On January 3, 2023 -Gilead Sciences, Inc. (Nasdaq: GILD) reported that the European Medicines Agency (EMA) has validated a Type II variation Marketing Authorization Application (MAA) for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting (Press release, Gilead Sciences, JAN 3, 2023, View Source;Metastatic-Breast-Cancer [SID1234625769]).

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"At Gilead Oncology our ambition is to transform care for people with cancer," said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. "Trodelvy is already moving us towards this ambition and changing the standard of care in second-line metastatic triple-negative breast cancer across the EU. The validation of our Marketing Authorization Application in pre-treated HR+/HER2- metastatic breast cancer marks an important step forward to potentially making Trodelvy available to even more patients with severely limited treatment options."

This Marketing Authorization Application is based on data from the registrational Phase 3 TROPiCS-02 study, which met its primary endpoint of progression-free survival (PFS) and key secondary endpoint of overall survival (OS) versus comparator chemotherapies (treatment of physician’s choice (TPC) of chemotherapy). PFS data were published in the Journal of Clinical Oncology, and OS data were recently presented at ESMO (Free ESMO Whitepaper) Congress 2022.

The safety profile for Trodelvy in TROPiCS-02 was consistent with prior studies, and no new safety signals were identified in this population.

In October 2022, the U.S. Food and Drug Administration (FDA) accepted for priority review the supplemental Biologics License Application (sBLA) for Trodelvy for the treatment of adult patients with unresectable locally advanced or metastatic HR+/HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. The Prescription Drug User Fee Act (PDUFA) target action date is currently set for February 2023.

Trodelvy has not been approved by any regulatory agency for the treatment of HR+/HER2- metastatic breast cancer. Its safety and efficacy have not been established for this indication.

Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; please see below for additional Important Safety Information.

About HR+/HER2- Metastatic Breast Cancer
Hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer is the most common type of breast cancer and accounts for approximately 70% of all new cases, or nearly 400,000 diagnoses worldwide each year. Almost one in three cases of early-stage breast cancer eventually become metastatic, and among patients with HR+/HER2- metastatic disease, the five-year relative survival rate is 30%. As patients with HR+/HER2- metastatic breast cancer become resistant to endocrine-based therapy, their primary treatment option is limited to single-agent chemotherapy. In this setting, it is common to receive multiple lines of chemotherapy regimens over the course of treatment, and the prognosis remains poor.

About the TROPiCS-02 Study
The TROPiCS-02 study is a global, multicenter, open-label, Phase 3 study, randomized 1:1 to evaluate Trodelvy versus physicians’ choice of chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine) in 543 patients with HR+/HER2- metastatic breast cancer who were previously treated with endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy for metastatic disease. The primary endpoint is progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by blinded independent central review (BICR) for participants treated with Trodelvy compared to those treated with chemotherapy. Secondary endpoints include overall survival, overall response rate, clinical benefit rate and duration of response, as well as assessment of safety and tolerability and quality of life measures. In the study, HER2 negativity was defined per American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the College of American Pathologists (CAP) criteria as immunohistochemistry (IHC) score of 0, IHC 1+ or IHC 2+ with a negative in-situ hybridization (ISH) test. More information about TROPiCS-02 is available at View Source

On January 3, 2023 JS InnoPharm Ltd reported that they initiated the JSI-1187 plus dabrafenib combination dose-escalation phase of the Phase 1 study for patients with locally advanced or metastatic solid tumors with confirmed BRAF V600E/K mutations (NCT04418167) (Press release, JS InnoPharm, JAN 3, 2023, View Source [SID1234625768]). The clinical study is being conducted at 8 NCI-designated Comprehensive Cancer Centers in the U.S.

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JSI-1187 is a potent, orally active ERK1 and ERK2 inhibitor. JS InnoPharm holds the U.S. IND for JSI-1187, and this trial is being managed by Strategia Pharmaceuticals LLC, JS InnoPharm’s clinical development partner in the United States.

The JSI-1187 monotherapy dose escalation phase of this study was initiated in 2020 for the treatment of patients with relapsed or refractory, locally advanced or metastatic solid tumors with MAPK pathway mutations, including hyperactivating mutations or gene fusions.

