On December 5, 2016 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported study findings demonstrating that KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, achieved an overall response rate (ORR) of 41 percent (n=7/17) (90% CI, 21-64) with follow-up of up to 27 months in patients with relapsed or refractory primary mediastinal large B-cell lymphoma (PMBCL), a type of non-Hodgkin lymphoma, who were ineligible for or failed to respond to autologous stem-cell transplantation (ASCT) (Press release, Merck & Co, DEC 5, 2016, View Source [SID1234516929]). In patients treated with KEYTRUDA, 86 percent of responses (n=6/7) were ongoing at the time of analysis with the median duration of response not yet reached (range: 2 to 23 months). These updated findings, from the ongoing phase 1b KEYNOTE-013 study, will be presented today at the 58th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in San Diego (Abstract #619). Preliminary findings from this cohort were first presented at the 2015 ASH (Free ASH Whitepaper) Annual Meeting.

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"For patients with primary mediastinal large B-cell lymphoma who are ineligible for, or fail to respond to, autologous stem-cell transplantation, the prognosis is very poor and there are limited treatment options," said Pier Luigi Zinzani, M.D., Ph.D., associate professor of hematology, Institute of Hematology "L. e A. Seràgnoli," University of Bologna. "Based on the rarity of this type of blood cancer, clinical research has been historically limited, and it’s encouraging to see clinical trials conducted in this disease where we are seeing durable responses with KEYTRUDA."

"We are committed to studying immuno-oncology approaches across a broad spectrum of cancers, including studies in more than 20 hematological subtypes," said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. "These data continue to support the efficacy and safety profile of KEYTRUDA in primary mediastinal large B-cell lymphoma and the importance of ongoing evaluation in this patient population."

The KEYTRUDA (pembrolizumab) clinical development program includes more than 30 tumor types in nearly 400 clinical trials, including more than 200 trials that combine KEYTRUDA with other cancer treatments. For hematologic malignancies specifically, Merck is conducting broad immuno-oncology research assessing the role of monotherapy and combination regimens with KEYTRUDA. The hematology program includes nearly 40 ongoing studies – including company sponsored, investigator sponsored and collaborative studies; several of these are registration-enabling trials.

Additional Results from KEYNOTE-013 Presented at ASH (Free ASH Whitepaper)

KEYNOTE-013 is an ongoing, multi-center, non-randomized, phase 1b trial of approximately 200 patients evaluating the safety, tolerability, and efficacy of KEYTRUDA monotherapy in patients with blood cancers, including myelodysplastic syndromes, multiple myeloma, classical Hodgkin lymphoma, PMBCL and certain other non-Hodgkin’s lymphomas (or lymphomata).

These findings are from a cohort of patients with relapsed or refractory PMBCL who were ineligible for or failed to respond to ASCT. The median age was 30.5 years (range: 22 to 62 years). Thirty-three percent of patients had failed prior autologous stem-cell replacement therapy (n=6/18) and 67 percent (n=12/18) were transplant ineligible. The co-primary endpoints of the study were ORR and safety; secondary endpoints included duration of response and complete remission rate. Patients were initially treated with KEYTRUDA as monotherapy (10 mg/kg every two weeks) which was later changed by protocol amendment to a fixed dose (200 mg every three weeks). Seventeen patients were included in the efficacy analysis.

KEYTRUDA demonstrated an ORR of 41 percent (n=7/17) (90% CI, 21-64), as assessed by International Harmonization Project Response Criteria, with a complete remission rate of 12 percent (n=2/17) (90% CI, 2-33) and a partial remission rate of 29 percent (n=5/17) (90% CI, 12-52). Additionally, 81 percent of patients (n=13/16) had reduction in target lesions. The median duration of follow-up was 11 months (range: 3 to 27 months). At the time of analysis, 86 percent of responses were ongoing (n=6/7) with the median duration of response not yet reached (range: 2 to 23 months). Two patients reached the maximum two years of treatment and remain in remission (follow-up: 25.4 months, 23.8 months).

