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Theralase® Phase II NMIBC Clinical Study (Interim) Data Presented at the ASCO GU Cancer Symposium

On February 23, 2023 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDCs") and their associated drug formulations, used to safely and effectively destroy various cancers, bacteria and viruses, reported that its Phase II clinical study ("Study II") interim data was recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Genito Urinary ("GU") Cancer Symposium via a moderated poster presentation (Press release, Theralase, FEB 23, 2023, View Source [SID1234628197]).

Study II has been designed to treat patients diagnosed with Bacillus Calmette-Guérin ("BCG")-Unresponsive, Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") (with or without resected papillary Ta/T1 disease) with a patented investigational study drug (TLD-1433) (Trade Name: Ruvidar), a ruthenium based PDC intravesically instilled into a patient’s bladder, then subsequently activated by a proprietary investigational study device (TLC-3200), a green (520 nm) laser system equipped with fiber-optic light emitters and detectors.

Girish Kulkarni M.D., Ph.D., FRCSC, Divisions of Urology and Surgical Oncology, Department of Surgery, Princess Margaret Cancer Centre, University Health Network, Professor, University of Toronto, (Toronto, Ontario, Canada), lead principal investigator of Study II stated, "Patients with BCG-Unresponsive CIS NMIBC have historically had limited treatment options other than bladder removal surgery to deal with this disease. I am encouraged by the positive interim results of the light-activated, intravesical study drug TLD-1433 (Trade Name: Ruvidar) currently under investigation by Theralase in Study II. The interim analysis of the clinical data collected from Study II to date supports that early results show complete response rates in 53% of patients evaluated at 90 days and 28 % of patients evaluated at 450 days. Based on the clinical data presented to date, Rudivar could represent a viable treatment option with an acceptable safety profile.

I look forward to enrolling and treating additional patients, alongside the other clinical study sites involved in Study II, to complete this study’s enrollment."

Arkady Mandel MD, Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer, Theralase stated, "The high complete response rates and duration of this complete response without serious adverse events, directly related to the study drug or study device, indicates that intravesical Ruvidar is a promising alternative to existing therapies and compares favorably to other approved therapies; including: valrubicin, pembrolizumab and Adstiladrin. Ruvidar, as an intravesical monotherapy, has the potential to be introduced into mainstream medical practice, subject to regulatory approval, based on its one to two treatment methodology, high efficacy and high safety profile. One day we hope that Ruvidar will become the organ-sparing solution that is a game-changer for both patients and physicians."

The poster presented at the ASCO (Free ASCO Whitepaper) GU Cancer Symposium can be found on the Company’s website at www.theralase.com/ASCO_Poster.

About ASCO (Free ASCO Whitepaper)

Founded in 1964, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) is the world’s leading professional organization for physicians and oncology professionals caring for people with cancer.

About Study II

Study II utilizes the therapeutic dose of TLD-1433 (0.70 mg/cm2) activated by the proprietary TLC-3200 (90 J/cm2) medical laser system. Study II is focused on enrolling and treating approximately 100 to 125 BCG-Unresponsive NMIBC CIS patients in up to 20 clinical study sites located in Canada and the United States.

About TLD-1433 (Ruvidar TM)

TLD-1433 is a patented PDC with 12 years of published peer reviewed preclinical research and is currently under investigation in Study II.

The trade name Ruvidar was selected by the Company, as Ru is the element symbol for Ruthenium, a rare transition metal belonging to the platinum group, which the Theralase PDC is based upon, vita is Latin for life and dar is Russian for gift; hence, roughly translated, "Ruthenium, the gift of life".

Olatec Therapeutics Announces the Final Closing, Led by Sanders Morris Harris, on Its $40 Million Series A Financing Round

On February 23, 2023 Olatec Therapeutics LLC ("Olatec" or the "Company"), a leader in developing NLRP3 inhibitors, reported the completion of the Company’s $40 million Series A round financing, the final closing of which was led by Sanders Morris Harris ("SMH") (Press release, Olatec Therapeutics, FEB 23, 2023, View Source [SID1234627663]). Participation in the round came from both existing investors as well as new investors identified by each of Sanders Morris Harris, Advection Growth Capital and the Company. Proceeds will be principally used to advance Olatec’s lead compound, dapansutrile, into later stage clinical development.

Founder of SMH, Don Sanders, and its Chairman, George Ball, in a joint statement said "Olatec has demonstrated its ability to bring to a later stage clinical trial its oral anti-inflammatory inhibitor, dapansutrile, a potentially major pharmaceutical medical innovation. Upon completion of its ongoing trials, the Company could be poised for even greater value creation. We are pleased to be part of Olatec’s progress in advancing dapansutrile towards its potential initial commercial uses."

Also commenting on the completion of the Series A financing, Greg Kennedy, the Founder and Managing Partner of Advection Growth Capital said, "Olatec’s mission to meaningfully improve patient outcomes in major diseases with dapansutrile and its talented team of drug developers is the reason we are supporting Olatec with our own capital and why we were pleased to introduce the Company to investors in our network."

