On October 7, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the dosing of the first patient in the therapeutic phase of its Phase I/II theranostic trial evaluating 64Cu/67Cu SAR-bisPSMA theranostic products in patients with metastatic, castrate-resistant prostate cancer (mCRPC) (Press release, Clarity Pharmaceuticals, OCT 7, 2022, View Source [SID1234621814]).

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The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of Prostate-Specific Membrane Antigen (PSMA) expressing mCRPC using Targeted Copper Theranostics (TCTs). 64Cu SAR-bisPSMA is used to visualise PSMA expressing lesions and select candidates for subsequent 67Cu SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion planned for up to 44 patients in the US. The aim of this trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA as a therapy.

The SECuRE trial initially underwent the dosimetry phase with 64Cu SAR-bisPSMA to determine product biodistribution and dosimetry over multiple time points. Upon the completion of the phase, the data was collected and reviewed by the Safety Review Committee, which has recommended the trial progresses into therapeutic applications with 67Cu SAR-bisPSMA. The first patient in the therapeutic phase was treated at the Urology Cancer Center and GU Research Network in Omaha, Nebraska.

Dr Luke Nordquist, CEO, Urologic Medical Oncologist and Principal Investigator at the Urology Cancer Center and GU Research Network in Omaha, Nebraska, commented, "We are excited to have successfully treated the first participant with the therapeutic 67Cu SAR-bisPSMA product. The preclinical and preliminary clinical data to date indicates potential diagnostic and therapeutic benefits of the optimised PSMA agent and we look forward to generating further evidence as we progress the recruitment into the SECuRE trial.

"GURN is now recruiting participants in three clinical trials with Clarity’s TCTs. We firmly believe that this next-generation platform will help to overcome the logistical and manufacturing challenges that currently plague the radiopharmaceutical field. With an on-demand distribution model that alleviates the reliance on antiquated nuclear reactors, TCTs hold great promise of shifting the treatment paradigm towards the patients and their treatment staff. This way, the clinicians can focus on providing the best patient care without the fear of reactor shutdowns or manufacturing outages disrupting the treatment process."

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "Clarity is excited to progress our second theranostic trial and continue exploring the benefits of TCTs. Prostate cancer is one of the largest oncology indications and there is a significant unmet need for improved diagnosis and therapy of patients with this insidious disease. Moreover, the preliminary data suggests the optimised PSMA product could deliver clinical benefits in oncology indications beyond prostate cancer, which we are excited to explore in the near future.

"Radiopharmaceuticals have a great opportunity of advancing the treatment paradigm for cancer patients, however, a number of challenges associated with the current generation products prevail. Firstly, production of currently approved therapeutic radiopharmaceuticals relies on an ageing fleet of nuclear reactors where shutdowns and interruptions are common. In addition, most currently approved therapeutic products need to be heated during the manufacturing process, which can cause potential quality issues. Finally, as the radiopharmaceutical field is expanding in the global oncology market, the environmental considerations, associated with inefficient supply chains and production of radioactive waste, become a concern.

"Clarity’s TCTs are the next-generation platform that aims to resolve these challenges and enable the radiopharmaceutical field to expand significantly in the large oncology market, addressing multiple large cancer indications. Our therapeutic products are based on copper-67 radioisotopes produced on electron accelerators, which are relatively inexpensive and infinitely scalable in comparison to medical nuclear reactors. TCTs also do not require heating during the manufacturing process, making it less costly and minimising quality concerns. Production of TCTs has favourable environmental characteristics in comparison to the current generation of theranostics with smaller infrastructure footprint and minimal radioactive waste disposal issues. In a field with too many unforeseen product outages and manufacturing issues, TCTs enable reliable and sustainable supply of radiopharmaceuticals.

"Given the myriad of logistical and manufacturing advantages of TCTs, we are committed to further validating the promising preclinical and clinical data to date and driving SAR-bisPSMA development in prostate cancer as well as other oncology indications with high unmet need," said Dr Taylor.

Clarity’s Prostate Cancer clinical trial program overview

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two prostate-specific membrane antigen (PSMA) binding motifs to Clarity’s proprietary sarcophagene (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide2. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease3.

