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Endocyte to Announce Updated Data on EC1456 and EC1169 at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 26, 2016 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported that two posters will be presented on its lead, clinical-stage assets, EC1456 and EC1169, at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 3 – 7, 2016, in Chicago (Press release, Endocyte, MAY 26, 2016, View Source [SID:1234512816]).

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Updated data will be presented on EC1456-01, a phase 1 dose escalation study in patients with advanced solid tumors who were imaged to assess folate receptor expression with 99mTc-etarfolatide (FR expression not an eligibility criteria). Findings include:

EC1456 is generally well tolerated in previously treated cancer patients at the doses administered to date. Fifty-eight patients have been treated and are evaluable for cycle 1 toxicity. To date, the maximum tolerated dose (MTD) has not been determined. Dose escalation is ongoing at 12.5 mg/m2 on the weekly (QW) schedule and at 7.5 mg/m2 on the twice weekly (BIW) schedule.
Anti-tumor activity is suggested with lesion-level responses and 20 patients demonstrating stable disease (SD) and SD ≥ 3 months being observed in 5 BIW patients and 5 QW patients.
An update also will be provided for EC1169-01, a phase 1 dose escalation study in patients with metastatic, castration-resistant prostate cancer (mCRPC) who failed prior chemotherapy. All patients were imaged to assess PSMA expression with 99mTc-EC0652 (PSMA expression not an eligibility criteria). Findings include:

99mTC-EC0652 uptake was observed in all patients in both bone and soft tissue lesions. Both positive and negative lesion uptake was observed.
EC1169 is well tolerated in mCRPC patients at the doses administered to date. Twenty-eight patients have been treated and are evaluable for cycle 1 toxicity (TIW: 5 patients; QW: 23 patients). To date, the MTD has not been determined. Dose escalation is ongoing at 6.5 mg/m2 on the QW schedule.
Anti-tumor activity is suggested with lesion-level reductions. Furthermore, fifteen patients have demonstrated stable disease, and 2 patients have demonstrated a ≥50% max decline in PSA.
The posters will be available on Endocyte’s website following presentation at the conference.

Presentations are as follows:

Abstract #: 2585
Title: A phase 1 dose-escalation study of the folic acid-tubulysin small molecule drug conjugate (SMDC) folate-tubulysin EC1456 in advanced cancer patients
Presenter: Jasgit C. Sachdev, MD, Scottsdale Healthcare
When: Sunday, June 5, 8 a.m. – 11:30 a.m. EDT
Session Title: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Location: Hall A

Abstract #: 2586
Title: Phase 1 study of the PSMA-targeted tubulysin small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC)
Presenter: Michael J. Morris, MD, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College
When: Sunday, June 5, 8 a.m. – 11:30 a.m. EDT
Session Title: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Location: Hall A

About EC1456

EC1456 is an investigational, proprietary, injectable SMDC consisting of folate (vitamin B9) linked to a potent cytotoxic agent, tubulysin B hydrazide (TubBH). EC1456 is wholly owned by Endocyte. TubBH is a member of the tubulysin class of anti-neoplastic agents that inhibit the polymerization of tubulin into microtubules, a critical component during cell division. The targeting ligand folate, essential for cell division, has been investigated with vintafolide. EC1456 is currently being evaluated in a phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT01999738).

About EC1169

EC1169 is an investigational, proprietary, injectable SMDC consisting of a PSMA targeting ligand (DUPA analog) linked to a potent cytotoxic agent, tubulysin B hydrazide (TubBH). EC1169 is wholly owned by Endocyte. TubBH is a member of the tubulysin class of anti-neoplastic agents that inhibit the polymerization of tubulin into microtubules, a critical component during cell division. EC1169 is currently being evaluated in a phase 1 study in patients with metastatic, castration-resistant prostate cancer (mCRPC) (ClinicalTrials.gov Identifier: NCT02202447).

Cigna Issues Positive Coverage Decision for NanoString’s Prosigna® Breast Cancer Assay

On May 26, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of molecular diagnostic testing products and life science tools for translational research, reported that Cigna has issued a positive Medical Coverage Policy decision for the Prosigna Breast Cancer Gene Signature Assay (Press release, NanoString Technologies, MAY 26, 2016, View Source [SID:1234512804]). Cigna and its roughly 13 million members join other payors now covering Prosigna, collectively representing more than 135 million covered lives throughout the United States.

