One May 4, 2017 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies and cancer vaccines, provided a corporate update and reported financial results for the first quarter ended March 31, 2017 (Filing, Q1, Agenus, 2017, MAY 4, 2017, View Source [SID1234518827]). Schedule your 30 min Free 1stOncology Demo! "In the first quarter we amended our agreement with Incyte and streamlined and optimized our R&D operations; our balance sheet has been strengthened and our projected burn reduced. Importantly, these steps allow us to focus on clinical programs that support our path to commercialization. In the forefront are our antibodies targeting CTLA-4 and PD-1," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus.
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"These initiatives also provide us with the ability to advance our other assets on an accelerated path, including our innovative programs which include next generation immune targets, such as TIGIT and 4-1BB, our neoantigen vaccine, AutoSynVax and our cell therapy programs which we anticipate will be advanced through an externally funded subsidiary."
Cell Therapy Program
Agenus unveils previously undisclosed I-O cell therapy discovery program. This program has been advanced over the last 18 months, including the identification of at least one potential development candidate. The Company plans to pursue its cell therapy assets with the formation of a separate business entity to be majority owned by Agenus and funded externally.
Anticipated Clinical Milestones for H2 2017:
AGEN1884 (anti-CTLA-4) Phase 1 trial: dose-escalation to be completed with safety and pharmacodynamic data compiled; ASCO (Free ASCO Whitepaper) poster presentation in June
AGEN2034 (anti-PD-1) Phase1/2 trial:
Dose-escalation with monotherapy and combination doses
Patient recruitment in a second line cervical cancer trial.
AGEN1884+AGEN2034: commencement of a Phase 1b combination trial, paving the way for a rapid path to registration
AutoSynVax (neoantigen vaccine): readouts for immunogenicity expected in patients with advanced malignancies
Recent Highlights:
Incyte agreement:
Cash infusion of $80 million; projected cost savings of $70M over an 18-month time period
Incyte responsible for fully funding GITR and OX40 clinical programs
Agenus eligible for royalties at 15%
TIGIT reverted to Agenus
Organizational streamlining:
Basel, Switzerland site to close-down later this year; key functions to transition to Cambridge, UK.
Patient enrollment commenced for Phase 1/2 clinical trial for anti-PD-1 antagonist AGEN2034
Initiated Phase 1 clinical trial for AutoSynVax; patient accrual complete
QS-21 milestones:
GSK’s shingles vaccine containing Agenus’ QS-21 filed for regulatory approval in Japan in addition to existing filings for US, Canada and EU
Regulatory approvals anticipated in H2
GSK’s malaria vaccine containing QS-21 to be distributed in select African countries as per WHO’s recommendation.
Identification of next generation anti-CTLA-4 antibody:
Novel differentiated candidate targeting CTLA-4
Manufacturing readiness:
Agenus West successful GMP production of AGEN1884 at 1,000L scale
First Quarter 2017 Financial Results
Cash, cash equivalents and short-term investments were $124 million as of March 31, 2017 compared to $76 million as of December 31, 2016. For the first quarter ended March 31 2017, Agenus reported a net loss of $17.1 million, or $0.18 per share, compared with a net loss for the first quarter of 2016 of $31.8 million, or $0.37 per share. The decrease in net loss for the three months ended March 31, 2017, compared to the net loss for the same period in 2016, was primarily due to the accelerated milestone payment received from Incyte. Our operating expenses increased $6.1 million over the same period in 2016 primarily due to the later stage advancement of our programs.