On May 31, 2018 Intensity Therapeutics, Inc., a privately held US biotechnology company developing proprietary immune cell-activating cancer treatments, reported that an abstract highlighting progress in the INT230-6 clinical development program will be presented as a poster at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 1-5 in Chicago (Press release, Intensity Therapeutics, MAY 31, 2018, View Source [SID1234526977]).

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"The abstract being presented at ASCO (Free ASCO Whitepaper) 2018 highlights the progress of our clinical program and the potential of INT230-6 as a medicine for multiple cancer types," said Lewis H. Bender, President and CEO of Intensity Therapeutics, Inc. "We are pleased to describe our current clinical study evaluating INT230-6 at this prestigious meeting, which to date has had no dose limiting toxicities following treatments to fourteen patients having nine different solid tumor types."

Details of the trials-in-progress abstract accepted for presentation at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting are below.

Abstract TPS2609: Phase 1/2 trial evaluating intratumoral administration of INT230-6 alone and in combination with an anti-PD1 antibody for advanced malignancies.

Presenter: Yada Kanjanapan, MBBS
Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Clinical Trial Registry Number: NCT03058289
Date/Time: June 4, 2018, 8:00 AM-11:30 AM
Location: Hall A; Poster Board Number: 428b

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 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. In mouse models the drug has shown strong synergy with checkpoint blockage including anti-PD-1 and anti-CTLA4 antibodies.

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 is currently recruiting in the U.S. and Canada with plans to open additional sites in multiple countries. The study’s primary objective is to assess the safety and tolerability of multiple intratumoral doses of INT230-6 with or without an anti-PD-1 or other checkpoint blockade antibodies. Secondary assessments are the measurement of injected and bystander tumor responses, and determination of 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).

On May 31, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that Michael Kauffman, MD, PhD, Chief Executive Officer, will participate in the following upcoming investor conferences (Press release, Karyopharm, MAY 31, 2018, View Source [SID1234526996]):

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The Jefferies 2018 Global Healthcare Conference on Thursday, June 7, 2018 at 8:30 a.m. ET.

The JMP Securities 2018 Life Sciences Conference on Wednesday, June 20, 2018 at 8:00 a.m. ET.
A live webcast of each of these events will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of each webcast will be archived on the Company’s website for 90 days following the presentation.

On May 31, 2018 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on our Probody therapeutic technology platform, reported it will present at the Jefferies 2018 Healthcare Conference. Sean McCarthy, D.Phil., president and chief executive officer will deliver a corporate overview on June 7, 2018, at 2:00 p.m. ET (Press release, CytomX Therapeutics, MAY 31, 2018, View Source [SID1234527014]).

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A live audio webcast of the presentation will be available through the Investors and News section of CytomX’s website. An archived replay will be available for 90 days following the event.

On May 31, 2018 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that company management will present at two investor conferences in June (Press release, Iovance Biotherapeutics, MAY 31, 2018, View Source;p=RssLanding&cat=news&id=2352504 [SID1234526978]):

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Jefferies 2018 Global Healthcare Conference in New York, NY on Thursday, June 7, 2018 at 9:00 a.m. ET

JMP Securities Life Sciences Conference in New York, NY on Wednesday, June 20, 2018 at 1:00 p.m. ET

A live audio webcast of both presentations will be available by visiting the Investors section of Iovance Biotherapeutics’ website at View Source A replay of the webcasts will be archived on Iovance Biotherapeutics’ website for 30 days following the presentations.

On May 31, 2018 MEI Pharma, Inc. (Nasdaq: MEIP), a pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer, and Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, reported that a planned interim analysis in the ongoing Phase 2 study of pracinostat and azacitidine in higher risk MDS patients successfully met a predefined patient retention threshold (Press release, MEI Pharma, MAY 31, 2018, View Source [SID1234526997]). The positive outcome supports continuation of the study.

