On December 12, 2016 Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase 2 proof-of-concept, reported a new strategic collaboration with Celgene Corporation (Press release, Triphase Accelerator, DEC 21, 2016, View Source [SID1234529641]). Under the Agreement, Celgene has an option to acquire all Triphase Accelerator’s assets relating to TRPH-222 (CD22-4AP), an antibody-drug conjugate in development for lymphoma.

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Pursuant to the Agreement, Triphase Accelerator received an upfront payment from Celgene. Triphase Accelerator will control development and will retain all commercial rights to TRPH-222 (CD22-4AP). If Celgene exercises its option to acquire TRPH-222 (CD22-4AP), Celgene will become responsible for development and commercialization, and Triphase Accelerator will be eligible to receive development, regulatory and sales milestone payments. This is the third product option deal between Triphase Accelerator and Celgene.

"This collaboration is important to Triphase Accelerator in multiple ways. First, it continues to solidify the relationship we have developed over time with Celgene. They have been a valued collaborator to us and we are grateful. Just as importantly, it continues to validate our business model of acquiring early-stage assets and applying our methodology to accelerate programs through the proof-of-concept phase and into the clinic," said Mohit Trikha, Ph.D., chief scientific officer, Head of Triphase Accelerator. "As we continue to acquire and develop new assets, we look forward to finding new ways to demonstrate how our approach is uniquely science based, efficient, and cost-effective, with the ultimate goal to help patients."

TRPH-222 is a novel, site-specific antibody-drug conjugate (ADC) targeting CD22, a B-cell-restricted sialogycoprotein that is an important modulator of B-cell signaling and survival, which is expressed on nearly all B-cell malignancies. CD22 is a validated ADC target for Non-Hodgkin’s lymphoma and acute lymphoid leukemia. The compound itself combines a site-specific modified humanized antibody conjugated to a toxin payload and a 4AP linker.

"We have enjoyed a long-standing relationship with Triphase Accelerator and believe in their approach to drug development," said Celgene’s President of Hematology Oncology, Michael Pehl. "This latest agreement, which closely follows our acquisition of their marizomib asset, represents our confidence in their approach to drug development, and we look forward to a continued collaboration with the company."

On December 21, 2016 Exosome Diagnostics, Inc. reported data that sets a new standard for EGFR-T790M resistance mutation detection in lung cancer, with the highest sensitivity reported to date (Press release, Exosome Diagnostics, DEC 21, 2016, View Source [SID1234517160]). This test is being developed to improve care and outcomes for the large population of patients who can benefit from second line EGFR Tyrosine Kinase Inhibitor (TKI) therapy but are missed with currently available tissue and liquid biopsy tests. Clinical validation data from a cohort of 160 patients, the largest of its kind in this patient population, was presented in plenary session during the recent AACR (Free AACR Whitepaper)-EORTC-NCI meeting in Munich, Germany. ExoDx Lung(T790M) has been optimally designed for ExosomeDx’s high throughput biomarker testing platform that is being deployed in 2017.

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Twenty percent of non-small cell lung cancer (NSCLC) patients test positive for an EGFR driver mutation (approximately 45,000 patients in the U.S. alone) and receive EGFR TKI therapy. Unfortunately, most will develop a resistance to EGFR TKI therapy. Tissue biopsies are the current standard for identifying T790M resistance. If a patient tests positive, they are eligible for treatment with a second line EGFR TKI therapy. Unfortunately, a tissue biopsy is not always a viable option for a large percentage of these patients.

Non-invasive liquid biopsies have emerged as a viable alternative for patients unable to have tissue biopsy procedure. Clinical studies have demonstrated that the FDA approved cobas test for liquid biopsy, only identifies 59% of patients who will respond to a second line EGFR TKI therapy. This is a direct result of lack of sensitivity and inability to test challenging intrathoracic disease. By analyzing exosomal RNA (exoRNA) and cell free tumor DNA (ctDNA) from the same sample Exosome Dx addresses current limitations by identifying 96% of the T790M positive population, with no loss of sensitivity in patients with intrathoracic disease.

"EGFR T790M mutations have previously been challenging for liquid biopsy assays. In this clinical study, we show that ExoDx Lung(T790M) has a higher clinical sensitivity and specificity than what has been reported to date for the FDA cleared test distributed by Roche. This study further demonstrates the power of our ExoLution Plus platform that combines exoRNA plus ctDNA. This result was not surprising since we have shown superior performance to ctDNA across several disease states in blinded head to head studies. Clinical samples are precious so we are thrilled to be able to offer a more sensitive test that take both exoRNA and ctDNA into consideration,"stated Dr. Johan Skog, Chief Scientific Officer at Exosome Diagnostics.
The test is the latest in a series of biofluids based diagnostic and companion diagnostic biomarker tests being developed by Exosome Diagnostics to potentially aid in therapy selection and patient monitoring in oncology and other diseases.

