On February 16, 2018 Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, reported the presentation of two studies highlighting the clinical use of the DecisionDx-Melanoma gene expression profile test, which uses tumor biology to provide an individual risk of recurrence in cutaneous melanoma patients (Press release, Castle Biosciences, FEB 16, 2018, View Source [SID1234524026]). The data will be presented during the 74th Annual Meeting of the American Academy of Dermatology (AAD), held in San Diego, CA from February 16-18.

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The clinical impact study titled, "A Prospective Multicenter Study to Evaluate the Clinical Impact of a 31-Gene Expression Profile Test on Physician Recommendations for Management of Melanoma Patients," (Abstract 6798) will be presented during the Late-Breaking Research: Basic Science/Cutaneous Oncology/Pathology session at the meeting. Researchers found that physicians used test results to inform risk-appropriate changes in patient management while remaining within the context of established practice guidelines.

The second study titled, "Factors Impacting Dermatologists’ Decision to Utilize a 31-Gene Expression Profiling Test to Assess Metastatic Risk for Melanoma Patients," (Abstract 7061) examined clinicopathologic factors that impact dermatologists’ decisions to recommend the DecisionDx-Melanoma test for patients. The study found that a majority of clinicians would order the DecisionDx-Melanoma test for tumor thickness of 0.5 mm or greater with or without ulceration, and for thinner tumors if a factor such as ulceration were present.

Clinical Impact Study

This multicenter, prospective clinical impact study included 247 patients from 15 dermatology, medical oncology or surgical oncology centers. Patients were clinical Stage I or II at time of enrollment. The patient cohort has a median age of 63 years and median Breslow thickness of 1.1 mm.

Pre and post-test management recommendations were collected, including laboratory tests, imaging, frequency of clinical visits, adjuvant treatment discussion, and plans for referral to surgical or medical oncology. To assess clinical impact of the test, changes between pre- and post-test plans were categorized as an increase, decrease or no change in care.

Key Study Findings:

181 patients (73%) had a Class 1 (low-risk) result and 66 (27%) had a Class 2 (high-risk) result.
Overall 49% of patients tested experienced a change in clinical management recommendations following the receipt of the DecisionDx-Melanoma test.
Class 1 patients showed a 36% post-test change in management plans, while 85% of Class 2 patients had a change following the DecisionDx-Melanoma test.
79% of management changes were assessed to be in a risk-appropriate direction based on test result, with 91% of decreases in care documented for low-risk (Class 1) patients, and 72% of increases in care provided for high-risk (Class 2) patients.
The most significantly changed management modalities were follow-up frequency and imaging.
"Across the different practice settings in this study, the DecisionDx-Melanoma test informed risk-appropriate patient management decisions, consistent with previous publications demonstrating that the test impacts one in two clinical management decisions," said Federico Monzon, MD, Chief Medical Officer, Castle Biosciences. "These findings align with national guidelines, which recommend that a patient’s individual risk of recurrence should drive management decisions."

Utilization of Clinicopathologic Factors for Decision-Making

Results from a clinical utility study designed to determine which factors impact clinicians’ decisions to use the DecisionDx-Melanoma prognostic test were also presented during the AAD meeting. The impact on use of the test by Breslow thickness, ulceration, and sentinel lymph node biopsy (SLNB) status were evaluated using clinical vignettes and an interactive response methodology. The vignettes included tumors with Breslow thicknesses of 0.26, 0.50, 0.76 and 2.10 mm, with or without ulceration or knowledge of SLNB status. A total of 181 dermatologists completed the study.

Key Study Findings:

87% of dermatologists in this study would recommend the DecisionDx-Melanoma test for all tumors with a Breslow thickness of 0.5 mm or greater in the absence of ulceration and 78% in the presence of ulceration.
Presence of ulceration was associated with an increase in the number of dermatologists who would recommend the test for all but the thickest tumor assessed (2.10 mm).
For the thinnest tumor assessed (0.26 mm) the presence of ulceration significantly increased the number of dermatologists who would recommend the test from 22% to 67% (p<0.001).
SLNB negative status was associated with an increase in the number of physicians recommending the test for the thinnest tumors from 22% to 34% (p=0.033).
"Overall, tumor thickness and presence of ulceration were found to be the most impactful factors influencing clinicians’ decisions to order the DecisionDx-Melanoma test," said study co-author Darrell S. Rigel, M.D., M.S., Clinical Professor at New York University School of Medicine. "The study shows that dermatologists are making appropriate decisions to use the test as an important part of metastatic risk assessment in early stage patients."

