On October 12, 2022 Australian diagnostics company Minomic International Ltd (Minomic) reported that their lead product, MiCheck Prostate,1 has recorded its initial commercial sales in the US, the world’s largest healthcare market (Press release, Minomic, OCT 12, 2022, View Source [SID1234621930]).

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Each year, two million American men2 undergo highly invasive prostate biopsies to diagnose prostate cancer after an elevated Prostate-Specific Antigen (PSA) test result. Prostate biopsies can result in side effects such as bleeding, infections and difficulty urinating.3 A significant proportion of these biopsies are unnecessary,4 as the patient does not have cancer or has a low-grade cancer that requires monitoring rather than intervention.

MiCheck Prostate is a blood test that can be quickly measured and reported providing an easy-to-understand graphical result. Urologists who have patients with elevated PSA can order the test and receive a report with the percentage risk of aggressive prostate cancer, helping avoid unnecessary biopsies.

The MiCheck Prostate test is run at Minomic Inc’s CLIA Certified "High Complexity" Laboratory located in Gaithersburg, Maryland. The test has become available following CLIA Laboratory registration and internal validation of MiCheck Prostate in 2022. The first tests have already been ordered by Las Vegas Urology, a large urology practice based in Nevada.

Each year, there are 1.2 million American men returning an elevated PSA result and a further 3 million under active surveillance due to an already elevated PSA, who would benefit from the use of MiCheck Prostate.

Importantly, MiCheck Prostate will be reimbursed through Medicare increasing access for a significant number of men. The most affected cohort are men over the age 65 with the majority (65%) covered by Medicare. Reimbursement also provides a direct pathway to commercial revenues for Minomic.

Dr Brad Walsh, Minomic CEO, said: "We are very excited to have completed the journey, bringing MiCheck Prostate to commercial reality in the key US market. The high negative predictive value of the test and its superior specificity can better inform urologists and uro-oncologists about the patient’s risk of aggressive prostate cancer."

Dr Vijay Goli, Urologist at Las Vegas Urology, said: "I really like the test, I can make a decision whether to biopsy in seconds using the graph in the MiCheck Prostate report. The report is much easier than other tests which take more time to work out the pathway and are very complicated."

Prostate cancer is the most commonly diagnosed cancer in Australia,5 with one in seven men affected. In the US, one in eight men will face this disease in their lifetime.6

Minomic is currently expanding their sales and marketing teams to reach more urology practices across the US, so that more men can benefit from this revolutionary test.

MiCheck Prostate is available through Minomic’s US laboratory and will soon be available for patients at selected Sonic pathology laboratories in Australia.

On October 12, 2022 Tavros Therapeutics, Inc., a precision oncology platform company leading the new frontier of targeted therapies exploiting tumors’ genetic vulnerabilities, and Vividion Therapeutics, Inc., a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders, and a wholly owned and independently operated subsidiary of Bayer AG, reported the companies have entered into a collaboration agreement to discover or target four oncology targets across an initial five-year term (Press release, Tavros Therapeutics, OCT 12, 2022, View Source [SID1234621928]).

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Tavros leverages its functional and computational genomics technologies to uncover unique vulnerabilities within tumors to discover novel targets and biomarkers in areas of high unmet clinical need and identify novel clinical positioning strategies for existing molecules.

Under the terms of the agreement, Tavros will receive $17.5 million in a cash upfront payment from Vividion, and is eligible to receive up to $430.5 million in potential future payments based on the achievement of prespecified preclinical, clinical development, and commercial milestones, as well as low-single-digit royalties on sales of certain potential programs. Vividion has options to pursue up to five additional targets with up to $482 million in potential additional future payments.

"The future of cancer treatment lies in the precision targeting of therapies in the optimal clinical settings. This partnership allows Tavros to expand the actionability of our platform into a new target space by pairing our precision oncology platform with Vividion’s unmatched ability to drug the traditionally undruggable," said Tavros CEO and co-founder Eoin McDonnell, Ph.D. "We’re thrilled to launch our work with Vividion and harness our combined expertise to reach patients with difficult-totreat cancers by uncovering and drugging the next generation of high-value targets and augmenting the efficacy of emerging compounds." RESTRICTED

"Despite decades of effort, many targets remain inaccessible to traditional small molecule drugs, and many others have uncertain relevance to disease," said Vividion Therapeutics CEO Jeffrey Hatfield. "This collaboration brings together two orthogonal, highly innovative and synergistic approaches to drug discovery that will address both of these challenges. Vividion has the ability to find and drug previously unknown, or cryptic, functional binding pockets on oncology and immunology targets of high interest, while Tavros has the potential to uncover previously unknown synthetic vulnerabilities or dependencies in deadly tumor cells. We believe this powerful combination of leading-edge technologies has the potential to deliver multiple breakthrough discoveries for cancer patients in need."

