AXIM® Biotechnologies Completes Pre-Clinical Drug Studies on SPX-1009 Compound Proving Suppression of Melanoma Cells

On May 26, 2021 AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech," "AXIM" or "the Company"), an international healthcare solutions company targeting oncological and COVID-19 research, reported that it has completed pre-clinical drug studies on its patent pending compound SPX-1009, demonstrating the suppression of malignant metastatic melanoma cells (Press release, AXIM Biotechnologies, MAY 26, 2021, View Source;utm_medium=rss&utm_campaign=axim-biotechnologies-completes-pre-clinical-drug-studies-on-spx-1009-compound-proving-suppression-of-melanoma-cells [SID1234585596]). The independent research was completed by Dr. Douglas Lake’s laboratory at Arizona State University.

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"We are extremely excited with the results of the in vitro testing," said John W. Huemoeller II, Chief Executive Officer of AXIM Biotechnologies, Inc. "This potential therapeutic treatment could someday help control melanoma growth and metastasis with our compound SPX-1009 in a topical treatment."

Melanoma is the most serious type of skin cancer because of its ability to spread to other organs rapidly if it is not treated at an early stage. According to SkinCancer.org, an estimated 207,390 cases of melanoma will be diagnosed in the U.S. in 2021 and an estimated 7,180 people will die of melanoma in the U.S. in 2021.

SPX-1009 was first screened in a cell-free enzymatic assay for its ability to inhibit Quiescin Sulfhydryl Oxidase I ("QSOX1"), a tumor-derived enzyme that is important for cancer growth, invasion and metastasis, and was then tested for its ability to inhibit growth and invasion of a well-established A375 melanoma cell line and a low-passage patient-derived melanoma. 2D invasion assays and 3D tumor spheroid assays were employed to measure the effect of the compounds on tumor invasion.

As a next step, AXIM intends to initiate animal studies to demonstrate the ability of SPX-1009 to suppress tumor growth and metastasis in a murine model of melanoma. AXIM’s intellectual property related to the SPX-1009 technology is the subject of numerous patent-pending applications.

For more information about AXIM, please visit www.aximbiotech.com.

Oncorus to Present at Upcoming Jefferies Virtual Healthcare Conference

On May 26, 2021 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported that its President and Chief Executive Officer, Theodore (Ted) Ashburn, M.D., Ph.D., will present at the upcoming Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 2:00 p.m. ET (Press release, Oncorus, MAY 26, 2021, View Source [SID1234584765]).

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A live webcast of the presentation will be available under the Investors & Media section of Oncorus’ website at View Source A replay of the presentation will be archived on Oncorus’ site for 30 days following the event.

Concert Pharmaceuticals to Present at Upcoming Investor Conferences

On May 26, 2021 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that it will participate at the following upcoming virtual investor conferences (Press release, Concert Pharmaceuticals, MAY 26, 2021, View Source [SID1234584686]):

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The Jefferies Virtual Healthcare Conference
Fireside Chat Presentation on June 2, 2021 at 3:30 p.m. ET
The JMP Securities Life Sciences Conference
Fireside Chat Presentation on June 16, 2021 at 11:30 a.m. ET
A live webcast of the presentations may be accessed in the Investors section of the Company’s website at www.concertpharma.com. Please log on to the Concert website approximately 15 minutes prior to the scheduled webcast to ensure adequate time for any software downloads that may be required. A replay of the webcasts will be available on Concert’s website for two weeks following the presentations.

Cleveland Clinic Researchers Identify New Drug Target for Treating Aggressive Prostate Cancer

On May 26, 2021 Cleveland Clinic researchers reported that they have identified a promising drug target for treating and preventing aggressive, drug-resistant prostate cancer (Press release, Cleveland Clinic Foundation, MAY 26, 2021, View Source [SID1234583288]).

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Nima Sharifi, M.D.

The team, led by Nima Sharifi, M.D., of Cleveland Clinic’s Lerner Research Institute, demonstrated that inhibiting the protein H6PD led to significantly reduced tumor sizes and improved survival among mouse models with drug-resistant prostate cancer. The H6PD levels also were elevated in biopsied patient tumors, suggesting the protein might be targeted in patients for treatment.

