On February 25, 2022 Johnson & Johnson and its U.S.-based Janssen Pharmaceutical Companies (collectively, the "Company") reported there is sufficient level of participation to move forward with the nationwide settlement agreement to resolve opioid-related claims and litigation by states, cities, counties, and other subdivisions in the United States (Press release, Johnson & Johnson, FEB 25, 2022, View Source [SID1234609126]).

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As previously announced on July 21, 2021, the Company will contribute up to $5 billion to the nationwide settlement, which is designed to directly support state and local efforts to make meaningful progress in addressing the opioid crisis in the United States. This settlement agreement is not an admission of any liability or wrongdoing, and the Company will continue to defend against any litigation that this final settlement agreement does not resolve. The Company no longer sells prescription opioid medications in the United States as part of our ongoing efforts to focus on transformational innovation and serving unmet patient needs.

The Company announced separate settlement agreements that are consistent with the terms of the nationwide settlement agreement with the States of New York in June 2021, Texas in October 2021, and Nevada and New Mexico in January 2022. The Company also announced a settlement agreement with the federally recognized Tribes in February 2022. The dollar amounts to be received in these settlement agreements are the pro-rated shares that would have been received under the nationwide settlement agreement and will be deducted from the $5 billion all-in settlement amount.

On February 25, 2022 Cerus Corporation (Nasdaq: CERS) reported that Kevin D. Green, Cerus’ chief financial officer, is scheduled to participate at the Cowen 42nd Annual Health Care Conference on Wednesday, March 9, 2022 at 1:30 p.m. EST (Press release, Cerus, FEB 25, 2022, View Source [SID1234609059]).

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A live webcast of the event will be available on the Investor Relations page of the Cerus web site at View Source A replay will be available for approximately two weeks following the completion of the event.

On February 25, 2022 Clovis Oncology, Inc. (NASDAQ: CLVS) reported a Trial-in-Progress poster detailing the Phase 1 portion of the LuMIERE clinical study for its targeted radiotherapy candidate FAP-2286 and a presentation titled "Initial Experience with FAP-2286 Imaging" related to an ongoing investigator-initiated trial (IIT) evaluating the ability of imaging agent gallium-68 (68Ga)-FAP-2286 to detect metastatic cancer in patients with solid tumors (Press release, Clovis Oncology, FEB 25, 2022, View Source [SID1234609060]). These data will be presented by Thomas A. Hope, M.D., Director of Molecular Therapy in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco (UCSF), and principal investigator of the LuMIERE trial and the IIT at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Mid-Winter and American College of Nuclear Medicine (ACNM) Annual Meeting being held virtually, Feb. 25-27, 2022.

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FAP-2286 is the first peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP) to enter clinical development and the lead candidate in Clovis Oncology’s targeted radionuclide therapy (TRT) development program.

Approximately 50 patients will be enrolled in the Phase 1 portion of the multicenter, open-label LuMIERE trial, which is currently enrolling patients with advanced solid tumors (NCT04939610). The Phase 1 portion of the study is evaluating the safety of the investigational therapeutic agent lutetium-177 (177Lu)-FAP-2286 and will identify the recommended Phase 2 dose and schedule. The safety and tumor uptake of the imaging agent gallium-68 (68Ga)-FAP-2286 is also being evaluated. Once the Phase 2 therapeutic dose is determined, Phase 2 expansion cohorts in multiple tumor types are planned for later in 2022.

"We believe the ongoing LuMIERE trial will underscore the valuable role of targeted radiotherapy in cancer treatment and the potential of FAP-2286 to treat a variety of solid tumor types," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We remain committed to advancing targeted radiotherapies in oncology and look forward to presenting initial data from the Phase 1 portion of the trial later this year."

After 10 a.m. Eastern time today, February 25, the LuMIERE Trial-in-Progress poster can be found at View Source with other recent Clovis-sponsored presentations, posters, and supplemental information.

Presentation of data from the IIT (NCT04621435) evaluating the ability of imaging agent 68Ga-FAP-2286 to detect metastatic cancer in patients with solid tumors is scheduled for Saturday, February 26.

For more information about FAP-2286, targeted radionuclide therapy, or Clovis’ TRT development program, please visit targetedradiotherapy.com.

About the LuMIERE Clinical Study

LuMIERE is a Phase 1/2 study evaluating FAP-2286 as a peptide-targeted radionuclide therapy (PTRT) targeting fibroblast activation protein, or FAP, in patients with advanced solid tumors. The Phase 1 portion of the LuMIERE study is evaluating the safety of the investigational therapeutic agent and will identify the recommended Phase 2 dose and schedule of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will be utilized as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types.

About FAP-2286

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. High FAP expression has been shown in pancreatic ductal adenocarcinoma, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non–small cell lung, squamous head and neck cancers, and cancer of unknown primary. High FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade.

Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

About Targeted Radionuclide Therapy

Targeted radionuclide therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue. Targeted radionuclides are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as "theranostics." Clovis, together with licensing partner 3B Pharmaceuticals, is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds.

