On February 16, 2021 ESSA Pharma Inc. ("ESSA", or the "Company") (Nasdaq: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that it has commenced an underwritten public offering of up to $100,000,000 of its common shares (the "Offering") (Press release, ESSA, FEB 16, 2021, View Source [SID1234575149]). ESSA intends to use the net proceeds of the Offering for pre-clinical and clinical activities, chemistry, manufacturing and controls, research and development, as well as working capital and general corporate purposes. In connection with the Offering, ESSA expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the common shares offered in the Offering (the "Option"). All common shares to be sold in the Offering will be offered by ESSA. The Offering is subject to market conditions, and there can be no assurance as to whether or when the Offering may be completed, or the actual size or terms of the Offering.

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Jefferies and Piper Sandler are acting as joint book-running managers for the Offering. Oppenheimer & Co. is acting as lead manager for the Offering and Bloom Burton Securities Inc. is acting as co-manager for the Offering.

The securities described above are being offered by ESSA in the United States pursuant to a shelf registration statement on Form S-3 (File No. 333-250971) that was previously filed by ESSA with the Securities and Exchange Commission (the "SEC") and became effective on December 29, 2020 and in Canada pursuant to ESSA’s Canadian short form base shelf prospectus (the "Canadian Base Shelf Prospectus") dated August 24, 2020 that was previously filed with the securities regulatory authorities in each of the provinces of British Columbia, Alberta and Ontario.

A preliminary prospectus supplement and accompanying prospectus relating to the Offering will be filed with the SEC and will be available on the SEC’s website at View Source A preliminary prospectus supplement to ESSA’s Canadian Base Shelf Prospectus will also be filed with the securities regulatory authorities in each of the provinces of British Columbia, Alberta and Ontario and will be available at View Source A copy of the preliminary prospectus supplement and accompanying prospectus can be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 547-6340; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924 or by email at [email protected].

The Offering is subject to customary closing conditions.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, 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.

On February 16, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at Citi’s 2021 Healthcare Services, Medtech, Tools & HCIT Virtual Conference on Thursday, February 25, 2021 at 9:50 a.m. EST (Press release, Bio-Techne, FEB 16, 2021, View Source [SID1234575092]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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On February 16, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing a drug to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer, castrate-resistant prostate cancer and leukemias, reported that Dr. Mark Erlander, chief executive officer of Cardiff Oncology will present at the upcoming LifeSci Partners Precision Oncology Day on February 17, 2021. The Company will also participate in one-on-one meetings (Press release, Cardiff Oncology, FEB 16, 2021, View Source [SID1234575114]).

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Details on the presentation can be found below.
Date: Wednesday, February 17, 2021 Time: 1:30 PM ET
Format:
Corporate Presentation

A replay of the presentation will be available by visiting the "Events" section of the Cardiff Oncology website after the conclusion of the presentation and will be archived on the Company website for 90 days.

On February 16, 2021 InteRNA Technologies reported that the first patient has been dosed in the first cohort of its first-in-human Phase I study with the Company’s lead microRNA candidate, INT-1B3 (Press release, InteRNA Technologies, FEB 16, 2021, View Source [SID1234575133]). The trial will evaluate safety and initial signs of efficacy of INT-1B3, a microRNA-mimic of the endogenous tumor suppressor miR-193a-3p formulated in next-generation lipid nanoparticles, in patients with advanced solid tumors. INT-1B3 represents a promising novel therapeutic approach that could address multiple hallmarks of cancer simultaneously by directly targeting tumor cells and the tumor microenvironment by specific modulation of multiple relevant signaling pathway components triggering a long-term T cell-mediated immune response against the tumor.

