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Intensity Therapeutics, Inc. Successfully Administers INT230-6 to First Patient in a Phase 1/2 Trial

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).

Merck KGaA, Darmstadt, Germany Licenses Selexis SUREtechnology Platform for Immuno-Oncology Antibody Program

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]).

"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."

HedgePath Pharmaceuticals Announces Granting of Type-C Meeting Request by FDA and Provides Positive Clinical Trial Update

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]).

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.

Heat Biologics to Present Poster at 2017 ASCO Annual Meeting

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]).

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

Dr. Razelle Kurzrock to Present Novel Biomarker Findings from XBiotech Phase III Colorectal Cancer Study Data at the 19th European Society for Medical Oncology World Congress on Gastrointestinal Cancer

On May 30, 2017 XBiotech Inc. (NASDAQ:XBIT) reported an upcoming presentation of findings on key biomarker analysis of colorectal cancer patients treated with Hutruo (MABp1) in its European Phase III study (Press release, XBiotech, MAY 30, 2017, View Source [SID1234519319]).

The abstract, entitled, "Pre-treatment Endogenous Interleukin-1 Receptor Antagonist (IL-1Ra) Levels in Metastatic Colorectal Cancer (mCRC) Patients are Associated with Clinical Outcomes After Anti-Interleukin-1a Therapy (MABp1)", will be presented by renowned oncologist, Dr. Razelle Kurzrock, Chief of Hematology & Oncology, UC San Diego School of Medicine. The data will be presented via poster presentation on Friday, June 30th from 10:30-11am and 4:40-5:10pm at the 19th ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer in Barcelona, Spain.

These findings indicate a significant association between pre-treatment circulating levels of IL-1Ra and responsiveness to MABp1 therapy. Lower pre-existing IL-1 antagonist activity was relatively responsive to pharmacological intervention with anti-IL-1α antibody therapy. This analysis provides new evidence that regulators of innate immunity may exert selection pressure on tumors and play an active role in the natural history of colorectal cancer. The impact of the body’s control of innate inflammation is thus found to affect the use of immune modulating therapy.

"Our analysis show a significant association between pre-treatment circulating levels of IL-1Ra and responsiveness to MABp1 therapy," stated Dr. Kurzrock. She further stated, "These results provide new insight on the active role for interleukin-1 regulation in disease progression in colorectal cancer and could help us create more personalized approaches to treatment of the disease."

About Razelle Kurzrock, M.D.
Dr. Kurzrock is a medical oncologist and a renowned expert in precision medicine. She is a thought leader in the use of anti-cytokine therapies for the treatment of cancer and one of the first to recognize the importance of the interleukin-1 pathway in cancer. While at the University of Texas MD Anderson Cancer Center, Dr. Kurzrock built one of the most successful Phase 1 clinical trials programs in the nation, and was the senior author in the pioneering study for the Company’s colorectal cancer study. Dr. Kurzrock currently serves as Senior Deputy Center Director for Clinical Science, Director at the Center for Personalized Cancer Therapy, Director of the Clinical Trials Office, and a Team Leader for Experimental Therapeutics at the Moores Cancer Center at UC San Diego. Dr. Kurzrock is also Chief of the Hematology & Oncology Division in the UC San Diego School of Medicine. Dr. Kurzrock serves on XBiotech’s Scientific Advisory Board.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.