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Ignyta Granted Breakthrough Therapy Designation for Entrectinib by U.S. Food and Drug Administration

On May 15, 2017 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation (BTD) to entrectinib "for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or who have no acceptable standard therapies (Press release, Ignyta, MAY 15, 2017, View Source [SID1234519116])." Entrectinib is the company’s investigational, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor NTRK1/2/3, ROS1, or ALK gene fusions.

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The FDA’s Breakthrough Therapy Designation is intended to expedite development and review timelines of potential new medicines for use in the treatment of a serious or life-threatening condition when preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints [1].

"The granting of Breakthrough Therapy Designation enables us to continue high quality engagement with the FDA during the development of entrectinib, and we greatly appreciate the commitment by FDA to move this investigational drug forward," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "We believe this designation validates the broad potential of entrectinib as a novel treatment for patients, regardless of age, with TRK-positive tumors, a group of cancers for which there currently is no approved treatment and which represents a clear unmet medical need."

About Entrectinib

Entrectinib is a novel, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TRKA/TRKB/TRKC), ROS1 or ALK. Entrectinib is the only TRK inhibitor with clinically demonstrated activity against primary and metastatic CNS disease, and does not have undesirable off-target activity. This product candidate is in a Phase 2 clinical trial called STARTRK-2, which is the second of the "Studies of Tumor Alterations Responsive to Targeting Receptor Kinases." The trial is a global, multicenter, open label, potentially registration-enabling Phase 2 clinical trial of entrectinib that utilizes a basket design with screening of patient tumor samples for the relevant targets. Such a basket design takes full advantage of entrectinib’s demonstrated preliminary clinical activity across a range of different tumor types and molecular targets.

Corvus Pharmaceuticals to Present Data on Lead Checkpoint Inhibitor CPI-444 in Renal and Lung Cancer at 2017 ASCO Annual Meeting

On May 15, 2017 Corvus Pharmaceuticals, Inc. (Nasdaq:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported that it will present an oral abstract presentation at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6 in Chicago, Illinois. The abstract for the presentation will be available on the ASCO (Free ASCO Whitepaper) website on May 17 at 5:00 p.m. ET (Press release, Corvus Pharmaceuticals, MAY 15, 2017, View Source [SID1234519115]). Following are details for the oral presentation.

ORAL PRESENTATION

ABSTRACT #: 3004
TITLE: Safety and clinical activity of adenosine A2a receptor (A2aR) antagonist, CPI-444, in anti-PD1/PDL1 treatment-refractory renal cell (RCC) and non-small cell lung cancer (NSCLC) patients
PRESENTER: Lawrence Fong, M.D., Leader, Cancer Immunotherapy Program, Co-Director, Parker Institute of Cancer Immunotherapy at University of California, San Francisco
PRESENTATION DATE AND TIME: Monday, June 5, 2:27 p.m. CT
LOCATION: Hall D1

Addition of a Second Clinical Site in the Expansion of its Chimeric Antigen Receptor T-cell (CAR-T) Phase I Clinical Trial for Its CARD-1 Trial

On May 15, 2017 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, reported the addition of a new independent Phase I clinical trial of the Company’s ongoing CARD-1 study in patients with chemorefractory and aggressive DLBCL (Press release, Cellular Biomedicine Group, MAY 15, 2017, View Source [SID1234519114]). The Company and Shanghai Tongji Hospital (Tongji) are conducting a single arm, non-randomized study to evaluate the safety and efficacy of C-CAR011 (Anti-CD19 single-chain variable fragment (scFv) (41BB-CD3ζ)) therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL). The trial will enroll 15 patients comprised of DLBCL, Primary Mediastinal Large B-Cell Lymphoma (PMBCL) and Follicular Lymphoma (FL).

"Driven by Shanghai’s regional demand, Tongji’s CAR-T expertise, the requirement to confirm site to site consistency and our need to prepare for the next phase of a confirmatory clinical trial, the new trial will benefit patients in Shanghai and provide CBMG with incremental data in safety and tolerability of C-CAR011 in more chemorefractory and aggressive DLBCL patients comprised of unique histogenesis and those with the most common indolent form of non-Hodgkin lymphoma (NHL). " said Mr. Tony Liu, Chief Executive Officer for CBMG.

