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Cleveland Diagnostics Presents New Data Supporting the Clinical Validation and Clinical Utility of IsoPSA at the 2021 Annual Meeting of American Urological Association

On September 14, 2021 Cleveland Diagnostics, Inc., a commercial stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, reported that Eric Klein, MD, Chairman of the Glickman Urological & Kidney Institute at Cleveland Clinic, delivered two presentations at the annual meeting of the American Urological Association regarding the company’s prostate cancer test, IsoPSA (Press release, Cleveland Diagnostics, SEP 14, 2021, View Source [SID1234587685]).

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In the first presentation, entitled "IsoPSA: Clinical Performance of a Single Parameter, Structure Based Test for High Grade Prostate Cancer in a Large, Multicenter, Prospective Validation Trial", Dr. Klein provided data used to validate the diagnostic accuracy of the novel, structure-based IsoPSA assay to improve early detection strategies for prostate cancer vs. standard of care PSA and % free PSA tests. In the prospective, multicenter study of 1,093 men IsoPSA showed an AUC of 0.790 for the detection of high grade cancer (Gleason grade group 2 or higher) (vs. 0.674 for PSA and 0.727 for % free PSA). IsoPSA had a sensitivity of 90% for high-grade prostate cancer, and specificity of 47% (compared to 21% for PSA and 14% for % free PSA). Data were consistent and reliable across patients who were biopsy naïve and who had a prior negative biopsy, and IsoPSA maintained its statistical accuracy across a wide range of elevated PSA values (from 4ng/mL to 100ng/mL).

In the second presentation, entitled "IsoPSA Reduces Provider Recommendations for Biopsy and MRI in Men with Total PSA ≥ 4ng/mL: A Real-World Observational Clinical Utility Study", Dr. Klein reported that 38 providers practicing in a variety of clinical settings evaluating 900 patients for prostate cancer substantially altered their behavior and patient management decisions following IsoPSA testing. Provider recommendations for biopsy and MRI were modified post-IsoPSA in 66% of cases in this prospective study, and concordance between IsoPSA results and biopsy recommendations was very high. Overall, IsoPSA test results reduced provider biopsy recommendations by 55% and MRI recommendations by 9%. In twenty cases, biopsies that were recommended after, but not before, IsoPSA testing, led to the detection of additional prostate cancers that would have been missed had it not been for IsoPSA testing.

"The data from these two studies demonstrate that IsoPSA is not only effective at detecting high-grade prostate cancer, but also holds promise to change the diagnostic paradigm, which could result in both improved patient outcomes and reduced costs to the healthcare system," said Eric Klein, MD.

"The real world implications of these findings are important and considerable," added Arnon Chait, PhD, CEO of Cleveland Diagnostics, Inc. "Using IsoPSA, we believe that providers save lives, and save the healthcare system considerable money while doing so. Reducing the number of unnecessary biopsies, increasing biopsy yield, and distinguishing high grade disease risk from low grade or benign disease with an effective blood test will be critical to savings lives, costs, and significantly improve overall patient care."

The 2021 American Urological Association annual meeting was held virtually this year from September 10-13, 2021. More information can be found at www.aua2021.org.

Andes Raises USD 15 Million in Series A Funding Co-Led by Leaps by Bayer and Cavallo Ventures

On September 14, 2021 Leaps by Bayer, the impact investment arm of Bayer AG, reported that it has co-led a USD 15 million Series A investment round in agriculture and biotechnology innovator, Andes, with Cavallo Ventures (Press release, Andes Biotechnologies, SEP 14, 2021, View Source [SID1234587684]). Other new investors Builders VC, Germin8, Accelr8 and Wilson Sonsini participated, alongside existing investors KdT Ventures and Endurance.

Through its novel seed treatment technology, called ‘Microprime’, Andes is reducing the need for synthetic fertilizers. The California-based company has developed a process for seamlessly integrating seeds with a unique library of microbes that colonize the seed’s root structure. This kick-starts a process known as biological nitrogen fixation, enabling the crop to draw down nitrogen from the air instead of relying on synthetic nitrogen fertilizers.

