InterVenn Biosciences Adds Glycoproteomic Clinical Testing Panel for Colorectal Cancer and Advanced Adenoma

On March 23, 2020 InterVenn Biosciences reported it has added a colorectal cancer/advanced adenoma diagnostic panel to its proprietary glycoproteomic analysis platform (Press release, InterVenn Biosciences, MAR 23, 2020, View Source [SID1234555766]). These new indications are the latest for the company which has already demonstrated capabilities in ovarian, pancreatic, prostate, renal, hepatocellular, nasopharyngeal, and lung cancer, and in non-alcoholic steatohepatitis (NASH) liver disease and idiopathic lung fibrosis. InterVenn’s blood test for ovarian cancer is currently being validated in a multicenter, international prospective clinical trial, V.O.C.A.L., to demonstrate its utility and value as a clinical decision-making tool.

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"One in every 25 Americans will be diagnosed with colorectal cancer at some point in their lifetime, making this the third-leading cause of cancer-related deaths. As many as 60 percent of these deaths could be avoided with early intervention based on improved screening. The availability of a readily accessible, simple blood test, supplementing and guiding the use of screening colonoscopies, could radically increase the numbers of patients in whom colorectal cancer is prevented, or detected at a curable stage," said Klaus Lindpaintner, Chief Scientific and Medical Officer of InterVenn Biosciences.

The addition of a colorectal cancer/advanced adenoma diagnostic panel follows similar highly promising results the company has seen in its use of glycoproteomics in other indications. InterVenn has demonstrated that combining proteomics with glycomics, along with relevant phenotypical annotation data and powerful, high-precision, scalable data processing, and bioinformatics engine affords critical advances in biomarker and target discovery and utilization that have not been possible using conventional technologies. A pilot study at InterVenn’s new South San Francisco laboratory has now demonstrated the platform’s capability to detect colorectal cancer with very high accuracy (98 percent sensitivity and 91 percent specificity). Moreover, the test performs similarly well (98 percent sensitivity and 85 percent specificity) in the detection of advanced adenomas, an unprecedented accomplishment in testing performance. InterVenn’s colon cancer testing panel will be part of the company’s portfolio of offerings as it works with partners towards commercialization both in the U.S. and globally.

"InterVenn works with multiple top-tier institutional and industry partners for every indication to ensure that the data and results we publish are of the highest quality. Our industry partners are excited about moving forward with us to co-develop our colorectal cancer and advanced adenoma test, and we look forward to working hand in hand with them to bring this test to the market and to patients and health care providers as quickly and widely as possible," said Aldo Carrascoso, Chief Executive Officer of InterVenn Biosciences.

InterVenn’s application of glycoproteomics leverages the power of ultra-high-pressure- liquid-chromatography and mass-spectrometry for the generation of high-resolution, accurate-mass data on post-translational protein modifications, coupled with the prowess of artificial intelligence and machine learning technology to streamline the analysis of clinically relevant data. Importantly, InterVenn’s robust workflows and algorithms ensure that the laboratory-related variabilities inherent in any clinical study are minimized – from sample collection, sample processing, all the way to mass spectrometry instrument measurements – and that the results are reproducible. OpenPIP, the company’s AI-enabled mass spectrometry analysis software, which the company has made available to the scientific community at large as a public-domain tool, dramatically reduces the time and cost of analyzing mass spectrometry data while increasing data quality by eliminating observer-based bias.

To find out more about InterVenn Biosciences and how the company is leveraging artificial intelligence and mass spectrometry to the transformation of medical technology, visit View Source For all general and media inquiries about InterVenn Biosciences, please contact Andrea Vuturo at [email protected].

INTELGENX TO REPORT FOURTH QUARTER AND FULL-YEAR 2019 FINANCIAL RESULTS ON MARCH 26; CONFERENCE CALL TO FOLLOW ON MARCH 27

On March 23, 2020 IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a leader in pharmaceutical films, reported that it will release its fourth quarter and full-year 2019 financial results before market open on Thursday, March 26, 2020 (Press release, IntelGenx, MAR 23, 2020, View Source [SID1234555746]).

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As previously announced, the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 26, 2020 for completion of its review of IntelGenx’s 505(b)(2) New Drug Application ("NDA") for RIZAPORT VersaFilm for the treatment of acute migraines.

