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Genmab to Participate in a Virtual Fireside Chat at the Goldman Sachs 41st Annual Global Healthcare Conference

On June 4, 2020 Genmab A/S (Nasdaq:GMAB) reported that its CFO, Anthony Pagano, will participate in a virtual fireside chat at the Goldman Sachs 41st Annual Global Healthcare Conference 3:00 PM EDT on June 11, 2020 (9:00 PM CEST) (Press release, Genmab, JUN 4, 2020, View Source [SID1234560832]). A webcast of the fireside chat will be available on Genmab’s website at View Source

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Global Coalition for Adaptive Research (GCAR) Selects DelMar Pharmaceuticals’ VAL-083 to Participate in the GBM AGILE Pivotal Study, an Adaptive Clinical Trial Platform in Glioblastoma Multiforme

On June 4, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported the acceptance of an invitation from the Global Coalition for Adaptive Research (GCAR) to include VAL-083 in GCAR’s Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study, an adaptive clinical trial platform in glioblastoma multiforme (GBM) (Press release, DelMar Pharmaceuticals, JUN 4, 2020, View Source [SID1234560830]). DelMar will utilize the GBM AGILE study to serve as the basis for VAL-083’s new drug application (NDA) submission and registration.

"We wish to convey our gratitude to GCAR for extending an invitation to DelMar to participate in the GBM AGILE study. We believe that GCAR’s already-approved robust adaptive trial design, industry leading partners and clinical support vendors, as well as strong regulatory endorsement can measurably accelerate our efforts to bring VAL-083 to market for GBM patients who have significant unmet medical needs," commented Saiid Zarrabian, Chief Executive Officer of DelMar Pharmaceuticals. "With 24 clinical sites currently enrolling patients and with additional sites in the US, Canada, Europe and China expected to come online in the next 12 months, our participation in GBM AGILE is expected to provide a significant time and cost savings advantage related to clinical trial initiation. We look forward to enrolling the first patient into the VAL-083 arm of the study which is planned for the fourth quarter of this year."

GBM AGILE is an international effort in newly-diagnosed and recurrent GBM, utilizing an FDA approved master protocol with multiple drugs to be tested simultaneously and over time against a common control arm. As an approved registrational study, results from the VAL-083 arm of GBM AGILE are intended to be utilized to file for FDA approval. This study employs a cost-efficient, adaptive trial design with a Stage 1 (Phase 2) learning and adapting phase and a Stage 2 (Phase 3) expansion and confirmation phase. The effort is led by top-tier key opinion leaders in the GBM field and has the collective support of an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, leaders from government and industry, and patient advocates. GCAR is a 501(c)(3) organization that functions as GBM AGILE study sponsor, and provides financial support for the program infrastructure, as well as general trial oversight. Comprising the world’s foremost clinical, translational, and basic science investigators, GCAR strives to support the development of novel treatments to fight against rare and deadly diseases like GBM where patient prognosis is poor and treatment options are limited.

"We look forward to advancing DelMar’s promising compound, VAL-083, in GBM AGILE. This registrational study is designed to accelerate the identification and approval of new drugs for patients with glioblastoma, a challenging disease with limited treatment options. We are very pleased to collaborate with DelMar Pharmaceuticals to initiate planning for the inclusion of VAL-083 in the trial for recurrent and newly-diagnosed GBM patients," commented Meredith Buxton, PhD, MPH, Chief Executive Officer of GCAR.

RCT Acquires Translational Drug Development, LLC

On June 4, 2020 Research Corporation Technologies, Inc. (RCT) reported that it has acquired and invested growth capital into Translational Drug Development (TD2), the leading fully integrated precision oncology medicine development organization (Press release, Research Corporation Tech, JUN 4, 2020, View Source [SID1234560829]). TD2 provides end-to-end solutions, including translational preclinical services; regulatory strategic guidance, planning and document submission services; and clinical trial design and execution for innovative oncology-focused companies.

TD2, based in Scottsdale, Arizona, focuses exclusively on oncology medicine development with unparalleled experience conducting translational studies from bench-to-bedside against all tumor types and hematology indications. RCT, based in Tucson, Arizona, with assets of more than $500 million, focuses on investing in promising biomedical companies using expertise acquired through the successful commercialization of therapeutics, medical devices and life science tools for more than 30 years. These capabilities will significantly expand TD2’s precision oncology drug development services.

"The acquisition of TD2 represents an opportunity for a unique partnership with an outstanding management team and, by providing additional growth capital, we plan to add scale and enable the expansion of TD2’s current offerings," said Shaun Kirkpatrick, RCT President. "TD2 will continue its successful business model of providing focused and comprehensive oncology drug development solutions to rapidly advance products to patients most likely to benefit from these treatments."

