to express CD19-specific CAR. GC019F is manufactured on Gracell’s FasTCAR technology platform, which significantly reduces manufacturing time from an industry norm of two to six weeks down to 22 to 36 hours.

"This marks the first IND approval for a product candidate manufactured on Gracell ‘s FasTCAR platform and sets an important milestone for furthering therapies manufactured on this platform. We are excited to bring this new therapy to adult B-ALL patients, who – once relapsed from or refractory to therapy – remain a high unmet medical need with limited treatment options in China," commented Dr. Martina Sersch, M.D., Ph.D., Chief Medical Officer of Gracell.

[1] View Source

[2] View Source

About GC019F

GC019F is an autologous investigational CD19-targeted CAR-T cell therapy, directed to eradicate CD19 positive leukemia cells.

About FasTCAR

FasTCAR-manufactured CAR-T cells appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next-day manufacturing (22 to 36 hours), FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients.

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 50.[1] In 2015, ALL affected around 837,000 people globally and resulted in 110,000 deaths worldwide.[2] It is also the most common cause of cancer and death from cancer among children.

On January 19, 2021 OncoHost, global leader in host response profiling for improved personalized cancer therapy, reported the completion of a $8 million Series B funding round (Press release, OncoHost, JAN 19, 2021, View Source [SID1234574115]). The funding will help finance OncoHost’s ongoing clinical trials, open a US-based affiliate and prepare for the upcoming launch of PROphet, the company’s machine learning-based Host Response Profiling platform that combines proteomic analysis with AI to predict patient response to immunotherapy, providing clinicians with potential combination strategies to overcome treatment resistance.

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The funding round was led by OurCrowd, an investment platform built for accredited investors and institutions to invest in start-ups, early-stage companies and venture funds. They were joined by a group of family offices and private investors.

"As the renowned entrepreneur Marc Andreesen said, ‘Software will the eat world,’ and OncoHost is proving that software will help eat cancer," said OurCrowd CEO, Jon Medved. "We are excited about leading this important funding round for such a transformational company. OncoHost is demonstrating that smart software can take an already promising technology such as immunotherapy and make it so much smarter."

OncoHost is a clinical stage precision oncology start-up, combining life-science research and advanced machine learning technology to develop personalized strategies for cancer patients. Clinical trials are currently focused on melanoma and non-small cell lung cancer (NSCLC) patients and will soon expand to other indications. OncoHost’s platform, PROphet, analyzes proteomic changes in patient blood samples to detect signs of resistance to cancer therapies in real-time, enabling biomarker-guided treatment planning for physicians, target discovery for drug development and, ultimately, improved outcomes for patients.

PROphet will first be made available to healthcare providers who can use it to help assess how a specific patient may respond to a given treatment. This will aid the oncologist and patient in making informed decisions regarding treatment options, lines of therapy, potential combination treatments, and participation in clinical trials.

"This investment round supports our mission to better predict response to immunotherapy and identify personalized treatment options for cancer patients, as we continue to expand our collaboration with pharma on clinical trials and drug development," said Ofer Sharon, MD, CEO of OncoHost. "Proteomic analysis is allowing us to make great advances in personalized cancer care, and we are grateful to our investors for their support in the midst of this particularly challenging time of a global pandemic. The future of personalized cancer care is no longer a distant reality, but within our reach. We look forward to what 2021 holds for OncoHost."

On January 19, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its fourth quarter and full year 2020 financial and operating results on Friday, February 5, 2021, before the U.S. financial markets open (Press release, Regeneron, JAN 19, 2021, https://www.prnewswire.com/news-releases/regeneron-to-report-fourth-quarter-and-full-year-2020-financial-and-operating-results-and-host-conference-call-and-webcast-on-february-5-2021-301211100.html [SID1234574114]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International), conference ID 1580376. A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On January 19, 2021 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 4,166,667 American Depositary Shares (ADSs) of the Company, at a price to the public of $2.40 per ADS, less underwriting discounts and commissions (Press release, BioLineRx, JAN 19, 2021, View Source [SID1234574113]). Each ADS represents fifteen ordinary shares, par value NIS 0.10 per share, of the Company. The closing of the offering is expected to occur on or about January 22, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to additional 625,000 ADSs at the public offering price, less underwriting discounts and commissions.

The gross proceeds to BioLineRx, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional ADSs, are expected to be approximately $10 million. The Company intends to use the net proceeds from this offering for general corporate purposes, which may include but are not limited to working capital and funding clinical trials.

The securities described above are being offered by BioLineRx pursuant to a "shelf" registration statement on Form F-3 (File No. 333-251857) previously filed with the Securities and Exchange Commission (the "SEC") on December 31, 2020 and declared effective by the SEC on January 11, 2021. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities 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.

On January 19, 2021 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported that it has priced an underwritten public offering of 5,400,000 shares of common stock at a public offering price of $14.00 per share, which would result in gross proceeds of approximately $75.6 million, before underwriting discounts and commissions (Press release, Syros Pharmaceuticals, JAN 19, 2021, View Source [SID1234574111]). The proceeds of the offering are expected to be used to fund the development of Syros’ ongoing clinical and preclinical programs, and for working capital and other general corporate purposes. All shares are being offered by Syros. Closing of the offering is expected to occur on or about January 22, 2021, subject to customary closing conditions. Syros has also granted the underwriters a 30-day option to purchase up to an additional 810,000 shares of common stock offered in the public offering on the same terms and conditions.

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Cowen and Piper Sandler & Co. are acting as joint book-running managers for the offering. JMP Securities and Oppenheimer & Co. are acting as lead managers and Roth Capital Partners and Brookline Capital Markets, a division of Arcadia Securities, LLC, are acting as co-managers.

The offering is being made pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on June 12, 2020 and declared effective by the SEC on June 22, 2020. The offering will be made only by means of the prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to, and describing the terms of, the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov.

The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, can be obtained from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at 833-297-2926; or from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924.

This press release does 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 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.