On November 2, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that DecisionDx DiffDx-Melanoma is now commercially available (Press release, Castle Biosciences, NOV 2, 2020, View Source [SID1234569711]). DecisionDx DiffDx-Melanoma is designed for use in patients with suspicious pigmented lesions.

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"We are pleased to offer DecisionDx DiffDx-Melanoma, which has been designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions as benign or malignant," said Derek Maetzold, president and chief executive officer of Castle. "I am particularly proud of our research and development team, who successfully maintained timelines from program initiation to validation. And employing our artificial intelligence tools, we were able to achieve our target product profile goals for DiffDx-Melanoma: improved accuracy metrics with a substantially reduced intermediate-risk zone, to enable dermatopathologists to act upon a test result from DiffDx-Melanoma. This test has been demonstrated to provide a definitive result in more than 96% of the reported cases, which allows for clinicians to have a greater, direct impact on patient care."

Sarah I. Estrada, M.D., FCAP, laboratory director of Affiliated Dermatology added, "Of the approximately 2 million suspicious pigmented lesions biopsied annually in the U.S., approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. Undertreatment or delayed identification of melanoma can lead to tumor spread and increased risk of melanoma-specific mortality. On the other hand, overtreatment can impact patient quality of life, potentially resulting in adverse events and increased morbidity. DecisionDx DiffDx-Melanoma is designed to provide diagnostic clarity for dermatopathologists and help dermatologists deliver more informed patient management plans."

DecisionDx DiffDx-Melanoma is a gene expression profile (GEP) test designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions and classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of melanoma). The intent-to-treat analysis of the DiffDx-Melanoma validation study showed that the test accurately diagnosed malignant and benign cases in 96.6% of the cases with 99.1% sensitivity, 94.3% specificity, 93.6% positive predictive value and 99.2% negative predictive value. An intermediate-risk result was identified in 3.6% of the cases.

Castle has three dermatologic cancer gene expression profile tests commercially available in the U.S.: DecisionDx-Melanoma, DecisionDx-SCC and DiffDx-Melanoma. All three tests were developed in-house by Castle and are validated and supported by multiple peer-reviewed publications.

About DecisionDx DiffDx-Melanoma

DecisionDx DiffDx-Melanoma (previously known as ConfirmDx-Melanoma) is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. Of the 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. DecisionDx DiffDx-Melanoma classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, DecisionDx DiffDx-Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists while helping dermatologists deliver more informed patient management plans.

On November 2, 2020 Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), reported the acceptance of publication in Frontiers in Immunology, outlining the positive long-term follow-up data from the company’s Phase I trial evaluating its proprietary universal cancer vaccine, UV1, in non-small cell lung cancer (Press release, Ultimovacs, NOV 2, 2020, View Source [SID1234569710]). The publication will cover detailed outcomes of the study for the 18 patients receiving UV1 monotherapy as maintenance treatment.

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"Today’s acceptance of publication in Frontiers in Immunology supports our goal to raise UV1 awareness among the scientific and medical communities through publications and presentations at medical conferences," stated Carlos de Sousa, Chief Executive Officer at Ultimovacs. "Continued positive signs of safety and tolerability are of great importance for us as we are currently evaluating UV1 in triple combinations in two Phase II studies and safety remains our primary focus as we develop treatments for patients in need."

In the study, a total of 18 non-small cell lung cancer patients whose disease had not progressed after receiving at least 2nd line treatment with chemotherapy were enrolled to receive UV1 monotherapy as maintenance treatment. Patients were assigned to three different dose-groups, of 100, 300 and 700 µg, with each cohort enrolling 6 patients. Data in the publication with a cut-off date of March 2020, demonstrated that administration of UV1 resulted in specific T-cell responses in the majority of the patients. The highest dose of 700 µg, resulted in the highest proportion of immune responses. In addition, immune responses in the high-dose cohort were stronger, occurred at an earlier timeframe and were associated with long survival. The 4-year overall survival (OS) for the patients in the highest cohort was 83%, as compared to 39% for the total patient group.

"The acceptance of our publication is a recognition of the confidence we have in UV1 as a universal cancer vaccine that could potentially treat a range of cancer indications," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. "The data in the publication together with the 5-year topline results that we announced last month, confirm that UV1 can potentially benefit patients with non-small cell lung cancer. In all four Phase I trials that Ultimovacs has conducted with UV1, we see promising overall survival outcomes that support our ongoing, extensive clinical development program for UV1."

The abstract of the publication is available here: https://www.frontiersin.org/articles/10.3389/fimmu.2020.572172/abstract, the full article can be accessed after publication at the Frontiers in Immunology website: www.frontiersin.org.

