On April 23, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that it will present data at the American Academy of Dermatology’s Virtual Meeting Experience, being held April 23 – 25, 2021 (Press release, Castle Biosciences, APR 23, 2021, View Source [SID1234578406]). The Company has two poster presentations highlighting its DecisionDx-Melanoma and DecisionDx-SCC genomic tests.

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!

Data presentation information is as follows:

DecisionDx-Melanoma:

The poster is entitled, "Risk stratification of patients with stage I cutaneous melanoma (CM) using 31-gene expression profiling (GEP)."

DecisionDx-Melanoma is Castle’s 31-gene expression profile test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors.

Study methods and findings:

Data were analyzed from 852 patients diagnosed with Stage I cutaneous melanoma according to the American Joint Committee on Cancer staging guidelines and a median follow-up of 3.8 years, who also had DecisionDx-Melanoma test results. Kaplan-Meier and Cox regression analyses were used to assess recurrence-free survival (RFS). Prognostic accuracy was assessed by comparing outcomes for Class 1A to outcomes for Class 2B.
The study demonstrated that along with staging factors (Breslow thickness and ulceration), a DecisionDx-Melanoma Class 2B (highest risk) result was a significant, independent predictor of recurrence in the stage I population.
A Class 2B DecisionDx-Melanoma result among these patients was associated with a recurrence rate of 20.4%, compared to the overall stage I population’s recurrence risk of 4.6%.
Among all stage I melanoma patients, those with a Class 2B DecisionDx-Melanoma result had seven times the odds of experiencing a recurrence than patients with a Class 1A result.
In the subgroup of patients with a confirmed negative sentinel lymph node biopsy, those with a Class 2B DecisionDx-Melanoma result had five times the odds of experiencing a recurrence than patients with a Class 1A result.
Although the stage I population has a low aggregate risk of recurrence, the study demonstrated that DecisionDx-Melanoma identified patients within that population who may experience recurrence and benefit from increased management intensity.
DecisionDx-SCC:

The poster is entitled, "Prospective adjuvant therapy trial design using a prognostic 40-gene expression profile (40-GEP) test for high-risk cutaneous squamous cell carcinoma (cSCC) and BWH staging-based risk assessment."

DecisionDx-SCC is Castle’s prognostic 40-gene expression profile test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC) designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors.

Study methods and findings:

This analysis evaluated the impact of DecisionDx-SCC’s risk stratification as enrollment criteria into trial design involving adjuvant therapy for SCC.
Using data from 420 validation cases, Brigham and Women’s Hospital (BWH) T2a-T3 stage SCC patients with or without DecisionDx-SCC results of Class 2A/B (high risk) or 2B (highest risk) were used for two-arm sample size calculations.
Metastasis rates for cases with BWH T2a-T3 tumors were 20% without DecisionDx-SCC results and 27% or 57% when selecting for cases with Class 2A/B or 2B results, respectively.
In the absence of DecisionDx-SCC results, 1,234 T2a-T3 patients would be required for randomization in a trial to provide 80% power to detect a hazard ratio of 0.7 with at least three years of follow-up (alpha=0.05), correlating with studies using the addition of radiation to surgery. However, sample size could be reduced to 915 (26% reduction) or 432 (65% reduction) patients by focusing enrollment on T2a-T3 patients with a DecisionDx-SCC Class 2A/B or 2B result, respectively.
Use of DecisionDx-SCC could be applied to improve trial inclusion criteria as it has demonstrated additive value for patient stratification in other risk assessment methods such as AJCC staging, NCCN risk groups, and individual risk factors.
Overall, the study demonstrated that incorporation of DecisionDx-SCC testing into trial design to identify patients who are at the highest risk for metastasis could facilitate selection of those who are most appropriate for adjuvant therapy (e.g., Class 2B patients), expedite time to trial completion and optimize healthcare costs.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. To predict likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithm, i31-GEP, to produce an integrated test result. i31-GEP is an artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through December 31, 2020, DecisionDx-Melanoma has been ordered more than 68,920 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1, 2A or 2B risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

More information about the test and disease can be found at www.CastleTestInfo.com.

