1stOncology™: Cancer Intelligence Service – Page 17757 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

BIND Therapeutics Reports Third Quarter 2015 Financial Results and Provides Corporate Update

On November 2, 2015 BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called AccurinsTM, reported financial results and business highlights for the third quarter ended September 30, 2015 (Press release, BIND Therapeutics, NOV 2, 2015, View Source [SID:1234507868]). Management will host a conference call today at 8:30 a.m. ET to provide a business update and review the Company’s third quarter financial results.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"This was an important quarter for BIND as we made significant progress with our proprietary pipeline, collaboration programs and research initiatives that have the potential to lead to breakthrough therapies," said Andrew Hirsch, president and chief executive officer at BIND Therapeutics. "Interim phase 2 data is forthcoming on our lead product BIND-014 in two studies across six tumor types with limited treatment options, starting with a readout by the end of 2015 in KRAS mutant and squamous histology non-small cell lung cancers. In addition, Pfizer exercised an option in our collaboration to move a kinase inhibitor towards clinical development and we expect our collaboration with AstraZeneca to result in a second Accurin to enter the clinic in the fourth quarter. We have also made tremendous progress in developing Accurins to target diseased immune cells, infectious disease, and to deliver oligonucleotides. Collectively, we are now positioned to potentially have at least four Accurins in clinical development within the next two years."

Recent Pipeline/Business Highlights:

Appointed Dr. Arthur Tzianabos, current president and chief scientific officer at OvaScience, to the Board of Directors.
Received notification from Pfizer that it would exercise its option to obtain an exclusive license to develop and commercialize an Accurin drug candidate for the treatment of solid tumors under the companies’ global collaboration agreement. BIND expects to receive the $2.5 million option fee in the fourth quarter of 2015.

Dosed the first patient in the iNSITE 2 trial in patients with four tumor histologies, each affecting fewer than 200,000 patients in the U.S.: cholangiocarcinoma, advanced cervical cancer, advanced bladder cancer, and advanced squamous cancer of the head and neck.

Completed build out of dedicated manufacturing space, through an arrangement with a large contract manufacturing organization, that is capable of producing Accurins at the double-digit kilogram scale.

Continued preclinical work in collaboration with Macrophage Therapeutics, completing derivatization of the Manocept targeting agent and producing multiple versions of Manocept-targeted Accurins for in vivo testing.
Continued preclinical work, and generated promising initial data, on Accurin versions of anti-infective and oligonucleotide-based therapies.
Anticipated upcoming milestones and activities include:

Dose the first patient in the phase 1 trial of AZD2811 with collaborator AstraZeneca. BIND expects to receive the $4.0 million milestone payment in the fourth quarter of 2015.

Present preclinical and clinical pharmacokinetic data from BIND’s clinical stage Accurin BIND-014, data from BIND’s preclinical stage Accurin BIND-510, and new data from a previously unannounced feasibility study with an Accurin formulation of Merck’s AKT inhibitor, MK-2206, at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper).
Report initial data from the first stage of the iNSITE 1 trial in KRAS mutant or squamous histology non-small cell lung cancer in the fourth quarter of 2015.

Report the results of ongoing proof-of-concept work with Macrophage Therapeutics before year-end.

Report overall survival data from the completed phase 2 non-small cell lung cancer study with BIND-014 in the broader patient population following occurrence of all survival events.

Report final results from the phase 2 prostate cancer study with BIND-014 following occurrence of 75 percent of the survival events.

Report initial stage 1 data readout from iNSITE 2 trial in the first half of 2016.
Initiate in vivo studies with Accurin containing an antibiotic that targets gram negative bacteria.
Initiate in vitro and in vivo studies aimed at characterizing the ability of Accurins to impact PK, biodistribution, cellular uptake and gene silencing activity of oligonucleotide drugs.

Third Quarter 2015 Financial Results
Revenue for the third quarter of 2015 was $2.1 million, compared to $3.4 million in the third quarter of 2014. Revenues are primarily related to collaborations with AstraZeneca, Pfizer and Roche. The decrease in 2015 third quarter revenue compared to 2014 third quarter revenue was primarily due to lower revenue recognized from the up-front license fee from the AstraZeneca collaboration. The Company uses a proportional performance model to recognize revenue related to the up-front license fees, milestones, option exercise fee, and research and development services. Revenue is recognized over estimated performance obligations over time – at times much later than when cash is received.

Research and development expenses totaled $9.7 million for the third quarter of 2015, compared to $7.1 million for the third quarter of 2014. The increase in research and development expenses was primarily driven by higher manufacturing and related expenses as we scaled up and completed the clinical manufacturing batch needed for Accurin AZD2811, as well as greater compensation expense to support the development of BIND’s internal pipeline and collaborations.

