On March 15, 2022 Olatec Therapeutics LLC, a leader in the developing class of selective NLRP3 inhibitors, reported that Mustafa Noor, MD, FACP, joins the Company as Chief Medical Officer (CMO), following the decision of current CMO, Dr. Curt Scribner, to retire from the position (Press release, Olatec Therapeutics, MAR 15, 2022, View Source [SID1234610141]).

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Dr. Noor remarked: "I believe this is a great time to be joining the Olatec team. I see Olatec at a major value inflection point and am excited to not only build on the world class translational science that has been elucidated, but help this exceptional team take dapansutrile through late-stage development and prospectively its approval in the lead indications." Dr. Noor continued, "Olatec is at the forefront of a compelling new inflammation target across multiple disease areas, which creates many opportunities for dapansutrile and the OLT Analogue compounds."

Dr. Charles Dinarello, Olatec’s Chief Scientific Officer, commented: "we are so pleased to welcome Dr. Noor to our team. He brings to Olatec extensive clinical trial expertise and experience as a clinician treating patients that will be valuable to the development of OLT1177 and its analogues."

Dr. Mustafa Noor’s remarkable career spans over two decades of industry experience. At both large and small pharma companies, Dr. Noor has contributed to numerous clinical drug development programs, leading and collaborating with teams in the development of novel therapeutics for inflammation, cardiometabolism, lipid and endocrine disorders as well as rare diseases. From 2001 to 2006, as medical director at Bristol-Myers Squibb, Dr. Noor held positions of increasing responsibility in metabolic, cardiovascular, and antiviral programs. From 2006 to 2014 at GSK and at Pfizer he served as vice president and clinical head for GSK’s Center of Excellence in External Drug Discovery and for Pfizer’s Centers for Therapeutic Innovation focusing on open innovation, translational research and collaboration with biotech and academic partners on a portfolio of early-stage programs in indications for inflammatory diseases, including inflammatory bowel disease, rheumatoid arthritis, lupus and sarcoidosis. For the last several years Dr. Noor has been a consultant CMO to emerging companies in the Boston/Cambridge area. Dr. Noor completed his medical training at the University of Chicago and fellowship training in Endocrinology and Metabolism at the University of California, San Francisco. He holds a Master of Science in Clinical Investigation from Vanderbilt University and is a board-certified Internal Medicine specialist in Endocrinology and Metabolism.

Olatec CEO, Damaris Skouras, said: "this appointment marks an important step in the continued development of dapansutrile and our portfolio of OLT Analogue compounds. Given Dr. Noor’s medical and drug development expertise, I am confident that Dr. Noor will make substantial contributions to the strategic direction and oversight of dapansutrile as it advances to late-stage studies and as our product pipeline of OLT Analogues also advances." Ms. Skouras continued, "I also extend my sincerest gratitude to Dr. Scribner whose contributions as CMO during the early stages of dapansutrile’s clinical development were significant. While retiring from his CMO function, we are pleased that Curt will remain on Olatec’s Scientific Advisory Board and continue to support dapansutrile’s development."

About Dapansutrile

Dapansutrile (lab code: OLT1177) is an investigational small molecule, new chemical entity that specifically binds to and blocks NLRP3 (nucleotide-binding and oligomerization domain [NOD]‑, leucine rich repeat-, pyrin domain-containing 3), the sensor molecule integral in the formation of the NLRP3 inflammasome. Inflammasomes are multiprotein complexes involved in intracellular surveillance of danger signals that trigger an intense inflammatory response, via generation of bioactive IL-1β and IL-18 through caspase-1 activation. Dapansutrile has been shown to prevent the formation of the NLRP3 inflammasome, which in turn inhibits the production of IL-1β and IL‑18. NLRP3 is one of the most characterized inflammasome sensors due to its involvement in a wide range of disorders, including sterile inflammation, infections, and rare genetic autoimmune syndromes. Dapansutrile has been well tolerated and shown to improve clinical outcomes in patients with acute gout flare (see The Lancet Rheumatology) and heart failure (see Journal of Cardiovascular Pharmacology). Dapansutrile has also been observed to have anti-inflammatory properties and other promising activity in a broad spectrum of over 20 preclinical animal models including arthritis, asthma, acute myocardial infarction (AMI), heart failure, contact dermatitis, multiple sclerosis, melanoma, pancreatic and breast cancers, spinal cord injury (SCI), Parkinson’s and Alzheimer’s disease.

On March 15, 2022 PharmaJet, a biotech company that has developed a more effective way of administering drugs and biologics with their innovative, needle-free injection technology, reported that its partner Immunomic Therapeutics will be starting a phase 1 clinical study of their plasmid DNA vaccine ITI-3000 in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer (Press release, Immunomic Therapeutics, MAR 15, 2022, View Source [SID1234610140]). The study will be conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Research Center in Seattle, Washington and will exclusively use the Stratis Needle-free injection System for delivery of the vaccine.

