On November 30, 2020 NuCana plc (NASDAQ: NCNA) reported that the final results of the Phase Ib study of Acelarin plus cisplatin for patients with advanced biliary tract cancer (ABC-08) have been published online ahead of print in The Oncologist (Press release, Nucana BioPharmaceuticals, NOV 30, 2020, View Source [SID1234571982]). Encouraging interim data had previously been reported and the final data confirm the high objective response rate and favorable safety profile of Acelarin plus cisplatin in this patient population.

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In the efficacy-evaluable patient population, the Objective Response Rate was 44%. By comparison, in the ABC-02 study, which led to gemcitabine plus cisplatin becoming the current standard of care for the first-line treatment of patients with advanced biliary tract cancer, an Objective Response Rate of 26% was achieved in the efficacy-evaluable population.

Dr. Mairéad McNamara, Co-Chief Investigator of the ABC-08 study and Senior Lecturer and Honorary Consultant in Medical Oncology at the University of Manchester and The Christie NHS Foundation Trust remarked: "Acelarin combined with cisplatin demonstrated a favorable safety profile and achieved good tumor control. Responses were seen across all five biliary tract cancer sub-types, including a Complete Response in one patient, a very rare occurrence in this patient population. In ABC-02, only one out of 161 efficacy-evaluable patients who received gemcitabine plus cisplatin achieved a Complete Response. Additionally, one patient with Stable Disease, whose tumor had initially been considered unsuitable for surgical resection, was able to have complete surgical removal of the tumor following treatment with Acelarin plus cisplatin. Four patients were still alive at the end of follow-up, having survived between 16 and 36 months."

"We are very encouraged by the final efficacy and safety data from ABC-08", said Hugh S. Griffith, NuCana’s founder and CEO. "We are committed to developing Acelarin plus cisplatin as the first approved front-line treatment for patients with advanced biliary tract cancer. We continue to drive recruitment in the ongoing Phase III NuTide:121 Study where we believe we have the potential opportunity to apply for accelerated approval based on Objective Response Rate. We remain on track to enroll the required number of patients in NuTide:121 by the end of 2021 in order to conduct the first interim analysis in 2022."

Professor Juan Valle, Co-Chief Investigator of the ABC-02, ABC-08 and NuTide:121 studies and Professor and Honorary Consultant in Medical Oncology at the University of Manchester and The Christie NHS Foundation Trust said: "Biliary tract cancer is a devastating disease for which more effective treatments are desperately needed. While targeted therapies and immunotherapies may play a role in the treatment of biliary tract cancer in the future, chemotherapy will remain the backbone of treatment. Medicines like Acelarin, with the potential for improved efficacy and safety, would be welcome additions to the treatment options for patients with biliary tract cancer."

About NuTide:121

NuTide:121 is a global, multi-center, randomized Phase III study that is enrolling up to 828 patients in approximately 130 sites across North America, Europe, Asia and Australia. Patients are being randomized 1:1 and treated with either a combination of Acelarin (725 mg/m2) plus cisplatin (25 mg/m2) or the current standard of care regimen, gemcitabine (1,000 mg/m2) plus cisplatin (25 mg/m2). The primary objectives of NuTide:121 are Overall Survival (OS) and Objective Response Rate (ORR). Three interim analyses, including two designed to support accelerated approval, are planned as part of the Phase III study protocol, in addition to the final analysis. Based on discussions with the FDA and subject to any further regulatory guidance, the Company believes that a statistically significant improvement in ORR at either of the first two interim analyses, supported by positive trends in other endpoints, could potentially allow for an accelerated approval of a new drug application (NDA) for Acelarin. Accelerated approval requires a confirmatory clinical study to verify the drug’s clinical benefit. If accelerated approval were to occur, NuTide:121 would continue and the Company anticipates that data from subsequent analyses could provide the confirmatory data to support full (regular) approval.

