On February 10, 2016 BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing innovative therapeutics called ACCURINS, report the publication of data highlighting the ability of ACCURIN polymeric nanoparticle technology to utilize hydrophobic ion pairing and improve the therapeutic index of a molecularly targeted anti-cancer drug (Press release, BIND Therapeutics, FEB 10, 2016, View Source [SID:1234509031]).

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Previous efforts with nanotechnology have focused almost exclusively on encapsulating chemotherapy payloads; the publication describes one of the first efforts to apply nanotechnology to a molecular targeted agent. Results highlight the potential for ACCURINS to control release kinetics and provide increased concentration of an aurora B kinase inhibitor, AZD2811, at tumor sites resulting in prolonged pharmacodynamic effects, superior tumor growth inhibition and a reduction in on-target but off-tissue toxicity. These data were published in the February 10, 2016 issue of Science Translational Medicine.

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"These data demonstrate the potential to extend the benefits of our ACCURIN platform beyond chemotherapy payloads to kinase inhibitors, which are a rapidly growing component of the armamentarium against cancer," said Jonathan Yingling, Ph.D., chief scientific officer at BIND Therapeutics. "The data in this publication illustrate that ACCURINS are able to entrap and control the release rate of payloads with wide ranging physicochemical properties, including molecules with ionizable functional groups, which enables our platform to generate more novel and innovative medicines beyond targeted chemotherapies. There are multiple oncogenic pathways that have proven difficult to target with conventional approaches and that we believe the targeted and modular nature of ACCURIN nanomedicines are well suited to address."

In the paper entitled, "Aurora kinase inhibitor nanoparticles target tumors with favorable therapeutic index in vivo," researchers demonstrated the accumulation and retention of a specific AZD2811 nanoparticle formulation in tumors, resulting in an extended reduction of tumor phosphorylated histone H3 levels in vivo for up to 96 hours following a single administration with minimal impact on bone marrow pathology. This formulation also demonstrated continuous drug release for more than one week in vitro, and displayed lower toxicity and increased efficacy in multiple tumor models at half the dose intensity of a water-soluble prodrug of AZD2811. These preclinical studies using ion pairing agents with AZD2811 and ACCURIN technology suggested improved tolerability as well as less frequent dosing.

"Data from this paper support the recent initiation of the phase 1 trial with AZD2811, the first nanoparticle that encapsulates a molecularly targeted drug to enter the clinic," said Andrew Hirsch, BIND’s president and chief executive officer. "The novel patented hydrophobic ion pairing approach that we developed partially through our collaboration with AstraZeneca demonstrates an important benefit of our collaboration strategy. This new approach has significantly expanded the number of payloads that are compatible with our ACCURIN platform and is enabling us to explore new applications of our ACCURIN technology such as extra-hepatic delivery of oligonucleotide-based therapeutics, targeted antibiotics, and novel immuno-oncology approaches."

On February 10, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported trial evaluating HS-410 either alone or in combination with standard of care Bacillus Calmette-Guérin (BCG), for the treatment of non-muscle invasive bladder cancer (NMIBC) (Press release, Heat Biologics, FEB 10, 2016, View Source [SID:1234509028]). Heat will resume patient enrollment.

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"We appreciate the FDA’s expedited review and resolution of this matter as we resume enrollment in our Phase 2 monotherapy trial arm. We are encouraged by the positive results reported to-date and believe HS-410 represents a potential treatment option for patients suffering with non-muscle invasive bladder cancer," said Jeff Wolf, Heat’s Founder and Chief Executive Officer. "Our clinical timelines remain materially unchanged with topline data expected in the fourth quarter of 2016 for the Phase 2 randomized trial arms evaluating HS-410 in combination with BCG. We are grateful for the ongoing support of the patients and their physicians participating in our clinical trial."

About HS-410 (vesigenurtacel-L)

HS-410 is an investigational product candidate for NMIBC based on Heat’s proprietary ImPACT immunotherapy platform, designed to generate CD8+ "killer" T cells that attack cancer cells. HS-410 is currently being evaluated in a Phase 2, placebo-controlled, 100-patient NMIBC trial at multiple centers and has been granted U.S. FDA Fast Track Designation for the treatment of NMIBC.

On February 10, 2016 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it received a recommendation by an independent data monitoring committee (IDMC) that the J-ALEX Study, a phase III study targeting ALK fusion gene positive non-small cell lung cancer (NSCLC) being conducted in Japan, should be stopped early as the study met its primary endpoint at a pre-planned interim analysis (Press release, Chugai, FEB 10, 2016, View Source [SID:1234509020]).

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The study showed that patients lived significantly longer without disease worsening (progression-free survival, PFS) when treated with Alecensa compared to crizotinib.

The J-ALEX study is an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 patients with ALK fusion gene positive advanced or recurrent NSCLC who either had not undergone chemotherapy or had undergone one chemotherapy regimen. The subjects were allocated to the Alecensa group or the crizotinib group in a one to one ratio.

Chugai carried out a prospectively defined interim analysis of the J-ALEX study, and had an IDMC examine the results. Since the results showed that Alecensa significantly prolonged the PFS to a higher extent than anticipated, the committee decided to recommend an early discontinuation of the study, as described above. The safety issues of Alecensa have not been pointed out.
The data of the J-ALEX study will be presented at a future medical meeting, etc.

"The fact that the J-ALEX study received a recommendation by an IDMC to be stopped early due to positive effects is great news, and a blessing for the patients who are involved in the study." said Chugai’s Director and Executive Vice President, Dr. Yutaka Tanaka. "We are extremely happy that these results can offer hope and encouragement to patients in need to be treated with Alecensa."

As a top pharmaceutical company in the field of oncology in Japan, Chugai believes that early treatment using Alecensa in ALK fusion gene positive NSCLC is expected not only to prolong these patients’ PFS, but also enable them to face their disease with a positive hope for the future.