On February 14, 2019 Minomic International Ltd is reported the company has executed an agreement with Cirrus Dx, a CLIA Certified "High Complexity" Laboratory, enabling US clinicians and patients early access to the company’s novel test for Prostate Cancer (Press release, Minomic, FEB 14, 2019, View Source [SID1234533296]). The agreement allows Cirrus Dx to perform MiCheck as a Laboratory Developed Test (LDT) in the company’s Rockville MD based laboratory once internal validation is completed. Finalising this agreement completes an important step in commercialising MiCheck in the world’s largest healthcare market.

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Dr Brad Walsh, Minomic’s CEO, noted "Being able to offer MiCheck as an LDT through our partnership with Cirrus Dx will provide the Company with three important outcomes, ‘Real World Data’ which can be used in subsequent FDA approval submissions, validation of MiCheck and its clinical utility and finally, royalty revenues. Our thanks to the Cirrus Dx team for making this possible with special acknowledgement for the hard work and vision provided by Cirrus’ Kyle Armantrout. We are very excited to be working with them as they continue to build their franchise in the urological testing space".

William M. Nelson, MD, Cirrus Dx’s President said "The ability of MiCheck to improve the diagnosis of Prostate Cancer and, in particular, reduce the number of unnecessary biopsies being performed is a game-changer and we look forward to working with Minomic to bring this vital improvement into the US market".

Minomic and Cirrus expect the required internal validation studies to be completed by the end of Quarter 1, 2019. Urologists and their patients in the US will have access to the MiCheck test shortly thereafter. A suitable reimbursement code has been identified and both companies believe that appropriate reimbursement will be available. Commercial details of the agreement will remain confidential.

On February 14, 2019 Helsinn Group, a Swiss pharmaceutical group focused on building quality cancer care products, and MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported the publication in the medical journal, Blood Advances, published by the American Society of Hematology (ASH) (Free ASH Whitepaper), the results from a Phase II study that evaluated the safety and efficacy of pracinostat, a potent oral pan-histone deacetylase inhibitor (HDACi), in combination with azacitidine, for the treatment of patients suffering from acute myeloid leukemia (AML), who cannot undergo treatment with intensive chemotherapy (IC) (Press release, MEI Pharma, FEB 14, 2019, View Source [SID1234533317]).

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AML is an haematological malignancy mostly diagnosed in older patients, with an average diagnosis age of 67 years of age. Although the cure rate for AML patients ≤60 years using intensive chemotherapy (IC) approaches 35% to 40%, it remains poor in older patients, typically not exceeding 15%.

The full article, just published online, Pracinostat plus azacitidine in older patients with newly diagnosed acute myeloid leukemia: results of a phase II study, G. Garcia-Manero et al., shows the results of the Phase II study, assessing pracinostat combined with azacitidine in patients ≥65 years with newly diagnosed AML and ineligible for standard induction chemotherapy. This was a multicentre, open-label, single-arm, two-stage study enrolling 50 patients, evaluating the treatment with oral pracinostat 60 mg/day, 3 days/week, for 3 consecutive weeks plus intravenous azacitidine 75 mg/m2 daily for 7 days in a 28-day cycle, until discontinuation due to progression, intolerable toxicity, intercurrent illness, or per patient request.

Primary endpoints for the Phase II study were the combined rates of complete remission (CR), CR with incomplete count recovery (CRi), and morphologic leukemia-free state (MLFS). Out of the 50 patients, 26 patients (52%) achieved the primary endpoint, with 42% achieving complete remission.

Ninety-four percent and 90% of patients had at least 1 TEAE related to pracinostat and azacitidine, respectively. The most common treatment-related AEs were nausea (56%), fatigue (40%), thrombocytopenia (38%), and neutropenia (30%). Pracinostat plus azacitidine is a well-tolerated and active regimen in the frontline treatment of older patients with AML unfit for intensive therapy.

This investigational study showed that pracinostat in combination with azacitidine is active in the frontline treatment of older patients with AML, unfit for intensive therapy. The CR rate of 42%, the median overall survival (OS) of 19.1 months, a PFS of 12.6 months and 1-year OS rate of 62% have been evidenced in patients unfit for intensive therapy.

