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MATEON THERAPEUTICS RECEIVES NOTICE OF PARTIAL CLINICAL HOLD FOR OX1222 STUDY

On August 17, 2018 Mateon Therapeutics, Inc. (OTCQB:MATN), a biopharmaceutical company developing investigational drugs for the treatment of orphan oncology indications, reported that the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on Study OX1222 during a telephone conversation held with the Company on August 16, 2018 (Press release, Mateon Therapeutics, AUG 17, 2018, View Source [SID1234528963]). OX1222 is the Company’s clinical trial of OXi4503 in combination with cytarabine for the treatment of relapsed/refractory acute myeloid leukemia and myelodysplastic syndromes. The partial clinical hold applies to the 12.2 mg/m2 dose of OXi4503. The FDA is allowing the study to continue to treat and enroll patients using a dose of 9.76 mg/m2 of OXi4503, which the Company previously tested in cohort 5 of Study OX1222.

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The partial clinical hold follows two potential dose-limiting toxicities (DLTs) observed at the 12.2 mg/m2 dose level that was being evaluated in cohort 6 of Study OX1222. These DLTs consist of one patient experiencing hypotension shortly following initial treatment with OXi4503, and another patient experiencing acute hypoxic respiratory failure approximately two weeks after receiving OXi4503 and cytarabine. Both events were deemed "possibly-related" to OXi4503, and both patients recovered following treatment. The protocol for Study OX1222 generally defines a DLT as any grade 3 serious adverse event (SAE) where a relationship to OXi4503 cannot be ruled out. The FDA has indicated that additional data on patients receiving 9.76 mg/m2 of OXi4503 must be evaluated before the Company resumes dosing at 12.2 mg/m2.

"Although it is disappointing that we are not currently continuing with the higher dose of OXi4503, we look forward to gathering more safety and efficacy data at the previous dose level, where we observed two complete remissions in the four patients that we treated," said William D. Schwieterman, M.D., Chief Executive Officer of Mateon.

ENDOCYTE ANNOUNCES PRESENTATIONS AT THE AMERICAN CHEMICAL SOCIETY (ACS) NATIONAL MEETING & EXPOSITION

On August 17, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported that two posters will be presented by Endocyte scientists at the ACS National Meeting & Exposition being held in Boston, MA from Aug. 19 – 23, 2018 (Press release, Endocyte, AUG 17, 2018, View Source [SID1234528962]).

Presentations are as follows:

Abstract # MEDI 425
Title: Pro-Pyrrolobenzodiazepine (pro-PBD) bioconjugates, part 3: Design and synthesis of pro-PBD conjugates containing a self-immolative substituted disulfide linkers
When: August 22, 2018, from 7:00 pm to 9:00 pm
Session ID: General Poster Session
Location: Galleria, Westin Boston Waterfront

Abstract # MEDI 426
Title: Pro-Pyrrolobenzodiazepine (pro-PBD) bioconjugates, part 4: Design of novel oxime-based pro-PBD conjugates that release active drug via intramolecular diazepine-ring-closure
When: August 22, 2018, from 7:00 pm to 9:00 pm.
Session ID: General Poster Session
Location: Galleria, Westin Boston Waterfront

Website Information

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

Immatics Initiates Second Phase I Clinical Trial of its Unique ACTengine® Platform in Patients with Advanced Solid Cancers

On August 16, 2018 Immatics, a leading company in the field of cancer immunotherapy, reported that it has initiated enrollment of patients into a phase I trial of IMA202, its second T-cell Receptor (TCR)-transduced adoptive cell therapy program. IMA202 is an investigational immunotherapy which uses Immatics’ proprietary ACTengine approach and is based on genetic engineering of the patient’s own T cells to express an exogenous TCR (Press release, Immatics Biotechnologies, AUG 16, 2018, View Source [SID1234569550]). The goal is to redirect and activate the T cells to treat solid tumors. The single-center clinical study is now open for enrollment at The University of Texas MD Anderson Cancer Center in Houston, Texas.

The study (IMA202-101) will include approximately 12 patients with relapsed and/or refractory solid tumors, including but not limited to advanced non-small cell lung cancer and hepatocellular carcinoma, for which no standard of care therapy is available.

