On August 26, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that the Company will release its 2021 fiscal year end financial results after the close of the U.S. financial markets on September 2, 2021 (Press release, MEI Pharma, AUG 26, 2021, View Source [SID1234586948]). The Company will host a conference call and live webcast with the investment community to provide a corporate overview and update the same day at 5:00 p.m. ET.

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Conference Call & Webcast Information

When: September 2, 2021, 5:00 p.m. ET
Dial-in: 1-833-974-2378 (United States) or 1-412-317-5771 (International)
When requested, please ask the operator to join the MEI Pharma earnings call
Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of MEI’s website at: www.meipharma.com. A replay of the conference call will be archived for at least 30 days after the call.

On August 26, 2021 Johnson & Johnson (NYSE: JNJ) reported thayt it will participate in the Cantor Virtual Global Healthcare Conference on Tuesday, September 28th (Press release, Johnson & Johnson, AUG 26, 2021, View Source;johnson-to-participate-in-the-cantor-virtual-global-healthcare-conference-301363618.html [SID1234586947]). Mathai Mammen, Global Head, Research & Development Janssen Research Development and Scott White, Company Group Chairman NA Pharmaceuticals will represent the Company in a session scheduled at 10:00 a.m. (Eastern Time).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast replay will be available approximately 48-hrs after the live webcast.

On August 26, 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 first person has been dosed in China as part of the global Phase 3 registration trial, TROPiCS-04, in metastatic urothelial cancer (UC) (Press release, Everest Medicines, AUG 26, 2021, View Source [SID1234586946]).

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The multicenter, open-label randomized controlled trial will evaluate sacituzumab govitecan-hziy (SG) compared with standard of care chemotherapeutic options in people with metastatic or locally advanced unresectable UC who have progressed after prior therapy with a platinum-based regimen and anti-programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy. The trial includes two study arms to evaluate SG compared to treatment of physician’s choice (TPC). The primary endpoint of the trial is overall survival.

"We are excited to continue advancing development of SG for people in China with metastatic UC – a devastating and fatal disease that continues to experience increasing incidence in the region," said Dr. Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "This comprehensive and ongoing global study has the potential to add to the existing and robust suite of data already generated for this novel therapeutic candidate."

About Urothelial Cancer

Urothelial cancer is the one of the most common malignancies diagnosed in China, with the five-year survival rate of metastatic UC estimated to be only 4.6%.[1] There is a significant need for new treatment options for people with UC who have failed platinum-based chemotherapies and checkpoint inhibitors. Urothelial cancer begins in urothelial cells that line the urethra, bladder, ureters, renal pelvis, and some other organs that make up the urinary system. It is estimated that there are more than 80,000 new cases of UC and nearly 33,000 deaths from UC in China per year.[2]

About Sacituzumab Govitecan-hziy

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. SG received accelerated approval for advanced or metastatic UC following platinum-containing chemotherapy and a PD-1/PD-L1 inhibitor in the U.S. in April 2021.

On August 26, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Bolt Biotherapeutics, Inc. ("Bolt") (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported a drug research and development collaboration to develop three new anti-cancer therapeutic immune-stimulating antibody conjugate (ISAC) candidates (Press release, Innovent Biologics, AUG 26, 2021, View Source [SID1234586945]).

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The parties will leverage Innovent’s proprietary therapeutic antibody portfolio and discovery capability against undisclosed oncology targets in combination with Bolt’s advanced ISAC technology and myeloid biology expertise to create three new cancer treatments with the potential to provide significant benefit to patients. The Boltbody ISAC platform combines a tumor-targeting antibody, a stable non-cleavable linker, and a proprietary immune stimulant. Boltbody ISACs unite the precision of antibody targeting with the power of innate and adaptive immune system response.

Under the agreement, Innovent has the rights to all three programs in Greater China, and retains an option to license global rights for one program, as well as rights for all territories except North America for another program. Bolt retains the option to license global rights outside of Greater China for one program, and North American rights for another program. Innovent is responsible for all research and development costs through clinical proof-of-concept (POC). Upon review of the initial clinical proof-of-concept data, the companies can exercise licensing options for continued development and exclusive commercialization rights in specific territories on a program-by-program basis. Bolt will receive an upfront payment of US$5 million in cash from Innovent at signing and a possible future equity investment of up to US$10 million. Furthermore, both Innovent and Bolt are eligible to receive additional milestones payments and royalties associated with the development and commercialization of products in each other’s territories.

Dr. Yong Jun Liu, President of Innovent Biologics, stated, "We are very excited about the potential for the Boltbody ISAC platform to generate best-in-class approaches treating multiple tumor types. Bolt has spent several years building and optimizing this platform, which we can leverage to expedite the development of important new products. We look forward to working together with Bolt to bring innovative therapies to patients as soon as possible."

