On May 31, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported the acquisition of a targeted nanobody platform to its Discovery pipeline (Press release, Clarity Pharmaceuticals, MAY 31, 2022, View Source [SID1234615238]). The intellectual property, including a provisional patent and know-how, has been acquired from leading nanotechnology researcher Dr Kurt Gehlsen, who developed the technology for a maximum consideration of 400,000 options over Clarity Pharmaceuticals shares with a strike price of $1.40 together with cash consideration of up to US$250,000. Both the cash consideration and options are subject to certain provisions that relate to the achievement of development milestones for new products. In addition, Dr Gehlsen has joined the Company as a consultant to help drive the new nanobody program forward within Clarity.

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Nanobodies are attractive targeting molecules which can be engineered to bind to a wide range of cancers. The nanobody platform allows the development of high affinity products suitable for targeting receptors specific to cancer cells. By only targeting cancer cells and not healthy cells, this approach aims to kill cancer cells while limiting the side effects elsewhere in the body.

The nanobody platform adds exciting new opportunities to Clarity’s Targeted Copper Theranostics (TCTs) Discovery pipeline. Dr Gehlsen will work with Clarity’s R&D team to combine the platform with the Company’s proprietary SAR Technology and advance it from the lab, through preclinical studies and into clinical development.

Dr Gehlsen commented, "Clarity’s proprietary SAR Technology is ideally positioned to fully exploit the benefits of the nanobody platform. In combination with copper-64 for imaging and copper-67 for therapy, we are hoping to achieve high accuracy and high precision of the nanobody-based targeted radiopharmaceuticals for the diagnosis and treatment of a range of cancers. I look forward to working together with the Clarity team on progressing this technology through the preclinical studies and into clinical development".

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "Clarity has always built its TCT products from the ground up, and the addition of targeted theranostic (diagnostic and therapeutic) nanobodies directed to novel cancer targets in combination with our proprietary SAR Technology is a logical step for our platform. The introduction of the nanobody platform solidifies Clarity as a pioneering developer of next-generation radiopharmaceuticals and will launch a new class of Targeted Copper Theranostics to our development pipeline, aiming to make the safest and most effective treatments to address unmet clinical needs in the large oncology market in a scalable and sustainable manner. We are excited to now have additional capability to develop further cutting-edge theranostics with Dr Gehlsen’s nanobody platform and streamline their development into clinical trials."

Dr Gehlsen’s academic experience is focused on cancer research and he held positions as an Associate Professor at the Sidney Kimmel Cancer Center, as an Associate Staff Scientist at the California Institute for Biological Research and as Founder, Vice President (VP) and Chief Operating Officer at the La Jolla Institute for Experimental Medicine. Dr Gehlsen has published over 140 manuscripts, book chapters and meeting abstracts and has over 100 patents and patent applications.

Previously, he was VP and Chief Scientific Officer (CSO) at Research Corporation Technologies, Inc. (RCT) Tucson, AZ., an investment and development company focused on early-stage technologies in the life sciences. He was Senior VP, Development and CSO at Maxim Pharmaceuticals, a public biopharmaceutical company that developed and launched Ceplene, the first immune counter-suppression therapeutic as a remission maintenance therapy for acute myeloid leukaemia. Dr Gehlsen was also Director of Research in the Experimental Medicine Division of Pharmacia, AB., Sweden, and La Jolla, CA, and was a Postdoctoral Fellow and Research Associate at the Sanford Prebys Burnham Institute.

This announcement has been authorised for release by the Executive Chairman.

On May 30, 2022 The board of directors of HBM Holdings Limited reported that the Company has commenced collaborations on antibody-drug conjugate ("ADC") projects with LegoChem Biosciences Inc. ("LegoChem Biosciences" or "LCB") and Duality Biotherapeutics ("Duality Biologics") as part of the Company’s ADC development and collaboration strategy (Press release, Harbour BioMed, MAY 30, 2022, View Source [SID1234628154]).

