On December 16, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported that new preliminary performance data for its noninvasive nasal swab test for early lung cancer detection and its Percepta Genomic Atlas for informing treatment decisions at the time of diagnosis (Press release, Veracyte, DEC 16, 2020, View Source [SID1234572946]). Both tests are in development and scheduled to launch in the second half of 2021 as part of Veracyte’s comprehensive portfolio of genomic tests in lung cancer. The data were shared during the company’s Virtual Lung Cancer R&D Day, which was held today.

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!

"We are excited to bring forward novel tests that we believe will address significant unmet needs throughout the patient journey in lung cancer," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "The preliminary data we presented today give us further confidence that our expanding portfolio of tests will improve the lives of patients through earlier diagnosis and comprehensive genomic profiling. This progress, on the heels of our expanded collaboration with the Lung Cancer Initiative at Johnson & Johnson, underscores our deep commitment to fighting this devastating disease."

Veracyte’s noninvasive nasal swab test is being developed to help physicians determine next steps for lung nodules found on CT imaging. Lung nodules identified as high risk for cancer warrant a diagnostic work-up to enable immediate treatment, while nodules identified as low risk may avoid unnecessary invasive procedures and be monitored with surveillance.

Veracyte’s chief scientific officer and chief medical officer, Giulia C. Kennedy, Ph.D., shared cross-validation data for four genomic test models, which are precursors to the final test. The models were all developed using RNA whole-transcriptome sequencing data from nasal samples of patients with lung nodules, which was combined with machine learning to classify patient nodules as high or low risk for cancer. Among the four models, 44-60 percent of the truly malignant nodules were classified as high risk with a range of specificity of 90-91 percent, and 39-57 percent of the truly benign nodules were identified as low risk, with a range of sensitivity of 90-94 percent.

"We are pleased with these preliminary findings, which suggest that our final test will provide physicians much-needed clarity on which patients with lung nodules need additional diagnostic procedures and which patients may safely avoid them," said Dr. Kennedy. "We look forward to locking the final algorithm and then measuring clinical validation performance on an independent test set prior to launching the test in the second half of 2021."

Dr. Kennedy also shared preliminary data for the Percepta Genomic Atlas, which will provide comprehensive genomic profiling information on cancerous lung nodules, utilizing small samples from the biopsy used for diagnosis. The data showed that the in-development test accurately detected known gene variants in lung cancer using bronchoscopy samples, including in stage I, II and III cancers, with over 95 percent concordance to a reference next-generation sequencing assay.

"Our preliminary data gives us confidence that the Percepta Genomic Atlas will be able to accurately detect gene alterations that may allow patients to be treated with targeted therapies that are available now and that will be available in the future. Importantly, we believe it will be able to provide this critical information at the time of diagnosis, enabling earlier and more appropriate treatment," said Dr. Kennedy.

The R&D Day event also featured leading pulmonologists who discussed the challenges and opportunities in lung cancer diagnosis and treatment. A replay of the event and the presentation materials will be available on Veracyte’s website at View Source for approximately 90 days.

About Lung Cancer
Lung cancer is the deadliest cancer globally, killing more than 1.75 million people worldwide each year, according to the World Health Organization. Early detection is key, with a five-year survival rate of nearly 60 percent when the cancer is found early, compared to six percent when it is found at a later stage, according to the American Lung Association. Lung nodules are typically the first sign of lung cancer. While the vast majority of lung nodules ultimately prove to be benign, physicians currently lack clear diagnostic tools to determine which patients have cancer and which do not. This can lead to unnecessary invasive biopsies, which are costly and risky, as well as to delayed diagnosis and treatment.

On December 16, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that the Company has achieved key milestones in its partnership with Bristol Myers Squibb in the field of targeted protein degradation with the first two targets transitioning into drug discovery after completing a comprehensive target validation process (Press release, Evotec, DEC 16, 2020, View Source;announcements/press-releases/p/evotec-achieves-key-milestones-in-its-collaboration-with-bristol-myers-squibb-on-targeted-protein-degradation-6008 [SID1234572965]).

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!

Evotec and Bristol Myers Squibb (the successor in interest to Celgene) initiated their long-term strategic drug discovery and development partnership in the field of targeted protein degradation in 2018 with the goal to identify novel drug targets. The partnership leverages Evotec’s proprietary PanOmics platform, which combines enhanced throughput proteomics, high throughput transcriptomics and cell imaging with an integrated data analysis platform PanHunter. This has enabled the generation of a pipeline of novel first-in-class targeted protein degradation projects.

