On June 4, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that the European Commission (EC) has granted Janssen-Cilag International NV (Janssen) marketing authorization for the subcutaneous (SC) formulation of DARZALEX (daratumumab), for the treatment of adult patients with multiple myeloma in all currently approved DARZALEX intravenous (IV) formulation indications in frontline and relapsed / refractory settings (Press release, Halozyme, JUN 4, 2020, View Source [SID1234560834]). The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in April 2020. The SC formulation is administered as a fixed-dose over approximately three to five minutes, significantly less time than IV DARZALEX, which is given over several hours. Patients currently on IV DARZALEX will have the choice to switch to the SC formulation.

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"We are delighted that the subcutaneous formulation of DARZALEX has been granted marketing authorization in the EU with a broad label so soon after the CHMP positive opinion," said Dr. Helen Torley. "DARZALEX SC has the potential to improve the treatment experience for multiple myeloma patients and physicians in the European Union as patients may benefit from a shorter treatment time when compared with a multi-hour intravenous infusion."

The approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the SC formulation of daratumumab to the IV formulation in patients with relapsed or refractory multiple myeloma, and data from the Phase II PLEIADES (MMY2040) study, which evaluated SC daratumumab in combination with certain standard multiple myeloma regimens. The topline results from the COLUMBA study were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress. Updated data of the COLUMBA and the PLEIADES studies were presented during poster sessions at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2019.

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

On June 4, 2020 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported that Alison Lawton, President and Chief Executive Officer, will participate in a fireside chat during the virtual Goldman Sachs 41st Annual Global Healthcare Conference on Thursday, June 11, 2020 at 11:20 a.m. ET (Press release, Kaleido Biosciences, JUN 4, 2020, View Source [SID1234560833]).

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A live webcast will be available in the Investors & Media section of Kaleido’s website at View Source An archived replay will be accessible for 90 days following the event.

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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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.

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"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.

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.

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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.