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I-Mab Biopharma Announces Clinical Collaboration to Evaluate TJC4 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Multiple Cancer Types

On September 23, 2019 I-Mab Biopharma ("I-Mab"), a China and U.S.-based clinical stage biopharmaceutical company exclusively focusing on the discovery and development of potential first-in-class and best-in-class biologics in immuno-oncology and autoimmune diseases, reported that it has entered into a clinical research collaboration agreement with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ., USA, to evaluate the combination of I-Mab’s TJC4 and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with multiple cancer types (Press release, I-Mab Biopharma, SEP 23, 2019, View Source [SID1234539726]).

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Under this collaboration agreement, MSD will supply KEYTRUDA (pembrolizumab) to I-Mab for use in clinical studies in combination with TJC4, a fully human anti-CD47 monoclonal antibody. Both parties will collaborate on a Phase 1 clinical trial, based on an agreed and finalized protocol, to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of TJC4 and KEYTRUDA in patients with multiple cancer types.

"TJC4 is a highly differentiated anti-CD47 antibody currently under clinical development. This collaboration will provide an excellent opportunity to further explore therapeutic potential of combining TJC4 with KEYTRUDA across different tumor types." said Dr. Jingwu Zang, Founder and Chairman of I-Mab.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About TJC4

CD47 represents one of the most promising immuno-oncology targets. The current investigational drugs targeting the CD47-SIRPa pathway have undesirable properties of binding to human red blood cells (RBC) or platelets. Such unwanted binding properties have been shown in pre-clinical and clinical settings to cause hematologic side-effects, e.g., anemia and thrombocytopenia, and the so-called "antigen sink effect" that affects pharmacokinetics of the investigational drugs. TJC4 is a highly differentiated monoclonal antibody made, by design, to recognize a unique epitope on CD47 and avoid strong binding to red blood cells. As such, TJC4 did not cause anemia in non-human primate studies，while it was shown to maintain anti-tumor activities. TJC4 is currently under clinical development in the U.S. and has been granted an IND approval by the National Medical Products Administration (NMPA) to start clinical trials in China.

ESMO Annual Meeting 2019: Menarini Ricerche Presents the Preclinical Characterization of MEN1611, a Novel PI3K Inhibitor in Development for the Treatment of Breast Cancer

On September 23, 2019 Menarini reported that results from the preclinical study conducted by Menarini Ricerche on MEN1611, a potent and selective orally available phosphatidylinositol 3-kinase (PI3K) inhibitor currently in development for the treatment of breast cancer (Press release, Menarini, SEP 23, 2019, View Source [SID1234539725]). The poster entitled "Characterization of the mechanism of action and efficacy of MEN1611, a novel PI3K inhibitor, in breast cancer preclinical models" will be presented at the ESMO (Free ESMO Whitepaper) Annual Meeting 2019, which will take place in Barcelona on September 27th, during the poster display session scheduled on September 30th (time 12-13).

The PI3K/AKT signaling pathway is often dysregulated in patients with cancer: about 25% of HER2-positive breast cancers carry PIK3CA gene mutations, known to confer resistance to anti-HER2 therapy (i.e. trastuzumab). This study, conducted in several HER2-positive PIK3CA-mutated breast cancer cell lines and patient-derived xenograft models, shows that MEN1611 is able to down-modulate the PI3K/AKT pathway both in vitro and in vivo, and acts synergistically when combined with trastuzumab; moreover, the in vivo efficacy in trastuzumab-resistant models is demonstrated by a long lasting antitumor activity.

These promising preclinical data, provide a strong rationale for MEN 1611 progression in clinical development in breast cancer patients. In this regard, the B-Precise-01 clinical trial (NCT03767335), a multicentre phase Ib study, is currently ongoing in Europe with the aim to evaluate the preliminary clinical activity of MEN1611 in combination with trastuzumab +/- fulvestrant, in patients affected by advanced or metastatic HER2-positive breast cancer, and to select the recommended phase 2 dose

This year Menarini Ricerche will be present at ESMO (Free ESMO Whitepaper) congress also with a dedicated area at the Menarini Silicon Biosystems booth, where it will be possible to get more detailed information about the entire Menarini oncology pipeline and the ongoing clinical trials. Indeed, MEN1611 is part of an innovative pipeline of investigational new drugs focused on precision medicine approaches, that represents the strong and growing commitment of Menarini to oncology and to patients affected by difficult to treat cancers.

Halozyme To Participate In 2019 Cantor Global Healthcare Conference

On September 23, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will participate in the 2019 Cantor Global Healthcare Conference in New York, NY (Press release, Halozyme, SEP 23, 2019, View Source [SID1234539724]). Dr. Helen Torley, president and chief executive officer, will represent the company in a question and answer session on Thursday, October 3 at 3:35 p.m. ET / 12:35 p.m. PT.

A live webcast of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 90 days following each event. To access a live webcast, please visit Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

Phoenix Molecular Designs Receives FDA Clearance to Begin Phase 1/1b Clinical Trial with PMD-026, a First-in-Class RSK Inhibitor, Targeting Advanced Breast Cancer

On September 23, 2019 Phoenix Molecular Designs (PhoenixMD), a clinical stage biotechnology company developing precise cancer therapeutics targeting essential kinases, reported clearance from the Food and Drug Administration (FDA) for PhoenixMD’s Investigational New Drug (IND) application for its proprietary PMD-026 (Press release, PhoenixMD, SEP 23, 2019, View Source [SID1234539723]. That clearance permits PhoenixMD to begin patient enrollment into its Phase 1/1b clinical trial, which is expected to start in the United States during the fourth quarter of 2019.

