Ignyta Announces Acquisition of Actagene Oncology and Entry into Oncology Personalized Medicine

On May 20, 2013 Ignyta, Inc. reported that it has acquired Actagene Oncology, Inc., effective May 20, 2013. Actagene was a San Diego based privately held biotechnology company founded in February 2013 that was developing personalized medicines for high unmet need cancer indications, based on cancer genome mining and sequencing (Press release, Ignyta, MAY 20, 2013, View Source [SID1234625377]).

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With the acquisition, Ignyta has evolved its business strategy from a sole focus on molecular diagnostics for autoimmune disease to an integrated "Rx/Dx" focus on drug and biomarker discovery and development for cancer and immunology. Patrick O’Connor, Ph.D., CEO of Actagene Oncology, has joined Ignyta as Chief Scientific Officer and SVP, Head of Research. His contributions to the field of oncology include over 100 publications and patents and over 20 compounds brought into development, including the recently approved anticancer drugs Xalkori (Crizotinib) and Inlyta (Axitinib), discovered at Pfizer where Dr. O’Connor served as the Global Research Therapeutic Area Head for Oncology.

Other additions to Ignyta’s management team include Jean-Michel Vernier, Ph.D., who formerly led chemistry groups at Ardea Biosciences, Valeant Pharmaceuticals and Merck Research Laboratories, to serve as VP, Medicinal Chemistry; Paul Pearson, Ph.D., former Global Head and VP, Pharmacokinetics and Drug Metabolism at Amgen, to head PK, Drug Metabolism & Safety; and Dave Matthews, Ph.D., the scientific founder of Agouron Pharmaceuticals, to head Crystallography at Ignyta. James Bristol, Ph.D., former Worldwide Head of Pfizer Discovery and Former Head of Discovery and Chemistry at Warner-Lambert/Parke Davis, at which site Lipitor was discovered by his Chemistry team, joined Ignyta’s Scientific Advisory Board.

"The Actagene acquisition provides Ignyta with a strategic entry into oncology personalized medicine, an area with high unmet medical need and opportunities to give patients customized treatment options that leverage Ignyta’s biomarker discovery capabilities. Ignyta also gains the addition of Patrick O’Connor and the rest of his world class oncology drug hunter team that has collectively discovered and developed 10 approved drugs representing over $5 billion in 2012 sales," said Jonathan Lim, M.D., chairman and CEO of Ignyta. "Actagene’s R&D team complements Ignyta’s existing team, platform and capabilities, such as whole genome methylation analysis, next generation sequencing, Methylome database, and bioinformatics expertise. This transaction reshapes us into a seamless Rx/Dx company pursuing a significant growth area of patient stratification and targeted drug discovery and development for cancer patients."

Actagene Oncology applies its proprietary Oncolome database and technologies such as synthetic lethal screening, x-ray crystallography and structure-based drug design to develop new chemical entities against genetic targets that are enriched in certain cancer populations.

"I am excited for the Actagene team to join forces with the Ignyta team, several of whom I had the pleasure to previously work with when I was at Halozyme," said Dr. O’Connor. "Actagene’s Oncolome platform will combine synergistically with Ignyta’s Methylome platform to provide both genetic and epigenetic insights from patient tumor samples to identify and pursue personalized medicines against activated genes in cancer. The driving scientific focus for our new company will be the discovery and development of revolutionary new drugs targeting activated genes driving cancer growth and evasion of the immune system."

In addition to its new focus on targeted therapeutic discovery for cancer, Ignyta will continue to advance its companion diagnostic initiatives to generate epigenetic signatures that are predictive of treatment response for specific drug mechanisms within both autoimmune disease and cancer.

(Filing, 10-Q, iBio, MAY 20, 2013, View Source [SID:1234502734])

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(Filing, 10-Q, TNI BioTech, MAY 15, 2013, View Source [SID:1234502812])

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Announcing the Acquisition of Exclusive Distribution Rights to Cynviloq™ for the European Union

On May 13, 2013 Sorrento Therapeutics reported the acquisition of exclusive distribution rights from Samyang Biopharmaceuticals to Cynviloq (marketed as Genexol-PM in South Korea) in the 27 countries of European Union (EU) (Press release Sorrento Therapeutics, MAY 13, 2013, View Source [SID:1234500326]). IGDRASOL had previously obtained the exclusive U.S. distribution rights to Cynviloq from Samyang. STI has the right to acquire IGDRASOL pursuant to a previously-announced option agreement, entered into in March 2013.

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Lilly Announces Enzastaurin Phase III Study Did Not Meet Primary Endpoint in Diffuse Large B-Cell Lymphoma

On May 10, 2013 Eli Lilly reported Phase III clinical trial results from enzastaurin’s PRELUDE study, which explored the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL) (Press release Eli Lilly, MAY 10, 2013, View Source [SID:1234501030]). The study failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy. There were no new safety findings, and the safety data were consistent with previously disclosed studies.

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"We are disappointed in the results that we’re announcing today," said Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology. "However, our oncology pipeline is still one of the most robust across the industry containing more than 20 molecules, including two Phase III molecules in five different tumor types."

Lilly plans to present data from this study at an upcoming scientific meeting.

Lilly will stop development of enzastaurin, which is expected to result in a second-quarter charge to R&D expense of approximately $30 million. The company’s previously-issued financial guidance for 2013 remains unchanged.

About the Study
Patients enrolled in PRELUDE had histologically confirmed DLBCL with an International Prognostic Index (IPI) score of three to five at diagnosis. The IPI is a simple, clinical tool that is used to predict survival outcomes for patients with DLBCL. Patients enrolled also achieved a complete response or complete response-unconfirmed to cyclophosphamide, doxorubicin, vincristine, and prednisone, plus rituximab (R-CHOP) therapy. Patients were randomized in a 2:1 fashion to receive enzastaurin or placebo.

Treatment continued until patients developed progression of disease, unacceptable adverse events, or completed three years of therapy.