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Worldwide Clinical Trials and Deep Lens Enter Strategic Alliance to Accelerate Recruitment and Development Timelines for Oncology Trials

On March 7, 2019 Worldwide Clinical Trials, Inc. (Worldwide), an award-winning, full-service, midsize, global CRO, and Deep Lens, an AI-driven digital pathology company focused on disease diagnosis confirmation and clinical trial recruitment, reported a new strategic alliance in oncology (Press release, Worldwide Clinical Trials, MAR 7, 2019, View Source [SID1234554046]). The companies will pair Worldwide’s expertise in clinical cancer research and global clinical trial operations with the Deep Lens VIPER digital pathology platform. This combination will support a new ecosystem for sponsors, researchers and care teams to accelerate cancer diagnoses and present clearer treatment and clinical trial options earlier in the process.

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Patient recruitment for clinical trials remains a time-intensive, costly barrier to the execution of drug development programs. More than 14,000 oncology clinical trials are actively recruiting patientsi, yet estimates put the rate of participation as low as 3 percent of potential trial candidates.ii Worldwide and Deep Lens will address this challenge by first collaborating to design a pilot study to marry innovative clinical trial designs and operational acumen with the VIPER platform. The aim is to enhance trial recruitment through real-time diagnosis and alerting and enhance coordination between research teams, care teams and patients.

"Cancer research is advancing at an incredible pace. We need to up our game as pathologists and CROs to deliver increased precision, speed and communication to find patients with particular disease subtypes or biomarkers," said Dave Billiter, co-founder and CEO, Deep Lens. "With the global reach and scientific and operations expertise of Worldwide, we believe we can streamline clinical trial recruitment. And, just as importantly, oncologists can inform patients and their caregivers about clinical research options from day one."

Through the strategic alliance, Worldwide and Deep Lens seek to:

Accelerate oncology patient recruitment for clinical trials
Advance clinical research as a care option (CRAACO) where the critical conversation with a patient is enabled at the point in their journey that is most impactful
Create trusted networks of precision diagnosis and clinical research options
Provide biopharmaceutical clients with a new platform for basket and umbrella study designs that can quickly process diagnosis and tumor response in real time
Support pre-competitive research into better clinical trial approaches by organizing "data clubs" (disease-specific consortia) of industry stakeholders
"Worldwide and Deep Lens are collaborating to drive critical, lifesaving decisions earlier in the treatment conversation – where days can impact outcomes. For sponsors, this further builds on our commitment to provide uncommon scientific and operational expertise throughout the clinical research process," said Dave Bowser, executive vice president and general manager, Worldwide Clinical Trials. "For patients, the alliance seeks to bring clarity and confidence to the incredibly challenging moment they are diagnosed with cancer."

With operations spanning 60 countries, Worldwide offers biopharma sponsors the clinical, technical and regulatory expertise they need to navigate the international and strategic complexities of oncology drug development – including proven ability to access hard-to-find patient populations.

Deep Lens offers a modernized, AI-driven approach to pathology.

Together, the companies will address unique barriers to recruitment. These include:

Deployment of advances in digital pathology, deep learning and workflow for interventional and observational research in oncology;
Accelerated characterization of complex oncology sub-types and stages in real time; and
Engaging study teams and care teams in meaningful patient conversations about treatment options.
By working with Deep Lens on clinical trial recruitment, Worldwide can reach upstream from the oncologist to the pathologist, enabling identification of eligible patients at the time of their diagnosis – much sooner than current methods. Going straight to the source can fast-track trial enrollment and potentially shorten the duration of the trial.

Autolus Therapeutics to Host R&D Day on March 26, 2019

On March 7, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, reported that the company will host an R&D Day in New York City on March 26, 2019 (Press release, Autolus, MAR 7, 2019, View Source [SID1234550821]).

The program will provide insights into the science behind tumor defense mechanisms and the company’s novel programmed T cell therapy programs in development utilizing targeted, modular approaches designed to address these mechanisms. The featured speaker, Dr. Samir N. Khleif, MD, Professor of Oncology, Director of Jeannie and Tony Loop Immuno-Oncology Laboratory, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, will discuss his work focused on understanding mechanisms through which the immune system and cancer cells interact as well as challenges and opportunities in addressing the hostile tumor microenvironment.

Dr. Christian Itin, chairman and chief executive officer and Dr. Martin Pule, founder and chief scientific officer of Autolus and Clinical Senior Lecturer at University College London Cancer Institute, along with other members of Autolus’ management, will highlight progress made in the company’s clinical portfolio and discuss the future direction for additional product candidates in hematological and solid tumors.

The event is open to institutional investors and sell side analysts. To attend in person, please notify the Investor Relations contact noted below in this press release. A live video webcast of the event will be available beginning at 8:00 am ET on the Events section of Autolus’ website. An archived replay will be available on the website for one year.

Alligator Bioscience: First Patient Dosed in Phase I study of ATOR-1015

On March 7, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the first patient has successfully been dosed in its phase I study of ATOR-1015, its drug candidate in development for tumor-directed immunotherapy (Press release, Alligator Bioscience, MAR 7, 2019, View Source [SID1234538669]). ATOR-1015 is designed with properties that shall enable it to accumulate in the tumor area after an intravenous injection, and selectively exert its effect there.

