Allovectin-7 (velimogene aliplasmid) / AnGes MG, Fresh Tracks Therap - LARVOL DELTA

Intralesional therapy for advanced melanoma: promise and limitation. (PubMed) - "Despite advances, many patients will need several lines of therapy. Some will not be eligible for systemic therapy. Their low toxicity, easy administration and likely systemic immune effects make intralesional therapies an attractive option.This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/4.0."

Journal • Biosimilar • Colorectal Cancer • Immunology • Melanoma • Oncology

Credit Suisse Global Healthcare Conference (Vical) - Anticipated top line results from P3 trial for melanoma by mid-2013

Anticipated P3 data: top line • Melanoma

Vical reports 2010 financial results and progress in key development programs (Globe Newswire) -

In 2010 Vical completed P3 trial's fourth scheduled safety analysis by an independent Safety Monitoring Board and got recommendation that the trial can continue per the protocol; Anticipates database lock in the H2 2011 in P3 trial;

Product update • Melanoma

Q3 2012 Results (Vical) - Anticipated results from P3 trial for melanoma in mid-2013

Anticipated P3 data • Melanoma

Vical phase 3 trial of Allovectin® fails to meet efficacy endpoints (Vical Press Release) - P3, N=390; NCT00395070; “Vical…announced top-line results from a Phase 3 trial of Allovectin®…390-subject trial failed to demonstrate a statistically significant improvement vs. first-line chemotherapy for either the primary endpoint of objective response rate at 24 weeks or more after randomization or the secondary endpoint of overall survival….we are terminating the Allovectin® program and focusing our resources on our infectious disease vaccine programs.”

Discontinued • P3 data: top line • Melanoma

Vical: Q1 2013 Results (Vical) - Anticipated overall survival data from P3 registration trial for metastatic melanoma in mid-2013; Data adjudication from Phase 3 melanoma trial in July 2013; Anticipated top-line data from primary and secondary end points for metastatic melanoma in Q3 2013

Anticipated P3 data: top line • Melanoma • Oncology

Vical: Leerink Swann Healthcare Conference (Vical) - "Allovectin Phase 2 Trial (N=127)"; "Open-label, multi-center, single arm study"; "Stage III (52%) or IV (48%) metastatic melanoma; "≦ M1b disease (no brain or liver mets) -normal LDH"; "Demonstrated safety and efficacy"; "No withdrawals for toxicity or adverse events"; "No grade 3 or 4 drug-related adverse events"; "11.8% objective response rate (RECIST); "18.8 months median overall survival"; ">60% of the subjects did not complete more than 1 treatment cycle"

P2 data • Melanoma

Vical: Q2 2013 Results (Vical) - Anticipated top-line data from P3 registration trial for metastatic melanoma in Aug 2013

Anticipated P3 data: top line • Melanoma

Vical: Annual Report 2012 (Vical) - Anticipated patent expiry in US, Canada, Europe and Japan between May 27, 2014 and June 8, 2016; Anticipated Hatch-Waxman patent term extension until June 08, 2021

Anticipated patent expiry • Melanoma

A phase 3 pivotal trial comparing Allovectin-7 alone vs chemotherapy alone in patients with stage 3 or stage 4 melanoma (clinicaltrials.gov) - P3, N=375; Sponsor: Vical; Completion date: Jun 2012 -> Aug 2013.

Trial completion date • Melanoma

Vical: Q3 2013 Results (Vical) - Anticipated presentation of data from P3 trial for metastatic melanoma in Nov 2013

Anticipated P3 data • Melanoma

Vical: Baird's Healthcare Conference (Vical) - "Allovectin Phase 3 Results in Metastatic Melanoma"; "Failed to meet primary or secondary efficacy endpoints"; "No statistically significant improvement vs. first-line chemotherapy"; "Clear and ambiguous result"

P3 data: top line • Melanoma

Vical provides Allovectin® and herpes simplex vaccine updates at BIO International Convention (Vical) - LX01-315; P3, N=375; Vical completed enrollment for its P3 trial evaluating Allovectin®compared with standard chemotherapy as a first-line therapy in pts with Stage III or IV recurrent metastatic melanoma in February 2010 of 390 chemo-naive patients randomized on a 2:1 basis for treatment with Allovectin® or chemotherapy; The company is presenting updates on its P3 trial at the BIO International Convention

Enrollment completion • Melanoma

Vical's CEO discusses Q1 2011 results - Earnings call transcript (SeekingAlpha) - In the P3 study of Allovectin, they generated great three-quarter reversals and immune response in 10% to 15% of the pts and had a drug-related death rate of more than 2%; In a P2 trial of Allovectin there was a median OS of 18.8 months with zero events of grave and three-quarters reversals as well

Melanoma

Citi Global Healthcare Conference (Vical) - Allovectin-7 / Vical;   P3 ongoing with commercial opportunity >$500 million & database lock expected in H2 ‘11 for MM

Melanoma

Vical: Bank of Merrill Lynch Healthcare Conference (Vical) - Anticipated BLA filing for metastatic melanoma in early 2014

Anticipated BLA • Melanoma

Intralesional immunotherapy as a strategy to treat melanoma. (PubMed) - Expert Opin Biol Ther - "The exact role of intralesional immunotherapy in the age of immune checkpoint blockade has still to be determined. A number of clinical trials are on the way in order to better understand synergistic actions of intralesional and systemic immunotherapy."

Journal • Biosimilar • Melanoma • Oncology

Vical: Allovectin P3 Results Conference Call (Vical) - "DTIC/TMZ was more effective than velimogene aliplasmid for best overall response rate at ≥24 weeks in this trial"; "Overall survival was not significantly different with velimogene aliplasmid than with DTIC/TMZ in this trial"; "The responses with velimogene aliplasmid were more durable than with DTIC/TMZ in this trial: Median OS (mos.) was greater for velimogene aliplasmid responders [n/a (19.7, n/a)] than for DTIC/TMZ responders [40.7 (28.9, n/a)], A substantial majority (83%) of velimogene aliplasmid responders were still alive at last contact"; "Follow-on treatments may have had an effect on overall survival" 

P3 data • Melanoma

Bank of America Merrill Lynch Healthcare Conference (Vical) - Anticipated top-line data from P3 SPA pivotal trial for melanoma in late 2012

Anticipated P3 top line data • Melanoma