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(Press release, Leo, OCT 8, 2013, View Source [SID:1234504699])

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New Drug Application Filed for ALK Inhibitor “Alectinib Hydrochloride” for the Treatment of ALK Fusion Gene Positive Unresectable, Recurrent / Advanced Non-Small Cell Lung Cancer

On October 8, 2013 (Tokyo) – Chugai Pharmaceutical Co., Ltd. [Main Office: Chuo-ku, Tokyo. Chairman & CEO: Osamu Nagayama (hereafter, "Chugai")] reported that it has filed a new drug application to the Ministry of Health, Labour and Welfare (MHLW) on October 7, 2013, for ALK (Anaplastic Lymphoma Kinase) inhibitor "alectinib hydrochloride (Development code: AF802, Roche Development Code: RG7853, Compound number: CH5424802)" for the treatment of ALK fusion gene positive non-small cell lung cancer (NSCLC) (Press release, Chugai, OCT 8, 2013, View Source [SID1234500029]). On September 13, 2013, alectinib hydrochloride for the treatment of "ALK fusion gene positive unresectable, recurrent / advanced non-small cell lung cancer" was designated as orphan drug by MHLW.

Chugai filed the application with the MHLW based on the results from a Japanese phase I/II clinical trial, before the phase III clinical trial results will be available. The clinical trial was conducted at 13 medical institutions in Japan in ALK fusion gene positive lung cancer patients with a treatment history of chemotherapy. The clinical trial was conducted in two phases; the phase 1 portion was conducted to evaluate safety and to determine the recommended dose (24 patients), and the phase 2 portion was conducted to evaluate the efficacy and safety of the confirmed recommended dose (46 patients).

As a result, the recommended dose was determined to be 300 mg twice daily in phase 1. Phase 2 was conducted using the recommended dose, and as a result, tumor regression was observed in 43 (93.5%) out of 46 patients. Regarding safety, there were no treatment-related deaths and grade 4 or higher serious adverse reactions assessed according to CTCAE (Common Terminology Criteria for Adverse Events) defined by the Japan Clinical Oncology Group. The most frequently observed grade 3 or higher adverse reactions were neutropenia and increase in creatine phosphokinase (CPK). The incidence of both adverse events was 2 (4.3%) out of 46 patients*.

Based on the results of an American Phase I dose-escalation study of patients with ALK fusion gene positive NSCLC whose disease had progressed on crizotinib therapy, in addition to Japanese Phase I/II clinical trial results, alectinib hydrochloride was found to meet the criteria for Breakthrough Therapy Designation by U.S. Food and Drug Administration (FDA) on June 26, 2013. The results of the American study were presented as a late-breaker at the 2013 European Cancer Congress (ECC) in Amsterdam.

As the top pharmaceutical company in the field of oncology in Japan, Chugai will work for the approval to provide patients and medical professionals with new treatment options as soon as possible.

* Seto et al., Lancet Oncol. 14: 590-598 (2013)

Immutep, Eddingpharm partner to develop and commercialize ImmuFact IMP321

On October 7 2013 Immutep S.A., the biopharmaceutical company specializing in immuno-oncology, and Eddingpharm reported that they have entered into an agreement regarding the development, commercialization and manufacturing of Immutep’s ImmuFact IMP321 (Press release, Eddingpharm, OCT 7/, 2013, View Source [SID:1234513850]). Financial details are undisclosed but include milestone payments and royalties. Burrill Securities acted as financial advisor on this transaction.

The agreement grants Eddingpharm exclusive rights to develop and market IMP321 in mainland China, Hong Kong, Macau and Taiwan. Immutep will provide full technical support for the development of the product. Immutep and Eddingpharm plan to develop the product for first-line metastatic breast cancer as well as other first-line metastatic indications.

Like the checkpoint inhibitors that induce tumor regression and extend survival, antigen presenting cell (APC) activators increase the T cell response against tumors by a different but complementary mechanism, which enhances antigen presentation to T cells. IMP321 (a first-in-class APC activator) can be used in combination with first-line chemotherapy or in combination with checkpoint inhibitors.

We have been very impressed by the dynamic and innovative approach of Eddingpharm, and believe them to have the capability of driving the development of IMP321 in China," said John Hawken, CEO. "Immutep is continuing the development of IMP321 in Europe and the USA. We are in partnering discussions at present."

"We are excited to be entering the new field of immuno-oncology. We believe that immuno-oncology will revolutionize cancer treatment, » said Xin Ni, chairman and chief executive officer of Eddingpharm. Our priority is bringing new and effective treatments to patients. We look forward to working closely with Immutep to develop IMP321 in first-line metastatic breast cancer as well as other first-line metastatic indications."

(Press release, TNI BioTech, OCT 2, 2013, View Source [SID:1234507314])

Myriad Genetics and BioMarin Advance PARP Collaboration Into Phase 3

On October 1, 2013 Myriad Genetics reported that BioMarin Pharmaceutical Inc. will use Myriad’s BRACAnalysis test in connection with its pivotal Phase 3 clinical studies for BMN 673. BMN 673 is a novel, orally-active PARP inhibitor designed to induce synthetic lethality in BRCA-deficient cells (Press release, Myriad Genetics, OCT 1, 2013, View Source [SID:1234502303]).

Myriad will collaborate with BioMarin to deliver BRAC testing for its pivotal clinical studies. As required by the U.S. Food and Drug Administration, Myriad also submitted an Investigational Device Exemption (IDE) to the FDA that will allow for BRACAnalysis testing to be used as a companion diagnostic to stratify patients in the BMN 673 clinical program. Additional terms of the deal were not disclosed.

"Companion diagnostics are a major focus of our business and are increasingly being integrated into drug development programs," said Mark C. Capone, president of Myriad Genetics Laboratories. "BRACAnalysis has shown promise as a companion diagnostic, and we are actively collaborating with BioMarin to identify responders and non-responders to therapy with BioMarin’s novel PARP inhibitor."

"Through our experience working with the Myriad BRACAnalysis test in our Phase 1 trial for BMN 673 in solid tumors, we appreciate the investment that Myriad has made in developing this assay and understanding its use," said Len Post, vice president, Chief Scientific Officer Drug Discovery at BioMarin. "Identifying the right patients to enroll in our Phase 3 study for BMN 673 in BRCA breast cancer will be critical in answering important scientific questions about the safety and efficacy of the compound in this select population."