The first two projects have now transitioned into lead optimisation after completing a comprehensive validation process on Evotec’s platforms. Targeted degradation of these novel targets impacts an established cancer pathway with the promise of providing new therapeutic options for difficult-to-treat breast cancers. Evotec will be responsible for progressing the drug discovery programmes to IND filing.

Evotec receives undisclosed milestone payments as well as research funding for the further development of the programmes and can earn further significant success-based milestone payments. Additionally, Evotec is entitled to tiered, potentially double-digit royalties of the net sales of programmes developed under the partnership.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We are extremely pleased with the progress of this unique and very exciting collaboration with Bristol Myers Squibb. Our PanOmics approach to targeted protein degradation is based on proprietary enhanced and high throughput multi-omics and phenotypic imaging platforms which allow unbiased and comprehensive profiling of novel targets and drug candidates. We are optimistic that many more projects will be taken forward as the collaboration advances and highly appreciate the opportunity to work with the world-leading company in targeted protein degradation."

On December 16, 2020 Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, reported that it has dosed its first patient in a Phase 1b clinical trial of CERC-007 (Press release, Cerecor, DEC 16, 2020, View Source [SID1234573113]). CERC-007 is a high affinity, fully human anti-IL-18 monoclonal antibody (mAb) being developed for patients with relapsed or refractory multiple myeloma (MM). The study will determine the recommended Phase 2 dose, safety and preliminary efficacy of CERC-007. The Company anticipates initial data to be reported in the first quarter of 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!

"We are very excited to have dosed our first patient. We are on track for initial data during the first quarter of 2021," said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor. "Multiple myeloma is the second most common form of blood cancer and is characterized by anemia, bone pain and fatigue with the majority of patients relapsing or becoming refractory on current treatments. Elevated levels of IL-18 are correlated with poor survival in patients with multiple myeloma.1 The approximately 50% mortality rate at five years reinforces the need for novel and targeted therapies, such as CERC-007, as another treatment option."

The Phase 1b clinical trial is a U.S. multicenter, open-label, dose-escalation, sequential group study of CERC-007 as a monotherapy in approximately 30 patients with relapsed or refractory MM. The primary objectives of the study will be to determine the safety and tolerability of CERC-007, the recommended Phase 2 dose, and preliminary efficacy as measured by response rate in accordance with International Myeloma Working Group (IMWG) criteria.

About Multiple Myeloma
Multiple myeloma is the second most common blood cancer, with approximately 140,000 patients in the United States.2 Multiple myeloma is characterized by an excess proliferation of plasma cells. Despite increased availability of new agents, the disease is characterized by a pattern of recurrent relapses and remains incurable for the majority of patients, with a 5-year survival rate of approximately 50%.2

About CERC-007
CERC-007 is a high affinity, fully human monoclonal antibody targeting the proinflammatory cytokine IL-18. It is in development for multiple auto-immune diseases, including Still’s disease (adult onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM).

On December 16, 2020 Kite, a Gilead Company (Nasdaq: GILD), reported that the European Commission has granted conditional marketing authorization for Tecartus (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19) (Press release, Kite Pharma, DEC 16, 2020, View Source [SID1234572947]). Tecartus is a chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Conditional authorization is granted in the interest of public health where the benefit of immediate availability outweighs the risk of less comprehensive data available.

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 conditional marketing authorization is supported from the multinational, single-arm, Phase 2 open-label ZUMA-2 pivotal trial in patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor. ZUMA-2 demonstrated an overall response rate (complete or partial) of 93 percent, with 67 percent of patients achieving a complete response, as assessed by an Independent Radiologic Review Committee following a single infusion of Tecartus. In the safety analyses, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were observed in 15 percent and 33 percent of patients, respectively.

"Significant gaps in treatment remain for patients with mantle cell lymphoma who progress following initial therapies," said Professor John G. Gribben, Consultant Haematologist and Medical Oncologist at Barts and The London NHS Trust, London. "The availability of this first cell therapy for relapsed or refractory mantle cell lymphoma, following at least two lines of systemic therapy including a BTK inhibitor, provides an important option for patients in Europe."

