On June 9, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company that utilizes the latest biotechnology to discover and deliver novel medicines, reported clinical data from a Phase 1b study of zandelisib, an investigational selective phosphatidylinositol 3-kinase delta ("PI3K") inhibitor in clinical development for the treatment of B-cell malignancies, and the trial design of COASTAL, a Phase 3 study of zandelisib in combination with rituximab, will be highlighted in poster presentations at the 16th International Conference on Malignant Lymphoma (16-ICML) to be held June 18 – 22, 2021 (Press release, Kyowa Hakko Kirin, JUN 9, 2021, View Source [SID1234583766]).

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Details on the two e-poster presentations are included below:

Title: Zandelisib, a PI3Kδ Inhibitor on Intermittent Schedule (IS) in Follicular Lymphoma Patients who Progressed within 24 Months of First-Line Chemoimmunotherapy (POD24)
Authors: John Pagel, et. al.
Abstract ID: 113

Title: COASTAL: A Phase 3 Study of the PI3Kδ Inhibitor Zandelisib with Rituximab (R) versus Immunochemotherapy in Patients with Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma (iNHL)
Authors: Wojciech Jurczak, et. al.
Abstract ID: 262

The abstracts are available on the Wiley Online Library website. The e-poster presentations will be available on the MEI Pharma website on June 18, 2021.

On June 9, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company, reported that Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics, will participate in the BIO Digital Conference being held June 10-11 and 14-18, 2021 (Press release, Cytori Therapeutics, JUN 9, 2021, View Source [SID1234583765]).

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The Company’s presentation will be made available through the BIO Digital Conference website and available on demand to registered participants during the conference at View Source Following the conference, the presentation will be available under the Presentations tab of the Investors section of the Company’s website at www.plustherapeutics.com.

On June 9, 2021 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported an update on research and development efforts on its proprietary technology platform, XR-17 (Press release, Oasmia, JUN 9, 2021, View Source [SID1234583764]).

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In addition to building a strong clinical product pipeline in cancer indications, Oasmia is committed to enhancing XR-17 which can be applied to medicines used in many therapeutic areas.

Recent progress in research aiming to enhance the XR-17 drug delivery platform has been made as follows:

XR-18 – Enhancement of the XR-17 platform: XR-18 is a research and development effort based on the XR-17 technology platform intended to provide enhanced properties that improve clinical formulations and applications of active pharmaceutical ingredients (APIs) for cancer treatment. This effort has recently generated promising data including:

Addition of components to existing XR-17 formulation improving certain properties.
Synthesis of novel excipients exhibiting XR-17-like properties with enhanced stability characteristics. These modifications will be evaluated for feasibility in various drug formulations.

XR-19 – Encapsulation of multiple APIs: XR-19 is an enhancement of existing XR-17 features with new functionalities, specifically the encapsulation of multiple APIs in one micellar envelope. Recent proof-of-concept studies have shown novel capabilities of the XR-17 platform, demonstrating its potential for dual encapsulation of APIs. Subsequent research demonstrated the molecular makeup of the encapsulation, providing the basis for future development. The Company will move forward and explore applications in cancer and other indications.

The company is pursuing intellectual property enhancements for these opportunities.

Dr. Reinhard Koenig, Oasmia’s Chief Scientific Officer added, "Oasmia has a growing pipeline of oncology programmes in clinical development. Internal research intended to expand applications of Oasmia’s XR-17 technology platform is ongoing and showing progress. Depending on our ongoing research, we hope to add more options to our future oncology portfolio. We look forward to progressing the research programme and to reporting progress in the future."

On June 9, 2021 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), hereafter "Onxeo" or "the Company", a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR), in particular against rare or resistant cancers, reported that it has received from the U.S. Patent and Trademark Office (USPTO), a Notice Allowance for a patent which enhances in the United States the protection of AsiDNA, its first- in-class inhibitor of tumor DNA repair, in combination with any PARP inhibitor (PARPi) (Press release, Onxeo, JUN 9, 2021, View Source [SID1234583763]). This patent protects both the combination of AsiDNA with a PARPi and its use for the treatment of certain cancers for which the DNA repair pathway via homologous recombination (HR) is not impaired or deficient. These so-called HR-proficient tumors are significantly less sensitive to treatment with PARP inhibitors.

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This new patent completes, in a key territory, the already robust patent family protecting AsiDNA in combination with PARP inhibitors. It will provide a term of protection until 2036.

