On May 27, 2022 Modra Pharmaceuticals ("Modra") reported the final results of the lower dose cohort in the Company’s Phase 2b trial evaluating its oral taxane therapeutic, ModraDoc006/r, in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) compared to standard-of-care IV chemotherapy docetaxel at 75 mg/m2 Q3W. ModraDoc006/r is an oral tablet formulation of docetaxel co-administered with ritonavir, a boosting agent which enhances bioavailability (Press release, Modra Pharmaceuticals, MAY 27, 2022, View Source [SID1234615206]). The lower 20-20/200-100mg dose demonstrated a significantly improved safety profile compared to IV docetaxel while maintaining efficacy levels. Based on these encouraging results, this optimal dose has been selected for Modra’s planned Phase 3 pivotal trial in mCRPC patients. The Phase 2b data will be presented in a "poster discussion" presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting 2022, held from June 3 – 7.

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 detailed analysis of the lower dose cohort has demonstrated that we can further improve the safety profile for ModraDoc006/r without compromising activity, making it a very attractive option to deliver chemotherapy. Now, with the optimal dosage of ModraDoc006/r selected, we are well-positioned to enter Phase 3 clinical testing and get one step closer to bringing a safer, effective and more convenient alternative to IV chemotherapy to patients living with mCRPC," said Colin Freund, CEO of Modra Pharmaceuticals.

Out of the 62 patients enrolled in the second cohort, 31 received IV docetaxel and 31 were administered ModraDoc006/r at 20mg ModraDoc006 combined with 200mg ritonavir in the morning, 20mg ModraDoc006 with 100mg ritonavir in the afternoon ("20-20/200-100") in a bi-daily weekly dosing (BIDW) regimen. Notably, neutropenia was eliminated with ModraDoc006/r 20-20; 0% vs. 26% on IV docetaxel. Neuropathy was significantly reduced at 10% G1 only on ModraDoc006/r vs. 29% total (10% G1, 19% G2) on IV docetaxel. Incidence of alopecia was 23% on ModraDoc006/r vs. 42% on IV docetaxel. ModraDoc006/r vs. IV docetaxel demonstrated an overall response rate (ORR) of 39% vs. 29% respectively. Prostate-Specific Antigen (PSA) responses were also comparable at 48% vs. 50%. Gastrointestinal toxicities with ModraDoc006/r 20-20 remained mild and similar to IV docetaxel.

"Not only did ModraDoc006/r 20-20 eliminate neutropenia, a significant hurdle in the oral taxane space, while maintaining equivalent efficacy to IV docetaxel, it also dramatically reduced neuropathy and alopecia, side-effects that frequently complicate the lives of mCRPC patients undergoing chemotherapy," said Ulka Vaishampayan, MD, Principal Investigator of the study and Professor of Internal Medicine, Division of Hematology/Oncology at the University of Michigan. "These encouraging data provide a compelling rationale for conducting further development in a pivotal study with ModraDoc006/r to further investigate its potential. ModraDoc006/r 20-20 will be applicable to a broader mCRPC patient population that may not have access to or tolerate more traditional IV chemotherapy regimens. The convenience of oral administration with maintained efficacy makes it an attractive option that is likely to improve prostate cancer outcomes."

The open label 1:1 randomized study compared ModraDoc006/r 20-20 in a BIDW schedule with IV docetaxel 75 mg/m2 administered in 21-day cycles. Participating patients had mCRPC with a performance status of 0-1 and had not received prior chemotherapy for mCRPC. All patients received 5 mg oral prednisone twice daily. The primary endpoint of the study was radiographic progression free survival (rPFS) per PCWG-3 criteria. Secondary objectives included ORR, PSA-PFS, time to skeletal related events, disease control rate, duration of response and safety assessments.

Presentation Details
Session: Genitourinary Cancer—Prostate, Testicular, and Penile
Poster Title: A Phase 2 randomized study of oral docetaxel plus ritonavir (ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer (mCRPC)
Presenter: Ulka N. Vaishampayan, MD | University of Michigan
Location: In-Person & Live Stream | Arie Crown Theater
Session Date and Time: June 6, 2022 from 16:30 CDT – 18:00 CDT
Abstract Number: 5016
Poster Number: 200

About metastatic Castration-Resistant Prostate Cancer (mCRPC)
mCRPC is an advanced form of prostate cancer and the fourth most common cause of cancer death overall. mCRPC is not amenable to surgical treatment and resistant to androgen deprivation therapy, a hormone therapy used as initial disease management to reduce growth of prostate cancer cells.