On April 23, 2021 Coherus BioSciences, Inc. (Nasdaq: CHRS) reported that it has received notice from immuno-oncology partner Junshi Biosciences that the Independent Data Monitoring Committee of the JUPITER-06 clinical trial has determined that toripalimab, an anti-PD-1 monoclonal antibody, in combination with paclitaxel/cisplatin as first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC), has achieved the pre-specified primary endpoints of progression free survival (PFS) and overall survival (OS) at the interim analysis. JUPITER-06 is a randomized, double-blind, placebo-controlled, multi-center, phase 3 clinical trial initiated in 2019 with 514 patients enrolled (Press release, Coherus Biosciences, APR 23, 2021, View Source [SID1234578430]).

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 interim analysis showed that toripalimab, in combination with paclitaxel/cisplatin, significantly prolonged the PFS and OS of patients with advanced ESCC, compared with paclitaxel/cisplatin chemotherapy alone. Data from the study are expected later this year.

Earlier in 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. More than 2,100 patients have received toripalimab treatment in clinical trials, and pivotal clinical trials are ongoing or completed evaluating toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin. In the U.S., a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted toripalimab Breakthrough Therapy Designation for this indication. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

About Esophageal Squamous Cell Carcinoma (ESCC)
Esophageal cancer is a primary malignant tumor of the esophageal mucosa epithelium. ESCC and adenocarcinoma are the two main histological subtypes of esophageal cancer. Approximately 6,000 patients in the United States are diagnosed annually with esophageal squamous cell carcinoma. The current standard first-line treatment is platinum-based chemotherapy. The prognosis of patients with advanced ESCC is poor with five-year survival rates of less than 20%.

About JUPITER-06 Study
JUPITER-06 is a randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial evaluating the efficacy and safety of toripalimab combined with paclitaxel/cisplatin versus placebo combined with paclitaxel/cisplatin as first-line treatments for advanced esophageal squamous cell carcinoma. The JUPITER-06 Clinicaltrials.gov identifier is NCT03829969. Professor Ruihua Xu from the Sun Yat-sen University Cancer Hospital is the principal investigator of the JUPITER-06 study. A total of 514 patients were enrolled in the study. The primary endpoints are PFS as assessed by the Blinded Independent Review Committee and OS. Secondary endpoints include the PFS assessed by investigator, objective response rate, disease control rate and duration of response.

On April 23, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported U.S. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients (Press release, Hoffmann-La Roche, APR 23, 2021, View Source [SID1234578389]). MMR is a molecular mechanism that functions to correct certain errors that can spontaneously occur during DNA replication. Testing can identify patients eligible for treatment with JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD1 immunotherapy from GlaxoSmithKline (GSK) that was approved by the FDA on 22 April 2021.

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!

Endometrial cancer is the most common gynecologic cancer in the U.S. and the fourth most common cancer in women in North America.2 In addition, about 90,000 women globally die from endometrial cancer each year.1 There are limited treatment options for women whose disease progresses on or after first-line therapy and this is the first companion diagnostic to identify endometrial cancer patients eligible for anti-PD1 immunotherapy.

"We are excited to launch this companion diagnostic test with GSK to help recurrent or advanced endometrial cancer patients with limited treatment options," said Thomas Schinecker, CEO of Roche Diagnostics. "This test provides clinicians with an effective tool to identify patients best suited for treatment with GSK’s JEMPERLI, providing a new therapeutic option for women with MMR-deficient endometrial cancer whose disease progresses on or following initial chemotherapy treatment."

MMR deficiency is most common in endometrial cancer. This companion diagnostic (CDx) provides clinicians with a standardised testing option that uses a comprehensive panel of DNA mismatch repair (MMR) biomarkers tested by immunohistochemistry (IHC). FDA approval of the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated, easy-to-use MMR test to identify patients who are eligible for therapy with JEMPERLI.

About the VENTANA MMR RxDx Panel
The VENTANA MMR RxDx Panel is a label expansion of Roche’s current on-market VENTANA MMR IHC Panel. VENTANA MMR RxDx Panel is a qualitative immunohistochemistry test intended for use in the assessment of mismatch repair (MMR) proteins (MLH1, PMS2, MSH2 and MSH6) in formalin-fixed, paraffin-embedded (FFPE) endometrial carcinoma tissue by light microscopy. The OptiView DAB IHC Detection Kit is used for MLH1, MSH2 and MSH6, and the OptiView DAB IHC Detection Kit with the OptiView Amplification Kit is used for PMS2 on a VENTANA BenchMark ULTRA instrument. DNA mismatch repair (MMR) proteins have been clinically proven to be predictive biomarkers for PD-1 targeted therapy; specifically, a loss of expression of one or more MMR proteins might predict an increased likelihood of response to such therapy.3,4,5 PD-1 inhibitors can be effective in cancers with a high frequency of MMR deficiency and/or microsatellite-instability, high (MSI-H) including endometrial cancer.3,5 MMR is a conserved molecular mechanism that functions to correct the improper base substitutions that spontaneously occur during DNA replication. Defects in the MMR machinery have been attributed to mutations in the MMR proteins.

