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ImmuneOncia and 3D Medicines Signed Exclusive License Agreement to Develop, Manufacture and Commercialize IMC-002 in Greater China

On March 30, 2021 ImmuneOncia Therapeutics, Inc., a clinical-stage, immuno-oncology company in South Korea, and 3D Medicines, Inc., a China-based biopharmaceutical company developing next-generation immuno-oncology drugs, reported an exclusive license agreement for the development, manufacture and commercialization of IMC-002, ImmuneOncia’s monoclonal antibody against CD47 (Press release, ImmuneOncia Therapeutics, MAR 30, 2021, View Source [SID1234577386]). The agreement includes uses of IMC-002 for oncology indication as a monotherapy or combination agent in the Territory of Greater China (Mainland China, Hong Kong, Macau, and Taiwan). ImmuneOncia will retain rights of IMC-002 in the rest of the world including the United States, European Union, and Japan.

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Under the terms of the agreement, ImmuneOncia will receive an upfront payment of $8 million from 3D Medicines. Additionally, ImmuneOncia is eligible to receive up to $462.5 million upon the achievements of all future development and commercial milestones, plus tiered royalties up to double-digits on annual net sales of IMC-002 in Greater China. In exchange, 3D Medicines will receive rights to develop, manufacture and commercialize IMC-002 in Greater China. 3D Medicines is planning to file IND to NMPA in China this year.

"3D Medicines is an established leader in oncology, with a track record of successfully developing in-licensed oncology programs." said Yun Jeong Song, Chief Executive Officer of ImmuneOncia. "We are confident that 3D Medicines is the ideal partner as we enter into our collaboration and look forward to accelerating our delivery of IMC-002 to patients in Greater China."

"We are very pleased to enter into this exclusive collaboration with ImmuneOncia" said John Gong, M.D., Ph.D., Chairman and Chief Executive Officer of 3D Medicines. "We believe that IMC-002, used in combination with existing standard of care therapeutics or Envafolimab, an innovative subcutaneous PD-L1 antibody which we have just filed for marketing approval in China, could alter the treatment paradigm across various tumor types."

YAFO Capital (Shanghai) Co. Ltd. acted as financial advisor on this transaction for ImmuneOncia.

About IMC-002

IMC-002 is a fully human IgG4 monoclonal antibody designed to block the CD47–SIRPα interaction in order to promote the phagocytosis of cancer cells by macrophages. According to its non-clinical results, it binds to human CD47 with an optimal affinity that maximizes efficacy without binding to RBCs or causing anemia which is often seen in other CD47 blocking agents under development. For more information about the Phase 1 clinical trial, visit clinicaltrials.gov, identifier number NCT04306224.

Everest Medicines Announces China NMPA Approval of Clinical Trial Application to Evaluate Trodelvy® in a Phase 2 Basket Trial for a Variety of Cancers with High TROP-2 Expression

On March 30, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, reported that the China National Medical Products Administration (NMPA) approved its Clinical Trial Application (CTA) for a Phase 2 basket trial of Trodelvy (sacituzumab govitecan-hziy) in a variety of cancers with high TROP-2 expression (Press release, Everest Medicines, MAR 30, 2021, View Source [SID1234577385]).

The Phase 2 single arm, multiple-cohorts basket trial will evaluate sacituzumab govitecan-hziy in 180 patients with relapse/refractory esophageal squamous cell carcinoma, gastric cancer, and cervical cancer at selected sites in China. The incidence of these indications is higher in China/Asia than Western countries, and there are very limited treatment options in later line settings, represent a significant unmet medical need in China and Asia.

"As of 2019, the incidence of cancers with TROP-2 expression was more than 3.5 million, accounting for approximately 78% of all cancer occurrences in China," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "Sacituzumab govetican-hziy’s unique TROP-2 directed antibody and topoisomerase inhibitor drug conjugate mechanism of action, along with its robust set of data in other TROP-2 expressing cancers suggest that it may be effective in a broad range of tumors. We look forward to advancing this important basket study as we work to expand potential indications of this novel therapy across a variety of cancers with high unmet medical need."

About Trodelvy (sacituzumab govitecan-hziy)

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class, antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers. It is indicated in the U.S. for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease and was granted accelerated approval by the U.S. Food and Drug Administration for this patient population in April 2020, based on overall response rate and duration of response results in a Phase 1/2 study.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize sacituzumab govitecan-hziy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.

Repare Therapeutics to Introduce RP-6306, a Potent and Specific Inhibitor of a Novel Target, at Virtual Investor Day on April 8

On March 30, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported it will host a virtual Investor Day on Thursday, April 8, 2021, from 10:30 a.m. to 12:00 p.m. Eastern Time (Press release, Repare Therapeutics, MAR 30, 2021, View Source [SID1234577382]). Repare Therapeutics’ executive management team will be joined by two distinguished physicians:

Carol Aghajanian, MD, Chief, Gynecologic Medical Oncology Service, Professor of Medicine, Weill Cornell Medical College, Memorial Sloan Kettering Cancer Center, New York, NY
Timothy Yap, MBBS, PhD, FRCP, Medical Director, Institute for Applied Cancer Science, Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX
The event will focus on RP-6306, a potent and selective inhibitor of a novel target that is synthetic lethal with CCNE-1 amplification. The Company expects to begin a Phase 1 clinical trial in the second quarter of 2021, one quarter earlier than prior guidance.