General and administrative expenses totaled $3.9 million for the third quarter of 2015, which was essentially flat when compared to the third quarter of 2014.

Net loss for the third quarter of 2015 was $10.2 million, compared to a net loss of $7.3 million for the third quarter of 2014.

Cash, cash equivalents and short-term investments were approximately $41 million as of September 30, 2015. Including the $2.5 million Pfizer option exercise fee and the anticipated R&D reimbursement for the next stage of the Pfizer collaboration, the Company expects that its cash, cash equivalents and short-term investments will fund operating expense and capital expenditure requirements into the fourth quarter of 2016. This expectation is based on BIND’s current operating plans and research and development funding that it expects to receive under its existing collaborations, but excludes any potential milestone payments under its collaboration agreements.

We expect to earn a $4.0 million milestone from AstraZeneca during the fourth quarter of 2015 for the first patient in a phase 1 trial for Accurin AZD2811. We only include milestones in our cash guidance once they are achieved.

ViroGin Biotech Announces Collaboration with Johnson & Johnson Innovation to Further Development of Oncolytic Therapeutics

On November 2, 2015 ViroGin Biotech Ltd (ViroGin), an early stage biotech research company, reported a collaboration agreement with Johnson & Johnson Innovation and Janssen Biotech, Inc. ("Janssen") to further the development of ViroGin’s novel oncolytic therapeutics for the treatment of cancer (Press release, Virogin Biotech, NOV 2, 2015, View Source [SID1234518863]).

The collaboration agreement will leverage the resources of Johnson & Johnson Innovation, including scientific experts, to continue the development of ViroGin’s technology.

Dr. William Jia, CSO of ViroGin said, "Our team has been developing oncolytic virotherapy since the 90s, including many years of study in Canada and the first oncolytic virotherapy clinical trial in China. Now, through our collaboration with Johnson & Johnson Innovation, we can leverage their global resources and scientific expertise to work together in China, the US, Canada, and leverage resources from across the world to continue the development of our unique technology. We are very excited to be working with Johnson & Johnson Innovation on oncolytic therapeutics and look forward to further development."
About ViroGin Biotech Ltd
ViroGin Biotech Ltd is a start-up company formed by a team of scientists with expertise of molecular virology and immunology. The company is located in Vancouver, Canada and Shenzhen, China. ViroGin Biotech is set to develop anti-cancer biological drugs using their novel platform of oncolytic viruses armed with multi-antitumour mechanisms.

Sanofi and BioNTech Announce Cancer Immunotherapy Collaboration and License Agreement

On November 3, 2015 Sanofi and BioNTech A.G. reported that they have entered into a multiyear exclusive collaboration and license agreement (Press release, Sanofi, NOV 2, 2015, View Source [SID:1234507892]). This research collaboration between Sanofi and BioNTech will leverage the scientific expertise of the two organizations to discover and develop up to five cancer immunotherapies, each consisting of a mixture of synthetic messenger RNAs (mRNAs).

Sanofi and BioNTech have agreed to $60 million in upfront and near-term milestone payments, payable to BioNTech under the terms of the agreement. Further, BioNTech could receive over $300 million in development, regulatory and commercial milestones and other payments per product. If commercialized successfully, BioNTech would also be eligible for tiered royalties on net sales up to double digits. In addition, BioNTech has the option to co-develop and co-commercialize two of the five mRNA therapeutics products with Sanofi in the European Union and the United States.

Complementing Sanofi’s global oncology footprint and scientific expertise, BioNTech will combine the use of its proprietary mRNA technology platform with its extensive capabilities in developing immune-stimulating pharmaceuticals. As part of this effort, BioNTech will utilize its mRNA formulation technology, which enables targeted mRNA delivery in vivo, to generate novel cancer immunotherapies. BioNTech will also supply part of the mRNA material needed for development activities from its in-house GMP manufacturing unit.

"Immunotherapy has shown promise as an avenue to develop potentially curative treatments for people with cancer, and Sanofi has strategically launched a number of inter-company collaborations in this area in recent months," said Elias Zerhouni, President, Global R&D at Sanofi. "Our collaboration with BioNTech has the potential to lay the foundation for a unique therapeutic modality in immuno-oncology."

"The collaboration with Sanofi is groundbreaking: through using our broad suite of mRNA technologies and extensive tumor immunology understanding, it will allow us to develop a completely new class of cancer immune-therapeutics with Sanofi, which we believe will have a profound and deep impact on the treatment of cancer," said Ugur Sahin, CEO of BioNTech. "This alliance is in line with our strategy to collaborate with companies that share our passion and drive to develop and commercialize truly innovative and disruptive immunotherapies for the treatment of cancer."

