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Guided Therapeutics Plans Growth for 2020 After Closing Significant Financing

On January 28, 2020 Guided Therapeutics, Inc. (Pink Sheets: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, reported the Company’s plans for 2020 (Press release, Guided Therapeutics, JAN 28, 2020, View Source [SID1234553628]).

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The Company’s main goals for this year are:

Restart discussions with the FDA and begin work on a small confirmatory study to support the claims of the previously completed pivotal study – The Company has already contacted FDA and informed them to expect the updated protocol for review. The outline for the protocol was previously agreed to during previous meeting between FDA and the Company. FDA also agreed to reduce the criteria for sensitivity of the test, a benchmark that was reached in the completed pivotal study of 2,000 women. Based on these developments, the company intends to discuss with FDA completing the smaller confirmatory study under one of three possible approval scenarios: 1) as part of the normal premarket approval process 2) via the de novo 510(k) route for new technologies or 3) as part of post-marketing studies. The latter two strategies would likely reduce the time to US market launch and would need to be agreed to by FDA.
Start clinical studies for Chinese FDA approval and achieve approval by Q4 2020 – Company intends to fill near term purchase order of 5 devices in Q1 2020 and, once our Chinese distribution partner Shandong Medical Instrumentation Co, Ltd. files with Chinese FDA as a Class 2 device, start to receive payments on larger $2.5 million Purchase Order.
Start taking new orders for Europe and Russia based on final assembly of LuViva at new manufacturing site in Hungary – Contract manufacturer is now ISO 13485 approved to assemble LuViva. New CE Mark with expanded claims has been applied for and expected to be granted in Q1 or Q2 of this year.
Jumpstart sales growth in Middle East and Indonesia – New agreements and subsequent sales with current distributors and addition of new distributor covering a total of 19 countries are expected to generate significant new orders in 2020.
Financial Filings – The Company anticipates releasing Q2 2019 (10Q) financial results later this month and 2019 Q3 (10Q) financial results early in February to catch up with its SEC filings.

Avacta’s Proprietary TMAC Cancer Therapy Platform Demonstrates Successful Proof-of-Concept in Pre-Clinical Study

On January 28, 2020 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, is reported that it has demonstrated initial proof-of-concept for its proprietary new class of drug conjugate, TMAC, in a pre-clinical animal model of cancer (Press release, Avacta, JAN 28, 2020, View Source [SID1234553627]). The study showed that AVA04-VbP outperformed Bavencio (Avelumab), a marketed anti-PD-L1 immunotherapy.

Avacta’s tumour microenvironment activated drug conjugates (TMAC) are a ground-breaking new form of cancer immunotherapy, combining its Affimer biotherapeutics with chemotherapies in a single drug, using a linker (incorporating its proprietary pre|CISION substrate) that is designed to only release the chemotherapy in the tumour microenvironment through the action of an extracellular enzyme called FAPα. This mechanism overcomes the need to target an internalising cancer marker, as with conventional antibody drug conjugates (ADCs), and allows extremely potent chemotherapies to be combined with Affimer immune-checkpoint therapies. Combining pre|CISION technology with the Affimer platform is enabling Avacta to build a pipeline of novel and safe cancer therapies applicable to a broader range of cancer patients, including those who do not respond to existing immunotherapies.

AVA04-VbP combines an Affimer PD-L1 checkpoint inhibitor with an I-DASH chemotherapy warhead, addressing the acute systemic toxicity associated with I-DASH inhibitors by targeting the release of the drug warhead in the tumour microenvironment. The drug warhead induces a highly pro-inflammatory cell death, which in turn stimulates an immune response in the tumour, which is supported by the Affimer PD-L1/PD-1 signalling pathway blockade.

In a mouse syngeneic tumour model study, Avacta has shown that AVA04-VbP outperforms Bavencio; animals treated with AVA04-VbP showed a significant reduction in the rate of tumour growth with respect to those treated with Bavencio. A considerably higher level of the released I-DASH warhead was measured in the tumours compared with very low levels in the blood, indicating that healthy tissues are less exposed to the highly toxic warhead. This tumour targeting is central to the TMAC mechanism of action, and permits the use of the highly potent cancer-killing warheads.

