Biotechnology Company Replimune Inc [NASDAQ: REPL] announced yesterday that it will be presenting data from its lead product candidate RP1, together with its first single-agent safety and the RP2 in advanced solid tumors at the Society for Immunotherapy of Cancer (SITC) annual meeting. The meeting will be held virtually from November 9-14, 2020.
The presentations’ abstract of these presentations appeared by mistake on the SITC website before their intended release dates which were to be November 9, 2020. The results of the presentations are as follows.
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Initial Results of Phase 1 Trial of RP2
Abstract Authors include Mark Middleton, Francesca Aroldi, and Suzanne Thomas among others.
The presentation time is Wednesday, November 11, 2020, from 5:15 to 5:45 p.m EST and Friday, November 13 as from 4:40 to 5:10 p/#.m EST.
Both presentations will be at Virtual Poster Hall.
RP2 is a potency oncolytic HSV1 antibody-like molecule that is being tested in an open sequence and is combined with PD-1 blockade.
Method of Testing
This initial testing aims to determine the efficacy and safety of the drug as well as its recommended phase 2 dose (RP2D) in combination with nivolumab. Physicians are to administer 3+3 dose escalation. The dosage is to be at two levels up to 10ml of the drug, up to 5 times. After the administration of RP2D, and addition of HSV-1, test patients are then to be dosed with RP2 still at RP2D together with nivolumab for four months. This test will involve a group of 30 test patients. Doctors are to inject lesions directly or use imaging guidance that is used for visceral lesions. They then observe biomarker analysis for tumor biopsies and check viral shedding as well as anti-HSV antibody titers.
Results of the Testing
Six patients with HSV seropositive were selected for the dose-escalation phase. They exhibited symptoms including febrile, local inflammation, and erythema. Out of the six patients that received single-agent RP2 treatment, three have shown ongoing partial responses. Objective responses have also been evident in patients with uveal melanoma, mucoepidermoid carcinoma as well as esophageal cancer. There is no enrolment of HSV seronegative patients that will combine with nivolumab. It is expected that the company will present updated data on biomarkers and biodistribution.
What next?
In the first phase, the clinical data indicate that single-agent P2 is safe and useful. This result includes patients with cancers that are difficult to treat. Positive news during the meeting could see the stock test $50 or more.