Boehringer Ingelheim initiates pivotal programme for novel third-generation EGFR targeting lung cancer compound

November 3, 2015 Boehringer Ingelheim reported at the BIO-Europe conference in Munich, Germany, the initiation of a global Phase II trial evaluating the efficacy and safety of BI 1482694 (HM61713) in patients with T790M mutation-positive non-small cell lung cancer (NSCLC), whose tumours stopped responding to currently available epidermal growth factor receptor (EGFR) directed therapies (Press release, Boehringer Ingelheim, NOV 3, 2015, View Source [SID:1234507889]). The primary endpoint of this trial, which is the first in a broad clinical development programme for BI 1482694, is objective response rate (ORR).

Coordinating investigator Professor Keunchil Park, Division of Hematology & Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, South Korea commented, "Third-generation EGFR TKIs, which were developed to overcome the most frequent resistance mechanism to available first- and second-generation compounds, could become an important addition to our armamentarium against EGFR-mutant lung cancer. In this patient population with T790M we are now able to investigate a follow-on targeted therapy and potentially further delay the use of burdensome chemotherapy regimens."

BI 1482694 is a novel, third-generation, oral, irreversible EGFR mutant-specific tyrosine kinase inhibitor (TKI) developed to specifically target tumours with T790M mutations. At this year’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, interim results of the Phase I/II clinical trial indicated strong efficacy signals in patients with such tumours, combined with a favourable safety profile.1 The T790M mutation is known as the most common resistance mechanism to develop in response to treatment with EGFR TKIs. It is found in approximately 50-60% of patients who previously received EGFR TKI therapy. There are currently no EGFR-directed therapies approved specifically for the treatment of this mutation, representing an area of great unmet need for these patients.

Boehringer Ingelheim has a strong presence in the field of EGFR mutated lung cancer with the approved GIOTRIF/GILOTRIF (afatinib*). Results from two large trials (LUX-Lung 3 and LUX-Lung 6) independently showed a significant improvement in the secondary endpoint of overall survival for the subgroup of patients with the most common EGFR mutation (del19) for this EGFR directed agent compared to chemotherapy. The most common adverse events were associated with mechanistic effects of EGFR inhibition and were generally predictable, manageable and reversible.2 VARGATEF (nintedanib**), a triple angiokinase inhibitor is approved for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. Further lung cancer compounds from Boehringer Ingelheim’s pipeline are in different stages of development and, together with BI 1482694, Boehringer Ingelheim remains committed to continuing to advance lung cancer therapy. The aim is to achieve first market authorisation for BI 1482694, in this patient population, by 2017.

Dr Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented, "We are investing strongly in our lung cancer pipeline, and together with the oncology community we aim to develop better treatment options for these patients. The addition of BI 1482694 to Boehringer Ingelheim’s lung cancer portfolio further underscores our commitment to patients with cancer. The initiation of the first pivotal trial of BI 1482694 is an important milestone in the forthcoming broad clinical trial programme, including several Phase III trials."

Advaxis Provides Additional Information on Clinical Hold

On November 02, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported additional information about the clinical hold issued by the U.S. Food and Drug Administration (FDA) on the Company’s Investigational New Drug (IND) application for axalimogene filolisbac (Press release, Advaxis, NOV 2, 2015, View Source [SID:1234507885]). Since announcing the verbal notification of the clinical hold of axalimogene filolisbac, Advaxis has received written notification from the FDA of the clinical hold.

Since early October, Advaxis has been in an ongoing dialogue with the FDA. Over the course of these discussions, the FDA has identified certain risk mitigation measures for implementation once the hold is lifted. The Agency requested proposals from the Company regarding such measures. The Company promptly provided its recommendations, including appropriate patient inclusion / exclusion criteria, as well as certain patient surveillance and monitoring measures.

Further, the FDA has concurred with the Investigator’s assessment that the patient’s cause of death, in the safety report triggering the clinical hold, was due to cervical cancer progression. While no additional safety concerns have been identified by the Agency, it also verbally notified the Company that the clinical hold included the INDs for ADXS-PSA and ADXS-HER2 so that their evaluation, and any mitigation measures, could be simultaneously applied to all product candidates.

Advaxis is continuing to work with the FDA to facilitate review and resolution of this matter. The Company expects that the clinical hold will be resolved without significant interruption to its clinical development programs.

About Axalimogene Filolisbac
Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology.

About ADXS-PSA
ADXS-PSA is an Lm Technology immunotherapy under investigation for targeting the prostate-specific antigen (PSA) associated with prostate cancer. ADXS-PSA is in clinical development both as a monotherapy and in combination with immune checkpoint inhibitors for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

About ADXS-HER2
ADXS-HER2 is an Lm Technology immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.