On November 23, 2021 Immunomic Therapeutics, Inc., ("ITI") a privately held clinical-stage biotechnology company focused on advancing its proprietary nucleic acid immunotherapy platform, reported an exclusive option to license or acquire a series of innovative technologies in the immuno-oncology space from iOncologi, Inc., ("iOi") (Press release, Immunomic Therapeutics, NOV 23, 2021, View Source [SID1234595977]).

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Preclinical studies led by iOi Co-Founders, Drs. Duane Mitchell and Catherine Flores, have demonstrated that resistance to immune checkpoint inhibitors (ICIs) can be overcome by iOi’s novel, intravenously delivered stem cell-based therapeutic. Rapid translation of this possible breakthrough discovery into first-in-human clinical trials is underway. ITI’s option offers potential opportunities for both companies to further facilitate clinical and commercial development in the field of cell therapy and for collaboration in the development of nucleic acid vaccines that complements ITI’s own UNITE technology. The option agreement contemplates additional investment by ITI dependent upon iOi achieving certain clinical trial milestones.

"We are pleased to expand our collaboration with Dr. Duane Mitchell, both in his role as Founder & President of iOncologi, and as a leading academic researcher in the immuno-oncology field. Dr. Mitchell has been instrumental in the development and leadership of our ATTAC-II clinical trial for patients with Glioblastoma," said Dr. William Hearl, CEO of Immunomic Therapeutics. "His determination to bring innovative treatments to patients is what compounds the complementary technologies in both companies."

"We are very excited to have iOncologi and Immunomic Therapeutics bring together complementary expertise in the advancement of new treatments for patients with refractory cancers," said Dr. Mitchell. "This agreement expands upon a longstanding and very fruitful collaboration with Dr. Hearl and the team at ITI in bringing forward novel immunotherapy treatments for patients with Glioblastoma. I look forward to the advances that will come from this agreement between the two companies."

On November 23, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that management will participate in a Fireside Chat at the 4th Annual Evercore ISI HealthCONx Conference, taking place virtually on Tuesday, November 30, 2021, at 3:30 pm ET (Press release, SpringWorks Therapeutics, NOV 23, 2021, View Source [SID1234595975]).

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A video webcast will be available on the Events & Presentations page within the Investors & Media section of the company’s website at View Source A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

On November 23, 2021 Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, reported two presentations at the 2021 San Antonio Breast Cancer Symposium (SABCS), to be held from December 7-10, 2021 (Press release, Carrick Therapeutics, NOV 23, 2021, View Source [SID1234595974]).

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Abstracts are available starting on Friday, November 19, 2021, at 8:00am CT (9:00am ET/2:00pm GMT). The Company will participate in Poster Session 1 on Wednesday, December 8, 2021, from 7:00am-8:30am CT (8:00am-9:30am ET/1:00pm-2:30pm GMT) and provide an oral presentation on Thursday, December 9, 2021, at 11:00am CT (12:00pm ET/5:00pm GMT).

"We are excited to present additional data from our on ongoing clinical studies of Samuraciclib in HR+, HER2- advanced breast cancer and triple negative breast cancer at SABCS in December," said Dr. Stuart Mcintosh, Chief Medical Officer of Carrick Therapeutics. "The updated data being presented will speak to the clinical activity and tolerability seen to date in the trials. We are encouraged by the progress we’ve seen in both diseases, particularly for the TP53 wildtype sub-population within the broader HR+, HER2- trial, which will be discussed in further detail during the conference."

Poster and oral presentation details are as follows:

Poster Presentation Title: A clinical study of Samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in patients with advanced triple negative breast cancer (TNBC)
Presenting Author: Dr Sacha Howell
Abstract number: P1-18-10

Oral Presentation Title: Study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in combination with fulvestrant in patients with advanced Hormone Receptor positive HER2 negative breast cancer (HR+BC)
Presenting Author: Professor Charles Coombes
Abstract number: ID: GS3-10

About Samuraciclib (CT7001)
Samuraciclib is the most advanced oral CDK7 inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer as CDK7 regulates the transcription of cancer-causing genes, promotes uncontrolled cell cycle progression and resistance to anti-hormone therapy. Samuraciclib has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies. In addition to the above study, it is currently being evaluated in triple negative breast cancer (TNBC) and prostate cancer with further potential in pancreatic, ovarian and colorectal cancers. Samuraciclib has been granted Fast Track designations from the U.S. Food and Drug Administration (FDA) for use in combination with fulvestrant for the treatment of CDK4/6i resistant HR+, HER2- advanced breast cancer and in combination with chemotherapy for the treatment of locally advanced or metastatic TNBC.

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)