Ranok Therapeutics Secures $40 Million Series B Financing to Advance its Innovative Targeted Protein Degradation Pipeline

On August 18, 2021 Ranok Therapeutics (Hangzhou) Co. Ltd., an emerging biopharmaceutical company focused on developing breakthrough therapies for cancer and other serious diseases, reported it had secured a $40 million Series B funding round denominated in both U.S. dollars and Chinese yuan (Press release, Ranok Therapeutics, AUG 18, 2021, View Source [SID1234586729]). The financing was led by Lapam Capital and Shanghai Healthcare Capital, with additional participation from Wu Capital, Zhongguancun Kaiyuan Capital and existing investors, and representatives of the new investors will join Ranok’s expanded board of directors. To date, Ranok has raised the equivalent of over $50 million in funding.

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Ranok has developed a proprietary and innovative targeted protein degradation (TPD) platform technology, CHAMP (Chaperone-mediated Protein Degradation), that leverages Ranok’s founders’ expertise in protein homeostasis to take advantage of the cellular chaperome network, potentially improving drug safety and efficacy due to selective targeting of disease tissues.

"We are delighted by the enthusiastic response from investors to this financing, which is a strong endorsement of Ranok’s strategic vision and research programs," said Weiwen Ying, Ph.D., Founder and Chief Executive Officer of Ranok Therapeutics. "These funds will enable us to advance our first cancer therapy into clinical trials in the near future and continue to progress our pipeline of novel CHAMP targeted protein degraders. We believe our approach may provide important benefits both in safety and in efficacy for areas of significant unmet need. We welcome our new investors and greatly appreciate the continued support of our existing investors."

"We are very optimistic about the direction and opportunity of the emerging field of TPD and its application to traditionally undruggable disease targets. Ranok’s founders, who bring decades of experience in protein degradation, have developed a unique technology platform that is highly differentiated from competing degrader approaches. We are delighted to work with innovative companies such as Ranok and look forward to helping quickly and efficiently bring their novel medicines to patients," said Zhihua Yu, Chairman of Lapam Capital.

"TPD is an exciting new paradigm in drug development, and Ranok’s CHAMP technology has unique advantages in comparison to other protein degrader approaches, such as PROTAC," said Hong Wen, Ph.D., Partner at Shanghai Healthcare Capital. "We share Ranok’s vision to become a leading protein degradation therapy company with a global impact by creating breakthrough medicines for patients suffering from cancer and other diseases."

The Series B financing proceeds will support continued development of Ranok’s most advanced cancer program, which is expected to be announced by the end of 2021, as well as expansion of its preclinical pipeline of novel therapies based on the proprietary CHAMP technology platform.

BeiGene Announces Acceptance by Swissmedic of Marketing Authorization Application for BRUKINSA® (Zanubrutinib) in Waldenström’s Macroglobulinaemia

On August 18, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that Swissmedic has accepted the marketing authorization application (MAA) for BRUKINSA, a treatment option for adult patients with Waldenström’s macroglobulinaemia (WM) (Press release, BeiGene, AUG 18, 2021, View Source [SID1234586728]). Swissmedic has started the formal review of the MAA. BRUKINSA has already been granted orphan drug status by Swissmedic.

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"The acceptance of the marketing authorization application of BRUKINSA by Swissmedic is a crucial step in the development of BRUKINSA for Swiss patients with WM. We are looking forward to continuing our work with the health authorities to bring BRUKINSA to patients living with this rare, incurable blood cancer."

Swissmedic, the Swiss Agency for Therapeutic Products, reviews new products for market authorization. Within this process, Swissmedic evaluates a product’s quality, safety, and effectiveness through clinical trial data.

Gerwin Winter, Senior Vice President, Head of Commercial, Europe, at BeiGene said: "The acceptance of the marketing authorization application of BRUKINSA by Swissmedic is a crucial step in the development of BRUKINSA for Swiss patients with WM. We are looking forward to continuing our work with the health authorities to bring BRUKINSA to patients living with this rare, incurable blood cancer."

The MAA is supported by data from the randomized Phase 3 ASPEN clinical trial (NCT03734016), evaluating zanubrutinib compared to ibrutinib in adult patients with WM.1

The approval by Swissmedic would grant marketing authorization for BRUKINSA in WM within Switzerland.

About Waldenström’s Macroglobulinemia

WM is a rare lymphoma representing approximately 1% of all non-Hodgkin lymphomas and typically progresses slowly after diagnosis.2 The disease usually affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen may be involved.3 Throughout Europe, the estimated incidence rate of WM is approximately 7 for every 1 million men and 4 for every 1 million women.4

About BRUKINSA (zanubrutinib)

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is currently approved in several regions for various indications.1 To date, more than 30 marketing authorization applications in multiple indications have been submitted covering the United States, the European Union, and more than 20 other countries or regions.

Bavarian Nordic to Host First Half 2021 Results Conference Call and Webcast

On August 18, 2021 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that it will announce its 2021 first half results on Wednesday, August 25, 2021 (Press release, Bavarian Nordic, AUG 18, 2021, View Source [SID1234586727]).

