On June 21, 2022 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds ("PDC") and their associated drug formulations intended to safely and effectively destroy various cancers reported that Theralase’s Phase Ib Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study ("Study") has been peer reviewed and published in the European Urology Open Science ("EUOS") Journal, Volume 41, July 2022 (Press release, Theralase, JUN 21, 2022, View Source [SID1234616125]).

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According to EUOS’s website, EUOS is dedicated to the publication of high quality, innovative research that will benefit patients with urological conditions. EUOS covers research in the urological field, including clinical, basic and translational research.

The publication can be accessed online at no charge at:

https://www.sciencedirect.com/science/article/pii/S2666168322005900

The publication states, "Despite efforts to bring new treatment strategies forward for Bacillus Calmette Guérin ("BCG")-Unresponsive NMIBC, a clear consensus for a standard treatment other than radical cystectomy has yet to be established. An effective therapy that provides a high initial and durable responses remains an unmet need."

The publication is entitled, "A Phase 1b Clinical Study of Intravesical Photodynamic Therapy in Patients with Bacillus Calmette-Guérin–unresponsive Non–muscle-invasive Bladder Cancer" and states, "Although limited by the small sample size typically inherent in phase 1 trials, we feel that the photosensitizer TLD-1433 and the delivery device TLC-3200 hold promise for the treatment of NMIBC. In this study, Photo Dynamic Therapy ("PDT") was well tolerated and demonstrated safety and potential efficacy, thus warranting further study."

As a result, the Medical and Scientific Advisory Board ("MSAB") unanimously agreed that Theralase should further investigate PDT in a multi-site, pivotal Phase II NMIBC Clinical Study ("Study II"). Study II is currently underway at 5 Clinical Study Sites ("CSS") in Canada and 7 CSSs in the United States, with 41 patients treated to date.

Girish Kulkarni, M.D., Ph.D., lead principal investigator of the Study at the Divisions of Urology and Surgical Oncology, Department of Surgery, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada ("UHN") stated, "I am delighted that the high-quality research conducted at UHN, in conjunction with Theralase, was successful, in this challenging patient population, both for safety and potential efficacy. Patients with BCG-Unresponsive NMIBC are a difficult patient population to treat since they have unfortunately failed the standard of care, BCG. Many also failed other investigational therapies prior to being treated with Theralase’s PDT. The clinical data that we collected was robust and clinically relevant. I am fully supportive of the multi-site Phase II NMIBC clinical study, currently in progress, to further investigate the role of PDT in BCG-Unresponsive NMIBC."

Dr. Arkady Mandel M.D., Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer of Theralase stated "The Company is very pleased to share the Study clinical data that has been peer-reviewed and published in EUOS. Indeed, the publication of clinical results in a peer reviewed journal like EUOS validates the quality of the Theralase research and the professionalism of the clinical study team, who conducted it. As a direct result of the success of this initial Study, Theralase elected to undertake Study II, which I am happy to report is proceeding well. I am encouraged by the clinical data generated to date with intravesical TLD-1433, activated by laser light therapy, as I believe Theralase’s PDT is a viable alternative for the BCG-Unresponsive NMIBC patient population, although significant data is still pending. The ongoing analysis of the patients supports that up to 50% of evaluable patients (patients who have been clinically assessed by the principal investigators at study visits and whose response to a treatment can be measured because enough information has been collected) have achieved the primary study objective. We are grateful for the ongoing support to all clinical and technical personnel involved in the successful completion of the Study and in the strong clinical data collected to date for Study II. Based on the strength of the clinical data collected and the consistently high safety and efficacy profile of Theralase’s PDT, I am confident that TLD-1433-based therapy has the potential to become the next gold-standard in the treatment of BCG-Unresponsive patients."

About Study I

The Study’s primary objective was safety and tolerability of PDT, with a secondary objective of pharmacokinetics ((drug evacuation from the body)) and a tertiary objective of efficacy (CR primarily at 90 and secondarily at 180 days for patients treated at the maximum recommended starting dose (0.35 mg/cm2 ) and the therapeutic dose (0.70 mg/cm2)). Patients who were treated at the therapeutic dose, consented to be followed clinically for 18 months, post initial treatment.

About Study II

Study II utilizes the therapeutic dose of TLD-1433 (0.70 mg/cm 2 ) activated by the proprietary TLC-3200 medical laser system. Study II is focused on enrolling and treating approximately 100 to 125 BCG-Unresponsive NMIBC Carcinoma In-Situ ("CIS") patients in up to 15 CSSs located in Canada and the United States.

