On April 22, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence (A.I.) and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that it will report its first quarter 2022 financial results on Tuesday, May 3, 2022, after the financial markets close (Press release, Lantern Pharma, APR 22, 2022, View Source [SID1234612841]). The company will host a conference call and webcast in a webinar format at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time on Tuesday, May 3, 2022.

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Management intends to discuss the operating and financial results for the first quarter ended March 31, 2022 and provide guidance on upcoming milestones. Panna Sharma, President and Chief Executive Officer of Lantern Pharma, will lead the call and will be joined by other members of the management team.

To register for the webinar, please sign up here: View Source

A replay of the webinar will be available on the investor relations section of the Company’s website: ir.lanternpharma.com.

On April 22, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), reported the start of data analysis of the multi-center, global Phase III AGENT Study investigating arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab in advanced, metastatic colorectal cancer (mCRC) (Press release, Isofol Medical, APR 22, 2022, View Source [SID1234612840]). The kick-off of the read-out process follows discussions with the U.S. Food and Drug Administration (FDA) on the censoring rules and the number of PFS events required to start the data gathering and analysis. Isofol will determine the number of PFS events for cut-off, which will then be considered by the FDA during the NDA review.

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The diligent review of options for a revised SAP led to new considerations for analyzing the data. Isofol will now submit analyses of the study based on 490 patients enrolled in the study (Japanese patients previously in addendum added to main study) and both the original and new censoring rules will be included in the New Drug Application (NDA). The integrity of the AGENT Study remains strong. Isofol is firmly focused on a comprehensive analysis and expects it will take two – four months from the start of the analysis before top-line results can be communicated.

Colorectal cancer is the third leading cause of cancer in the world and the second leading cause of cancer mortality with almost one million deaths in 2020. Recent advancements in mCRC treatment have focused on targeted therapies for select populations and still require combination with 5-FU based chemotherapy regimens for meaningful results during treatment. This means that almost all first line mCRC patients will receive a folate containing regimen as part of standard of care. 

"There is a profound unmet need in metastatic colorectal cancer, yet few therapies are being studied to benefit the majority of patients vs. specific targets," said Ulf Jungnelius, CEO of Isofol. "At Isofol, we have been singularly focused on identifying a simple and more effective modernization of the standard of care to further reduce the tumor burden and increase life span for more patients." 

For the past 40 years, 5-FU has been administered to more than 70 percent of patients with mCRC in combination with leucovorin/levoleucovorin and other cytostatics. Despite these combinations, only a limited portion of patients become eligible for surgical resection (higher in liver-limited disease), an effective way to achieve sustainable outcomes. And only 10 percent of people living with mCRC survive five years after diagnosis. Arfolitixorin is the first and only immediately active folate that bolsters 5-FU, enhancing its tumor-killing effect.

Audiocast, April 22, at 3:00 p.m. CEST.

In connection to this announcement Isofol invites investors, analysts, and media to an audiocast (in English) with a Q&A-session. The presentation will be held in English by Isofol’s CEO Ulf Jungnelius and CMO Roger Tell and will conclude with a Q&A session. Questions can be asked on the telephone conference or in written form through the webcast. No preregistration is needed.

Date and time
April 22, 2022, at 3:00 p.m. CEST

Webcast link
View Source

Dial-in numbers
For dialing in to the call, please use to following numbers:

SE: +46850558359
UK: +443333009263
US: +1 6319131422 PIN: 99623879#

The webcast will also be available on demand on Isofol’s corporate website after the event.

On April 22, 2022 Incyte (Nasdaq:INCY) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA) has issued a positive opinion that recommends granting marketing authorization for capmatinib (Tabrecta) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymalepithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy (Press release, Incyte, APR 22, 2022, View Source [SID1234612836]).

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"We are pleased by the positive CHMP opinion recommending capmatinib as a treatment for certain patients with METex14 advanced non-small cell lung cancer and encouraged by what this Incyte-discovered product could mean for patients in Europe," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. "Now patients in Europe who have advanced NSCLC with alterations leading to METex14 skipping are closer to having another therapeutic option that may target the recognized oncogenic driver of their cancer."

The CHMP opinion is based on data the Phase 2 GEOMETRY mono-1 study that demonstrated positive overall response rates (ORR) among adult patients with advanced NSCLC whose tumors have alterations leading to METex14 skipping1. Based on data presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, in the 31 patients who received Tabrecta as second-line therapy in the METex14 skipping pretreated population, a confirmed ORR of 51.6% (95% CI, 33.1-69.8)was achieved, and the ORR across all 100 previously-treated patients, which included patients who received one or two prior lines of systemic therapy, was 44.0% (95% CI, 34.1-54.3)1. The most common treatment-related adverse events (AEs) (incidence ≥20%) were peripheral oedema, nausea, fatigue, vomiting, dyspnea, decreased appetite and back pain1.

"Patients with alterations leading to METex14 skipping have an urgent need for treatment options, as this form of lung cancer is aggressive, often diagnosed in an advanced stage and frequently comes with a poor prognosis," said Juergen Wolf, MD, from the Center for Integrated Oncology, University Hospital Cologne, Germany, and lead investigator of the GEOMETRY mono-1 trial. "The positive CHMP opinion for Tabrecta brings an option to for a treatment specific to their tumor. If approved by the European Commission, new targeted therapies like Tabrecta—supported by early and broad molecular testing of patients’ tumors—can better guide treatment decisions and ensure patients receive the appropriate therapy for their cancer."

In the European Union, there are an estimated 291,000 patients with locally advanced or metastatic NSCLC4. METex14 skipping, a recognized oncogenic driver2, occurs in approximately 3-4% of NSCLC cases3.

