On January 6, 2019 GE Healthcare and Vanderbilt University Medical Center (VUMC) reported a five-year partnership to enable safer and more precise cancer immunotherapies (Press release, GE Healthcare, JAN 6, 2019, View Source [SID1234532487]). Multiple diagnostic tools will be developed to help predict both the efficacy of an immunotherapy treatment and its adverse effects for a specific patient before the therapy is administered. This would allow physicians to better target immunotherapies to the right patients and avoid potentially damaging, ineffective and costly courses of treatments.

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Immunotherapies use the immune system to recognize and attack cancer cells and can be more effective than traditional treatments, but response rates are often low and side effects can be severe1. GE Healthcare and VUMC will retrospectively analyze and correlate the immunotherapy treatment response of thousands of VUMC cancer patients, with their anonymized demographic, genomic, tumor, cellular, proteomic and imaging data. They will then develop AI-powered apps that draw on this data to help physicians identify the most suitable treatment for each individual patient.

Simultaneously, GE Healthcare and VUMC will develop new positron-emission tomography (PET) imaging tracers, which together with the apps, will help physicians to stratify cancer patients for clinical trials. It currently takes an average of 12 years2 and costs almost $2bn3 to bring a drug to market. In many cases, inappropriate patients are recruited to participate in immunotherapy trials, incurring unnecessary expense and slowing down approvals of new therapies. It is hoped that the PET tracers will ultimately also be used to monitor the efficacy of immunotherapies in everyday practice.

"Immunotherapy offers tremendous promise but given the current unpredictability of some patients’ reactions to treatments, it is also associated with increased morbidity and cost. This partnership provides the opportunity to leverage strengths of both of our organizations to further personalize cancer care by creating new tools that allow clinicians to more accurately predict how patients will respond to a specific therapy," said Jeff Balser, MD, PhD, President and Chief Executive Officer, Vanderbilt University Medical Center and Dean of the Vanderbilt University School of Medicine.

"GE Healthcare and Vanderbilt will combine their data science, genomic, imaging and cellular analysis capabilities to help improve clinical decision making. This partnership is a great example of the increasing convergence of the tools, technologies and data used by therapy innovators and healthcare providers," said Kieran Murphy, President and Chief Executive Officer, GE Healthcare.

GE Healthcare and the Vanderbilt-Ingram Cancer Center, a world-renowned stem cell transplant facility, will also collaborate on methods to improve productivity, efficiency and cost of stem cell transplant processing operations by automating processes, digitizing workflows, improving throughput and industrializing operations.

The first analytics application prototype will be available by the end of 2019 and the PET tracer proof-of-concept by the end of 2020.

On January 6, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported its key 2018 accomplishments and outlined the Company’s priorities for 2019 (Press release, Zymeworks, JAN 6, 2019, View Source [SID1234532473]).

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"With our clinical, preclinical, and business development achievements in 2018, along with a robust balance sheet, we believe we are in a strong position to continue delivering on our corporate objectives in 2019 and beyond," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "Our priorities include aggressively advancing our clinical and preclinical programs and continuing the development of our therapeutic platforms, which not only underpin our in-house pipeline but have also served as the basis of eight major pharmaceutical partnerships. We remain committed to our mission of creating novel biotherapeutics that allow patients worldwide to return home to their loved ones, disease free."

2018 Achievements

Presented Expanded ZW25 Data, Underscoring its Anti-Tumor Activity and Tolerability
Zymeworks reported clinical results for ZW25, a novel Azymetric bispecific HER2-targeting antibody, at multiple medical meetings. Data continues to demonstrate ZW25’s robust single-agent anti-tumor activity and tolerability in heavily pretreated patients across a variety of HER2-expressing cancers.

ZW49 Investigational New Drug (IND) Application Accepted by the FDA
ZW49, Zymeworks’ second clinical candidate, is a novel bispecific HER2-targeting antibody drug conjugate. IND-enabling studies demonstrated promising efficacy and tolerability, suggesting a wide therapeutic window.

New Corporate Partnerships Established and Existing Ones Expanded
Zymeworks entered into new collaborations with BeiGene, which includes a licensing agreement in the Asia Pacific region (excluding Japan) for ZW25 and ZW49, and with LEO Pharma, which expands Zymeworks’ pipeline into new disease areas. The Company also expanded its existing collaborations with Daiichi Sankyoand Celgene. Zymeworks currently has eight active collaborations that offer up to US$7.6 billion in potential milestone payments plus royalties.
Drug Candidate from First Corporate Partnership Poised to Enter Clinical Studies

Eli Lilly submitted an IND application for one of its bispecific antibodies enabled by Zymeworks’ Azymetric platform resulting in a milestone payment to the Company.

Introduced Robust Immune Oncology (IO) Preclinical Pipeline
Zymeworks unveiled a number of IO programs showcasing the versatility of its platform technologies. Leveraging the Azymetric platform, Zymeworks showed how optimizing bispecific geometry and formats can maximize activity, potentially creating new classes of precision therapeutics.

Expanded Executive Leadership Team
Tony Polverino, Ph.D., joined Zymeworks as Executive VP of Early Development and CSO. In this newly created role, he oversees the Company’s R&D strategy and advances product candidates from discovery through translational research/early development.

