On August 12, 2020 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) reported preliminary data from the first out of two bioequivalence studies in healthy volunteers with its lead product candidate HyNap-Dasa (Press release, Xspray, AUG 12, 2020, View Source [SID1234649570]). The primary aim was to demonstrate bioequivalence for HyNap-Dasa compared to the reference product Sprycel. The first study did not fulfil statistical bioequivalence requirements due to high variability in pharmacokinetic parameters for the reference product Sprycel. A few subjects had very low absorption from Sprycel which was not observed for HyNap-Dasa. As these data with negligible absorption from Sprycel do not represent a clinically relevant treatment drug exposure, Xspray intends to discuss the results with the FDA before submitting the ANDA application.

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This first pivotal study with HyNap-Dasa was performed in 51 healthy volunteers under fasting conditions over a period of four weeks where each volunteer received two repeated single doses of HyNap-Dasa and Sprycel in a randomized cross-over design. Final results from full data analysis are expected in September. The second bioequivalence study, where the effect of food intake on the absorption is assessed, is ongoing and preliminary results are expected in the end of September. The totality of data from the two clinical studies will form the basis for the coming ANDA application.

"These first data indicate that formal bioequivalence criteria were not met which was mainly related to unusually poor absorption of dasatinib from the Sprycel formulation in a few subjects. We are now waiting for the final study report of this first study, as well as the preliminary data from the second study with food intake which is expected end of September. Both studies will form the basis for the ANDA application. Provided positive response from the FDA, we can still file at the end of the year." says Per Andersson, CEO of Xspray Pharma.

In addition to Xspray’s continued work towards an ANDA application based on the current and the ongoing study, Xspray will in parallel prepare for an additional bioequivalence study as a back-up. The validated manufacturing process enables this study to be initiated within 4 – 6 months.

"Since we have achieved bioequivalence earlier in two smaller studies, the outcome of this study was unexpected. We have analysed the results and have a good understanding of the factors that contributed to this outcome. We are planning to adjust the formulation in case the FDA decides that an additional study is needed. Alongside our efforts of getting the ANDA for HyNap-Dasa approved we are proceeding with the preparation of the next products in our portfolio as planned, an improved version of HyNap-Dasa and HyNap-Nilo, which both will follow the 505(b)(2) regulatory pathway. Furthermore, our planned business development efforts around HyNap-Dasa will progress according to plan," Per Andersson concludes.

An audiocast with the possibility to ask questions on the results is scheduled at 08:00 CEST on August 13 (audiocast will be held in Swedish): View Source 12, 2020

On August 12, 2020 Theralase Technologies Inc. ("Theralase" or "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds ("PDC") and associated drug formulations, reported that three out of four of its Canadian clinical study sites have re-commenced new patient enrollment and treatment in the Company’s Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study ("Study II") (Press release, Theralase, AUG 12, 2020, View Source [SID1234568619]).

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Specifically:

Study Site Location Site Status
University Health Network ("UHN") Toronto, Ontario Enrolling
London Health Sciences Centre ("LHSC"), London, Ontario Enrolling
Nova Scotia Health Authority ("NSHA") Halifax, Nova Scotia Enrolling
McGill University Health Centre ("MUHC") Montreal, Quebec COVID-19 Hold
On a go forward basis, all future and existing patients to be enrolled and treated (initial and second treatment) in Study II will be treated using the Study II treatment optimizations as communicated via press release on July 30, 2020, specifically:

Bladder volume calculation
Study drug volume calculation
Study device volume calculation
Study device treatment time
Four of the patients previously treated are awaiting second treatment subject to the clinical study site operating room availability. One additional patient is undergoing additional assessments prior to proceeding to second treatment.

The Company is in advanced discussions to launch a number of US based clinical study sites, subject to the United States economy recovering from the COVID-19 pandemic.

The US based Trial Management Organization ("TMO") could potentially launch 4 clinical study sites in 4Q2020 and commence Study II patient enrollment and treatment in 1Q2021.

Shawn Shirazi, Ph.D., Chief Executive Officer of Theralase stated, "Theralase is pleased that 3 out of 4 Canadian clinical study sites are open for new patient enrollment and treatment receiving the new optimized Study II treatment. The clinical data collected on the first twelve patients treated shows a favorable clinical response, which the Company expects will improve due to the implemented Study II treatment optimization."

About Study II

Study II utilizes the Therapeutic Dose (0.70 mg/cm2) of TLD-1433 and is focused on the enrollment and treatment of approximately 100 Bacillus Calmete Guérin ("BCG")-Unresponsive NMIBC patients presenting with Carcinoma In-Situ ("CIS") in approximately 20 clinical study sites located in Canada and the US.