Treatment-related adverse events were consistent with previously reported safety data for KEYTRUDA (pembrolizumab). The most common treatment-related adverse events were decreased appetite (n=2), diarrhea (n=2), fatigue (n=2), hypothyroidism (n=2), nausea (n=2), and pyrexia (n=2). Grade 3 treatment-related adverse events included neutropenia (n=1) and veno-occlusive liver disease (n=1). Immune-related adverse events included aggravated diarrhea (n=1) and radiation pneumonitis (n=1), both grade 2. There were no discontinuations or treatment-related deaths due to adverse events.

About Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

PMBCL is a rare subtype of diffuse large B-cell lymphoma (a type of non-Hodgkin lymphoma) that arises in the thymus. PMBCL affects young adults in their thirties and forties and has a slight female predominance. It accounts for five to seven percent of all aggressive lymphomas and two to three percent of all non-Hodgkin lymphomas.

About KEYTRUDA (pembrolizumab)

KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

KEYTRUDA is administered as an intravenous infusion over 30 minutes every three weeks for the approved indications. KEYTRUDA for injection is supplied in a 100 mg single use vial.

KEYTRUDA Indications and Dosing

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma at a dose of 2 mg/kg every three weeks until disease progression or unacceptable toxicity.

Lung Cancer

KEYTRUDA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA (pembrolizumab) is also indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

In metastatic NSCLC, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Head and Neck Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In HNSCC, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Selected Important Safety Information for KEYTRUDA (pembrolizumab)

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 94 (3.4%) of 2799 patients receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%) pneumonitis, and occurred more frequently in patients with a history of prior thoracic radiation (6.9%) compared to those without (2.9%). Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 48 (1.7%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%) colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

KEYTRUDA (pembrolizumab) can cause immune-mediated hepatitis. Hepatitis occurred in 19 (0.7%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%) hepatitis. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

KEYTRUDA can cause hypophysitis. Hypophysitis occurred in 17 (0.6%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%) hypophysitis. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3 or 4 hypophysitis.

KEYTRUDA can cause thyroid disorders, including hyperthyroidism, hypothyroidism, and thyroiditis. Hyperthyroidism occurred in 96 (3.4%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.8%) and 3 (0.1%) hyperthyroidism. Hypothyroidism occurred in 237 (8.5%) of 2799 patients receiving KEYTRUDA, including Grade 2 (6.2%) and 3 (0.1%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in patients with HNSCC occurring in 28 (15%) of 192 patients with HNSCC, including Grade 3 (0.5%) hypothyroidism. Thyroiditis occurred in 16 (0.6%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.3%) thyroiditis. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer replacement hormones for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism.

KEYTRUDA can cause type 1 diabetes mellitus, including diabetic ketoacidosis, which have been reported in 6 (0.2%) of 2799 patients. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 9 (0.3%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

KEYTRUDA can cause other clinically important immune-mediated adverse reactions. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA (pembrolizumab) and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), exfoliative dermatitis, bullous pemphigoid, rash (1.4%), uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, and partial seizures arising in a patient with inflammatory foci in brain parenchyma.

KEYTRUDA can cause severe or life-threatening infusion-related reactions, which have been reported in 6 (0.2%) of 2799 patients. Monitor patients for signs and symptoms of infusion-related reactions, including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). Adverse reactions leading to interruption of KEYTRUDA occurred in 21% of patients; the most common (≥1%) was diarrhea (2.5%). The most common adverse reactions with KEYTRUDA vs ipilimumab were fatigue (28% vs 28%), diarrhea (26% with KEYTRUDA), rash (24% vs 23%), and nausea (21% with KEYTRUDA). Corresponding incidence rates are listed for ipilimumab only for those adverse reactions that occurred at the same or lower rate than with KEYTRUDA.

In KEYNOTE-002, KEYTRUDA was discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (≥1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). Adverse reactions leading to interruption of KEYTRUDA occurred in 14% of patients; the most common (≥1%) were dyspnea (1%), diarrhea (1%), and maculopapular rash (1%). The most common adverse reactions with KEYTRUDA vs chemotherapy were fatigue (43% with KEYTRUDA), pruritus (28% vs 8%), rash (24% vs 8%), constipation (22% vs 20%), nausea (22% with KEYTRUDA), diarrhea (20% vs 20%), and decreased appetite (20% with KEYTRUDA). Corresponding incidence rates are listed for chemotherapy only for those adverse reactions that occurred at the same or lower rate than with KEYTRUDA.