Study II Objectives:

Primary – Efficacy (defined by CR) at any point in time.
Secondary – Duration of CR (defined by duration of CR lasting a minimum 360 days post-initial CR).
Tertiary – Safety measured by incidence and severity of AEs Grade 4 or higher that do not resolve within 450 days post primary study treatment. (Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Serious, Grade 4 = Life Threatening and Grade 5 = Death)
About TLD-1433

TLD-1433 is a patented PDC with over 10 years of published peer-reviewed preclinical and clinical research and is currently under investigation in Study II.

On June 21, 2022 Brand Institute reported that having worked with Adello Biologics (acquired by Kashiv Biosciences in 2019) in developing the brand name FYLNETRA (pegfilgrastim-pbbk), for an injection used to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia (Press release, Brand Institute, JUN 21, 2022, View Source [SID1234616141]). In addition to working on the brand name, Brand Institute also partnered with Adello Biologics in developing the suffix "pbbk" for the non-proprietary name for FYLNETRA, pegfilgrastim-pbbk.

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FYLNETRA was developed by Kashiv Biosciences in collaboration with Amneal Pharmaceuticals. FYLNETRA is the most recent pegfilgrastim biosimilar approved by the FDA.

"The entire Brand Institute and Drug Safety Institute team congratulates Kashiv Biosciences and Amneal Pharmaceuticals on the FDA approval for FYLNETRA," said Brand Institute’s Chairman and C.E.O., James L. Dettore.

On June 21, 2022 Ashvattha Therapeutics ("Ashvattha"), a clinical-stage company developing novel hydroxyl dendrimer therapeutics, reported a poster presentation of preclinical data demonstrating the potential of hydroxyl dendrimer therapeutics (HDTs) to reduce toxicity in the targeted treatment of plexiform neurofibroma, a slow-growing tumor associated with neurofibromatosis type 1 (NF1), at the 2022 Neurofibromatosis (NF) Conference hosted by the Children’s Tumor Foundation and taking place at Loews Philadelphia Hotel in Philadelphia, PA, June 18–21, 2022 (Press release, Ashvattha Therapeutics, JUN 21, 2022, View Source [SID1234616126]).

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The data was presented by Emma C. Mazurek, a scientific collaborator at Indiana University School of Medicine, in a poster titled, "Hydroxyl Dendrimer Therapeutics Reduce Toxicity in Targeted Delivery to Plexiform Neurofibroma."

The study investigated the uptake of HDs varying in size. The data showed selective uptake of HDs only by tumor associated macrophages and microglia, but not adjacent neurons, in an NF1-associated PNF mouse model. Notably, the smaller HD (~14 kDa) showed greater uptake in tumor associated macrophages and microglia, than the larger HD (~56 kDa). In vivo evaluation of HD therapeutics is currently underway in an NF1 mouse model of PNF to assess efficacy as measured by a reduction in tumor burden. These results lay the groundwork for future HD therapies towards treatment of NF1-associated PNF.

"Systemic toxicity remains a challenge in treating PNF, limiting the use of pharmacologic agents. These results suggest that by conjugating drugs to HDs there’s potential to improve safety and reduce toxicity associated with current treatments for NF. HDs allow for the uptake of highly toxic drugs specifically in immune cells within the PNF microenvironment impairing tumor growth," said Jeffrey Cleland, Ph.D., Chairman, CEO and President of Ashvattha Therapeutics. "Studies are currently underway to evaluate novel HDTs in this mouse model of disease to further demonstrate the potential of HDTs in NF1-associated PNF."

Chronic activation of macrophages and microglia plays a critical role in the progression of many neurological diseases, including NF1. Due to the high inoperability of neurofibromas, pharmacological therapeutics are the main strategy in treatment. Current therapies cause systemic toxicity that is not tolerated by patients leading to discontinuation of treatment. For patients with NF1, there is a need for safer treatments to achieve greater efficacy and durability. Previous data suggests that the combined targeting of tumorigenic pathways and immunosuppressive cells within the PNF tumor microenvironment (TME) may be an effective strategy to overcome these challenges. HDs can be conjugated to more than one drug, enabling one HDT to affect multiple pathways.

