On May 3, 2022 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, reported first quarter 2022 financial results and provided a corporate update (Press release, Kiniksa Pharmaceuticals, MAY 3, 2022, View Source [SID1234613397]).

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"With the one-year anniversary of our commercial launch of ARCALYST for recurrent pericarditis, we remain committed to supporting the continued growth in prescriber adoption, patient adherence, and payer coverage," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "Looking to the rest of the year, we anticipate continued efficient commercial execution and key progress of our clinical-stage pipeline."

Corporate Update:

In February, Kiniksa and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (Huadong Medicine) announced a strategic collaboration to develop and commercialize ARCALYST and mavrilimumab in the Asia Pacific Region, excluding Japan.
Kiniksa received a total upfront payment of $22.0 million, consisting of $12.0 million and $10.0 million for the rights to ARCALYST and mavrilimumab, respectively, in the Asia Pacific Region.
Kiniksa is eligible to receive up to approximately $640.0 million in specified development, regulatory, and sales-based milestones as well as tiered royalties ranging from the low-teens to the low-twenties on annual net sales.
Portfolio Execution
ARCALYST (IL-1α and IL-1β cytokine trap)

ARCALYST net revenue was $22.2 million for the first quarter of 2022.
More than 400 prescribers have written ARCALYST prescriptions for recurrent pericarditis since launch, with a growing number of repeat prescribers.
Approximately 95% of completed patient enrollment cases for recurrent pericarditis were approved for coverage in the first quarter of 2022.
Approximately 60% of recurrent pericarditis patients who started ARCALYST in the second quarter of 2021 remained on continuous therapy through the end of the first quarter of 2022.
Vixarelimab (monoclonal antibody inhibitor of signaling through OSMRβ)

Kiniksa expects data from the Phase 2b dose-ranging clinical trial of once-monthly subcutaneous vixarelimab in prurigo nodularis in the second half of 2022.
KPL-404 (monoclonal antibody inhibitor of CD40-CD154 signaling)

Kiniksa is conducting a Phase 2 clinical trial of KPL-404 in rheumatoid arthritis which is designed to enable potential development in a spectrum of autoimmune diseases believed to be mediated by the CD40-CD154 pathway.
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)

Kiniksa is evaluating the development of mavrilimumab in rare cardiovascular diseases where the granulocyte macrophage colony stimulating factor (GM-CSF) mechanism has been implicated and that have synergies with the company’s existing commercial infrastructure.
Financial Results

Total revenue for the first quarter of 2022 was $32.2 million, consisting of $22.2 million in ARCALYST net product revenue and $10.0 million in collaboration revenue, representing the upfront payment from Huadong Medicine for the rights to mavrilimumab in the Asia Pacific Region. Kiniksa did not generate revenue in the first quarter of 2021.
The upfront payment of $12.0 million from Huadong Medicine for the rights to ARCALYST in the Asia Pacific Region was deferred and will be recognized over the life of the agreement.
Total operating expenses for the first quarter of 2022 were $55.5 million, compared to $49.3 million for the first quarter of 2021.
Collaboration expenses in the first quarter of 2022 were $8.3 million reflecting two obligations payable to Regeneron Pharmaceuticals, Inc. (Regeneron): a $2.3 million ARCALYST profit-split expense and a $6.0 million expense, representing 50% of the upfront payment from Huadong Medicine for the rights to ARCALYST in the Asia Pacific Region. Kiniksa did not report collaboration expenses in the first quarter of 2021.
Non-cash, share-based compensation expense for the first quarter of 2022 was $6.0 million, compared to $7.1 million for the first quarter of 2021.
Net loss for the first quarter of 2022 was $25.2 million, compared to a net loss of $49.5 million for the first quarter of 2021.
As of March 31, 2022, the company had $145.6 million of cash, cash equivalents and short-term investments and no debt.
Financial Guidance

Kiniksa expects ARCALYST net revenue for the full-year 2022 to be between $115 million and $130 million.
Kiniksa expects that its cash and cash equivalents will fund its current operating plan into at least 2024.
Conference Call Information

Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, May 3, 2022, to discuss first quarter 2022 financial results and to provide a corporate update.
Individuals interested in participating in the call should dial (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 7787467. To access the webcast, please visit the Investors and Media section of Kiniksa’s website. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.

