Innovent Biologics | September 02, 2021
Innovent Biologics, Inc., 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 GenFleet Therapeutics (Shanghai) Inc., a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, today jointly announced that they have entered into an exclusive license agreement for the development and commercialization of GenFleet's lead KRAS G12C candidate, GFH925 in China, including mainland China, Hong Kong, Macau and Taiwan with additional option-in rights for global development and commercialization.
GFH925, GenFleet's lead KRAS G12C candidate, has recently received Investigational New Drug (IND) approval from National Medical Products Administration (NMPA) in China. Preclinical data showed that GFH925 has potential best-in-class activity that can effectively inhibit the growth of a variety of tumor cell lines carrying the KRAS G12C mutation, which may be helpful in accelerating the clinical validation of GFH925. In addition, other preclinical data have also demonstrated the potent potential for GFH925 in combination therapies.
According to the agreement, Innovent will be responsible for clinical development and commercialization of GFH925 in China, while retaining option-in right for development and commercialization outside of China as well. Following approval of a New Drug Application (NDA), Innovent will leverage its broad commercialization capability that includes an experienced commercialization team with extensive nationwide coverage to roll out GFH925, with the goal to benefit cancer patients in China. GenFleet will continue to be responsible for supplying GFH925 for both development and commercial purposes in China.
GenFleet will receive an upfront payment of US$22 million at signing. If Innovent exercises the option-in rights, GenFleet will receive up to US$50 million of global development support from Innovent. Upon achieving certain pre-specified milestones in development, registration, and annual sales performance of GFH925 globally, GenFleet is eligible to receive up to US$240 million in milestone payments in addition to tiered royalties based on annual net sales of GFH925 both in China and global markets.
About GFH925 (KRAS G12C Inhibitor)
Being developed by GenFleet Therapeutics, GFH925 is a novel, orally active, potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRAS G12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of GFH925 towards G12C. Subsequently, GFH925 effectively inhibits the downstream signal pathway to induce tumor cells' apoptosis and cell cycle arrest.
Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 26 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products.
About GenFleet Therapeutics
Dedicated to serving significant unmet medical needs, GenFleet Therapeutics established its proprietary R&D platform based on the deep understanding of disease biology, translational medicine, as well as researches into latest biological mechanism of cancer pathways, tumor microenvironment and human immunoregulation. GenFleet's rich and diversified pipeline highlights multiple cutting-edge products with novel mechanisms and global IP. Since its inception in 2017, GenFleet has built up industry-leading capabilities and expertise in developing novel drug candidates - both small molecules and biologics. Its pipeline includes over 13 programs in development, four of which have entered clinical stages. GenFleet is expected progress additional programs into clinics, as well as transition from a clinical stage biotech company into a commercial stage biopharmaceutical company in the next 3-5 years.
Karmanos Cancer Institute | October 05, 2021
The Barbara Ann Karmanos Cancer Institute and KSP Specialty Pharmacy (KSP) are pleased to announce the launch of new services and a new website: www.ksppharmacy.org. The new site features provider resources and information for payers and pharmaceutical companies. Most notably, the site includes an online portal where patients can refill their prescriptions. This tool also allows patients to see their list of medications, get reminders and interact with their pharmacist. A portal for patient education and tips is forthcoming. Additionally, KSP has begun offering non-oncology specialty drugs to serve providers and patients throughout the McLaren Health Care network.
KSP is a specialty pharmacy within the McLaren Health Care Network, serving the needs of patients with complex disease states and high-cost therapeutic treatments. KSP began as an extension of the Barbara Ann Karmanos Cancer Institute in 2019 and has since grown to assist with specialty medication needs of patients throughout the McLaren system in Michigan, Ohio and Indiana.
Additionally, the Karmanos ambulatory pharmacy, which provides non-specialty medication, has launched a portal with similar functionality. Those undergoing cancer treatment at Karmanos can now access their prescription information and request refills on the Karmanos pharmacy web page.
We are continually striving to provide our patients with tools and convenience to help them understand their treatment. The new website and app will provide the outstanding service we offer over the phone and in person on a new, convenient platform,
- Stephen Smith, RPh, MS, FASHP, Chief Pharmacy Officer.
