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U.S. Food and Drug Administration has Granted Orphan Drug Designation to XOMA’s Licensed anti-TGFβ Asset NIS793

On July 28, 2021 XOMA Corporation (NASDAQ: XOMA), reported NIS793 in combination with standard of care chemotherapy has been granted Orphan Drug Designation in pancreatic cancer by the U.S. Food and Drug Administration (Press release, Xoma, JUL 28, 2021, View Source [SID1234585306]). NIS793 is a potential first in class novel antibody specific for Transforming Growth Factor Beta (TGFβ). An Orphan Drug Designation grants special status to a drug that treats a rare disease or condition and provides companies certain benefits to encourage the continued development of medicines that bring novel solutions to patients with these severe diseases1.

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"Pancreatic cancer is a particularly difficult diagnosis for a patient to receive. The statistics clearly demonstrate pancreatic cancer is an unmet medical need, and we are highly supportive of Novartis’ efforts to bring NIS793 to this patient population," said Jim Neal, Chief Executive Officer at XOMA.

Under the terms of the 2015 agreement between XOMA and Novartis, XOMA has the potential to earn up to $445 million in additional milestone payments. Upon receipt of regulatory approval to commercialize NIS793, XOMA will receive tiered royalties on any net product sales that range from the mid-single digits to the low double digits.

NIS793 is an investigational compound. Efficacy and safety have not been established. There is no guarantee that NIS793 will become commercially available.

Synthetic Biologics to Report 2021 Second Quarter Operational Highlights and Financial Results on August 5, 2021

On July 28, 2021 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, reported that the Company intends to release its operational highlights and financial results for the quarter ended June 30, 2021 on Thursday, August 5, 2021, and to host a conference call the same day at 4:30 p.m. ET (Press release, Synthetic Biologics, JUL 28, 2021, View Source [SID1234585305]). The dial-in information for the call is as follows:

Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archived replay of the call will be available for approximately ninety (90) days at the same URL, View Source beginning approximately one hour after the call’s conclusion.

Bio-Techne and PROGEN Introduce New Simple Plex AAV2 Immunoassay

On July 28, 2021 Bio-Techne Corporation (NASDAQ: TECH) and PROGEN reported the launch of the Simple Plex Adeno-Associated Virus (AAV2) viral titer assay for AAV2 total capsid quantification (Press release, Bio-Techne, JUL 28, 2021, View Source [SID1234585304]). Bio-Techne, owner of the leading ProteinSimple branded protein analysis portfolio of products, and PROGEN will offer the Simple Plex AAV2 viral titer assay on Ella instruments, its multiplexing immunoassay system. Combining the efficiency and reproducibility of the established AAV2 ELISAs from PROGEN with the convenient workflow and robustness of the Ella platform, the Simple Plex AAV2 viral titer assay offers a broad dynamic range and hands-free automation to accelerate cell and gene therapy process development. Featuring antibodies from PROGEN, the Simple Plex AAV2 viral titer assay detects assembled viral capsids as well as the comprehensively characterized AAV2 standard to deliver industry leading specificity.

AAV2 is commonly used in gene transduction because of its ability to readily infect a variety of cell types. During the viral vector production process, a series of robust analytical measurements are required to determine the viral titer. The Simple Plex AAV2 assay features an automated workflow designed to minimize variability and ensure optimum and consistent quantitation throughout the viral purification process.

Available on the Ella platform, the Simple Plex AAV2 assay utilizes the recombinant AAV2 antibody (A20R) from industry leader PROGEN to quantify assembled AAV2 capsids. The AAV2 assay offers the same proven specificity as the industry standard PROGEN ELISA along with the convenience and simplicity of the fully automated Ella platform.

"As the cell and gene therapy field continues to expand, the ability to meet increased throughput and safety demands is critical," said Dave Eansor, President of BioTechne’s Protein Sciences division. "The Simple Plex AAV2 assay’s high sensitivity and broad dynamic range is particularly useful for AAV2 quantitation, providing researchers with a fully automated and quantitative method of vector analysis."

"Working with ProteinSimple to develop the Simple Plex AAV2 assay was a great experience," said Katja Betts, CEO of PROGEN. "As the leader in AAV capsid titer quantification and exclusive manufacturer of the most commonly used AAV antibodies and accompanying AAV ELISA kits, we are delighted to drive forward the development of robust & reliable quantification methods for the gene therapy community."

The Ella platform allows users to perform high-quality immunoassays with no manual intervention, delivering results in just 90 minutes and requiring only 50 µL of diluted sample. Factory calibration of each Simple Plex assay cartridge minimizes setup time and user error. Setting up an assay simply requires loading diluted samples into the cartridge. Once loaded, the Ella platform performs every step of the immunoassay automatically, from wash steps to final quantification of results.

PROGEN provides an exclusive portfolio of AAV antibodies including antibodies against intact AAV virus particles of which the A20R, used for the PROGEN AAV2 ELISAs as well as the Simple Plex AAV2 assay represents the most frequently used example. The AAV antibodies are also used for the analysis of AAV capsid integrity, purification and represent a suitable positive control for neutralization assays to analyze pre-existing AAV antibodies in patient sera. Due to their high affinity and specific binding to fully assembled AAV particles the PROGEN antibodies are well-established tools for AAV gene therapy R&D and quality control.

IntelGenx Announces Subscription for Notes

On July 28, 2021 IntelGenx Technologies Corp. (TSXV: IGX) (OTCQB: IGXT) (the "Company" or "IntelGenx") reported that it has received subscriptions from investors in the United States for U.S.$2.1 million principal amount of 8% convertible notes due July 31, 2025 (the "Notes") (Press release, IntelGenx, JUL 28, 2021, View Source [SID1234585302]). The Notes will bear interest at a rate of 8% per annum, payable quarterly, and will be convertible into shares of common stock of the Company (the "Shares") beginning 6 months after their issuance at a price of U.S.$0.40 per Share. The offering of the Notes (the "Offering") is subject to the approval of the TSX Venture Exchange, receiving an exemption from the prospectus requirement from the Autorité des marchés financiers, and other customary closing conditions. The Offering is expected to close on or about July 30, 2021.

The Company intends to use the proceeds of the Offering to finance the Company’s Montelukast study.

This press release does not constitute an offer to sell, or a solicitation of an offer to buy, securities in any jurisdiction where not permitted by law. Any securities described in this announcement have not been registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and may not be offered or sold in the United States, or to, or for the account or benefit of a "U.S. person" as defined in Regulation S under the U.S. Securities Act, except in transactions exempt from, or not subject to, registration under the U.S. Securities Act and applicable state securities laws.

TRACON to Report Second Quarter 2021 Financial Results and Company Highlights on August 11, 2021

On July 28, 2021 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that it will report its second quarter 2021 financial and operating results after the close of U.S. financial markets on Wednesday, August 11, 2021 (Press release, Tracon Pharmaceuticals, JUL 28, 2021, View Source [SID1234585299]). In addition, management will host a conference call to provide an update on corporate activities and discuss the financial results.