On October 6, 2022 Theolytics, a biotechnology company harnessing viruses to combat disease, reported it will release data on their proprietary systemic therapy for stromal-rich tumours at the 2022 International Oncolytic Virus Conference, and announce executive appointments (Press release, Theolytics, OCT 6, 2022, View Source [SID1234630915]).

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Stromal rich cancers pose a challenge to many cancer therapies due to the abundance of cancer associated fibroblasts (CAFs). This compartment of the tumour microenvironment physically blocks the penetration of drugs, immune cells and promotes resistance to many therapies. THEO-260 is a new oncolytic virus in development that is intrinsically capable of targeted killing of both cancer cells and CAFs.

Theolytics’ Chief Scientific Officer and Co-Founder, Margaret Duffy shared "up to 60% of the tumour volume of many solid cancers is CAF-rich stroma. To effectively target the majority of metastatic solid carcinomas we need therapies that can be systemically delivered, and are able to tackle all components of the tumour microenvironment. THEO-260 is a virotherapy that potentially could demonstrate something that neither chemotherapy, nor immunotherapeutic approaches have been capable of to date. This lead programme demonstrates the power of Theolytics’ platform to deliver a long-awaited step-change for the oncolytic virus field".

Whilst progressing this lead programme into the clinic, the company is strengthening their leadership team with the appointment of Andrew Oakley as Chief Financial Officer and Miriam Bazan Peregrino as Vice President Translational Development.

Andrew brings a wealth of experience as a public and private biotech company CFO to Theolytics with previous CFO positions at Actelion, Sosei Group Corp and Vectura Group. Before joining Theolytics, Andrew was the CFO of Autolus through their IPO. Andrew said: "I am proud to join the team at Theolytics at this juncture of the company’s development. The data being generated points to the potential for highly differentiated and targeted therapeutic options for cancer patients".

Over her career to date, Miriam has led the translational development activities required to start six phase I clinical trials with novel viral therapies across Europe and the United States. Miriam says: "It is very exciting to join Theolytics’ leadership team. The company has strong foundations, backed by world leading scientists, talented people, and a unique platform and bioselection system to discover the best oncolytic therapy for each cancer indication". Dr Bazan Peregrino most recently served as Director of R&D at oncolytic viral therapy company VCN Biosciences.

"I warmly welcome Andrew and Miriam to our leadership team" comments Charlotte Casebourne, Chief Executive Officer and Co-Founder of Theolytics. "They are joining us at an important time – as we prepare to transition from a preclinical, to clinical-stage company, with the goal of developing transformative new therapies for cancer patients."

On October 6, 2022 Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported that Thomas Willemsen, President and CEO, Wilson W. Cheung, Chief Financial Officer, and Ivan D. Horak, M.D., Chief Medical Officer and Chief Scientific Officer, will participate in the 2nd Annual Needham Biotech Private Company 1×1 Forum being held virtually October 18-19 2022 (Press release, Tessa Therapeutics, OCT 6, 2022, View Source;1-forum/ [SID1234623201]).

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During the conference, Mr. Willemsen, Mr. Cheung, and Dr. Horak will conduct one-on-one meetings with registered investors to discuss Tessa’s business strategy, recent corporate achievements, advancements with its autologous and allogeneic CAR-T programs, and anticipated developmental milestones.

On October 6, 2022 Domain Therapeutics ("Domain" or "the Company"), a drug discovery and development company focused on G Protein-Coupled Receptors (GPCRs) in immuno-oncology, reported that it will present data on its proprietary GPCR programs at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (STIC) Annual Meeting, taking place on 8-12 November 2022 in Boston, US (Press release, Domain Therapeutics, OCT 6, 2022, View Source [SID1234622444]).

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Domain will present two posters on its oral small molecule EP4R antagonist, DT-9081. The first poster will highlight preclinical data illustrating the synergy of DT-9081 in combination with immune checkpoint inhibitors in different cancer models. The second poster will focus on the clinical trial design for the upcoming Phase I clinical study, which is expected to start before the end of the year.

