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.

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"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

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.

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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."

Synthorx Appoints Immuno-Oncology Veteran Joseph Leveque, M.D., as Chief Medical Officer

On August 16, 2018 Synthorx, Inc., a biotechnology company using a first-of-its-kind Expanded Genetic Alphabet platform to discover and develop innovative protein therapeutics for cancer, autoimmune disorders and other serious diseases, reported the appointment of Joseph Leveque, M.D., as chief medical officer (Press release, Synthorx, AUG 16, 2018, View Source [SID1234528935]). Dr. Leveque brings over 20 years of biotechnology management and therapeutic development experience to Synthorx, with a particular focus on immuno-oncology (IO).

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"Dr. Leveque joins us with a deep-rooted knowledge of the immuno-oncology space, notably with his experience at ARMO BioSciences leading the pivotal Phase 3 trials of the company’s lead IO drug candidate, as well as his involvement in the development and commercialization of Opdivo, Yervoy, and Bavencio, during his time at Bristol-Myers Squibb and Merck KGaA," said Laura Shawver, Ph.D., chief executive officer of Synthorx. "Dr. Leveque is an invaluable addition to our leadership team as we advance our Synthorin cytokine pipeline, including moving our IL-2 Synthorins into clinical trials, where we expect to demonstrate proof of clinical activity in our initial studies in oncology and autoimmune indications."

Dr. Leveque joins Synthorx from his previous role as chief medical officer of ARMO BioSciences, a late-stage immuno-oncology company that was acquired by Eli Lilly in May 2018. Prior to this, he was chief medical officer of EMD Serono, the North American subsidiary of Merck KGaA and the vice president and head of U.S. medical oncology at Bristol-Myers Squibb, where he was involved in the development and commercialization of the first generation of immuno-oncology therapeutics. Before his role at Bristol-Myers Squibb, Dr. Leveque was the vice president of medical and scientific affairs at Onyx Pharmaceuticals. Earlier in his career, he served as vice president of medical and scientific affairs at Cephalon Oncology and as medical director at Amgen, where he worked on several therapeutic programs for solid tumor and hematological malignancies.

Dr. Leveque earned a Medical Doctorate from The University of Texas School of Medicine in Houston, TX and completed his post-graduate medical training in internal medicine at the Cedars-Sinai Medical Center, a teaching affiliate of the University of California, Los Angeles (UCLA). In addition, Dr. Leveque holds a Master of Business Administration from the Wharton School of the University of Pennsylvania.

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]).

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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.

RXI PHARMACEUTICALS AND KAROLINSKA INSTITUTET ENTER INTO COLLABORATION TO DEVELOP SD-RXRNA COMPOUNDS TO IMPROVE FUNCTIONALITY AND PERSISTENCE OF T CELLS AND NK CELLS FOR THE ADVANCEMENT OF IMMUNO-ONCOLOGY THERAPEUTICS FOR SOLID TUMORS

On August 15, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform reported that it has entered into a research collaboration with the Karolinska Institutet in Stockholm, Sweden (Press release, RXi Pharmaceuticals, AUG 15, 2018, View Source [SID1234528886]). This collaboration will explore RXi’s sd-rxRNA compounds against targets involved in T cell and NK cell differentiation and/or in the immune cell tumor-induced stress response with the aim of producing anti-tumor adoptive cell therapy grafts with improved functionality and persistence.

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This work will expand on the recently published results from the Kiessling group demonstrating that an sd-rxRNA targeting PD-1 can enhance TIL antitumor activity against melanoma cells in vitro, further showing that ex vivo treatment with the sd-rxRNA compounds was easily incorporated into a clinically relevant rapid expansion protocol for TILs.1

Dr. Gerrit Dispersyn, Chief Development Officer of RXi Pharmaceuticals, stated: "We are pleased to expand our collaboration with Dr. Kiessling’s group, to further harness their expertise in oncology and to expand on the successful research they have previously done with our sd-rxRNA technology platform in immuno-oncology. The combination of their prior results and the anticipated research results from this new collaboration are critical elements for a rapid advancement of sd-rxRNA immuno-oncology therapeutics into the clinic, further supported by our prior clinical experience with sd-rxRNA in other indications."

Rolf Kiessling, MD, PhD, Senior Professor in Experimental Oncology at the Karolinska Institutet, Senior Chief Physician at the Oncology clinic at the Karolinska University Hospital and member of RXi’s Scientific Advisory Board stated: "Our results to date provide direct clinical relevance for the use of sd-rxRNA technology to improve ACT. In this collaboration, we look forward to exploring using sd-rxRNA to modulate targets outside of checkpoints to improve efficacy of immune effector cells such as T cells and NK cells."

Immunotherapy of cancer has become increasingly important in clinical practice over the recent decade. By activating the patient’s immune system, immunotherapy treatments have shown remarkable promise in extending the lifespan of previously untreatable cancer patients. Adoptive cell therapy is an emerging immunotherapy approach which uses immune cells, such as T-lymphocytes or NK cells that are isolated from the patient or retrieved from allogeneic immune cell banks, and then expanded and in some cases processed to express tumor-binding receptors.

A new and important step in this ex-vivo processing of the immune cells is in development where self-delivering RNAi compounds (sd-rxRNA) are used to eliminate the expression of immunosuppressive receptors or proteins from the therapeutic immune cells, thereby making them less sensitive to tumor resistance mechanisms and improving their ability to destroy tumor cells. In this way, sd-rxRNA therapeutic compounds can be used to weaponize therapeutic immune cells to attack cancer and ultimately provide patients battling terminal cancers with a powerful new treatment option that goes beyond current treatment modalities.

About RXi Pharmaceuticals

RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company developing the next generation of immuno-oncology therapeutics based on its self-delivering RNAi (sd-rxRNA) therapeutic platform. The Company’s discovery and research efforts are focused on developing sd-rxRNA therapeutic compounds to be used with an Adoptive Cell Transfer (ACT) approach. This process uses immune cells, such as T-lymphocytes that are isolated from the patient or retrieved from allogeneic immune cell banks, and then expanded and in some cases processed to express tumor-binding receptors. Our approach introduces a new and important step in ex-vivo processing of the immune cells where sd-rxRNA is used to eliminate the expression of immunosuppressive receptors or proteins from the therapeutic immune cells, making them less sensitive to tumor resistance mechanisms and thus improving their ability to destroy the tumor cells. Essentially, we aim to maximize the power of our sd-rxRNA therapeutic compounds by weaponizing therapeutic immune effector cells to attack cancer and ultimately provide patients battling terminal cancers with a powerful new treatment option that goes beyond current treatment modalities.