To access the event virtual event, please dial (833) 638-9655 (U.S. and Canada) or (602) 585-9856 (international) at least 10 minutes prior to the start time and refer to conference ID 1093819. A live video webcast will be available in the Investor section of the Company’s website at View Source A webcast replay will also be available on the corporate website at the conclusion of the call.

About RP-6306

RP-6306 is the result of Repare’s proprietary drug discovery program for tumors with genetic alterations characterized by CCNE1 amplification, which typically do not respond well to platinum or PARP inhibitor treatment. Through Repare’s SNIPRx screen campaign for targets that are SL with CCNE1 amplification, the Company has identified and validated a novel SL gene that is believed to have the characteristics of a therapeutic target. Subsequently, the Company developed novel and selective inhibitors against the target that have repeatedly demonstrated compelling anti-tumor activity and announced the advancement of a clinical candidate for this potential first-in-class program. Repare anticipates initiating a Phase 1 clinical trial for RP-6306 in the second quarter of 2021. This trial is expected to enroll patients suffering from recurrent tumors characterized by CCNE1 amplification and other genomic alterations predicted to be sensitive to RP-6306. The primary objective of the trial is to establish the recommended Phase 2 dose and schedule for RP-6306 for further studies as monotherapy and to assess preliminary safety in patients. An additional trial is planned to evaluate combination with approved anticancer agents.

Ikena Oncology Announces Closing of Initial Public Offering and Exercise in Full of the Underwriters’ Option to Purchase Additional Shares

On March 30, 2021 Ikena Oncology, Inc. (Nasdaq: IKNA) ("Ikena"), a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer, reported the closing of its initial public offering of 8,984,375 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,171,875 additional shares of common stock, at a public offering price of $16.00 per share (Press release, Ikena Oncology, MAR 30, 2021, View Source [SID1234577381]). The aggregate gross proceeds to Ikena from the offering were approximately $143.8 million, before deducting underwriting discounts and commissions and other offering expenses.

Jefferies, Cowen, Credit Suisse and William Blair acted as joint book-running managers for the offering.

The registration statement relating to these securities has been filed with the Securities and Exchange Commission ("SEC") and became effective on March 25, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at [email protected].

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

Illumina Committed to Pursuing GRAIL Acquisition to Accelerate Access to Breakthrough Multi-Cancer Early Detection Blood Test

On March 30, 2021 Illumina, Inc. (NASDAQ: ILMN), reported that it disagrees with, and will oppose, the U.S. Federal Trade Commission (FTC)’s challenge to its previously announced acquisition of GRAIL, a pre-commercial company founded to accelerate early screening of cancer (Press release, Illumina, MAR 30, 2021, View Source [SID1234577380]). Illumina will pursue its right to proceed with the transaction, the impact of which would accelerate the adoption of a breakthrough multi-cancer early detection blood test.

Cancer kills around 10 million people annually worldwide and 600,000 people in the United States alone. Survival rates are higher when cancer is detected early. Seventy-one percent of all deadly cancers do not currently have a screening test. GRAIL’s Galleri test is able to detect more than 50 cancers across all stages, more than 45 of which do not have recommended screening in the United States. And, in 93 percent of the positive results, the test correctly identified the tissue of origin – all with a specificity greater than 99 percent.

"Illumina’s commitment to advancing human health by innovating next generation sequencing is unwavering. Improving early cancer detection is the most promising approach to bending the cancer mortality curve," said Francis deSouza, Chief Executive Officer of Illumina. "We have a deeply vested interest in ensuring that all organizations have equal and fair access to high quality, reliable and cost-effective sequencing to enable them to develop breakthrough products, such as liquid biopsy, and make them accessible to the greatest number of patients possible, quickly and safely."

Illumina originally founded GRAIL five years ago and the two companies do not compete in any way. In reuniting the two organizations, Illumina will leverage its global scale of manufacturing and clinical capabilities, as well as its global regulatory and reimbursement expertise, to bring early-stage, multi-cancer testing to patients more quickly and more affordably, resulting in more lives being saved.

"Combining GRAIL’s innovative multi-cancer early detection test with Illumina’s experience and scale will enable more patients in both the United States and worldwide to garner access to GRAIL’s test faster," said Hans Bishop, Chief Executive Officer of GRAIL. "We continue to believe that together we could transform cancer care by catching more cancers earlier."

Illumina strongly believes that acquiring GRAIL is in the best interest of patients, is procompetitive, and benefits the multi-cancer early detection field as a whole. The FTC’s challenge to the proposed transaction is a marked departure from longstanding antitrust precedent. Illumina intends to pursue all legal options in order to complete the acquisition and deliver the strategic benefits to its stakeholders. For clinical oncology customers, Illumina has offered contractual guarantees of equal and fair access to Illumina sequencing, and a commitment to drive down prices by more than 40 percent by 2025.