About DecisionDx-Melanoma
The DecisionDx-Melanoma test uses tumor biology to provide a prediction of individual risk of melanoma recurrence beyond traditional factors. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi-center studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in four prospective studies including 702 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1300 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multi-center studies which included over 1400 patients. Clinical impact has been demonstrated in multi-center and single-center studies showing that test results change approximately 50% of management decisions. More information about the test and disease can be found at www.SkinMelanoma.com.

On February 16, 2018 Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported Dr. Johnson Lau, Chief Executive Officer, will present at the 2018 RBC Capital Markets Healthcare Conference in New York City on Wednesday, February 21, 2017 at 11:00 am EST (Press release, Athenex, FEB 16, 2018, View Source;p=RssLanding&cat=news&id=2333004 [SID1234524025]).

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The presentation will be webcasted, and can be accessed at the Investor Relations section of the Company’s website, located at www.athenex.com. An archive will be available at this website until May 22, 2018.

On 15 February, 2018 ISA Pharmaceuticals B.V. (‘ISA’), a clinical-stage immunotherapy company, and Scancell Holdings plc, (‘Scancell’ or the ‘Company’), the developer of novel immunotherapies for the treatment of cancer, reported that they have entered into a worldwide licensing and collaboration agreement to use ISA’s AMPLIVANT adjuvant technology for the manufacturing, development and commercialisation of Scancell’s first Moditope development candidate, Modi-1 (Press release, ISA Pharmaceuticals, FEB 15, 2018, https://www.isa-pharma.com/isa-pharmaceuticals-and-scancell-enter-collaboration-agreement-for-the-manufacturing-development-and-commercialisation-of-modi-1-amplivant-combination/ [SID1234612392]). This partnership has the potential to provide a new treatment option for patients with triple negative breast cancer, ovarian cancer, sarcomas, and other solid tumours.

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Under the terms of this agreement, ISA has granted Scancell an exclusive worldwide license to manufacture, develop and commercialise the AMPLIVANT:Modi-1 conjugate therapy and will contribute know-how and expertise related to AMPLIVANT. Clinical studies will be conducted by Scancell and are expected to commence in H1 2019.

In return, ISA will receive an upfront payment from Scancell and is entitled to milestone and royalty fees following achievement of certain criteria as defined in the agreement. Financial details were not disclosed.

Previous pre-clinical data demonstrated that conjugation of the Modi-1 peptides to AMPLIVANT enhances anti-tumour immune responses 10-100 fold and resulted in highly efficient tumour eradication, including protection against tumour re-challenge.

ISA’s AMPLIVANT technology can be applied to any type of targeted immunotherapy, significantly enhancing its efficacy. It is based on a proprietary and synthetic small molecule TLR1/2 ligand with enhanced immunostimulatory activity that can be chemically coupled to the respective immunotherapeutic. AMPLIVANT conjugates allow lower dosing with higher efficacy through better dendritic cell antigen processing and presentation, as well as enhanced T cell priming.

Scancell’s Moditope platform acts by stimulating the production of CD4+ T cells using citrullinated tumour-associated peptide epitopes. This technology overcomes the immune suppression induced by tumours themselves, allowing activated T cells to seek out and kill tumour cells that would otherwise be hidden from the immune system.

"This collaboration is an important step to advance new adjuvant technologies such as AMPLIVANT to clinical-stage programmes and bring patients better treatments," said Ronald Loggers, CEO of ISA Pharmaceuticals. "The partnership will further validate the power of AMPLIVANT conjugates for use in therapeutic cancer vaccines that carry a variety of epitopes, including post-translationally modified epitopes such as Scancell’s Moditope products."

Cliff Holloway, CEO of Scancell, commented: "This collaboration with ISA Pharmaceuticals is an important step in the continued development and commercialisation of our first Moditope immunotherapy, Modi-1, which has the potential to treat patients with triple negative breast cancer, ovarian cancer and sarcoma who are resistant to other immunotherapies. Our pre-clinical studies have demonstrated Modi-1 induces potent anti-tumour responses and significant improvements in survival. We believe that combining Modi-1 with an enabling adjuvant technology such as AMPLIVANT has the potential to significantly enhance its efficacy in patients and we are looking forward to moving this important and novel therapy into the clinic in the first half of 2019."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

On February 15, 2018 GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) ("GT" or the "Company"), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products as well as central nervous system treatments, reported that Shawn M. Cross will become Chairman and Chief Executive Officer effective February 15, 2018 (Press release, GT Biopharma , FEB 15, 2018, View Source [SID1234539533]).