On February 25, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported that it has successfully treated its first participant in cohort 2 of the 64Cu/67Cu SARTATE neuroblastoma therapy trial (CL04) at the increased dose level of 175MBq/kg body weight (Press release, Clarity Pharmaceuticals, FEB 25, 2022, https://www.claritypharmaceuticals.com/news/1patient_cohort2/ [SID1234608956]).

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Clarity has recently progressed to cohort 2 of the CL04 trial following the completion of cohort 1 where three participants received therapy with 67Cu SARTATE at a dose of 75MBq/kg body weight. The Safety Review Committee assessed the data from cohort 1 where no dose limiting toxicities have occurred and recommended to progress the trial to cohort 2, without modification, increasing the dose to 175MBq/kg body weight.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very excited to dose the first patient in cohort 2 in our neuroblastoma therapy trial in the US, having successfully completed cohort 1 in January 2022. The increase in administered activity between cohorts 1 and 2 is significant in radiation-sensitive disease, such as neuroblastoma, and cohort 2 will see administered activities more than double in comparison to cohort 1. We look forward to continuing recruitment in cohort 2 at all five clinical sites in the US, building upon the encouraging initial data from cohort 1 and further gathering evidence of diagnostic and therapeutic benefits of the SARTATE product for the treatment of children with neuroblastoma."

The CL04 trial is a theranostic (diagnosis and therapy) trial in paediatric patients with high-risk neuroblastoma (NCT04023331)1. It is a multi-centre, dose-escalation, open label, non-randomised, Phase 1/2a clinical trial with up to 34 participants conducted at five clinical sites in the US.

Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality.2 High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.3

In 2020, the US Food and Drug Administration (FDA) awarded Clarity two Orphan Drug Designations (ODDs), one for 64Cu SARTATE as a diagnostic agent for the clinical management of neuroblastoma and one for 67Cu SARTATE as a therapy of neuroblastoma, as well as two Rare Paediatric Disease Designations (RPDDs) for these products. Should Clarity be successful in achieving US FDA New Drug Applications for these two products, RPDDs may potentially allow the Company to access a total of two tradeable Priority Review Vouchers (PRVs) which most recently traded at USD110M per voucher.4

Dr Taylor said, "Our team, clinicians and collaborators have all shown strong dedication to progressing the neuroblastoma trial at some of the best cancer centres in the US, driven by our mutual goal of improving the treatment paradigm for children with this insidious disease. In the times when the pandemic was having a significant impact on clinical site operations and recruitment, this support is indicative of the importance and urgency of improving the prognosis of children with high-risk neuroblastoma, where current treatment strategies are limited. We continue working closely with the clinical sites and the US FDA to progress this trial swiftly, building upon the mounting evidence of the advantages of the SARTATE treatment paradigm over current treatment regiments, in pursuit of Clarity’s ultimate goal of improving treatment outcomes for children and adults with cancer."

This announcement has been authorised for release by the Executive Chairman.

On February 24, 2022 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the fourth quarter and full year of 2021 and provided a corporate update (Press release, Aclaris Therapeutics, FEB 24, 2022, View Source [SID1234608927]).

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"2021 was a tremendous year for the progression of our drug development pipeline, and I’m very proud of what our team has accomplished," said Dr. Neal Walker, President & CEO of Aclaris. "We reported positive data for our Phase 2a trials of zunsemetinib in subjects with moderate to severe rheumatoid arthritis (RA) and ATI-1777 in subjects with moderate to severe atopic dermatitis (AD), and strengthened our balance sheet to continue this momentum in 2022. Moving forward, we are progressing zunsemetinib in three immuno-inflammatory indications, moving ATI-1777 forward in moderate to severe AD, and progressing ATI-2138 in SAD/MAD studies. Our KINect drug discovery platform continues to be productive and we now have three clinical-stage compounds as well as an early-stage immuno-inflammatory and oncology pipeline. We have the privilege of working toward the goal of helping address the needs of patients with immuno-inflammatory diseases as well as cancer and look forward to progressing our assets to achieve this goal."

Research and Development Highlights:

The global COVID-19 pandemic continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its research and development and regulatory activities listed below.

Clinical Programs

Zunsemetinib, an investigational oral small molecule MK2 inhibitor:
Currently being developed as a potential treatment for immuno-inflammatory diseases
ATI-450-RA-202: This Phase 2b dose ranging trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses (20 mg and 50 mg twice daily) of zunsemetinib in combination with methotrexate in subjects with moderate to severe RA is ongoing.
Aclaris anticipates increasing the size of the patient population from approximately 195 to approximately 240 subjects and expects topline data in 2023.
ATI-450-HS-201: This Phase 2a trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of zunsemetinib (50 mg twice daily) in subjects with moderate to severe HS is ongoing.
Aclaris expects topline data in the first half of 2023.
ATI-450-PsA-201: Aclaris plans to progress zunsemetinib (50 mg twice daily) into a Phase 2a trial in subjects with moderate to severe psoriatic arthritis in the first half of 2022.
ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor:
Currently being developing as a potential treatment for moderate to severe AD
Aclaris plans to progress ATI-1777 into a Phase 2b trial in subjects with moderate to severe AD in the first half of 2022. In this trial, Aclaris plans to explore multiple concentrations of twice daily treatment with ATI-1777 and a single concentration of once daily treatment with ATI-1777, in patients 12 years and older.
ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor:
Currently being developed as a potential treatment for T cell-mediated autoimmune diseases
ATI-2138-PKPD-101: This Phase 1 single ascending dose (SAD) trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-2138 in healthy subjects is ongoing.
Aclaris expects topline data in 2022.
If the Phase 1 SAD trial is successful, Aclaris currently plans to initiate a two-week Phase 1 multiple ascending dose trial of ATI-2138 in subjects with psoriasis in 2022. Aclaris is also currently exploring alternative indications to the planned indication that are relevant to the mechanism of action.
Preclinical Programs