About Neurofibromatosis Type 1 (NF1)
NF1 is the most common cancer predisposition syndrome. It is characterized by changes in skin coloring (pigmentation) and the growth of tumors along nerves in the skin, brain, and other parts of the body known as plexiform neurofibromas (PNF). According to the American Academy of Pediatrics, NF1 is one of the most common inherited disorders affecting 1 in every 3000 individuals. The signs and symptoms of this condition vary widely among affected people. Current treatments are limited and somewhat effective in reducing tumor gral trials. HDTs provide a novel approach to treating tumors in their specificity to tumor-associated macrophages (TAMs), further differentiating Ashvattha’s precision medicine approach.

On June 21, 2022 G42 Healthcare, an Abu Dhabi-based leading health tech company and subsidiary of G42, an artificial intelligence and cloud computing company located in Abu Dhabi reported that it has signed a letter of intent (LOI) with global biopharmaceutical company, AstraZeneca, in presence of the Department of Health – Abu Dhabi (DoH), the regulator of the healthcare sector in the emirate of Abu Dhabi aiming to expand their collaboration into the domains of diagnostics and clinical research, providing access to innovative solutions and treatments for patients in the United Arab Emirates and beyond (Press release, AstraZeneca, JUN 21, 2022, View Source [SID1234616142]).

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Left to right – Ghaleb Al Ahdab Government Affairs, Associate Director Gulf at AstraZeneca, Hicham Mirghani, Corporate Affairs Director GCC at AstraZeneca, Dr. Asma Al Mannaei, Executive Director, Research and Innovation Centre at DoH, Dr. Fahed Al Marzooqi, Chief Operating Officer at G42 Healthcare, Francesco Redivo Senior Director at G42 Healthcare
Left to right – Ghaleb Al Ahdab Government Affairs, Associate Director Gulf at AstraZeneca, Hicham Mirghani, Corporate Affairs Director GCC at AstraZeneca, Dr. Asma Al Mannaei, Executive Director, Research and Innovation Centre at DoH, Dr. Fahed Al Marzooqi, Chief Operating Officer at G42 Healthcare, Francesco Redivo Senior Director at G42 Healthcare
Witnessed by Dr. Asma Al Mannaei, Executive Director, Research and Innovation Centre at DoH, Hicham Mirghani, Corporate Affairs Director GCC at AstraZeneca and Dr. Fahed Al Marzooqi, Chief Operating Officer at G42 Healthcare, the agreement was signed by Ghaleb Al Ahdab Government Affairs, Associate Director Gulf at AstraZeneca, and Francesco Redivo Senior Director at G42 Healthcare during the BIO International Convention held in San Diego, California.

G42 Healthcare and AstraZeneca initially signed a Declaration of Collaboration in December 2021. This agreement further expands on their partnership to build local research capabilities, conduct RWE / clinical trials in UAE and localize Oncology biomarkers testing in UAE.

Ashish Koshy, CEO of G42 Healthcare, said, "We value collaboration and believe the strategic partnership with AstraZeneca will yield incredible growth for the healthcare ecosystem. We are proud to align ourselves with these organizations to generate new treatments and technologies to solidify the UAE’s place as a global hub for life sciences, medical tourism and innovation."

Hicham Mirghani, Corporate Affairs Director GCC, AstraZeneca said, "We are excited about expanding our existing partnership with G42 Healthcare to further advance the healthcare sector in the country and region. There is no doubt that innovation is key to healthcare advancements, and we are eagerly looking forward to collaboratively exploring greater possibilities in clinical research and diagnostics, enabling us to together create a more patient-centric healthcare offering in the UAE."

On June 21, 2022 xCures, Inc., reported their partnership with Novocure with the intent to develop the first comprehensive, longitudinal Quality of Life (QoL) dataset for glioblastoma (GBM) patients (Press release, xCures, JUN 21, 2022, View Source [SID1234616127]). The alliance between both oncology companies will leverage xCures’ novel, patient-centric platform and deep connections to GBM patient and provider communities through direct engagement with GBM patients, unique partnerships with advocacy groups such as the Musella Foundation, and the offering of valuable services such as cancer history structuring and treatment options research.

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"We are delighted to team up with Novocure and see our extensive real-world data from GBM patients applied towards developing a time series analysis of QOL in GBM," said Mika Newton, CEO of xCures. "As a patient-centric company, we look forward to the outputs of this partnership and to seeing how they improve Quality of Life for those with this devastating cancer."

Participants enrolled in xINFORM are invited weekly to complete the EuroQol 5-Dimension (EQ-5D-5L) QoL survey. The survey results provided by patients will allow for time series analysis of QoL in GBM. Over the coming year, Novocure and xCures will generate QoL data for 250 patients and integrate it with regulatory-compliant longitudinal outcomes data.