On April 23, 2021 Anavo Therapeutics, a global leader in unlocking the full therapeutic potential of human phosphatase biology, reported with a EUR 20 million (approx. $24 million) seed financing (Press release, Anavo Therapeutics, APR 23, 2021, View Source [SID1234578407]). Anavo’s mission is to pioneer systematic drug discovery and development approaches aimed at phosphatases, a rich and largely untapped therapeutic target class. The funds will be used to advance a proprietary drug discovery portfolio in oncology and establish a versatile and robust platform to address the target space broadly across multiple indications. Anavo’s leadership team, Dr. Birgit Zech and Dr. Gerhard Müller, are building on several years of joint experience in the biopharmaceutical industry and have demonstrated the ability to navigate rapidly emerging sectors in biopharma most recently as co-founders of Gotham Therapeutics. The founding team is further complemented by Claus Schalper, a renowned finance expert and serial biotech entrepreneur.

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!

Phosphatases and kinases regulate the activity of numerous crucial signaling pathways by removing or adding a phosphate group from proteins or other biomolecules. Imbalances in this process can lead to a multitude of diseases. While kinases have been exploited by drug developers worldwide, phosphatases stayed largely untouched after setbacks earlier in this century.

Anavo’s approach focuses on combining profound understanding of phosphatase biology with deep drug discovery expertise and state-of-the-art technologies to design first-in-class and best-in-class small molecule modulators of phosphatase activity. The company has attracted world-leading phosphatase biology expertise to its advisory board in Mathieu Bollen, Professor of Molecular Cell Biology at University of Leuven, and Nicholas Tonks, Professor of Cancer Research at Cold Spring Harbor Laboratory. Taken together, both have authored and co-authored more than 500 scientific publications on phosphatases and related physiological processes.

"Anavo was founded to unlock the full potential of phosphatase-targeting allosteric modulators and has attracted one of the largest European biotech seed rounds to date. Recent progress especially around SHP2 has demonstrated that the time is ripe to address phosphatase drug discovery more systematically and on a much larger scale," said Dr. Birgit Zech, Chief Executive Officer of Anavo Therapeutics. "With Mathieu Bollen and Nicholas Tonks as our initial scientific advisory board members, we have attracted two world-leading scientists in phosphatase biology which complements our deep drug discovery know-how."

"Academic research on the human phosphatome has moved way ahead of the industry and we are now sitting on a real treasure trove of potential therapeutic avenues to explore, targets to validate, and programs worth translating into preclinical and clinical evaluation," said Dr. Gerhard Müller, Chief Scientific Officer of Anavo Therapeutics. "Among all target classes currently defined as ‘undruggable’, we expect phosphatases to have the deepest and most profound impact on clinical outcomes once addressed in a systematic and coherent fashion."

Therese Liechtenstein, Principal at M Ventures, added: "Anavo’s novel approach and its experienced management team provide us with the best tools and key ingredients to address challenges in phosphatase drug discovery, and unlock this rich target class. We are excited to be part of Anavo and their mission."

Simone Botti, Junior Partner at INKEF Capital, added: "The progress that has been made with SHP2 in our industry has revived the phosphatase sector but is only scratching the surface of this largely untapped attractive molecular target class. We are very pleased to support Anavo, a company poised to deliver first-in-class therapeutics in oncology and establish itself as a world leader in phosphatase drug discovery."

Therese Liechtenstein and Simone Botti will be joined by Sakae Asanuma, President and CEO of Taiho Ventures, and Debora Dumont, Managing Partner at Bioqube Ventures, on Anavo’s Board of Directors.

On April 22, 2021 Mission Therapeutics ("Mission"), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), reported that members of its management will be attending the upcoming SVB Leerink Biopharma Private Company Connect Event (Press release, Mission Therapeutics, APR 22, 2021, View Source [SID1234578340]).

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 event, which will take place virtually on 6-7 May 2021, is intended to bring together private companies with institutional investors and to facilitate discussions on the trends and opportunities shaping the future of healthcare.

For individuals interested in attending the conference, please contact SVB Leerink for more information.