KEYTRUDA was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC. The most common adverse event resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.8%). Adverse reactions leading to interruption of KEYTRUDA occurred in 23% of patients; the most common (≥1%) were diarrhea (1%), fatigue (1.3%), pneumonia (1%), liver enzyme elevation (1.2%), decreased appetite (1.3%), and pneumonitis (1%). The most common adverse reactions (occurring in at least 20% of patients and at a higher incidence than with docetaxel) were decreased appetite (25% vs 23%), dyspnea (23% vs 20%), and nausea (20% vs 18%).

KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (reported in at least 20% of patients) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC, with the exception of increased incidences of facial edema (10% all Grades; 2.1% Grades 3 or 4) and new or worsening hypothyroidism.

It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA and for 4 months after the final dose.

Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.

Our Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer.

As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the fastest-growing development programs in the industry. We are currently executing an expansive research program that includes nearly 400 clinical trials evaluating our anti-PD-1 therapy across more than 30 tumor types. We also continue to strengthen our immuno-oncology portfolio through strategic acquisitions and are prioritizing the development of several promising immunotherapeutic candidates with the potential to improve the treatment of advanced cancers.

For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

On December 5, 2016 Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, and MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported final results from a Phase 2 clinical study of the investigational drug candidate Pracinostat and azacitidine in elderly patients with acute myeloid leukemia (AML) who were not eligible for induction chemotherapy, including evidence of prolongation of survival in the overall population and across a number of patient subgroups (Press release, MEI Pharma, DEC 5, 2016, View Source [SID1234516928]).

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In an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on Saturday, Dr. Guillermo Garcia-Manero, MD Anderson Cancer Center, principal investigator of the study, reported a median overall survival of 19.1 (95%CI: 10.7-26.5) months, one-year survival of 62% and a complete response (CR) rate of 42%.

"The results from this study of Pracinostat and azacitidine in elderly patients deemed unfit for intensive therapy are particularly encouraging," said Dr. Garcia-Manero. "Despite recent advances in the treatment of AML, options for these elderly unfit patients remain limited. The combination of Pracinostat and azacitidine appears to show a long-term survival benefit in this population, including an unprecedented two-year survival rate of 41% in this study. Furthermore, the prolongation of survival over what is generally expected for azacitidine alone is observed not only in the overall population, but across virtually every defined patient subset, including cytogenetic risk group, de novo or secondary AML, age and ECOG performance status."

A copy of the presentation, entitled "A Phase 2 Study of Pracinostat and Azacitidine in Elderly Patients with Acute Myeloid Leukemia (AML) Not Eligible for Induction Chemotherapy: Response and Long-Term Survival Benefit," is available at www.meipharma.com.

The open-label Phase 2 study enrolled a total of 50 patients at 15 centers across the U.S. Median age in the study was 75 years. Patients received 60 mg of Pracinostat orally three times a week for three weeks followed by one week of rest and 75 mg m2 of azacitidine via subcutaneous injection or intravenous infusion for the first seven days of each 28-day cycle. The combination of Pracinostat and azacitidine had no unexpected toxicities. The most common grade 3/4 treatment-emergent adverse events reported in >10% of all patients included thrombocytopenia, febrile neutropenia, neutropenia, fatigue and anemia.

Site recruitment is ongoing for the global Phase 3 study of Pracinostat and azacitidine in newly diagnosed AML patients who are ≥75 years of age or unfit for intensive induction chemotherapy.

About Pracinostat
Pracinostat is a potential best-in-class, oral histone deacetylase (HDAC) inhibitor. The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for Pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy. In August 2016, Helsinn and MEI Pharma entered into an exclusive licensing, development and commercialization agreement for Pracinostat in AML and other potential indications. The deal provides the complementary resources from both organizations to rapidly advance Pracinostat into Phase 3 clinical development and expand into additional indications, including high and very high risk myelodysplastic syndrome (MDS).

