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).

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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.

On September 23, 2019 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported that Brian M. Culley, Chief Executive Officer, will be presenting at the 2019 Cell & Gene Meeting on the Mesa on October 3rd, 2019 at 5:00pm Pacific Time at the Park Hyatt Aviara Resort in the BlueRock Therapeutics Ballroom in Carlsbad, CA (Press release, Lineage Cell Therapeutics, SEP 23, 2019, View Source [SID1234539693]).

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Organized by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mesa is a premier conference combining discussions between senior executives and top decision-makers in the industry. The program also includes presentations by the field’s most promising companies in the areas of cell therapy, gene therapy, gene editing, tissue engineering, and broader regenerative medicine technologies and extensive one-on-one partnering capabilities.

A live video webcast of all company presentations will be available at: View Source and will also be published on the conference website shortly after the event.

On September 23, 2019 PharmaMar is a biopharmaceutical company reported that During the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, to be held from September 27th to October 1 st in Barcelona, the recent results of the lurbinectedin trial for the treatment of progressive malignant pleural mesothelioma, carried out by SAKK (Swiss Group for Clinical Cancer Research) in collaboration with PharmaMar (MSE:PHM), will be presented (Press release, PharmaMar, SEP 23, 2019, View Source [SID1234539709]).

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The oral presentation will be entitled "SAKK 17/16: Lurbinectedin as second or third line palliative chemotherapy in pleural malignant mesothelioma (MPM): A multicenter, single-arm Phase II trial". During this conference, the primary results will be shown from a single arm, multicenter, Phase II trial, which has enrolled 42 patients with progressive malignant pleural mesothelioma, which met its primary endpoint of PFS at 12 weeks.

Malignant mesothelioma is a rare tumor, arising from the mesothelial cells of the pleural, peritoneal or pericardial lining, and is often associated with exposure to asbestos, usually with a very poor prognosis at the time of diagnosis, being pleural mesothelioma the most frequent location. There is currently no cure for most malignant mesotheliomas. Therefore, the goal of current cancer treatments (surgery, radiation therapy, and chemotherapy) is to reduce or eliminate symptoms, as well as to prolong progression-free survival (PFS) and/or overall survival (OS). It is estimated that the incidence of this type of cancer may increase in the coming years, after the exposure to asbestos. It usually takes a long time before a malignant mesothelioma forms.

Trabectedin 2 In addition, the data obtained in several clinical studies carried out with trabectedin, evaluating new combinations of trabectedin for the treatment of soft tissue sarcoma, ovarian cancer and different solid tumors will be presented. Among them, data from a multicenter Phase II study of trabectedin in combination with a low dose of radiotherapy conducted by Sarcoma Research Groups in Spain, France and Italy, will be presented.

The studies presented at the ESMO (Free ESMO Whitepaper) 2019 congress are available at: View Source Highlighted studies at ESMO (Free ESMO Whitepaper) 2019 Lurbinectedin  Proffered Paper 2 – Non-metastatic NSCLC and other thoracic malignancies (mesothelioma and thymic carcinoma) Oral presentation-30.09.2019, 10:15-11:45, Pamplona Auditorium (Hall 2) Autor principal: Yannis Metaxas (Chur, Switzerland)  Lurbinectedin (LUR) in combination with Irinotecan (IRI) in patients (pts) with advanced solid tumors Poster Display session-28.09.2019, 12:00-13:00, Poster Area (Hall 4) Autor principal: Santiago Ponce Yondelis (trabectedin)  Trabectedin with concurrent low-dose of radiation therapy for metastatic soft tissue sarcomas: A phase II trial of Spanish, French and Italian sarcoma groups Poster Discussion – Sarcoma. 28.09.2019, 15:00-16:00, en Malaga Auditorium (Hall 5) Autor principal: J Martin-Broto (Sevilla)  Inhibition of mTOR signaling enhances Trabectedin activity in Soft Tissue Sarcoma Poster Display session. 28.09.2019, 12:00-13:00, Poster Area (Hall 4). Autor principal: David S. Moura, PhD. 3  Randomized Phase II Study of Trabectedin/Olaparib Compared to Physician’s Choice in Subjects with Previously Treated Advanced or Recurrent Solid Tumors Harboring DNA Repair Deficiencies Poster-30.09.2019, 12:00-13:00, en el Hall A3-Poster Area (Hall 4) Autor principal: S Christoph E. Heilig, Germany.  Impact of prior pegylated liposomal doxorubicin (PLD) treatment in recurrent ovarian cancer (ROC): Sub-group analysis from a randomized, open-label study comparing trabectedin (T) and PLD versus PLD alone in ROC (ET743-OVC-3006) Poster-29.09.2019, 12:00-13:00, Poster Area (Hall 4). Autor principal: Bradley J Monk, USA.

Legal warning This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

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.

On September 23, 2019 Celsius Therapeutics, a company focused on bringing personalized medicine to patients with cancer, autoimmunity and other complex diseases, reported that it has been named by FierceBiotech as one of 2019’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Celsius Therapeutics, SEP 23, 2019, View Source [SID1234539743]).

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"It is an incredible honor and we are humbled to be named a ‘Fierce 15’ company, which is a testament to both our promising single cell genomics-driven drug discovery approach as well as the hard work of our entire team," said Tariq Kassum, M.D., chief executive officer of Celsius. "At Celsius, the combination of patient tissue samples, massive datasets, and sophisticated machine learning algorithms allows us, for the first time, to understand the specific cells driving disease. With this new level of clarity, our approach has fierce potential to deliver a powerful new class of precision medicines in autoimmune disease and cancer."

"This year has seen unrivalled scientific talent in the early-stage life sciences world and it has been a pleasure to for us at FierceBiotech to speak to all 15 winners and hear their passion, progress and panache," said Ben Adams, Senior Editor of FierceBiotech. "Each company brought something different, exciting and potentially life-changing for myriad patients around the world across a host of diseases and disorders, using cutting-edge science, top-notch teams and a drive to genuinely make the world a better place, despite the risks and challenges that, as ever in biotech, lay ahead."

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. Every year FierceBiotech evaluates hundreds of private companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position. This is FierceBiotech’s 17th annual Fierce 15 selection.