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In 2022, the Company entered into a collaboration agreement with Duality Biologics, pursuant to which the Company shall grant the exclusive rights of its monoclonal antibodies for specific tumor to Duality Biologics to develop the world’s first-in-class ADCs based on Duality Biologics’ Duality Immune Toxin Antibody Conjugate platform.

The Company also entered into a license agreement with LegoChem Biosciences in 2022, over an antibody for ADC. The agreement also contemplated that the contracting parties may collaborate in developing the ADC for therapeutic applications.

Pursuant to the license agreements and subject to the terms and conditions thereof, the Company shall receive upfront payments, milestone payments and sales-based royalties. The Company believes that the aforementioned collaborations will contribute further to the Harbour Mice platform’s ADC Ecosphere with the Company’s other industrial leading partners such as MediLink Therapeutics and Kelun-Biotech.

On May 30, 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 PhotoDynamic Compounds ("PDC") and their associated drug formulations intended to safely and effectively destroy various cancers reported that it has released the Company’s unaudited 1Q2022 condensed interim consolidated Financial Statements ("Financial Statements") (Press release, Theralase, MAY 30, 2022, View Source [SID1234615268]).

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(1) Other represents gain from legal settlement, (gain) loss on foreign exchange, interest accretion on lease liabilities and interest income

Total revenue increased 70%, year over year, and is primarily attributed to the anticipated Canadian and US economic recovery from the COVID-19 pandemic in 2020 and 2021.

Cost of sales for the three-month period ended March 31, 2022 was $120,430 or 57% of revenue resulting in a gross margin of $91,232 or 43% of revenue. In comparison, the cost of sales in 2021 was $74,463 or 60% of revenue resulting in a gross margin of $50,320 or 40% of revenue. The gross margin increase, as a percentage of sales, year over year, is primarily attributed to a decrease in labour and material costs.

Selling expenses for the three-month period ended March 31, 2022, decreased to $87,640, from $95,780 in 2021, an 8% decrease. The decrease in selling expenses is primarily attributed to the COVID-19 pandemic, resulting in reduced advertising (48%), and salaries (8%).

Administrative expenses for the three-month period ended March 31, 2022, decreased slightly to $418,087 from $418,454 in 2021, a 1% decrease. The decrease in administrative expenses is primarily attributed to decreased spending in administrative salaries (4%) and insurance expenses (8%). Stock based compensation expense decreased 61% in 2022 due to a reduction in stock options granted.

Net research and development expenses for the three-month period ended March 31, 2022, increased to $1,298,035 from $589,567 in 2021, a 120%. The increase in research and development expenses for the three-month period ended March 31, 2022, is primarily attributed to the costs related to Study II. Research and development expenses represented 72% of the Company’s operating expenses and represents investment into the research and development of the Company’s ACT technology.

The net loss for the three-month period ended March 31, 2022 was $1,701,489 which included $99,600 of net non-cash expenses (i.e.: amortization, stock-based compensation expense and foreign exchange gain/loss). This compared to a net loss in 2021 of $919,093 which included $179,925 of net non-cash expenses. The ACT division represented $1,436,985 of this loss (84%) for the three-month period ended March 31, 2022.

The increase in net loss is primarily attributed to Increased spending in research and development expenses in Study II.

Operational Highlights:

1. Break Through Designation Update. In 2020, the FDA granted Theralase Fast Track Designation ("FTD") for Study II. As a Fast Track designee, Theralase has access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure the timely collection of clinical data to support the approval process. FTD can also lead to Break Through Designation ("BTD"), Accelerated Approval ("AA") and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD to represent a complete clinical dataset on approximately 20 to 25 patients enrolled, treated and followed-up, who demonstrate significant safety and efficacy clinical outcomes.

In 2021, Theralase completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 day assessment for 25 patients, expected in 4Q2022, subject to the Clinical Study Sites ("CSS") availability to complete all required assessments.