ATI-2231, an investigational oral MK2 inhibitor compound:
Currently being explored as a potential treatment for pancreatic cancer and metastatic breast cancer as well as in preventing bone loss in patients with metastatic breast cancer
Second MK2 inhibitor generated from Aclaris’ proprietary KINect drug discovery platform and designed to have a long half-life.
IND-enabling studies are underway, and Aclaris expects to submit an IND by the end of 2022.
Discovery Programs

Currently developing oral gut-biased JAK inhibitors with limited systemic exposure as potential treatments for inflammatory bowel disease.
Central nervous system (CNS) kinase inhibitor targets:
Currently engaged in research to identify brain penetrant kinase inhibitor candidates and assess their impact on neuronal pro-inflammatory cytokine production, microglia growth and survival, and neurodegeneration.
Other Highlights:

James Loerop appointed as Chief Business Officer in January 2022.
Aclaris plans to hire additional key leadership positions over the coming months to support its operational plans and strategic direction.
Financial Highlights:

Liquidity and Capital Resources

As of December 31, 2021, Aclaris had aggregate cash, cash equivalents and marketable securities of $225.7 million compared to $54.1 million as of December 31, 2020. The primary factors for the change in cash, cash equivalents and marketable securities during the year ended December 31, 2021 included:

Net cash used in operating activities of $52.1 million. This amount was comprised of the following:
$90.9 million net loss
$1.3 million cash used from changes in operating assets and liabilities
$24.3 million of non-cash charges for the revaluation of contingent consideration
$14.1 million of non-cash stock-based compensation expense
$1.7 million of other non-cash charges
Net cash used to repay outstanding debt and fees of $11.5 million in July 2021.
Aggregate net proceeds of $238.2 million from public offerings in January 2021 and June 2021 in which Aclaris sold a total of 14.4 million shares of common stock.
Aclaris anticipates that its cash, cash equivalents and marketable securities as of December 31, 2021 will be sufficient to fund its operations through the end of 2024, without giving effect to any potential business development transactions or financing activities.

Financial Results

Fourth Quarter 2021

Net loss was $22.8 million for the fourth quarter of 2021 compared to $13.2 million for the fourth quarter of 2020.
Total revenue was $1.5 million for the fourth quarter of 2021 compared to $1.6 million for the fourth quarter of 2020.
Research and development (R&D) expenses were $14.1 million for the quarter ended December 31, 2021 compared to $9.0 million for the prior year period.
The $5.1 million increase was the result of additional zunsemetinib expenses, including costs associated with clinical development activities for a Phase 2b trial for moderate to severe RA and a Phase 2 trial for moderate to severe HS and preclinical development activities related to ATI-2231.
General and administrative (G&A) expenses were $6.9 million for the quarter ended December 31, 2021 compared to $4.9 million for the prior year period.
The $2.0 million increase was primarily the result of higher compensation-related costs, including stock-based compensation, as well as higher accounting, compliance and professional fees. Severance payments relating to the retirement of our former Chief Legal Officer also contributed to the increase.
Revaluation of contingent consideration charges related to the Confluence acquisition was $2.2 million for the quarter ended December 31, 2021 compared to $0 for the prior year period.
Full Year 2021

Net loss was $90.9 million for the year ended December 31, 2021 compared to $51.0 million for the year ended December 31, 2020.
Total revenue was $6.8 million for the year ended December 31, 2021 compared to $6.5 million for the year ended December 31, 2020.
R&D expenses were $43.8 million for the year ended December 31, 2021 compared to $29.3 million for the prior year period.
The $14.5 million increase was primarily the result of additional zunsemetinib expenses, including costs associated with drug candidate development and clinical development activities for a Phase 2b trial for moderate to severe RA and a Phase 2a trial for moderate to severe HS. Continued investment in the further development of Aclaris’ immuno-inflammatory drug development pipeline also contributed to the increase as Aclaris progressed toward the October 2021 IND submission for ATI-2138 and began pre-clinical development activities on ATI-2231.
G&A expenses were $23.6 million for the year ended December 31, 2021 compared to $20.5 million for the prior year period.
The $3.1 million increase was primarily the result of higher stock-based compensation costs as well as higher accounting, compliance and professional fees. Severance payments relating to the retirement of our former Chief Legal Officer also contributed to the increase.
Revaluation of contingent consideration charges related to the Confluence acquisition was $24.3 million for the year ended December 31, 2021 compared to $2.4 million for the prior year period.