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"This therapeutic vaccine trial is the first of its kind in the world and may help address the fact that MCC recurs in 40% of cases after initial treatment, but no adjuvant therapy is approved for these patients," noted Dr. Paul Nghiem, co-lead of the clinical study, and Head of Dermatology at University of Washington. The PharmaJet Needle-free System was chosen due to its ability to precisely deliver the vaccine to the intramuscular tissue layer.

Chris Cappello, President and CEO, PharmaJet commented, "We are pleased to be collaborating with our partner in this important therapeutic DNA vaccine clinical trial for this aggressive skin cancer. Oncology applications are a very important part of our R&D pipeline. Our PharmaJet Needle-free Systems have been successfully used for the prevention or treatment of HPV-related lesions, Lymphoma and solid tumors, among other oncology indications."1

On March 15, 2022 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapies for cancer, reported financial results and operational highlights for the fourth quarter and year ended December 31, 2021 (Press release, Adicet Bio, MAR 15, 2022, View Source [SID1234610139]).

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"2022 marks an exciting new chapter for Adicet. Our clinical and operational accomplishments in the fourth quarter of 2021, including the presentation of positive clinical data for our lead asset ADI-001 in NHL, in which we observed complete responses starting at our lowest dose level, and our subsequent successful capital raise, serve as a strong foundation to continue to execute against key upcoming milestones," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "We’re pleased to share that we’ve completed dosing of subjects in dose level two and are enrolling subjects in dose level three in our Phase 1 trial and remain on track to report additional interim clinical data in the first half of 2022, which we hope will further reinforce the potential of Adicet’s first-in-class allogeneic, off-the-shelf gamma delta CAR T cell platform for patients living with cancer."

Fourth Quarter 2021 and Recent Operational Highlights:

Announced positive interim clinical data from Phase 1 study ADI-001. In December 2021, Adicet reported positive interim data from its ongoing dose escalation Phase 1 study evaluating the safety and tolerability of ADI-001, Adicet’s investigational therapy targeting CD20 for the potential treatment of NHL. Complete and near complete responses were observed starting at lowest dose level (30 million CAR+ cells), as well as evidence of in vivo expansion and circulating pharmacodynamic biomarkers consistent with ADI-001 activation. Overall, ADI-001 infusions were generally well-tolerated, with no ADI-001 related serious adverse events, including Graft Versus Host Disease (GvHD), neurotoxicity or high-grade Cytokine release syndrome (CRS) reported as of the November 22, 2021, data cutoff. Adicet has completed dosing of subjects in dose level two and is currently enrolling subjects in dose level three. The Company anticipates reporting additional interim clinical data in the first half of 2022.
Successfully raised $94.2 million in net proceeds through a public follow-on offering. In December 2021, Adicet successfully completed a capital financing of $100.6 million in aggregate gross proceeds. After deducting underwriting discounts and commissions and offering expenses, the Company received $94.2 million of net proceeds. The Company plans to utilize the net proceeds from the financing to advance its pipeline of gamma delta CAR T cell therapies.
Regeneron Pharmaceuticals to license the exclusive, worldwide rights to ADI-002. In January 2022, Regeneron Pharmaceuticals, Inc. exercised its option to license the exclusive, worldwide rights to ADI-002, Adicet’s allogeneic gamma delta CAR T cell therapy directed against Glypican-3. In conjunction with the exercise of the option, Regeneron paid an exercise fee of $20.0 million to Adicet.
ADI-001 preclinical data published in Clinical and Translational Immunology. In February 2022, Clinical and Translational Immunology published data highlighting the key properties of ADI-001, the Company’s investigational therapy targeting CD20 for the potential treatment of B-cell NHL. These preclinical findings underscore ADI-001’s potent, rapid targeting activity, which combines innate, adaptive and CAR-mediated mechanisms. Preclinical data also demonstrated efficient kinetics of cell killing compared to traditional CAR T cells, highly durable and proliferative cell activity, and decreased expression of cell exhaustion markers, all of which may support high anti-tumor potency and therapeutic potential.
Appointed Michael G. Kauffman, M.D., Ph.D., to the Company’s Board of Directors. In November 2021, Adicet announced the appointment of Dr. Michael Kauffman to its Board of Directors. Dr. Kauffman is currently a board member for Karyopharm Therapeutics, Verastem Oncology and Kezar Life Sciences, and brings over 20 years of experience in the life sciences industry, including expertise in preclinical research, clinical development and regulatory strategy to Adicet’s board.
Presented Preclinical Data for ADI-002 at the 36th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. In November 2021, Adicet presented preclinical findings for ADI-002 at the SITC (Free SITC Whitepaper) Annual Meeting. The data demonstrated potent gamma delta CAR T cell activation, cytotoxicity, tumor-specific homing, proliferation, and enhanced activity without evidence of graft versus host alloreactivity. ADI-002 is designed specifically to target solid tumors.
Financial Results for Fourth Quarter and Full Year 2021:

