On Inspyr Therapeutics (OTCQB:NSPXD), a clinical-stage biotechnology company, and Lewis and Clark Pharmaceuticals, a privately-held biotechnology company, reported that they have entered into an agreement to create an integrated company with a proprietary platform driving a pipeline of novel therapeutics (Press release, Inspyr Therapeutics, MAY 30, 2017, View Source [SID1234520533]).

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Under this agreement, Inspyr will purchase Lewis and Clark in an all-stock transaction and will execute plans to leverage a team with significant experience to advance a broader pipeline of novel therapeutics. The boards of directors of both Inspyr and Lewis and Clark have unanimously approved the proposed agreement, which is subject to customary closing conditions as well as reaching a definitive agreement on all of the terms.

“By combining the strengths of each organization, we are creating an integrated biopharmaceutical company with a unique ability to potentially improve outcomes for patients in a variety of therapeutic areas. Our capabilities will span from the discovery of new molecules through clinical development and regulatory filings,” said Peter Grebow Ph.D., Chairman of Inspyr. “Over the last 12 months, we embarked on a path to unlock the potential of our lead therapy Mipsagargin, strengthen the management team and broaden the pipeline. We will now have proprietary platform technology, additional expertise and laboratory facilities, while also broadening the pipeline. We believe this transaction immediately creates a stronger company and longer term allows us to explore new options to generate additional value from this proprietary platform and pipeline of novel therapies.”

“Our proprietary platform has been validated with multiple therapies and we are eager to advance into IND-enabling studies,” said Robert Thompson, Ph.D., Founder and Chief Executive Officer of Lewis and Clark Pharmaceuticals. “We are excited to leverage the Inspyr team’s expertise in translational medicine and clinical development, in particular for oncology therapeutics, to accelerate our pipeline toward the clinic and unlock additional value from this technology.”

Inspyr will become an integrated biopharmaceutical company focused on advancing a broad pipeline of novel therapies to treat cancer, inflammation, and other serious diseases. Inspyr’s lead product candidate Mipsagargin, a novel prodrug therapeutic for cancer, is being developed initially for hepatocellular carcinoma (HCC), or liver cancer. Lewis and Clark’s pipeline of novel proprietary and potentially first-in-class adenosine receptor modulator based compounds are currently in advanced preclinical development as oncology or anti-inflammatory agents. For more information on the pipeline, please visit View Source

Key strategic benefits from creating an integrated company include:
• Novel proprietary technology platform. Lewis and Clark’s industry-leading proprietary technology platform is based on adenosine chemistry and biology. From this platform, Lewis and Clark has developed multiple adenosine receptor modulator based compounds that are advancing into studies to support planned Investigational New Drug (IND) applications. Inspyr intends to leverage this platform to explore future potential license opportunities.
• Broad pipeline of novel therapies for oncology and inflammation.

Lewis and Clark’s pipeline of novel proprietary therapies includes four lead programs: a dual A2A/A2B antagonist, an A2A antagonist, an A2B antagonist, and an A2A agonist. These therapies are highly potent and selective, with important molecular properties that enable enhanced distribution in tissue and penetration of human skin. These therapies are in advanced preclinical development.
The dual A2A/A2B antagonist has both immune function modulation and anti-angiogenic properties and thus has potential as an immuno-oncology and anti-angiogenic agent to treat multiple types of solid and hematological malignancies.
The A2A agonists offers the potential to treat inflammatory and autoimmune diseases as arthritis, Crohn’s disease, diabetic nephropathy, and psoriasis.
The A2B antagonist offers the potential to treat asthma, type 2 diabetes, atherosclerosis, and nonalcoholic fatty liver disease.
Inspyr’s lead therapy, Mipsagargin, currently is in development for the treatment of solid tumors.
– For liver cancer, Mipsagargin in combination with Nexavar is being evaluated in a preclinical study in liver tumor models that express different levels of PSMA, the target of Mipsagargin. Inspyr is finalizing the design of a clinical study to examine the potential benefits of Mipsagargin in combination with Nexavar in patients with advanced hepatocellular carcinoma (HCC), or liver cancer.
– For gastric cancer, Inspyr has initiated a preclinical study in gastric cancer tumor models that express different levels of PSMA. In this initial study, Mipsagargin will be evaluated first in combination with paclitaxel and in a subsequent study will be evaluated in combination with DC101 (Cyramza surrogate antibody).
– Utilizing Lewis and Clark’s wet laboratory facilities, Inspyr has the potential to internally develop additional pro-drugs targeting PSMA with different toxic payloads.

