Dong-A ST and Beactica Therapeutics Achieve Key Milestone in Their Collaboration to Develop New Cancer Treatments

On December 4, 2019 Dong-A ST Co., Ltd. (170900: Korea SE), a Korean pharmaceutical company, and Beactica Therapeutics AB, a Swedish drug discovery company, reported that a lead compound meeting certain pre-defined criteria has been selected in their collaborative research programme aimed at developing first-in-class protein-protein interaction inhibitors for a target of therapeutic importance in cancer and other diseases (Press release, Dong-A, DEC 4, 2019, View Source [SID1234551944]).

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The milestone transition provides Dong-A ST with exclusive global rights for further development and commercialization of products based on, or derived from, the lead compound. In return, Beactica receives an undisclosed milestone payment and is eligible to further payments for certain preclinical, clinical and regulatory milestones as well as royalties on commercial sales of the products resulting from the partnership. Beactica is also entitled to a revenue share from any related future licensing activities by Dong-A ST. Full financial details remain undisclosed.

"The collaboration between Dong-A and Beactica was initiated to develop next generation anti-cancer therapeutics and we greatly appreciate the phenomenal contribution Beactica has made in identifying novel modulators for a highly sought-after target," said Dr Taeyoung Yoon, Senior Vice President and Head of Research of Dong-A ST. "We are committed to advance this innovative programme with the ultimate aim to make a clinical impact where it is urgently needed."

"We are delighted to achieve this milestone under our collaboration with Dong-A, further validating the strength of our approach and drug discovery platform, as well as our success in collaborating globally with leading pharmaceutical companies," said Dr Per Källblad, CEO of Beactica. "Dong-A’s commitment to advance this programme towards the clinic is encouraging."

The collaboration between Dong-A ST and Beactica Therapeutics was initiated in October 2016 and expanded in December 2018.

MaxCyte and KSQ Therapeutics Announce Development and Commercialization Agreement to Enable the Advancement of KSQ’s Adoptive Cell Therapy Programs

On December 4, 2019 MaxCyte, the global cell-based therapies and life sciences company, and KSQ Therapeutics, a biotechnology company using its proprietary CRISPRomics discovery platform to achieve higher probabilities of success in drug development, reported that the companies have entered into a new development and commercialization agreement (Press release, MaxCyte, DEC 4, 2019, View Source;adoptive-cell-therapy-programs-300968617.html [SID1234551943]). Under the agreement, KSQ gains rights to use MaxCyte’s Flow Electroporation technology and ExPERT instruments for the advancement of KSQ’s engineered tumor-infiltrating lymphocyte (eTIL) programs, which the company is developing for the treatment of PD-1 refractory solid tumors.

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Under the terms of the agreement, KSQ obtains non-exclusive clinical and commercial use rights to MaxCyte’s cell engineering platform to develop multiple adoptive cell therapies. In return, MaxCyte is eligible to receive certain milestone payments in addition to other licensing fees.

"Adoptive cell therapies hold significant potential to improve outcomes for patients that are otherwise unresponsive to current treatments," said David Meeker, M.D., Chief Executive Officer of KSQ. "MaxCyte’s technology will play an important role in enabling the further development of our eTIL programs as we work to bring best-in-class, cell-based medicines forward for difficult to treat solid tumors."

MaxCyte’s ExPERT instrument family represents the next generation of leading, clinically validated, electroporation technology for complex and scalable cellular engineering. By delivering high transfection efficiency with enhanced functionality, the ExPERT platform delivers the high-end performance essential to enable the next wave of biological and cellular therapeutics.

"We are delighted to have signed this agreement with KSQ Therapeutics, a company that’s forging an exciting path in the field of adoptive cell therapies with the potential to deliver significant benefits to patients. This is the fifth commercial license we have signed this year, demonstrating that MaxCyte is the partner of choice for leading technology companies, like KSQ, that are at the cutting edge of cell therapy and gene editing," said Doug Doerfler, President & CEO of MaxCyte, Inc.