On October 12, 2022 Dr. Gregory Fiore, Co-Founder, President and CEO of Exacis Biotherapeutics reported that it will discuss strategies for funding RNA-based cell therapies as a panel member at the RNA Cell Therapies Summit (Press release, Exacis Biotherapeutics, OCT 12, 2022, View Source [SID1234621927]). The panel discussion, "The Science Speaks for Itself – But What Else is Required to Secure an Investment," will include both medical and venture capital experts. Panelists will reveal what investors look for when investing in RNA-based cell therapies and share insights into how best to work holistically with scientists, investors, and lawyers to secure investments. Discussion will also include the role a founders legacy plays in investment opportunities.

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With experience as CEO and CMO of multiple pharmaceutical and biotechnology companies and C-suite advisor for several early-stage biotechnology companies, Dr. Fiore is uniquely qualified to provide his expert knowledge in raising capital to advance new therapeutics.

"While scientific discovery is vital to the development of novel treatment options, securing financial support is a critical requirement in progressing new therapeutics all the way through to patient delivery," said Dr. Fiore.

The panel will take place at 2:30 pm ET on Thursday, January 26, 2023.

The RNA Cell Therapies Summit will take place January 24-26, in Boston. The meeting will focus on specific challenges associated with RNA cell therapy development and how to accelerate these promising therapies through the value chain.

On October 12, 2022 Dr. Gregory Fiore, Co-Founder, President and CEO of Exacis Biotherapeutics reported that it will participate in an industry leader fireside chat focused on "Taking a Look at the Current Learnings from iPSC-Derived Cell Therapies and Determining Future Outlook and Developments" at the 2nd iPSC-Derived Cell Therapies Summit (Press release, Exacis Biotherapeutics, OCT 12, 2022, View Source [SID1234621926]). Dr. Fiore will join an expert panel that will reflect on current learnings from therapy development to drive focus and motivation while highlighting the demands of the future. Discussion will include validating iPSCs as starting material for immuno-oncology and regenerative medicine therapies to drive further investment and efforts in the space.

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"These cutting-edge therapies are the future of medicine" said Dr. Fiore. "I am excited to be part of this forum where industry leaders can share their expertise on what is happening with iPSC-derived cell therapies and where the industry is heading."

The discussion will take place at 9 am ET on Tuesday, December 6, 2022.

Held December 6-7 in Boston, the 2nd iPSC-Derived Cell Therapies Summit will focus on the creation of safe and effective iPSC-derived therapies for immuno-oncology and regenerative medicine. Participants will include iPSC drug developers working from discovery to CMC and will cover topics such as optimizing directed differentiation, enhancing expansion, advancing next-generation gene engineering approaches to improve safety, and defining the critical quality attributes to develop best-in-class iPSC-based therapies.

On October 12, 2022 Dr. Gregory Fiore, Co-Founder, President and CEO of Exacis Biotherapeutics reported that it will present "Strategies to Develop Safe Cell Therapies Without Compromising Efficacy" at the 3rd Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit (Press release, Exacis Biotherapeutics, OCT 12, 2022, View Source [SID1234621925]). Dr. Fiore has gained a deep understanding of the complexity of developing cell-based therapies as CEO. CMO and C-suite advisor of multiple pharmaceutical and biotechnology companies.

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"Patient safety is essential in developing new therapies," said Dr. Fiore. "Finding the optimal benefit-risk balance where a therapy is as effective as possible, while limiting the risk to patients requires thorough exploration and is crucial for success."

The panel will take place at 5:00 pm CET on Wednesday, November 16, 2022.

The 3rd Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit will be November 16-17, in Vienna, Austria and online. The meeting will focus on the unique challenges related to CMC, analytical, process development, automation, manufacturing, facility design, aseptic processing, supply chain and others that developers of gene and cell therapies must resolve.