On October 6, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that its data will be featured in oral presentations during the 2020 American Society for Dermatologic Surgery (ASDS) Virtual Annual Meeting, October 9-11, 2020 (Press release, Castle Biosciences, OCT 6, 2020, View Source [SID1234568162]).

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!

Presentation details are as follows:

Title: Clinical validation and incorporation of a prognostic 40-gene expression profile test into clinicopathological risk assessment for cutaneous squamous cell carcinoma (cSCC)
Session: Skin Cancer & Reconstruction
Presenter: Sherrif Ibrahim M.D., Ph.D., associate professor, University of Rochester Medical Center
Date: Friday, October 9, 2020
Time: 6:24 p.m. – 6:27 p.m. ET

Title: Cutaneous melanoma prognostic model combining 31-gene expression profile and sentinel lymph node biopsy
Session: Skin Cancer & Reconstruction
Presenter: Aaron Farberg, M.D., Baylor University Medical Center, Dallas, Texas
Date: Friday, October 9, 2020
Time: 6:30 p.m. – 6:33 p.m. ET

The virtual presentations will be available to meeting registrants for 30 days following the meeting.

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. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. 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 June 30, 2020, DecisionDx-Melanoma has been ordered more than 59,900 times for use in patients with cutaneous melanoma.

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 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.mySCCskincancer.com.

On October 6, 2020 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, reported that the Phase 3 study of omidubicel, an investigational advanced cell therapy in development as a potential life-saving treatment option for patients in need of bone marrow transplant, met all three of its secondary endpoints (Press release, Gamida Cell, OCT 6, 2020, View Source [SID1234568161]). Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has the potential to be the first FDA-approved engineered bone marrow transplant graft.

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 international, multi-center, randomized Phase 3 study was designed to evaluate the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing a bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. In May, Gamida Cell reported that omidubicel achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in recovery from a bone marrow transplant. The prespecified secondary endpoints of the study, analyzed in all randomized patients (intent-to-treat), were the proportion of patients who achieved platelet engraftment by day 42, the proportion of patients with Grade 2 or Grade 3 bacterial or invasive fungal infections in the first 100 days following transplant, and the number of days alive and out of the hospital in the first 100 days following transplant. All three secondary endpoints demonstrated a statistically significant improvement among patients who received omidubicel compared to the comparator group. The company anticipates reporting the full data set at a medical meeting in the fourth quarter of 2020.

"These data, obtained in a global, randomized, multi-institutional setting could represent an important step forward in the field. In addition to more rapid platelet engraftment, a key step toward recovery, reducing infections and hospitalizations are considered meaningful patient outcomes and have the potential to provide substantial value for patients, their families and the healthcare system," said Mitchell Horwitz, M.D., principal investigator and professor of medicine at the Duke Cancer Institute. "The totality of these data strengthen my belief that omidubicel has the potential to be a graft source for any patient who does not have access to a matched related donor and could help make stem cell transplantation more accessible and more successful for patients with lethal blood cancers."

"These additional data reinforce the potential of omidubicel and move us another step closer toward bringing potentially curative therapies to patients. We look forward to presenting data at a future medical meeting, and we are continuing our work to enable the submission of our biologics license application for omidubicel to the FDA on a rolling basis, both expected in the fourth quarter," stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. "We deeply appreciate the patients who participated in this study, the incredible encouragement from their caregivers and the support we have received from investigators and their teams."

Despite the curative potential of bone marrow transplant, it is estimated that more than 40 percent of eligible patients in the United States do not receive a transplant for various reasons, including the lack of a matched donor.1 Even for patients who do receive a transplant, treatment is not always effective and can lead to serious complications that can dramatically affect their quality of life.2 Omidubicel is intended to address the current limitations of bone marrow transplant by providing a therapeutic dose of stem cells while preserving the cells’ functional therapeutic characteristics.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated.3,4 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On October 6, 2020 Oncology Venture A/S ("OV" or the "Company") reported that it has called upon Global Corporate Finance (GCF) to invest in the Company in a directed share issue in accordance with the Company’s share subscription agreement with GCF (Press release, Oncology Venture, OCT 6, 2020, View Source [SID1234568160]). A total of 5,370,617 shares at a price per share of SEK 1.7438 is issued to Global Corporate Finance.

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 share price is fixed at SEK 1.7438 per share of nominal DKK 0.05 share and has been calculated as 95% of the daily volume weighted average price (VWAP) of the Company’s shares for the five (5) consecutive trading days following 24 September 2020, the date of the draw down notice from OV.

