Roche Cancer Vaccine Pact Could Net Immatics $1B

Roche will oversee clinical development and commercialization of all immunotherapies generated by immatics biotechnologies under a cancer vaccine and immunotherapy collaboration that could net the German clinical-stage biopharma more than $1 billion.

Roche agreed to pay immatics $17 million up-front and additional unspecified committed research funding, plus more than $1 billion in milestone payments and royalties across three cancer indications, to be based on sales of the cancer vaccines and immunotherapies resulting from the companies’ collaboration.

The collaboration will focus on research, clinical development, and commercialization of a number of new tumor-associated peptide (TUMAP)-based cancer vaccine candidates and other immunotherapies in oncology, targeting primarily gastric, prostate, and non-small cell lung cancer. Furthest along in development among the candidates is IMA942, for gastric cancer, which according to the companies is ready for Phase I trials.

Also as part of the collaboration, immatics will use its XPRESIDENT® technology platform to identify TUMAP candidates for development of cancer vaccines and other compounds targeting cancer peptide antigens, primarily in gastric, prostate, and non-small cell lung cancer. According to the companies, XPRESIDENT is the only known high-throughput research technology capable of directly identifying, quantifying, and prioritizing cancer antigens recognized by T lymphocytes based on the ability of the immune system to detect them.

“The wealth of relevant cancer-specific antigens that we expect to emerge from this research collaboration will provide an extraordinary opportunity to elicit broad tumor-specific immune responses upon vaccination, especially when combined with other immunomodulatory molecules in our pipeline,” Hy Levitsky, Roche’s head of cancer immunology experimental medicine, said in a statement. “Discovery of novel antigens also will provide unique targets for other protein-based anti-cancer agents currently under development.”

immatics’ collaboration with Roche comes about a month after the company won €34 million ($46 million) in Series D financing—of which €12 million ($16 million) will be received immediately—to conclude development of its lead vaccine IMA901, now in a Phase III trial, including completing all activities needed to prepare for regulatory filings in the United States and Europe.

IMA901 is a cancer vaccine consisting of 10 TUMAPs found to be highly overexpressed in the majority of patients suffering from renal cell carcinoma (RCC). The vaccine has U.S. and European orphan drug designations for treating RCC in HLA-A*02 positive patients. The Phase III trial is designed to evaluate overall survival with IMA901 in combination with Pfizer ‘s Sutent® (sunitinib), the current standard first-line therapy, compared with sunitinib alone in patients with metastatic and/or locally advanced RCC. A total of 339 patients are enrolled in the trial, which is expected to generate interim overall survival results in 2014, with final data in 2015.

Source : genengnews

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Pfizer: Sutent Potentially Linked to Severe Skin Reactions

Pfizer: Sutent Potentially Linked to Severe Skin Reactions, Such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, Health Canada Says
There have been rare but severe skin reactions in people worldwide taking a medication used to treat cancer of the stomach and bowels, kidney, and pancreas, Health Canada says. Pfizer’s drug, Sutent, is potentially associated with severe and sometimes life-threatening skin rashes such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), the regulator said.
Signs and symptoms of the severe skin reactions include:

  •  Initially, reddish target-like spots or circular patches often with central blisters on the trunk or elsewhere on the body.
  •  Rash progressing to widespread blistering or peeling of the skin, blisters in the mouth and ulcers in the eyes.
  • Skin changes may follow fever, tiredness, headache and cough.

Health Canada said early recognition is important in improving prognosis. If signs or symptoms of SJS or TEN occur then treatment with Sutent should be stopped and if the diagnosis of the skin treatments is confirmed then it must not be taken again.
« Out of an estimated 214,848 patients exposed to sunitinib between 26 January, 2006 and 30 April, 2013, there were 4 reported cases of TEN and 5 reported cases of SJS internationally, although diagnosis was not confirmed in all cases, » Health Canada said in a letter to health professionals posted on its website. « Two of the potential TEN cases had fatal outcomes. There have been no Canadian cases reported as of April 30, 2013. »
Pfizer Canada will update the prescribing information for Sutent, sunitinib malate.