Three months Ended December 31, 2021

Research and Development (R&D) Expenses: R&D expenses were $14.7 million for the three months ended December 31, 2021, compared to $9.7 million during the same period in 2020. The $5.0 million increase is primarily driven by an increase of $1.8 million of payroll and personnel expenses, a net increase of $1.8 million for expenses related to contract manufacturing organizations (CMO), contract research organizations (CRO) and consultant costs related to our lead product candidate ADI-001, and other externally sponsored research expenses, and an increase of $1.3 million in facility and other expenses. Payroll and personnel expenses for the three months ended December 31, 2021, includes $1.6 million of non-cash stock-based compensation expense compared to $0.6 million during the same period in 2020.
General and Administrative (G&A) Expenses: G&A expenses were $6.4 million for the three months ended December 31, 2021, compared to $5.1 million during the same period in 2020. The $1.3 million increase is primarily driven by an increase of $1.8 million of payroll and personnel expenses, partially offset by a decrease of $0.5 million of professional fees for legal, consulting, accounting, tax and other services. Payroll and personnel expenses for the three months ended December 31, 2021, includes $2.7 million of non-cash stock-based compensation expense compared to $1.1 million during the same period in 2020.
Net Loss: Net loss attributable to common shareholders for the three months ended December 31, 2021, was $15.8 million, or a net loss of $0.47 per basic and diluted share, including non-cash stock-based compensation expense of $4.3 million, as compared to a net loss of $9.0 million during the same period in 2020, or a net loss of $0.46 per basic and diluted share, including non-cash stock-based compensation expense of $1.6 million.
Twelve Months Ended December 31, 2021

Research and Development (R&D) Expenses: R&D expenses were $48.9 million for the year ended December 31, 2021, as compared to $34.3 million for year ended December 31, 2020. The increase of $14.6 million in R&D expenses year-over-year was primarily due to an increase of $5.8 million related to payroll and personnel expenses due to increases in headcount of employees involved in research and development activities and an increase in stock-based compensation of $3.1 million. In addition, there was an increase of $3.7 million in fees incurred for CMO, CRO and consultant costs due to ramping up manufacturing and clinical development activities related to our first product candidate ADI-001 and other externally sponsored research, and an increase of $4.9 million in facilities and other expenses.
General and Administrative (G&A) Expenses: G&A expenses were $22.2 million for the year ended December 31, 2021, compared to $22.8 million for the year ended December 31, 2020. The decrease was primarily due to a decrease of $6.3 million in professional fees related to legal and audit fees incurred due to our reverse merger in 2020, partially offset by an increase of $3.1 million of payroll and personnel expenses, which included higher stock-based compensation of $4.2 million and salaries and benefits of $1.0 million and lower temporary contractor fees of $2.2 million. There was also an increase of $2.8 million in facilities and other expenses and $0.5 million in other administrative costs.
Net Loss: Net loss attributable to common shareholders for the year ended December 31, 2021, was $62.0 million, or a net loss of $2.00 per basic and diluted share, including non-cash stock-based compensation expense of $12.5 million, as compared to a net loss in 2020 of $36.7 million, or a net loss of $5.01 per basic and diluted share, including non-cash stock-based compensation expense of $5.3 million.
Cash Position: Cash and cash equivalents and marketable debt securities were $277.5 million as of December 31, 2021, compared to $94.6 million as of December 31, 2020. In December 2021, the Company successfully completed a public offering resulting in $94.2 million of net proceeds. The Company expects that current cash and cash equivalents and marketable debt securities as of December 31, 2021, will be sufficient to fund its operating expenses at least into the second half of 2024.

On March 15, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160, SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, and Medison Pharma Ltd. a global pharma company focused on providing access to highly innovative therapies to patients in international markets ("Medison"), reported that the State of Israel Ministry of Health has approved BRUKINSA (zanubrutinib) for the treatment of adult patients with Waldenström’s Macroglobulinemia (WM). BRUKINSA is reimbursed nationally for patients with second- or third-line WM (Press release, BeiGene, MAR 15, 2022, View Source [SID1234610137]). This is the second approval for BRUKINSA in Israel, following its initial marketing and reimbursement approval in 2021 for patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

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"We are delighted that patients with WM in Israel will now have access to BRUKINSA, a potentially best-in-class BTK inhibitor. We are committed to expanding access to high-impact medicines on behalf of the patients who need them, all over the world. With two approvals and reimbursement coverage in Israel, we are working with Medison Pharma to bring BRUKINSA to the patients in Israel who need it," commented Itzik Mizrahi, General Manager of Israel, at BeiGene.

The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.