Immatics’ ACTengine approach engineers the patients’ own T lymphocytes (a type of white blood cell) to express a novel, exogenous T-cell receptor (TCR) which is targeted to a site on the tumor identified by Immatics’ proprietary XPRESIDENT target discovery platform. ACTengine combines several innovative features:

TCRs specifically recognizing the XPRESIDENT-identified target are selected via Immatics’ proprietary high-throughput TCR discovery platform from the natural, human T-cell repertoire. The TCR used in this trial has been selected for highest specificity from more than one hundred TCRs using Immatics’ XPRESIDENT-guided on- and off-target toxicity screening.
The novel TCR recognizes its target with optimal affinity for an adoptive cellular therapy (ACT) approach.
The TCR-transduced T cells are activated and multiplied outside the body before being infused into the patient.
Patients are eligible for ACTengine cell therapy if the target of interest is present on the patient’s tumor as demonstrated by biomarker profiling.
The primary objective of the study is to evaluate the safety and tolerability of the ACTengine approach, and specifically IMA202, in target-positive solid cancer patients. The secondary objectives include the evaluation of feasibility, the persistence of T cells in vivo, and the assessment of anti-tumor activity and biomarkers. The IMA202 phase I trial will be conducted by the Department of Thoracic Oncology, the Department of Gastrointestinal Medical Oncology and the Department of Investigational Cancer Therapeutics at MD Anderson Cancer Center in Houston, Texas.

Stephen L. Eck, M.D., Ph.D., Chief Medical Officer of Immatics US, commented: "Regulatory approval to start our second clinical study in our ACTengine-based cell therapy program is a significant step for Immatics. This study exemplifies Immatics’ XPRESIDENT target discovery capability and TCR discovery pipeline which are industry-leading cancer immunotherapy platforms. We are very excited to combine these capabilities in a trial led by the world-class investigators from MD Anderson Cancer Center in order to develop exciting new treatment options for cancer patients."

Mirati Therapeutics Announces Presentation Of KRAS G12C Chemistry Advances At The 255th American Chemical Society (ACS) National Meeting And Exposition

On August 16, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, reported that a KRAS G12C poster will be presented by scientists from Mirati and Array BioPharma at the 255thAmerican Chemical Society (ACS) National Meeting & Exposition being held in Boston, MA, August 19-23, 2018 (Press release, Mirati, AUG 16, 2018, View Source [SID1234529038]). The poster will focus on the discovery and preclinical characterization of covalent inhibitors of KRAS G12C that have demonstrated potent pathway inhibition in cells and efficacy in tumor xenograft models.

"We are looking forward to the first public presentation of our orally-active series of covalent inhibitors of KRAS G12C. We will describe the identification of novel lead matter and the structure-based approach that led to increases in potency. Further, we will present in vivo data for an early lead molecule that resulted in regressions in a xenograft tumor model. These results led us to our lead candidate, MRTX849, that has a planned IND (investigational new drug) filing in Q4 2018," said Matt Marx, Ph.D., Vice President of Drug Discovery.

Details for the poster presentation are listed below.

Poster Title: Structure-based drug discovery of a selective, covalent KRAS G12C inhibitor with oral activity in animal models of cancer
Poster Number: MEDI 144
Date and Time: Sunday, August 197:00 PM
Location: Exhibit Hall B1, Boston Convention & Exhibition Center

Immutep to Present at the BioCentury 25th Annual NewsMakers in the Biotech Industry Conference

On August 16, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported that it has been invited to present at the BioCentury 25th Annual NewsMakers in the Biotech Industry Conference on Friday, September 7, 2018, at the Millennium Broadway Hotel & Conference Center in New York City (Press release, Immutep, AUG 16, 2018, View Source [SID1234529023]).

Marc Voigt, CEO of Immutep, is scheduled to present a corporate overview and business update at 11:30 am ET on Friday, September 7, 2018, with one-on-one meetings held throughout the day.

Hosted by BioCentury, only 48 companies are handpicked to present their stories to institutional investors in the Biotech sector. At the NewsMakers conference held in 2017, more than 500 delegates congregated at NewsMakers, including money managers who controlled more than $600 billion in equity assets, with over $50 billion dedicated to healthcare and $15 billion dedicated to biotech.