Mr. Tony Liu added, "Due to our robust clinical pipeline, we believe the Company’s stock is currently undervalued. The management and our scientific team are committed to delivering long-term clinical benefits to patients that have the potential to address very large cancer and knee osteoarthritis markets and create long-term value for shareholders. We believe that CBMG has one of the very few leading integrated chemistry, manufacturing, and controls (CMC) facilities in the world for a cell therapy company, which when fully built out in China, will have the manufacturing capacity to support the treatment of 10,000 cancer and 10,000 knee osteoarthritis patients per year. With a healthy balance sheet and an efficient deployment of capital that will enable CBMG to execute on its clinical developments over the next twelve months, we are well equipped to further our clinical trials including the addition of new cancer indications by adding more top cancer centers in China for DLBCL and ALL trials using our C-CAR011 product. As a reminder, each year China has approximately five million new cancer patients, which far surpasses the U.S. We are pleased with our CAR-T patient screening and trial enrollment progress thus far and are on track to share our topline clinical data in the fourth quarter of this year as it becomes available. We look forward to evaluating new interests in expanding our clinical development and CAR-T partnerships with leading hospitals in major cities in China."

2017 Business & Technology Highlights

In 2016, commenced patient enrollment in China for its CARD-1 ("CAR-T Against DLBCL") Phase I clinical trial utilizing CBMG’s optimized proprietary C-CAR011 construct of CD19 chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of patients with refractory Diffuse Large B-cell Lymphoma (DLBCL);
Announced addition of second clinical trial site for its Chimeric Antigen Receptor T-cell (CAR-T) Phase I Clinical Trial for its CARD-1 Trial in patients with refractory Diffuse Large B-cell Lymphoma (DLBCL) in Shanghai with Tongji Hospital;
Commenced CALL-1 ("CAR-T against Acute Lymphoblastic Leukemia") Phase I clinical trial in China utilizing its optimized proprietary C-CAR011 construct of CD19 chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of patients with relapsed or refractory (r/r) CD19+ B-cell Acute Lymphoblastic Leukemia (ALL);
Received the first disbursement of $1.2 million in the $2.29 million grant by California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, to support pre-clinical studies of AlloJoinTM, CBMG’s "Off-the-Shelf" Allogeneic Human Adipose-derived Mesenchymal Stem Cells for the treatment of Knee Osteoarthritis in the United States;
Completed expansion of its 30,000 square foot facility in Huishan High Tech Park in Wuxi, China, with 20,000 square feet of the Wuxi GMP facility dedicated to advanced stem cell culturing, centralized plasmid and viral vector production, cell banking and development of reagents;
Began construction of a new GMP facility in "Pharma Valley" in Shanghai Zhangjiang High-Tech Park, which will consist of 40,000 square feet dedicated to advanced cell manufacturing;
Established a strategic research collaboration with GE Healthcare Life Sciences China to co-develop certain high-quality industrial control processes in Chimeric Antigen Receptor T-cell (CAR-T) and stem cell manufacturing, and form a joint laboratory within CBMG’s new Shanghai Zhangjiang GMP-facility dedicated to the joint research and development of a functionally integrated and automated immunotherapy cell preparation system.

About PMBCL & FL
Primary mediastinal B-cell lymphoma (PMBCL) belongs to the group of aggressive diffuse large B-cell lymphomas. Its molecular signature and clinical features resemble classical Hodgkin lymphoma. It constitutes approximately 2 % to 4 % of all non-Hodgkin lymphomas (around 6 % of diffuse large B-cell lymphomas (DLBCL)).
Follicular lymphoma (FL) is the most common indolent (slow- growing) form of NHL, accounting for approximately 12 percent of all B-cell NHLs.

Advaxis Provides Phase 1 Data of Higher Dose Axalimogene Filolisbac

On May 15, 2017 Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing cancer immunotherapies, reported online a poster previously presented at the National Cancer Research Institute (NCRI) Cancer Conference in Liverpool that showed axalimogene filolisbac achieved durable response in a patient with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) (Press release, Advaxis, MAY 15, 2017, View Source [SID1234519112]).