Pracinostat is an investigational agent and is not approved for use in the U.S.

About AML
Acute myeloid leukemia (also known as acute myelogenous leukemia) is the most common acute leukemia affecting adults, and its incidence is expected to continue to increase as the population ages. The American Cancer Society estimates about 20,830 new cases of AML per year in the U.S., with an average age of about 67 years. Treatment options for AML remain virtually unchanged for nearly 40 years. Front line treatment consists primarily of chemotherapy, while the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology recommend hypomethylating agents azacitidine or decitabine as low intensity treatment options for AML patients over the age of 60 who are unsuitable for induction chemotherapy.

On December 5, 2016 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported data on new product candidate CDX-1140, a fully human antibody targeted to CD40 that has demonstrated potent agonist and anti-lymphoma activity (Press release, Celldex Therapeutics, DEC 5, 2016, View Source [SID1234516926]). Found on antigen presenting cells, such as dendritic cells, macrophages and B cells, CD40 is a key activator of the immune response and is expressed on many cancer cells, in particular B cell lymphomas. The data were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on Saturday, December 3 in a poster titled "CDX-1140, A Novel Agonist CD40 Antibody with Potent Anti-lymphoma Activity" (Abstract #1848). CDX-1140 is expected to be ready to enter clinical studies in patients with advanced cancers, including lymphoma, in 2017.

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"We have previously characterized CDX-1140 as possessing a needed balance between its agonist activity and its safety profile to allow for systemic dosing at levels that provide good tissue and tumor penetration, which we believe to be important in order to fully capture the benefit of CD40 immunotherapy," said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. "With this study in preclinical lymphoma tumor models, we show both direct and indirect anti-lymphoma activity as well as synergistic anti-lymphoma activity with our CD27 agonist varlilumab, supporting potential combination treatment in this setting."

The poster features detailed analyses of the anti-lymphoma efficacy of CDX-1140 both as a single-agent and in combination with varlilumab, Celldex’s agonist antibody that binds and activates CD27, or with human immune cells. It is available on the "Publications" page of the "Science" section of the Celldex website. Key findings include:

CDX-1140 elicits direct anti-tumor activity against CD40-positive lymphomas in preclinical tumor models.
The addition of human peripheral blood mononuclear cells (PBMCs) to the tumor models enhances the anti-tumor activity of CDX-1140 compared to the administration of either human PBMC or CDX-1140 alone, indicating an activated anti-tumor immune response by CDX-1140 in addition to direct anti-tumor activity.
The combination of CDX-1140 and varlilumab, elicited greater anti-tumor activity than either antibody alone.
Celldex is currently performing manufacturing and IND-enabling studies to support Phase 1 dose-escalation studies of CDX-1140. The Company believes that the potential for CDX-1140 will be best defined in combination studies with other immunotherapies or conventional cancer treatments.

Additionally, data from investigator sponsored research with varlilumab, CDX-301 and CDX-1401 were/will be presented by Celldex’s collaborating investigators during the ASH (Free ASH Whitepaper) Annual Meeting.

Varlilumab: "Anti-CD27 Enhances Lymphoma Immunotherapy through Profound Myeloid Cell Recruitment" was presented in a poster session on Sunday, December 4 (Abstract #3024). This poster was selected for discussion in a Special-Interest Session called, "Novel Approaches to Immunotherapy — Not Just Checkpoint" to be held on Monday, December 5, 2016 from 12:15-1:15 pm PST.
CDX-301: "Combining In Situ Vaccination with Immune Checkpoint Blockade Induces Long-Term Regression of Lymphoma Tumors" was presented in an oral session on Sunday, December 4 (Abstract #465).

CDX-1401: "Vaccination with NY-ESO-1 in Combination with Decitabine for Patients with MDS" will be presented in a poster session on Monday, December 5 (Abstract #4326)

On December 5, 2016 Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, reported that an anti-CD27 antibody developed by Aduro Biotech Europe and derived from its proprietary B-select technology has been selected to be advanced into clinical development by Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the U.S. and Canada), through a subsidiary (Press release, Aduro BioTech, DEC 5, 2016, View Source [SID1234516924]). CD27 has been recognized as having a critical role in activating a productive anti-cancer immune response and has demonstrated the potential to be combined with checkpoint inhibitors in pre-clinical studies.