These data have shown that pracinostat in combination with azacitidine is a potential treatment option for the frontline treatment of older AML patients unfit for IC. Based on these results, a Phase III, multicenter, double-blind, randomized study of pracinostat with azacitidine vs placebo with azacitidine (NCT03151408) is ongoing to demonstrate an improvement of pracinostat in combination in this difficult-to-treat AML population.

Dr. Guillermo Garcia-Manero, MD Professor, Department of Leukemia, at MD Anderson Cancer Center in Houston, Texas, US, said: "We are thrilled to be in a position to outline the encouraging results of this Phase II study in Blood Advances, as the data is highly encouraging for older patients suffering from acute myeloid leukemia, and who cannot be treated with intensive chemotherapy. We look forward to continuing with our ongoing Phase III study with pacinostat to show improvement of the pracinostat combination vs azacitidine with placebo, in this difficult-to-treat AML patients population."

Sergio Cantoreggi, PhD, Chief Scientific Officer and Helsinn Group Head of R&D, commented: "The publication of this data in Blood Advances, shows the potential of pracinostat in combination with azacitidine as a safe and effective regimen for difficult-to-treat AML patients. There are only few treatment options for older patients suffering from AML and who are unfit for intensive chemotherapy treatment. We are committed to further investigate the effects of this drug combination in an ongoing Phase III study."

Richard Ghalie, M.D., Senior Vice President, Clinical Development at MEI Pharma added: "AML is a rapidly progressing, often fatal disease, with an urgent need for new treatment options. This Phase II study provided the rationale for our ongoing Phase III study and show the potential for pracinostat, in combination with azacytidine, as a treatment option in this AML population. As such, we’re delighted that these data are being published in Blood Advances."

About Pracinostat

Pracinostat is an oral histone deacetylase ("HDAC") inhibitor that is in a pivotal Phase III study in combination with azacitidine for the treatment of adults with newly diagnosed acute myeloid leukemia ("AML") who are unfit for intensive chemotherapy. It is also being evaluated in a Phase II study in patients with high or very high-risk myelodysplastic syndrome ("MDS"). The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy.

In August 2016, Helsinn and MEI Pharma entered into an exclusive license, development and commercialization agreement for pracinostat in AML and other potential indications.

The agreement provides that Helsinn is primarily responsible for development and commercialization for pracinostat in AML and other indications, including MDS.

Pracinostat is an investigational agent and is not approved for commercial use in the U.S. and any country worldwide

On February 14, 2019 Forbius, a clinical-stage company that develops biologics for the treatment of cancer and fibrosis, reported a collaboration agreement with the Icahn School of Medicine at Mount Sinai and the Myeloproliferative Neoplasm Research Consortium (MPN-RC) (Press release, Forbius, FEB 14, 2019, View Source [SID1234533334]). This collaboration will launch an investigator-initiated trial (IIT) evaluating AVID200, a highly potent and isoform-selective TGF-beta inhibitor, as a potential treatment for myelofibrosis (MF). The Phase 1/2 clinical trial will be sponsored by the MPN-RC with NIH grant support and is expected to start during Q1 2019.

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"We have demonstrated that blocking TGF-beta signaling reverses bone marrow fibrosis and restores hematopoiesis in preclinical models. We believe that selective TGF-beta inhibition by AVID200 could address the underlying cause of bone marrow failure and become the first disease-modifying therapy in MF. Our consortium is eager to commence evaluation of AVID200 in the upcoming clinical study," commented Dr. Ronald Hoffman, founder of the MPN-RC and Director of the Myeloproliferative Disorders Research Program at the Icahn School of Medicine at Mount Sinai.

Forbius is evaluating the immuno-oncology and anti-fibrotic effects of AVID200 in Phase 1 trials, including solid tumors and systemic sclerosis. Additionally, Forbius is expanding the AVID200 clinical development program by supporting IITs through the provision of drug, scientific input, and collaboration on the conduct of translational studies. Additional details pertaining to the prospective IIT in MF will be disclosed in due course.