"Kite is committed to bringing the curative intent potential of CAR T-cell therapy to patients with hematological cancers," said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. We are proud our second cell therapy has been approved for use in Europe, and I extend my thanks to the patients who participated in the clinical trial and their families and caregivers, clinical researchers, regulators and dedicated colleagues at Kite who helped make this approval possible for patients living with relapsed or refractory mantle cell lymphoma."

Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma that arises from cells originating in the "mantle zone" of the lymph node and predominantly affects men over the age of 60. Patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a BTK inhibitor have a poor prognosis, with a median overall survival of 6 to 10 months. In Europe, it is estimated that at least 7,400 people are diagnosed with mantle cell lymphoma each year.

Tecartus is a CAR T-cell therapy, an individualized method of treatment that harnesses the body’s own immune system to target cancer cells. The therapy uses the XLP manufacturing process that includes T cell enrichment, a necessary step in certain B cell malignancies in which circulating lymphoblasts are a common feature. In recognition of its potential to benefit patients with significant unmet medical need, Tecartus was granted Priority Medicines (PRIME) designation by the EMA.

Conditional marketing authorization in Europe is initially valid for one year but can be extended or converted into an unconditional marketing authorisation after the submission and assessment of additional confirmatory data. Conditional approval is granted to a medicinal product that fulfils an unmet medical need where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required. It requires additional monitoring and post-marketing data before full approval is granted.

For full details on the Special Warnings and Precautions for Use and Adverse Reactions (including appropriate management), please refer to the EU Summary of Product Characteristics (SmPC).

About ZUMA-2

ZUMA-2 is an ongoing, multinational, single arm, Phase 2 open-label pivotal trial. The study enrolled 74 adult patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor (ibrutinib or acalabrutinib). The treatment was manufactured for 71 patients and administered to 68 patients. The primary endpoint was objective response rate per the Lugano Classification (2014), defined as the combined rate of complete response and partial responses as assessed by an Independent Radiologic Review Committee.

On December 16, 2020 ONA Therapeutics, Absolute Antibody and RIC-three leading European companies in the biotech landscape reported that have been awarded a Eurostars grant for a two-year project that will develop a proprietary biological drug with a unique mode of action for the treatment of various types of metastatic cancers (Press release, Ona Therapeutics, DEC 16, 2020, View Source [SID1234572930]). Taking the lives of more than 9 million people globally each year, metastatic cancers are often unresponsive to existing cancer treatments, leaving a large unmet need. In order to tackle this important health problem, the newly established consortium-named LIPOLOGIC-will combine industry know-how in complementary areas of drug development: from target discovery, across molecule formatting and manufacturing, to lead selection and characterization.

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!

ONA Therapeutics, a Spanish biotech company specialized in the discovery and development of therapeutic biologics targeting tumor metastatic-initiating cells and lipid metabolism, will take the lead in the LIPOLOGIC program. "Our research demonstrates that the survival of metastatic cells is linked to the intake of certain saturated fats and if we block the capacity for intake of these fats, we significantly reduce the cell’s metastatic potential. We are excited to partner with Absolute Antibody and RIC to develop novel revolutionary therapies that target this mechanism of action and with the potential to treat multiple types of metastatic cancer" said ONA co-founder and CEO Valerie Vanhooren.

Absolute Antibody, experts in recombinant antibody technology, will engineer the biologic into an optimized format and then recombinantly produce and purify the molecule for preclinical analysis. According to Ian Wilkinson, Chief Scientific Officer, "Our contribution to the team will result in a reproducible, defined biologic to progress to the IND stage and clinical trials. We are very excited about the potential of this unique mode of action."

RIC, expert in biopharma analytics, will apply its comprehensive knowledge and in-house platforms to provide the CMC data necessary for evaluating the project’s candidate molecules and selecting the best lead: identifying physicochemical liabilities, better understanding target binding through epitope mapping and evaluating overall pharmacokinetics. "The complex nature of biological products makes the development of innovative therapies like these truly challenging. We are proud to bring our analytical skill set to the table and help make this new type of treatment a reality" said Koen Sandra, CEO at RIC.

The LIPOLOGIC consortium has just kicked off its pre-clinical development against a variety of tumor types and plans to move its lead candidate into first clinical studies in patients with metastatic cancer in the upcoming years. The initiative is funded by the Eurostars-2 joint programme with co-funding from the European Union Horizon 2020 research and innovation programme.