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ADC Therapeutics Announces First Patients Dosed in Phase I/II Clinical Trial of ADCT-602 in Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

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.

LifeArc and C4X Discovery join forces to develop small molecule drug candidates active against a high value, novel oncology and inflammation target

On November 27, 2018 C4X Discovery Holdings plc (AIM: C4XD), a pioneering drug discovery company, reported that it has entered into a discovery partnership with LifeArc, one of the UK’s leading medical research charities (Press release, C4X Discovery, NOV 27, 2018, View Source [SID1234533247]). C4XD and LifeArc will join forces to progress medicinal chemistry efforts on a novel, commercially attractive programme with applicability across oncology and inflammation indications. The undisclosed target originated from LifeArc’s extensive partnerships in early-stage academic research.

The partnership will combine leading drug discovery expertise from both organisations, including application of C4XD’s unique and proprietary ligand-focussed conformational analysis platform, Conformetrix, to LifeArc’s extensive background and experience in the programme. The aim is to develop oral, potent and selective small molecule drug candidates against the undisclosed target suitable for pre-clinical out-licensing to a clinical development partner and, ultimately, to deliver a novel treatment in an area of high unmet clinical need.

This discovery partnership adds a high value programme to C4XD’s portfolio. Furthermore, it demonstrates continued progress against its stated strategy of utilising its cutting-edge drug discovery engine, and establishing productive partnerships, to develop novel small molecules against targets with high partnering interest.

Terms of the agreement are undisclosed.

Dr Clive Dix, CEO of C4X Discovery, said: "LifeArc is a highly-respected medical charity with access to world-leading academic research for conditions where there is a clear need for new treatments coupled with deep experience in drug discovery. This partnership not only demonstrates the potential of our Conformetrix platform, it also highlights our strategic approach of accelerating towards a diversified portfolio of pre-clinical assets for out-licensing. We are delighted to be working with the LifeArc team and look forward to a successful outcome and continuing to build on our strategic relationship."

Dr Justin Bryans, LifeArc’s Executive Director, Drug Discovery, added: "LifeArc is delighted to partner with C4XD. Our new partner’s expertise in the rapid design and analysis of novel small molecule therapeutics complements LifeArc’s drug discovery expertise. C4XD’s focus on diseases with high unmet medical need is entirely in line with our objective of ensuring that innovative life sciences technologies progress along their development pathway towards the patients who so desperately need them."

Evelo Enters into Clinical Trial Collaboration Agreement with Merck

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.

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.

Lilly to Announce 2019 Financial Guidance, Highlight Late-Stage Pipeline Opportunities and Discuss Commercial Performance at Upcoming Investment Community Meeting

On November 27, 2018 Eli Lilly and Company (NYSE:LLY) reported that it will host a meeting for the investment community on Wednesday, December 19, 2018, from 9:00 a.m. (EST) until approximately 12:00 p.m (Press release, Eli Lilly, NOV 27, 2018, View Source [SID1234531672]).

Earlier that day, the company will announce its financial guidance for 2019. At the investment community meeting, Lilly leadership will further detail the 2019 financial guidance and discuss progress towards the company’s strategic goals, as well as the commercial performance of recently launched medicines. A substantial portion of the meeting will then focus on Lilly’s research and development opportunities in the areas of oncology, pain, neurodegeneration, immunology and diabetes.

Meeting attendees will include institutional investors, sell-side analysts, ratings agency representatives, and financial and business media. Because of limited space, advance registration is required and in-person attendance is by invitation only. A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

Altimmune Appoints Vipin K. Garg, Ph.D. as its New President and Chief Executive Officer

On November 27, 2018 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported the appointment of Vipin K. Garg, Ph.D. as its President and Chief Executive Officer succeeding Bill Enright, current President and Chief Executive Officer, effective November 30 (Press release, Altimmune, NOV 27, 2018, View Source [SID1234531665]).

"Vipin was chosen in a very competitive selection process and we are very excited to have him join Altimmune as President and CEO," said Mitch Sayare, Chairman of the Board of Altimmune. "His extensive experience and success in building, managing, and financing private and public biotech companies makes him an extraordinary fit for Altimmune. We thank Bill for his contributions over the years and wish him well in his future endeavors."

Dr. Garg added, "The success of the recent financings coupled with a talented scientific and business team position Altimmune for an exciting future. In addition to advancing our current product candidates through the clinic, we plan to explore opportunties to either acquire products or partner in novel immunotherapy indications to expand our pipeline. I am thrilled to be joining the Company and look forward to building and executing a strategy to increase value for our shareholders."

Dr. Garg joins Altimmune with over three decades of experience in the biotechnology and pharmaceutical industries. He has a proven track record of building and managing both private and publicly traded companies. Before joining Altimmune, he served as President and CEO of Neos Therapeutics (Nasdaq: NEOS), where he built a commercial-stage biopharmaceutical company launching three branded therapeutic products including Adzenys XR- ODTTM and Cotempla XR-ODTTM the first ever XR-ODTTM medications for the treatment of ADHD. Prior to Neos, he served as president and CEO of Tranzyme Pharma where he progressed a discovery-stage, emerging biotech company to a Nasdaq-listed clinical-stage, drug development company. Prior to joining Tranzyme, Dr. Garg served as Chief Operating Officer of Apex Bioscence, Inc. (acquired by Curacyte AG of Munich, Germany), and held senior management positions at DNX Bio-Therapeutics, Inc. until its acquisition by Baxter Healthcare Corporation, Sunovion Pharmaceuticals, Inc. (formerly known as Sepracor Inc., now a subsidiary of Sumitomo Dainippon Pharma), and Bio-Response Inc. (acquired by Baxter Healthcare Corporation). Dr. Garg received his Ph.D. in Biochemistry in 1982 from the University of Adelaide, Australia, and his M.S. from IARI Nuclear Research Laboratory, New Delhi, India in 1978.