The registered share capital of Oncology Venture will after the conversion be nominal DKK 9,937,244 divided into 198,744,880 shares of nominal DKK 0.05 each.

The investment is the third investment tranche Oncology Venture has requested from Global Corporate Finance (New York City, NY, U.S.). Oncology Venture may call upon up to a total investment of SEK 50 million in a series of tranches, no single tranche may exceed SEK 10 million.

For further information on the conditions and structure of the financing agreement; please, refer to the press release concerning the agreement published by Oncology Venture on May 6, 2020.

On October 6, 2020 Oncology Venture A/S ("OV" or the "Company") reported that a small group of recipients has received a total of 1,619,912 shares in Oncology Venture A/S (Press release, Oncology Venture, OCT 6, 2020, View Source [SID1234568159]).

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 share issue was announced on 21 August 2020 and concerns warrants of certain OV employees, board members, and consultants who were previous holders of warrants in Oncology Venture Sweden AB. These warrants have since been annulled, and the share issue announced today concludes the related clean-up of the obligations related to this annulment, incurred prior to departure of the prior management team.

Following the share issue, the registered share capital of Oncology Venture A/S is nominal DKK 9,668,713.15 divided into 193,374,263 shares of nominal DKK 0.05 each.

For additional information, please see the relevant press release announcing the issue published on 21 August 2020:

View Source

On October 6, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation for TK216, an investigational potentially first-in-class targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins, for treatment of Ewing sarcoma (Press release, Oncternal Therapeutics, OCT 6, 2020, View Source [SID1234568158]).

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!

Under the FDA’s rare pediatric disease designation and voucher program, the FDA may grant a priority review voucher to a sponsor who receives a product approval for a "rare pediatric disease," which is defined as a serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years and which either affects fewer than 200,000 people in the U.S., or affects more than 200,000 people in the U.S. but with no reasonable expectation that the cost of developing and making the drug available in the U.S. will be recovered from U.S. sales. Subject to FDA approval of TK216 for the treatment of Ewing sarcoma, Oncternal may be eligible to receive a priority review voucher if the marketing application submitted for the product satisfies certain additional conditions, including approval no later than September 30, 2022 (unless this statutory sunset provision is modified by Congress). If issued, this voucher may be redeemed to receive priority review for a subsequent marketing application or may be sold or transferred to another sponsor.

"The FDA’s rare pediatric disease designation of TK216 for treatment of Ewing sarcoma, for which Oncternal had previously received FDA’s Orphan Drug and Fast Track designations, underscores the agency’s recognition that Ewing sarcoma is a devastating cancer, with a high unmet medical need," said James Breitmeyer, M.D., Ph.D., President and CEO, Oncternal. "An expansion cohort in the clinical trial of TK216 for patients with relapsed/refractory Ewing sarcoma is currently enrolling, and we expect to present additional interim clinical data from our ongoing Phase 1 clinical trial at a scientific conference in the fourth quarter of 2020."

About Ewing sarcoma

Ewing sarcoma is the second most common bone tumor among children and adolescents. The median age at diagnosis of patients with Ewing sarcoma is 15, and the incidence is about 3 cases per 1 million per year in children under the age of 20 and about 1.3 cases per 1 million overall in the U.S. Nearly all Ewing sarcoma cases are driven by translocations of ETS family oncogenes, including 85-90% of cases driven by the EWS-FLI1 fusion, and approximately 10% by EWS-ERG. Patients diagnosed with metastatic disease have five-year survival rates between 18% and 30%. The prognosis for patients with recurrent Ewing sarcoma is particularly poor, and five-year survival after recurrence is approximately 10 to 15%.

About TK216

TK216 is an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins including fusion proteins. Tumorigenic fusion proteins involving the EWS protein and an ETS protein can be found in most cases of Ewing sarcoma. ETS-related translocations or overexpression are also found in many other tumors such as prostate cancer and acute myeloid leukemia (AML). TK216 was developed based on discoveries in the laboratory of Jeffrey Toretsky, M.D., at Georgetown Lombardi Comprehensive Cancer Center, who discovered inhibitors of EWS-FLI1 using a novel chemical screening assay. In preclinical models, TK216 was observed to bind to EWS-FLI1, blocking the interaction between this fusion protein and other transcriptome proteins such as RNA helicase A, leading to tumor cell apoptosis and inhibiting tumor growth in animal models. The U.S. Food and Drug Administration (FDA) has granted Orphan designation, Fast Track designation, and Rare Pediatric Disease designation to TK216 for the treatment of Ewing sarcoma. TK216 is an investigational medication that has not been approved by the FDA for any indication.