To assure future access to the company’s novel biomarker tests worldwide, Exosome Diagnostics also announced that it has developed a high throughput version of its proprietary ExoLution Plus system to prepare samples that can be analyzed with exoRNA and cfDNA analysis test kits. This system utilizes Exosome Diagnostics’ patented technology and has been developed with high throughput capability to be integrated with leading clinical laboratory analytical systems including those marketed by Roche and Thermo Fisher

"This data illustrates one of the many indications for which Exosome Diagnostics can leverage its extremely sensitive liquid biopsy technology to improve patients’ lives by guiding therapy, where other technologies could not in a reliable fashion" stated John Boyce, President and CEO of Exosome Diagnostics. "Exosome Diagnostics has proven that its technology is extremely robust and can scale on a variety of existing commercial platforms in diagnostic laboratories," Boyce continued.

On December 21, 2016 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) reported that, following a recent independent Data and Safety Monitoring Board (DSMB) recommendation and subsequent futility analysis, it has decided to stop the Phase 2 HERMIONE study of MM-302 (HER2 antibody-targeted liposomal doxorubicin) in HER2-positive metastatic breast cancer patients who had previously been treated with trastuzumab (Herceptin), pertuzumab (Perjeta) and ado-trastuzumab emtansine (T-DM1, Kadcyla) (Press release, Merrimack, DEC 21, 2016, View Source [SID1234517147]).

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The decision to stop the trial was made following the DSMB’s opinion that continuing would be unlikely to demonstrate benefit over the comparator treatments. Subsequent to this recommendation, a futility assessment was performed that confirmed the DSMB’s opinion. Both the treatment and control arms were found to have shorter than expected median progression free survival.

Importantly, there were no new or unexpected safety concerns. Patients currently enrolled in the trial may choose to continue on their assigned treatment based upon discussion with their study physician.

"Late line HER2-positive breast cancer is very difficult to treat, especially in this new and previously unstudied group of patients who appear to experience rapid cancer progression following treatment with trastuzumab, pertuzumab and ado-trastuzumab emtansine," said Istvan Molnar, MD, Vice President of Clinical Development at Merrimack Pharmaceuticals. "While we are disappointed with this outcome, we would like to thank the study Steering Committee, the investigators and, most importantly, the patients who participated in the HERMIONE trial. We will report our learnings from this study at a later date."

In light of this development, Merrimack now expects to provide further details about MM-302, as well as the results of its full pipeline review, in January.

On December 20, 2016 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD), reported that it has received approval from the Competent Authority and Ethics Committee in the UK for its Phase IIb, AIPAC clinical trial of IMP321 (Filing, 6-K, Prima Biomed, DEC 20, 2016, View Source [SID1234517148]). Following conclusion of the safety run in phase, expected in late December, and subject to the dose escalation committee meeting, screening for the larger, randomised phase of the trial is expected to commence in January 2017.
AIPAC (Active Immunotherapy PAClitaxel) is a multi-national, randomised, double-blind, placebo-controlled study of IMP321-plus-paclitaxel in metastatic breast cancer. The safety run-in phase of the first cohort of 15 patients is being conducted across 11 clinical sites in Belgium, The Netherlands and Hungary. Recruitment of the last two patients in this cohort was completed in October. The first safety and pharmacokinetic data from these 15 patients is expected in late December 2016. As previously announced, AIPAC’s expected duration based on forecast recruitment times and patient follow up is approximately three years.
Prima also confirms that interim data from the first cohort of patients in its Phase I, TACTI-mel clinical trial of IMP321 together with KEYTRUDA for metastatic melanoma patients is also expected in late December 2016.

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On December 20, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused clinical stage biotechnology company, reported two patent allowances for imaging agents delivered via the company’s patented PDC platform (Filing, 8-K, Cellectar Biosciences, DEC 20, 2016, View Source [SID1234517150]). The United States Patent and Trademark Office ("USPTO") issued patent allowances covering method of use for CLR 124 in the detection of radiation- and chemo-insensitive cancer or cancer metastases. Concurrently, the Japanese patent office granted a composition of matter allowance covering two optical imaging agents in the CLR 1500 series.

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"While we remain focused on the development of our phospholipid drug conjugate, or PDC, delivery technology for therapeutic applications, our imaging assets and platform capability represents an excellent partnership opportunity," said Jim Caruso, president and CEO of Cellectar. "The continued expansion of our intellectual property portfolio provides additional protection and increases the value of our delivery platform to potential partners."

The USPTO allowance for CLR 124 pertains to the detection of radiation- and chemo-insensitive cancer or cancer metastasis specifically using PET, SPECT or gamma camera scintigraphy, as well as quantitative 3-D imaging with PET/MRI. These allowed claims are a continuation in part of US Patent No. 8,877,160 with coverage extending until March 2, 2025. The Japanese composition of matter allowance for the CLR 1500 series agents using the company’s PDC platform was allowed by the Japanese Patent Office for two additional optical imaging agents for intraoperative imaging of tumors and tumor margins. These CLR 1500 compounds are from a divisional application from JP 5702366 with coverage extending through May 11, 2030.

About Phospholipid Drug Conjugates (PDCs)

Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.