2. COVID-19 Pandemic Update. In the ACT division, the Company continues to experience delays in patient enrollment and treatment rates in Study II due to the ongoing COVID-19 pandemic; however, these rates have improved as Canada and the US commence their recovery from the business and economic impacts of the COVID-19 pandemic.

In the CLT division, the Company continues to experience variations in sales and the timing of these sales due to the ongoing COVID-19 pandemic and has taken actions to minimize expenses by eliminating non-essential personnel and imposing a temporary hiring freeze commencing in March 2020. The Company lifted the temporary hiring freeze in 4Q2021, now that the Canadian and United States ("US") economies have started to demonstrate a sustainable business and economic recovery from COVID-19.

3. Clinical study site status and update. The Company has successfully launched five CSS in Canada and seven CSSs in the US that are open for patient enrollment and treatment for a total of 12 CSSs.

To date, the phase II NMIBC clinical study has enrolled and provided the primary study treatment for 38 patients (including three patients from Phase Ib study treated at the Therapeutic Dose) for a total of 41 patients.

An analysis of Evaluable Patients (defined as patients who have been evaluated by the principal investigator and thus excludes data pending), Study II clinical data provides the following interim analysis:

For all Evaluable Patients, who achieved a CR at 90 days, 88% demonstrate that CR at 180 days, 69% at 270 days, 50% at 360 days and 56% at 450 days, demonstrating a strong duration of complete response.

Note: The current interim data analysis presented above should be read with caution, as the clinical data is interim in its presentation, as Study II is ongoing and new clinical data collected may or may not continue to support the current trends, with significant data still pending.

For a more comprehensive analysis of the interim data please refer to Managements Discussion and Analysis ("MD&A") for the three-month period ended March 31, 2022.

4. Additional cancer indications. The Company has demonstrated significant anti-cancer efficacy of Rutherrin, when activated by laser light or radiation treatment across numerous preclinical models; including: Glio Blastoma Multiforme ("GBM") and Non-Small Cell Lung Cancer ("NSCLC"). The Company has commenced Non – Good Laboratory Practices ("GLP") toxicology studies with Rutherrin in animals to help determine the maximum recommended human dose of the drug when administered systemically into the human body, via intravenous injections. Theralase plans to commence GLP toxicology studies in animals in 4Q2022.

5. COVID-19 Research Update. In April 2021, Theralase executed a Collaborative Research Agreement ("CRA") with the National Microbiology Laboratory, Public Health Agency of Canada ("PHAC") for the research and development of a Canadian-based SARS-CoV-2 ("COVID-19") vaccine. Under the terms of the agreement, Theralase and PHAC are collaborating on the development and optimization of a COVID-19 vaccine by treating the SARS-CoV-2 virus grown on cell lines with Theralase’s patented PDC and then light activating it with Theralase’s proprietary TLC-3000A light technology to inactivate the virus and create the fundamental building blocks of a COVID-19 vaccine. This inactivated virus would then be purified and used to inoculate naive animals followed by challenge with the SARS-CoV-2 virus, to ascertain the efficacy of the vaccine. The project is entitled, "Photo Dynamic Compound Inactivation of SARS-CoV-2 Vaccine" and commenced in mid-April 2021.

In February, 2022 Theralase reported that PHAC had demonstrated that light-activated TLD-1433, was effective in rapidly inactivating the SARS-CoV-2 virus by up to 99.99%, compared to control in an in vitro study. Further research is required to confirm these findings.

These results have now laid the groundwork for the next phase of the CRA, which is evaluating the Theralase COVID-19 vaccine in the ability to prevent animals from contracting COVID-19, when exposed to the virus, which is expected to commence in 2Q2022 and be completed by 4Q2022.

Note: The Company does not claim or profess that they have the ability to treat, cure or prevent the contraction of the COVID-19 coronavirus.

About Study II
Study II utilizes the therapeutic dose of TLD-1433 (0.70 mg/cm2) 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 Clinical Study Sites ("CSS") located in Canada and the United States.