In order to facilitate a discussion on both the financial results and the FDA’s anticipated decision on the RIZAPORT NDA, a conference call has been scheduled for Friday, March 27. The call will be hosted by Dr. Horst G. Zerbe, Chief Executive Officer, and Mr. Andre Godin, President and Chief Financial Officer. Details of the conference call and webcast are below:

Date: Friday, March 27, 2020

Time: 8:30 a.m. ET

Conference dial-in: (833) 231-8269

International dial-in: (647) 689-4114

Conference ID: 5685777

Live Webcast Registration: Click here

CEL-SCI Announces Bought Deal Offering

On March 23, 2020 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported that it has entered into an underwriting agreement with Aegis Capital Corp. under which the underwriter has agreed to purchase on a firm commitment basis a minimum of 500,000 shares of common stock of the Company, at a price to the public of $12.22 per share (the "Public Price"), representing a 5% discount to the closing price per share (Press release, Cel-Sci, MAR 23, 2020, View Source [SID1234555767]). The closing of the offering is expected to occur on or about March 26, 2020, subject to customary closing conditions.

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Aegis Capital Corp. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 45-day option to purchase up to 15% of the offering at the Public Price. The use of proceeds will be to fund the continued development of Multikine, LEAPS and for other general corporate purposes.

The shares of common stock described above are being offered by CEL-SCI pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226558) filed with the Securities and Exchange Commission (SEC) and the accompanying prospectus contained therein. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering has been filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained on the SEC’s website at View Source or by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.

Oasmia presents Q3 report through audiocast on March 27

On March 23, 2020 Oasmia reported that it will hold an audiocast and telephone conference on Friday 27 March at 10:00 (CET) to present the company’s Q3 report for the financial year 2019/2020 (Press release, Oasmia, MAR 23, 2020, View Source [SID1234556576]).

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The presentation of the Q3 report will be in English.

Presenters will be Francois Martelet, CEO, and Michael af Winklerfelt, CFO.

The audiocast is viewed via the link
View Source
It will be possible to ask texted questions directly via the Audiocast solution.

Vaccitech and Oxford University Announce Promising Phase 2a Data on Prostate Cancer Immunotherapy

On March 23, 2020 Vaccitech Limited and the University of Oxford reported initial efficacy and safety data for ADVANCE, a Phase 2a study testing VTP-800, an immunotherapeutic product candidate in patients with metastatic castration resistant prostate cancer (mCRPC) (Press release, Vaccitech, MAR 23, 2020, View Source [SID1234555747]). The study demonstrated that VTP-800 is safe and showed an encouraging efficacy trend in patients with mCRPC.

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ADVANCE (NCT03815942) is an open-label, non-randomized study sponsored and conducted by the University of Oxford and funded by the European Commission FP7 programme and Vaccitech. The objectives of the study are to measure the safety of the immunotherapeutic VTP-800 when combined with an anti-PD-1 agent, and the reduction in serum prostate-specific antigen (PSA) levels as a surrogate biomarker used to evaluate the efficacy of prostate cancer treatments.

VTP-800 is comprised of Vaccitech’s Chimpanzee Adenovirus Oxford 1 vector (PRIME) encoding the oncofetal antigen 5T4 (ChAdOx.5T4), followed by a Modified Vaccinia Ankara vector (BOOST) encoding the same antigen (MVA.5T4) administered in a heterologous prime-boost regimen.

In the 23 mCRPC patients who received VTP-800 in conjunction with an anti-PD-1, 5 patients (22%) had a >50% reduction in PSA level at any timepoint compared to baseline (median of 88 ng/ml). This compares favourably to the 9% response rate reported from a previous anti-PD-1 monotherapy study, KEYNOTE-199, which evaluated 243 mCRPC patients with similar baseline PSA levels. Additionally, four of the five ADVANCE patients (17.4%) maintained their response when tested three weeks later versus 5.8% in the KEYNOTE-199 study. One ADVANCE patient had a response with a PSA level of 0 at 24 weeks.

Whilst full analysis is still pending, initial safety data is comparable to that seen from dosing anti-PD-1 alone and there are no serious adverse events attributable to VTP-800.

ADVANCE patients received two cycles of VTP-800 four weeks apart and 480 mg of an anti-PD-1 agent on weeks 4, 8 and 12 of treatment. KEYNOTE-199 patients received 200 mg of anti-PD-1 every three weeks for up to 35 weeks.

"We are encouraged by these data and we believe they validate the application of our platform in other oncology indications using different antigens," stated Bill Enright, Vaccitech CEO. "We look forward to continuing to work with Oxford University to explore options for future clinical studies to evaluate the added patient benefit VTP-800 can provide when combined with checkpoint inhibitors."

"We have seen promising clinical activity of VTP-800 in conjunction with an anti-PD-1, including responses in patients with advanced hormone resistant prostate cancer that are resistant to standard treatments. These encouraging data will hopefully lead to the initiation of a larger phase 2 clinical trial in patients with advanced prostate cancer," commented Dr Mark Tuthill, Chief Investigator of ADVANCE.

Previous VTP-800 studies

Phase 1 study (VANCE) in pre-surgical, early-stage prostate cancer patients. Data presented at ASCO (Free ASCO Whitepaper) 2018: View Source