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Mr. Cross has held the position of President and Chief Operating Officer of GTBP since November 16, 2017. The plan to add The Chairman of the Board and CEO positions to Mr. Cross’ duties as President/COO was initiated by the Company’s board of directors to prepare the company for its next phase of growth. Mr. Cross will lead GTBP through NASDAQ capital markets listing process, attract institutional investment and analyst coverage to the company, and guide development of its neurology portfolio and its first TriKE into human clinical testing in 2018.

Dr. Kathleen Clarence-Smith will become Vice Chairwoman of the Board of Directors and President of the Neurology Division to focus her efforts on creating value in GTBP’s central nervous system portfolio and drive the company’s intellectual property developments.

Anthony J. Cataldo will remain as a member of the Board of Directors and become a consultant to the company.

Mr. Cross is an internationally recognized healthcare investment banker specializing in the biopharmaceutical sector with over 20 years of experience and has completed dozens of capital markets and strategic transactions for growth-oriented biopharmaceutical companies. He joined GTBP as President and Chief Operating Officer of the Company. Previously he was Managing Director, Head of Biotechnology Investment Banking at Deutsche Bank Securities Inc. and Managing Director and Head of Biopharmaceutical Investment Banking at Wells Fargo Securities, LLC where he completed dozens of capital markets and strategic transactions for growth-oriented biopharmaceutical companies.

GT Biopharma Executive Chairman Anthony J. Cataldo said, "It is now time to move GT Biopharma to an institutional quality biotech company. I created GTBP using the same model I used when creating, what is now known as, Iovance Biotherapeutics, Inc. (IOVA); an approximately $1.5 billion market cap company. The leadership provided by Shawn Cross, Dr. Kathleen Clarence-Smith and Dr. Ray Urbanski, our Chief Medical Officer will be invaluable to moving these assets towards clinical and commercial success. I am excited for our shareholders and look forward to helping the board and management progress GT Biopharma to becoming a significant biotech company."

GT Biopharma Chief Executive Officer Dr. Kathleen Clarence-Smith said, "Having known Shawn for over a decade, I’m confident that Shawn will be a very effective CEO for GTBP while I focus on maximizing the value of our neurology portfolio. I look forward to moving the company to the next level."

GT Biopharma President and COO Shawn M. Cross said, "I continue to see a great deal of promise in GT Biopharma’s pipeline of immuno-oncology and neurology therapeutics and am honored to become Chairman and Chief Executive Officer of such a dynamic company. I look forward to announcing additional experienced members to our management team and board in the coming weeks. I also am excited to work closely with Dr. Urbanski as we prepare to enter our first TriKE into human clinical testing as well as with Dr. Clarence-Smith in creating value from our neurology portfolio."

On February 15, 2018 Celularity reported that it has been created through the contribution and acquisition of extensive intellectual property, clinical-stage assets, basic and clinical research, and product development expertise including (Press release, Celularity, FEB 15, 2018, View Source [SID1234530906]):

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First proprietary allogeneic "off-the-shelf" immunotherapeutic platform
Proprietary clinical stage Placental Natural Killer (PNK) Cell Program
IND-ready CD38 CAR-T program
Innovative allogeneic CD38 CAR NK program
Phase 3-ready placental adherent cell products for serious Crohn’s Disease
Sorrento Therapeutics G-MAB Library of 50+ fully-human antibody-CAR constructs
Unparalleled IP position: 800+ issued patents in cell therapy and regenerative medicine; dominating position worldwide for placental stem cells
World-class cell and biomaterials manufacturing capabilities
Commercial-stage functional regeneration products Biovance and Interfyl, and late-stage pipeline assets across broad disease indications
LifeBankUSA, pioneering stem cell biobanking business with two decades’ operating expertise
Celularity, a biotechnology company founded by stem cell pioneer Robert Hariri, MD, PhD, is announcing the formation of the company with $250M in funding with contributions from Celgene (NSDQ: CELG), United Therapeutics (NSDQ: UTHR), Sorrento Therapeutics (NSDQ: SRNE), Human Longevity, Inc., Genting Group, the Dreyfus Family Office, Section 32, and Heritage Group. Celularity is co-founded with Vice Chairman, Peter H. Diamandis, MD, alongside Dr. Hariri, and has a board of industry luminaries including Vice Chairman, John Sculley, formerly of Apple and Pepsi-Cola, Bill Maris of Section 32 (previously founder and CEO of Google Ventures), and Andrew von Eschenbach, former commissioner of the US Food and Drug Administration.

