On June 26, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported the online publication in The Lancet Oncology of the results from the completed Phase I dose-escalation and expansion clinical trial of IPH4102 in advanced CTCL patients (Press release, Innate Pharma, JUN 26, 2019, View Source [SID1234537267]). The Lancet Oncology publication can be accessed here.

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"We are very pleased with the publication of our IPH4102 Phase I results in a top tier, peer-reviewed medical journal," said Pierre Dodion, Chief Medical Officer of Innate Pharma. "The specific mode of action of IPH4102 and its therapeutic potential in advanced T-cell lymphoma, now available to the broader Lymphoma community, demonstrate that targeting of KIR3DL2 by IPH4102 result in a combination of high and durable responses, a favorable safety profile and a substantial improvement in quality of life in Sézary syndrome. The IPH4102 Phase I study design included several innovative features including a smaller cohort of patients at the lowest dosages and intra-patient dose escalation which allowed for the optimization of the overall study execution. Based on these Phase I clinical trial data, we launched the TELLOMAK Phase II clinical trial in June 2019, which simultaneously could enable the registration of IPH4102 in Sézary syndrome and allow us to explore its potential in broader patient populations of T-cell lymphoma such as Mycosis fungoides (MF) and peripheral T-cell lymphoma (PTCL)."

On June 25, 2019 Rafael Pharmaceuticals, a leader in the growing field of cancer metabolism-based therapeutics, reported that it has entered into an out-licensing agreement with Ono Pharmaceutical Co., Ltd. ("Ono"), a pharmaceutical company committed to creating innovative medicines. (Press release, Ono, JUN 25, 2019, View Source [SID1234574183]). The exclusive license agreement is for the development and commercialization of CPI-613 (devimistat), Rafael’s first-in-class clinical lead compound, which targets cancer metabolism enzymes, as well as its other related compounds.

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Under the terms of the agreement, Rafael will receive a one-time upfront payment of approximately $12.9 million USD and up to an additional approximately $150.3 million USD if certain development and commercial milestones are achieved. Rafael will also receive low-double digit royalties based on net sales of the Products in Japan, South Korea, Taiwan and ASEAN (Association of Southeast Asian Nations) countries. ONO will have exclusive rights to develop and commercialize the Products for all indications in ONO’s territory. Rafael continuously retains all exclusive rights to develop and commercialize the Products outside of ONO’s territory.

"It is a true honor to partner with ONO, which is one of the oldest pharmaceutical companies in Japan with an abundance of experience in drug discovery and development," said Sanjeev Luther, President and CEO of Rafael. "With ONO’s extensive expertise and deep roots in the region, we hope that devimistat can help fill a major gap in oncology therapeutics in Japan and other Asian countries. It is our ongoing mission to have a meaningful impact on the lives of cancer patients around the globe, and ONO enables us to have even greater reach."

"Devimistat has shown tremendous promise in clinical trials, and partnering with ONO allows us to extend the benefits of the drug to large patient populations in Asia," said Howard Jonas, Chairman of Rafael. "ONO has demonstrated an impressive track record in drug development and commercialization in Asian countries, specifically in oncology, which makes them a natural fit as our partner."

"We are very delighted to collaborate on devimistat with Rafael, a leader in the growing field of cancer metabolism-based therapeutics," said Gyo Sagara, President, Representative Director of ONO. "Devimistat has shown promising efficacy and safety in the previous clinical trials, and we believe that devimistat will be a new treatment option to patients suffering from devastating cancers in Asian countries."

On June 25, 2019 Frontier Medicines reported the closing of a Series A Preferred Stock financing round of $67 million led by Deerfield Management, Droia Oncology Ventures and MPM Capital, with participation from DCVC Bio (an affiliated fund of DCVC), RA Capital Management and other investors (Press release, Frontier Medicines, JUN 25, 2019, View Source [SID1234540983]). Frontier Medicines is a new pre-clinical stage biopharmaceutical company developing breakthrough medicines to redefine the course of debilitating diseases, starting with cancer.

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According to the American Cancer Society, approximately 1,762,000 new cancer cases and approximately 607,000 deaths from cancer are expected to occur in the US in 2019. However, even after decades of research, the majority of known cancer-causing proteins are still considered "undruggable," or inaccessible for therapeutic intervention. This reality has become one of the most critical challenges in advancing oncology therapy and is central to the research at Frontier Medicines.