"For more than 17 years, TD2 has been supporting oncology innovators by designing clinical programs that predict unique contexts of sensitivity for new medicines which then provide accelerated patient benefits in clinical testing. Using our combined infrastructure and expertise, we intend to strategically expand the suite of capabilities to match the future needs of biotechnology and pharmaceutical companies seeking comprehensive solutions from early-stage, proof-of-concept programs to registration," said Kirkpatrick.

"We believe that RCT is the ideal partner for TD2 to expand its mission of accelerating exciting new medicines to patients that urgently need them," said Stephen Gately, PhD, CEO of TD2. "We share a common vision about the future of oncology drug development and have a passion to deploy solutions that increase the likelihood that patients on TD2 supported trials have the opportunity for clinical benefit."

"We have known RCT and their outstanding team for many years and have had the opportunity to work closely with them on numerous successful programs," said Daniel Von Hoff, MD, FACP, Chief Development Officer for TD2. "We could not be more pleased about having TD2 join the RCT family."

The acquisition of TD2 by RCT will be a catalyst to expand and accelerate TD2’s platform of integrated oncology solutions and to position TD2 as the leader in strategic oncology medicine development to assist life sciences companies in this fast-paced time of therapeutic innovation in oncology.

OncoSec to Present at Virtual Summer Investor Summit

On June 4, 2020 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a company developing late-stage intratumoral cancer immunotherapies, reported that Daniel J. O’Connor, President and Chief Executive Officer of OncoSec, will present a company overview at the Virtual Summer Investor Summit on Tuesday, June 9th at 9:45 a.m. Eastern Time (Press release, OncoSec Medical, JUN 4, 2020, View Sourcepress-releases/detail/2050/oncosec-to-present-at-virtual-summer-investor-summit" target="_blank" title="View Sourcepress-releases/detail/2050/oncosec-to-present-at-virtual-summer-investor-summit" rel="nofollow">View Source [SID1234560828]).

A live audio webcast of the presentation will be available on the Investors section of OncoSec’s website at View Source, where it will be archived for approximately 30 days.

GSK announces new data presentations from the DREAMM programme exploring investigational belantamab mafodotin in patients with relapsed/refractory multiple myeloma

On June 4, 2020 GlaxoSmithKline (GSK) plc reported new data from its DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial programme of belantamab mafodotin in relapsed/refractory multiple myeloma will be presented at the upcoming virtual edition of the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress from 11-21 June 2020 (Press release, GlaxoSmithKline, JUN 4, 2020, View Source [SID1234560827]).

Sixteen presentations in total will be shared at the meeting, including new analyses from the pivotal DREAMM-2 study evaluating belantamab mafodotin in heavily pre-treated patients with relapsed/refractory multiple myeloma. Key presentations include:

DREAMM-1 and DREAMM-2 Pooled Data: Safety and Tolerability of Single-agent Belantamab Mafodotin in Heavily Pre-Treated Patients With Relapsed/Refractory Multiple Myeloma (ePoster #EP948; Trudel S)
DREAMM-2: Assessing Efficacy Via Indirect Comparison of Single-agent Belantamab Mafodotin Versus Selinexor Plus Dexamethasone Combination in Anti-CD38 Exposed Relapsed/Refractory Multiple Myeloma (ePoster #EP1016; Popat R)
DREAMM-4: Evaluating Safety and Clinical Activity of Belantamab Mafodotin in Combination With Pembrolizumab in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) (ePoster #EP955; Trudel S)
Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "In today’s challenging environment we are committed to helping address the COVID-19 pandemic, while also progressing our scientific research to deliver innovative treatments for patients with cancer. We are proud to present data at EHA (Free EHA Whitepaper) from our extensive DREAMM clinical trial programme as we continue to advance belantamab mafodotin in various relapsed/refractory multiple myeloma treatment settings."

Belantamab mafodotin is an investigational humanised, anti-BCMA (antibody-drug conjugate against B-cell maturation antigen).[1] BCMA is a cell-surface protein that plays an important role in the survival of plasma cells and is universally expressed in patients with multiple myeloma.[2] A Biologics License Application (BLA) and Marketing Authorisation Application (MAA), are currently under review by the US Food and Drug Administration and European Medicines Agency, respectively. Data from the DREAMM-2 study of single-agent belantamab mafodotin in patients with RRMM who had received a median of seven prior lines of treatment and whose disease was progressing despite treatment with an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody, serve as the basis for the BLA and MAA.

Additional GSK presentations can be found below.