By developing self-sustaining Microprime seeds, Andes reduces the need for synthetic fertilizers, which require huge amounts of energy to produce and account for 3%, or 1.5 gigatons, of global greenhouse emissions. In enabling microbes to ride along with the seeds as they get planted, Andes’ Microprime technology provides a highly scalable solution that saves growers time and money.

The first generation of Microprime treated corn seeds will provide the equivalent of 30 to 50 lbs/acre of nitrogen through biological nitrogen fixation. The company is creating second generation microbes that target doubling the amount of nitrogen provided by the Microprime seeds.

Andes is also developing microbial strains for nature-based permanent carbon capture solutions to sequester and store CO2 from the atmosphere into the soil. This initially focuses on capturing carbon via microbial-powered corn crops. If deployed successfully at scale, it could capture gigaton-levels of carbon from corn and other crops. With the world’s total annual greenhouse gas emissions estimated to be 50 gigatons, nature-based carbon capture could make a sizeable contribution to global decarbonisation.

Agriculture currently consumes 50% of habitable land and 70% of the earth’s fresh water. Andes and Leaps by Bayer are committed to better using these resources through more efficient and sustainable agricultural practices.

Dr. Jürgen Eckhardt, Head of Leaps by Bayer said: "We invest in paradigm-shifting advances that can radically reduce the environmental impact of agriculture. Andes is an exceptional example of that: using novel seed technology to reduce the use of synthetic fertilizers and developing the next generation of agricultural carbon capture solutions. It’s exciting that our funding will help the Andes team scale its current offering and explore the possibilities of truly world-changing technologies like carbon capture."

"We are well past the need for sustainable products and practices. We can only avoid an irreparable climate disaster through solutions that are highly scalable and reliable," Gonzalo Fuenzalida, Andes CEO, explained. "At Andes we are seamlessly integrating the power of microbes within seeds to dramatically cut the need for synthetic fertilizers. This investment will allow us to expand on this success, as well as expand our technology to utilize the millions of acres of agricultural land to capture and store carbon emissions."

Andes will use part of the funds to scale its self-sustaining, nitrogen-fixing seeds across the U.S. market and expand into South America. The balance of funding will be invested to advance further research and development into Andes’ complementary nature-based permanent carbon capture technology.

KSQ Therapeutics Announces First Patient Dosed in Phase 1 Study of KSQ-4279, a First-in-Class USP1 Inhibitor, in Patients with Advanced Solid Tumors

On September 14, 2021 KSQ Therapeutics, a biotechnology company developing drugs to treat cancer and autoimmune diseases using its proprietary, integrated discovery platform to systematically screen the whole genome in cancer and immune cells, reported the initiation of dosing in a Phase 1 clinical study of KSQ-4279, a first-in-class USP1 inhibitor, in patients with advanced solid tumors (Press release, KSQ Therapeutics, SEP 14, 2021, View Source [SID1234587683]).

"This is an important milestone for KSQ as we initiate clinical development of KSQ-4279, a compound that offers great potential for robust and durable anti-tumor activity in a number of cancers," said Qasim Rizvi, Chief Executive Officer of KSQ. "This is also a strong proof point for both our team and our CRISPRomics platform, which quickly enabled us to identify and validate USP1 as a promising target that exploits synthetic lethality in cancers with specific DNA repair defects. This work was part of our broader efforts to run expansive genome-scale screens across both a diverse range of cancer cell lines and multiple immune cell types, including T cells, NK cells, and Tregs. We believe that the insights derived from our platform create tremendous opportunities to develop therapies with curative potential for a wide range of cancers, in particular solid tumors and autoimmune diseases."

"KSQ-4279 showed tumor growth inhibition as a single agent and led to deep and durable tumor regressions when administered in combination with a PARP inhibitor in multiple preclinical tumor models," said Frank Stegmeier, Ph.D., Chief Scientific Officer of KSQ. "Based on these data, we believe that KSQ-4279 has the potential to be an important treatment for many different tumor types. Additional preclinical data indicate combination opportunities beyond PARP inhibitors, which sets KSQ-4279 up as a potential pipeline of treatments within a single molecule."