Domain will also present a poster on its CCR8 depleting-antibody program illustrating key differentiating properties of its patent-protected proprietary series of antibodies targeting CCR8. It’s known that this GPCR is specifically expressed on tumor-infiltrating regulatory T cells, a highly immuno-suppressive cell population driving tumor progression. This target is currently attracting significant interest for the development of novel game-changing immunotherapies.

Dr. Stephan Schann, VP Research at Domain Therapeutics, commented: "The data to be presented will highlight the potential of our proprietary GPCR programs as attractive immuno-oncology drug candidates. We look forward to presenting these exciting new findings which will demonstrate the potential advantages of our drug candidates, whilst positioning Domain Therapeutics as key player in the field of immunotherapies."

On October 6, 2022, Propanc Biopharma, Inc. (the "Company") reported that it entered into a securities purchase agreement (the "Purchase Agreement") with Red Road Holdings Corporation, a Virginia corporation ("Red Road"), pursuant to which Red Road purchased a convertible promissory note (the "Note") from the Company in the aggregate principal amount of $53,750, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of Red Road (Filing, 8-K, Propanc, OCT 6, 2022, View Source [SID1234621942]). The transaction contemplated by the Purchase Agreement closed on October 12, 2022. The Company intends to use the net proceeds ($50,000) from the Note for general working capital purposes.

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The maturity date of the Note is October 6, 2023 (the "Maturity Date"). The Note shall bear interest at a rate of 8% per annum, which interest may be paid by the Company to Red Road in shares of common stock, but shall not be payable until the Note becomes payable, whether at the Maturity Date or upon acceleration or by prepayment, as described below. Red Road has the option to convert all or any amount of the principal face amount of the Note, beginning on the date which is one hundred eighty (180) days following the date of this Note and ending on the later of: (i) the Maturity Date and (ii) the date of payment of the Default Amount (as defined below), each in respect of the remaining outstanding amount of this Note, to convert all or any part of the outstanding and unpaid amount of this Note into common stock at the then-applicable conversion price. The conversion price for the Note shall be equal to the Variable Conversion Price (as defined herein) (subject to equitable adjustments for stock splits, stock dividends or rights offerings by the Company relating to the Company’s securities or the securities of any subsidiary of the Company, combinations, recapitalization, reclassifications, extraordinary distributions and similar events). The "Variable Conversion Price" shall mean 65% multiplied by the Market Price (as defined herein) (representing a discount rate of 35%). "Market Price" means the average of the lowest three (3) Trading Prices (as defined below) for the common stock during the ten (10) Trading Day period ending on the latest complete Trading Day (as defined below) prior to the conversion date. "Trading Price" means, for any security as of any date, the closing bid price on the OTCQB, OTCQX, Pink Sheets electronic quotation system or applicable trading market (the "OTC") as reported by a reliable reporting service designated by Red Road (i.e. Bloomberg) or, if the OTC is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the "pink sheets". "Trading Day" shall mean any day on which the common stock is tradable for any period on the OTC, or on the principal securities exchange or other securities market on which the common stock is then being traded. Notwithstanding the foregoing, Red Road shall be restricted from effecting a conversion if such conversion, along with other shares of the Company’s common stock beneficially owned by Red Road and its affiliates, exceeds 4.99% of the outstanding shares of the Company’s common stock.

The Note may be prepaid until 180 days from the issuance date. If the Note is prepaid within 60 days of the issuance date, then the prepayment premium shall be 110% of the face amount plus any accrued interest, if prepaid after 60 days from the issuance date, but less than 91 days from the issuance date, then the prepayment premium shall be 115% of the face amount plus any accrued interest, if prepaid after 90 days from the issuance date, but less than 121 days from the issuance date, then the prepayment premium shall be 120% of the face amount plus any accrued interest, if prepaid after 120 days from the issuance date, but less than 151 days from the issuance date, then the prepayment premium shall be 125% of the face amount plus any accrued interest, and if prepaid after 150 days from the issuance date, but less than 181 days from the issuance date, then the prepayment premium shall be 129% of the face amount plus any accrued interest. So long as the Note is outstanding, the Company covenants not to, without prior written consent from Red Road, sell, lease or otherwise dispose of all or substantially all of its assets outside the ordinary course of business which would render the Company a "shell company" as such term is defined in Rule 144.