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Importantly, only 10% of patients discontinued from the study due to adverse events in the first 3 cycles of therapy. The 10% rate is consistent with the established discontinuation rate for azacitidine given as a monotherapy, and it meets the predefined threshold to continue enrollment in the study. Based on the positive interim analysis announced today, Helsinn and MEI are expanding open-label enrollment to a total of up to 60 MDS patients. The goal of this expanded cohort is to gain an estimate of the response rate and overall survival in this patient population to better inform the design of a global registration study.

"Patients with higher risk MDS currently face limited treatment options and poor outcomes," stated Ehab Atallah, M.D., Study Chair, Associate Professor of Medicine, Medical College of Wisconsin. "Given the substantial need among this patient group, I am very encouraged by my experience to date in this study investigating pracinostat in combination with azacitidine. Frequently, higher risk MDS develops into AML. The potential to offer patients a novel combination therapy that is generally well tolerated with the prospect for improved outcomes in MDS and possibly AML is exciting."

The ongoing Phase 2 open-label study is evaluating a 45 mg dose of pracinostat in higher risk MDS patients in order to improve tolerability and retain patients in study longer than in an earlier Phase 2 study evaluating a 60 mg dose. A prolonged treatment may result in a systemic exposure to pracinostat sufficient to achieve the desired treatment effect, unlike in the earlier study.

The Phase 2 Study

The ongoing Phase 2 dose optimization study is investigating a 45 mg dose of pracinostat in combination with the standard dose of azacitidine in patients with high and very high-risk MDS who are previously untreated with hypomethylating agents. The high and very high-risk groups represent the highest unmet need in MDS, with median survival estimates of only 1.6 years and 0.8 years, respectively.

The pre-planned interim analysis of the study established a 10% discontinuation rate among the first 20 evaluable patients treated, beating a predefined threshold in the first 3 treatment cycles. Having met this threshold, the study is expanding open-label enrollment to 60 patients. Patients will be followed for one year to evaluate safety and efficacy. If the expanded open-label study is successful, the companies intend to initiate a global registration study. To date 29 patients have completed at least one cycle of therapy.

The primary endpoints of the study are 1) safety and tolerability and 2) overall response rate, defined as complete remission (CR), partial remission (PR) and marrow CR. Secondary endpoints include CR rate, overall hematologic improvement (HI) response rate, clinical benefit rate (defined as rate of CR + PR + HI + Marrow CR), rate of cytogenetic complete response/remission, duration of response, rate of leukemic transformation, event-free survival, progression-free survival and overall survival.

The study as initially designed included two stages: the completed first stage that met the predefined discontinuation rate threshold, and a randomized and placebo-controlled second stage triggered upon meeting the predefined discontinuation threshold in the first stage. The study design is being amended by substituting stage 2 with an expanded open-label portion of the study to obtain data intended to better inform the design of a registration study upon successful completion of the Phase 2 study.

About Higher Risk MDS

Higher risk MDS (high and very high risk in the IPSS-R classification) is a serious medical condition, with median survival of less than 18 months. The only curative therapy is allogeneic stem cell transplantation (SCT), however most patients with MDS are not candidates for SCT given their typically advanced age, comorbidities and lack of a suitable donor. Standard therapy with HMAs in higher risk MDS provides modest responses, though azacitidine has been shown to improve survival when compared to conventional care regimens. Patients who do not respond to HMAs or progress after therapy with HMAs have a very poor outcome, with a median survival of less than one year.

About Pracinostat

Pracinostat is an oral histone deacetylase ("HDAC") inhibitor that is in a pivotal Phase 3 study in combination with azacitidine for the treatment of adults with newly diagnosed acute myeloid leukemia ("AML") who are unfit for intensive chemotherapy. It is also being evaluated in a Phase 2 study in patients with high or very high-risk myelodysplastic syndrome ("MDS"). The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy.

In August 2016, Helsinn and MEI Pharma entered into an exclusive license, development and commercialization agreement for pracinostat in AML and other potential indications. The agreement provides that Helsinn is primarily responsible for development and commercialization costs for pracinostat in AML and other indications, including MDS. Pracinostat is an investigational agent and is not approved for commercial use in the U.S. and any country worldwide.