On March 2, 2023 The co-founder of Aldevron, Dr. John Ballantyne, reported that it has invested $3M in CureLab Oncology and CureLab Veterinary (Press release, CureLab Oncology, MAR 2, 2023, View Source [SID1234628096]). The two sister companies have developed an anti-cancer and anti-inflammatory drug that was contract-manufactured by Aldevron at the time Dr. Ballantyne served there as chief scientific officer. The investment positions both companies to attain the R&D milestones needed to secure additional rounds of funding.

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Both CureLab Oncology and CureLab Veterinary are developing therapies that employ plasmids (circular DNA encoding a gene called p62/SQSTM1). CureLab Oncology is applying the p62 plasmid to treat human cancers. Following impressive clinical data presented at the European Society for Medical Oncology Congress in Paris, and the considerable ongoing progress of the company’s clinical studies, the funds will enable CureLab Oncology to ramp up toward FDA-monitored clinical trials for triple-negative breast cancer and platinum-resistant ovarian cancer in 2023.

"I have been observing the CureLab journey since Aldevron produced the very first batch of their product. I have witnessed the CureLab team growing and evolving, obtaining patent protection around the world, and keeping an eye on their pre-clinical and clinical progress. The team and the strength of their recent clinical data is what made me want to invest," said Dr. John Ballantyne.

"Distributing Dr. Ballantyne’s investment among the two companies will greatly reduce the R&D risks for both CureLab Oncology and CureLab Veterinary," said Dr. Alexander Shneider, CEO of CureLab Oncology.

The research activities of the two CureLab sister companies are highly synergistic. The data obtained in real-life veterinary settings, in pets, serves as a much stronger predictor for human clinical trials than experiments conducted on laboratory animals. For example, if CureLab Veterinary demonstrates that the product is effective in the treatment of canine osteoarthritis or inflammatory bowel syndrome, both of which are highly prevalent among dogs, CureLab Oncology could extend its clinical programs to treat these pathologies.

For the treatment of domestic animals, CureLab Veterinary received positive clinical results in 10 out of 11 dogs diagnosed with breast cancer. The company is looking to take its patented p62 plasmid technology through the USDA-CVB process with a view to marketing new anti-cancer and anti-inflammatory technologies for use by veterinarians.

"As an industry leader in both thought and action, I am pleased that John has decided to support our efforts to bring innovative animal technology through the US approval process," said Robert Devlin, president of CureLab Veterinary. "Through his generous support, we hope to help many animals and bring joy to pet owners worldwide."

CureLab Veterinary is currently engaged in a crowdfunding effort with Netcapital.

About Elenagen
CureLab’s lead investigational compound is code-named Elenagen, an experimental DNA therapy that consists of a circular piece of DNA called a plasmid that includes a gene for a human protein called p62/SQSTM1. In animal studies and Phase I/II human trials conducted ex-US, Elenagen demonstrated promise in reversing tumor grade, changing the tumor microenvironment, and enhancing the anti-cancer effects of chemotherapy. Experimental results also indicate mitigation of chronic inflammation and stimulation of an immune response to the tumor.

About CureLab Veterinary
Today, our four-legged family members are living longer than ever. Unfortunately, with this longer lifespan, our furry friends now are experiencing many of the same cancers and diseases due to chronic inflammation as their pet parents. CureLab Veterinary, a sister company of CureLab Oncology, is dedicated to bringing advanced therapies to treat cancer and inflammatory diseases to support better pet health and longevity. To learn more, visit curelabveterinary.com.

On March 2, 2023 Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, reported it will be presenting data comparing risk stratification and radiation benefit (RT) for patients with ductal carcinoma in situ (DCIS) using DCISionRT with a clinicopathologic (CP) model similar to the Memorial Sloan Kettering Cancer Center (MSKCC) DCIS nomogram at the 40th Annual Miami Breast Cancer Conference (MBCC), being held on March 2 – 5, 2023 at the Fontainebleau Miami Beach (Press release, PreludeDx, MAR 2, 2023, View Source [SID1234628095]).