The study, being initiated in five different clinics across Sweden and Denmark, is a first-in-human dose-escalation study in up to 53 patients with advanced solid tumor disease. The primary aim of the study is to investigate the safety and tolerability of the drug and to identify the recommended dose for subsequent phase II studies. The results of the study are expected to read out in the second half of 2020.

"I state with satisfaction that ATOR-1015 is the first investigational tumor-localizing bispecific CTLA-4 antibody ever being tested in the clinic. With this, Alligator takes the lead in a very hot area of research. While immune activation through CTLA-4 has shown impressive efficacy in multiple cancers, it is coupled with severe toxicity. We believe that ATOR-1015 will be at least as effective as the approved monospecific CTLA-4 antibody Yervoy, and with less side effects," said Per Norlén, CEO of Alligator. "As the study progresses we look forward to learning more about the potential of this investigational medicine to improve the treatment of multiple cancers".

As previously communicated, Alligator has appointed Theradex Oncology, a global contract research organization with extensive expertise in oncology clinical development, to conduct the phase I study.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 11:45 a.m. CET on March 7, 2019.

About ATOR-1015
ATOR-1015 is a next generation CTLA-4 bispecific antibody developed for tumor-directed immunotherapy with increased capability of regulatory T-cell depletion. It is wholly-owned by Alligator. ATOR-1015 binds to two different immune receptors: the checkpoint receptor CTLA-4 and the co-stimulatory receptor OX40. The immune activation is increased in areas where both target molecules are expressed at high levels, notably in the tumor microenvironment, which is believed to reduce adverse immune reactions.

About Yervoy
The active ingredient in Yervoy is ipilimumab, a protein that helps the body’s immune system to attack and destroy cancer cells. Yervoy is approved for the treatment of advanced melanoma (a type of skin cancer), and for combination treatment of advanced renal cell cancer (RCC) and colorectal cancer (MSIhigh CRC). The global total sales of Yervoy amounted to USD 1.2 billion in 2017. (Source: Fass.se, Cowen Therapeutics Outlook March 2018.)

First Patient Dosed in a Phase II Randomized Study of L-DOS47 With Vinorelbine and Cisplatin

On March 7, 2019 Helix BioPharma Corp. (TSX: HBP), (FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, is reported the first patient has been successfully dosed with L-DOS47, vinorelbine and cisplatin in its Phase IIB, open-label, randomized study in metastatic lung adenocarcinoma patients (LDOS003 study) (Press release, Helix BioPharma, MAR 7, 2019, View Source [SID1234536458]). The goals of the study are to compare the safety, tolerability and preliminary efficacy of L-DOS47 in combination with vinorelbine/cisplatin as compared to vinorelbine/cisplatin alone, in patients with lung cancer.

The LDOS003 study involves two parts: In Part 1 of the study (dose escalation), patients in cohorts will receive escalating amount of L-DOS47 in combination with vinorelbine/cisplatin. Once the maximum tolerated dose of L-DOS47 as an adjunct to vinorelbine/cisplatin is determined, patients in Part 2 of the study (randomized treatment) will be randomly assigned to receive L-DOS47 in combination with vinorelbine/cisplatin or vinorelbine/cisplatin alone. Additional information about the trial can be found in the EU Clinical Trials Register (View Source).

"This is our second chemo-combination study for L-DOS47 in advanced non-small lung cancer study," said Dr. Heman Chao Ph.D., Chief Executive Officer of Helix. "We are very excited to see that L-DOS47 continues to advance in this disease indication.

CASI PHARMACEUTICALS ANNOUNCES CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) APPROVAL OF CTA TO CONDUCT REGISTRATION TRIAL FOR MARQIBO®

On March 7, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. based pharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, U.S., and throughout the world, reported that the National Medical Products Administration (NMPA) has approved the Company’s Clinical Trial Application (CTA) allowing for a registration clinical trial to evaluate the efficacy and safety of vincristine sulfate LIPOSOME injection (MARQIBO) (Press release, CASI Pharmaceuticals, MAR 7, 2019, View Source [SID1234534307]).

MARQIBO is a U.S. Food and Drug Administration (FDA)-approved product currently marketed in the U.S. by Spectrum Pharmaceuticals, Inc. (Spectrum), for the treatment of adult patients with Philadelphia chromosome–negative (Ph‒) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. CASI acquired greater China rights to this drug from Spectrum.

The Company is currently reviewing certain requirements provided by the Center for Drug Evaluation (CDE), a division of the NMPA, and upon satisfying those requirements, the Company will commence the registration trial for MARQIBO.

Wei-Wu He, Ph.D., CASI’s Executive Chairman commented, "Ph negative ALL is a rare but aggressive disease and while patient outcomes have vastly improved over the last three decades, patients continue to relapse and current salvage therapies are inadequate, particularly among the aging Chinese patient population. MARQIBO is the first and only liposome-encapsulated vincristine approved and marketed in the U.S. for second line treatment of adult Philadelphia chromosome-negative acute lymphoblastic leukemia and has been safely administered in patients since its U.S. approval in 2012. Receiving NMPA approval to conduct the registration trial in China with MARQIBO is an important milestone for CASI. This approval, along with the recent CTA approval for ZEVALIN and the fast track market approval of EVOMELA, further demonstrates CASI’s regulatory strength in working with the NMPA to advance products through the approval process."