Sharad Ghamande, MD, principal investigator and Professor and Director of Gynecologic Oncology at the Georgia Cancer Center at Augusta University, discussed cervical cancer and axalimogene filolisbac in detail recently on the JENNIE Show on the News Channel ABC 6, WJBF in Augusta, GA. Also, one patient in this phase 1 study experienced an ongoing and durable partial response, and this patient was recently featured in the Augusta Chronicle, as she is being treated by Dr. Ghamande at the Georgia Cancer Center at Augusta University. Read the full Augusta Chronicle article here.

Overall, nine patients who had documented disease progression after they had received curative treatments of chemotherapy and/or radiation with or without bevacizumab were enrolled in this phase 1, open-label, dose-determining study. Axalimogene filolisbac was well-tolerated across two dose levels. The study also established a recommended phase 2 dose of 1×1010 CFU and demonstrated antitumor activity at that dose. Axalimogene filolisbac was safely administered at 5 and 10 times the dose levels previously studied, without significant toxicity.

"The best overall tumor response in eight of the nine enrolled patients is encouraging in evaluating the potential of axalimogene filolisbac," said Dr. Ghamande. "We were pleased to see a sustained and durable partial response in one patient, which is very rare for this kind of tumor that is unresponsive to chemotherapy, and survival in these patients is often less than 10 months. In addition, we could safely administer the drug at 5 and 10 times the dose levels previously studied, without any significant toxicity."

There was only one instance of dose-limiting toxicity, with that patient experiencing a grade 3 treatment related adverse event (TRAE) of hypotension at a dose of 5×109 CFU. Across all doses, eight of nine patients experienced a grade 1-2 TRAE, including chills, nausea and hypotension.

The poster on the phase 1 data, "High-dose treatment with ADXS11-001, a Listeria monocytogenes-listeriolysin O (Lm-LLO) immunotherapy, in women with cervical cancer: a phase I, dose-escalation study" (no. 58) is available at www.advaxis.com. The company is preparing to initiate a phase 3 trial in PRmCC later this year.

About Axalimogene Filolisbac

Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack. In a phase 2 trial evaluating axalimogene filolisbac for the treatment of persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), the drug candidate showed a 12-month overall survival rate of 38 percent observed in 50 patients in the trial. This is a 52 percent improvement over the 12-month overall survival rate that was expected in the trial’s patient population based on prognostic factors.

Axalimogene filolisbac has received Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. The immunotherapy has also received orphan drug designation in three clinical indications.

First quarter 2017 report

On May 15, 2017 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported its revenues and cash position for the first three months of 2017 (Press release, Innate Pharma, MAY 15, 2017, View Source [SID1234519103]).

Cash, cash equivalents and financial assets of the Company amounted to €223.8 million* as of March 31, 2017. At the same date, financial liabilities amounted to €5.0 million.

Revenues for the first three months of 2017 amounted to €7.3 million (€5.7 million for the same period in 2016). This revenue results from the co-development and commercialization agreement with AstraZeneca, corresponding to the recognition over the period of the initial payment received in June 2015.

In 2016, revenue for the first three months also resulted mainly from the recognition over the period of the initial payment from the agreement with AstraZeneca.

At the beginning of 2017, Innate Pharma received a USD 15.0 million (€13.8 million) milestone payment from Bristol-Myers Squibb for the continued exploration of lirilumab in combination with Opdivo (nivolumab). This milestone has been recognized as revenue in its entirety in 2016 since the trigger event occurred in 2016.

Mondher Mahjoubi, Chief Executive Officer of Innate Pharma, commented: "During the first quarter of 2017, we were thrilled by the transition by Bristol-Myers Squibb of the combination of lirilumab with nivolumab to a randomized controlled cohort in squamous cell carcinoma of the head and neck, as part of a broad expansion of the trial in solid tumors. We look forward to potential further update at an upcoming scientific conference.

With a clear strategy for growth, encouraging progress across our clinical programs, a strong financial position and several near-to-medium term read-outs on the horizon, we are well placed to deliver shareholder value and