• Experienced leadership. Inspyr’s team has significant clinical development, translational medicine, and business operations experience in the biopharmaceutical industry. Lewis and Clark, which was founded by Robert Thompson, Ph.D, an industry-recognized leader in adenosine chemistry, has a team with significant expertise in preclinical development, toxicology, regulatory filings, adenosine receptor pharmacology, physiology, and molecular biology.

Pursuant to the terms of the transaction, Lewis and Clark Pharmaceuticals will become a wholly-owned subsidiary of Inspyr. Upon the closing of the transaction, existing Lewis and Clark stockholders are expected to own 50% of Inspyr’s common shares, on an as converted basis.

About Inspyr Therapeutics
Inspyr Therapeutics, Inc. develops therapies for cancer using a novel technology platform that combines a powerful therapeutic (thapsigargin) with a patented prodrug delivery system that targets the release of drugs within solid tumors. Mipsagargin, its lead drug candidate, has been studied in a Phase 2 clinical trial in patients with Nexavar-refractory hepatocellular carcinoma (HCC) and has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) in this indication. For additional information on Inspyr Therapeutics, visit www.inspyrtx.com.

About Lewis and Clark Pharmaceuticals
Lewis and Clark Pharmaceuticals is a privately-held biotechnology company developing novel proprietary compounds from an industry-leading technology platform based on adenosine chemistry and biology. In addition, Lewis and Clark maintains fully-equipped, state-of-the-art organic and analytical chemistry laboratories located in Charlottesville, Virginia. The Company’s chemists and toxicologist have expertise in chemical synthesis and analysis, non-clinical dose formulation and plasma concentration analysis, assay development, and toxicology.

On May 30, 2017 Intensity Therapeutics, Inc., a privately held biotechnology company developing proprietary cancer immunotherapy products, reported that the first patient successfully received treatment with the Company’s lead product, INT230-6, as part of a Phase 1/2 international clinical study (Press release, Intensity Therapeutics, MAY 30, 2017, View Source [SID1234519325]). Initiation of the study followed acceptance of an investigational new drug (IND) submission by the US Food and Drug Administration’s Division of Oncology Products 1 (DOP1) and receipt from Health Canada of a No Objection Letter following submission of a clinical trial application (CTA). The clinical trial, IT-01 (NCT#03058289), entitled A Phase 1/2 Safety Study of Intratumorally Administered INT230-6 in Adult Subjects with Advanced Refractory Cancers, aims to enroll approximately 60 patients with several different types of advanced solid tumors.

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"Bringing our novel product, INT230-6, into human testing is a major milestone for Intensity Therapeutics," commented President and CEO Lewis H. Bender. "Over the past few years our Company has demonstrated impressive tumor shrinkage in several murine models of cancers. INT230-6 eradicated large tumors, activated a systemic immune response and improved survival. Animals having a complete response acquired the capability to spontaneous clear re-challenges of the same cancer throughout the remainder of their lives, suggesting a protective effect similar to that of a vaccine. We are therefore excited to have initiated human testing. Our staff, investigators and clinical centers are enthusiastic about bringing patients our potentially lifesaving product."

This unique Phase 1/2 study will first assess the safety of INT230-6 in tumors treated at the skin surface (e.g. breast, melanoma, head-and-neck and lymphoma). Subsequent patients receiving INT230-6 will include those with deep tumors (e.g. liver, pancreatic, colon, lung and others). Investigators will utilize image guidance to inject the tumors. Additionally, a cohort is planned to explore INT230-6 in combination with anti-PD1 agents. The study’s primary goal is to demonstrate the safety of INT230-6. Secondary analyses will examine the efficacy of INT230-6 treatment via multiple parameters. The trial includes several adaptive components that will allow for adjustments in patient groups, dosing schedule and dose volumes administered.

