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Innovent and Bolt Biotherapeutics Announce Collaboration to Develop Three New Oncology Boltbody™ ISAC Programs

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.

Laekna Therapeutics Receives IND Approvals in China and US for Phase Ib/III Global Multi-center Clinical Study of Afuresertib in combination with fulvestrant for patients with HR+/HER2- breast 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]).

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.

Personalis to Participate at the Morgan Stanley 19th Annual Global Healthcare Conference

On August 26, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will participate at the Morgan Stanley 19th Annual Global Healthcare Conference on Thursday, September 9, 2021 at 3:30 p.m. Eastern Time (Press release, Personalis, AUG 26, 2021, View Source [SID1234586943]).

TumorGen Receives $390K NCI Grant to Counter Metastasis

On August 26, 2021 TumorGen Inc., a biotechnology company, reported that it has received a $390,000 Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) to validate a revolutionary microfluidic platform used to develop anti-metastatic therapies (Press release, TumorGen, AUG 26, 2021, View Source [SID1234586942]).

With this funding, the company will test the new technology in lung cancer patients, capturing metastatic cancer cell clusters (MCCCs) in their blood. Analyzing MCCCs will lead to new drugs that directly target metastasis, potentially saving many lives.

Cancer treatments, particularly immunotherapies, have made tremendous advances in recent years; however, despite these breakthroughs, metastasis remains deadly. Researchers and clinicians have largely focused on primary tumors, yet 90% of cancer patients die from metastasis.

"Metastasis is the real killer of any cancer," said Jeffrey K. Allen, Ph.D., TumorGen’s Founder, President and CEO. "It’s time we start focusing on metastasis and change the way cancer is treated."

TumorGen scientists believe targeting MCCCs is the key to halting metastasis. These clusters are the malignant messengers tumors release into the blood stream to attack other vital organs. Unfortunately, MCCCs are extremely rare and challenging to find.

"It’s beyond difficult to develop new drugs that directly target metastasis if we can’t find and study the cells that are causing the cancer to spread," said Darren Finlay, Ph.D., Director of Tumor Analysis at the Sanford Burnham Prebys Medical Discovery Institute, an NCI-Designated Cancer Center and Co-Investigator on the grant. Dr. Finlay also stated: "TumorGen’s MCCC capture platform combines biomimicry and antibody-based cancer cluster capture technology in a revolutionary microfluidic system. It leverages the same bio-molecules found in human blood vessels; the same bio-molecules cancer cells use to home in on new metastatic sites."

Using this advanced microfluidic platform, TumorGen scientists will isolate extremely rare MCCCs from patients’ whole blood. Analyzing the captured MCCCs can reveal previously unseen therapeutic targets directly linked to metastasis.

"By giving biopharmaceutical companies better insights to develop cluster-buster drugs that stop metastasis, we give them a critical new tool to develop life-saving medicines," said Dr. Allen. "This technology has the power to refocus research on metastasis, where it’s most needed."

Ontada Signs Strategic Agreement with Merck to Facilitate the Development of Data-Driven Insights to Impact Quality of Cancer Care

On August 26, 2021 OntadaTM, McKesson’s oncology and insights business, reported a strategic agreement with Merck, known as MSD outside the United States and Canada, that will facilitate the development of real-world research excellence and innovation OntadaTM, McKesson’s oncology and insights business, reported a strategic agreement with Merck, known as MSD outside the United States and Canada, that will facilitate the development of real-world research excellence and innovation. This agreement enables the two healthcare leaders to harness the power of real-world evidence (RWE) towards the common goal of improving patient outcomes and the quality of cancer care. Ontada and Merck’s combined experience and expertise can help enable the confidence, acceptance, and ultimately impact of RWE on the quality of patient care.

Susan Shiff, PhD, president of Ontada, shared, "Building on McKesson’s long history in community oncology, Ontada is uniquely positioned to advance cancer care by enabling collaboration between life sciences companies and oncology providers. With data insights from greater than two million records available for research and more than 2,000 oncology providers, Ontada helps life sciences companies like Merck leverage real-world data (RWD) and evidence-based insights at the point of care to accelerate innovation and improve cancer therapy."

As part of the agreement, Merck and Ontada can collaborate on RWD studies to explore new scientific evidence, advanced methods development, and assessment of efficiency in cancer care.

"Merck is focused on bringing excellence to RWE generation by advancing methods and applying rigorous methods to gain RWD based insights," said Ravinder Dhawan, PhD, Vice President and Head, Center for Observational and Real-World Evidence (CORE), Merck Research Laboratories. "We look forward to working with Ontada on our shared purpose of improving the lives of patients with cancer."

"The patients we serve depend on strong relationships between oncology insights leaders like Ontada, life science innovators like Merck, and oncology providers," said Dr. Michael Seiden, MD, PhD, president, The US Oncology Network. "RWD studies build on the body of evidence that oncology providers use in their treatment decision making, and innovation depends on all of us working together to achieve continued improvements in patient outcomes."

Ontada combines real-world data and research capabilities, targeted channels to connect life sciences and providers for education and engagement, and a leading suite of technologies for oncology clinicians – including the iKnowMed℠ electronic health record system and Clear Value Plus℠ regimen support tool – with the reach of The US Oncology Network, supported by McKesson.. This agreement enables the two healthcare leaders to harness the power of real-world evidence (RWE) towards the common goal of improving patient outcomes and the quality of cancer care. Ontada and Merck’s combined experience and expertise can help enable the confidence, acceptance, and ultimately impact of RWE on the quality of patient care.

As part of the agreement, Merck and Ontada can collaborate on RWD studies to explore new scientific evidence, advanced methods development, and assessment of efficiency in cancer care.