On February 6, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported that the Health Sciences Authority (HSA) of Singapore has approved Trodelvy(sacituzumab govitecan or SG) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease (Press release, Everest Medicines, FEB 6, 2022, View Source [SID1234607772]). This marks the first drug approval of Trodelvy received by Everest. The Company expects a series of approvals for Trodelvy in its license territories in the coming year.

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"As part of our larger business strategy to build a robust commercial presence in Asia Pacific markets, we are well-positioned to accelerate quickly during this next phase of growth with an established commercial team, bridging the gap between patients with unmet medical needs and first-in-class biopharmaceutical innovation," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "As a next step we will be working collaboratively with all stakeholders to bring Trodelvy to women in Singapore living with metastatic TNBC."

"TNBC accounts for 15-20% of all breast cancer cases in Singapore, and breast cancer is the country’s leading cause of cancer death in women. This aggressive and difficult-to-treat form of the disease has historically had very limited treatment options, with overall survival remaining unchanged among patients for nearly two decades," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. This regulatory milestone brings Trodelvy one step closer to Singaporean patients with metastatic TNBC."

In addition to Singapore, Everest is closely coordinating with regulatory bodies in Greater China and South Korea to review its applications for Trodelvy for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.

In May 2021, the China National Medical Products Administration accepted its Biologics License Application for Trodelvy with priority review.
In December 2021, the Ministry of Food and Drug Safety (MFDS) of South Korea accepted a New Drug Application (NDA) for Trodelvy. Trodelvy was previously granted Fast Track Designation and Orphan Drug Designation in South Korea.
In December 2021, the Taiwan Food and Drug Administration accepted its NDA for Trodelvy. Trodelvy was previously granted Pediatric and Rare Severe Disease Priority Review Designation in Taiwan.
About Triple-Negative Breast Cancer (TNBC)

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells do not have estrogen and progesterone receptors and have limited human epidermal growth factor receptor 2 (HER2). Due to the nature of TNBC, effective treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.

About Trodelvy

Trodelvy is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the TROP-2 receptor, a protein overexpressed in multiple types of epithelial tumors, including metastatic TNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse. Trodelvy is approved for adults with second-line metastatic TNBC in the United States, the European Union, Australia, Canada, Great Britain and Switzerland and approval is based on data submitted from the Phase 3 ASCENT study. Review is also underway in Greater China and South Korea through Everest Medicines. Trodelvy is also approved under the accelerated approval pathway for use in metastatic UC in the United States and continues to be developed for potential use in other TNBC and metastatic UC populations. It is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, SG was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.

On February 6, 2022 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that ATG-037 has received approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the Phase I STAMINA trial, a first-in-human study of ATG-037 in patients with locally advanced or metastatic solid tumors (Press release, Antengene, FEB 6, 2022, View Source [SID1234607771]). The primary objective of the study is to evaluate the safety and tolerability of ATG-037 as monotherapy and in combination with an immune checkpoint inhibitor (CPI), to determine the appropriate dose for Phase II studies, and to assess preliminary signal of activity; the secondary objective is to characterize the pharmacology of ATG-037.

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ATG-037 is an orally available, small molecule CD73 inhibitor. CD73 generates adenosine, which leads to immunosuppression in the tumor microenvironment. ATG-037 has demonstrated promising preclinical efficacy as a monotherapy and in combination with CPIs and chemotherapy agents. In preclinical studies, the compound has demonstrated to overcome the "hook effect" that is common in anti-CD73 antibodies. In addition, GLP toxicology studies indicate the compound will have a broad therapeutic window.

Kevin Lynch, M.D., Chief Medical Officer of Antengene commented, "Developing novel molecules that can make a clinical difference in cancer is of paramount importance to Antengene. Preclinical toxicology data suggests that ATG-037 will have a broad therapeutic window and further preclinical data suggests the potential for differentiated characteristics compared to other CD73 inhibitors."

Dr. Lynch continued, "While we remain very interested to explore the drug as a monotherapy, combination therapy of ATG-037 with CPIs and chemotherapies could enable synergistic improvements in tumor response for patients with advanced and metastatic cancers. ATG-037 also has the potential to be used in combination with several agents in the Antengene pipeline including ATG-101, a proprietary PD-L1/4-1BB bispecific antibody, demonstrating the in-house combinatory potential of our pipeline programs. I’m very excited about the start of the clinical program and look forward to next steps with ATG-037."