"JSI-1187 is a selective ERK1/2 inhibitor. By utilizing an ERK inhibitor against tumors harboring mutations in the MAPK pathway, we hope to develop more effective single-agent and combination therapies by preventing the early development of resistance seen with current MAPK targeted agents," said Dr. Linda Paradiso, Chief Development Officer for Strategia Pharmaceuticals.

"Our preclinical studies have demonstrated significant potential of JSI-1187 in combination with dabrafenib, and we are excited to initiate the ERK/BRAF combination treatment at these important clinical cancer sites in the US," said Dr. Jintao Zhang, Chief Executive Officer for JS InnoPharm.

The Role of ERK in Cancer

MAPK signaling via the RAS-RAF-MEK-ERK pathway plays a critical role in cancer growth and proliferation. Alterations in the MAPK-ERK pathway are found in a variety of cancer types, including KRAS mutations in pancreatic (>90%), biliary tract (3-50%), colorectal (30-50%), lung (25-30%), ovarian (15-39%) and endometrial (18%) cancers; NRAS mutations in melanoma (20%); BRAF V600 mutations in melanoma (50%) and a variety of other tumor types (7% overall).

BRAF/MEK inhibitor combination therapy provides a significant benefit beyond single agent therapy in melanoma and other cancers. However, many patients don’t respond to the combination therapy and most responding patients eventually develop acquired resistance and disease progression. Several mechanisms of acquired resistance have been identified and the reactivation of ERK signaling is central to these mechanisms. Therefore, a combination of ERK inhibition with JSI-1187 and dabrafenib may provide a targeted approach to delay or overcome resistance, as ERK is the most distal kinase of the MAPK signaling pathway.

About JSI-1187

JSI-1187 is a selective and orally administered small molecule inhibitor of ERK1 and ERK2. In preclinical studies, JSI-1187 demonstrated high potency against a variety of tumors with MAPK pathway mutations.

On January 3, 2023 ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics, reported that first dosing has initiated in the Phase 1 first-in-human clinical trial of PRO1184 (NCT05579366), and second the company received clearance from the U.S. Food and Drug Administration (FDA) to initiate the Phase 1 clinical trial evaluating PRO1160 (Press release, ProfoundBio, JAN 3, 2023, View Source [SID1234625767]).

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PRO1184

PRO1184 is an ADC comprising a folate receptor alpha-directed antibody conjugated to the exatecan payload with ProfoundBio’s novel, proprietary hydrophilic linker. The Phase 1 study will evaluate the safety, activity, and pharmacokinetics of PRO1184 in patients with ovarian, endometrial, breast, non-small cell lung cancers and mesothelioma. This first-in-human study is actively enrolling with multiple clinical trial sites across the United States.

PRO1160

PRO1160 is an antibody-drug conjugate (ADC) comprising a CD70-directed antibody conjugated to the exatecan payload with ProfoundBio’s novel, proprietary hydrophilic linker. The Phase 1 study will evaluate the safety, activity, and pharmacokinetics of PRO1160 in patients with metastatic renal cell carcinoma, metastatic or relapsed nasopharyngeal carcinoma, or advanced non-Hodgkin lymphoma. In preclinical studies, PRO1160 demonstrated the potential to be a best-in-class ADC therapeutic with a wide therapeutic window.

"We are taking a major step forward with our next generation ADCs." said Naomi Hunder, MD, CMO of ProfoundBio. "Our preclinical data support the potential for improved safety and activity over prior programs targeting folate receptor alpha and CD70, based on our novel hydrophilic linker and exatecan payload. We are excited to bring these advancements to the clinic, where we hope to help a broader patient population due to a potentially wider therapeutic window and ability to target antigens with low-moderate or heterogeneous tumor expression."