"Innovent is a leader in the development of innovative antibody therapeutics for the treatment of cancer, with advanced research and development teams and an expanding commercial infrastructure in China. We look forward to collaborating with Innovent on the development of novel ISAC anti-cancer therapeutic candidates," said Randall Schatzman, Ph.D., CEO of Bolt. "Our preclinical and early clinical studies have demonstrated the safety and efficacy of the ISAC approach and the benefits of stimulating both the innate and adaptive arms of the immune system in the fight against cancer."

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform

ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs are comprised of three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient’s innate immune system. By initially targeting a single marker on the surface of a patient’s tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.

On August 26, 2021 Laekna Therapeutics reported that the Center for Drug Evaluation (CDE), the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application of its Category 1 new drug candidate afuresertib (LAE002) in combination with anti-estrogen receptor drug fulvestrant in the Phase Ib/III clinical trial of patients with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer (Press release, Laekna Therapeutics, AUG 26, 2021, View Source;breast-cancer-301364146.html [SID1234586944]).

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This global multi-center clinical trial will be initiated simultaneously in the United States and China a month earlier than previously planned. The Phase III global registrational study will be started soon after afuresertib plus fulvestrant demonstrates proof of concept results in tolerability and anti-tumor efficacy in patients enrolled in the Phase Ib study.

Clinical trials of afuresertib cover four different cancers

Afuresertib (LAE002) is a clinically proven, with a first-in-class potential, highly potent small-molecule pan-AKT inhibitor. Currently, afuresertib is being studied in global clinical studies in four different cancers including ovarian cancer, prostate cancer, triple-negative breast cancer, and HR+/HER2- breast cancer. In the four ongoing clinical trials, afuresertib is explored in combination with chemotherapy, anti-androgen therapy, anti-PD-L1 monoclonal antibody, and anti-estrogen therapy, respectively.

Aiming to be a first-in-class AKT inhibitor

"The IND approval came one month earlier than expected, demonstrating the NMPA’s prioritization and support for the clinical development of new treatment options for drug resistant breast cancer patients. It also showcases effective collaboration between our teams in the US and China," said Dr. Chris Lu, Chairman and Chief Executive Officer of Laekna Therapeutics. "We continue to be a tier-1 player globally in the development of AKT kinase inhibitors. We are accelerating multiple clinical trials to potentially make afuresertib a potential first-in-class therapy."

Striving to address drug resistance in patients with HR+/HER2- breast cancer

Breast cancer is the most common cancer among women worldwide. About 62% and 68% of all breast cancer patients in China and the US are HR+/HER2- respectively. Current treatment are available in the form of first- and second-line endocrine/anti-estrogen therapies and/or in combination of CDK4/6 inhibitors, or chemotherapy, however, the patients often develop drug resistance after a period of time.

"The HR+/HER2- subtype accounts for the largest subgroup of breast cancer. One of the urgent unmet medical needs is to provide a new therapy after patients develop resistance to prior standard of care treatments. It will also help significantly improve the clinical outcomes and quality of life for patients with breast cancer," said Dr. Yue Yong, Chief Medical Officer of Laekna Therapeutics. "Combination therapies based on afuresertib are being explored in clinical trials in patients with various types of drug-resistant cancers, and results showed preliminary anti-tumor efficacy and manageable safety profiles, particularly in ovarian and breast cancers. We expect these new treatment options will benefit patients and provide doctors with better choices in treating patients with drug-resistant tumors."

About Afuresertib（LAE002）

Afuresertib (LAE002) is a differentiated oral, small molecule pan-AKT kinase inhibitor that has been investigated in over 10 Phase 1/2 clinical trials, including ovarian cancer, gastric cancer, multiple myeloma, and melanoma. These studies have demonstrated that afuresertib has strong anti-cancer activities and a tolerable safety profile. The global randomized, open-label, multi-center Phase 2 PROFECTA-II clinical trial of afuresertib is the world’s first registration-directed clinical study of a pan-AKT kinase inhibitor to treat platinum-resistant ovarian cancer.

In recent years, AKT (a serine/threonine-protein kinase) has emerged as an important mechanism in oncology, as it plays an important role in regulating various cell functions such as metabolism, survival, proliferation, tissue invasion, and chemotherapy resistance. PTEN deletion and AKT/PIK3CA alteration may lead to excessive activation of the AKT signaling pathways, which is one of the key drivers for cancer growth. The increased activation of the AKT signaling pathway is particularly common in recurrent ovarian cancer, breast cancer, and prostate cancer.