"Our IND clearance marks an important developmental milestone for PhoenixMD," said Sandra Dunn, Ph.D., chief executive officer of PhoenixMD. "To our knowledge, PMD-026 is the only purpose-built agent designed specifically to treat triple-negative breast cancer (TNBC). Additionally, we will be assessing the potential of PMD-026 to extend beyond TNBC and into other forms of advanced breast cancer."

PMD-026 is a proprietary first-in-class orally-available RSK (kinase) inhibitor being developed to treat certain forms of breast cancer. The Phase 1/1b clinical trial will evaluate safety, tolerability, pharmacokinetics and anti-tumor activity of PMD-026 in patients with advanced disease and a sub-group of women with TNBC. Importantly, this trial will include a CAP/CLIA certified companion diagnostic designed to detect RSK2 activation in breast tumors and to then correlate it with response to PMD-026. This is a new approach for the treatment of cancer that hinges on precision medicine and functional kinomics.

"TNBC patients with metastatic disease have limited treatment options and new drugs have not generally been specifically developed based on the biology of this type of tumor," said Gerrit Los, Ph.D., chief scientific officer of PhoenixMD. "We have had substantial interest from some of the top clinical oncology centers eager to participate in our upcoming trial, underscoring the need for treatment options for women with advanced disease."

About PMD-026
PhoenixMD’s lead candidate, PMD-026, is the first RSK inhibitor being developed for the treatment of TNBC. PMD-026 was precisely designed for TNBC because RSK2 was specifically identified as the key kinase, out of 519 kinases, that drives the growth of this breast cancer subtype. Preclinical data shows the potential for PMD-026 to be effective alone or in combination with conventional chemotherapies. It has the potential to be a platform technology for chemotherapy, hormone therapy and/or immunotherapy sensitization for a wide range of refractory cancers in the future.

Menarini Silicon Biosystems to Host ESMO Symposium on Clinical Importance of Circulating Tumor Cells

On September 23, 2019 Menarini Silicon Biosystems, the pioneer of liquid biopsy and rare cell technologies, reported that it will host a symposium on the importance of liquid biopsy and circulating tumor cells (CTCs) in advancing precision medicine for patients with metastatic breast and prostate cancer (Press release, Menarini, SEP 23, 2019, View Source [SID1234539722]).

The pro+gram will take place at the 2019 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and will feature some of the world’s leading clinical researchers in the field of liquid biopsy and CTCs. They will present summaries of available data supporting the clinical impact of prognostic value of CTCs in both early and advanced breast cancer, as well as in advanced prostate cancer. The researchers will also discuss potential clinical applications for liquid biopsy technologies and provide recommendations for using CTC enumeration to manage patients.

"Liquid biopsy plays an increasingly important role in bringing personalized medicine to patients with metastatic breast and prostate cancer," said symposium co-chair Wolfgang Janni, MD, University of Ulm, Germany. "The goal of this symposium is to define the role of CTCs and other blood-based markers in helping physicians better understand cancer evolution and progression. This is the future of precision medicine."

In addition to Dr. Janni, the distinguished presenters include co-chair Massimo Cristofanilli, MD, Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Chicago, IL; as well as faculty members Jean-Yves Pierga, MD, PhD, Institut Curie & Universite Paris Descartes, France, and Johann De Bono, MD, PhD, The Institute of Cancer Research and Royal Marsden, London, UK.

"The liquid biopsy field has grown tremendously in the past 15 years, thanks to the initial fundamental demonstration of the ability to detect circulating tumor cells in the blood of cancer patients and the continual improvements in CTC detection and characterization technology," said Dr. Cristofanilli. "Attendees can expect to get a comprehensive overview of state-of-the-art technology for CTC analysis. In addition, they will take part in discussions with the faculty about the future of this field and how we can move toward liquid biopsy as a standard of care for patients with advanced disease."

New Clinical Perspectives of CTCs in the Era of Precision Medicine will take place 28 September 2019, 18:30-20:00 in Santander Auditorium, Hall 3, Fira Gran Via, Barcelona Spain. The presentations are:

A single baseline CTC count for staging of metastatic Breast Cancer: Beyond anatomical description – M Cristofanilli
Prognostic and predictive value of CTC count in the management of HR+ Metastatic Breast Cancer – JY Pierga
Prognostic role of CTC detection in HR+ Early Breast Cancer – W Janni
CTC count and single cells evaluation in metastatic Prostate Cancer – J De Bono
The program will conclude with a 30-minute roundtable discussion between the faculty and audience members to discuss the current value of CTC enumeration for patient management and its potential future impact on clinical practice.

To learn more, ESMO (Free ESMO Whitepaper) attendees can visit Menarini Silicon Biosystems at Booth #311.

ESMO is the leading professional organization for medical oncology in Europe. The 2019 ESMO (Free ESMO Whitepaper) Congress will take place 27 September – 1 October, 2019, Barcelona, Spain.