About UV1
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as a therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action. To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

About UV1 Clinical Programs
As a universal cancer vaccine, UV1’s unique mechanism of action has the potential to be applicable across most cancer types. The clinical development of the UV1 vaccine includes three randomized, multinational, Phase II combination trials recruiting more than 400 patients in total. The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic malignant melanoma to evaluate UV1 in combination with ipilimumab and nivolumab as first-line treatment. The NIPU study is testing UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab as second-line treatment in 118 patients with advanced malignant pleural mesothelioma, a rare lung cancer. The study is sponsored by Oslo University Hospital and Bristol-Myers Squibb is providing the checkpoint inhibitors for this study. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2022. A third Phase II clinical trial will evaluate UV1 in a new cancer indication in combination with indication-specific standard of care cancer therapies different from those to be tested in INITIUM and NIPU. In this new collaboration, Ultimovacs will supply UV1 and a big pharma company will supply its proprietary cancer treatment to the clinical trial group which will sponsor the trial.

On November 2, 2020 Mission Therapeutics ("Mission"), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), reported that it has appointed Dr Suhail Nurbhai as Chief Medical Officer (CMO) with immediate effect (Press release, Mission Therapeutics, NOV 2, 2020, View Source [SID1234569709]).

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Dr Nurbhai has more than 25 years of experience and a strong track record in the strategic and operational leadership of all phases of clinical research and development at companies across Europe and the US. He joins Mission from VHsquared, where he held the position of CMO since 2014.

Prior to VHsquared, Suhail was Senior Vice President and Head of Development and Medical Affairs for Shionogi in Europe. He joined Shionogi from Takeda where he was Vice President and Head of Clinical and Analytical Science in Europe, with responsibility for all Clinical Science activities in Neurosciences, Cardiovascular/Renal/Metabolic, Oncology, Gastrointestinal/Genitourinary and Respiratory Medicine, as well as Clinical Pharmacology, Medical Writing, Statistics and Data Management.

Suhail’s initial industry experience was at Pfizer, where he spent 12 years, initially in Sandwich, UK and then at Global R&D Headquarters in Connecticut, USA. During his time at Pfizer he held roles of increasing responsibility across multiple therapeutic areas including GI/GU, anti-bacterial, sexual medicine and anti-fungal, prior to completing his time at Pfizer as Head of Neuroscience Clinical R&D at the Groton site in Connecticut.

During his career he has led teams bringing multiple compounds from pre-clinical phase into clinical studies in both Europe and US, and achieved multiple successful NDA and MAA submissions and approvals.

Suhail qualified in Medicine at Dundee University in Scotland and completed his post-graduate medical training at Hope Hospital in the University of Manchester.

Commenting on the appointment, Dr Anker Lundemose, CEO of Mission Therapeutics said: "We are pleased to be welcoming Suhail to further strengthen Mission’s leadership team. His in-depth knowledge and proven track record in clinical research will be invaluable as we work to bring our first-in-class USP30 inhibitor compound into the clinic. Suhail’s appointment is the last of a series of organisational changes, including the promotions of Dr Paul Thompson and Dr Nick Edmunds, to ready the Company for this next phase."

Dr Suhail Nurbhai added: "It’s great to be joining Mission at such an exciting time for the Company. The ongoing collaboration with AbbVie and recently signed agreement with Pfizer represent solid industry validation of the Company’s approach and ground-breaking technology. I look forward to building on this success progressing its lead assets into the clinic."

On November 2, 2020 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that it will host a conference call and webcast on Monday, November 9, 2020 at 5:00 p.m. Eastern Time to review its third quarter 2020 financial and operating results and provide a corporate update (Press release, Marker Therapeutics, NOV 2, 2020, View Source;utm_medium=email&utm_campaign=investor_alerts&utm_content=%5B%5Brssitem_title%5D%5D [SID1234569708]).

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The webcast will be accessible in the Investors section of the Company’s website at markertherapeutics.com. Individuals can participate in the conference call by dialing 877-407-8913 (domestic) or 201-689-8201 (international) and referring to the "Marker Therapeutics Third Quarter 2020 Earnings Call."

The archived webcast will be available for replay on the Marker website following the event.

On November 2, 2020 Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported its participation in the following upcoming investor conferences (Press release, Moderna Therapeutics, NOV 2, 2020, View Source [SID1234569707]):

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Credit Suisse 29th Annual Virtual Healthcare Conference on Wednesday, November 11, 2020 at 8:00 a.m. ET.
Jefferies Virtual London Healthcare Conference on Wednesday, November 18, 2020 at 11:25 a.m. ET.
A live webcast of each presentation will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of each webcast will be archived on Moderna’s website for 30 days following the presentation.