On January 14, 2019 Oncoceutics, Inc. reported that the United States Patent and Trademark Office (USPTO) has issued patent #10,172,862 for the use of ONC201 to treat midline gliomas having a histone 3 K27M (H3 K27M) mutation (Press release, Oncoceutics, JAN 14, 2019, View Source [SID1234558362]). This patent extends the ONC201 patent life through at least 2038.

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This patent is the eighth issued on ONC201 in the United States, and expands the IP protection the company has received covering the compound’s use in cancer. These patents, combined with issued patents around the compound’s formulation and use in combination with other therapies, as well as FDA regulatory designations, provide ONC201 with a robust suite of intellectual property.

ONC201, a member of the imipridone family, has demonstrated anti-cancer activity and safety in preclinical models and ongoing clinical trials, including multiple clinical trials in adult and pediatric patents harboring this mutation, funded by grants from the NCI. These trials are being carried out at Massachusetts General Hospital, Dana Farber Cancer Institute, NYU Langone, MD Anderson Cancer Center, Levine Cancer Institute, Miami Cancer Institute, UCSF, and the University of Michigan. Recently, the FDA granted Fast Track Designation to ONC201 for the Treatment of Adult Recurrent H3 K27M-mutant High-Grade Glioma.

"We are delighted that the USPTO has recognized these indications as novel uses of ONC201 and granted the appropriate patent protections," said Martin Stogniew, Ph.D., Chief Development Officer of Oncoceutics. "The company’s current patent portfolio provides Oncoceutics more than 19 years of patent protection for the vast majority of human cancers, including tumor types where ONC201 is currently in Phase II trials."

On January 14, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported that the first clinical centers of the investigator-sponsored Phase II study EMERGE are open for patient recruitment (Press release, 4SC, JAN 14, 2019, View Source [SID1234532636]). The study is conducted by Prof. David Cunningham, MD FRCP FMedSci, Head of the Gastrointestinal and Lymphoma Unit and Director of Clinical Research at The Royal Marsden NHS Foundation Trust (London, UK).

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The multi-center, single-arm, open-label study examines domatinostat (formerly 4SC-202) plus checkpoint inhibitor avelumab in up to 70 patients with advanced gastrointestinal cancer – precisely microsatellite-stable esophago-gastric and colorectal (MSS-GI) cancer. The study is intended to establish the safety of combining domatinostat with avelumab as well as to generate proof-of-concept clinical data in this patient population.

Prof. Cunningham said: "Although checkpoint inhibitors are very successful in various solid tumor indications, MSS-GI cancer has proven to be largely therapy-resistant to these. The EMERGE study will seek to address this high medical need by using domatinostat to render the tumor tissue susceptible to avelumab. We need to study more drug candidates like domatinostat, which aim to broaden the efficacy of checkpoint inhibitors when used in combination."

Jason Loveridge, Ph.D., CEO of 4SC, added: "We are happy to support investigator-sponsored research conducted by third parties on our drug candidates. This research can provide valuable information regarding the safety, efficacy, pharmacology and tolerability of 4SC’s drug candidates and supplement the data generated in our own clinical studies. We are very proud that Prof. Cunningham, a widely respected expert in the field, chose to perform the EMERGE study with domatinostat and we are looking forward to the outcome."

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20 September 2018, 4SC AG: Domatinostat plus chemotherapy – Overcoming drug resistance

15 August 2018, FDA approves IND application for domatinostat (4SC-202) in melanoma

31 July 2018, First patient enrolled in 2nd dose cohort of Phase Ib/II study SENSITIZE of domatinostat (4SC-202) + pembrolizumab in melanoma

About domatinostat (4SC-202)

Domatinostat is an orally administered small molecule Class I selective HDAC inhibitor with a unique mode of action that was designed to strengthen the body’s own anti-tumor immune response. Domatinostat also influences the tumor microenvironment facilitating infiltration of immune cells into the tumor and making it more visible to the immune system.

Domatinostat has been investigated in a Phase I study with 24 heavily pretreated patients with several types of advanced hematologic cancers and was well tolerated. Positive signs of anti-tumor efficacy were also observed; with one complete remission (28 months) and one partial responder (8 months).

In addition to its therapeutic potential in cancer monotherapy, 4SC is evaluating domatinostat’s capacity as a partner in combination therapies, specifically in the immuno-oncology area. In this respect, 4SC initiated a Phase Ib/II study of domatinostat in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with advanced-stage melanoma. A second Phase II study of domatinostat in combination with the anti-PD-L1 checkpoint inhibitor avelumab in patients with advanced-stage microsatellite-stable gastrointestinal cancer is conducted by Prof. David Cunningham of The Royal Marsden NHS Foundation Trust (London, UK).

As soon as results from the aforementioned trials will be available, 4SC plans to advance domatinostat into a potentially pivotal study in combination with a checkpoint inhibitor in PD-(L)1 refractory patients with advanced Merkel-cell carcinoma (MCC).