"With two clinical-stage programs, ProfoundBio is poised to validate our novel, proprietary, and internally developed ADC technology platform in the clinic and to bring a series of ADCs with best- and/or first-in-class potential to patients with unmet medical need." said Baiteng Zhao, PhD, Co-founder, Chief Executive Officer, and Chair of the Board of ProfoundBio. "We conclude 2022 with several significant accomplishments including the FDA clearance of two INDs and a Series A+ funding round. I am very excited about the momentum and look forward to continued progress of our lead programs in the clinic as well as advancing more pipeline assets through preclinical development and making further breakthroughs in ADC technologies in 2023."

On January 3, 2023 ZielBio, Inc., a clinical-stage biotechnology company reported that it discovering new treatments for cancer through its innovative drug discovery platform, has appointed Alan S. Bash as the company’s new Chief Executive Officer and member of the company’s Board of Directors (Press release, ZielBio, JAN 3, 2023, View Source [SID1234625766]).

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The appointment of Mr. Bash comes as ZielBio reaches the completion of enrollment in the Phase 1, dose escalation, open-label study of lead asset ZB131 (proposed international nonproprietary name Ibentatug), a cancer specific plectin (CSP)-targeting functional antibody, in tumors likely to express CSP. The company plans to open Phase 2 expansion cohorts with ZB131 as monotherapy and in combination with a standard of care therapeutic in the first quarter of 2023.

"I am excited to work with Alan, continuing ZielBio’s mission to bring innovative therapeutics to patients," said Dr. Kimberly Kelly, who will continue to serve ZielBio as President, Chief Operating Officer and member of the Board of Directors. "I am encouraged by the preliminary safety data from our clinical trial. With an expanding clinical program in several cancers with high unmet need on the horizon, Alan arrives at a pivotal time for our company."

Dieter Weinand, Chairman of the Board of ZielBio said, "We are very pleased to welcome Alan to lead ZielBio through its next phase of growth. Alan’s demonstrated ability to develop and commercialize innovative treatments for cancer patients, combined with his experience in both large pharmaceutical and smaller biotechnology settings, will provide the strategic and operational expertise needed to help ZielBio reach its full potential."

"ZielBio has demonstrated a unique capability to discover novel targets and has already brought a promising, highly differentiated antibody, ZB131, into the clinic," said Mr. Bash. "I am honored to work alongside Kimberly Kelly and the entire ZielBio team, to help make a difference in the lives of patients with difficult-to-treat tumors."

Mr. Bash most recently served as President and Chief Executive Officer of Checkmate Pharmaceuticals, a publicly traded clinical-stage oncology biotechnology company that was acquired by Regeneron Pharmaceuticals in May 2022. He joined Checkmate after a 22-year career at Bristol Myers Squibb (BMS), where he served as Senior Vice President, Commercial Model Innovation, and prior to that, Senior Vice President for Immunology and Fibrosis, partnering with Research & Development to advance early and late-stage assets in the integrated BMS and Celgene portfolios. During his years leading teams in oncology at BMS, he led the U.S. launch of the PD-1 checkpoint inhibitor, Opdivo, and the first FDA-approved checkpoint combination. He also served as Worldwide Vice President for BMS’s lung cancer franchise and led the product team for a targeted antibody for head and neck cancer and colorectal cancer. He earned his BA from Georgetown University and his MBA from Columbia Business School.

On January 3, 2023 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that Antengene will present at the 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11th, 2023 at 9:30 a.m. PST in San Francisco, California (Press release, Antengene, JAN 3, 2023, View Source [SID1234625765]). The presentation will be made by Dr. Jay Mei, Antengene’s Founder, Chairman and CEO.

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Details of the event are as follow:

41st Annual J.P. Morgan Healthcare Conference

JPM Presentation Date: Wednesday, January 11th, 2023

JPM Presentation Time: 9:30 am PST, followed by a short question and answer session

Presenter: Dr. Jay Mei, Antengene’s Founder, Chairman and CEO

Participating in Q&A: Members of Antengene Management

Webcast Link: View Source;kiosk=true

1X1/Small Group Meetings: Monday, January 9th, 2023 to Thursday, January 12th, 2023 for Investor and Business Development Meetings

*To schedule a meeting, please contact Antengene’s Investor Relations Team at [email protected]

An archived version of the presentation also will be available on the Company website following the live presentation.