KSQ-4279 preclinical data highlights:

KSQ-4279 is active as a monotherapy in ovarian PDX models, with tumor regressions observed at doses well below its maximum tolerated dose.
KSQ-4279 activity is seen in cancers that harbor specific defects in homologous recombination (HR), a genetic driver event that is prevalent in several solid tumor types.
The combination of KSQ-4279 with a PARP inhibitor led to more pronounced antitumor activity than either agent alone across multiple ovarian and TNBC PDX models, leading to durable tumor regressions in settings where PARP inhibitors only achieved partial tumor control.
Preclinical safety data indicate that KSQ-4279 is well-tolerated.
KSQ-4279 induces cell cycle arrest and DNA damage leading to apoptosis and cell death in BRCA1 mutant cells.
Functional genomic resistance screens indicate that the major genetic drivers of resistance to USP1 and PARP inhibitors are distinct, indicating that combination treatment may be able to delay or prevent the emergence of resistance.
KSQ utilized its proprietary CRISPRomics platform to identify the deubiquitinating enzyme USP1 as an attractive cancer target with established roles in DNA damage repair processes that are distinct from PARP inhibitors and other approaches currently being tested in the clinic. Potent and highly selective inhibitors of USP1 were developed, and profiling of the clinical development candidate KSQ-4279 across a large collection of tumor models confirmed an enriched response rate in cancers with genetic alterations in BRCA1/2 or other HRD lesions.

This Phase 1 clinical trial is being conducted at five centers in the United States and is expected to enroll approximately 140 patients with advanced solid tumors. It is a dose-escalation and expansion study of KSQ-4279 as a monotherapy and in combinations. The study’s primary endpoint is to assess the safety of KSQ-4279 both alone and in combination, determine the maximum tolerated dose, and establish a recommended Phase 2 dose level. Secondary endpoints include characterizing the pharmacokinetics of KSQ-4279 and evaluating its preliminary antitumor activity both alone and in combination. The trial will also explore potential predictive biomarkers and other genetic factors and their correlation with clinical outcomes.

ROME Therapeutics Secures $77 Million in Series B Financing to Advance Repeatome-derived Pipeline for Cancer and Autoimmune Diseases and Expand Repeatomics Platform

On September 14, 2021 ROME Therapeutics, a biotechnology company harnessing the power of the repeatome for drug development, reported the completion of a $77 million Series B financing led by new investor Section 32 (Press release, Rome Therapeutics, SEP 14, 2021, View Source [SID1234587682]). In addition, new investors Sanofi Ventures, Casdin Capital, Andreessen Horowitz and Alexandria Venture Investments participated in the round, alongside existing investors ARCH Ventures, GV and Mass General Brigham Ventures (formerly Partners Innovation Fund). Concurrent with the financing, Steven J. Kafka, Ph.D., managing partner at Section 32, and Jim Trenkle, Ph.D., head of investments at Sanofi Ventures, were appointed to ROME’s Board of Directors.

ROME’s mission is to harness the power of the repeatome – the roughly 60% of the human genome consisting of repetitive sequences of nucleic acids, known as repeats – to discover powerful new classes of medicines for cancer and autoimmune diseases. Repeats have long been considered part of the "dark genome," but recent discoveries have demonstrated that the repeatome has pathological consequences in cancer, autoimmune disease and other therapeutic areas. Since launching in April 2020, ROME has identified multiple repeatome-derived targets and created an internal data science platform, called repeatomics, to analyze vast quantities of data available through the repeatome.

"In the short time since our founding, ROME has made significant progress uncovering the role and mechanism of the repeatome in cancer and autoimmune disease, which has led to our foundational repeatomics platform and identification of multiple tractable targets for drug discovery," said Rosana Kapeller, M.D., Ph.D., president, chief executive officer and co-founder of ROME. "With the support of this group of premier investors, we are well-capitalized and resourced to continue advancing our lead programs into the clinic, expanding our pipeline of repeatome-derived programs and enhancing our repeatomics platform, as we seek to revolutionize the way cancer and autoimmune diseases are treated."

"Traditional genomics has transformed how we think about drug development, diagnosis and treatment; however, for too long we have been unable to extend this approach to the ‘dark genome,’" said Dr. Kafka. "Leveraging the deep insights garnered by ROME’s experienced team of drug hunters and data scientists, ROME has developed innovative tools and techniques to generate novel insights from the repeatome in order to bring forward an entirely new and important class of disease-modifying medicines."