"New treatment approaches for drug-resistant prostate cancer are desperately needed," said Dr. Sharifi, director of Cleveland Clinic’s Genitourinary Malignancies Research Center. "These findings suggest an entirely new strategy for treatment of men with this aggressive form of prostate cancer."

Enzalutamide, a current standard-of-care hormone therapy for metastatic prostate cancer, works by blocking androgen receptors, which are proteins that help drive cancer cells. While initially effective, most patients eventually develop resistance to the treatment. This resistance occurs when androgen receptors are blocked and cancer cells adapt to get their "fuel" from a similar receptor, called the glucocorticoid receptor.

These glucocorticoid receptors bind to and interact with the stress hormone cortisol. In an earlier study published in eLife, Dr. Sharifi and his team linked enzalutamide resistance to increased tumor cortisol levels. They found that tumors typically express a protein called 11β-HSD2, which inactivates cortisol. However, when this protein expression is inhibited in some tumors, cortisol and the glucocorticoid receptor are stimulated and become available for use by cancer cells.

"Taken together, our study findings suggest that pharmacologically inhibiting the H6PD protein can reverse drug resistance in prostate cancer cells," said Dr. Sharifi. "By blocking this protein, we are able to prevent cancer cells from utilizing their backup fuel supply – cortisol and its receptor. When we block this pathway, tumors begin to become responsive to standard treatments again."

In this new study, the researchers demonstrated that, in addition to decreased expression of 11β-HSD2, resistant tumors also have increased H6PD levels.

"With lower levels of 11β-HSD2, which normally functions to cut off the fuel supply to drug-resistant cancer cells, the cells are free to continue to grow and spread unchecked," said Dr. Sharifi. "By inhibiting the H6PD protein, however, we were able to reinstate anti-cortisol effects. This finding is key to better understanding how disruptions in cortisol metabolism contribute to cancer cells’ growth and spread."

Dr. Sharifi’s clinical collaborator Eric Klein, M.D., chair of Cleveland Clinic’s Urology & Kidney Institute and a co-author on the study, said, "We found elevated levels of H6PD in both animal models and patient tissues, particularly after treating tumors with enzalutamide. These findings hold promise for novel precision medicine approaches in the management of men with aggressive prostate cancer."

The researchers targeted H6PD with rucaparib, a drug already approved by the U.S. Food and Drug Administration. Dr. Sharifi collaborated with scientists from Cleveland Clinic’s Center for Therapeutics Discovery to identify what parts of rucaparib are chemically necessary to inhibit the protein.

Researchers administered enzalutamide to mouse models of aggressive prostate cancer that expressed H6PD and those where the protein was blocked with rucaparib. The models where H6PD was blocked had significantly smaller tumors and longer progression-free survival following enzalutamide treatment.

Jianneng Li, PhD, a post-doctoral fellow in Dr. Sharifi’s lab, is first author on the study, which was supported by the National Cancer Institute and the Prostate Cancer Foundation.

"These findings represent an exciting new opportunity to potentially reverse drug resistance in advanced prostate cancer," said Howard R. Soule, PhD, Executive Vice President and Chief Science Officer of the Prostate Cancer Foundation. "PCF commends Dr. Sharifi and the team on their achievement and proudly supports their work to bring us closer to our mission to eliminate death and suffering from prostate cancer."

Ysios Capital Closes its Third Fund at €216 Million ($260 Million)

On May 26, 2021 Ysios Capital, Spain’s largest and leading European venture capital firm specialised in the biotechnology sector, reported that it has closed its third fund, Ysios BioFund 3 (YBF 3) at €216 million ($260 million) (Press release, Ysios Capital, MAY 26, 2021, View Source [SID1234583259]).

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YBF 3 – Ysios’ largest fund to date – provides biotech ventures with the resources to develop novel and disruptive therapies for indications with high-unmet medical need, supporting pioneering businesses striving to make a difference in patients’ lives.