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"The enrollment of the first patient in this trial, especially during the ongoing COVID-19 pandemic, is a significant milestone for InteRNA," said Dr. Roel Schaapveld, CEO of InteRNA Technologies. "microRNAs represent a new class of therapeutic agents that have the potential to change the treatment paradigm in immune-oncology, delivering a combination approach as a single regimen. We are very pleased that the first patient completed the first cycle without dose-limiting toxicity, and enrolment of the second cohort could already be initiated. The trial will allow us to generate further important insights on the potential and underlying mechanisms of INT-1B3 and reinforces our commitment to bringing this novel modality to patients, especially for the treatment of hard-to-treat solid tumors."

This two-part, open-label, multiple ascending dose Phase I/Ib trial (NCT04675996) will evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of INT-1B3. The dose escalation part of the study (part 1) will be conducted in trial sites located in the Netherlands and Belgium and will enroll approximately 30 patients with advanced solid tumors. The dose expansion part of the trial (part 2) will be conducted in multiple clinical study centers located in several European countries as well as in the United States and will enroll up to 50 patients with hepatocellular carcinoma or triple negative breast cancer. All patients will receive INT-1B3 via infusions twice per week in 21-day cycles. Topline results from the dose escalation part of the study are expected by the end of 2021.

About INT-1B3

INT-1B3’s unique mechanism of action addresses multiple hallmarks of cancer simultaneously. It directly targets tumor cells and the tumor microenvironment by specific modulation of multiple signaling pathway components across the PTEN tumor suppressor pathway and the oncogenic PI3K/Akt and Ras/MAPK pathways resulting in inhibition of proliferation and migration and induction of cell cycle arrest and apoptosis. The triggering of the immunogenic tumor cell death (ICD) process as well as downregulation of the adenosine-A2A receptor pathway through inhibition of CD39/CD73 leads to a decrease in immunosuppressive FoxP3/Lag3 regulatory T cells and monocytic myeloid-derived suppressor cells (mMDSCs), and maturation of dendritic cells. As a result, the immune system is activated, and long-term immunity is triggered by recruitment of CD8+ effector T cells leading to decreased metastasis development and improved animal survival compared to anti-PD1 treatment in preclinical models.

On February 16, 2021 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported the final results of its in-vivo study evaluating the efficacy of the company’s proprietary drug candidate RCC-33 for the treatment of colorectal cancer in nude-mice (Press release, Cannabics Pharmaceuticals, FEB 16, 2021, View Source [SID1234575150]). The final study results demonstrate a significant and robust inhibitory effect on tumor growth, as evidenced by a 33% reduction in tumor volume in mice exposed to RCC-33 in comparison with sham control mice (p ≤ 0.016).

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Both the experimental and the control groups were inoculated with human colorectal cancer cells. Daily doses of intraperitoneal (IP) delivery of RCC-33 or sham control were initiated on day 5. Differences in tumor volume between the two groups were first observed after 5 days of treatment (day 10). Previously published interim results showing a 27% reduction in tumor volume were recorded after 12 days of treatment (day 17), with p value ≤ 0.022. The study was concluded after 16 days of treatment (day 21) when a member of the control group reached a predetermined tumor size. Final results recorded a significant and robust 33% reduction in tumor volume in RCC-33 treated mice in comparison with the control group, p value ≤0.016.

Eyal Barad, Cannabics Pharmaceuticals’ Co-founder and CEO said: "The outlook of the oncology market puts this sector’s therapeutics sales forecast at $250 billion by 2024, according to a recent McKinsey report. While this is the market we ultimately have in sight, our initial penetration efforts with RCC-33 are focused on developing a colorectal cancer treatment catering to a $10 billion market with a ‘massive unmet need’, as articulated in the same McKinsey report".

Gabriel Yariv, Cannabics Pharmaceuticals’ President and COO said: "Having successfully completed this in-vivo POC study, the company is now planning to finalize its product dossier preparation for a forthcoming submission to the FDA along with a request for a pre-IND meeting for RCC-33. We are paving the way with a potentially new treatment approach for colorectal cancer patients, one that could possibly have an important positive impact on a large group of patients, and we feel comfortable and look forward to bringing our scientific data before the regulatory authorities for review".