About ModraDoc006/r
ModraDoc006/r is a proprietary boosted taxane therapy based on docetaxel, an intravenously administered therapy, that is very broadly used in a variety of tumor types. ModraDoc006 – an oral docetaxel tablet – is given in combination with ritonavir (r), which acts as a booster to increase the systemic bioavailability of ModraDoc006. ModraDoc006/r is designed to combine the convenience and practicality of taking chemotherapy treatment at home with the potential for an improved safety profile, as compared to standard IV docetaxel.

On May 27, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, reported that management will participate in an upcoming investor conference (Press release, Zymeworks, MAY 27, 2022, View Source [SID1234615205]):

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!

Jefferies Healthcare Conference. Zymeworks will participate in one-on-one meetings on June 8th – 9th and will present on June 8th at 9:30 a.m. ET in New York, NY.
The presentation will be available on Zymeworks’ website at View Source

On May 27, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that it has been selected as the winner of the "Best New Technology Solution – Dermatology" award in the sixth annual MedTech Breakthrough Awards program for its innovative DecisionDx-Melanoma gene expression profile (GEP) test (Press release, Castle Biosciences, MAY 27, 2022, View Source [SID1234615204]). DecisionDx-Melanoma leverages Castle’s advanced technologies to identify the risk of metastasis, recurrence and sentinel lymph node (SLN) positivity for patients diagnosed with invasive cutaneous melanoma. In 2021, Castle was awarded "Best New Technology Solution – Oncology" by MedTech Breakthrough for its DecisionDx-SCC and DecisionDx DiffDx-Melanoma GEP tests, both of which were launched in the second half of 2020.

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 mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories. This year’s program attracted more than 3,900 nominations from over 15 different countries throughout the world.

DecisionDx-Melanoma is Castle’s proprietary risk stratification GEP test that is designed to use a patient’s tumor biology to predict individual risk of metastasis or recurrence for patients diagnosed with invasive cutaneous melanoma, a deadly skin cancer, as well as the risk of SLN positivity, independent of traditional staging factors. Unlike traditional treatment plans that are developed using clinical and pathologic factors alone (e.g., a patient’s age, tumor thickness, ulceration, etc.), incorporating the patient’s primary tissue biology can help physicians and patients make more informed disease management decisions aligned with each patient’s unique biologic risk.

"Having an accurate picture of whether melanoma is likely to recur or spread is critical to making the right treatment and disease management decisions, and though risk indicators like clinicopathological factors and patient history are important, they have their limitations," said James Johnson, managing director, MedTech Breakthrough. "Genomic testing can supplement these traditional factors, and Castle’s GEP test has been shown to accurately and independently predict individual risk of recurrence or metastasis, and can provide clinically actionable and personalized information to inform the treatment plan for each patient. Congratulations to the Castle team for being our choice for ‘Best New Technology Solution – Dermatology.’"

In 2021, Castle incorporated two new proprietary, independently validated algorithms into its DecisionDx-Melanoma test: i31-SLNB (designed to predict SLN positivity) and i31-ROR (designed to predict an individual patient’s risk of recurrence). These algorithms combine a patient’s clinical and pathologic risk factors with their DecisionDx-Melanoma class result to provide an Integrated Test Result with precise and personalized risk information specific to each patient, including his/her:

Personalized likelihood of SLN positivity, thus informing consideration of the SLN biopsy surgical procedure.
Personalized, patient-specific risk of recurrence predictions, including five-year outcomes for melanoma-specific survival, distant metastasis-free survival and recurrence-free survival, to give guidance for patient follow-up and treatment intensity decisions.
"The choices that clinicians and patients make immediately after a diagnosis of invasive melanoma can be critical and ultimately determine the outcome of a patient’s disease," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Thus, it was important to us at Castle that our DecisionDx-Melanoma test provided the most precise and personalized information possible to help inform potentially life-changing decisions around the management and treatment of a patient’s cancer. We are thrilled to win this award, recognizing our innovative DecisionDx-Melanoma test that we believe is transforming the management of melanoma and guiding improved patient care."

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 (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,300 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. Additionally, Castle has an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM cases. This collaboration has resulted in Castle’s analysis of 5,226 samples (clinically tested through December 31, 2018) in a study to evaluate melanoma-specific survival and overall survival; in this study, patients tested with DecisionDx-Melanoma had better survival rates than untested patients, and the data suggested that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. 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. Additionally, impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through March 31, 2022, DecisionDx-Melanoma has been ordered 97,288 times for patients with cutaneous melanoma.