About New Directors

Steven J. Kafka, Ph.D., is a managing partner at Section 32, a venture capital fund investing at the frontiers of technology and healthcare. Dr. Kafka serves as chairman of the board of Glympse Bio and a director at ImmuneID, as well as CEO and director of DA 32 Life Science Tech Acquisition Corp. Previously, Dr. Kafka served as both founding CEO and executive chairman of Thrive Earlier Detection, which was acquired by Exact Sciences in January 2021. Dr. Kafka also served as executive chairman of ArcherDX, Inc., which was acquired by Invitae in October 2020. Earlier, Dr. Kafka served as president and chief operating officer of Foundation Medicine, Inc., which was acquired by Roche in 2018, and held executive roles at multiple public and private oncology drug discovery and development companies. Dr. Kafka earned a Ph.D. in political economy and government from Harvard University and a B.A. in economics and political science from Stanford University.

Jim Trenkle, Ph.D., is currently head of investments at Sanofi Ventures and has a background in research and development, commercialization and early-stage biotech investing. Dr. Trenkle currently serves on the board of directors at Therini Bio, Glycomine and Veralox Therapeutics. Prior to joining Sanofi, Dr. Trenkle was part of the early team at Pivotal bioVenture Partners in San Francisco, where he served as Board observer for Entasis (ETTX), Inozyme (INZY), Akouos (AKUS), Fusion Pharmaceuticals (FSUN) and Karuna Therapeutics (KRTX). He began his career with Gilead Sciences where he held positions of increasing responsibility in medicinal chemistry, project and portfolio management and commercial strategy, largely focused on hepatitis C and other liver diseases. Dr. Trenkle holds a B.S. in honors chemistry from the University of Michigan, a Ph.D. in organic chemistry from Massachusetts Institute of Technology and an MBA from the University of California Berkeley, Haas School of Business.

Epizyme Announces Data from TAZVERIK® (Tazemetostat) Clinical Programs to be Presented During Poster Sessions at 2021 ESMO Virtual Congress

On September 14, 2021 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that clinical data will be presented at the upcoming 2021 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress, taking place on September 16-21, 2021 (Press release, Epizyme, SEP 14, 2021, View Source [SID1234587681]).

At the conference there will be two posters on two of the trials examining tazemetostat use in solid tumors. One details updated data from the ongoing safety run-in portion of the EZH-1101 prostate cancer study evaluating tazemetostat in combination with either abiraterone/prednisone or enzalutamide. The second poster describes the ongoing study investigating tazemetostat’s use in combination with other agents to treat solid tumors.

"Consistent with the preliminary data we shared during our Next Episode vision call earlier this year, the data presented at ESMO (Free ESMO Whitepaper) from our EZH-1101 study suggest tazemetostat combinations in prostate cancer led to a subset of patients having durable ≥50% decline in prostate-specific antigen levels (PSA50) with one patient having a radiographic tumor response," said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer at Epizyme. "We are encouraged to see the progression free survival data with a follow-up of almost two years in the safety run-in, and this data, while still maturing, will be shown in the poster session. Additionally, the adverse events data with the combination treatment were consistent with the known safety profile of the individual agents with no new safety signals. The randomized portion of the EZH-1101 study is ongoing with more than one-third of patients enrolled to date. This study is one part of our overall program exploring tazemetostat as both monotherapy and in combinations across multiple hematologic and solid tumor cancers."

Details of the presentations are listed below:

ESMO Poster Presentations

Title: Safety of Tazemetostat in Combination With Abiraterone/Prednisone or Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer
Presenters: Wassim Abida, MD, PhD; Daniel Saltzstein, MD
Abstract Code: 586P
Title: Trial in Progress: Tazemetostat in Combination With a PARP Inhibitor or Durvalumab in Patients With Solid Tumors
Presenter: Charles M. Rudin, MD, PhD; Robert L. Coleman, MD
Abstract Code: 1870TiP
The ESMO (Free ESMO Whitepaper) abstracts are available at View Source All oral and poster presentations will be available on the ESMO (Free ESMO Whitepaper) website on Thursday, September 16, 2021 8:30 a.m. CEST / 2:30 a.m. ET.

About TAZVERIK (tazemetostat)

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

View the U.S. Full Prescribing Information here: Epizyme.com