About the Myeloproliferative Neoplasm Research Consortium (MPN-RC)

The MPN-RC was founded in 2006 and is the only independent, multi-center, international consortium of scientists and clinicians that is dedicated to developing novel therapeutic strategies for MF and other myeloproliferative neoplasms (MPN). The MPN-RC is funded by the NIH to conduct clinical trials based on the most promising preclinical MPN research. The goal of the consortium is to adapt quickly in response to scientific advances and a changing clinical landscape, in order to develop effective therapeutics for MPN patients.

About AVID200

AVID200 is an isoform-selective and highly potent inhibitor of TGF-beta 1 & 3, the two principal pro-fibrotic TGF-beta isoforms. These TGF-beta isoforms are central regulators in the pathogenesis and progression of fibrotic diseases, including MF (Chagraoui et al., 2002). AVID200 was rationally designed to be minimally active against TGF-beta 2, which is a promoter of hematopoiesis and normal cardiac function. This optimal selectivity positions AVID200 to be an effective and well-tolerated therapeutic in MF and other fibrotic diseases.

About Myelofibrosis (MF)

MF is a rare, life-threatening blood cancer characterized by progressive bone marrow fibrosis, which causes ineffective hematopoiesis. Approximately 30,000 people in the US alone are affected by this disease. Currently, there are no approved therapies targeting the underlying bone marrow fibrosis available to MF patients.

On February 14, 2019 Tanabe Research Laboratories U.S.A. Inc. (TRL), a subsidiary of Mitsubishi Tanabe Pharmaceutical Corporation, is a California based research, development and clinical stage company specializing in antibody technologies to treat cancer and other diseases with unmet medical needs (Press release, Mitsubishi Tanabe Pharma, FEB 14, 2019, View Source [SID1234533335]). TRL announced today that the U.S. Food and Drug administration (FDA) accepted the company’s first Investigational New Drug (IND) application to initiate a phase I trial for its Antibody Drug Conjugate TR1801-ADC (MT- 8633) in patients with cMet positive solid tumors.

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"We are excited to be able to move TR1801-ADC into the clinic," said Roland Newman, TRL’s Chief Scientific Officer. "TR1801-ADC is an extremely potent ADC that combines a non-agonizing anti-c-Met antibody developed at TRL, with a pyrrolobenzodiazepine dimer (PBD) toxin, and has demonstrated potent dose dependent anti-tumor activity against Met positive tumors in preclinical models."

The PBDs were developed by TRL’s collaborative partner MedImmune, the global biologics research and development arm of AstraZeneca (LSE: AZN), via its proprietary Spirogen technology and licensed to TRL. PBDs are of an order of magnitude more potent than other warheads currently used with other ADCs, and in the case of TR1801-ADC are linked to the antibody via a site-specific conjugation site.

cMet, also referred to as the hepatic growth factor receptor (HGFR), is a validated target expressed on a variety of tumor types including colorectal, NSCLC, gastric, esophageal, pancreatic, bile duct and many other cancers. "Patients will be selected based on c-Met expression levels using a histological screening system (IHC) to determine their eligibility. Patients that have either cMet gene amplification or are non-gene amplified will both be eligible for the trial as long as they meet the IHC expression cutoff requirement," said Gary Woodnutt, TRL’s VP of Development.

"The acceptance of this IND by the FDA is an important milestone for TRL," said CEO and President Naoki Sakurai, "as it validates our research efforts and represents the first ADC product in a rich future pipeline. This achievement is a result of hard work by our dedicated employees and is the first drug in TRL’s mission of creating therapies with a meaningful clinical benefit for patients."

About TRL:

TRL is an independent subsidiary of MTPC located in San Diego California, whose role is to discover and develop biological drug candidates for therapy. Currently, TRL’s efforts are directed towards antibody-related research to target tumors and other diseases with high unmet needs. TRL has established collaborative relationships with other companies and academic research organizations to develop Antibody Drug Conjugates (ADCs) and to identify therapeutic lead compounds for development. View Source

On February 14, 2019 Glenmark Pharmaceuticals Ltd, a research-led integrated global pharmaceutical company, reported that its Board of Directors has given an in-principle approval to spin off the innovation business into a new company in the US. Setting up of the new company will provide an enhanced focus to the innovation business and help accelerate the pipeline towards commercialization (Press release, Glenmark, FEB 14, 2019, View Source [SID1234553887]).

