On November 29, 2022 Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, reported that the National Cancer Institute (NCI) of the National Institutes of Health (NIH) has awarded the company a Small Business Innovation Research (SBIR) grant of nearly $2 million (Award Number R44CA277890) (Press release, Vergent Bioscience, NOV 29, 2022, View Source [SID1234624558]). The grant will help fund a Phase 2 clinical study evaluating the company’s targeted fluorescent imaging agent, VGT-309, for intraoperative imaging of tumors in patients undergoing lung cancer surgery.

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"This Phase 2 SBIR award further validates the promise of VGT-309 to help surgeons realize the full potential of minimally invasive and robotic-assisted surgical procedures by improving the visibility of tumors during surgery," said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. "We are grateful to the NCI for their support and to the team at the University of Pennsylvania’s Perelman School of Medicine for conducting this Phase 2 study."

The majority of lung cancer surgery is now performed using minimally invasive approaches, which have multiple advantages for patients, but require that surgeons work in a small area with a restricted view and limited tactile clues, presenting the potential for tumor to be missed and left behind. Early Phase 1 and 2 clinical trials evaluating VGT-309 in lung cancer yielded compelling safety and efficacy data that support the agent’s ability to help surgeons see previously undetected or difficult-to-find tumors in real-time, ensuring all tumor tissue is removed during minimally invasive (MIS) and robotic-assisted surgical procedures.

The NCI SBIR grant will support a Phase 2 clinical study of VGT-309 led by Sunil Singhal, M.D., the William Maul Measey Professor of Surgical Research and the chief of the Division of Thoracic Surgery at Penn (NCT05400226). The study will evaluate the safety and efficacy of VGT-309 to locate and identify tumor tissue that may have otherwise been missed during lung cancer surgery.

"As minimally invasive surgical approaches are increasingly becoming the standard of care for treatment of many solid tumors, surgeons urgently need imaging agents that will support better tumor visualization," said Dr. Singhal. "We’re encouraged by early data from studies evaluating VGT-309 and look forward to further exploring its utility in this trial."

The NIH’s SBIR program is a congressionally mandated set-aside program to encourage research and development that has a strong potential for technology commercialization. The program allows small business entrepreneurs a chance to obtain non-dilutive funding for early-stage R&D.

About VGT-309
VGT-309 is a tumor-targeted imaging agent intentionally designed to enable a complete solution for optimal tumor visualization during open, MIS, and robotic-assisted surgical procedures. VGT-309 is delivered to patients via a short infusion several hours before surgery. Invented in Professor Matt Bogyo’s Lab at Stanford University School of Medicine, the molecule binds tightly (i.e., covalently) to cathepsins, a family of proteases that are highly overexpressed across a broad range of solid tumors. This approach provides distinct clinical advantages and positions VGT-309 as an ideal tumor imaging agent. VGT-309’s imaging component is the near infrared (NIR) dye indocyanine green (ICG), which is compatible with all commercially available NIR intraoperative imaging systems that support MIS technologies and is the preferred dye to minimize confounding background autofluorescence.

On November 29, 2022 Turnstone Biologics Corp, a clinical-stage biotechnology company developing next-generation immunotherapies to treat and cure solid tumors, reported that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), to evaluate the generation of tumor-reactive T-cells, which form the basis of Turnstone’s tumor-infiltrating lymphocyte platform (Selected TILs), from clinical tissue samples obtained from patients treated with Turnstone’s proprietary viral immunotherapies (Press release, Turnstone Biologics, NOV 29, 2022, View Source [SID1234624557]). The combination of Selected TILs and viral immunotherapy have the potential to enhance the efficacy of TILs and to extend their benefit to patients with a broad array of solid tumors. The collaboration will be co-led by Stewart Abbot, Ph.D., Chief Scientific Officer, Turnstone Biologics, and Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI’s Center for Cancer Research and a pioneer in the fields of immunotherapy and cell therapy.

