On October 19, 2021 EQRx, a new type of pharmaceutical company committed to developing and delivering important new medicines to patients at radically lower prices, reported it has signed a memorandum of understanding (MOU) with the National Health Service in England (NHSE) (Press release, EQRx, OCT 19, 2021, View Source [SID1234591530]). The MOU signals the intention of NHSE and EQRx to enter into a long-term, strategic partnership to secure patient access to EQRx’s pipeline of innovative and cost-effective cancer medicines, contingent on regulatory approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and a positive health technology assessment recommendation by the National Institute for Health and Care Excellence (NICE).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Additionally, EQRx’s lead oncology programs, aumolertinib and sugemalimab, have been granted Innovation Passport designations through the Innovative Licensing and Access Pathway (ILAP) from the ILAP partner organizations including the MHRA, NICE, Scottish Medicines Consortium (SMC) and The All Wales Therapeutics and Toxicology Centre (AWTTC). The ILAP was established in early 2021 to accelerate the development and access to promising medicines in the UK, with benefits including the potential for an accelerated Marketing Authorization Application (MAA) assessment as well as rolling review and a continuous benefit-risk assessment.
"We’re immensely proud to partner with the NHS, one of the largest public healthcare systems globally, who share our objective to bring innovative, cost-effective cancer medicines to patients in England," said Melanie Nallicheri, chief executive officer of EQRx. "This MOU comes at a particularly exciting time, as our two lead pre-registrational cancer therapies, aumolertinib and sugemalimab, gain Innovation Passports as a first step towards securing approval and access through the UK’s new Innovative Licensing and Access Pathway."
Aumolertinib, an epidermal growth factor receptor (EGFR) inhibitor, and sugemalimab, an anti-PD-L1 antibody, have both shown promising Phase 3 data for the treatment of patients with advanced non-small cell lung cancer (NSCLC). In the UK, lung cancer is the third most commonly diagnosed cancer.1 Every year, approximately 48,500 people in the UK are diagnosed with a new case of lung cancer, with NSCLC representing more than 87% of lung cancer cases.2
"As outlined in the UK’s Life Sciences Vision, the NHS seeks to become a sustainable, critical driver of innovation," said Sir John Bell, regius chair of medicine at the University of Oxford. "This agreement with EQRx, a new kind of pharmaceutical company committed to offering innovative medicines at lower prices, aims to improve treatment for cancer patients while delivering greater value for taxpayers."
"The NHS has a steadily growing pipeline of innovative, forward-thinking partnerships in areas such as heart disease, early detection of cancer and through this latest arrangement with EQRx, targeted cancer drugs," said Lord David Prior, chair of NHS England. "The NHS will continue to seek opportunities to secure the latest innovations to improve patients’ care, while also ensuring we are obtaining value for taxpayers."
About the UK’s Innovative Licensing and Access Pathway (ILAP)
Launched in January 2021, the Innovation Passport aims to accelerate treatment through regulatory approval and reimbursement as part of the ILAP. The ILAP, as part of the UK’s plan to attract life sciences development in the post-Brexit era, was established as a new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access. Therapies that qualify for this designation must demonstrate how the condition to be treated is life-threatening or falls under a significant public health need, how the medicine fulfills a specific need including an innovative medicine, approved medicines for a significant new indication, medicines for a rare disease or special population, or development aligning with objectives for UK public health priorities.
Permanent partners in the ILAP include the Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC) and The All Wales Therapeutics and Toxicology Centre (AWTTC). The process is also supported by additional bodies including the NHS England, the NHS Improvement, Health Research Authority and the National Institute for Health Research. Benefits of the ILAP include the potential for an accelerated Marketing Authorization Application (MAA) assessment as well as rolling review and a continuous benefit-risk assessment.
About Aumolertinib
Aumolertinib 110 mg once-daily is a prescription medicine approved in China as AMEILE for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by a genomic test, who have progressed on or after prior EGFR TKI therapy. Aumolertinib is a novel, irreversible EGFR-TKI that selectively inhibits both EGFR sensitizing and resistance mutations with high selectivity over wild-type EGFR. Aumolertinib was approved in China in March 2020 based on the large single arm Phase 2 APOLLO study in second-line settings. The ongoing Phase 3 AENEAS trial in first-line settings met its primary endpoint of progression-free survival and topline results were presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting. Hansoh Pharma and EQRx have partnered to expand global access to aumolertinib. EQRx holds the development and commercialization rights to aumolertinib outside of Greater China and is pursuing regulatory discussions in multiple countries.
About Sugemalimab
Sugemalimab is an investigational monoclonal antibody targeting programmed death-ligand 1 (PD-L1) discovered by CStone Pharmaceuticals. Authorized by the U.S.-based Ligand Corporation, sugemalimab is developed by the OmniRat transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 (IgG4) human antibody, which reduces the risk of immunogenicity and potential toxicities in patients, a potential advantage during treatment. Currently, sugemalimab is being investigated in a number of ongoing clinical trials including four Phase 3 registration studies in Stage III NSCLC (GEMSTONE-301), Stage IV NSCLC (GEMSTONE-302), gastric cancer and esophageal cancer. Both the GEMSTONE-301 and GEMSTONE-302 studies met their primary endpoints of progression free survival and results were recently presented at global medical congresses. In November 2020, the National Medical Products Administration (NMPA) of China accepted the New Drug Application for sugemalimab combined with chemotherapy for the first-line treatment of advanced squamous and non-squamous NSCLC patients. EQRx holds the development and commercialization rights to sugemalimab outside of Greater China and plans to pursue regulatory discussions in multiple countries.