On February 4, 2022 Aptamer Science reported on the 4th that it signed a contract development and manufacturing (CDMO) contract with China’s Cailaing (Asymchem) for ‘AST-201’, an aptamer drug conjugate (ApDC)-based anticancer treatment (Press release, Aptamer Sciences, FEB 4, 2022, View Source;idx=171 [SID1234641605]).

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According to this contract, Aptamer Science has established a basis for mass production and stable supply of AST-201 clinical trial material.

AST-201 is an ApDC-based targeted treatment that internalizes the anticancer drug ‘gemcitabine’ in the form of a prodrug within the anticancer target aptamer structure. A specific aptamer was applied to the ‘GPC3’ protein, a tumor biomarker.

Accordingly, it is expected to minimize the systemic side effects of gemcitabine and maximize the target-specific anticancer effect. Additionally, it is believed that gemcitabine can be internalized within the aptamer to overcome the tumor’s anticancer drug resistance mechanism.

In addition, it is said to have the property of effectively overcoming the toxic side effects of antibody drug conjugate (ADC) treatments. Aptamers have a relatively short half-life in the blood compared to antibodies, so they have high tumor selectivity and tissue penetration while minimizing systemic exposure to the drug.

An Aptamer Science official said, "The process for clinical trials of ApDC-based anti-cancer treatments is proceeding smoothly," and added, "We will strive to quickly advance to the clinical development stage through collaboration with Kai-Laying."

On February 4, 2022 Athebio AG, an innovation leader in the discovery and design of designed ankyrin repeat proteins (DARPins), reported that it has entered a research agreement with REGENXBIO Inc., a clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy, to develop novel, targeted, adeno-associated virus (AAV) vectors that combine Athebio’s proprietary Athebody DARPin Platform and REGENXBIO’s NAV Technology Platform (Press release, AtheBio, FEB 4, 2022, View Source [SID1234638736]).

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Under the terms of the agreement, Athebio will provide select Athebody DARPins from its proprietary library to REGENXBIO, which intends to utilize the DARPins as elements of novel AAV vectors targeted to an undisclosed, cell-specific receptor. REGENXBIO may option the selected Athebody DARPins for a commercial license for development of potential gene therapy candidates. In exchange, Athebio will receive an undisclosed upfront payment, research funding fees, and has the potential to receive milestones, as well as royalties on net sales.

"As a leader in the field of AAV-mediated gene therapy, REGENXBIO perfectly matches with Athebio’s pioneering mindset," said Patrik Forrer, one of the inventors of the DARPin technology and CEO and Chairman at Athebio. "Our mission is to make our proprietary Athebody DARPin Platform accessible to our partners, and provide them with tailor-made binding domains and access to our in-depth repeat protein expertise. The small size, excellent intracellular expression, and high specificity make Athebody DARPins excellent candidates to enable novel, targeted AAV vectors."

On February 4, 2022, Nuvectis Pharma, Inc. (the "Company"), reported that entered into an Underwriting Agreement (the "Underwriting Agreement") with H.C. Wainwright & Co., LLC, as representative of the several underwriters named therein (the "Underwriters") (Filing, Nuvectis Pharma, FEB 4, 2022, View Source [SID1234607776]). Pursuant to the Underwriting Agreement, the Company agreed to sell in an underwritten offering (the "Offering") an aggregate of 3,200,000 shares (the "Shares") of the Company’s common stock, par value $0.00001 per share (the "Common Stock"), at an offering price of $5.00 per share, for gross proceeds of $16,000,000, less underwriting discounts and commissions and offering expenses. The Shares are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-260099), initially filed with the Securities and Exchange Commission (the "Commission") on October 6, 2021, as amended, and declared effective on February 4, 2022. The Company subsequently filed a registration statement on Form S-1MEF (File No. 333-262512) pursuant to Rule 462(b) under the Securities Act of 1933, as amended, which was effective immediately upon filing.

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The closing of the Offering is subject to satisfaction of customary closing conditions set forth in the Underwriting Agreement and is expected to occur on or about February 8, 2022.

The summary of the Underwriting Agreement set forth above does not purport to be complete and is subject to and qualified in its entirety by reference to the text of the Underwriting Agreement, a form of which is filed herewith as Exhibit 1.1. The Underwriting Agreement includes customary representations, warranties, closing conditions and covenants by the Company and the Underwriters.