"Our studies with INT230-6 have shown the ability to stimulate a strong T-cell response as a monotherapy. There is considerably enhanced activity using INT230-6 in combination with checkpoint inhibitors such as anti-PD-1 antibodies, while maintaining a favorable safety profile," said Chief Medical Officer Ian B. Walters, MD. "We are optimistic that our novel trial design can quickly detect evidence of direct tumor killing and immune system activation. Physicians
desperately need improved treatments for patients with advanced cancers that are not responding to approved immunotherapies. Intensity Therapeutics is grateful to the volunteers participating in our study and looks forward to collecting data on INT230-6 in different cancer types."

About INT230-6

INT230-6 is a novel, anti-cancer drug for direct intratumoral injection. The product contains potent anti-cancer agents that disperse throughout tumors and diffuse into cancer cells. INT230-6 was identified from Intensity’s DfuseRxSM platform and is being evaluated in a clinical trial; IT- 01. In preclinical studies INT230-6 administration eradicated tumors by a combination of direct tumor kill coupled with recruitment of dendritic cells to the tumor micro-environment that stimulated anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers.

About Study IT-01

IT-01 is entitled A Phase 1/2 Safety Study of Intratumorally Administered INT230-6 in Adult Subjects with Advanced Refractory Cancers. The trial aims to enroll approximately 60 patients with different types advanced solid tumor malignancies in a multicycle dosing regimen. The study will be conducted in multiple countries and includes a cohort combining INT230-6 with an anti-PD-1 antibody. Currently the study is recruiting in the U.S. at two hospitals associated with the University of Southern California (USC) and in Canada at the University Health Network (UHN) in Toronto. The principal investigator at USC is Dr. Anthony El-Khoueiry; the principal investigator at UHN is Dr. Lillian Siu. The study’s primary objective is to assess the safety and tolerability of multiple intratumoral doses of INT230-6. Secondary assessments are to understand preliminary efficacy of INT230-6 by measuring the injected and bystander tumor responses. The study will characterize the systemic pharmacokinetic profile of multiple doses of INT230-6’s drug substances after single and then multiple intratumoral injections. Exploratory analysis will characterize patient outcome, as well as evaluate various tumor and anti-tumor immune response biomarkers that may correlate with response. Data will be used to assess the progression free and overall survival in subjects receiving INT230-6. Further information can be found at www.clinicaltrials.gov (NCT#03058289).

On May 30, 2017 Selexis SA, a pioneering life sciences company and a global leader in mammalian cell line generation technology, reported that it has entered an agreement with an affiliate of Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the U.S. and Canada, to leverage the Selexis SUREtechnology Platform and SURE CHO-M (suspension-adapted CHO-K1) cell line to advance a Merck KGaA, Darmstadt, Germany immuno-oncology antibody program (Press release, Selexis, MAY 30, 2017, View Source [SID1234519324]).

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"It’s a testament to the value of our technologies that another major multinational pharmaceutical company has selected Selexis as a development partner. We are proud to enter an agreement with Merck KGaA, Darmstadt, Germany, a respected leader in the fields of oncology and immunology," said Igor Fisch, PhD, Selexis chairman and chief executive officer. "Our talented team offers a unique and innovative technology solution to our partners; a model that continues to be validated by the expansion of our collaborations across many biologics and vaccine development programs."
Selexis’ proprietary and high performance SUREtechnology Platform facilitates the rapid, stable, and cost-effective production of virtually any recombinant protein including those that are difficult to express in other systems. It also provides seamless integration of the biologics and vaccine development continuum, spanning discovery to commercialization.

"Our SUREtechnology Platform is a one of the most viable options that biopharmaceutical companies like Merck KGaA, Darmstadt, Germany choose for developing cell lines for production of antibodies that address unmet needs in immuno-oncology," said Marco Bocci, PhD, DPharm, Selexis vice president, licensing and business development. "We’re proud to offer this platform and other tools that can assist in bringing drugs to patients that otherwise may not have been possible to develop."