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"I believe TIL therapy is one of the most exciting areas of modern research in the cancer arena," notes Dr. Abbot. "The low concentration of functional tumor-reactive T-cells in many solid tumors is a key challenge to immunotherapy of cancer, and better methods to generate these immune cells are needed to prevail against solid tumors. Viral immunotherapy has the potential to synergistically drive infiltration of tumor-reactive T-cells and modulate immune responses, and thereby deepen the activity and durability of TIL therapy to reach new frontiers for this highly promising field."

Selected TILs represent the foundational therapeutic modality driving Turnstone’s cancer immunotherapy pipeline and leverage decades of published work grounded in academia that have demonstrated the promise of treating solid tumor cancers through the identification, selection, and expansion of the most potent patient specific tumor-reactive T-cells. Turnstone’s viral immunotherapies are designed to enhance trafficking of these Selected TILs directly to the site of the tumor and modify the immunosuppressive microenvironment to support the anti-tumor functions of infiltrating immune cells. Through this novel combination, Turnstone aims to improve and broaden the clinical efficacy of Selected TILs and overcome the limitations of current treatment options to achieve positive outcomes in intractable solid tumors.

Under the terms of the CRADA, the parties will evaluate the impact of Turnstone’s proprietary oncolytic viruses on increasing the immune response to tumor neoantigens in clinical patient samples. Turnstone will be responsible for manufacturing and administering its viral immunotherapies to patients and subsequent tissue collection. NCI investigators will use NCI-developed methods and proprietary in vitro techniques to study lymphocytes derived from these patients, characterize their specificity and evaluate their persistence. The parties will jointly analyze data and exchange information and expertise to advance the development of oncolytic viruses as an improved method for the generation of Selected TILs.

"Dr. Rosenberg pioneered cancer immunotherapy and cell therapy and we are honored to have him and the NCI as collaborators for this study," said Sammy Farah, Ph.D., M.B.A., President and Chief Executive Officer, Turnstone Biologics. "Turnstone’s combination strategies with TIL and viral immunotherapy are designed to improve TIL harvest and overcome the immunosuppressive tumor microenvironment for better trafficking and expansion of our Selected TILs. This CRADA with the highly distinguished team at the NCI provides us with an optimal path towards demonstrating the value of this innovative approach and translating our scientific advances into more effective treatments."

On November 29, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported that new preclinical data from the Company’s pan-cancer fibroblast activation protein-α (FAP-α) targeted program, PNT2004 (Press release, Point Biopharma, NOV 29, 2022, View Source [SID1234624556]).

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The preclinical study focused on assessing the potential of the lead candidate in the PNT2004 clinical program, 177Lu-PNT6555, in combination with anti-PD-1 immunotherapy. The CT26-mFAP tumor model used expresses low levels of FAP, grows aggressively, and is insensitive to anti-PD-1 immunotherapy. The study found that combination treatment with 177Lu-PNT6555 and anti-PD-1 resulted in a significant survival benefit, as compared to either treatment independently. The new preclinical data from the study can be found in an updated investor presentation available on the investors section of the Company’s website.

"While the initial clinical development of 177Lu-PNT6555 has focused on its application as a monotherapy, we have always held optimism for its broad potential in combination therapies." said Joe McCann, Ph.D., Chief Executive Officer of POINT Biopharma. "Radioligand therapy could offer a synergistic mechanism of action with multiple existing therapeutic classes, expanding their applicability or effectiveness. For example, RLT combined with checkpoint blockade could unleash an immune attack against tumors that are otherwise insensitive to immunotherapy, or RLT combined with DNA repair/cell cycle inhibitors could amplify DNA damage to increase cell death. As a pan-cancer program, the 177Lu-PNT6555 lead presents significant opportunities for both monotherapy and combination trials in a variety of indications of high unmet need. We look forward to providing more data in the coming months on both our FAP program as well as our other exciting next generation radioligand programs."

177Lu-PNT6555, the lead of the PNT2004 program, is currently in the phase 1 FRONTIER trial with cohort 1 underway and three clinical sites open. Cohort 2 in FRONTIER is expected to commence in Q1 2023. Preclinical activities are currently underway, including additional studies in syngeneic and PDX models, and will be used to inform phase 2 opportunities. CMC and clinical teams are actively expanding access to gallium-68 imaging agent, technology transfers of imaging agent to multiple sites to expand phase 1 recruitment, and plans for phase 2 are underway.