On May 3, 2022 Bayer reported the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for the oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) (Press release, Bayer, MAY 3, 2022, View Source [SID1234613431]).

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The sNDA is based on positive results from the investigational Phase III ARASENS trial demonstrating a statistically significant improvement in overall survival (OS) for NUBEQA plus androgen deprivation therapy (ADT) and docetaxel in men with mHSPC compared to ADT plus docetaxel, which were published in The New England Journal of Medicine.1 NUBEQA is currently indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

"Bayer remains dedicated to addressing unmet needs in prostate cancer treatment for various stages of the disease," said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceutical Division and Head of the Oncology SBU at Bayer. "Today’s sNDA acceptance, confirmation of Priority Review and participation in Project Orbis, bring us closer to adding a new indication for NUBEQA in combination with docetaxel to benefit men with mHSPC."

The application is being conducted under the FDA Oncology Center of Excellence’s (OCE) Project Orbis initiative, which provides a framework for concurrent submission and review of cancer treatments among participating international health authorities.

Bayer recently submitted applications to the European Medicine Agency (EMA), the Ministry of Health, Labor and Welfare (MHLW) in Japan, and China’s Center of Drug Evaluation (CDE). Additional submissions in mHSPC are planned globally.

About the ARASENS Trial2

The ARASENS trial (NCT02799602) is the only randomized, Phase III, multi-center, double-blind, placebo-controlled trial prospectively designed to compare the use of a second-generation androgen receptor inhibitor (ARi) (NUBEQA) plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel to ADT plus docetaxel (a guideline recommended standard-of-care) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). A total of 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of NUBEQA twice a day or matching placebo, plus ADT and docetaxel.

The primary endpoint of this trial was overall survival (OS). Secondary endpoints included time to castration-resistant prostate cancer (CRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent anticancer therapy, all measured at 12-week intervals, as well as adverse events (AEs) as a measure of safety and tolerability.

About NUBEQA (darolutamide)3

NUBEQA is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.3

On July 30, 2019, the FDA approved NUBEQA (darolutamide) based on the ARAMIS trial, a randomized, double-blind, placebo-controlled, multi-center Phase III study, which evaluated the safety and efficacy of oral NUBEQA in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were receiving a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of NUBEQA orally twice daily in combination with androgen deprivation therapy (ADT) or ADT alone. The primary efficacy endpoint was metastasis-free survival (MFS). NUBEQA is also being investigated in further studies across various stages of prostate cancer, including in the ARANOTE Phase III trial evaluating NUBEQA plus ADT versus ADT alone for metastatic hormone-sensitive prostate cancer (mHSPC), as well as in the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating NUBEQA as an adjuvant treatment for localized prostate cancer with very high risk of recurrence. Information about these trials can be found at www.clinicaltrials.gov.

Developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, NUBEQA is indicated for the treatment of men with nmCRPC.3 The approvals of NUBEQA for nmCRPC in the U.S., European Union (EU), and other global markets have been based on the pivotal Phase III ARAMIS trial data evaluating the efficacy and safety of NUBEQA plus ADT compared to ADT alone.3 Filings in other regions are underway or planned.

INDICATION FOR NUBEQA (darolutamide)

NUBEQA (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

IMPORTANT SAFETY INFORMATION FOR NUBEQA (darolutamide)

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Adverse reactions occurring more frequently in the NUBEQA arm (≥2% over placebo) were fatigue (16% vs 11%), pain in extremity (6% vs 3%) and rash (3% vs 1%).

Clinically significant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs 3.4% on placebo) and heart failure (2.1% vs 0.9% on placebo).

Drug Interactions

Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.

Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.

Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.

