On February 4, 2021 McKesson, a global leader in healthcare committed to transforming cancer research,reported that it has joined together with life sciences companies, oncology providers and patient advocacy groups in a unique collaborative effort, titled MYLUNG, to advance precision medicine options for non-small cell lung cancer (NSCLC) patients who are being treated in the community (Press release, McKesson, FEB 4, 2021, View Source [SID1234574634]). NSCLC is the most common type of lung cancer according to the American Cancer Society, accounting for about 84% of lung cancer cases.

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The MYLUNG consortium – or "Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium" – will observe up to 12,000 community-based, metastatic NSCLC patients over a five-year period in one of the first broad, collaborative, research endeavors in lung cancer. In particular, MYLUNG aims to deepen understanding of molecular testing barriers to improve care for lung cancer patients, including those with mutations who may benefit from receiving precision medicine, the practice of leveraging targeted therapies across the continuum of care, as well as expand the opportunity for patients to participate in clinical trials.

"Many patients are not receiving the molecular testing they need to initiate targeted therapy early in their cancer care journey due to long timeframes, lack of coverage or another factor. This testing is critical to determine the patient’s cancer at a molecular level, so oncologists can create a more targeted and precise treatment plan," said Robert L. Coleman, MD, FACOG, FACS, chief scientific officer, US Oncology Research. "In order to fulfill the promise of precision medicine for NSCLC patients, we need a fuller understanding of the barriers, challenges, risks and opportunities around molecularly guided therapies. MYLUNG will draw insights from these datasets that can lead to better therapy for patients in a timelier manner."

Lung cancer treatment is becoming increasingly personalized to include targeted therapies into earlier stages of disease. To support this, MYLUNG provides the framework to conduct research studies that will help define best practices for providers, as well as provide insights for life sciences companies seeking to quickly deliver potentially life-saving treatments to the patients who need them.

The MYLUNG consortium brings together several McKesson-supported organizations focused on transforming and enhancing the cancer care experience including The US Oncology Network, US Oncology Research, and OntadaTM – McKesson’s new oncology technology and insights business – along with life sciences companies and patient advocacy groups. MYLUNG life sciences members currently include Amgen, Eli Lilly and Company and Mirati Therapeutics. Healthcare provider members include Illinois Cancer Specialists, Maryland Oncology Hematology, Minnesota Oncology, New York Oncology Hematology, Oncology Hematology Care, Rocky Mountain Cancer Centers, Southern Cancer Center, Virginia Cancer Specialists, Virginia Oncology Associates and Willamette Valley Cancer Institute and Research Center. Additional collaborators are expected to join throughout the next few months.

"McKesson has always served at the center of care delivery, which has provided a unique perspective on the complexities of cancer care and the growing needs among providers and life sciences companies," said Kirk Kaminsky, president, McKesson U.S. Pharmaceutical. "MYLUNG highlights our ability to integrate a continuous virtual cycle with feedback loops between the US Oncology Research and Ontada research teams and The US Oncology Network sites of care to quickly integrate best practices across The Network, while adaptively responding to the constantly changing landscape of oncology discovery for both diagnostics and treatment."

MYLUNG will consist of three protocols over a five-year period:

Protocol 1 retrospectively reviews real-world data from Ontada’s iKnowMedSM electronic health records (EHRs) of about 3,500 patients treated by providers in The US Oncology Network to understand baseline data on molecular testing across practices and identify historical barriers to testing and precision medicine in community practice.
Protocol 2, enrolling about 1,000 patients from approximately 10 practices, will monitor the real-world patient journey from presentation through their first line of cancer therapy, focusing on how diagnostic biomarker information is obtained, utilized and operationalized in decision-making. Patients are currently being enrolled into Protocol 2.
Protocol 3 will serve as a platform upon which prospectively assessed interventional strategies in patient-engagement algorithms will be conducted. Up to 7,500 patients from approximately 20 participating practices will be recruited over a five-year period. The individual clinical trials will integrate findings from the previous protocols and explore new processes and associated outcomes to help providers make the best treatment recommendations based on the data available and improve access to testing and appropriate therapies for NSCLC patients.
The real-world research model is uniquely suited to take lung cancer care to the next level by providing a window into the actual provider and patient experience. "We created Ontada to help providers, patients and life sciences companies navigate a cancer care world that is growing more complex every day as new precision medicines come to market," said Derek Rago, interim president, Ontada. "MYLUNG will gather real-world data with Ontada’s technology solutions and develop novel insights through its real-world analytics capabilities so that all stakeholders can make informed decisions that are actionable at the point-of-need."

