Dr. Mark A. Goldberg recently served as president and COO of PAREXEL International, one of the world’s largest global biopharmaceutical service providers, with consolidated service revenue of approximately $2.1B, over 18,000 employees, and 86 locations in 51 countries. He was responsible for overseeing all revenue generating business segments including Clinical Research Services, PAREXEL Informatics, and PAREXEL Consulting as well as sales, marketing, corporate quality, and information technology. Dr. Goldberg helped to pioneer PAREXEL’s strategic partnering approach with some of the world’s leading pharmaceutical companies and to build out the company’s global infrastructure, particularly in the Asia Pacific region, through both organic growth and acquisitions. Earlier in his PAREXEL career, he founded the company’s medical imaging business and helped establish its technology subsidiary, Perceptive Informatics (now PAREXEL Informatics). Dr. Goldberg holds a BS degree in computer science from MIT and an MD from the University of Massachusetts Medical School. He completed residency training in radiology at Massachusetts General Hospital, where he also served as chief resident and a staff physician with academic appointments at Harvard Medical School.
“We are very pleased to welcome Mark to our board,” said Intensity Therapeutics’ President and CEO Lewis H. Bender. “Intensity will benefit greatly from his broad industry knowledge, operational experience, and medical imaging expertise. We look forward to the contributions and insights Mark will offer the Company as we continue the clinical development of our lead product, INT230-6, grow our business and advance through the regulatory process.”
“I am delighted to be joining the Board of Intensity Therapeutics,” said Dr. Mark A. Goldberg. “The data generated to date in the clinical study IT-01 for the Company’s lead anti-cancer product is encouraging. The potential to attenuate tumors and activate the immune system offers exciting possibilities. I look forward to working with the Company and the other Board members to help advance this promising new cancer treatment approach.”
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 induced 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. and in Canada. 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. The trial includes several adaptive components that will allow for adjustments in patient groups, dosing schedule and dose volumes administered. 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).
About Intensity Therapeutics, Inc.
Intensity Therapeutics, Inc. is a clinical-stage biotechnology company whose mission is to greatly extend the lives of patients with cancer. Intensity Therapeutics is pioneering a new immune-based approach to treat cancer. The Company uses its DfuseRxSM platform technology to create new drug formulations that following direct injection rapidly disperse throughout a tumor and diffuse therapeutic agents into cancer cells. Drug products created using the technology are capable of attenuating (killing) a tumor in a manner that allows for the adaptive immune system to recognize the cancer and attack distal tumors and micrometastases. Further information can be found at www.intensitytherapeutics.com.
This press release contains forward-looking statements regarding Intensity Therapeutics’ plans, future operations and objectives. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual performance or achievements to be materially different from those currently anticipated. These forward-looking statements include, among other things, statements about the initiation and timing of future clinical trials.