Citius Pharmaceuticals to Present at the 12th Annual LD Micro Main Event

On December 4, 2019 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, reported that the Company will present at the 12th Annual LD Micro Main Event on Wednesday December 11, 2019 at 11:40 AM PT (Press release, Citius Pharmaceuticals, DEC 4, 2019, View Source [SID1234551942]). The conference is being held at the Luxe Sunset Boulevard Hotel in Bel Air, California on December 10-12, 2019.

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Presentation Date: Wednesday, December 11, 2019

Presentation Time: 11:40 AM PT – Track 3

Location: Luxe Sunset Boulevard Hotel – Bel Air, CA

Mr. Leonard Mazur, Chairman of Citius, will deliver an overview of the Company, answer questions from investors, and be available for one-on-one meetings. To arrange a meeting with the Company, please contact Mr. Andrew Scott: [email protected].

Adastra Pharmaceuticals Announces FDA and EMA Orphan Drug Designation Has Been Granted for Zotiraciclib in the Treatment of Glioma

On December 4, 2019 Adastra Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of first-in-class therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Orphan Drug Designation to zotiraciclib for the treatment of glioma (Press release, Adastra Pharmaceuticals, DEC 4, 2019, View Source [SID1234551941]). Zotiraciclib is currently the subject of two separate Phase 1b clinical trials in glioblastoma (GBM). Adastra expects to report results from the two studies during 2020.

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The first Phase 1b clinical trial, sponsored by the National Cancer Institute (NCI), is a multi-arm, dose-finding study examining the combination of zotiraciclib and temozolomide (TMZ) for the treatment of recurrent malignant gliomas. Having recently enrolled the Phase 1 portion, the NCI and Adastra expect to report top-line data early in 2020, expanding upon results previously reported at the 2019 ASCO (Free ASCO Whitepaper) Annual meeting and also via e-Poster at the 2019 Society of Neuro Oncology.

The second Phase 1b trial of zotiraciclib is being conducted by the European Organisation for Research and Treatment of Cancer (EORTC) and is designed as a three-parallel cohort, open-labeled, non-randomized, multicenter study in elderly patients with IDH1R132H-non mutant and MGMT promoter-unmethylated anaplastic astrocytoma or glioblastoma. Group A consists of First-Line patients with unmethylated disease and is designed to determine the application of zotiraciclib in combination with radiation. Group B consists of First-Line patients with methylated disease and is designed to determine zotiraciclib use in combination with TMZ. Group C consists of patients with recurrent GBM and is single agent zotiraciclib intended to measure progression free survival at six months.

"We are very pleased to have been granted Orphan Drug Designation by the FDA and EMA for zotiraciclib in the treatment of glioma. These designations are important in the continued development of zotiraciclib and the ongoing clinical trials in the U.S. at the NCI and throughout Europe with the EORTC," said Scott Megaffin, Chief Executive Officer of Adastra. "Though rare, glioblastoma is one of the most devasting and difficult-to-treat cancers, urgently necessitating the development of new treatments with unique mechanisms of action. Data from the ongoing clinical trials of zotiraciclib have been encouraging and are suggestive of a therapy that is safe and capable of eliciting clinical benefit in high grade gliomas. We greatly look forward to reporting top-line data from the NCI Phase 1b study in early 2020, as well as completing enrollment in two of the EORTC study cohorts later in the year."

About Orphan Drug Designation
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. and not more than five in 10,000 in the E.U. Orphan Drug Designation provides important incentives, including marketing exclusivity upon approval and tax credits for qualified clinical testing, as well as fee exemptions and reductions.

Accelerate Diagnostics to Participate in 31st Annual Piper Jaffray Healthcare Conference in New York on December 4, 2019

On December 4, 2019 Accelerate Diagnostics, Inc. (NASDAQ: AXDX) reported that Larry Mehren, chief executive officer, will participate in a 25-minute question and answer session at the 31st Annual Piper Jaffray Healthcare Conference in New York on December 4, 2019 at 3:30 p.m. Eastern Time (Press release, ACCELERATED MEDICAL DIAGNOSTICS, DEC 4, 2019, View Source [SID1234551940]). Jack Phillips, chief operating officer, and Steve Reichling, the company’s chief financial officer, will accompany Mr. Mehren.

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A live audiocast of the session will be accessible through the company’s investor relations website at ir.axdx.com. A replay of the audiocast will be available for at least 30 days following the conference.