YBF 3 will invest broadly across multiple therapeutic areas and modalities, targeting seed/early stage and development-stage companies at the forefront of the future of medicine. The total investment size per company will typically be of up to €20 million.

Ysios takes lead positions and works closely with entrepreneurial management teams. Emphasis will be placed on building sustainable companies with business models offering dual paths to liquidity. As with previous funds, about 80% of the YBF 3 investments will target Europe, with a special focus on Spain, while the remainder of the fund will target opportunities in North America.

More than 60% of the portfolio has already been constructed, with eight investments made in the last 12 months by blue-chip European and US investors. YBF 3 has participated in the following fund raisings, mostly taking a lead or co-lead role:

Ona Therapeutics (Oncology, Spain) – €30M Series A
SpliceBio (Gene therapy, Spain) – Seed/company build-up
VarmX (Blood clotting, The Netherlands) – €32M Series B
Lava Therapeutics (Oncology, The Netherlands) – €70M Series C/IPO NASDAQ: LVTX $103M
SparingVision (Gene therapy, France) – €44.5M Series A2 round
Synendos (Neuropsychiatry, Switzerland) – CHF 24M Series A
Adcendo (Oncology, Denmark) – €51M Series A
Cytoki (Inflammation, Denmark) – €38M Series A
Commenting on the close, Joël Jean-Mairet, Managing Partner at Ysios Capital, said: "Our latest close is testament to the stellar track record we have built up at Ysios over the last ten years, securing investment beyond our initial target size. The quality of this company portfolio, exemplified by the recent IPO on NASDAQ of Lava Therapeutics shortly after our initial investment demonstrates the role we play in driving forward the future of medicine."

Karen Wagner, Managing Partner at Ysios Capital, added: "We are very proud of the work Ysios has supported over the last decade. With our latest fund, we have expanded the team and advisory board, which is key to our long-term commitment to bring medical products from lab to market."

A proven track record

Since its inception, Ysios has invested in 33 companies – including several of Spain’s biotech success stories – and has brought 14 innovative medical products to market. Currently, over 40 medical products across the portfolio are at the clinical stage for serious diseases and over €1bn has been invested in R&D.

Key liquidity events over the last years include the sale of Tigenix (formerly Cellerix) to Takeda (€450M), the purchase of STAT-Diagnostica by Qiagen (up to €172M), the sale of Endosense to St. Jude Medical ($331M), the investment and purchase option of Pfizer into Vivet (up to €540M), the sale of Biovex to Amgen (up to $1bn), the sale of Prexton to Lundbeck (€100M) and three listings on NASDAQ including Galecto (GLTO), Kala Pharmaceuticals (KALA) and Lava Therapeutics (LVTX).

YBF 3 receives EU backing

Following an initial investment of €30 million, the European Investment Fund (EIF), part of the European Investment Bank Group and a leading player in the European Venture Capital market, mobilised an additional €30 million of participation in the fund. This brings the total EIF related participation to €60 million, representing 27.7% of the total commitments.

Out of this additional €30 million investment, €20 million is backed by the European Guarantee Fund (EGF), part of the European Union’s €540 billion response to the economic fallout caused by COVID-19. The remaining €10 million investment is supported by the Health Compartment of the Sustainable Development Umbrella Fund (SDUF), which aims to crowd-in resources from private investors operating in the pharma and med-tech industry and foster collaboration between the latter and VC firms through the VCoE program, particularly emerging managers addressing markets such as Spain, where the innovation potential is relatively untapped.

Alain Godard, EIF Chief Executive, said: "The science, technology and innovation sectors have been pivotal in helping to address the immediate health challenges of the COVID-19 crisis. I am delighted to see that thanks to the European Guarantee Fund and the Sustainable Development Umbrella Fund we could increase our participation in YBF 3, backing the investment needs and growth of innovative life science companies that develop disruptive therapeutic products."

Jean-Marc Bourez, Managing Director/Head of the Venture Centre of Excellence said: "We are really delighted to welcome Ysios BioFund 3 that will gain access to the VCoE Programme, and brings together an exclusive community of selected venture capital funds and private corporate investors to bolster the flow of co-investment directed towards European life science start-up and small mid-caps."