This positive coverage decision is in line with updated ASCO (Free ASCO Whitepaper) guidelines released in February, wherein Prosigna is considered medically necessary to assess the necessity of adjuvant chemotherapy in ER-positive, HER2-negative, node-negative breast cancer patients, when adjuvant chemotherapy is not precluded due to any other factor.

"Cigna’s decision to cover Prosigna is another milestone in expanding access to this state-of-the-art-test," said Brad Gray, president and chief executive officer of NanoString Technologies. "We estimate that more than 80% of patients indicated for Prosigna testing are now covered and our team is dedicated to working with the remaining health insurance providers to ensure that their patients have access to this important test."

The updated healthcare policy for Cigna, which now includes the Prosigna Assay, is available on its website:
View Source

About the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analysis System
The Prosigna Assay provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna Assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma.

The Prosigna Assay requires minimal hands-on time and runs on NanoString’s proprietary nCounter Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision.

The nCounter Dx Analysis System is a highly automated and easy-to-use platform that utilizes a novel digital barcoding chemistry to deliver high precision multiplexed assays. The system is available in the multi-mode FLEX configuration, which is designed to meet the needs of high-complexity clinical laboratories seeking a single platform with the flexibility to run the Prosigna Breast Cancer Assay and, when operated in the "Life Sciences" mode, process translational research experiments and multiplexed assays developed by the laboratory.

In the United States, the Prosigna Assay is available for diagnostic use when ordered by a physician. The Prosigna Assay has been CE-marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark, as well as Canada, Israel, Australia, New Zealand and Hong Kong.

In the U.S., the Prosigna Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:

(1) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes.

For more information, please visit www.prosigna.com.

Cancer Research Technology and Pangaea Biotech sign license agreement for new cancer drugs

On May 26, 2016 Cancer Research Technology and Pangaea Biotech reported to sign license agreement for new cancer drugs (Press release, Cancer Research Technology, 26 26, 2016, View Source [SID1234523185]).

These promising new drugs have been developed by scientists at CRT’s Discovery Laboratories with support from Cancer Research UK-funded scientists at King’s College London.

PAK is involved in cell growth and survival and is overexpressed in many cancers including ovarian, breast, pancreatic, melanoma and lung. Scientists hope that the PAK inhibitors will block the activity of overexpressed PAK protein – killing cancer cells. Although researchers have linked PAK with tumour development, there are no approved compounds available on the market.

Under the terms of the agreement, Pangaea Biotech will be responsible for research and development of the PAK inhibitors, taking CRT’s compounds through clinical development. CRT will receive undisclosed upfront and downstream payments.

CRT and Pangea Biotech will work collaboratively to complete lead optimisation, then Pangaea will assume responsibility for pre-clinical and clinical development.

Javier Rivela, CEO of Pangaea Biotech, said: "This strategic agreement maximises the capabilities of both parties, with CRT focusing on the earlier stages of development involving specialised medicinal chemistry work, and Pangaea on regulatory preclinical development, early stage clinical trials and development of biomarkers, where our main abilities and experience lie.

"We are excited about this partnership as it marks the beginning of what we expect to be a fruitful long-term collaboration with one of the most important global players in cancer drug development."

Dr Phil L’Huillier, CRT’s director of business management, said: "It’s fantastic to see this new investment in Cancer Research UK-funded science that has progressed through our Discovery Laboratories. We look forward to working with Pangaea to develop the PAK inhibitor for clinical trials."

CRT’s Discovery Laboratories build on Cancer Research UK’s investment in world-class research and focus on forming drug discovery alliances with industry, to develop potential novel therapies based on the cancer targets identified in academic research.

