On December 8, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported that the U.S. Food and Drug Administration (FDA) has approved OPKO’s 4Kscore Test (Press release, Opko Health, DEC 8, 2021, View Source [SID1234596602]). This test is approved for use in men age 45 and older who have not had a prior prostate biopsy or are biopsy negative and have an age-specific abnormal total PSA and/or abnormal digital rectal exam (DRE). The 4Kscore Test provides a numerical value to assess the presence of aggressive prostate cancer before a decision is made to perform a prostate biopsy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The 4Kscore Test is currently available at BioReference Laboratories, an OPKO Health Company, through its specialty oncology and urology division, GenPath.

"The 4Kscore Test has been available as a Laboratory Developed Test (LDT) since 2014. The FDA approval provides further validation of its value as an important tool in the diagnostic paradigm for prostate cancer," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories, Inc.

The FDA approval is based on data from two prospective clinical studies carried out in the United States. Annually, about 20 million total PSA tests are performed in the United States and 10-15% of the results are found to be abnormal. The 4Kscore Test is calculated using a proprietary algorithm that includes values of a subject’s four different prostate specific kallikrein biomarkers, age, prior biopsy history and DRE status. The algorithm was developed by a team at Memorial Sloan Kettering, based on more than 30,000 cryopreserved blood samples, including assessment of the relationship of the 4Kscore Test to the subjects’ long-term prostate health outcome.

The 4Kscore Test has been used by more than 7,700 health care providers including approximately 4,200 urologists. Over 300,000 tests have been performed since its launch as an LDT in 2014. The test has been included in the National Comprehensive Cancer Network Guidelines (NCCN) since 2015 and European Association of Urology Prostate Cancer Guidelines since 2016. OPKO has offered the 4Kscore Test in the U.S., Europe and elsewhere.

About the 4Kscore Test

The 4Kscore Test is an in vitro serum or plasma test that combines four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA and human kallikrein 2) into a single numerical score that also incorporates a patient’s age, previous biopsy status and digital rectal exam results. The 4Kscore Test is indicated for use with other patient information as an aid in the decision for prostate biopsy in men 45 years of age and older who have an abnormal age-specific total PSA and/or abnormal DRE. The 4Kscore Test is intended to aid in detection of aggressive prostate cancer (Gleason score ≥7/Gleason Grade Group ≥2) for whom a biopsy would be recommended by a urologist, based on current standards of care before consideration of the 4Kscore Test. A 4Kscore <5.0 is associated with decreased likelihood of a Gleason score ≥7 on biopsy.

The intended use population are:

Men 45-54 years old and total PSA ≥2 ng/mL and/or abnormal DRE
Men 55-75 years old and total PSA ≥3 ng/mL and/or abnormal DRE
Men ≥76 years old and total PSA ≥4 ng/mL and/or abnormal DRE
Prostate biopsy is required for the diagnosis of cancer. The test is not recommended more than once every 6 months. The test is intended for professional use only. For more information about the 4Kscore Test, please visit www.4Kscore.com.

On December 8, 2021 Onxeo S.A. (Euronext Growth Paris: ALONX, First North Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR), reported the presentation of new preclinical data confirming the differentiated antitumoral properties of AsiDNA, its first-in-class DNA Damage Response (DDR) inhibitor, in poster and oral sessions during the EACR-AstraZeneca Virtual Conference organized by the European Association for Cancer Research and AstraZeneca on the theme of "Drug Tolerant Persister Cells" (7-8 December, 2021) (Press release, Onxeo, DEC 8, 2021, View Source [SID1234596601]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Several studies have shown that a small population of tumor cells, treated by targeted therapies, evade cell death by entering a reversible dormancy state known as the Drug-tolerant persister (DTP) state. These DTP cells are identified as major source of targeted therapy failures, thus leading to cancer relapse.

The data presented by Onxeo show that the addition of AsiDNA to targeted therapies prevents the regrowth of the DTP cells, thereby completely and irreversibly abolishing the emergence of resistance in tumor cells. The Company first discovered this unique property of AsiDNA in combination with PARPi (see Poster at AAC virtual meeting 2020). The most recent preclinical studies presented at EACR-AstraZeneca Virtual Conference, confirmed the prevention of resistance in other relevant tumor models where AsiDNA was combined with targeted therapies such as KRASi and EGFRi.

Judith Greciet, Chief Executive Officer of Onxeo, stated: "As already demonstrated in our previous studies, drug-tolerant persister cells are a well-established cause of resistance to targeted therapies such as TKIs and PARPi. Our new data provide further evidence that these cells are a major source of resistance to different cancer treatments, and that AsiDNA could be a therapeutic strategy of choice to specifically address this therapy failure. From a medical perspective, this is a major achievement as it paves the way for multiple combination strategies with our leading drug candidate in order to abolish tumor resistance. We are pleased that our pioneering approach has gained strong interest of the international medical and research community at the EACR-AstraZeneca Virtual Conference."