MYLUNG is poised to support meaningful progress and innovation in care delivery and potentially touch and improve thousands of lives. Makenzi Evangelist, MD, physician lead for the pragmatic study and oncologist with New York Oncology Hematology (NYOH), a practice in The Network, said, "During the study and after, we hope that the interventions and our understanding of NSCLC improve, and we see increased testing and appropriate use of targeted therapies – all of which we hope will improve cancer care and patient outcomes."

On February 4, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported virtual posters on its three skin cancer gene expression profile tests at the 19th Annual South Beach Symposium, taking place from Feb. 4 – 7, 2021 (Press release, Castle Biosciences, FEB 4, 2021, View Source [SID1234574633]).

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DecisionDx-Melanoma:

DecisionDx-Melanoma is Castle’s 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 (SLN) positivity, independent of traditional staging factors.

Castle Biosciences is highlighting data on DecisionDx-Melanoma with two posters. The first highlights new data and is entitled, "31-Gene expression profiling improves risk stratification in patients with T1 cutaneous melanoma."

Study methods and findings:

Nearly 70% of melanomas are diagnosed with tumor thickness that is less than or equal to 1.0 mm (T1 tumors), and recurrence-free survival (RFS) is generally good among these patients. However, up to 15% of patients with T1 tumors may experience a recurrence. Moreover, due to the large number of patients with T1 tumors, 27-30% of melanoma-related deaths occur in patients originally diagnosed with a T1 tumor, suggesting better identification of T1 patients at high risk of recurrence or metastasis is needed.
DecisionDx-Melanoma is designed to classify a patient’s recurrence risk as low (Class 1: Class 1A lowest) or high (Class 2: Class 2B highest) and has been validated in multiple prospective and retrospective studies.
Univariate analysis of the study data shows DecisionDx-Melanoma to be a stronger predictor of RFS than SLN status.
Multivariable analysis shows DecisionDx-Melanoma to be a strong, independent predictor of RFS.
With Class 2B RFS status similar to SLN positive status, Class 2B patients warrant follow-up strategies similar to SLN positive patients.
The second DecisionDx-Melanoma poster is entitled, "The clinical and financial impact of the 31-gene expression profile testing on sentinel lymph node biopsy patients selection in patients with T1b cutaneous melanoma."

Study methods and findings:

DecisionDx-Melanoma identifies patients with T1 tumors who have less than a 5% risk of SLN positivity and who have good survival outcomes. These outcomes suggest that such patients could forego the sentinel lymph node biopsy (SLNB) surgical procedure.
The authors analyzed all clinical DecisionDx-Melanoma tests that were reported from Jan. 3, 2019 through Sept. 4, 2020. The data showed that 75% of eligible patients with T1b tumors had a Class 1A result and could potentially forego SLNB. The authors estimate that foregoing SLNB in these patients could reduce healthcare expenditures by up to $120 million in SLNB-related costs.
DecisionDx DiffDx-Melanoma:

DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions.

The virtual poster is entitled, "Development, Validation, and Clinical Utility of the 35-Gene Expression Profile Test for Use as an Adjunctive Melanoma Diagnostic Tool."

Study methods and findings:

DecisionDx DiffDx-Melanoma has demonstrated accuracy metrics of: 99.1% sensitivity, 94.3% specificity, 93.6% positive predictive value and 99.2% negative predictive value; the test also provides a modest intermediate-risk zone of 3.6% and a technical success rate of 96.6%.
Dermatopathologists who used DecisionDx DiffDx-Melanoma to refine their diagnoses in lesions reported increased diagnostic confidence by 51%. Dermatologists used the test result to gauge prognosis, case difficulty, office visit frequency and re-excisions, which were influenced by DecisionDx DiffDx-Melanoma’s result in the appropriate manner in most responses.
The diagnosis of challenging melanocytic lesions and subsequent clinical management decisions were determined to be influenced by the test in agreement with its result, potentially alleviating uncertainty in difficult-to-diagnose lesions. Therefore, DecisionDx DiffDx-Melanoma could lead to a potential increase in accurate diagnoses and focused reduction of burdensome and unnecessary procedures for cases that receive a benign DecisionDx DiffDx-Melanoma result.
DecisionDx-SCC:

DecisionDx-SCC is Castle’s prognostic gene expression profile test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC) designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors.

The virtual poster is entitled, "Clinical utility of the 40-gene expression profile (40-GEP) for improved patient management decisions and disease related outcomes when combined with current clinicopathological risk factors for cutaneous squamous cell carcinoma (cSCC): Case Series."

