Welcome to your weekly digest of approaching regulatory and clinical readouts. The cancer vaccine field has seen a run of clinical failures, including that of Heat Biologics, but undeterred the group is trying again, this time with another vaccine, HS-110, in combination with Opdivo in lung cancer. Phase II results are due at the end of this month.
Meanwhile, Armo Biosciences will shortly report interim data from its phase III trial of AM0010 in pancreatic cancer, a highly intractable disease that has seen little progress in treatment. The company has had an impressive run since last month’s flotation, and it plays into cytokines, one of the hottest oncology areas of this year.
Feeling the Heat
Heat will reveal phase II data on HS-110 on February 27 at a poster presentation at the 2018 Keynote Symposia Conference XI, with an investor event planned the following day.
HS-110, known generically as viagenpumatucel-L, is being given in combination with Opdivo in patients with advanced NSCLC in the study, called Durga. The trial passed an interim review, and the company will report data from the first 35 patients of a planned total of 120. Efficacy measures, blood immunologic response and safety data are expected.
HS-110 was given intradermally as 1 x 10
Data from the phase Ib portion of the trial showed that the combination did not show additional toxicities compared with existing data on Opdivo alone, and five of 15 patients treated with the combination had 20% or greater tumour reduction.
Heat says it designed Durga with the Checkmate-057 trial in mind; that study reported a 19% response rate with Opdivo monotherapy in a similar patient population.
At the end of 2016 Heat’s shares took a 64% tumble when its other cancer vaccine, HS-410/vesigenurtacel-L, failed to show a benefit over placebo in reducing recurrence-free survival at one year in bladder cancer patients. The group's market cap now stands at $12m, and with just $4.3m in cash the company desperately needs some good news.
The first interim analysis from Armo’s pivotal Sequoia trial of AM0010 should report shortly. The open-label study, which is still recruiting, aims to enrol 566 patients with metastatic pancreatic cancer who have progressed on one prior gemcitabine-containing regimen.
AM0010, Armo’s lead asset, is a pegylated form of recombinant IL-10, an immune growth factor that stimulates the survival, expansion and killing potential of CD8+ T cells.
The Sequoia trial compares AM0010 plus Folfox versus Folfox alone, with 36-month overall survival its primary endpoint; PFS and ORR are secondary measures. A second interim analysis, which could provide the basis for a BLA filing, is expected in 2020.
In Armo’s 21-patient phase Ib study there was a 16% objective response rate, including two complete remissions (Asco-GI – Pancreatic cancer field awaits sparse data, January 24, 2017). This could be viewed as especially positive given that pancreatic cancer is usually diagnosed late and has a highly aggressive phenotype.
Armo raised $128m in its IPO last month, and shares are up 62% to date, making the company worth over $1bn. Armo plans to start two phase IIb trials this quarter testing AM0010 in combination with either Opdivo or Keytruda in NSCLC.
Cytokines are a particularly hot area in oncology. It will not go unnoticed that just this week Bristol-Myers Squibb paid a huge $1.85bn up front for Nektar’s early-stage NKTR-214, which stimulates CD8+ T cells using the IL-2 pathway.