Study II has a:

Primary endpoint of efficacy (defined by Complete Response ("CR")) at any point in time
Secondary endpoint of duration of CR at 360 days post-initial CR (approximately 450 days post initial Study treatment)
Tertiary endpoint of safety measured by incidence and severity of Adverse Events ("AEs") grade 4 or higher that do not resolve within 450 days post-initial treatment
"For single-arm trials of patients with BCG-unresponsive disease, the FDA defines a CR as at least one of the following:

Negative cystoscopy and negative (including atypical) urine cytology
Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology
For intravesical therapies without systemic toxicity, the FDA includes, in the definition of a CR, negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative.
Intravesical instillation does not deliver the investigational drug to the upper tract or prostatic urethra; therefore, the development of disease in these areas cannot be attributed to a lack of activity of the investigational drug. Thus, sponsors can consider patients with new malignant lesions of the upper tract or prostatic urethra, who have received intravesical therapy to have achieved a CR in the primary analysis; however, sponsors should record these lesions and conduct sensitivity analyses in which these patients are not considered to have achieved a CR."1

On August 12, 2020 PDL BioPharma, Inc. ("PDL" or the "Company") (Nasdaq: PDLI) reported it has entered into a settlement agreement (the "Settlement Agreement") with related entities of Defined Diagnostics, LLC (f/k/a Wellstat Diagnostics, LLC) ("Wellstat Diagnostics" and, together with such related entities, the "Wellstat Parties") resolving previously reported litigation relating to loans made to Wellstat Diagnostics by PDL (Press release, PDL BioPharma, AUG 12, 2020, View Source [SID1234565092]). The loans totaling $44,100,000 were made pursuant to a loan agreement between Wellstat Diagnostics and PDL dated August 2013, and the notes were carried on PDL’s balance sheet for $51,391,184 as of June 30, 2020.

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Under the terms of the Settlement Agreement, the parties agreed that the Wellstat Parties would pay an amount of $7,500,000 upon the signing of the Agreement and either (1) $5,000,000 by February 10, 2021 and $55,000,000 by July 26, 2021; or (2) $67,500,000 by July 26, 2021. Further under the terms of the Agreement, upon payment of either $5,000,000 prior to April 21, 2021 or completion of the payment of $67,500,000 by July 26, 2021, the Company will transfer to Wellstat Diagnostics on an "as is" and "where is" basis certain assets currently owned by the Company which were obtained through the Company’s credit bid in 2017 for the assets of Wellstat Diagnostics. If the Wellstat Parties fail to make payment in full by July 26, 2021, the Company shall be authorized to record and confess judgment against the Wellstat Parties for an amount of $92,500,000 or such lesser amount as may be owed under the Agreement.

"We are pleased that we have finally reached this settlement with the Wellstat parties. We look forward to receiving the agreed payments, which should increase the net proceeds from our monetization strategy that we can ultimately distribute to our stockholders," commented PDL’s President and CEO Dominique Monnet. "I commend our legal team, led by our General Counsel Christopher Stone, for their dedication and persistence."

In September 2019, PDL announced that the Supreme Court of New York County of New York, Commercial Division, issued a summary judgment in favor of PDL in the Company’s litigation with Wellstat Diagnostics recognizing the validity and enforceability of guarantees on the loans made by the guarantors under the loan facility.

On August 12, 2020 GeneCentric Therapeutics reported it has entered into a research collaboration with Janssen Research & Development, LLC (Janssen) around RNA-based drug response biomarkers for non-muscle invasive bladder cancer (NMIBC) (Press release, GeneCentric Therapeutics, AUG 12, 2020, View Source [SID1234564816]). The research will involve the application of GeneCentric’s advanced RNA-based molecular profiling platform to elucidate potential signatures of disease progression and drug response to standard of care therapy, including the role of genomic alterations in the fibroblast growth factor receptor (FGFR). Financial terms were not disclosed.

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While cancer subtypes identified in the setting of metastatic urothelial carcinoma (mUC) have been associated with disease risk and potential therapeutic response, there is a paucity of such characterization in the area of NMIBC to potentially inform clinical decision making. The application of GeneCentric’s RNA-based gene-expression signatures have potential to identify relevant NMIBC subtypes and markers of response to potential therapeutic options. FGFR genomic alterations are among the more common tumor mutations in these patients.

"We look forward to continued deployment of our suite of RNA-based genomics analysis solutions in this collaboration as we explore the potential role of FGFR in NMIBC," said Dr. Mike Milburn, President and CEO of GeneCentric Therapeutics. "This study comes on the heels of the retrospective analysis of mUC patients that were presented earlier this year at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium."

Specifically, the research collaboration aims to deepen tumor genomic and immune microenvironment insights in the setting NMIBC patients utilizing GeneCentric’s RNA-based tumor bioinformatics technology, including the Bladder Cancer Subtype Profiler (BCSP), pan-cancer diagnostics, cancer antigen discovery, immunogenomic biomarkers, and prototype FGFR activation gene signatures.

On August 12, 2020 Targovax ASA (OSE: TRVX) reported that it will announce its second quarter and first half 2020 results on Thursday 20 August 2020 (Press release, Targovax, AUG 12, 2020, View Source [SID1234564006]). An online presentation by Targovax’s management to investors, analysts and the press will take place at 10:00am CET.

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The results report and the presentation will be available at www.targovax.com in the Investors section from 7:00am CET.

Presentation

As a consequence of the Corona situation, there will only be a virtual presentation of the results with a live webcast 20 August at 10.00am CET. You can join the webcast here. It will be possible to ask questions during the presentation.