Boehringer pairs its lung cancer drug with a vaccine in $600M tie-up with CureVac September 17, 2014 | By John Carroll A little more than two months after inking a licensing deal with Sanofi ($SNY), CureVac has completed another tie-up, banking a $45 million upfront from Boehringer Ingelheim and partnering its therapeutic vaccine aimed at lung cancer. The deal also includes up to about $556 million in prospective milestones for the German biotech. In exchange for the cash, Boehringer gains the global commercial rights to CV9202, a cancer vaccine. The private German pharma company plans to match it with Gilotrif (afatanib) for non-small cell lung cancer, with added plans to pair CV9202 with chemo/radiation therapy for unresectable--or inoperable--stage III NSCLC. While cancer vaccines have had a bleak history in the clinic in recent years, Boehringer believes that CureVac's mRNA approach has the potential to kick up a powerful immune response which could succeed where others have failed. Tubingen, Germany-based CureVac has been working on both therapeutic cancer vaccines as well as the more traditional prophylactic vaccines used to fight the spread of a virus--which is what attracted Sanofi Pasteur. On the cancer side, it's pursuing the vision of company founder and CEO Ingmar Hoerr, who believes that RNA can be injected into humans to illicit a specific immune response targeting cancer cells. Its most advanced program is in a Phase IIb study for prostate cancer, using a slate of 6 mRNA-based molecules encoding specific antigens that are overexpressed in prostate cancer cells. CV9202 is built the same way, only targeting NSCLC. CureVac is backed by Dietmar Hopp, the German billionaire who orchestrates his biotech investing through dievini Hopp BioTech. In addition to funding CureVac, Hopp--who clearly loves supporting companies with a complex technology--also finances immatics, another cancer vaccine company, as well as Switzerland's AC Immune, which is focused on Alzheimer's. Boehringer won an approval for Gilotrif (afatanib) for lung cancer a little more than a year ago. The drug is a tyrosine kinase inhibitor which is most likely to work in patients whose tumors express EGFR exon 19 deletions or exon 21 L858R substitution gene mutations. Patients taking the drug had an average rate of progression-free survival of 11.1 months compared to 6.9 months for the standard therapy arm. Clearly, Boehringer believes it can do better in fighting lung cancer. Like a lot of cancer drug developers, its researchers back the notion that a cancer vaccine could well act as a booster to an existing therapy. And they intend to test that theory with CureVac. The deal marks a significant new outreach for Boehringer, which has been very focused up to now on its own homegrown pipeline of cancer drugs. The company was attracted to evidence that the cancer vaccine has produced a "very, very strong immune response" involving CD8-positive T cells, Hoerr tells FierceBiotech. Boehringer's combination approach is quite similar to many other cancer drug development programs that are mixing a variety of therapies to obtain the most potent, targeted cancer cell killer. And the cancer vaccine strategy reminds Hoerr of the early days in HIV research, when a eries of failures was followed by the success of new cocktail therapies. Other R&D teams in the cancer vaccine field have been bitterly disappointed in recent months. Stimuvax, renamed tecemotide, was recently scrapped (for the second time) by Merck KGaA after a new clinical setback in Japan. GlaxoSmithKline's MAGE A-3 has experienced a full slate of late-stage failures. Vical's Allovectin flunked out and the pioneering Provenge from Dendreon failed to succeed against the competition in prostate cancer. CureVac, though, intends to be the exception to a harsh rule, gambling that its multi-antigen technology will provide the therapeutic punch that's needed. The sizable upfront provides CureVac, which has a staff of 140, with some additional capital as it ponders its evolving business plan. Hoerr says he's planning more such partnerships with Big Pharma to provide liquidity for the biotech. Eventually, CureVac could file for an IPO if the timing was right. In the meantime, there's a very rough estimated timeline on its Phase IIb trial, with data coming in around 2017--give or take a year--which would provide key efficacy data relevant to all of its programs.
Tecemotide On August 18, 2014, Oncothyreon and finally on September 12, 2014, also Merck KGaA informed that a randomized Phase 1/2 study, EMR 63325-009, of tecemotide compared to placebo in Japanese patients with Stage III non-small cell lung cancer did not meet its primary endpoint of an improvement in overall survival, and no treatment effect was seen in any of the secondary endpoints (progression free survival, time to progression or time to failure). Merck made the recommendation to stop the investigational treatment of patients in the EMR 63325-009 study in Japan. Furthermore, Merck KGaA announced its decision to discontinue the Phase III START2 and INSPIRE studies, and all other Merck-sponsored clinical trials with tecemotide in NSCLC worldwide. Merck will continue to supply tecemotide for ongoing investigator-sponsored trials in other indications in accordance with their agreements with the sponsors of these studies.
MAGE-A3 is a tumor-specific protein, and has been identified on many tumors including melanoma, non-small cell lung cancer, hematologic malignancies, among others. MAGE-A3 Lung Cancer Vaccine Provides No Benefit Over Placebo News | October 13, 2014 | Lung Cancer, ESMO 2014 By Dave Levitan With these results, the future of lung cancer vaccines is very much in...The future of lung cancer vaccines is very much in doubt as results of the large, randomized MAGRIT trial have been presented. The trial showed no benefit with the recMAGE-A3 + AS15 cancer immunotherapeutic (MAGE-A3 CI) compared with placebo in completely resected, MAGE-A3-positive non–small-cell lung cancer (NSCLC). Lung cancer immunotherapeutics are intended to improve poor outcomes in stage II and IIIA NSCLC; the current standard of care is adjuvant chemotherapy, but the 5-year disease-free survival remains below 50%. The MAGRIT trial, which was stopped earlier this year due to futility, randomized 2,272 MAGE-A3-positive patients to either MAGE-A3 CI or placebo and followed them for a median of 38.8 months. Final results were presented at the European Society of Medical Oncology (ESMO) 2014 Congress in Madrid.
CV9202 A non-small cell lung cancer (NSCLC) vaccine containing six modified mRNAs, which encode six different NSCLC associated antigens, with potential antitumor and immunomodulatory activities. Upon intradermal administration, mRNA-derived lung cancer vaccine CV9202 may stimulate the immune system to mount both humoral and cellular responses against NSCLC cells. The six tumor-associated antigens (TAAs) encoded by these mRNAs are frequently expressed by NSCLC cells and are minimally expressed or absent in normal, healthy cells. CV9202 is a self-adjuvanting mRNA vaccine that targets six antigens commonly expressed in NSCLC (NY-ESO-1, MAGEC1, MAGEC2, 5 T4, survivin, and MUC1).
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