Ikena Oncology Announces Dosing of First Patient in Phase 1 Study Evaluating IK-175 in Patients with Advanced Solid Tumors

On January 28, 2020 Ikena Oncology, a clinical-stage biotechnology company that discovers and develops patient-directed, biomarker-driven therapies, reported dosing of the first patient in the first Phase 1 clinical trial evaluating IK-175 (formerly KYN-175), an internally-developed, orally administered, selective aryl hydrocarbon receptor (AHR) antagonist, in patients with advanced solid tumors (Press release, Ikena Oncology, JAN 28, 2020, View Source [SID1234553626]). This Phase 1 study is expected to enroll approximately 50 patients in the US across both the dose escalation and dose expansion portions of the study.

This first-in-human, single-arm, open-label, dose-escalation and expansion study (NCT04200963) is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of IK-175 as a single-agent in patients with locally advanced or metastatic solid tumors, including urothelial carcinoma. The primary objectives of the study include determination of the maximum tolerated dose, characterizing dose-limiting toxicities, and identification of the recommended Phase 2 dose of single-agent IK-175. Secondary objectives include evaluating disease response, including overall response rate, progression-free survival, duration of treatment, disease control rate and duration of response, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Jason Luke, MD, FACP, associate professor of medicine in the Division of Hematology/Oncology and director of the Cancer Immunotherapeutics Center at the University of Pittsburg Medical Centre (UPMC) Hillman Cancer Immunology and Immunotherapy Program, and a clinical investigator on the IK-175 study, commented: "Activated AHR prevents immune recognition in a range of cancers which makes it a highly evocative drug target, especially in patients who do not fully benefit from standard-of-care, including checkpoint inhibitors. Compelling preclinical evidence supports the clinical potential of IK-175, including its ability to potently inhibit AHR activity. We look forward to further elucidating the safety, tolerability and preliminary efficacy of IK-175 in the clinic."

"Advancing IK-175 into the clinic, less than 3 years after we initiated the discovery program, is a key milestone for Ikena and we are delighted to commence investigation of this promising agent in patients with advanced solid tumors," said Mark Manfredi, Ph.D., President and Chief Executive Officer of Ikena Oncology. "This accelerated timeline is a testament to our ability to rapidly advance assets from the bench to patients. Assuming a positive outcome from the dose-escalation and expansion portion of this single-agent study, we plan to commence an additional portion of the study to evaluate IK-175 in combination with a checkpoint inhibitor. We look forward to providing updates over the course of the study."

About IK-175

IK-175 (formerly known as KYN-175) is an internally-developed, orally-administered, selective aryl hydrocarbon receptor (AHR)antagonist which prevents AHR-modulated tumor promotion through its influence on both the tumor and the immune system. Ikena Oncology recently commenced a first-in-human, Phase 1 clinical study (NCT04200963) in which the safety and antitumor activity of IK-175 is being evaluated as a single agent in advanced solid tumors. A patent application with claims directed to IK-175 has been allowed by the United States Patent and Trademark Office. The AHR antagonist program is the subject of a global strategic collaboration with Bristol-Myers Squibb.

Lung Cancer Study Shows Barriers in Patient Access to Care in Europe

On January 28, 2020 MSD, tradename of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK), reported preliminary results from a study carried out by The Economist Intelligence Unit (The EIU) on lung cancer, which show a fragmented policy approach across Europe (Press release, Merck & Co, JAN 28, 2020, View Source [SID1234553625]). The study underlines that awareness needs to be addressed on multiple fronts to fight the stigma associated with this disease and to ensure patients receive timely access to the best possible care. The data were presented days before the European Commission’s official launch of the stakeholders’ consultation on Europe’s Beating Cancer Plan.

"There is no room for complacency in lung cancer; 1 out of 5 of all cancer deaths in Europe is caused by lung cancer and it kills as many Europeans as breast, colon and prostate cancer combined. The study uncovers actionable solutions to empower countries and their health systems to better manage lung cancer, and ultimately, improve the lives of people living with a diagnosis of this treatable disease," commented Mary Bussell, Associate at The Economist Intelligence Unit.

The study shows that of the 27 countries participating, 15% (4 countries) do not have a National Cancer Control Plan (NCCP). 14 countries with existing NCCPs have not updated them within the past five years, and only one has a lung cancer-specific control plan.