On May 27, 2022 Mercy BioAnalytics, Inc., a pioneer in extracellular vesicle-based liquid biopsies for the early detection of cancer, reported that the Mercy Halo Ovarian Cancer (OC) assay substantially outperformed CA125 when distinguishing patients with early-stage high-grade serious ovarian cancer (HGSOC) from women with benign conditions in a new study to be presented next week at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Mercy BioAnalytics, MAY 27, 2022, View Source [SID1234615203]). The assay uses a novel method of analyzing biomarkers based on individual extracellular vesicles (EVs).

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!

"These preliminary data suggest this approach may detect all stages of ovarian cancer with high sensitivity at a very high specificity and works equally well in both plasma and serum. Mercy’s assay shows promise in improving on CA125 by distinguishing stage I/II cancer from benign ovarian tumors and could have clinical utility for both early detection and surgical referral recommendation for benign and malignant ovarian tumors," said Christine D. Berg, M.D., retired Chief, Early Detection Research Group, National Institutes of Health.

The study, titled "Extracellular vesicle-based biomarker assay for the detection of early-stage ovarian cancer," will be presented on Saturday, June 4, 2022, at ASCO (Free ASCO Whitepaper) by Daniel Gusenleitner, Ph.D., Head of Computational Biology for Mercy Bioanalytics (Abstract #5542).

The study found that the Mercy Halo OC assay:

Displayed separation of HGSOC from benign adnexal masses and healthy controls that was superior to CA125.
When run against a variety of off-target cancers and inflammatory conditions, in most instances, discriminated them from ovarian cancer.
When run in paired serum and plasma samples, had highly correlated signals with virtually no bias, indicating the assay can be validated further in established blood biorepositories, which offers the potential to accelerate clinical study and development.
HGSOC is the most aggressive of all ovarian cancers and accounts for up to 70 percent of all ovarian cancer cases. Nearly 50 percent of ovarian cancer is detected at stage III or stage IV with poor survival outcomes. Current surveillance methods, including CA125, a current standard of care for ovarian cancer diagnosis, and ultrasound, are not effective enough at detecting early-stage disease. Emerging methods for early cancer detection rely primarily on tumor DNA circulating in blood (ctDNA), which is scarce in early-stage cancers, costly to measure, and not reliably obtained from tumors that are not well vascularized.

The novel Mercy Halo technology enables simultaneous detection of multiple cancer-related biomarkers co-localized on the surface of individual tumor-derived extracellular vesicles, which are abundant in circulation and can be readily measured. The Mercy Halo OC assay is designed to detect stage I/II ovarian cancer and to distinguish cancer from benign conditions.

"Too many women today suffer, and ultimately lose their lives, as a result of the late detection of ovarian cancer. We are encouraged by the data of our most recent study comparing the Mercy Halo Ovarian Cancer assay to CA125 in detecting early-stage ovarian cancer and distinguishing it from benign disease," said Paul Blavin, Chief Executive Officer of Mercy BioAnalytics. "Our unique approach, focused on co-localization to interrogate single extracellular vesicles, has important advantages over current early cancer detection methods, and our work thus far has fueled our passion for relieving suffering and saving lives through the early detection of cancer. We look forward to expanding our studies of the Mercy Halo Ovarian Cancer assay to include average risk, asymptomatic women who might benefit from an improved ovarian cancer screening paradigm."

On May 27, 2022 CEL-SCI Corporation (NYSE American: CVM) reported the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has published two abstracts related to CEL-SCI’s pivotal Phase 3 Multikine (Leukocyte Interleukin, Inj.)* head and neck cancer clinical trial (Press release, Cel-Sci, MAY 27, 2022, View Source [SID1234615202]). The poster will be presented by CEL-SCI’s Chief Scientific Officer, Eyal Talor, Ph.D., at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting to be held June 3-7, 2022 in Chicago, Illinois.

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!

Abstract titles and corresponding links are as follows:

"Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study." Link to abstract: View Source
"Novel algorithm for assigning risk/disease-directed treatment (DDT) choice in locally advanced primary squamous cell carcinoma of the head and neck (SCCHN): Using pretreatment data only." Link to abstract: View Source
ASCO is the largest cancer meeting in the world, bringing together thousands of cancer experts from academia, industry, patient advocacy and policy.