Belantamab mafodotin

Abstract Name

Presenter

Presentation Details

DREAMM-2 Pivotal Study: Analysis of the Lyophilized Presentation Cohort of Single-Agent Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma

Richardson P

ePoster #EP1048

DREAMM-2: Single-Agent Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma RRMM–Outcomes by Prior Therapies

Lonial S

ePoster #EP937

DREAMM-2: Belantamab Mafodotin Effect on Disease Symptoms and Health-Related Quality of Life in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

Popat R

ePoster #EP1746

DREAMM-1: Patient Perspectives From the First-in-Human Study of Single-Agent Belantamab Mafodotin for Relapsed and Refractory Multiple Myeloma (RRMM)

Eliason L

Abstract #PB2064

DREAMM-2: Single-Agent Belantamab Mafodotin in Relapsed/Refractory Multiple Myeloma Refractory to PIs, Immunomodulatory Agents, and Refractory and/or Intolerant to Anti-CD38 mAbs

Lonial S

ePoster #EP970

DREAMM-2: Single-Agent Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) and High-Risk (HR) Cytogenetics

Trudel S

ePoster #EP1037

DREAMM-2: Single-agent Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) and Renal Impairment

Lee H

ePoster #EP1006

DREAMM-3: A Phase III, Open-label, Randomized Study of Single-Agent Belantamab Mafodotin Versus Pom/Dex in Relapsed/Refractory Multiple Myeloma (RRMM)

Weisel K

Abstract #PB2041

DREAMM-5 Platform Trial: Belantamab Mafodotin in Combination With Novel Agents in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

Richardson P

Abstract #PB2065

DREAMM-6: Safety and Tolerability of Belantamab Mafodotin in Combination with Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma (RRMM)

Popat R

ePoster #EP1031

DREAMM-9: Phase III Study of Belantamab Mafodotin Plus VRd vs. VRd Alone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM)

Usmani S

Abstract #PB2038

Relapsed/Refractory Multiple Myeloma

Abstract Name

Presenter

Presentation Details

Characteristics, Treatment Patterns, and Outcomes Among Patients with Relapsed/Refractory Multiple Myeloma in Europe

Casey V

ePoster #EP971

Estimating the Number of US Patients with Multiple Myeloma at Different Lines of Therapy

Nikolaou A

ePoster #EP963

About multiple myeloma
Multiple myeloma is the third most common blood cancer and is generally considered treatable, but not curable.[3] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[4]

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B-cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.[2]

About belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an investigational antibody-drug conjugate comprising a humanised anti-B-cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

Belantamab mafodotin is not currently approved for use anywhere in the world.

Trial Name

GSK ID/NCT ID

Status

Design

DREAMM-1

117159/ NCT02064387

Completed

A Phase I Open-label Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of Belantamab Mafodotin (GSK2857916) in Subjects with Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic Malignancies Expressing BCMA

DREAMM-2

205678/ NCT03525678

Active, not recruiting

A Phase II Study to Investigate the Efficacy and Safety of Two Doses of Belantamab Mafodotin (GSK2857916) in Subjects with Relapsed/Refractory Multiple Myeloma Who are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed Prior Treatment with an Anti-CD38 Antibody

DREAMM-3

207495/ NCT04162210

Recruiting

A Phase III Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) Compared to Pomalidomide plus low-dose Dexamethasone (Pom/Dex) in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-4

205207/ NCT03848845

Recruiting

A Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pembrolizumab in Subjects with Relapsed/Refractory Multiple Myeloma

DREAMM-5

208887/

NCT04126200

Recruiting

A Phase I/II, Randomized, Open-label Platform Study of Belantamab Mafodotin (GSK2857916) with Innovative Combination Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-6

207497/ NCT03544281

Recruiting

A Phase I/II Randomized Study to Evaluate Safety, Tolerability and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Lenalidomide plus Dexamethasone (Arm A), or in Combination with Bortezomib plus Dexamethasone (Arm B) in Subjects with Relapsed/Refractory Multiple Myeloma

DREAMM-7

207503/

NCT04246047

Recruiting

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Dexamethasone versus Daratumumab, Bortezomib, and Dexamethasone in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-8

207499

Planned

A Phase III, Multicentre, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) in Combination with Pomalidomide plus Low-Dose Dexamethasone (BPd) versus Pomalidomide plus Bortezomib and Low-Dose Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-9

209664/ NCT04091126

Recruiting

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Lenalidomide and Low-Dose Dexamethasone (VRd) vs. VRd in Participants with Newly Diagnosed Multiple Myeloma who are Ineligible for Transplant

DREAMM-10

207500

Planned

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with a Novel Agent versus SoC

ISS/GSK Co-Sponsored Study

209418/ NCT03715478

Recruiting

A Phase I/II Dose-escalation and Dose-expansion Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pomalidomide plus Low-dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma Who Have Received Two or More Prior Lines of Therapy That Must Have Included Lenalidomide and a Proteasome Inhibitor