More information about 177Lu-PNT6555, including the new preclinical data from the study, can be found in an updated investor presentation available on the investors section of the Company’s website at View Source

About the FRONTIER Trial

The FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability, and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients with Select Solid Tumors (FRONTIER) trial is an open-label, phase 1 trial to evaluate safety, tolerability, and dosimetry of 177Lu-PNT6555 and 68Ga-PNT6555, the lead assets of the PNT2004 program. The phase 1 clinical trial commenced in summer 2022 in Canada and uses a 68Ga-based PNT6555 molecular imaging agent to select patients to receive a no-carrier-added (n.c.a.) 177Lu-based PNT6555 therapeutic agent. The phase 1 clinical protocol will evaluate PNT6555 in approximately 30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcoma.

On November 29, 2022 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported it has reached an important recruitment milestone in the Company’s ACCENT clinical trial in frontline patients with pancreatic cancer (Press release, Amplia Therapeutics, NOV 29, 2022, View Source;[email protected] [SID1234624555]). This week, enrolment of the first cohort of patients was completed.

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The first stage of the ACCENT trial is designed to test ascending doses of AMP945 given in combination with standard gemcitabine/nab-paclitaxel chemotherapy in patients with advanced pancreatic cancer. Cohorts of patients (three per cohort) are given the same dose of AMP945 in addition to standard chemotherapy so that safety, tolerability, pharmacokinetics and pharmacodynamics of the combined therapy can be assessed. After 1 month of treatment, the trial’s Safety Committee will review the clinical data collected for each cohort and, subject to the data, authorise dose escalation of AMP945 in a subsequent cohort.

Amplia’s CEO and Managing Director Dr John Lambert commented that "This month, we have opened four additional ACCENT clinical trial sites, taking our total number of sites to seven. There has been a lot of interest in the ACCENT clinical trial and we expect that recruitment rates will accelerate as the trial builds further momentum. We are delighted to have reached today’s recruitment milestone and we will make further announcements as we reach future milestones and dose escalate AMP945. As ever, our thanks go to the patients who have consented to participate in the ACCENT trial."

This ASX announcement has been approved and authorised for release by the Board of Amplia Therapeutics.

On November 29, 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, bacteria and viruses reported that it has released the Company’s unaudited 3Q2022 condensed interim consolidated Financial Statements ("Financial Statements") (Press release, Theralase, NOV 29, 2022, View Source [SID1234624554]).

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Financial Highlights:

(1)Other represents gain from legal settlement, (gain) loss on foreign exchange, interest accretion on lease liabilities and interest income
Total revenue increased 43%, 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 nine-month period ended September 30, 2022 was $389,232 or 48% of revenue resulting in a gross margin of $423,766 or 52% of revenue. In comparison, the cost of sales in 2021 was $317,397 or 56% of revenue resulting in a gross margin of $249,415 or 44% of revenue. Cost of sales is represented by the following costs: raw materials, subcontracting, direct and indirect labour and the applicable share of manufacturing overhead.

Selling expenses for the nine-month period ended September 30, 2022, decreased to $238,904, from $271,708 in 2021, a 12% decrease. The decrease in selling expenses is primarily attributed to the COVID-19 pandemic, resulting in reduced advertising (51%), and salaries (15%).

Administrative expenses for the nine-month period ended September 30, 2022, decreased to $1,068,979 from $1,211,834 in 2021, a 12% decrease. The decrease in administrative expenses is primarily attributed to decreased spending on professional fees (28%) and insurance (12%). Stock based compensation expense decreased 62% in 2022 due to a reduction in stock options granted.

Net research and development expenses for the nine-month period ended September 30, 2022, increased to $3,464,664 from $2,036,415 in 2021, a 70% increase. The increase in research and development expenses is primarily attributed to the costs related to the Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study ("Study II"). Research and development expenses represented 73% of the Company’s operating expenses and represents investment into the research and development of the Company’s Anti-Cancer Therapy ("ACT") technology.