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The poster entitled, ‘Comparing Risk Stratification and Radiotherapy Benefit for Patients with DCIS Using a 7-gene Biosignature as Compared to a Clinicopathologic Nomogram’ will be available for viewing during the duration of the conference and available during the in-person poster receptions on March 2nd and 3rd. The study included 926 DCIS patients from four cohorts who were treated with breast conserving surgery (BCS) or BCS + radiation therapy (RT). The study compared MSKCC DCIS nomogram-like model with the DCISionRT 7-gene biosignature.

DCISionRT re-classified nearly two-thirds of patients in the Low-Risk MSKCC nomogram-like group as Elevated Risk, which had elevated 10-yr IBR rates and an 80% relative benefit from RT.

"It is important for clinicians to follow the clinical evidence to enable the best treatment decisions for their patients," said Julie Margenthaler, MD, FACS, Siteman Cancer Center, Washington University School of Medicine. "In this study, we demonstrated the ability of DCISionRT to better risk-stratify DCIS patients following BCS and identify patients with low-risk CP who may benefit from RT, avoiding potential undertreatment."

"Previously we were limited to clinicopathologic criteria, such as nomograms, to guide DCIS treatment decisions," said Chirag Shah, MD, Co-Director of Comprehensive Breast Program and Director of Clinical Research in the Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic Cleveland OH. "DCISionRT provides us the clinical evidence to identify which DCIS patients, despite having low-risk clinicopathologic features, can actually benefit from RT and which patients may safely omit RT."

"We are pleased to share our latest data demonstrating the clinical significance of DCISionRT," says Dan Forche, President and CEO of PreludeDx. "We have been able to consistently demonstrate that the integration of DCISionRT into clinical decision processes has substantial impact on recommendations aimed at optimal patient management to prevent over-or under treatment of DCIS patients."

Additional MBCC Poster Presentations Include:

Posters will be available for viewing during the duration of the conference and available during the in-person poster receptions on March 2nd and 3rd.

Characterization of Recurrence Risk After Lumpectomy and Radiotherapy in HER2-Positive Ductal Carcinoma In Situ of the Breast Using a 7-gene Predictive Biosignature: Implications for the NSABp-B43 Trial Results

A 7-Gene Predictive Biosignature Improves Risk Stratification for Breast Ductal Carcinoma in Situ Patients Compared to Clinicopathologic Criteria, Identifying a Low Risk Group Not Clinically Benefiting from Adjuvant Radiotherapy

Changes in Treatment Recommendation for Patients with Ductal Carcinoma In Situ Using a 7-gene Predictive Biosignature: Analysis of the PREDICT Study

The PREDICT study is a prospective, multi-institutional registry for patients who received DCISionRT testing as part of their routine care. The registry includes females 26 and older who are diagnosed with DCIS and are candidates for BCS and eligible for RT. The analysis demonstrates RT recommendations to add or omit RT based on the 7-gene predictive biosignature in 2,308 patients was changed in 38% of women after testing and hormonal treatment (HT) recommendations was changed in 11%.

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman’s individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Score that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.

On March 2, 2023 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a precision oncology company, reported that Yuval Cohen, Ph.D., Chief Executive Officer of Corbus, will provide a corporate update and participate in one-on-one investor meetings at the Oppenheimer 33rd Annual Healthcare Conference, to be held virtually from March 13-15, 2023 (Press release, Corbus Pharmaceuticals, MAR 2, 2023, View Source [SID1234628094]).

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Oppenheimer 33rd Annual Healthcare Conference
Format: Corporate update and one-on-one investor meetings
Presentation Date: Tuesday, March 14, 2023
Presentation Time: 9:20 a.m. ET
Webcast: Click Here

On March 2, 2023 Debiopharm (www.debiopharm.com), an independent Swiss-based, biopharmaceutical company aiming to develop tomorrow’s standard-of-care treatments to cure cancer and infectious diseases, reported having obtained the global rights for FT-3171, a small molecule USP1 inhibitor program targeting a novel DNA damage repair (DDR) pathway from Novo Nordisk (Press release, Debiopharm, MAR 2, 2023, View Source [SID1234628093]).