Review the prescribing information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Metastatic Hormone-Sensitive Prostate Cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide.4

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy.5,6 Upon relapse, when the disease will metastasize or spread, the disease is hormone-sensitive and androgen deprivation therapy (ADT) is the cornerstone of treatment. Current treatment options for men with metastatic hormone-sensitive prostate cancer (mHSPC) include hormone therapy, such as ADT, androgen receptor pathway inhibitors plus ADT or a combination of docetaxel chemotherapy and ADT. Despite these treatments, a large proportion of men with mHSPC will eventually experience progression to metastatic castration-resistant prostate cancer (mCRPC), a condition with high morbidity and limited survival.7,8

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

On May 3, 2022 Omega Therapeutics (NASDAQ: OMGA) (Omega), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming platform, reported that will present preclinical data on its novel Omega Epigenomic Controller (OEC) to regulate expression of the c-Myc (MYC) oncogene via epigenomic programming in models of NSCLC in a poster presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting, taking place in Washington, D.C., May 16-19, 2022 (Press release, Omega Therapeutics, MAY 3, 2022, View Source [SID1234613448]).

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"These preclinical data establish epigenomic programming as a differentiated approach to correct aberrant MYC expression by control of its insulated genomic domain (IGD) in NSCLC, which accounts for almost 25% of cancer deaths worldwide," said Thomas McCauley, Ph.D., Omega’s Chief Scientific Officer. "Combined with our previously presented data demonstrating sustained MYC downregulation in preclinical models of hepatocellular carcinoma by our lead OEC, these new results further highlight the power of our approach and the capabilities of our platform, fueled by our pioneering research, to design and develop potentially transformative medicines."

Details for the poster presentation:

Title: Novel Epigenetic Targeting of the MYC Oncogene for the Treatment of NSCLC using programmable mRNA therapeutics
Abstract #: 1114
Date and Time: Wednesday, May 18, 2022, from 5:30 p.m. through 6:30 p.m. EDT

Key findings:

OEC treatment yields precise, targeted changes in the epigenetic landscape of the MYC IGD in NSCLC cell lines
Epigenetic changes drive robust downregulation of both MYC mRNA and protein in multiple NSCLC cell lines, leading to associated changes in MYC-driven genes and an increase in cell death via apoptosis
Treatment with the OEC did not strongly impact the viability of healthy primary lung epithelial and endothelial cells
Combining OEC treatment with either a MEK or EGFR inhibitor in NSCLC cells yielded greater reductions in MYC protein and cell viability, suggesting the potential for additive or synergistic effects of the OEC with standard of care therapies in patients
OEC treatment effectively reduced tumor growth in vivo and was well tolerated in murine xenograft models, further supporting the therapeutic potential of this asset

On May 3, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that it will announce its financial results for the first quarter of 2022 on Wednesday, 11 May 2022 (Press release, Evotec, MAY 3, 2022, View Source [SID1234613504]).

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The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our homepage shortly before the event.

The on-demand version of the webcast will be available on our website: View Source

On May 3, 2022 AmerisourceBergen (NYSE: ABC), Cardinal Health (NYSE: CAH) and McKesson (NYSE: MCK) reported that they have reached an agreement with the Washington Attorney General, under which the distributors will pay up to $518 million to the State of Washington and its participating subdivisions to resolve opioid-related claims (Press release, Cardinal Health, MAY 3, 2022, View Source [SID1234613639]). This amount is consistent with Washington’s allocation under the previously announced comprehensive agreement to settle the vast majority of the opioid lawsuits filed by state and local governmental entities, as well as certain attorneys’ fees and costs.

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Upon effectiveness of the settlement, the State of Washington will dismiss the lawsuit that is currently being tried. The agreement is subject to certain contingencies, including the rate of subdivision participation. The terms of the agreement with the State of Washington are consistent with the comprehensive settlement agreement, which became effective on April 2, 2022.

While the companies strongly dispute the allegations made in the plaintiffs’ complaints and during trial, they believe that resolving all of the litigation filed by the State of Washington and its political subdivisions will further the companies’ goal of achieving broad resolution of governmental opioid claims while delivering meaningful relief to communities across the United States that have been impacted by the opioid epidemic.