The net loss for the nine-month period ended September 30, 2022 was $4,352,100, which included $391,321 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 $3,129,731 which included $486,010 of net non-cash expenses. The ACT division represented $3,820,222 of this loss (88%) for the nine-month period ended September 30, 2022.

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

Operational Highlights:

1.)Non-Brokered Private Placement. On September 22, 2022, the Company completed a financing by way of a non-brokered private placement, where 10,000,000 units were issued at a price of $0.25 per unit for gross proceeds of $2,500,000. Each unit consisted of 1 common share and 1 non-transferable common share purchase warrant. Each whole warrant entitles the holder thereof to acquire 1 common share at a price of $0.35, expiring on September 22, 2024. An aggregate of 2,400,000 units, representing gross proceeds of $600,000, were issued to certain insiders of the Corporation.

On November 17, 2022, the Company completed a financing by way of a non-brokered private placement, where 1,000,000 units were issued at a price of $0.25 per unit for gross proceeds of $250,000. Each unit consisted of 1 common share and 1 non-transferable common share purchase warrant. Each whole warrant entitles the holder thereof to acquire 1 common share at a price of $0.35, expiring on November 17, 2024. An aggregate of 511,000 units, representing gross proceeds of $127,750, were issued to certain insiders of the Corporation.

2.)Break Through Designation Update. 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 assessments for 25 patients, expected in 4Q2022, subject to the CSS’s availability to complete all required assessments and biostatistical review and analysis.

3.)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.

4.)Clinical study site status and update. To date, Study II has provided the primary study treatment for 51 patients (including three patients from the Phase Ib NMIBC Clinical Study treated at the Therapeutic Dose for a total of 54 patients.

An analysis of Evaluable Patients (defined as patients who have been evaluated by the principal investigator and thus excludes data pending), in Study II provides the following interim analysis (including three patients from the Phase Ib NMIBC Clinical Study treated at the Therapeutic Dose):

Note: The Primary Objective CR is determined at any point in time (defined above under Study II Objectives). CR was achieved as follows: 23 patients at 90 days, 1 patient at 180 days and 2 patients at 270 days.

Note: Indeterminate Response ("IR"), previously referred to as Partial Response, is defined as patients assessed with negative cystoscopy and suspicious or positive urine cytology.

The clinical data to date demonstrates a strong initial CR (53%) and a strong duration of that response for 450 days (28%).

In accordance with the FDA’s 2018 guidelines to industry, the patients who have achieved an Indeterminate Response ("IR") are being further assessed via Computerized Tomography ("CT") scan and/or biopsy of the prostatic urethra to determine if upper tract Urothelial Cell Carcinoma ("UCC") or prostatic urethra UCC can be detected to allow these patients to be re-categorized as CR.

Note: The current interim data analysis presented above, should be read with caution, as the clinical data is interim in its presentation, has not been formally reviewed by Health Canada and/or the FDA, 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.

5.)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.

6.)COVID-19 Research Update. In February 2022 Theralase reported that Public Health Agency of Canada 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.

In July 2022, Theralase executed a Testing and Technical Services Agreement ("TTSA") with the National Research Council of Canada ("NRC") to produce inactivated SARS-CoV-2 virus using Theralase’s patented PDC and proprietary TLC-3000B medical laser system technology. This inactivated virus will be used to create a vaccine to vaccinate animals to determine the immunogenicity effects of the TLD-1433 SARS-CoV-2 (COVID-19) vaccine and assess its efficacy in protecting the animals from contracting SARS-CoV-2 during SARS-CoV-2 challenge.

Theralase is currently designing and developing a new proprietary light activation platform; specifically, the TLC-3000B, to inactivate the virus and create the fundamental building blocks of a COVID-19 vaccine. The TLC-3000B is expected to be completed for use by PHAC and NRC in 1Q2023.

The above results and completion of the TLC-3000B will lay the groundwork for the next phase of the CRA and TTSA, which is evaluating the Theralase COVID-19 vaccine in the ability to prevent animals from contracting COVID-19, at two world class laboratories, when exposed to the virus, which is expected to commence in 1Q2023 and be completed by 1Q2024.

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.