On November 23, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported the commencement of an initial public offering (STAR Offering) on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange (SSE) (Press release, BeiGene, NOV 23, 2021, View Source [SID1234595973]). The total number of shares being offered in the STAR Offering is 115,055,260 ordinary shares, par value $0.0001 per share, which represents 8.62% of BeiGene’s total outstanding ordinary shares as of October 31, 2021, after giving effect to the shares being offered. The shares offered in the STAR Offering (RMB Shares) will be issued to and subscribed for by permitted investors in the People’s Republic of China (PRC) and listed and traded on the STAR Market in Renminbi. In addition, BeiGene expects to grant China International Capital Corporation Limited a 30-day overallotment option for up to 17,258,000 additional RMB Shares. The consummation of the STAR Offering is subject to, among other things, market conditions, and there can be no assurance as to whether or when the STAR Offering may be completed, or as to the actual size or terms of the STAR Offering.

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China International Capital Corporation Limited and Goldman Sachs Gao Hua Securities Co. Ltd. are acting as joint sponsors and joint bookrunners for the STAR Offering. J.P. Morgan Securities (China) Company Limited, CITIC Securities Co., Ltd. and Guotai Junan Securities Co., Ltd. are acting as joint bookrunners for the STAR Offering.

BeiGene expects to use the net proceeds from the STAR Offering to fund its research and clinical development, construction of its research and development centers and a manufacturing plant in China, sales and marketing force expansion in China, and for working capital and general corporate purposes.

In accordance with applicable PRC laws and regulations, the STAR Offering will be conducted solely within the PRC and only to permitted investors who are eligible to participate in the STAR Offering in accordance with applicable PRC securities laws and regulations, and rules promulgated by the SSE and the China Securities Regulatory Commission (CSRC). The STAR Offering will be conducted pursuant to a prospectus and other offering materials prepared by BeiGene in Chinese language and as approved by and registered with the SSE and the CSRC, which are only permitted to be used within the PRC. No part of the STAR Offering is intended to involve a public offering or sale of the RMB Shares into or in the United States or any other jurisdiction outside of the PRC. In addition, although the RMB Shares are of the same class and have the same rights as the Company’s existing ordinary shares listed on the Hong Kong Stock Exchange (HKEx), the RMB Shares will not be fungible with the ordinary shares listed on the HKEx or the Company’s American Depositary Shares (ADSs) representing its ordinary shares listed on the NASDAQ Global Select Market (NASDAQ), and in no event will any RMB Shares be able to be converted into ordinary shares listed on the HKEx or ADSs listed on NASDAQ, or vice versa.

An automatically effective shelf registration statement on Form S-3 was filed with the Securities and Exchange Commission (SEC) on May 11, 2020. A preliminary prospectus supplement relating to and describing the key terms of the STAR Offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. The final terms of the STAR Offering will be disclosed in a final prospectus supplement to be filed with the SEC. The purpose of the prospectus supplement is to register all RMB Shares offered in the STAR Offering under the Securities Act of 1933, as amended (Securities Act), to ensure that the offer and sale of the RMB Shares, if any, to permitted investors who are U.S. persons (as defined in Regulation S under the Securities Act) in transactions outside the United States will not violate the registration requirements under Section 5 of the Securities Act.

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 offer or sale of these securities in any state or 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 jurisdiction. This press release is being issued pursuant to, and in accordance with, Rule 134 under the Securities Act.

On November 23, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that Apollomics has dosed the first patient in China in a Phase 3 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) (Press release, GlycoMimetics, NOV 23, 2021, View Source [SID1234595972]). Apollomics’ Phase 3 trial with APL-106 is part of the overall development program for Apollomics in China that also includes an ongoing Phase 1 pharmacokinetics (PK) and tolerability study. The Phase 3 clinical trial is part of a randomized, double-blind, placebo controlled, bridging study program that will evaluate the efficacy of uproleselan in combination with chemotherapy, compared to chemotherapy alone, for treating relapsed/refractory AML, in Chinese patients. The trial will enroll approximately 140 adult patients with primary refractory AML or relapsed AML (first or second untreated relapse) and eligible to receive induction chemotherapy.

