On April 28, 2021 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment for cancer and fibrosis, reported that data that it has received during its collaboration with Professor Paul Timpson of the Garvan Institute of Medical Research, Sydney ("Garvan") (Press release, Amplia Therapeutics, APR 28, 2021, View Source;[email protected] [SID1234578670]).

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In March, Amplia announced that it had agreed terms for a collaboration with the Garvan. This collaboration has brought together Amplia’s clinical-stage FAK inhibitors with the Garvan’s unique insights into FAK biology and its clinical research network.

Amplia has now received data from work conducted under this collaboration in which AMP945 was tested in a range of different in vitro and in vivo experimental systems that have been established over many years in Professor Paul Timpson’s laboratory at the Garvan. These data have demonstrated that AMP945 impacts several key markers of disease, including the level of fibrosis and collagen maturity in the tumour environment in a mouse model of pancreatic cancer. Furthermore, when combined with gemcitabine/Abraxane, which is a standard of care in pancreatic cancer, AMP945 enhances the activity of the chemotherapy as determined by key indicators of cell death and of cancer cell proliferation. Specifically, after a single round of treatment, AMP945, in combination with gemcitabine/Abraxane, caused a significant increase in levels of cleaved Caspase-3 which is a marker of cancer cell death. In addition, Ki67, a marker of cancer cell proliferation, was significantly decreased after dosing with both AMP945 and gemcitabine/Abraxane.

John Lambert, CEO of Amplia Therapeutics commented that "We are extremely happy to see such positive results coming out of the Timpson Lab with AMP945. These data provide further validation of our approach of using our proprietary FAK inhibitors to enhance the effectiveness of the current therapies for this difficult to treat disease. It is very encouraging to see that AMP945 is able to directly reduce the levels of fibrosis is these tumour models, as well as enhance the activity of gemcitabine/Abraxane, which is currently standard treatment for many pancreatic cancer patients."

In light of the positive data received from the Timpson Laboratory and the emerging clinical data from the Company’s Phase 1 trial in healthy volunteers, Amplia has now started planning a Phase 2 clinical trial of AMP945 in pancreatic cancer patients. Amplia is currently working closely with a range of clinical advisors, clinical pharmacologists, statisticians and potential vendors to finalise the required regulatory applications and refine the study protocol. This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On April 28, 2021 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel therapies for serious rare and ultra-rare genetic diseases, reported that it will host a conference call on Tuesday, May 4, 2021 at 5pm ET to discuss its financial results and corporate update for the first quarter ended March 31, 2021 (Press release, Ultragenyx Pharmaceutical, APR 28, 2021, https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-host-conference-call-first-quarter-2021-financial [SID1234578668]).

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The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call by phone, dial (855) 797-6910 (USA) or (262) 912-6260 (International) and enter the passcode 6883837. The replay of the call will be available for one year.

On April 28, 2021 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) (the "Company") reported it has entered into a definitive agreement with institutional investors in a private placement of 3,669,724 shares of common stock and warrants to purchase 1,834,862 shares of common stock at a combined purchase price of $2.18 per share for gross proceeds of approximately $8,000,000 before deducting fees and other estimated offering expenses (Press release, Nymox, APR 28, 2021, View Source [SID1234578667]). The warrants will have an exercise price of $2.50 per share, will be immediately exercisable and will expire five years from the date of issuance.

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The Company expects to use the net proceeds from the private placement for working capital and other general corporate purposes. The private placement is expected to close on or about April 30, 2021, subject to the satisfaction of customary closing conditions.

A.G.P./Alliance Global Partners is acting as sole placement agent for the private placement.

The private placement is being made pursuant to the exemption from securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506 of Regulation D as promulgated by the United States Securities and Exchange Commission (the "SEC") and the securities being sold in the private placement may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement on Form F-3 with the SEC covering the resale of the shares of common stock, as well as the shares of common stock issuable upon exercise of the warrants, issued in the private placement.

This 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 other 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 other jurisdiction.

On April 28, 2021 RACON 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 first quarter 2021 financial and operating results after the close of U.S. financial markets on Wednesday, May 5, 2021 (Press release, Tracon Pharmaceuticals, APR 28, 2021, View Source [SID1234578665]). In addition, management will host a conference call to provide an update on corporate activities and discuss the financial results.

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Conference call and webcast:
Date: May 5, 2021
Time: 4:30 pm Eastern Time (1:30 pm Pacific Time)
Dial-in: (855) 779-9066 (Domestic) or (631) 485-4859 (International)
Passcode: 8852857
Via web: www.traconpharma.com; "Events and Presentations" section within the "Investors" section
A replay of the webcast will be available for 60 days on the website.

On April 28, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported their plan to add a blood-based 52-gene next generation sequencing (NGS) test to their portfolio of molecular testing based on a recent publication (Press release, Biodesix, APR 28, 2021, View Source [SID1234578664]). Of critical importance, the publication, "Targeted Next-Generation Sequencing of Liquid Biopsy Samples from Patients with NSCLC," in Diagnostics showed that the rapid liquid biopsy testing was able to detect actionable genomic alterations in patients with non-small cell lung cancer (NSCLC) with an unmatched turnaround time of only 72 hours.

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The test has been in use for biopharma research testing and is performed in Biodesix’s ISO 13485-certified, New York Clinical Laboratory Evaluation Program (CLEP)-approved, College of American Pathologists (CAP)-accredited, Clinical Laboratory Improvement Amendments (CLIA)-high complexity certified clinical testing laboratory. With the turnaround time for existing, on-market liquid biopsy NGS tests ranging from 7-14 days, improving turnaround time to three days can be critical for patients with advanced NSCLC who are unable to undergo biopsy or whose biopsies have yielded insufficient test results.

"We observed significant agreement (95.7%–100%) with an orthogonal, high-sensitivity Droplet Digital Polymerase Chain Reaction (ddPCR) test," said Gary Pestano, Ph.D., Chief Development Officer at Biodesix. "This method offers a valuable supplement to assessing targeted mutations from blood while conserving specimens and maintaining sensitivity, with rapid turnaround time to actionable results."

The NGS test will complement the now 36-hour turnaround time that GeneStrat ddPCR and VeriStrat tests currently offer with the expanded coverage of 52-genes and broader molecular markers. The 52-gene NGS test will be used for advanced, late-stage, or recurrent cancer mutation detection, and the targeted 6-gene GeneStrat test can be used for identification of the select mutations for treatment guidance, recurrence monitoring, and detection of the development of resistance mutations over time. The company expects to begin offering this testing strategy in the first half of 2022.

"This test allows Biodesix to offer comprehensive molecular test results, with small and large genomic testing panels in combination with our immune profiling test for early and advanced NSCLC," said Scott Hutton, CEO of Biodesix. "We believe that by adding this NGS test to our current portfolio and multi-omics approach, we can enable physicians to make critical treatment decisions for their patients across the continuum of care in the shortest amount of time available today."