About Waldenström’s Macroglobulinemia

WM is a rare B-cell lymphoma that occurs in less than two percent of patients with non-Hodgkin lymphomasi. The disease usually affects older adults and is primarily found in bone marrow, although lymph nodes and the spleen may be involved.ii Typically, patients present between the ages of 60 and 70. For reasons that are unclear, WM is almost twice as common in men as in women and is more common in Caucasians than other ethnic groups.iii Waldenström macroglobulinemia is a rare cancer seen only in approximately three to five per million people per year.iii

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

To date, BRUKINSA has received more than 20 approvals covering more than 40 countries and regions, including the United States, China, the EU and Great Britain, Canada, Australia, and additional international markets. Currently, more than 40 additional regulatory submissions are in review around the world.

IMPORTANT U.S. SAFETY INFORMATION FOR BRUKINSA (ZANUBRUTINIB)

Warnings and Precautions

Hemorrhage

Fatal and serious hemorrhagic events have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax have been reported in 3.4% of patients treated with BRUKINSA monotherapy. Hemorrhage events of any grade occurred in 35% of patients treated with BRUKINSA monotherapy.

Bleeding events have occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Co-administration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections

Fatal and serious infections (including bacterial, viral, or fungal) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher infections occurred in 27% of patients, most commonly pneumonia. Infections due to hepatitis B virus (HBV) reactivation have occurred.

Consider prophylaxis for herpes simplex virus, pneumocystis jiroveci pneumonia and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (26%), thrombocytopenia (11%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA monotherapy. Grade 4 neutropenia occurred in 13% of patients, and Grade 4 thrombocytopenia occurred in 3.6% of patients.

Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.

Second Primary Malignancies

Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA monotherapy. The most frequent second primary malignancy was non-melanoma skin cancer, reported in 8% of patients. Other second primary malignancies included malignant solid tumors (4.0%), melanoma (1.7%) and hematologic malignancies (1.2%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies.

Cardiac Arrhythmias

Atrial fibrillation and atrial flutter were reported in 3.2% of patients treated with BRUKINSA monotherapy. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher events were reported in 1.1% of patients treated with BRUKINSA monotherapy. Monitor signs and symptoms for atrial fibrillation and atrial flutter and manage as appropriate.

Embryo-Fetal Toxicity

Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Adverse reactions

The most common adverse reactions, including laboratory abnormalities, in ≥ 30% of patients who received BRUKINSA (N = 847) included decreased neutrophil count (54%), upper respiratory tract infection (47%), decreased platelet count (41%), hemorrhage (35%), decreased lymphocyte count (31%), rash (31%) and musculoskeletal pain (30%).

Drug Interactions

CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A Inducers: Avoid coadministration with moderate or strong CYP3A inducers.

Specific Populations

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

Please see full U.S. Prescribing Information at www.beigene.com/PDF/BRUKINSAUSPI.pdf and Patient Information at www.beigene.com/PDF/BRUKINSAUSPPI.pdf.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU and Great Britain, Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under FDA review, BeiGene and Novartis announced two new agreements in December 2021 granting Novartis an option to co-develop, manufacture, and commercialize BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development and adding five approved Novartis oncology products to the BeiGene product portfolio across designated regions of China.

On March 15, 2022 MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs ("MAIA"), reported that the company’s lead compound, THIO, has received approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the THIO-101 Phase 2 clinical study evaluating the administration of THIO followed by cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (Press release, MAIA Biotechnology, MAR 15, 2022, View Source [SID1234610136]). The primary objectives of the trial are to evaluate the safety of THIO administered as a direct anticancer and priming immune system agent prior to cemiplimab administration and to assess the clinical efficacy of THIO in patients.

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"We are thrilled to receive the Ethics Committee approval to proceed with our Phase 2 clinical study, THIO-101, in Australia," said Mihail Obrocea, M.D., MAIA’s Chief Medical Officer and Head of Clinical Development. "Our approach to treating NSCLC patients with THIO is unique – we look forward to exploring the utility of THIO as a lead-in agent for checkpoint inhibitors, which we believe will enhance and extend the immune system’s response, allowing for a more effective and targeted therapeutic approach. In the near term, we look forward to dosing our first patient with THIO in this Phase 2 study."

About THIO-101, a Phase 2 Clinical Trial

This trial (THIO-101) will be the first to test THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of the checkpoint inhibitor cemiplimab (co-developed by Regeneron and Sanofi), potentially allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to checkpoint inhibitor treatment will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or progressed after first-line treatment regimen containing a checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety of THIO administered as an anticancer agent and a priming immune system agent prior to cemiplimab administration and (2) to assess the clinical efficacy of THIO followed by cemiplimab using Overall Response Rate (ORR) as the primary clinical endpoint. We expect the study to start initially in Australia and Europe followed by the United States.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in NSCLC. Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.