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"Dosing of the first patient in this Phase 3 clinical trial in Greater China is a significant accomplishment for Apollomics and comes quickly on the heels of our recent completion of enrollment in our own pivotal Phase 3 trial evaluating uproleselan in addition to a standard chemotherapy regimen in patients with relapsed/refractory AML," commented Harout Semerjian, GlycoMimetics Chief Executive Officer.

The primary endpoint for the Apollomics Phase 3 trial is overall survival. Secondary outcome measures include the rate and duration of remission, and whether uproleselan could reduce the rate of oral mucositis, a chemotherapy-related side effect. Apollomics expects to conduct this study at approximately 20 blood cancer clinical research centers across China. Additional information on the Phase 3 trial can be found on clinicaltrials.gov (NCT05054543)

On November 23, 2021 Isofol Medical AB (View Source) (publ) (Nasdaq Stockholm: ISOFOL), reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the development of the Company’s lead drug candidate arfolitixorin, the stabilized and biologically active pure form of folate ([6R]-MTHF), for treatment of patients with metastatic colorectal cancer (mCRC) (Press release, Isofol Medical, NOV 23, 2021, View Source [SID1234595971]). The FDA’s decision is based on the potential for arfolitixorin to address a large unmet medical need for new and more effective treatments of mCRC, the second deadliest and third most common form of cancer. Fast Track Designation facilitates frequent communication with the FDA and can result in expedited review timelines and a potential earlier market authorization and approval to ensure that new treatments can be made available quicker for patients with serious diseases.

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– We are thrilled that the FDA has granted Fast Track Designation to our lead candidate arfolitixorin. This serves as a strong external validation of arfolitixorin’s potential to benefit patients with this devastating disease. Our next clinical milestone is reaching 300 progression-free survival events in the Phase III AGENT study which means that data can be deblinded so that we can analyze and present top-line results in the first half of 2022. The Fast Track Designation will enable us to engage more frequently with the FDA to optimally plan for the continued development of arfolitixorin and potentially make it the first novel drug to improve the standard of care in mCRC in over 40 years, said Ulf Jungnelius, CEO of Isofol.

As defined by the FDA, Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions, thereby meeting an unmet medical need. The designation allows for such options as eligibility for priority review, if relevant criteria are met, more frequent meetings with FDA, and rolling review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. The NDA review otherwise usually does not begin until the drug company has submitted the entire application to the FDA. More information about the Fast Track Designation can be found here.

As the first and only pure form of the folate ([6R]-MTHF) that increases 5FU-cytotoxicity, arfolitixorin is currently being evaluated in the global pivotal Phase III AGENT study. The AGENT study is fully recruited and approximately 90 clinics in the United States, Canada, Europe, Australia and Japan have been involved in the study. Isofol’s ambition is to conclude the AGENT study in 2022 and thereafter apply for market approval with the FDA and EMA, which could result in a potential commercialization of arfolitixorin as early as 2023.

This is information that Isofol Medical AB 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 18:45 CET on November 23, 2021.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global pivotal Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

About the AGENT study
The Phase III AGENT study is a randomized, controlled, multi-centre study assessing the efficacy and safety of arfolitixorin, [6R]-5,10-methylene-THF acid (MTHF), compared to leucovorin, both used in combination with 5-FU, oxaliplatin, and bevacizumab, in first line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumour cells. The study is designed to show superiority for arfolitixorin over leucovorin.

The study has involved approximately 90 clinics in the U.S., Canada, Europe, Australia and Japan. In December 2020, the last of the AGENT study’s 440 patients were recruited, which is the basis in the statistical analysis plan. Isofol is now focusing on completing the ongoing AGENT study where the patients receive first-line standard treatment with either leucovorin or arfolitixorin for metastatic colorectal cancer (mCRC). The company expects that top-line results of the AGENT study will be available during H1 2022. Further information about the study, including patient eligibility requirements, is available at www.clinicaltrials.gov id:NCT03750786.

On November 23, 2021 Nykode Therapeutics (formerly Vaccibody*)) (Euronext Growth (Oslo): VACC (ticker will soon be changed)), a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported that the Company is changing its name to reflect its exciting development and mark a milestone in our journey of growth and transformation (Press release, Vaccibody, NOV 23, 2021, View Source [SID1234595970]). It acts as a visible symbol of a new phase of opportunity based on collaborations, internationalization, and future ambitions. And it conveys how we are truly starting to realize our vision of being a leading immunotherapy platform company, breaking down the boundaries of conventional drug design to unlock the future of medicine.