On May 30, 2017 HedgePath Pharmaceuticals, Inc. (OTCQX:HPPI), a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, reported the grant of a Type-C Guidance Meeting Request by the U.S. Food and Drug Administration (FDA) concerning further guidance from FDA for HPPI’s ongoing, open-label Phase 2(b) clinical trial studying the effect of SUBA-Itraconazole (SUBA-Cap) oral capsules in patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS), also known as Gorlin Syndrome (Press release, HedgePath Pharmaceuticals, MAY 30, 2017, View Source [SID1234519323]).

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Included in HPPI’s meeting request were summary data for 35 patients enrolled in the trial relating to reduction in target tumor burden, safety and time on study, along with specific questions to FDA regarding further steps necessary for completion of the study and reporting of final data. HPPI noted in its meeting request to FDA that all patients on SUBA-Cap therapy had some degree of measurable target tumor burden decrease with a median time on study of 32 weeks and a dropout rate of only 11%.
As a result of FDA granting HPPI’s meeting request, HPPI is required to file a complete background package for its Phase 2(b) trial results to FDA by mid-June 2017, and FDA has indicated its goal is to provide a written response to HPPI with further guidance before the end of July 2017.
Nicholas Virca, President and CEO of HPPI, stated that, "We reported to FDA that 37% of our patients in our Phase 2(b) trial have demonstrated an equal to or greater than 30% reduction in target tumor burden and there has been a complete disappearance of 28% of all target lesions across all subjects. We are testing SUBA-Cap therapy in BCCNS patients with a significant history of BCC surgeries and intend to further note in our background package that, for the 35 patients being dosed in our trial, the mean number of prior BCCs removed by surgery was 195 per patient, yet 97% of our study group have avoided surgery while on SUBA-Cap therapy. We are very pleased with these results and look forward to FDA’s feedback as we move towards the conclusion and reporting of the results of this trial."
While these data appear to be predictive of the desired final study results while HPPI seeks further guidance from FDA, readers are cautioned that no assurances can be given that (i) the final study results will match these latest results or (ii) the study when and if completed will achieve its primary and secondary endpoints or (iii) that the study will be found by FDA to be sufficient for the filing of a New Drug Application (NDA) or (iv) if an NDA is filed, that it will be approved by FDA. Further, HPPI is not committing to providing further interim updates prior to the reporting of the final study results.
About BCCNS
BCCNS results from a genetic mutation which causes the Hedgehog pathway (a major regulator of processes in cells) to function improperly, leading to the chronic formation of basal cell tumors, including potentially disfiguring lesions on the face. Industry sources estimate that there are approximately 10,000 patients in the United States with BCCNS, which has qualified SUBA-Itraconazole under the FDA’s Orphan Drug Designation Program.
About SUBA-Itraconazole
SUBA-Itraconazole is a patented and proprietary itraconazole formulation that enhances the absorption of itraconazole to improve the bioavailability of orally administered drugs that are poorly soluble. The U.S. rights to SUBA-Itraconazole for the treatment of cancer are exclusively licensed to HPPI by an affiliate of Mayne Pharma Group Limited. SUBA-Itraconazole was developed to improve absorption and significantly reduce variability compared to generic itraconazole. These benefits provide enhancements to patients and prescribers with reduced intra- and inter-patient variability, enabling a more predictable clinical response and a reduction in the active drug quantity to deliver the required therapeutic blood levels.

On May 30, 2017 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a leader in the development of novel therapies designed to activate a patient’s immune system against cancer, reported that it will present a poster from the Phase II trial evaluating HS-410 (vesigenurtacel-L) in combination with standard of care, Bacillus Calmette-Guérin (BCG), in the treatment of non-muscle invasive bladder cancer (NMIBC) at the 2017 ASCO (Free ASCO Whitepaper) (American Association of Clinical Oncologists) Annual Meeting at McCormick Place in Chicago, Illinois on Sunday, June 4th, 2017 (Press release, Heat Biologics, MAY 30, 2017, View Source [SID1234519321]).

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Poster Presentation Details

Title: Immune response results from vesigenurtacel-l (HS-410) in combination with BCG from a randomized phase 2 trial in patients with non-muscle invasive bladder cancer (NMIBC).
Date and Time: Sunday, June 4, 8:00 AM to 11:30 AM
Poster Number: 209