Concurrent with this financing, investor Kenneth Wells MD, who was introduced to the Company by SMH will be joining Olatec’s Board of Directors subject to all requisite approvals. Dr. Well’s, who is President of Alken Health Resources, said: "NLRP3 inhibitors are a highly sought-after pharmaceutical target given their critical role in innate immune systems. Olatec is a leader in the NLRP3 area through the development of oral dapansutrile and I look forward to helping the drug achieve its potential as a significant medical breakthrough for patients suffering from major inflammatory diseases."

Founder and CEO, Damaris Skouras, commented, "We are very pleased to welcome Don Sanders and George Ball and the other highly regarded SMH and Advection investors in the A-9 Round, and particularly welcome Ken Wells as both an investor and prospective Board member. Ken brings extensive experience in support of Olatec’s continued growth and drug development, including working with payors, risk management, and board expertise."

Dr. Ken Wells is the Chief Medical Officer for the Marsh McLennan Agency Southwest. Previously he was a Board member of Baylor St. Luke’s Medical Center Houston, serving on the Executive Committee and as Governance Committee Chair. Over the past two decades, Dr. Wells has served on nine not-for-profit and six advisory corporate boards with executive, governance, nominations, HR, and quality committee responsibilities. Dr. Wells holds a medical doctorate and master’s degree in public health from the University of Texas Health Science Center, Houston. He has earned a master’s degree in management from Northwestern University and a bachelor’s degree in pharmacy from Texas Southern University. He completed a fellowship in primary care policy with the U.S. Department of Health & Human Services and residencies in occupational and family medicine at the University of Texas Health Science Center and aviation medicine instruction at the U.S. Army School of Aerospace Medicine.

Median Technologies to Participate in the Cowen’s 43rd Annual Health Care Conference

On February 23, 2023 Median Technologies (Paris:ALMDT), reported that it will be participating in the Cowen’s 43rd Annual Health Care Conference, taking place on March 6 – 8 ,2023, at the Boston Marriott Copley Place in Boston, MA, USA (Press release, MEDIAN Technologies, FEB 23, 2023, View Source [SID1234627661]).

Fredrik Brag, Median’s CEO and Founder will present on March 7th at 1:30 pm ET (7:30 pm CET).

The live presentation will be available here and the replay will be posted on Median Technologies’ website, Investors section.

Cowen’s 43rd Annual Health Care Conference is taking place March 6 – 8, 2023, at the Boston Marriott Copley Place in Boston, MA. The conference incorporates presentations, fireside chats and innovative panel discussions hosted by members of the Cowen research team that focus on various aspects of the health care industry. Cowen Inc. ("Cowen" or the "Company") is a diversified financial services firm that operates through two business segments: a broker dealer and an investment management division. The Company’s broker dealer division offers investment banking services, equity research, sales and trading, prime brokerage, global clearing and commission management services. Cowen’s investment management division builds on Cowen’s core insights by developing differentiated, actively managed investment strategies that seek to meet the dynamic needs of our clients. Founded in 1918, the firm is headquartered in New York and has offices worldwide. Learn more at Cowen.com.

InnoCare and Keymed Jointly Announce First Subject Dosed in Clinical Trial of CCR8 Monoclonal Antibody ICP-B05

On February 23, 2023 InnoCare Pharma (HKEX: 09969; SSE: 688428) and Keymed Biosciences (HKEX: 02162) jointly reported that the first subject has been dosed in clinical trial of ICP-B05 (CM369), an anti-CC chemokine receptor 8 (CCR8) monoclonal antibody, developed by a joint venture between the two companies called Tiannuojiancheng Pharma in China (Press release, InnoCare Pharma, FEB 23, 2023, View Source [SID1234627660]).

ICP-B05 is a potential first-in-class drug co-developed by InnoCare and Keymed as a monotherapy or in combination with other therapies for the treatment of various cancers.

There are no CCR8-targeted drugs in the world. ICP-B05 selectively depletes Tregs in the tumor microenvironment, which is more specific than other immunotherapies. CM369 binds to CCR8 on Tregs and eradicates immunosuppressive Tregs through ADCC to augment the anti-tumor immunity in TME while preserving peripheral homeostasis. CM369 has the potential to deliver optimal tumor targeted Treg depletion and be more specific in anti-tumor activity than other immunotherapies.

Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said: "CCR8 is a highly promising immuno-oncology target. ICP-B05 will strengthen our large molecule pipeline in solid tumor and has a potential for combination with other therapies for synergistic effects. We will accelerate clinical development, diversify our innovative drug solutions to solve unmet clinical needs, and make unremitting efforts to benefit solid tumor patients."

Dr. Bo Chen, Co-founder, Chairman and CEO of Keymed Biosciences, said: "CM369 has the potential to specifically eliminate tumor-infiltrating Treg cells, and has a positive therapeutic effect on a variety of advanced tumors. We are mindful of the importance of this therapy and are committed to expediting the clinical development of a potentially transformative solution for patients in need."