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The Company’s new name is inspired by its Norwegian roots and links to our platform’s modularity. Nykode translates as ‘new code’, playing on the potential of our technology to generate novel codes and create innovative patient therapies. Michael Engsig, CEO of Nykode Therapeutics: "Over the last few years, the Company has made significant steps forward. We have reported promising clinical data, continued to grow our pipeline and forged significant partnerships."

Michael Engsig added, "We continue our exciting transformation from a two-asset focused company to a fully-fledged platform biotech company. During the past year, we have increased the number of talented colleagues, made important additions to our senior management team, invested strategically, and expanded internationally. This positive evolution, combined with our future ambitions, inspired the need to revisit our brand."

Agnete B. Fredriksen, Chief Innovation & Strategy Officer of Nykode Therapeutics, continued, "The challenge of changing our name was to consolidate everything we have achieved to date with our future plans to expand, and combine this into a powerful new brand." Agnete B. Fredriksen added, "We have shown that we can generate novel molecules by combining multiple different genes or codes to generate new medicines with unique properties. We will build further on this know-how, driven by our guiding purpose to push the boundaries of human advancement by rethinking conventional drug design. We want to express how our platform’s intelligent modular design and tailored hyper targeting may deliver game-changing medicines for patients. This vision aims to create innovative therapies and continues to broaden our reach into multiple therapeutic areas, both with and without our partners. In essence, we believe that our new name, Nykode, uniquely captures our progress and possibilities."

Read more about the journey and inspiration regarding our new name, logo, and visual identity on our new website, nykode.com. *)

Vaccibody AS, which is changing its company name to Nykode Therapeutics AS, has called for an EGM on November 30, 2021, to vote for the approval of the change of its company name from Vaccibody AS to Nykode Therapeutics AS.

On November 23, 2021 AI medical technology company Artrya Limited reported its partnership with leading global commercial services provider EVERSANA Life Sciences LLC ("EVERSANA") as its launch and commercialisation partner to access the UK market (Press release, EVERSANA, NOV 23, 2021, View Source [SID1234595969]).

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The announcement follows Artrya’s recent appointment onto the United Kingdom National Health Service Shared Business Services (NHS SBS) Framework as a supplier of artificial intelligence software and platforms, following a successful tender bid.

Artrya’s core software is the novel technology Salix – a fast and effective AI-based solution which analyses cardiac CT scans. Salix supports clinicians in their diagnosis of coronary artery disease by detecting key disease biomarkers, including location and severity, on a 3D heart image. The comprehensive patient report is produced in approximately 15 minutes, assisting ‘first-time-right’ treatment.

EVERSANA’s CEO Jim Lang commented: "We are delighted to partner with Artrya to initiate the company’s UK commercialisation plan. Around the world we have seen first-hand how digital innovations such as Salix have the ability to change lives and improve care, but these technologies require commercialisation strategies that reach beyond traditional life science tactics."

"There’s an opportunity for hospitals to substantially benefit from the efficiencies AI can offer, especially with high patient demand and staff shortages," said Mr. Lang.

Artrya’s Managing Director and Co-founder John Barrington said the partnership with EVERSANA is a significant step in making coronary heart disease diagnosis more efficient and accurate in the UK.

"Hospitals will soon have the opportunity to access cutting edge technology which can detect vulnerable plaque in a patient’s arteries. Vulnerable plaques are the major cause of most fatal and non-fatal heart attacks in individuals.

"There is a growing need for better diagnostics around the international problem of coronary artery disease which is responsible for one in three deaths globally. The cost to the United Kingdom economy alone annually is £7.6 billion," said Mr. Barrington.

Under the NHS SBS framework agreement Artrya is listed among a select, preferred, and pre-qualified shortlist of approved suppliers from which various public organisations, including 1,250 NHS hospitals, can commission services.

Market pilots of Salix are presently underway in Perth and Sydney, with an unrestricted launch planned across Australia in early 2022.

Artrya anticipates the ability to sell into the UK in mid-2022.