About Biliary Tract Cancer

Biliary tract cancer, including cholangiocarcinoma, gallbladder and ampullary carcinoma, is cancer originating in the bile duct, a vessel that transports bile from the liver to the gallbladder and small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 18,000 of those diagnoses in the United States. There are currently no agents approved for the treatment of biliary tract cancer; however, the worldwide standard of care in the first-line setting for patients with advanced biliary tract cancer is the combination of gemcitabine and cisplatin.

On November 30, 2020 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported it will participate virtually in the Piper Sandler 32nd Annual Healthcare Conference on Wednesday, December 2, 2020 (Press release, Medtronic, NOV 30, 2020, View Source;president-of-cardiovascular-portfolio-mike-coyle-to-speak-at-piper-sandler-healthcare-conference-301181942.html [SID1234572000]).

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Mike Coyle, executive vice president and president of the Cardiovascular Portfolio for Medtronic, will answer questions about the company beginning at 10:30 a.m. EST (9:30 a.m. CST).

A live audio webcast of the session will be available on December 2, 2020, by clicking on the Investors Events link at View Source An archived audio file will be available for replay on the same webpage later in the day.

On November 30, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that the Company will host a conference call and live audio webcast on Saturday, December 5, 2020, at 2:00 p.m. ET (Press release, IGM Biosciences, NOV 30, 2020, https://igmbio.com/2020/11/30/igm-biosciences-to-host-conference-call-and-webcast-to-review-igm-2323-data-presented-at-the-62nd-annual-ash-meeting/ [SID1234571949]). The event will take place following a poster presentation featuring the first clinical data from the Company’s Phase 1 trial evaluating IGM-2323 at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

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The conference call may be accessed by dialing (866) 649-1996 (domestic) or (409) 217-8769 (international) and referring to conference ID 1141638. A live webcast of the presentation will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On November 30, 2020 Saniona reported its interim report for the third quarter 2020 (Press release, Saniona, NOV 30, 2020, View Source,institutional%20investors%20and%20sector%20specialists. [SID1234571984])

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Financial highlights

Jan – Sep 2020 (Jan – Sep 2019)

Net revenues were SEK 4.6 M (2.7 M)
EBIT was SEK -97.0 M (-75.8 M)
Net profit/loss was SEK -117.3 M (-72.3 M)
Earnings per share were SEK -3.47 (-2.89)
Diluted earnings per share were SEK -3.47 (-2.89)
Q3 2020 (Q3 2019)

Net revenues were SEK 2.2 M (0.3 M)
EBIT was SEK -40.9 M (-26.0 M)
Net profit/loss was SEK -52.7 M (-27.7 M)
Earnings per share were SEK -1.24 (-1.00)
Diluted earnings per share were SEK -1.24 (-1.00)
Business highlights in Q3 2020

On August 10, 2020, Saniona announced the direct issue of shares raising USD $65 million (approximately SEK 567 million) with a syndicate of U.S. and international institutional investors and sector specialists. The Directed Issue was led by RA Capital Management with participation from Pontifax Venture Capital, New Leaf Venture Partners, and other U.S. and international investors including the Second Swedish National Pension Fund (AP2), the Third Swedish National Pension Fund (AP3) and the Fourth Swedish National Pension Fund (AP4).
On August 26, 2020, Saniona announced the expansion of its executive team with the appointments of Jason A. Amello as Chief Financial Officer, Trista Morrison as Chief Communications Officer, and Linea Aspesi as Chief Human Resources Officer.
On September 23, 2020, Saniona completed the exercise of warrants of series TO2, which were issued in connection with Saniona’s rights issue and directed issue in the first quarter of 2020. In total, 1,329,141 warrants of series TO2 were exercised, corresponding to a subscription rate of approx. 90 percent. Saniona will thereby receive proceeds of SEK 33.2 million (USD 3.6 million), before issue costs, which amount to approx. SEK 0.4 million.
Significant events after the reporting period