Celularity sources, develops, and deploys transformative therapies derived from the placenta for treatment of complex medical conditions including hematological and solid tumors, autoimmune disease, diabetes, as well as degenerative effects of aging. By combining synergistic assets from Celgene, United Therapeutics, Sorrento Therapeutics, and Human Longevity Inc., Celularity is accelerating the development of cell and tissue regenerative products to address unmet medical needs. These treatments have the potential to reverse life-threatening diseases and extend the healthy human lifespan.

"My goal is to make it so the next generation grows up in a world where cancer is managed just like the common cold, and the body’s natural regenerative engine remains empowered throughout our lives," said Dr. Hariri, Founder, Chairman and Chief Executive Officer of Celularity. "Celularity is a new biotechnology company model founded to harness the placenta as a platform for discovery and therapeutics, ultimately with a goal of amplifying the body’s ability to fight disease, restore function and extend the healthy lifespan. It is my vision that the cellular medicines we derive from the placenta will lead to abundant and affordable treatments."

Celularity has assembled an industry-leading intellectual property portfolio of more than 800 issued patents, which attain a dominating position around placental-derived stem and progenitor cells. Celularity is also the first to own and deploy the full value chain ranging from sourcing placental stem cells to delivering patient treatment. The company is built on three key pillars: Cell Therapy, Functional Regeneration, and Biosourcing:

Cell Therapy: Celularity has developed five clinical stage cell therapy candidates currently being evaluated for cancer, and immunological and degenerative diseases
Functional Regeneration: Celularity is addressing serious wounds, burns, orthopedic, and other surgical indications including reconstructive and aesthetic applications with a broad range of placental biomaterials. Derived from placental tissue, Celularity’s BIOVANCE and Interfyl were the first biomaterial products introduced to the market to enhance the body’s regenerative processes
Biosourcing: Celularity owns and operates LifeBankUSA, the world’s only repository that allows families to bank their newborn’s placental cells and biomaterials for future therapeutic and regenerative use
Celularity is the only company with an allogeneic placental cell platform. Placental stem cells are uniquely immunoprivileged, therefore treatments do not require cells to be engineered or matched for each individual patient. Celularity is focused on this highly-scalable platform of technology to optimize economics and access to these cutting-edge therapies, including immuno-oncology. These placental stem cells allow for unprecedented scalability for Celularity’s CAR-T and CAR-NK platforms.

"Celularity’s technology has the potential to augment human immunity and longevity," said Dr. Peter H. Diamandis, Co-Founder and Vice-Chairman of Celularity. "The company’s ultimate vision is to make 100 years old the new 60, providing people with maximal cognition, mobility and aesthetics as they age. The 20 years of science, research, and intellectual property pioneered by Dr. Bob Hariri has the highest potential to become the cornerstone for this vision."

Andrew von Eschenbach, MD, among the founding members of the Celularity Board of Directors, and the former United States Food and Drug Administration (FDA) Commissioner and Director of the National Cancer Institute, said, "The pioneering work of Celularity founder Bob Hariri has unleashed the unique properties of placental derived stem cells, which have renewed hope for creating safe and effective therapies for the most challenging degenerative diseases." Dr. von Eschenbach added, "Celularity, with its focus on accelerating innovation in regenerative medicine, can become the leading catalyst for cell therapy to address many of the world’s unmet medical needs."

"Our investment in Celularity brings together its proprietary allogeneic placental platform and Sorrento’s best in class CAR-T products and cGMP manufacturing capabilities," said Henry Ji, another founding member of Celularity’s Board of Directors and Chairman, President and CEO of Sorrento Therapeutics. "Together, we can deliver these health solutions at scale to treat exponentially more people than we ever thought possible."