"National guidelines for high-risk SCC patients leave room for subjectivity in assessing which patients warrant additional management," said study author and assistant professor of clinical dermatology at the Indiana University School of Medicine, Ally-Khan Somani, M.D., Ph.D. "Meanwhile, the incidence of SCC is rising with time, which increases the need for physicians to assess metastatic risk objectively for these patients, so that we can provide care accordingly. We have found that DecisionDx-SCC, by predicting tumor aggressiveness based on its gene expression, may stratify risk when integrated with commonly used staging factors to better inform SCC management decisions."

Study methods and findings:

Two SCC cases were presented that highlight DecisionDx-SCC’s utility in stratifying risk in SCC.
The cases were very similar at diagnosis, both presenting with a history of immunosuppression along with identical staging (T2a per Brigham and Women’s Hospital staging; T1 per American Joint Committee on Cancer staging), but had divergent outcomes:
Case 1 did not recur, despite incomplete resection.
Case 2 developed local recurrence and regional metastasis, and died from SCC, despite clear surgical margins, radiation and chemotherapy treatments.
Subsequent DecisionDx-SCC test results yielded risk level assignments that correlated with the two patients’ outcomes:
Case 1 had a retrospective low-risk (Class 1) DecisionDx-SCC result.
Case 2 had a highest-risk (Class 2B) DecisionDx-SCC result.
The authors concluded that incorporating DecisionDx-SCC as a prognostic factor with traditional clinicopathological risk factors can improve stratification of high-risk SCC patients with at least one risk factor, thereby informing risk-appropriate management strategies.
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 September 30, 2020, DecisionDx-Melanoma has been ordered more than 64,560 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

About DecisionDx DiffDx-Melanoma

DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately 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.

More information about the test and disease can be found at www.CastleTestInfo.com.

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 cutaneous 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.

On February 4, 2021 Catamaran Bio, Inc., a biotechnology company developing allogeneic CAR-NK cell therapies to treat diseases with significant unmet medical need, reported the appointment of Alvin Shih, MD, MBA, as President and Chief Executive Officer (Press release, Catamaran Bio, FEB 4, 2021, View Source [SID1234574632]). He has concurrently been appointed to the Board of Directors for Catamaran. Dr. Shih is an experienced biopharma executive with a track record of success in building companies across a broad spectrum of disease areas and therapeutic modalities, including cell and tissue therapies.

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"We are delighted to welcome Alvin to Catamaran, as his exceptional leadership skills for high-growth biotech companies are an ideal fit to lead the next phase of growth and CAR-NK cell therapy product development at Catamaran," said Kevin Pojasek, PhD, founder, initial Executive Chairman and current Board member of Catamaran. "Alvin will join the outstanding team at Catamaran that is rapidly advancing programs based on a cutting-edge and differentiated platform for developing allogeneic CAR-NK cell therapies capable of reaching solid tumors."

Dr. Shih was most recently CEO of Disarm Therapeutics, a private biotechnology company developing therapeutics for neurodegenerative diseases, until its acquisition by Eli Lilly in October 2020. Prior to Disarm, he was CEO of Enzyvant Therapeutics, where he led the company’s development of a cell/tissue-based therapy for a rare immunologic disease. Previously, he was Executive Vice President and Head of R&D at Retrophin, Inc. (now Travere Therapeutics) where he led the development of a diverse pipeline encompassing multiple disease areas. Alvin was previously the Chief Operating Officer and a founding member of Pfizer’s rare disease research unit, and he began his career as a management consultant at L.E.K. Consulting and McKinsey & Company. Dr. Shih holds an MD from the University of Alabama and an MBA from the Kellogg School of Management at Northwestern University. He completed residency training in internal medicine at Massachusetts General Hospital.

"Catamaran has a unique set of capabilities for developing highly-potent CAR-NK cell therapies with the potential to dramatically expand the reach of cell therapies to solid tumors and bring transformative benefit to patients in need," said Dr. Shih. "I am thrilled to have the opportunity to lead the very talented team at Catamaran as we advance our leading-edge TAILWIND Platform for engineering and manufacturing off-the-shelf CAR-NK cell therapies."

About the TAILWIND Platform

Catamaran’s TAILWIND Platform integrates proprietary capabilities to create novel, allogeneic CAR‑NK cell therapies by harnessing the natural cancer-fighting properties of natural killer (NK) cells and enhancing them with the power of synthetic biology and innovative NK cell engineering and manufacturing. With the TAILWIND Platform, CAR-NK cells are programmed with NK cell-specific CAR architectures and potency-boosting switches to neutralize the hostile tumor microenvironment and enable efficacy against diverse cancer types, especially solid tumors. Additionally, the TAILWIND Platform includes proprietary, non-viral NK cell engineering technology for efficient modification of NK cells with customized genetic programs enabled by synthetic biology. Catamaran’s CAR-NK cell therapies use healthy donor cells that are engineered and manufactured for off‑the‑shelf use, unlike current CAR-T cell therapies that use a patient’s own genetically modified T cells and require a customized, multi-week manufacturing process.

