On November 27, 2018 Evelo Biosciences, Inc. (NASDAQ:EVLO) ("Evelo"), a clinical-stage biotechnology company developing monoclonal microbials to engage immune cells in the small intestine and drive changes in systemic biology, reported that it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the US and Canada) (Press release, Evelo Biosciences, NOV 27, 2018, View Source [SID1234531985]). The collaboration will evaluate EDP1503 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in multiple cancer indications. EDP1503 is an orally delivered monoclonal microbial product candidate being developed for the treatment of cancer.

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The planned Phase 1/2 trial will evaluate the safety, tolerability, immune response markers and overall response rates (ORRs) achieved with EDP1503 in combination with KEYTRUDA (pembrolizumab) in three groups of patients: microsatellite stable colorectal cancer; triple-negative breast cancer; and patients across multiple tumor types who have relapsed on prior PD-1/L1 inhibitor treatment. Evelo expects to commence this clinical trial in the first half of 2019 and plans to enroll up to 120 patients in this non-comparative, single-arm, multicenter clinical study.

‘’We are very pleased to collaborate with Merck, one of the world leaders in immuno-oncology, in our clinical investigation of EDP1503 in combination with Keytruda. We have shown preclinically that oral delivery of EDP1503 activates multiple systemic immune pathways across clinically validated mechanisms of tumor immune stimulation which are complementary to and potentially synergistic with checkpoint inhibitors," said Humphrey Gardner, M.D., FCAP, chief of medical oncology at Evelo. "These immune-activation properties of EDP1503, including upregulation of MHC Class I expression, increased production of CXCL9 and CXCL10, and augmentation of NK cell infiltration point to the potential to offer a treatment approach in tumors that have, to date, proved unresponsive to checkpoint inhibitor monotherapy, such as microsatellite stable colorectal cancer."

EDP1503 is currently being evaluated in an investigator-sponsored Phase 2a clinical trial in combination with KEYTRUDA in patients with metastatic melanoma (CT.gov: NCT03595683). First patient dosing in this study is expected by the end of 2018.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About EDP1503

EDP1503 is Evelo’s first monoclonal microbial oncology product candidate and is being developed under the umbrella of its exclusive worldwide license with the University of Chicago. Under this license, Evelo has exclusive patent rights related to the administration of microbes to treat cancer, including in combination with checkpoint inhibitors. The patent rights describe many genera of microbes and will provide broad patent protection. A US patent covering the combination of Bifidobacteria and checkpoint inhibitors to treat cancer was granted in January 2018. Preclinical data suggests that EDP1503 is active through different and complementary immune mechanisms beyond those targeted by checkpoint inhibitors. In preclinical models, EDP1503 alone stimulated upregulation of the immune response to tumors, delayed tumor progression and, when combined with a checkpoint inhibitor, showed additive effects in delaying tumor progression.

On November 27, 2018 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported that the first patients have been dosed in a Phase I/II clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-602 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) (Press release, ADC Therapeutics, NOV 27, 2018, View Source [SID1234596072]). The trial is being led by The University of Texas MD Anderson Cancer Center.

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ADCT-602 is an ADC that incorporates a pyrrolobenzodiazepine (PBD) drug linker and targets CD22, which is a clinically validated ADC target. Preclinical studies have demonstrated that ADCT-602 has significant anti-tumor activity in a number of animal models.

Hagop Kantarjian, MD, Professor and Chair of the Department of Leukemia, and Nitin Jain, MD, Associate Professor in the Department of Leukemia, at MD Anderson, are leading the Phase I/II clinical trial of ADCT-602. The open-label trial will enroll up to 65 patients.

Dr. Kantarjian said, "There is a significant unmet need for new treatment options for adult patients with B-cell ALL who have not responded to initial treatment or whose cancer has returned after treatment. We are excited to evaluate the safety and anti-tumor activity of a CD22-targeted ADC in these patients."

Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President at ADC Therapeutics, said, "We are delighted to be partnered with MD Anderson on this important clinical trial in adult patients with relapsed or refractory B-cell ALL, who have limited therapeutic options and for whom the prognosis is typically poor. We are hopeful that the response rates seen in our ADCT-402 and ADCT-301 lymphoma clinical trials can be replicated in the ALL patient population with ADCT-602, and that our growing portfolio of hematology-focused ADCs targeting CD19, CD25 and now CD22 can make a positive impact on patient outcomes."

For more information about this clinical trial, please visit www.clinicaltrials.gov (identifier NCT03698552).

About ADCT-602

ADCT-602 is an antibody drug conjugate (ADC) composed of a monoclonal antibody that binds to CD22 conjugated to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD22-expresing cell, ADCT-602 is internalized into the cell where enzymes release the PBD-based warhead. CD22 is an attractive and clinically validated ADC target. CD22 is highly expressed on most malignant B-cells, including expression in greater than 90% of patients with B-cell acute lymphoblastic leukemia.