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

On May 30, 2022 Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, reported that new biomarker data from patients treated with bexmarilimab as part of the ongoing phase I/II MATINS (Macrophage Antibody to Inhibit Immune Suppression) trial, will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting being held in Chicago, US from June 3 – 7 (Press release, Faron Pharmaceuticals, MAY 30, 2022, View Source [SID1234615233]). These data (Abstract #2645) will be featured in the "Developmental Therapeutics—Immunotherapy" session on Sunday, June 5, 2022 at 9:00 AM EDT.

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The MATINS trial is investigating the safety and efficacy of bexmarilimab as a monotherapy in patients with solid tumors who have exhausted all treatment options. Faron’s wholly-owned novel precision cancer immunotherapy targets Clever-1, a receptor known to be expressed on immunosuppressive macrophages in the tumor microenvironment. Bexmarilimab works by converting highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages, which activates antigen presentation and promotes interferon gamma secretion by leukocytes. This can turn "cold" tumors into "hot" tumors; allowing the immune system to recognize and target cancer cells.

The biomarker analysis shows that the tumors of patients benefiting from bexmarilimab treatment expressed low levels of PD-L1 – a patient group that generally does not receive benefit from or is ineligible for treatment with currently approved checkpoint inhibitors. Median PD-L1 Combined Positive Score (CPS) was 1 (range 0-2) in patients that benefitted from bexmarilimab. The PD-L1 CPS score was 5 (range 0-100) for patients who did not benefit from bexmarilimab treatment. Further, the analysis showed that patients with higher levels of Clever-1 positive intra-tumoral cells were more likely to experience a clinical benefit when treated with bexmarilimab [15% vs 3%, respectively; p=0.038].

"While the arrival of currently available checkpoint inhibitors was, undoubtedly, one of the most exciting breakthroughs in cancer care, their low response rate in most tumor types continues to hinder their clinical application," said Petri Bono, MD, PhD., Chief Medical Officer, Terveystalo Finland and Principal Investigator of the MATINS trial. "There remains an urgent need for effective new treatment options, including novel assets that work synergistically with existing checkpoint inhibitors to ignite and amplify the patient’s immune response."

These data build on Faron’s continued research to identify the patient population most likely to benefit from bexmarilimab treatment and follow the Company’s earlier findings, announced in December 2021, that patients with low baseline serum levels of serum interferon gamma (IFNy) and tumor necrosis factor alpha (TNFa) were more likely to experience clinical benefit following treatment with bexmarilimab. Those patients with immunologically cold tumors also exhibited an ignition of immune response, as indicated by increased levels of IFNy following therapy, which suggests bexmarilimab may serve as a catalyst for the immune system allowing initially checkpoint inhibitor resistant or ineligible patients to become responsive to PD-1 blockade.

"Using a validated staining technique, these preliminary biomarker analyses indicate that bexmarilimab treatment may benefit patients whose tumors express low levels of PD-L1 and higher levels of CLEVER-1 positive intra-tumoral cells, which is opposite to what is usually seen with checkpoint inhibitors and other T cell activating agents," said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. "We are encouraged by this data as it furthers our belief that bexmarilimab has the potential to bring the promise of immunotherapy to a much broader patient population both as a monotherapy and in combination with currently approved anti-PD-1/L1 therapies."

About Bexmarilimab

Bexmarilimab is Faron’s wholly-owned, investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid cell function. A novel anti-Clever-1 humanised antibody, bexmarilimab targets Clever-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumour associated macrophages (TAMs) in the tumour microenvironment, converting these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. In mouse models, bexmarilimab has successfully blocked or silenced Clever-1, activating antigen presentation and promoting interferon gamma secretion by leukocytes. Additional pre-clinical studies have proven that Clever-1, encoded by the Stabilin-1 or STAB-1 gene, is a major source of T cell exhaustion and involved in cancer growth and spread. Observations from clinical studies to date indicate that Clever-1 has the capacity to control T cell activation directly, suggesting that the inactivation of Clever-1 as an immune suppressive molecule could be more broadly applicable and more important than previously thought. As an immuno-oncology therapy, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