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FT-3171 was developed by Forma Therapeutics, which was acquired by Novo Nordisk in 2022, and is currently in late preclinical development. FT-3171 (Debio 0432) could potentially be deployed to combat multiple tumor types in poly ADP ribose pathway inhibitor-sensitive and resistant settings.

This new pipeline entry will join WEE1-inhibitor Debio 0123, reinforcing Debiopharm’s commitment to improve cancer patients’ treatment response and to overcome treatment resistance to current therapies. Through translational and eventual clinical investigation, Debiopharm is poised to further apply their DDR inhibitor expertise to efficiently advance the development of Debio 0432 with the ultimate aim of producing a novel therapy that responds to unmet needs of cancer patients.

"In 2017, Debiopharm dove into the DDR inhibitor field, firstly through its WEE1-inhibitor Debio 0123 and now through this innovative asset, targeting USP1. We are eager to establish the research necessary to bring this product to the clinical phase." explained Angela Zubel, Chief Development Officer at Debiopharm.

"Leveraging the principle of synthetic lethality by inhibiting the right DDR pathway targets to enable tumor cell destruction is an emerging field that deserves further exploration, this target is complementary with Debiopharm development pipeline like our ADC programs or Debio 0123" mentioned Bertrand Ducrey, CEO, Debiopharm. "We are thrilled about this licensing deal with Forma Therapeutics and Novo Nordisk and evaluating the potential of this USP1-inhibitor program."

About ubiquitin-specific protease 1 (USP1)

The USP family is one of the largest subfamily of deubiquitinases (DUB).1 Ubiquitin-specific protease 1 (USP1), in particular, is a nucleus-localized enzyme and a well-established component of DNA repair, acting both in the Fanconi Anemia pathway (on FANCD2 and FANC1) and in translesion synthesis (TLS) on PCNA (Proliferating Cell Nuclear Antigen) substrate. It catalyzes the removal of specific monoubiquitin signals, is a critical regulator of genome integrity and its dysfunction plays a key role in cancer initiation and progression,2-3 explaining why USP1 has recently drawn special attention as cancer target. In addition, USP1 was recently identified as a novel synthetic lethal interaction partner with BRCA1 loss offering a good rationale for the investigation of USP1 inhibitors in patient populations currently treated with PARP inhibitors.4 The potential of this class of new therapeutic agents might however be exploited in further settings as understanding of USP1 biology is progressing.5

On March 2, 2023 Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, and Myriad Genetics Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported the expansion of a strategic partnership to broaden access to and availability of oncology homologous recombination deficiency (HRD) testing in the United States (Press release, Illumina, MAR 2, 2023, View Source [SID1234628092]). Under the agreement, Illumina TruSight Oncology 500 HRD (TSO 500 HRD), a research-use-only test, is now available in the US. The expanded partnership also establishes a unique companion diagnostic (CDx) alliance for the pharmaceutical industry, which will enable more clinical research for gene-based, targeted therapies.

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Expanding access to HRD research test

The TSO 500 HRD research test aligns Myriad’s gold standard MyChoice CDx HRD technology with Illumina’s pan-cancer test, TSO 500. The test was codeveloped with Merck (known as MSD outside the US and Canada) and Myriad Genetics. Myriad and Illumina’s initial partnership led to Illumina’s combined HRD and TSO 500 offering launch worldwide—excluding the US and Japan—in June 2022.

TSO 500 HRD offers a single, comprehensive pan-cancer test to identify key genetic variants and homologous recombination deficiency critical for understanding cancer development and progression. HRD status is an important biomarker in tumors that harbor high levels of DNA damage, such as those present in ovarian, breast, prostate, and pancreatic cancers.