On November 27, 2018 Celgene Corporation (Nasdaq: CELG) and bluebird bio, Inc. (Nasdaq: BLUE) reported the completion of enrollment for the KarMMa pivotal study of bb2121, the companies’ lead investigational anti-BCMA CAR T cell therapy candidate for patients with relapsed and refractory multiple myeloma (Press release, bluebird bio, NOV 27, 2018, View Source [SID1234531638]). bb2121 is being developed as part of a Co-Development, Co-Promote and Profit Share Agreement between Celgene and bluebird bio.

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"We continue to be excited about bb2121 as a potential first-in-class BCMA-targeted therapy for patients with multiple myeloma," said Alise Reicin, M.D., President, Global Clinical Development for Celgene. "We would like to thank everyone who enabled this achievement, especially the patients and caregivers, and we congratulate the physicians and others involved in the KarMMa study, including our dedicated partners at bluebird bio. We look forward to seeing the data from this study and are progressing our broader bb2121 development program as we advance closer toward delivering this important new option to appropriate patients in need."

"We are committed to developing new treatment options to improve the care of patients with multiple myeloma, and completing enrollment of the KarMMa study moves us closer to this goal," said David Davidson, M.D., chief medical officer, bluebird bio. "As we advance our clinical studies of bb2121 in earlier lines of therapy in collaboration with our partners at Celgene, we remain very grateful to the patients, families and healthcare providers who have made this program possible."

KarMMa is a pivotal, open-label, single-arm, multi-center phase 2 study evaluating the efficacy and safety of bb2121 in patients with relapsed and refractory multiple myeloma. In November 2017, bb2121 was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration and PRIority Medicines (PRIME) eligibility by the European Medicines Agency. The BTD designation and PRIME eligibility were based on preliminary clinical data from the phase 1 CRB-401 study.

The FDA action date for the bb2121 NDA is anticipated in 2020. bb2121 is currently an investigational therapy; safety and efficacy have not yet been established. bb2121 has not been approved for use by any health authority.

On November 27, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that Dr. David Ralph, Director of Drug Development and IP Manager of Navidea, will be presenting at the RSNA 104th Scientific Assembly and Annual Meeting, which is taking place November 25-30, 2018 in Chicago, IL (Press release, Navidea Biopharmaceuticals, NOV 27, 2018, View Source [SID1234531659]).

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The oral presentation will highlight an abstract evaluated and selected through a competitive, blind peer-review process. The presentation will focus on recent imaging results obtained from Kaposi Sarcoma patients who have received 99mTc-tilmanocept by either a subcutaneous or an intravenous route of administration.

Oral Presentation Details
Presentation Title: Planar and SPECT/CT Imaging in Human Immunodeficiency Virus (HIV) Subjects Diagnosed with Kaposi Sarcoma (KS) using Intravenous 99mTc-tilmanocept
Abstract: SSK19-06
When: Wednesday, November 28 at 11:20am CT
Where: McCormick Place, Chicago, IL
Room: S504AB

RSNA 2018 annual meeting provides a hands on experience with cutting-edge tech, including artificial intelligence, 3D printing and virtual reality. Sessions cover the latest research and provides a platform to enhance skills and network. Over 70,000 people will attend this annual meeting.

More details on the annual meeting, including the full agenda can be found at View Source

On November 27, 2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported that it will host an Analyst & Investor call on Monday, December 3rd at 4:30 pm Eastern Time (ET) to discuss newly reported clinical data for its lead drug candidate, momelotinib, a potent, selective and orally-bioavailable JAK1, JAK2 and ACVR1 inhibitor for the treatment of myelofibrosis (Press release, Sierra Oncology, NOV 27, 2018, View Source [SID1234531662]).

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The call will be led by Dr. Nick Glover, President and CEO of Sierra Oncology and will include distinguished medical oncologist Dr. Srdan Verstovsek, MD, PhD, Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston, Texas. The call will highlight emerging clinical data obtained from two completed Phase 3 clinical trials that demonstrate momelotinib’s unique anemia benefit in patients with myelofibrosis and validate the drug’s pro-erythropoietic mechanism of action. Additional supportive data from a translational biology study in transfusion dependent patients with myelofibrosis are being presented in a poster at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in San Diego, California, on December 3, 2018.

Dial-In & Webcast Information
Date and Time: Monday, December 3rd at 4:30 pm ET
Domestic (Toll Free- US): 1-800-289-0438
International (Toll): 1-323-794-2423
Conference ID: 6168197

Webcast: www.sierraoncology.com
Direct link: View Source

Dr. Verstovsek and members of Sierra’s senior management team will be available to answer questions at the conclusion of the presentation. If you are participating by webcast and would like to ask a question during the live Q&A, please submit your request via email at [email protected].