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Invivoscribe Inks CDx Agreement with Astellas Pharma

On April 28, 2015 Invivoscribe Technologies reported that it has signed an agreement with Astellas Pharma to develop a companion diagnostic for an investigational drug (Press release, Invivoscribe Technologies, APR 28, 2015, View Source [SID1234550141]).

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Under the terms of the agreement, Invivoscribe will develop and commercialize a companion diagnostic based on the FLT3 tyrosine kinase gene and use the international harmonized signal ration test to stratify and enroll acute myeloid leukemia (AML) patients for Astellas clinical trials of the drug candidate ASP2215 in the US, Europe, Japan, and other countries.

San Diego-based Invivoscribe will receive an upfront payment; reimbursements for development, regulatory, and commercialization costs; and milestone payments for reaching certain goals. The firm will be responsible for all development, commercialization, and regulatory activity in the US, Europe, and Japan.

FLT3 mutation status is typically determined for AML patients as a part of the standard of care, the firm said in a statement.

"We are looking forward to this expanded use of our harmonized companion diagnostic around the FLT3 biomarker," Invivoscribe Chairman and CEO Jeffrey Miller said in a statement. "This signal ratio assay is an internationally recognized test for identifying patients with FLT3 mutations and an important tool for stratifying cytogenetically normal AML."

In 2011, Invivoscribe signed a companion diagnostics partnership with Novartis based on the FLT3 gene for AML.

10-Q – Quarterly report [Sections 13 or 15(d)]

Epizyme has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Epizyme, APR 28, 2015, View Source [SID1234503203]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

Hospira has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Hospira, APR 28, 2015, View Source [SID1234503193]).

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8-K – Current report

On April 28, 2015 Bio-Path Holdings reported that they have received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its lead compound Liposomal Grb-2 for the treatment of acute myeloid leukemia (AML) (Filing, 8-K, Bio-Path Holdings, APR 28, 2015, View Source [SID:1234503201]). Orphan drug status provides Bio-Path with seven years of exclusivity after receiving formal marketing approval, as well as additional development incentives. The FDA grants this designation to certain drugs that are targeting diseases affecting fewer than 200,000 people in the United States.

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"This designation from the FDA demonstrates the unmet need for an effective therapy for patients suffering from AML," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "It also marks a key regulatory milestone for Bio-Path and will be valuable as we continue to progress Liposomal Grb-2 through clinical trials and toward potential commercialization."

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Liposomal Grb-2 is currently in a safety segment of a Phase 2 trial in combination with Ara-C, for acute myeloid leukemia; and is being evaluated for chronic myelogenous leukemia.

Pre-clinical development is underway for triple negative and inflammatory breast cancers.

About Acute Myeloid Leukemia

AML is a fast-growing cancer of the blood and bone marrow where the bone marrow makes many cancerous cells called leukemic blasts. Normal blasts develop into white blood cells that fight infection. In AML, the leukemic blasts do not develop properly and cannot fight infections. These leukemic blasts grow quickly and crowd out the bone marrow, preventing it from making the normal red blood cells, white blood cells, and platelets that the body needs.
Nearly 15,000 people in the United States are diagnosed with AML each year.

About Growth Receptor Bound protein-2 (Grb-2)

The adaptor protein Growth Receptor Bound protein-2 (Grb-2) is essential to cancer cell signaling because it is utilized by oncogenic tyrosine kinases to induce cancer progression. Suppressing the function or expression of Grb-2 should interrupt its vital signaling function and have a therapeutic application in cancer. BP-1001 is a neutral-charge, liposome-incorporated antisense drug substance designed to inhibit Grb-2 expression.

PTC Therapeutics’ Cancer Stem Cell Program Targeting BMI1 Enters Phase 1

On April 28, 2015 PTC Therapeutics reported that its oncology program targeting BMI1, a protein linked to drug-resistant cancers, has entered a Phase 1 study in patients with advanced solid tumors (Press release, PTC Therapeutics, APR 28, 2015, View Source [SID:1234503200]). The open-label, first-in-human study will investigate the safety and pharmacokinetics of PTC596, an orally available small molecule. PTC’s BMI1 program is supported by a collaboration with the Wellcome Trust.

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BMI1 has been implicated in a wide variety of cancers and has been demonstrated to contribute to therapeutic resistance and treatment failure. BMI1 is thought to play a role in the survival and maintenance of tumor stem cells in many cancers, including central nervous system cancers such as glioblastoma. Elevated levels of BMI1 have been associated with advanced tumor grade and a poor prognosis.

"We’re excited to begin clinical trials for PTC596, an investigational drug that targets an important stem cell regulator, BMI1, which is elevated in a wide array of tumor types," said Robert Spiegel, M.D., Chief Medical Officer, PTC Therapeutics, Inc. "In preclinical models, PTC596 reduced BMI levels leading to depletion of the cancer stem cell population. Importantly, we saw this effect when PTC596 was used alone and in combination with current standards of care."

"Targeting cancer stem cells by BMI1 inhibition is a promising approach to address the challenge of drug-resistant cancers," stated Lillian Siu, M.D., Princess Margaret Cancer Center, Professor of Oncology, University of Toronto. "Cancer is a complex problem and the development of treatments that focus on molecular targets shows promise for the next generation of cancer therapies to make a difference in patients’ lives."

PTC’s collaboration with the Wellcome Trust began in June 2010 when the Wellcome Trust awarded PTC $5.4 million to support the development of drugs that target BMI1.