On December 8, 2021 OncoMyx Therapeutics, a privately-held immuno-oncology platform company, reported the closing of a $50 million Series B financing, co-led by Lumira Ventures and B Capital Group with participation from LYZZ Capital and all Series A investors: Boehringer Ingelheim Venture Fund, Delos Capital, Xeraya Capital, Korea Investment Partners, City Hill Ventures, and Madison Partners (Press release, OncoMyx Therapeutics, DEC 8, 2021, View Source [SID1234596600]). In conjunction with the financing, Benjamin (Beni) Rovinski, Ph.D., Managing Director of Lumira Ventures and Widya Mulyasasmita, Ph.D., Senior Principal, Healthcare at B Capital Group will join the company’s Board of Directors. The proceeds of the financing will support the further development of OncoMyx’s pipeline of multi-armed myxoma immunotherapies for the treatment of solid tumors and hematological malignances and the advancement of the company’s lead candidate into clinical trials.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

OncoMyx has leveraged myxoma’s unique qualities to build an immunotherapy platform to deliver multiple cancer-killing payloads in one therapeutic. Myxoma is a natural oncolytic virus, selectively infecting and killing a wide range of cancer cell types. It is also inherently highly immuno-interactive, and as a large dsDNA poxvirus, is engineerable to express multiple payloads. OncoMyx’s multi-armed myxoma virus delivers different antitumor immunomodulatory proteins that hit critical points in the cancer immunity cycle to modulate the tumor microenvironment and stimulate a robust anti-tumor response. Because myxoma is not pathogenic to humans, it does not have to overcome pre-existing immunity and is highly amenable to IV and repeat dosing with a longer dosing window.

"OncoMyx builds on more than three decades of research into the myxoma virus, brings together the top team with experience developing targeted cancer treatments, immunotherapies, and virotherapies, and is fueled by a commitment to addressing unmet medical needs in patients with cancer," said Steve Potts, Ph.D., MBA, cofounder and CEO of OncoMyx. "The power of our myxoma platform is the potential to systemically deliver broad and selective targeting of cancer cells combined with robust activation of the cancer immunity cycle in a single therapeutic. With this financing, we plan to advance our lead multi-armed myxoma immunotherapy into clinical trials to demonstrate initial safety and efficacy of intravenous dosing."

"I have long been interested and was previously involved in the development and use of modified, recombinant viruses as immunotherapeutic agents. Oncolytic viruses in particular have shown clinical promise but a significant challenge has been the inability to engineer a safe and versatile oncolytic virus platform that is not restricted to local intratumoral delivery," said Dr. Rovinski. "The use of myxoma virus, which is not pathogenic to humans and can accommodate several insertions of heterologous therapeutic agents, as the backbone of OncoMyx’s immunotherapy platform, represents a uniquely differentiated feature that has the potential to overcome the well-known historical challenge of effectively delivering oncolytic viruses systemically for optimal dosing. We believe that OncoMyx’s myxoma-based oncolytic viruses may become best-in-class components of novel immunotherapeutic regimens, and we look forward to supporting the world class team at OncoMyx to bring these therapies to patients in need."

"We always seek to invest in companies with visionary founders and world-changing technology, and we saw the unmatched potential of OncoMyx’s myxoma platform to make a significant breakthrough in cancer immunotherapy by delivering multiple immune-activating and anti-tumor agents in one off-the-shelf package. We are impressed with the extensive preclinical data OncoMyx has generated demonstrating efficacy and safety of the myxoma platform across a broad range of cancers, from hematological malignancies to solid tumors," said Dr. Mulyasasmita. "OncoMyx has attracted an exceptionally experienced and talented team who are as committed as the founders about building the next great immuno-oncology company that delivers lifesaving medicines for many difficult-to-treat cancers. We couldn’t be more thrilled and honored to support their mission."

OncoMyx has presented preclinical safety and efficacy data at major scientific conferences demonstrating their myxoma immunotherapies stimulate anti-tumor immunity and produce anti-tumor efficacy in a wide range of models following IV or intratumoral administration. The data, along with previously published studies, support the advancement of these therapies into clinical development as a monotherapy and in combination with many cancer therapeutics and immunotherapies, including checkpoint inhibitors and chemotherapies. The company plans to advance its lead candidate into clinical trials next year to generate safety and efficacy data for IV dosing.

On December 8, 2021 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported the positive recommendation from its safety review committee to escalate to the second dose level in its camsirubicin Phase 1b trial in patients with advanced soft tissue sarcoma (ASTS) (Press release, Monopar Therapeutics, DEC 8, 2021, View Source [SID1234596599]). This decision was made following a review of safety data from the patients in the first dose cohort and will allow evaluation of a higher dose level of camsirubicin than has been administered in any prior clinical trial.