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"Pre-clinical studies have shown that an anti-CD27 agonist can induce a T cell-mediated anti-cancer immune response, and in combination with PD-1 immune checkpoint inhibitors complete tumor eradication can be achieved," said Hans van Eenennaam, Ph.D., chief operational officer, Aduro Biotech Europe.

The CD27 antibody was licensed by MSD to advance as a part of their successful immunotherapy development program and was identified in close collaboration with Prof. Jannie Borst, Ph.D., professor at the University of Amsterdam and division head at the Netherlands Cancer Institute, through Aduro’s B-select monoclonal antibody technology. This technology includes a proprietary ultra-selective functional screening process to identify antibodies with unique binding properties against a broad repertoire of targets that can modulate the innate and adaptive arms of the immune system.

"In 2014, prior to the acquisition by Aduro Biotech, BioNovion entered into a worldwide license agreement with MSD that covers the product candidate’s development and advancement through commercialization," said Andrea van Elsas, Ph.D., chief scientific officer of Aduro Biotech Europe. "Both companies recognized the significant potential of targeting CD27 as a new and distinct mechanism in cancer immunotherapy, especially in the context of PD-1 checkpoint inhibitors, and were strongly committed to accelerate a quality candidate into the clinic."

Conference Call with Management
Aduro’s management will host a conference call to review this announcement and provide a program update, including STELLAR, today at 5:30 a.m. PT/ 8:30 a.m. ET. To participate in the conference call, please dial (844) 309-0604 (domestic) or (574) 990-9932 (international) and refer to conference ID 31336163. Live audio of the conference call will be simultaneously webcast and will be available to members of the news media, investors and the general public at View Source

About the Aduro – MSD Collaboration
BioNovion B.V. and MSD, through a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, entered into a worldwide license agreement in 2014 for the development and commercialization of CD27 antibody agonists, and BioNovion received an up-front payment of $15 million. In 2015, BioNovion was acquired by Aduro Biotech and became its subsidiary, Aduro Biotech Europe B.V.

Under the agreement, a Joint Research Committee was formed to advance the program. Aduro has been reimbursed for certain research activities and is eligible to receive future development, commercial and net sales milestone payments. In addition, Aduro is eligible to receive royalties in the mid-single digits to low teens based on any net sales of the product, if it is approved for marketing.

On December 5, 2016 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it has initiated a study of its NY‑ESO SPEAR T‑cells in myxoid/round cell liposarcoma (MRCLS) (Press release, Adaptimmune, DEC 5, 2016, View Source [SID1234516923]). Patient screening is underway, and the results from this study in up to 15 patients will inform a potential future registration trial. The initiation of screening in this study meets a milestone set forth in the Company’s strategic collaboration agreement with GlaxoSmithKline plc (LSE/NYSE: GSK).

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This is an open-label pilot study in patients to assess preliminary safety and efficacy in this new indication. Initially, 10 patients will be enrolled. If further characterization of the treatment is required, up to 5 additional patients may be enrolled. Eligible patients will be HLA-A*02:01, HLA‑A*02:05 and/or HLA-A*02:06 with advanced (metastatic or inoperable) high grade MRCLS whose tumor shows positive NY-ESO-1 expression defined as ≥30 percent of cells that are 2+ or 3+ by immunohistochemistry. Patients will receive preconditioning with fludarabine and cyclophosphamide at the same dose that is being used in Cohort 4 of the Company’s ongoing synovial sarcoma study.

About MRCLS
Soft tissue sarcomas can develop from tissues like fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues. There are approximately 50 types of soft tissue sarcomas, including MRCLS. Myxoid/round cell liposarcoma is associated with specific chromosomal translocations and represents about 30 to 35 percent of liposarcomas and 5 to 10 percent of all adult soft tissue sarcomas. Myxoid/round cell liposarcoma commonly presents at an age ranging from 35 to 55 years.