OncoResponse Secures Investment from Baxalta

On May 26, 2016 OncoResponse, an immuno-oncology antibody discovery company, reported an investment from Baxalta Incorporated (NYSE: BXLT) (Press release, OncoResponse, MAY 26, 2016, View Source [SID1234522899]). In October 2015, OncoResponse closed a Series A financing co-led by ARCH Venture Partners, Canaan Partners and MD Anderson, with William Marsh Rice University and Alexandria Real Estate Equities also participating . The investment by Baxalta brings the total Series A to $12.5 million and will be used to support OncoResponse’s ongoing efforts to interrogate the humoral response of elite responders to cancer immunotherapy to identify antibodies and potential targets for novel therapeutic development.

OncoResponse utilizes a validated platform technology to rapidly screen antibodies made by the human immune system and identify those with exceptional reactivity to cancer immunotherapy. The company has an ongoing strategic alliance with the MD Anderson Cancer Center, which provides access to patient samples and oncology and translational medicine expertise including clinical and regulatory input.

"We are pleased to welcome Baxalta to our solid team of investors," said Clifford J. Stocks, CEO of OncoResponse. "Our current partnership with MD Anderson has seen significant progress, and this additional investment reinforces our continued commitment to the identification of rare cancer-fighting antibodies and novel targets that may lead to the development of improved cancer treatments."

"This investment will assist OncoResponse in the advancement of its research programs which seek to develop a deeper understanding of the immune response in patients who have responded exceptionally well to cancer immunotherapy," said Geeta Vemuri, PhD, Managing Venture Partner at Baxalta. "Their innovative approach is in line with Baxalta’s investment strategy to accelerate the development of cuttingedge biotechnologies that address unmet patient needs in hematology, immunology and oncology."

ProNAi Licenses Cancer Drug Candidate Targeting CDC7 from Carna Biosciences

On May 26, 2016 ProNAi Therapeutics, Inc. (NASDAQ: DNAI), a clinical-stage oncology company advancing novel targeted therapeutics for patients with cancer, reported it has obtained an exclusive license from Carna Biosciences, Inc., Kobe, Japan (JASDAQ: 4572), for worldwide rights to develop and commercialize AS-141, a small molecule kinase inhibitor targeting CDC7 (Press release, ProNAi Therapeutics, MAY 26, 2016, View Source [SID:1234512843]).

"Our exclusive license with Carna gives us access to a highly promising asset that was created leveraging Carna’s world-class kinase drug discovery expertise. Our team has extensive experience developing oncology drugs and will be focused on the rapid and efficient advancement of this drug candidate," said Dr. Nick Glover, President and CEO of ProNAi. "This agreement, and our focused efforts to identify additional high-quality assets to acquire, reflect our strategy of building a broad and diverse pipeline of targeted oncology drugs that will change people’s lives."

Under the terms of the agreement, ProNAi will pay Carna Biosciences an initial upfront payment of $0.9 million and aggregate additional potential payments upon achievement of certain developmental, regulatory and commercial milestones of up to $270 million. ProNAi will also pay Carna single-digit tiered royalties on the net sales of any product successfully developed.

"ProNAi and Carna Biosciences are fully aligned in our vision of making a meaningful difference for patients with cancer," said Kohichiro Yoshino, PhD, Founder, President and CEO of Carna Biosciences. "We are confident the further development of AS-141 will be well-managed under the stewardship of the ProNAi team."

"We are very excited to work with the highly experienced team at ProNAi to progress AS-141 to the clinic," added Dr. Masaaki Sawa, Chief Scientific Officer of CarnaBio. "AS-141 has demonstrated compelling anti-tumor activity against multiple tumor types in preclinical studies and represents an opportunity for promising clinical development."

"CDC7’s role as a key regulator of both DNA replication and DNA damage response make it a compelling emerging target for the treatment of a broad range of tumor types, providing significant commercial potential for the agent," said Dr. Angie You, Chief Business & Strategy Officer and Head of Commercial for ProNAi. "While there is growing interest in targets of this class, we believe we have an opportunity with this potent and selective kinase inhibitor to be first-in-class and highly differentiated."

"Preclinical data and published literature suggest a variety of oncology indications with potential for response to CDC7 inhibitors," added Dr. Barbara Klencke, ProNAi’s Chief Development Officer. "Continued preclinical assessment of AS-141 will further inform our clinical development plans and patient selection strategies, with the objective of advancing this drug into the clinic in H2 2017.