The DNA repair pathways, BRCA-dependent homologous recombination pathway and PARP pathway, are complementary and essential for tumor cell survival and proliferation. If one pathway is deficient (homologous recombination by BRCA mutation) and the other is blocked by a PARP inhibitor, the tumor cell dies. This deadly combination of two genetic mutations, called synthetic lethality, is a prerequisite to PARPi efficacy.

This patent is based on the fact that AsiDNA is able, through its original mechanism of action, to hinder DNA repair pathways, including the homologous recombination pathway. AsiDNA thus induces a context of "HR deficiency" needed by PARPi to be effective, regardless of the initial genetic context of the tumor.

"This patent represents a further recognition in the strategic US market of the very original properties of AsiDNA. We have already started the clinical demonstration that AsiDNA has the potential to reverse the resistance acquired to a PARP inhibitor, notably thanks to its effect on the drug-tolerant cells who play a key role on acquired resistance. The drug-induced synthetic lethality provided by AsiDNA opens an important new application to our lead product. Indeed, extending the efficacy of PARP inhibitors to the important group of HR-proficient patients could represent another major therapeutic opportunity," said Judith Greciet, Chief Executive Officer of Onxeo.

PARPi have demonstrated a real clinical benefit[1], particularly in the treatment of ovarian cancer with BRCA mutations, but this benefit is much reduced, or even insignificant, when homologous recombination remains active, which is the case in about 50% of patients[2].

[1] Moore et al. N Engl J Med 2018; 379:2495-2505

[2] Zeimet, A.G., Wieser, V., Knoll, K. et al. PARP inhibitors in the treatment of ovarian cancer. memo (Magazine of European Medical Oncology) 13, 198–201 (2020).

On June 9, 2021 NanOlogy, LLC, a clinical-stage oncology company, reported that additional data from its Phase 2 dose-rising and expansion clinical trial of intracystic NanoPac for mucinous cystic neoplasms of the pancreas were presented via poster by Somashekar Krishna, MD, MPH of The Ohio State University Wexner Medical Center and The James Comprehensive Cancer Center during Digestive Disease Week held virtually from May 21-23, 2021 (Press release, NanOlogy, JUN 9, 2021, View Source [SID1234583762]). NanoPac is composed of large surface area microparticles of pure paclitaxel designed as a drug depot for local administration and sustained drug release over several weeks. In this study, the investigational drug was delivered once or twice via endoscopic ultrasound guided fine needle injection following aspiration of cyst fluid in patients with branch duct intraductal papillary mucinous neoplasms (BD-IPMNs) or mucinous cystic neoplasms (MCNs).

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The 6-month trial enrolled 19 subjects and was completed in late 2020. The clinical study report was submitted to FDA in April 2021 and clinical trial results can be found at NCT03188991 in clinicaltrials.gov. Overall, the drug was well tolerated with no dose limiting toxicities or drug-related significant adverse events observed. Reduction in cyst volume was demonstrated in 14/19 (74%) of subjects at 6 months.

Dr. Krishna presented a series of five subjects enrolled at his clinical site in whom additional testing revealed no detectable DNA mutations in 2/4 subjects following NanoPac treatment, all of whom were positive at baseline. Absence of DNA indicates the possibility of cyst epithelial lining necrosis, a key goal in treatment. In addition, high concentrations of paclitaxel (>1000 ng/mL) were found in cyst fluid prior to the second injection at the 3-month timepoint confirming retention of NanoPac in the cyst while plasma concentrations were never greater than 3.5 ng/mL at any timepoint.

Large IPMNs or MCNs grow rapidly and are at high risk for progression to pancreatic cancer, one of the deadliest of all cancers. Surgery is recommended to eliminate the risk, but a significant number of patients refuse or cannot withstand surgery due to the associated morbidities. For these patients, there are few therapeutic options and no approved drug therapies. Additional studies of NanoPac are being considered to further evaluate its potential in these patients.

In addition to this trial, NanOlogy’s clinical programs are advancing in pancreatic, lung, genitourinary, and dermal cancers. Data from preclinical and clinical studies in a variety of solid tumors indicate persistent tumor kill, antitumoral immune response, and minimal local or systemic toxicity.

The NanOlogy large surface area microparticle (LSAM) therapeutic platform is based on a proprietary supercritical precipitation technology that converts taxane API crystals into stable LSAMs of pure drug for tumor-directed therapy and sustained drug release. The taxane particles are covered by composition of matter patents issued in the US (US 9,814,685, US 10,507,195, & US 10,993,927), Europe, Japan, and Australia all valid until 2036, plus applications pending globally. These composition of matter patents form the foundation of an extensive intellectual property portfolio protecting the investigational drugs, methods, and technology.