On October 9, 2020, Saniona announced that it received written feedback from the U.S. Food and Drug Administration (FDA) regarding pre-Investigational New Drug (IND) submissions for Tesomet in Prader-Willi Syndrome (PWS) and Hypothalamic Obesity (HO). In both indications, the FDA recommended that the clinical development program include a supportive Phase 2b study followed by a Phase 3 study. In PWS, Saniona expects to begin the Phase 2b study in the first half of 2021. In HO, Saniona is working on a plan, which it intends to present to the FDA to ensure that should Tesomet receive regulatory approval for HO, its use would be restricted only to the appropriate patients. Once this is addressed, Saniona anticipates beginning the HO Phase 2b study in the first half of 2021.
On November 9, 2020, Saniona announced that it had refined its pipeline to align its early-stage discovery research with its strategic focus on rare diseases. Saniona regained exclusive, global rights to its GABAa5 negative allosteric modulator program ("GABAa5 program") from Boehringer Ingelheim, which terminated this collaboration for strategic reasons. The termination of the collaboration provided Saniona with rights to a portfolio of more than 800 molecules, and it does not impact the 2020 collaboration between Saniona and Boehringer Ingelheim, which remains ongoing. Separately, Saniona and the Treatment Research Center (TRC) at the University of Pennsylvania jointly discontinued their collaboration to develop NS2359 for cocaine addiction. Saniona will evaluate the applicability of the GABAa5 program assets and NS2359 in rare diseases.
On November 23, 2020, Saniona announced positive top-line results from the Phase 2 open-label extension study of Tesomet in patients with hypothalamic obesity (HO). Patients treated with Tesomet for nearly one year (24 week double-blind [DB] followed by 24 week open label extension [OLE]) demonstrated statistically significant and clinically meaningful reductions in body weight and waist circumference, as well as improvements in glycemic control. Tesomet was well tolerated, and no clinically meaningful differences in heart rate or blood pressure were observed over the course of the trial.

"In the third quarter, we continued to transform Saniona into a fully-integrated biopharmaceutical company with the ability to discover, develop and ultimately commercialize our own innovative treatments for rare diseases. We were particularly encouraged by the positive data from the Phase 2 open-label extension study of Tesomet in HO, which we intend to discuss with FDA as we clarify the path forward in this rare indication," said Rami Levin, President & Chief Executive Officer of Saniona. "During the quarter, one of our most important achievements was raising USD $65 million, which coupled with our existing cash resources, will fund our current operating plan into the second half of 2022, as originally planned. We believe access to U.S. patients, physicians and the U.S. financial market are critical for Saniona to unlock its long-term potential, and as such we are continuing to build our U.S. team and considering listing our shares on the U.S. Nasdaq exchange in addition to our existing listing on Nasdaq Stockholm."

There are multiple potential advantages to a dual listing, including increased visibility and access to a greater number of potential investors, as well as potential increased liquidity (trading volume) from different markets with different macroeconomic conditions, allowing investors to purchase and sell shares on either exchange.

This information is such information as Saniona AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8:00 CET on November 30, 2020.

On November 30, 2020 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that it has commenced an underwritten public offering of $60,000,000 of shares of its common stock (Press release, Cogent Biosciences, NOV 30, 2020, View Source [SID1234572001]). In addition, Cogent Biosciences has granted the underwriters a 30-day option to purchase up to an additional $9,000,000 of shares of its common stock. All of the shares of common stock to be sold in the underwritten public offering are being offered by Cogent Biosciences.

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Cogent Biosciences intends to use the net proceeds from the offering for development, regulatory and commercial preparation activities relating to PLX9486 and other product candidates, as well as for working capital and general corporate purposes.

Jefferies and Piper Sandler & Co. are acting as joint book-running managers for the offering. Wedbush PacGrow, LifeSci Capital and Ladenburg Thalmann are also acting as co-managers for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission (SEC) and became effective on May 1, 2019.

A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering have been filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the 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. The offering can be made only by means of a prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]); or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at [email protected].