LATEST DRUG DEVELOPMENTS IN THE CANCER SPACE

● In November 2020, US’ Pfizer invested $60 million in US’ Homology Medicines. Homology presented positive data from a Phase I/II trial (NCT03952156) for pheNIX, a gene therapy for adults with phenylketonuria (PKU) in the same month

● In March 2021, the USFDA approved US’ Celgene’s Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy. Abecma is the first cellbased gene therapy approved by the FDA for the treatment of multiple myeloma

● In April 2021, the USFDA approved US’ BristolMyers Squibb’s Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer

● In June 2021, US based Intellia announced the first clinical data in history to demonstrate potent reduction of disease-causing proteins with a singledose infusion of CRISPR genome editing therapy. They were able to directly deliver lipid nanoparticles containing Cas9 mRNA and gRNA to liver cells to correct ATTR amyloidosis. This is the first case of direct gene editing in humans and appeared to be safe and very effective. These landmark data represented a momentous milestone for the patients and the biotech industry

● In October 2021, China’s IMPACT Therapeutics announced that its ATR inhibitor IMP9064 has received the IND clearance from USFDA for the Phase I/II clinical study, which will begin soon in the U.S. This will be the first in human study for the ATR inhibitor of IMPACT Therapeutics, representing a major leap of the company’s global development strategy for its synthetic lethality pipelines