National Lung Cancer Clinical Guidelines (NLCCGs) should include timeframes for fast-tracking people suspected of having lung cancer for diagnostic testing and provide a rapid referral for secondary or tertiary treatment for those diagnosed with lung cancer. Although 26 of the 27 countries covered in the study have national clinical guidelines for lung cancer, discrepancies remain:

11 countries do not include fast-tracking of suspected lung cancer patients to receive diagnostic testing;
12 do not include a timeframe within which diagnostic testing should be given to suspected lung cancer patients;
15 do not include rapid referral to secondary or tertiary care, once a diagnosis of lung cancer has been made; and
3 countries do not include fast-tracking for diagnosis within timeframes or rapid referral to secondary or tertiary care in their lung cancer clinical guidelines. However, they are included in government policies, national agreements, or are mandated by law.
"The presentation of this data is quite timely. While Europe has agreed on the need for a European Cancer Plan, the study draws attention to specific issues around lung cancer and its burden. Clearly, prevention and health promotion have important roles to play. At the same time, we know that early detection and fast referral to treatment are crucial to improve patient outcomes – lung cancer is a race against time. The study shows that we have plenty of work to do there," said Deepak Khanna, Senior Vice President and Regional President Oncology for Europe, Middle East, Africa and Canada, MSD.

"The data presented helps us understand the specificities of lung cancer better. As we design a European Cancer Plan aiming at reducing the cancer burden for patients, their families and health systems, and addressing cancer related inequalities, it is important to gather available information on best practices and knowledge from research and clinical experience, that can help us build a robust evidence base for better policy making", added Martin Seychell, Deputy Director General, DG SANTE, European Commission.

About the Study

The study analysed 17 performance indicators across 27 countries – Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, the Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. The indicators were categorised into five domains focused on the degree to which a country considers lung cancer to be a strategic priority and a public health issue, ensures timely diagnostic and treatment services and the quality of cancer registries which can help to facilitate high-quality research. Each country received a score for all 17 indicators. Once draft scores were assigned to each country, national workshops were conducted with external country-based experts to discuss the findings and develop recommendations for policy and programme improvements. Preliminary results of the first phase of the study were presented at the 2018 European Cancer Forum in Brussels. An additional 16 countries are being analysed and the preliminary results of this second phase were presented at the 2020 European Cancer Forum in Brussels. The final report with a full analysis of the results is expected in Spring 2020. The Economist Intelligence Unit benchmarking study is supported by MSD. Editorial decisions are the responsibility of The Economist Intelligence Unit.

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. According to WHO, in 2018 470,000 Europeans were diagnosed with lung cancer, and 388,000 Europeans died of the disease that year. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. Small cell lung cancer (SCLC) accounts for about 10 to 15% of all lung cancers.

CNS Pharmaceuticals Completes Pilot Manufacturing Steps Pursuant to FDA Pre-IND Guidance

On January 28, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, reported that Anthem Biosciences of Bangalore, India (Anthem) has completed a pilot run of the recrystallization of the Reata Pharmaceuticals, Inc. API (Reata) (Press release, CNS Pharmaceuticals, JAN 28, 2020, View Source [SID1234553624]). It has also completed a lyophilization of the API. Samples of the drug product, which include 299 capped vials, have been shipped to Intertek Pharmaceutical Services (Intertek) for further analysis and release.

As previously announced, the FDA agreed in a preclinical submission that CNS could use Reata API as long as it was reprocessed and released under GMP conditions, and that the new lyophilized form of the drug product could be used during the Company’s upcoming clinical trial. Anthem, a full-service provider of GMP manufacturing for APIs, completed this pilot run of the Reata API. The pilot run recrystallization passed all specifications at Intertek. The recrystallized API was shipped to Lyophilization Technology, Inc. a leader of GMP lyophilization of Drug Products for clinical trials, which completed a pilot lyophilization. The pilot run of lyophilized API was successfully tested and released by Intertek. DavosPharma, a Davos Chemical Company, acted on behalf of the Company as the coordinating manufacturing broker for all of these processes.

"We are excited to achieve another important milestone in the development of Berubicin," stated John Climaco, CEO of CNS Pharmaceuticals. "We look forward to completing both GMP manufacturing processes and release for clinical trials."

About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata.