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 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 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.

On January 14, 2019 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported the closing and funding of its previously announced underwritten public offering of 13,333,334 shares of its common stock ("Common Stock") at a public offering price of $0.225 per share (Press release, BioServe Biotechnologies, JAN 14, 2019, View Source [SID1234532671]). The Company has also granted the underwriter an option for 45 days to purchase an additional 2,000,000 shares, at a price to the public of $0.225 per share. The Company’s Chairman, John Pappajohn; board director, Geoffrey Harris and President and Chief Executive Officer, John A. Roberts, each purchased shares in the offering. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses are $3.0 million.

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H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

Cancer Genetics intends to use the net proceeds from this offering to pay lender fees and other costs incurred in connection with the potential forbearance agreements Cancer Genetics is negotiating with its banks, to pay certain costs previously incurred in connection with its on-going strategic initiatives, and if any proceeds remain available, to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 5, 2017. A prospectus supplement describing the terms of the offering was filed with the SEC on January 9, 2019, and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.