"Our therapeutic programs are focused on several of the most important and difficult targets in cancer," said Chris Varma, Ph.D., co-founder and CEO of Frontier Medicines. "With our platform, we have the ability to address previously inaccessible disease-causing proteins. While we are taking on a considerable challenge, we believe this approach will have a tremendous impact on transforming patients’ lives for the better, which is our ultimate goal."

Frontier Medicines is using chemoproteomics – an innovative approach to chemically interrogate proteins in living systems – to discover and pharmacologically target new binding pockets (or "hotspots") on proteins, making them accessible to small-molecule drug discovery and development. The company’s proprietary chemoproteomics platform also integrates advanced computational approaches and machine learning to further accelerate the path to drug discovery.

"Our platform currently includes a database of hotspots that cover a majority of human proteins, including those that were previously considered ‘undruggable;’ an expanding library of diverse, covalent compounds being driven by machine learning; and a novel approach to protein degradation," said Daniel K. Nomura, Ph.D., co-founder of Frontier Medicines. "This platform enables us to go after almost any protein target of interest for therapeutic intervention."

Founders
Frontier Medicines is founded by a team of experts in chemoproteomics, cancer biology and company building:

Chris Varma, Ph.D., Co-founder, CEO and President. Dr. Varma is a serial entrepreneur, including co-founder & former CEO of Blueprint Medicines (Nasdaq: BPMC); and VC veteran, having worked with MPM Capital, Third Rock Ventures and Flagship Ventures to build and invest in several successful companies.
Daniel K. Nomura, Ph.D., Co-founder; Associate Professor of Molecular and Cell Biology, Chemistry, Nutritional Science and Toxicology, UC Berkeley. For more than eight years, the Nomura Research Group has focused on reimagining druggability using chemoproteomic platforms to develop new disease therapies.
Roberto Zoncu, Ph.D., Co-founder; Assistant Professor of Molecular and Cell Biology, UC Berkeley. Zoncu’s research focuses on fundamental mechanisms of growth regulation in both normal and cancer states. His work has been recognized by numerous awards, including the NIH Director New Innovator Award, the Pew Stewart Scholarship for Cancer Research, the Edward Mallinckrodt, Jr. Foundation Scholarship and the Damon Runyon-Rachleff Innovation Award.
Frontier Medicines’ investors include leading crossover, venture, life sciences and technology funds, positioning Frontier Medicines well for the future. The Series A financing, building on a founding investment by MPM Capital, will enable Frontier Medicines to invest in research and development, talent acquisition and advancement of its platform and therapeutic programs.

On June 25, 2019 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 completed patient enrolment of the Phase IIb Active Immunotherapy PAClitaxel (AIPAC) clinical trial in HER2-negative/ Hormone Receptor positive (HR+) metastatic breast cancer (MBC) (Press release, Immutep, JUN 25, 2019, View Source [SID1234537271]).

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The AIPAC study has enrolled 226 patients at more than 30 clinical trial sites across Germany, the UK, France, Hungary, Belgium, Poland and the Netherlands. The trial is evaluating Immutep’s lead product candidate, eftilagimod alpha (efti or IMP321), in combination with paclitaxel, a standard of care chemotherapy, as a chemo-immunotherapy combination in patients with HR+ MBC not eligible for human epidermal receptor 2 (HER2) therapies. This combination is designed to boost the immune response against tumour cells compared to chemotherapy plus placebo. Apoptotic tumour cells induced by chemotherapy release antigenic tumour debris which are then captured by APCs. Boosting the APC network with efti increases cytotoxic T-cell responses which complements the direct cytotoxic effect of the chemotherapy.

The primary endpoint of the AIPAC study is PFS according to RECIST as evaluated by blinded independent central readers. Additional efficacy endpoints include PFS by local read, overall response rate (ORR) and overall survival (OS). The Company expects to report PFS data, together with ORR data, in Q1 of calendar year 2020.

AIPAC is a potentially pivotal clinical trial, meaning it could serve as a basis to pursue appropriate regulatory approval pathways for efti with, for example, the European Medicines Agency (EMA) or the U.S. Food and Drug Agency (FDA), subject to sufficient and clinically meaningful data from the trial and regulatory interactions. Before AIPAC started, the Company received scientific advice from the EMA and is currently exploring ways to bridge its research efforts in HR+ MBC to the United States.