About MATINS

The MATINS (Macrophage Antibody To INhibit immune Suppression) study is a first-in-human open label phase I/II clinical trial investigating the tolerability, safety and efficacy of bexmarilimab in ten different hard-to-treat metastatic or inoperable solid tumour cohorts – cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid carcinoma – which are all known to host a significant number of Clever-1 positive tumour-associated macrophages (TAMs). The completed Part I of the trial dealt with tolerability, safety and dose escalation. The ongoing Part II is focused on identifying patients who show an increased number of Clever-1 positive TAMs and exploring safety and efficacy. Part III will be focused on assessing efficacy. Data from MATINS have shown that bexmarilimab has the potential to be the first macrophage immune checkpoint therapy. To date, the investigational therapy has been shown to be safe and well-tolerated, making it a low-risk candidate for combination with existing cancer therapies, and has demonstrated early signs of clinical benefit in patients who have exhausted all other treatment options.

On May 30, 2022 Sirnaomics Ltd. (the "Company" or "Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported the launch of a Phase I clinical trial of the Company’s siRNA (small interfering RNA) drug candidate, STP705, in adults undergoing abdominoplasty for submental fat reduction (Press release, Sirnaomics, MAY 30, 2022, View Source [SID1234615232]). This study is the first application for Sirnaomics to apply an RNAi therapeutic candidate for medical cosmetology treatment.

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The global non-invasive fat reduction market size was valued at USD1.1 billion in 2021 and is anticipated to register a compound annual growth rate (CAGR) of 16.1% from 2022 to 2030, up to approximately USD4.0 billion (Grand View Research). Non-invasive fat reduction is a procedure that is done to decrease or eliminate stubborn fat pockets in specific areas of the body by using methods like cryolipolysis, radio frequency, and laser lipolysis. Non-invasive devices that are used in these procedures to permanently abolish fat cells are approved by the U.S. Food and Drug Administration (FDA) as their efficiency and safety have been tested and the results have been proven to show significant results. However, the market is currently dominated by devices that have mild therapeutic effects and require multiple treatment sessions. Sirnaomics will initially focus on the use of STP705 for submental fat reduction.

The dose-ranging, randomized, double-blind, vehicle-controlled study will enroll 10 patients to evaluate the safety and tolerability of STP705, which will be delivered via subcutaneous injection. The primary endpoints are to assess injection comfort, characterize local and systemic safety, and evaluate histological changes of subcutaneous doses of STP705, and to compare the safety and tolerability of three different concentrations of STP705 to select dosages for future studies.

"Submental fullness is a common condition that is resistant to diet and exercise and is influenced by multiple factors including aging and genetics," said Sirnaomics Executive Director and Chief Medical Officer Michael Molyneaux M.D. "Our goal in expanding our applications of STP705 with this study is to examine the safety and efficacy of this treatment in patients who are undergoing abdominoplasty. We hope to use the information from this study to expand into the treatment of submental fat reduction and other areas of non-invasive fat sculpting. This Phase I study will serve as a blueprint for future studies of STP705 in the medical aesthetics category."

"The current devices and procedures for non-invasive fat reduction have mild therapeutic effects, and require multiple and sometimes challenging treatment sessions, which are costly for patients and don’t always achieve the desired results," said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics. "Based on a discovery from our previous clinical study and a series of preclinical evaluations with animal models, we decided to expand STP705 therapeutic application into medical aesthetics with this Phase I study."

About STP705

Sirnaomics’ leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX2 gene expression. The product candidate has received multiple IND approvals from both the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC). STP705 is currently in five clinical trials for different indications: a Phase IIa for squamous cell carcinoma in situ (isSCC), a Phase II for basal cell carcinoma (BCC), a Phase I/II for keloid scarring, a Phase I/II for hypertrophic scar (HTS), and a Phase I for liver cancer (basket).