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Agenus Enters into Clinical Collaboration with Nelum for Zalifrelimab Combination

On Jan. 26, 2021 Agenus Inc., an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that it has entered into a clinical collaboration with Nelum Corp. to evaluate the safety and efficacy of zalifrelimab, Agenus’ anti-CTLA-4 antibody, in combination with NLM-001, Nelum’s small molecule hedgehog inhibitor, and chemotherapy for first-line advanced pancreatic cancer. (Press release, Agenus, JAN 26, 2021, View Source [SID1234577556])

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"This collaboration with Nelum is an exciting next step in our partnership strategy to broaden combinations and indications with our late stage checkpoint antibodies," said Julie DeSander, Vice President of Business Development and Alliance Management. "Zalifrelimab, our first generation anti-CTLA-4 antibody, shows promising results alone and in combination with balstilimab, our anti-PD-1 antibody, and offers the potential to expand therapeutic benefit in novel combinations."

Nelum’s NLM-001 is a best-in-class small-molecule hedgehog inhibitor that targets cancer-associated fibroblasts. It synergizes with checkpoint inhibitors by promoting immune cell infiltration into the tumor microenvironment and increases tumor penetration of chemotherapy. NLM-001 is active and well-tolerated in patients with solid tumors, as demonstrated in a Phase I study.

"NLM-001 is designed to disrupt the tumor microenvironment for increased responsiveness to checkpoint inhibition and improved delivery of chemotherapy," said Evelio Perea, Chairman of the Board of Nelum. "We look forward to evaluating NLM-001 in combination with Agenus’ checkpoint inhibitor zalifrelimab to expand therapeutic options for patients with advanced pancreatic cancer."

Under the terms of the agreement, Agenus will supply zalifrelimab to Nelum for the combination study. Nelum will sponsor and be responsible for the conduct of the trial, which is set to begin enrolling in 1H 2021.

Novo Nordisk A/S – Share repurchase programme

On January 26, 2021 Novo Nordisk reported initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, JAN 26, 2021, View Source [SID1234577312]). This programme is part of the overall share repurchase programme of up to DKK 17 billion to be executed during a 12-month period beginning 5 February 2020.

Under the programme initiated 3 November 2020, Novo Nordisk will repurchase B shares for an amount up to DKK 2.7 billion in the period from 4 November 2020 to 1 February 2021.

With the transactions stated above, Novo Nordisk owns a total of 39,263,659 B shares of DKK 0.20 as treasury shares, corresponding to 1.7% of the share capital. The total amount of A and B shares in the company is 2,350,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 17 billion during a 12- month period beginning 5 February 2020. As of 22 January 2021, Novo Nordisk has since 5 February 2020 repurchased a total of 39,325,522 B shares at an average share price of DKK 425.27 per B share equal to a transaction value of DKK 16,723,794,610.

Nirogy Therapeutics Launches with $16.5 Million Series A Financing

On January 26, 2021 Nirogy Therapeutics Inc., a privately-held biotechnology company developing novel small molecules to target cellular transporters, reported the closing of a $16.5 million Series A financing (Press release, Nirogy Therapeutics, JAN 26, 2021, View Source [SID1234576777]). The financing was co-led by Santé Ventures and Sporos. In conjunction with the financing, Dennis McWilliams of Santé and Joseph Kekst of Sporos will join Nirogy’s board of directors, and Casey Cunningham, Ph.D. will join Nirogy’s scientific advisory board.

Nirogy plans to use the proceeds to advance its drug discovery platform to generate a pipeline of small-molecule drugs designed to target the solute carrier family of transporter proteins (SLCTs) embedded in the cell membrane. SLCTs are gatekeepers of essential physiological functions, including nutrient uptake and metabolite disposal, which are aberrantly altered in many diseases. Enabled by its proprietary small-molecule compound library and rapid development strategies, Nirogy is developing first-in-class medicines with an initial focus on oncology and autoimmune diseases.