"Camsirubicin belongs to a class of drugs, anthracyclines, that have repeatedly demonstrated a dose-dependent anti-tumor response," said Andrew Mazar, PhD, Monopar’s Chief Scientific Officer. "Camsirubicin has already shown potential signs of anti-tumor activity in a traditional all-comer advanced cancer Phase 1 and in a pilot Phase 2 study in ASTS, so the ability to achieve a higher dose than previously used in those studies is an important milestone for the company."

"We are pleased with the swift progress accomplished to date, rapidly moving from regulatory trial allowance to first site activated to clearing the first dose level in only a few months," said Chandler Robinson, MD, Monopar’s Chief Executive Officer. "We are eager to continue evaluating progressively escalating dose levels of camsirubicin, which may demonstrate increasing anti-tumor activity."

Further information about this actively enrolling, open-label, dose-escalation Phase 1b clinical trial is available at www.ClinicalTrials.gov under study identifier NCT 05043649.

About Camsirubicin

Camsirubicin is a novel proprietary analog of the widely used cancer drug doxorubicin. It has been investigated in ASTS patients in a Phase 1 and a single-arm Phase 2 clinical trial. In these studies, no camsirubicin-treated patients developed the irreversible cardiotoxicity common to doxorubicin at higher cumulative doses. The most frequent adverse event observed in the Phase 1 study was neutropenia, which was mitigated in the Phase 2 study using prophylactic G-CSF. Based on encouraging clinical results to date, the current Phase 1b trial is designed to test camsirubicin at progressively higher doses than previously administered while using concomitant prophylactic G-CSF to prevent neutropenia.

About Soft Tissue Sarcoma

Soft tissue sarcomas (STS) are a diverse type of cancer that typically develop in the connective tissue of the body. According to the American Cancer Society, in 2021, an estimated 13,460 new STS cases will be diagnosed in the US alone, and about 5,350 people will not survive their disease. These tend to be the advanced cases; those with sarcomas that are unresectable and/or have metastasized. The average life expectancy from time of diagnosis for those patients with advanced disease (ASTS) is about 12 to 15 months. Doxorubicin is the current standard of care in the 1st-line setting for ASTS, and has been for decades, since there have been no 1st-line therapeutic advancements that have improved overall survival for this patient population.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On December 8, 2021 H3 Biomedicine Inc. (H3), a U.S.-based precision medicine research & development subsidiary of Eisai Co., Ltd., reported the presentation of two posters at the 2021 San Antonio Breast Cancer Symposium (SABCS) being held in a hybrid format on December 7- 10, 2021 (Press release, H3 Biomedicine, DEC 8, 2021, View Source [SID1234596597]). The presentations include interim investigational data from H3’s ongoing clinical development program, H3B-6545, a potential first-in-class, orally available Selective ERα Covalent Antagonist (SERCA), in women with ER-positive, HER2-negative breast cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"At H3, we are developing a pipeline of targeted medicines with the potential to impact the future of cancer treatment," said Ping Zhu, Ph.D., President and Chief Scientific Officer of H3. "Our ongoing clinical study of H3B-6545 is evaluating its potential to address current unmet medical needs in breast cancer either as a single agent or in combination with therapies such as palbociclib. We look forward to showcasing its progress at SABCS 2021."

H3B-6545 Presentations
Abstract Number: 976
Title: H3B-6545, a Novel Selective Estrogen Receptor Covalent Antagonist (SERCA), in Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced Breast Cancer – A Phase II Study
Program Number: P1-17-10 Poster Session: 1
Date and Time: Wednesday, December 8, 2021, 7:00am – 8:30am CT
Presenter: Erika P. Hamilton, Sarah Cannon Research Institute, Tennessee Oncology

Abstract Number: 1166
Title: H3B-6545 in Combination with Palbociclib in Women with Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer, Phase 1b Study Program Number: P1-17-03
Poster Session: 1
Date and Time: Wednesday, December 8, 2021, 7:00am–8:30am CT Presenter: Stephen Johnston, Royal Marsden NHS FDN Trust, London, UK

About H3B-6545
Estrogen receptor alpha (ERα) plays an important oncogenic role in the genesis and progression of luminal breast cancers, and historically has been a target of endocrine therapies. However, recently, hotspot mutations in ERα have been detected in nearly 30% of endocrine-therapy resistant metastases. Functional studies have shown that these ERα mutations can confer ligand-independent activation of the ERα pathway and can promote partial resistance to existing classes of ER-directed therapies. H3B- 6545, a first-in-class small molecule selective estrogen receptor covalent antagonist (SERCA) demonstrates activity in tumor models that harbor wild-type or mutant ERα. H3B-6545 activity against ERα mutants resistant to standard therapy provides an opportunity to target a currently unmet medical need both as a single agent and in combination with other breast cancer therapies.

This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.