On January 14, 2019 ASLAN Pharmaceuticals (NASDAQ:ASLN, TPEx:6497), a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe, reported an update on its global placebo-controlled, double-blind phase 2 clinical study of varlitinib as a first-line therapy in HER1/HER2 co-expressing advanced or metastatic gastric cancer patients, comparing varlitinib plus mFOLFOX6 to placebo plus mFOLFOX6 (Press release, ASLAN Pharmaceuticals, JAN 14, 2019, View Source [SID1234532652]). In the recently completed study, varlitinib did not meet the primary endpoint of significant reductions in tumour size after 12 weeks of treatment.

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Based on independent central review, patients treated with varlitinib plus mFOLFOX6 had an average tumour shrinkage of 22.0% after 12 weeks compared to 12.5% for patients treated with mFOLFOX6 alone. This difference did not reach statistical significance. Upon review of 17 progression free survival (PFS) events to date, there was a trend towards an improvement in PFS in patients treated with varlitinib.

Overall patient characteristics were well-balanced between the two arms with the exception of baseline ECOG status. The proportion of patients with the best performance status (ECOG of 0) was substantially higher in the control arm (46.2%) than in the varlitinib arm (19.2%).

Varlitinib in combination with mFOLFOX6 was very well-tolerated with 73.1% of patients taking varlitinib experiencing a grade 3 or higher adverse event compared to 88.5% of patients taking mFOLFOX6 alone.

Dr Mark McHale, Chief Operating Officer, ASLAN Pharmaceuticals, said: "First-line gastric cancer is a very challenging indication to treat and the majority of patients present with advanced disease at initial diagnosis. To date, no targeted therapies have been approved to treat gastric cancer with low HER-family expression. Whilst we are disappointed by the study findings, we are encouraged by the positive safety data and remain confident that varlitinib’s potent pan-HER inhibition has the potential to yield benefits in biliary tract cancer where HER family expression is known to be high. We look forward to presenting the upcoming data in first-line biliary tract cancer at ASCO (Free ASCO Whitepaper) GI later this week and delivering topline data from our pivotal TreeTopp study in second-line biliary tract cancer which is expected in the second half of 2019."

ASLAN will continue to analyse data from this study, working with study investigators on the future publication of these results, and will focus on development in biliary tract cancer and other indications where varlitinib has shown activity.

Ends

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About varlitinib (ASLAN001)

Varlitinib (ASLAN001) is a highly potent, oral, reversible, small molecule pan-HER inhibitor that targets the human epidermal growth factor receptors HER1, HER2 and HER4. These receptors can be mutated or overexpressed in many tumours, which can cause excessive proliferative activity and uncontrolled growth. Therefore, by inhibiting the activation of the HER receptors, varlitinib could inhibit proliferation and control tumour growth. Varlitinib is currently being studied in gastric, biliary tract, breast and colorectal cancers. Varlitinib has been granted orphan drug designation in the United States for gastric cancer and cholangiocarcinoma, a sub-type of biliary tract cancer, and was awarded orphan drug designation for the treatment of biliary tract cancer by the Ministry of Food and Drug Safety in South Korea.

On January 14, 2019 Bio-Thera Solutions Ltd ("Bio-Thera") reported that it has reached a licensing agreement with Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla") for BAT1706, its bevacizumab biosimilar, under which Cipla will have exclusive rights to distribute and market the drug in select emerging markets (Press release, BioThera Solutions, JAN 14, 2019, View Source [SID1234532637]).

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BAT-1706 is a mAb biosimilar to Genentech’s Avastin which is currently approved for six indications including metastatic colorectal cancer, recurrent glioblastoma and non-squamous non-small cell lung cancer. Bio-Thera’s BAT-1706 is currently in a global Phase III study (NCT03329911) in patients with previously untreated advanced non-squamous non-small cell lung cancer. Bio-Thera intends to file for regulatory approval with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA) in 2020.

This partnership will leverage Cipla’s strong local presence, sales and marketing capabilities in the select emerging markets. Bio-Thera will be responsible for full development, product registration with the FDA and EMA, and commercial supply of BAT1706 out of its manufacturing facilities in Guangzhou, China.

"Bio-Thera is pleased to partner with Cipla to commercialize our lead biosimilar program in select emerging markets", said Dr. Shengfeng Li, CEO of Bio-Thera. "This partnership is an important first step towards making BAT1706, our bevacizumab biosimilar product, availability globally to help increase patient access to this important cancer therapeutic at affordable prices."

"This agreement is in keeping with Cipla’s stated intention to build a strong pipeline of biosimilars through partnerships. We are committed to working towards ensuring patients receive access to life-saving drugs. Through this partnership, Cipla will leverage its strengths in marketing to take this key oncology biosimilar to patients in need." said Umang Vohra, MD & Global CEO of Cipla Limited.

On January 14, 2019 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that it will be presenting at the 21st Annual Needham Growth Conference, on Jan. 16, at 4:10 p.m., EST, at the Lotte New York Palace Hotel, New York City (Press release, Quanterix, JAN 14, 2019, View Source [SID1234532638]).

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To access the live webcast of Quanterix’ presentations, please visit the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. Replays of the webcast will be available on the Quanterix website for 90 days following the conference.