Built Strong Balance Sheet
Zymeworks completed a US$97.8 million public financing and added non-dilutive capital from its corporate partnerships totaling US$89 million in 2018.

2019 Corporate Priorities

Zymeworks will focus on achieving the following in 2019:

Initiating multiple Phase 2 studies for ZW25
Expanding the global clinical development of ZW25 into Asia and Europe
Reporting ZW25 data from combination studies (chemotherapy and/or targeted agents)
Reporting data from the Phase 1 trial for ZW49
Establishing additional drug development collaborations with a focus on new platforms
In addition, Zymeworks expects its pharmaceutical partners to continue nominating new Azymetric bispecific antibody therapeutic candidates for clinical development in 2019.

On January 5, 2019 NantKwest (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of the human immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases reported that the company will be hosting an Investor/Analyst Day on Tuesday, January 8, 2019 in San Francisco, California (Press release, NantKwest, JAN 5, 2019, View Source [SID1234532486]).

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NantKwest will be sharing with analysts and investors a review of the company’s activities in 2018 and provide an overview for 2019.

At this event, senior management of NantKwest will provide a review of its ongoing R&D program, as well as provide a roadmap for the company’s clinical programs for 2019.

The event will begin at 7:00 PM PT on Tuesday, January 8, 2019 and is expected to conclude at 9:00 PM PT. A replay of the presentation will be posted on the NantKwest website and will be available for 30 days following the event

On January 5, 2019 Bristol-Myers Squibb Company (NYSE: BMY) reported that Giovanni Caforio, M.D., chairman and chief executive officer, will join Mark Alles, chairman and chief executive officer of Celgene, for a fireside chat at the 37th Annual J.P. Morgan Healthcare Conference at 7:30 a.m. PT (10:30 a.m. ET) on Monday, January 7, 2019 at the Westin St. Francis in San Francisco (Press release, Bristol-Myers Squibb, JAN 5, 2019, View Source [SID1234532483]).

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Investors and the general public are invited to listen to a live webcast of the presentation at View Source Materials related to the presentation will be available at the same website at the start of the live webcast. An archived edition of the presentation will be available later that day.

On January 4, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported that the first patient has been dosed in its Phase Ib clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-301 (camidanlumab tesirine) in patients with selected solid tumors that are locally advanced or metastatic (Press release, ADC Therapeutics, JAN 4, 2019, View Source [SID1234596069]).

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ADCT-301 is already being evaluated in relapsed and refractory Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). At the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, ADC Therapeutics presented interim data on 113 patients dosed in its Phase Ia/Ib clinical trial in lymphoma. In HL patients with a median of five prior lines of therapy and no other approved therapy options, the overall response rate was 86.5 percent, including a 43 percent complete response rate, at the dose being considered for a pivotal Phase II clinical trial that the Company anticipates initiating in 2019.

Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "We continue to be very encouraged by the anti-tumor activity of ADCT-301 in Hodgkin lymphoma and non-Hodgkin lymphoma. In addition, based on the immune-oncology potential ADCT-301 has demonstrated in preclinical studies, we are excited to be starting this clinical trial for ADCT-301 in solid tumors to see if we can make an impact and improve patient outcomes in multiple difficult-to-treat solid tumor cancers."

ADCT-301 in Solid Tumors

At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, ADC Therapeutics presented preclinical data showing that an engineered version of ADCT-301 demonstrated highly potent anti-tumor activity, both as a monotherapy and in combination with a checkpoint inhibitor, in multiple solid tumor models with infiltrating CD25-positive regulatory T cells (Tregs).

Patrick van Berkel, PhD, Senior Vice President of Research and Development at ADC Therapeutics, said, "ADCT-301 targets CD25, which is expressed on Tregs that infiltrate the local tumor environment. In preclinical models, a single dose of the CD25-targeted ADC induced strong and durable anti-tumor activity against established CD25-negative solid tumors with infiltrating Tregs both as a monotherapy and in combination with a checkpoint inhibitor. Moreover, re-challenged mice did not develop new tumors indicating the CD25-targeted ADC was able to induce tumor-specific protective immunity."

The Phase Ib trial of ADCT-301 in patients with advanced solid tumors has both dose escalation and cohort expansion parts. The dose escalation part is designed to establish a safe and tolerated dose and dosing schedule of ADCT-301 in these patients. The identified dose and dosing schedule will be studied in the dose expansion part. Approximately 50 patients will be enrolled in the trial.

For more information about this Phase Ib clinical trial in solid tumors, please visit www.clinicaltrials.gov (identifier NCT03621982).

About ADCT-301

ADCT-301 (camidanlumab tesirine) is an antibody drug conjugate (ADC) composed of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD25-expresing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead. The intra-tumor release of its PBD warhead may cause bystander killing of neighboring tumor cells. In addition, the PBD warhead will trigger immunogenic cell death, which in turn will strengthen the immune response against tumor cells. In addition to the Phase Ib clinical trial in solid tumors, ADCT-301 is being evaluated in ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma (NCT02432235).