Metastatic breast cancer, also called stage IV breast cancer, is the most advanced stage of breast cancer where it has spread beyond the breast to other organs in the body, most often the bones, lungs, liver or brain. It is estimated that each year there are over 800,000 new cases worldwide of MBC that are HER2 negative and HR positive1. Paclitaxel is a taxane-based standard of care chemotherapy that is widely used for patients in the EU and United States with this cancer.

1
GlobalData PharmaPoint: HER2-Negative/HR+ and Triple Negative Breast Cancer – Global Drug Forecast and Market Analysis to 2025, December 2016

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Immutep CEO Marc Voigt commented: "The completion of recruitment for our Phase IIb AIPAC study is an important milestone for Immutep as this is our largest and most advanced clinical trial. As the first PFS data read-out is event-driven, the timeline for reporting remains on track for early in 2020. We sincerely thank our principal investigators, the patients and their families for being part of this study.

MBC is a serious medical condition where patients have a median life expectancy of approximately two years from the start of first line chemotherapy. This means there is a clear high unmet medical need for new therapies that may deliver improved outcomes compared to current standard of care therapies."

AIPAC Principal Investigator Dr Hans Wildiers added: "By combining efti with chemotherapy, we hope to boost the body’s immune response against tumour cells and improve treatment outcomes compared to giving chemotherapy alone. Most studies in metastatic breast cancer, including immune therapy, are focusing on blocking the PD-1/PD-L1 checkpoint pathway, but results have been disappointing in this type of hormone sensitive metastatic breast cancer. With efti, we hope to activate the immune system more efficiently in hormone sensitive metastatic breast cancer, the most frequent breast cancer subtype. Through the AIPAC study, we are leading the search for effective immune therapy in this subtype."

Immutep CSO and CMO, Dr Frederic Triebel said: "APC activators are a new class of drug products that could nicely complement the action of standard of care, either chemotherapy or immune checkpoint inhibitors. Despite recent positive announcements including preliminary anti-CD40 agonist mAb data in a difficult-to-treat "cold tumor" indication such as advanced pancreatic carcinoma, this new class of IO drug products has not yet been validated in a pivotal trial in terms of efficacy. We hope that the results of the AIPAC trial will unequivocally demonstrate the value of APC activators in combined advanced cancer therapies."

About AIPAC

Active Immunotherapy PAClitaxel (AIPAC) is a Phase IIb clinical trial in HER2-negative/ HR positive metastatic breast cancer. Based on Immutep’s LAG-3 technology, the study evaluates the combination of the Company’s lead product candidate, eftilagimod alpha (efti, LAG-3Ig or IMP321), and a taxane-based chemotherapy, called paclitaxel, as an immunotherapy. This combination is aimed at boosting the immune response against tumour cells compared to chemotherapy alone. In AIPAC, 226 hormone receptor positive metastatic breast cancer patients are randomised 1:1 to treatment A (paclitaxel chemotherapy plus placebo) or treatment B (paclitaxel chemotherapy plus eftilagimod alpha) for six months. Thereafter, patients will pass over to the maintenance phase with efti alone.

The primary endpoint of the study is progression-free survival (PFS). The Company expects to report first PFS data in Q1 of calendar year 2020.

For more information regarding the AIPAC trial, visit clinicaltrials.gov (identifier NCT02614833) and View Source).

On June 25, 2019 LabCorp (NYSE: LH) reported that it will release its second quarter of 2019 financial results before the market opens on Thursday, July 25, 2019, followed by a conference call and webcast beginning at 9:00 a.m. EDT to discuss the results (Press release, LabCorp, JUN 25, 2019, View Source;p=RssLanding&cat=news&id=2402266 [SID1234537268]). Interested parties can access the conference call by dialing 844-634-1444 within the U.S. and Canada, or 1-615-247-0253 internationally, using the passcode 9679477.

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An audio replay of the conference call will be available from 1:00 p.m. EDT on July 25, 2019, until 11:30 a.m. EDT on August 8, 2019, by dialing 855-859-2056 within the U.S. and Canada, or 1-404-537-3406 internationally, using the passcode 9679477.

The earnings release, accompanying financial information, and a real-time webcast of the conference call will be available on the LabCorp Investor Relations website. The webcast will be archived and accessible through July 24, 2020.