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The new innovation company will be a wholly-owned subsidiary of Glenmark and will be based in the US. It will have an independent board and a new Chief Executive Officer. The other members of the management and the team remain unchanged.

According to the plan, all innovative molecules in the pipeline, including preclinical assets and technology; the R&D centres in Switzerland, R&D centre at Paramus in the US and R&D centre at Navi Mumbai, India related to the innovation business, and the biologics manufacturing facility in Switzerland along with all employees associated with innovative R&D will be part of the new company. The new company will have over 400 employees as part of this business. The specialty and generics business will continue to be housed in the parent company and will not be part of this new company.

The transfer of the assets and employees to the new innovation company is expected to be completed in the next 6 to 9 months.

"Glenmark has built strong capabilities in the area of innovation in terms of world class infrastructure, talent pool, and technology. We currently have a pipeline of 8 NMEs most of which are first-in-class globally. The cutting edge work that the innovation team has delivered over the years has resulted in numerous achievements most notably among them being the fact that we have out-licensed our novel molecules to big pharmaceutical organizations consistently. With the pipeline at an advanced stage, we believe it’s the right time for the innovation business to be an independent entity and charter its own journey towards becoming a leading biotech organization globally. This change will provide enhanced focus to the business, a better operating ecosystem and additional opportunities to unlock value for the parent company in future," said Glenn Saldanha, chairman and managing director of Glenmark Pharmaceuticals.

Glenmark has been a pioneer in the area of drug discovery and development globally. For nearly two decades, the company has been expanding its capabilities for world-class research in small molecules and biologics. To date, Glenmark has generated around USD 250 million through 8 out-licensing deals for novel molecules to global pharmaceutical companies including Merck, Eli Lilly, Sanofi and Forest Laboratories.

Glenmark’s current innovation pipeline consists of 8 assets, including new chemical entities (NCEs) and new biological entities (NBEs), in various stages of development in the areas of immunology, oncology and pain management. The pipeline includes 3 immuno-oncology bispecific antibodies developed through Glenmark’s proprietary BEAT platform. The new company will further leverage the BEAT platform to enhance the pipeline. Of the 5 clinical and 3 pre-clinical assets in development, 2 clinical assets are currently in Phase 2b, and 1 asset is likely to enter Phase 2b in FY20.

The new innovation company will operate in an environment of cutting edge technology, biotech research and attract best in class talent to complement existing capabilities, which will help provide further impetus to the innovation business.

About Glenmark’s innovative pipeline
Glenmark has the following innovative assets in its pipeline currently:

Oncology: Glenmark has 4 assets in the area of oncology. The 2 assets in Phase 1 clinical development are: GBR 1302, a HER2xCD3 bispecific antibody (bsAb), being evaluated for HER2 positive cancers and GBR 1342, a CD38xCD3 bsAb, being studied for multiple myeloma and other malignancies of hematopoietic origin as well as a variety of solid tumours. The 2 assets in pre-clinical studies are GBR 1372, an EGFRxCD3 bsAb, being evaluated for treatment of colorectal cancer and a small molecule oncology program based on tumor antigen presenting biology.

Immunology: The company has 2 assets in this area: GBR 830, an anti-OX40R monoclonal antibody, is currently in Phase 2b clinical development for indication in moderate-to-severe atopic dermatitis and GRC 39815, a new chemical entity, currently being evaluated in pre-clinical studies as an inhaled compound for the possible treatment of Chronic Obstructive Pulmonary Disorder (COPD). GRC 39815 is an inhibitor of the Retinoid-related Orphan Receptor gamma t (RORγt).

Pain: Glenmark has 2 assets for pain management in clinical studies: GRC 27864, a non-opioid, potent, selective and orally bioavailable inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1), is currently being evaluated in Phase 2b clinical development for osteoarthritic pain and GRC 17536, a TRPA1 antagonist, has completed a Phase 2a proof of concept study in patients with painful diabetic neuropathy.