On February 4, 2021 Illumina, Inc. (NASDAQ:ILMN) reported an agreement with the Belgian Society of Medical Oncology (BSMO) which is running a new national pilot to evaluate the use of comprehensive genomic profiling (CGP) in 864 patients with advanced metastatic cancer (Press release, Illumina, FEB 4, 2021, View Source [SID1234574631]). The BALLETT (Belgian Approach for Local Laboratory Extensive Tumor Testing) study will recruit patients from 12 participating sites to be offered CGP from one of nine next-generation sequencing laboratories across Belgium. Data from CGP will be used to determine the best therapeutic options for patients through access to targeted medicines with the aim of improving clinical outcomes in advanced cancer. The study will begin next month.

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CGP uses NGS to analyze hundreds of genes and biomarkers in tissue and blood samples and detect those that are clinically relevant in driving cancer growth. Illumina will provide its CGP panel, TruSight Oncology 500 (TSO500), as well as NovaSeq 6000 and NextSeq sequencing platforms for the study. Clinical interpretation of the sequencing data will be carried out using PierianDx Clinical Genomic Workspace solution and OncoDNA Clinical Decision Support Platform OncoKDM.

"Belgium is a leader in the application of new technologies to make precision healthcare a reality. Through this new study, we want to ensure that patients across Belgium can receive the right treatment for their particular cancer at the right time," said Dr. Sylvie Rottey, Chair BSMO.

"CGP reveals the unique molecular profile of a patient’s cancer which empowers their oncology team to propose the most effective course of treatment suited to them," said Phil Febbo, MD, Chief Medical Officer at Illumina. "We are very pleased to be working with the BSMO and the different cancer institutes across Belgium to examine the value of CGP in a real-world setting in terms of its ability to improve patient outcomes through more targeted treatment options."

Doctor Brigitte Maes of the Jessa Hospital in Belgium, Coordinator of the BALLETT study, said, "As part of Belgium’s broad approach to advancing precision medicine the study will generate valuable insights into the value of CGP versus currently reimbursed sequencing approaches. For example, in addition to genetic mutations that drive cancer formation, CGP will also identify cancers driven by the tumor mutational burden (TMB) biomarker which can guide patients towards immunotherapy treatments. This means that the study will give access to additional treatments which may not have been considered through more traditional diagnostic testing."

Genomic data together with de-identified clinical data from the study will be used to populate a newly-established national genomic tumor database, collated with oversight from Belgium’s Scientific Institute for Public Health, Sciensano, designed to advance precision medicine and patients’ access to novel effective therapies.

On February 4, 2021 DURECT Corporation (Nasdaq: DRRX) ("DURECT"), a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program, reported the pricing of its underwritten public offering of 17,708,333 shares of its common stock (the "Offering") for gross proceeds of approximately $42,500,000, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by DURECT (Press release, DURECT, FEB 4, 2021, https://investors.durect.com/news-releases/news-release-details/durect-corporation-announces-pricing-425-million-public-offering [SID1234574630]). The offering is expected to close on or about February 8, 2021, subject to customary closing conditions. In addition, DURECT has granted the underwriter for the Offering a 30-day option to purchase up to an additional 2,656,249 shares of its common stock.

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Cantor Fitzgerald & Co. is acting as the sole book running manager for the Offering.

The underwriter may offer the shares from time to time for sale in one or more transactions on the Nasdaq Capital Market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. On February 3, 2021, the last sale price of the shares as reported on the Nasdaq Capital Market was $2.87 per share.

DURECT intends to use the net proceeds of the Offering for general corporate purposes, which may include clinical trials, research and development activities, capital expenditures, selling, general and administrative costs, facilities expansion, and to meet working capital needs.

The Offering is being made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226518) previously filed by DURECT with the Securities and Exchange Commission (the "SEC") on September 28, 2019 and declared effective by the SEC on October 9, 2018. The Offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement describing the terms of the Offering and the accompanying prospectus have been filed with the SEC. Before you invest, you should read the registration statement, the preliminary prospectus, the documents that DURECT has filed with the SEC that are incorporated by reference into the registration statement, and the other documents DURECT has filed with the SEC for more complete information about DURECT and the Offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the final prospectus and the accompanying prospectus relating to the Offering can be obtained, when available, from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.