"Research continues to reveal the growing relevance of HRD status across multiple cancers," said Kevin Keegan, vice president and general manager, Oncology Business Unit, at Illumina. "Now with this test, we are empowering labs in the US to unlock the most comprehensive tumor analysis from a single sample."

"Our partnership with Illumina brings together best-in-class HRD technology and next-generation sequencing to create a comprehensive testing solution that supports the advancement of clinical research which should ultimately lead to an improvement for patients," said Michael Lyons, general manager of Oncology, Myriad Genetics. "The availability of TSO 500 HRD in the US furthers our ability to partner with leading pharmaceutical companies and academic institutions, broadens access to clinical trials, and accelerates the pace of research and scientific innovation."

The product is available to order now and ready to ship in the US. Illumina and Myriad are offering distributable kits and centralized laboratory service, respectively. TSO 500 customers, such as Florida Cancer Specialists & Research Institute, one of the largest independent medical oncology/hematology practices in the US, are anticipating access to the kit.

"We are excited for the opportunity to provide Illumina’s TSO 500 genomic profiling pan-cancer test with HRD assessment in a single workflow," said Dr. Lucio N. Gordan, president and managing physician at Florida Cancer Specialists & Research Institute. "Leveraging technology from Myriad’s MyChoice CDx, our physician’s first choice among HRD tests, will help to unlock comprehensive understanding of the tumor genome and maintain laboratory efficiency. We look forward to expanding and building upon our relationships with both Illumina and Myriad Genetics."

New CDx alliance
Under this strategic alliance, Illumina and Myriad will seek joint HRD companion diagnostics partnerships with pharmaceutical companies worldwide (excluding Japan). The joint HRD CDx alliance will aim to pursue HRD regulatory approvals for both the MyChoice HRD Assay companion diagnostic and a future clinical in vitro diagnostic test based off the TSO 500 HRD Assay.

"This CDx alliance aims to further enable clinical research for HRD testing and therapeutics, globally. Which could lead to greater access to clinical trials for precision, gene-based therapies," said Keegan.

About TruSight Oncology 500 and TSO 500 HRD
TSO 500 is a research-use-only pan-cancer assay that enables comprehensive genomic profiling. Designed to identify known and emerging tumor biomarkers across 523 genes, TSO 500 utilizes both DNA and RNA from tumor samples to identify key variants critical for cancer development and progression, such as small DNA variants, fusions, and splice variants. In addition, it assesses key genomic signatures, such as tumor mutational burden, microsatellite instability, and HRD.

TSO 500 HRD enables researchers to unlock deeper insights about the tumor genome by identifying genetic mutations used in the evaluation of HRD. HRD is a genomic signature used to describe when cells are unable to effectively repair double-stranded DNA breaks. When this occurs, cells rely on alternative, error-prone DNA repair mechanisms, which may lead to genomic instability and, eventually, tumor formation.

Learn more here.

About MyChoice CDx
Myriad’s MyChoice CDx test is the most comprehensive tumor test for determining homologous recombination deficiency (HRD) status caused by a range of mutations in genes such as BRCA1 and BRCA2. It can be used to identify people with tumors that have lost the ability to repair double-strand DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as PARP inhibitors commonly used in cancer treatment. It enables healthcare professionals to identify patients with ovarian cancer who are eligible for treatment with targeted therapies.

Use of forward-looking statements
This release contains forward-looking statements that involve risks and uncertainties, including the expectation for lower costs related to the storing and managing of genomic data costs. Among the important factors that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing and launching new products and services; (ii) our ability to deploy new products, services, and applications, and to expand the markets for our technology platforms; (iii) the acceptance by customers of our newly launched products, which may or may not meet our and their expectations once deployed, and (iv) our ability to obtain relevant regulatory approvals for future products, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts’ expectations, or to provide interim reports or updates on the progress of the current quarter.