"Cellular transporters, which are central to many aspects of cell biology and dysregulated in myriad diseases, have not been effectively targeted due to the complex structures of SLCTs. Our team’s strength in computational modeling, medicinal chemistry and cancer biology has enabled us to overcome the challenge of drugging these critical untapped targets," said Vincent Sandanayaka, Ph.D., founder, president and chief executive officer of Nirogy Therapeutics. "We are fortunate to have a world-class scientific advisory board, highly committed investor partners and a dedicated team with proven scientific and drug development expertise."

Nirogy’s lead program targets lactate transporters for the treatment of cancer and is expected to enter human clinical trials in 2022. Unlike normal cells, cancer cells consume large amounts of glucose and excrete a huge excess of lactic acid to the tumor microenvironment via lactate transporters for their rapid growth and survival. Lactate-rich tumors create a hostile environment for immune cells to survive, thus suppressing anti-tumor immunity. Nirogy’s lactate transport inhibitors have shown robust anti-tumor efficacy in preclinical models, either as monotherapy or combination therapy. Nirogy’s pipeline also includes a second transporter target in cancer and a third program in immunology.

Dennis McWilliams, partner at Santé Ventures, said: "We recognize the potential of the Nirogy team and its proprietary drug discovery engine in SLCTs, which could yield over 450 potential druggable targets and open up new treatment modalities for a number of life-threatening diseases."

Ronald DePinho, M.D., Nirogy co-founder and chair of the Sporos strategic advisory board, added: "It is a privilege to work with this incredible team that’s focused on revealing the mysteries of cellular transport biology and converting such insights into medicines for our patients in need."

Calliditas Therapeutics launches proposed global offering

On January 26, 2021 Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX – CALTX; Nasdaq – CALT) reported that launch a proposed public offering of American Depositary Shares ("ADSs"), in the United States for trading on The Nasdaq Global Select Market in the United States (the "U.S. Offering") and a concurrent private placement of common shares to certain qualified investors in Europe and other countries outside of the United States (the "Private Placement", and together with the U.S. Offering, the "Global Offering") (Press release, Calliditas Therapeutics, JAN 26, 2021, View Source [SID1234576685]). The target size of the Global Offering is 4,500,000 common shares plus a potential 30-day over-allotment option of 15 percent of the common shares (including common shares in the form of ADSs) offered by Calliditas at the U.S. Offering price. The Global Offering is subject to market conditions and investor demand and the number of ADSs (which represents two common shares) and common shares that may be offered and the price for such instruments have not yet been determined.

Stockholm, January 26, 2021 – Calliditas announces that it has today commenced an underwritten global offering with a target size of 4,500,000 common shares, plus a potential 30-day over-allotment of 15 percent of the common shares (including common shares in the form of ADSs) offered by Calliditas at the U.S. Offering price.

Calliditas will announce the outcome of the Global Offering after pricing in a subsequent press release; however, any further details regarding the offering remain subject to market conditions and investor demand and the Global Offering may not be consummated. Calliditas’ common shares are currently listed on Nasdaq Stockholm under the symbol "CALTX", and Calliditas’ ADSs are currently listed on The Nasdaq Global Select Market under the symbol "CALT".

This company announcement does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

A registration statement relating to the ADSs referred to herein has been filed with the SEC, but has not yet been declared effective. These ADSs may not be sold, nor may offers to buy these ADSs be accepted prior to the time such registration statement becomes effective. Citigroup Global Markets Inc., Jefferies LLC and Stifel, Nicolaus & Company, Incorporated are acting as the global coordinators and joint book-running managers of the Global Offering. Kempen & Co, LifeSci Capital LLC and Carnegie will act as co-managers for the Global Offering. Citigroup Global Markets Inc. and Jefferies LLC are acting as representatives of the underwriters in the U.S. Offering. Citigroup Global Markets Limited, Jefferies International Limited and Jefferies GmbH are acting as representatives of the underwriters in the Private Placement. Copies of the preliminary prospectus related to the U.S. Offering are available at www.sec.gov. Alternatively, copies of the preliminary prospectus relating to the U.S. Offering may be obtained from Citigroup Global Markets Inc., Attention: Prospectus Department, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by telephone at +1 (800) 831-9146; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, via telephone: +1 877-821-7388 or via email: [email protected] or from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at +1 (415) 364-2720 or by email at [email protected].

The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on January 26, 2021 at 10:10 p.m (CET).

bridgebio pharma, inc. announces completion of merger with eidos therapeutics, inc.