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The management of Bavarian Nordic will host a conference call at 2:00 pm CEST (8:00 am EDT) on the same day to present the interim results followed by a Q&A session. A live and replay version of the call and relevant slides will be available at https://bit.ly/3xzOiQo.

To join the Q&A session dial one of the following numbers and state the participant code 8569159: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495.

Van Andel Institute earns prestigious grant to train postdoctoral fellows in cancer epigenetics

On August 18, 2021 The National Cancer Institute reported that it has awarded Van Andel Institute a five-year, $1.7 million grant to establish a cutting-edge training program for postdoctoral fellows in cancer epigenetics, a growing field with untold potential to impact human health (Press release, Van Andel Institute, AUG 18, 2021, View Source;utm_medium=rss&utm_campaign=t32-award-cancer-epigenetics-training-program [SID1234586725]).

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The new Cancer Epigenetics Training Program combines extensive professional development with comprehensive, interdisciplinary research training by VAI’s internationally recognized cadre of experts. Postdoctoral trainees also will have access to the Institute’s state-of-the-art shared scientific resources and technologies as well as opportunities to participate in established translational research programs and partnerships led by VAI investigators.

Epigenetic abnormalities are universally found across cancers and serve as major drivers for malignancy, making them promising new targets for the development of novel cancer therapies. As such, the field — and its capacity for producing breakthroughs — is rapidly expanding.

"In the past few years, VAI has become a global destination for groundbreaking, collaborative cancer epigenetics research," said VAI Chief Scientific Officer Peter A. Jones, Ph.D., D.Sc. (hon). "Postdoctoral trainees will emerge from our Cancer Epigenetics Training Program with extensive, rigorous training and a solid foundation from which to launch their independent research careers."

Jones and VAI Associate Professor Scott Rothbart, Ph.D., will lead the program in collaboration with Erica Gobrogge, Ph.D., program director of VAI’s Office of Postdoctoral Affairs. The program also benefits from the guidance of its advisory committee, which includes renowned scientists from across the U.S.

VAI’s Cancer Epigenetics Training Program is now accepting applications from candidates who are near completion of a Ph.D., M.D. or other appropriate terminal degree. For a full list of eligibility criteria, please visit vari.vai.org/cancer-epigenetics-training-program.

The Cancer Epigenetics Training program is supported by a National Cancer Institute T32 training grant (no. T32CA251066). The content is solely the responsibility of VAI and does not necessarily represent the official views of the National Institutes of Health.

PROMIS NEUROSCIENCES INC. ANNOUNCES UPSIZE OF PREVIOUSLY ANNOUNCED PUBLIC OFFERING OF UNITS TO US$17.5M

On August 18, 2021 ProMIS Neurosciences Inc. ("ProMIS" or the "Company") (TSX: PMN), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported it has upsized its public offering (the "Offering") of units ("Units") to US$17.5M from US$15M at a price of US$0.16 per Unit. If the Agent’s Option (as defined below) is exercised in full, the aggregate gross proceeds of the Offering will be approximately US$20.1M (Press release, ProMIS Neurosciences, AUG 18, 2021, View Source [SID1234586724]).

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Each Unit consists of one common share of the Company (a "Common Share") and one quarter of one Common Share purchase warrant (each whole purchase warrant, a "Warrant"). Each Warrant will entitle the holder thereof to purchase one Common Share (each, a "Warrant Share") at a price of US$0.21 per Warrant Share at any time up to 60 months following the issuance date thereof, subject to acceleration.

The Offering will be conducted on a commercially reasonable efforts basis pursuant to the terms and conditions of an agency agreement to be entered into between the Company and Leede Jones Gable Inc. (the "Agent"). The Company will also grant the Agent an option (the "Agent’s Option"), exercisable, in whole or in part, at the sole discretion of the Agent, to increase the size of the Offering by up to 15%. The Agent’s Option is exercisable, in whole or in part, at any time until the date that is two business days prior to the Closing Date (as defined herein).

The Offering is expected to close on or about August 24, 2021, or such other date as may be mutually agreed to by the Company and the Agent (the "Closing Date"), subject to satisfaction of customary closing conditions, including the approval of the Toronto Stock Exchange (the "TSX").

The Offering is being made pursuant to a prospectus supplement to the Company’s short form base shelf prospectus dated June 30, 2021 (the "Base Prospectus"), which the Company will file with the securities commissions or other security regulatory authorities in each of the provinces and territories of Canada (other than Québec). Additionally, the Offering is expected to be conducted by way of private placement in other jurisdictions where the Offering can lawfully be made.

The Company intends to use the net proceeds from the Offering (including additional proceeds from the possible exercise of the Agent’s Option) to advance its lead Alzheimer’s therapy PMN310 to the filing of an Investigational New Drug application to enable a first clinical trial, expanding the ProMIS portfolio of antibodies and patents, and general corporate purposes, as more fully described in the preliminary prospectus supplement of the Company dated August 17, 2021 (the "Preliminary Prospectus Supplement").

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and such securities may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as such terms are defined in Regulation S under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This news release does not constitute an offer for sale of securities nor a solicitation for offers to buy any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.