On December 9, 2020 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of fully human antibody therapeutics, reported the presentation of the latest interim data from its ongoing phase Ib combination trial of olinvacimab and pembrolizumab for metastatic triple-negative breast cancer (mTNBC) patients (Press release, PharmAbcine, DEC 9, 2020, View Source [SID1234572553]). The results were presented at the SABCS (San Antonio Breast Cancer Symposium) 2020, currently taking place virtually.

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As of the data cut-off date of September 2020, all 11 mTNBC patients were recruited and received at least one dose of treatment. No DLT (Dose Limiting Toxicity) was observed. Three patients were receiving treatment at the data cut-off date. 4 patients (36%) had partial response (PR) as best overall response, and 5 patients (45%) had clinical benefit (PR+SD≥24weeks). In the high-dose cohort, 3 patients (50%) showed PR and 4 patients (67%) received clinical benefit. 1 patient in PR showed complete response in the target lesion but was included in PR because a tumor was found in a non-target lesion.

The number of PR and SD remains the same from our previous interim results whose cut-off date was June 2020. The same 3 patients who were receiving treatment as of the previous cut-off date continued to receive treatment as of September 2020. As such, PFS (Progression Free Survival) and OS (Overall Survival) are likely to improve for the final results. Adverse events were similar to those shown in the previous interim results.

mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after the diagnosis. mTNBC accounts for 10-20% of all breast cancers and shows a 5-year survival rate of approximately 11%. Unlike some other breast cancers, mTNBC does not express estrogen or progesterone receptors or human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is very difficult to treat, and there are very few FDA approved treatment options for these patients.

"The early activity signals for olinvacimab in combination with pembrolizumab for mTNBC patients are highly encouraging. We believe these findings provide an encouraging safety profile and evidence of clinical activity of the combo therapy," said Dr. Jin-San Yoo, CEO of PharmAbcine. "We are particularly thrilled by the efficacy data from the high-dose cohort, heightening our expectation for its continued clinical development or future planned clinical studies."

About San Antonio Breast Cancer Symposium

San Antonio Breast Cancer Symposium (SABCS) is the world’s largest breast cancer conference held annually. Nearly 10,000 researchers and medical experts participate event every year. The core mission of this event is to provide the latest research data in breast oncology to all participants around the globe. For the safety and security of all members in the COVID-19 global pandemic, the SABCS executive committee has decided to hold this year’s event virtually.

On December 9, 2020 Quirem Medical, a Terumo company, reported that it is awarded top 3 innovative medical device in the 2019 Belgian Galenus prize with the innovative Holmium-166 SIRT diagnostic scout dose product QuiremScout (Press release, Quirem Medical, DEC 9, 2020, View Source [SID1234573385]).

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The Galenus prize recognizes and rewards outstanding achievements that improve the global human condition through the development of innovative therapies1. It was created in France in 1970 by a pharmacist named Roland Mehl with the aim to advance pharmaceutical research. Recently, the Prix Galien award is also granted to innovative medical devices.2

The role of QuiremScout microspheres is to evaluate the expected safety and efficacy of the Selective Internal Radiation Therapy (SIRT). QuiremScout microspheres are based on the same Holmium-166 microspheres as the therapeutic treatment (QuiremSpheres). QuiremScout microspheres are intended to evaluate lung-shunt3 and extrahepatic deposition3 as part of the SIRT work-up. Moreover, they are intended for evaluation of the intrahepatic distribution3 during the work-up, which can be used to plan the SIRT treatment.4

Currently, 99mTc-MAA is most often used during the pre-treatment work-up of the SIRT treatment algorithm3.

However, QuiremScout has recently proven to be more accurate in terms of intrahepatic targeting5 and lung shunt assessment6 compared to 99mTc-MAA during the work-up. The usage of QuiremScout microspheres may allow physicians to improve their SIRT treatment planning.3

Recent clinical results continue to support the validation of QuiremScout microspheres in patient selection and planning as part of the Holmium Platform, such as the latest publication in the Lancet Oncology Journal from UMC Utrecht for the non-randomized HEPAR PLuS study7, which included Neuroendocrine tumor (NET) patients with liver metastasis after systemic radiation therapy with 177Lu-Dotatate.

The Holmium platform consists of three integrated products (QuiremScout, QuiremSpheres & Q-suite), which equips physicians with the necessary tools to optimize SIRT outcomes through more individualized treatment.

"QuiremScout is part of the Holmium platform that enables physicians to perform Selective intra-arterial radiation therapy. This technology uniquely allows a fine patient selection and individualized treatment for better outcomes. At Terumo, we are proud of this important recognition by the community.", said Laurent Domas, Vice President Global Interventional Oncology & Therapy Development, Terumo Interventional Systems.

On December 9, 2020 Qu Biologics Inc., a private clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies designed to restore innate immune function, reported an oversubscribed $8 million financing (Press release, Qu Biologics, DEC 9, 2020, View Source [SID1234574979]). With the proceeds, Qu Biologics will complete stage 1 of the RESTORE Phase 2 clinical trial for patients with moderate to severe Crohn’s disease and its Phase 2 Study to assess activation of anti-cancer immune response in colon cancer.

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"We are pleased to have oversubscribed our bridge round based on the promising interim data from our RESTORE trial and we are looking forward to the important full data from our two studies, which will both complete in the first half of 2021", said Hal Gunn, MD, CEO of Qu. "Our first-in-paradigm platform is designed to safely achieve immune balance and healing by restoring multiple important immune functions simultaneously – we are excited about our unique and novel treatment’s transformational potential in preventing and treating cancer and chronic disease."

Qu Biologics will use the funds raised to expand its team and capacity and progress its proprietary immunotherapy platform.

On December 9, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that due to demand, the underwriter has agreed to increase the size of the previously announced offering and purchase on a firm commitment basis 16,666,667 shares of common stock of the Company, at a price to the public of $4.50 per share, less underwriting discounts and commissions (Press release, Oncternal Therapeutics, DEC 9, 2020, View Source [SID1234576290]). The closing of the offering is expected to occur on or about December 14, 2020, 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 an additional 2,495,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Oncternal, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional common stock, are expected to be approximately $75.0 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical and preclinical development of cirmtuzumab and TK216, preclinical development of its ROR1 CAR-T program, and for working capital.

The shares of common stock are being offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock is 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 shares of common stock being offered has been filed with the SEC and is available on the SEC’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A final prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final 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 December 9, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported the pricing of an underwritten public offering of 5,434,783 shares of its common stock at a price to the public of $23.00 per share (Press release, Syndax, DEC 9, 2020, View Source [SID1234572493]). The gross proceeds to Syndax from this offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $125 million. The offering is expected to close on December 11, 2020, subject to customary closing conditions. Additionally, Syndax granted the underwriters a 30-day option to purchase up to 815,217 additional shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock in the offering will be sold by Syndax.

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Goldman Sachs & Co. LLC, Citigroup and Cowen are acting as joint book-running managers for the offering. BTIG is acting as lead manager for the offering. Baird is acting as co-manager for the offering.

The shares are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the website of the SEC at www.sec.gov. When available, copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs and Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; or Citigroup Global Markets Inc., c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, or by phone at (800) 831-9146; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at [email protected], or by phone at (833) 297-2926.

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 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. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus, which are a part of the effective registration statement.