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Titan V

10/08/16 12:20 PM

#205045 RE: Titan V #205042

Re: Bladder cancer
Heat Biologics (NASDAQ: HTBX) will be sharing phase 2 results from their HS-410 bladder cancer trial this quarter (monotherapy as well as with BCG).

Vesigenurtacel-L (HS-410) in the management of high-grade nonmuscle invasive bladder cancer.
https://www.ncbi.nlm.nih.gov/pubmed/?term=hs-410

HS-410 received Fast Track designation from FDA.

HS-410's phase 2 trial was a finalist for Pharma Intelligence's "Most Innovative Clinical Trial Design"
HS-410 was also a finalist for "Most Successful Early Phase Trial (Preclinical & Phase I)"
https://ibiawards.com/careawards/finalists/

Heat Biologics Corporate Presentation
http://content.stockpr.com/heatbio/media/3848f8c4739fa3f88470f3337f8369f9.pdf

Q&A with CEO Jeffrey Wolf
http://thebioconnection.com/qa-heat-biologics-founder-ceo-jeffrey-wolf-t-cell-stimulating-cancer-immunotherapies/

Titan V

10/08/16 1:57 PM

#205054 RE: Titan V #205042

Keytruda Leads over Opdivo in Head and Neck Cancer Treatment
http://marketrealist.com/2016/10/keytruda-leads-over-opdivo-in-head-and-neck-cancer-treatment/

DewDiligence

10/21/16 8:07 AM

#205388 RE: Titan V #205042

Keytruda monotherapy shows statsig superior OS compared to chemo in second-line bladder cancer in phase-3 KEYNOTE-045 study:

http://finance.yahoo.com/news/merck-keynote-045-studying-keytruda-104500768.html

MRK…today announced that the phase 3 KEYNOTE-045 trial investigating the use of KEYTRUDA…in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival (OS). In this trial, KEYTRUDA was superior compared to investigator choice chemotherapy. Based on a pre-specified interim analysis, an independent Data Monitoring Committee has recommended that the trial be stopped early.

This PR contains no actual data; MRK will present the KEYNOTE-045 data at an unspecified medical conference.

Note: KEYNOTE-045 is not the bladder-cancer study MRK presented at ESMO (#msg-125667541). That was a single-arm study of Keytruda monotherapy in which patients were considered too frail to receive chemo.