On January 26, 2021 BridgeBio Pharma, Inc. ("BridgeBio") (Nasdaq: BBIO) reported that it has completed its acquisition of all of the outstanding shares of Eidos Therapeutics, Inc. ("Eidos") (formerly Nasdaq: EIDX) common stock that BridgeBio did not already own (Press release, BridgeBio, JAN 26, 2021, View Source [SID1234576240]). The transaction was overwhelmingly approved by BridgeBio and Eidos stockholders.

The merger reunites the teams at BridgeBio and Eidos and allows BridgeBio to deploy its full clinical and commercial infrastructure to support the development and global commercialization plans underway for Eidos’ acoramidis, a potential best-in-class therapy for patients with transthyretin (TTR) amyloidosis (ATTR). BridgeBio’s mission is to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers.

"2021 is an important year for BridgeBio and the patients we serve," said Neil Kumar, Ph.D., founder and CEO of BridgeBio. "With significant near-term pivotal and proof-of-concept data anticipated in our four core programs, including acoramidis, we are eager to accelerate our critical work for patients as a single unified company."

Acoramidis for ATTR is one of BridgeBio’s four core value driver programs, along with encaleret (CaSR inhibitor) for autosomal dominant hypocalcemia type 1 (ADH1), low-dose infigratinib (FGFR inhibitor) for achondroplasia, and BBP-631, an AAV5 gene therapy for congenital adrenal hyperplasia (CAH). 2021 is poised to be a transformational year for BridgeBio with major catalysts in all four programs anticipated in 2021 or the first quarter of 2022. This year BridgeBio also expects to launch two drugs, if approved, and is building its global commercial capabilities.

Acoramidis (AG10) – TTR stabilizer for ATTR: Topline results from Part A of the ATTRibute-CM trial are expected in late 2021 or early 2022 and from Part B in 2023. If Part A is successful, BridgeBio expects to file for regulatory approval of acoramidis in 2022. ATTR is a form of amyloidosis caused by the accumulation of misfolded TTR protein. It is estimated to affect more than 400,000 people worldwide and is largely undiagnosed today.

Encaleret – calcium-sensing receptor (CaSR) inhibitor for ADH1: Phase 2 proof-of-concept results are anticipated in the third quarter of 2021. If the development program is successful, encaleret would be the first approved therapy for ADH1, a condition caused by gain of function variants in the CASR gene estimated to be carried by 12,000-13,000 individuals in the United States alone.

Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia: Initial data from the ongoing Phase 2 dose ranging study are expected in the fourth quarter of 2021. Achondroplasia is the most common form of genetic short stature and one of the most common genetic diseases, with 55,000 cases in the United States and European Union. Low-dose infigratinib is the only known therapy in development for achondroplasia that targets the disease at its genetic source and the only orally administered product candidate in clinical stage development.

BBP-631 – AAV5 gene therapy candidate for CAH: Initiation of a first-in-human Phase 1/2 study is expected in 2021, with initial data anticipated in the fourth quarter of 2021 or the first quarter of 2022. CAH is one of the most prevalent genetic diseases potentially addressable with AAV gene therapy, with more than 75,000 cases in the United States and European Union. The disease is caused by deleterious mutations in the gene encoding an enzyme called 21-hydroxylase, leading to lack of endogenous cortisol production. BridgeBio’s AAV gene therapy candidate is designed to provide a functional copy of the 21-hydroxylase-encoding gene (CYP21A2) and potentially address many aspects of the disease course.
As a result of the merger, former Eidos stockholders are entitled to receive, for each share of Eidos common stock issued and outstanding immediately prior to the effective time of the merger that was not owned by BridgeBio or any of its subsidiaries and that was not a restricted share award, either (i) 1.85 shares of BridgeBio common stock or (ii) if an election to receive cash was properly made prior to 5:00 P.M., New York City time, on January 21, 2021, $73.26 in cash. Eidos stockholders should contact American Stock Transfer & Trust Company, LLC, the exchange agent for the transaction, by calling toll-free at (877) 248-6417 or at (718) 921-8317, if they have any questions regarding the consideration to which they are entitled.