KSP provides patient care and customer service through a panel of expert clinical pharmacy specialists that can assist in drug education and management of not only a patient's specialty prescriptions, but their entire prescription portfolio. The pharmacy team has direct access to the patient's medical records and providers to ensure the time to delivery of the first dose is swift. In fact, the average rate to the first dose at KSP during fiscal year 2021 is 3.92 days, while the industry standard is more than ten days. A primary goal is to ensure that our in-house social worker and account resolution team find unique programs to allow patients access to high-cost medications without being financially burdened. This allows patients to stay adherent and compliant with their prescribed therapies and start a path to faster healing and recovery.
Specialty medications are used to treat complex health conditions that include hepatitis C, multiple sclerosis, cancer, rheumatoid arthritis, organ transplant, migraines and others. KSP Specialty Pharmacy's expanded services include the ability to dispense medications for patients within the McLaren Health System who face these disease states. These medications may need to be administered by a health care professional, self-injected or taken by mouth, which may require clinical monitoring. Specialty medications often require special handling, delivery and storage requirements.
KSP is accredited by the Utilization Review Accreditation Commission (URAC) and the Accreditation Commission for Health Care (ACHC). URAC designation was earned in 2020 and allows for the provision of agents in other specialized areas, such as HIV, gastroenterology, neurology and many others.
About the Barbara Ann Karmanos Cancer Institute
Karmanos Cancer Institute is a leader in transformative cancer care, research and education through courage, commitment and compassion. Our vision is a world free of cancer. As part of McLaren Health Care, Karmanos is the largest provider of cancer care and research in the state of Michigan. For more than 75 years, our administrative and research headquarters, along with our premier specialty cancer hospital, have been located in downtown Detroit. Our 15 network sites throughout the state deliver market-leading cancer care and clinical trials conveniently to the communities where many of our patients live. Karmanos is recognized by the National Cancer Institute as one of the best cancer centers in the nation. Our academic partnership with the Wayne State University School of Medicine provides the framework for cancer research and education – defining new standards of care and improving survivorship.
Avacta | November 29, 2021
Avacta Group plc, a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AVA6000. This will allow the Group to expand its Phase I clinical trial, ALS-6000-101, into clinical trial sites in the United States.
AVA6000 is a novel form of doxorubicin that has been modified with Avacta’s pre|CISION™ platform to improve its safety and therapeutic index. Anthracyclines such as doxorubicin, a generic chemotherapy for which the market is expected to grow to $1.38bn by 20241, are widely used as part of standard of care in several tumour types, but their use is limited by cumulative toxicity. AVA6000 has been designed to limit cell penetration of the drug, and therefore its cell killing effect, until it is specifically activated by fibroblast activation protein α (FAP) which is in high concentration in many solid tumours compared with healthy tissues. The resulting reduced exposure of healthy tissues to active doxorubicin has the potential to significantly increase its therapeutic index by reducing the incidence of adverse effects, including cardiotoxicity and myelosuppression.
The FDA has completed its 30-day review of Avacta’s IND application, which was submitted ahead of schedule in October 2021, and has concluded that the Group may proceed with its proposed clinical investigation. This allows Avacta to enroll eligible patients into US clinical trial sites for the company’s Phase I multi-centre study, ALS-6000-101. As previously announced in August 2021, the Company has begun recruiting and dosing patients for this study at several clinical trial sites in the UK, and continues to expect the dose escalation phase for this trial to complete by Q2 2022 followed by completion of the dose expansion phase around mid-2023. Enrollment in US clinical trial sites is expected to begin in early 2022.
“We are delighted to have received approval from the FDA to add clinical trial sites in the United States as part of the Phase I study for AVA6000. This is a major milestone in our development of pre|CISION™ chemotherapies and is testament to the performance of our clinical development team and the quality of the pre-clinical data for AVA6000.
Dr. Alastair Smith, Chief Executive of Avacta Group
Provided that the study shows that the pre|CISION™ technology is effective in reducing systemic toxicity of Doxorubicin, then that would open up an extensive and proprietary pipeline for Avacta of next-generation pre|CISION™ chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74 billion by 20272.
We now look forward to opening up clinical trial sites in the United States and additional clinical trial sites in the UK.”
Neil Bell, Chief Development Officer of Avacta Life Sciences, commented: “We are excited to bring the first FAP-activated chemotherapeutic to the clinic in the US, which has the potential to meaningfully impact patients with difficult-to-treat tumours. The clearance of the AVA6000 IND by the FDA enables the opening of key US sites to support the ALS-6000-101 clinical trial which is currently recruiting patients across clinical sites in the UK.”