Novartis has exclusive worldwide development and commercialization rights to Tabrecta. Incyte is eligible for a total of over $500 million in milestones as well as royalties of between 12-14% on global net sales by Novartis.

About GEOMETRY mono-1
The Novartis-sponsored GEOMETRY mono-1 trial is a Phase 2, multi-center, non-randomized, open-label, multi-cohort study in adult patients with EGFR wild-type, ALK-negative rearrangement, advanced NSCLC with alterations that lead to MET exon-14 skipping who received 400 mg of capmatinib orally twice daily1.

Patients were assigned to cohorts on the basis of MET status and previous lines of therapy. The primary endpoint was overall response rate (ORR) based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. The key secondary endpoint was duration of response (DOR) evaluated by BIRC1.

Mature data from the trial, including from an expansion cohort analysis, showed Tabrecta demonstrated a median duration of response of 9.7 months (95% CI, 5.6-13.0) in all previously-treated patients (n=100)1. In addition, Tabrecta demonstrated a median overall survival of 13.6 months (95% CI, 8.6-22.2) in previously-treated patients (n=69)1. The median progression-free survival was 5.5 months (95% CI, 4.2‑8.1) for all previously-treated patients (n=100) and 6.9 months (95% CI, 4.2-13.3) for patients who received Tabrecta as second-line therapy (n=31)1. The Disease Control Rate across all previously-treated patients was 82.0% (95% CI, 73.1-89.0)1. The expansion cohort analysis enrolled 160 patients with MET alterations and included previously-treated cohorts (n=100) who had been treated with one or two prior lines of systemic therapy for advanced disease, as well as treatment-naive cohorts (n=60)1.

Overall, Tabrecta demonstrated a manageable safety profile and there were no new safety signals or unexpected safety findings1. The most common treatment-related adverse events (AEs) (incidence ≥20%) were peripheral oedema, nausea, fatigue, vomiting, dyspnea, decreased appetite and back pain1.

About Tabrecta (capmatinib)
Tabrecta is approved in several countries including the U.S., Japan and Switzerland. It is the number one prescribed targeted therapy for patients with advanced NSCLC with alterations leading to METex14 skipping globally5.

Tabrecta is a kinase inhibitor that targets MET. Tabrecta was discovered by Incyte and licensed to Novartis in 2009. Under the agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.

About MET exon 14 skipping
MET (mesenchymal-epithelial transition), a receptor tyrosine kinase coded by the MET gene, normally plays an important role in cell signaling, proliferation and survival2. Many cancers are associated with abnormal signaling through the MET receptor pathway, caused by multiple mechanisms including point mutations, insertions, and deletions that lead to skipping of exon 14. MET exon 14 (METex14) skipping is an oncogenic alteration in NSCLC that can result in overstimulation of the MET pathway2.

Patients with alterations that lead to METex14 skipping often have a poor prognosis due to the aggressiveness of the cancer and limited treatment options6-8.

On April 22, 2022 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that the Company will host a conference call and live audio webcast on Wednesday, May 4, 2022 at 5:00 PM ET to report its first quarter 2022 financial results and provide a corporate update (Press release, Fate Therapeutics, APR 22, 2022, https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-first-7 [SID1234612831]).

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In order to participate in the conference call, please dial (877) 303-6235 (domestic) or (631) 291-4837 (international) and refer to conference ID 9978043. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

On April 22, 2022 Bayer reported the submission of a regulatory application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), for the oral androgen receptor inhibitor (ARi) darolutamide (Press release, Bayer, APR 22, 2022, View Source;sessionID=1650690511 [SID1234612824]). Bayer is seeking approval for the use of darolutamide for the treatment of adult patients with metastatic hormone sensitive prostate cancer (mHSPC) in combination with docetaxel. The compound is already approved under the brand name Nubeqa for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease, in more than 60 markets around the world, including the U.S., the European Union (EU), Japan and China.

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The CDE submission is supported by positive results from the Phase III ARASENS trial, showing a statistically significant improvement in overall survival (OS) for darolutamide plus androgen deprivation therapy (ADT) and docetaxel in men with mHSPC. These results were presented in February at the 2022 ASCO (Free ASCO Whitepaper) GU Cancers Symposium and simultaneously published in The New England Journal of Medicine.

"The incidence and mortality rate of prostate cancer continues to rise in China, and nearly a third of newly diagnosed patients have metastatic disease. Additionally, a large proportion of men living with mHSPC will experience disease progression within 2-3 years. There is therefore a significant need for treatment options that extend overall survival and delay disease progression," said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology SBU at Bayer. "Bringing forward this potential new treatment option with high efficacy and a favorable safety profile to more appropriate patients around the world, is part of Bayer’s broader commitment to improve outcomes for men living with prostate cancer."

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. Additional submissions in mHSPC are planned globally. The compound is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801).

About the ARASENS Trial
The ARASENS trial is the only randomized, Phase III, multi-center, double-blind, trial which was prospectively designed to compare the use of a second-generation oral androgen receptor inhibitor (ARi) plus androgen deprivation therapy (ADT) and docetaxel to ADT plus docetaxel (a guideline recommended standard-of-care) in 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 darolutamide 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 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.1

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. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately 5% of men will already suffer from prostate cancer with distant metastases when first diagnosed. 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 the chemotherapy docetaxel and ADT. Despite these treatments, a large proportion of men with mHSPC will eventually progress to metastatic castration-resistant prostate cancer (mCRPC), a condition with high morbidity and limited survival.

About Nubeqa (darolutamide)
Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans. A low blood-brain barrier penetration would explain the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS Phase III trial and the improved verbal learning and memory observed in the darolutamide arm of the Phase II ODENZA trial.

The product is approved under the brand name Nubeqa in more than 60 markets around the world, including the U.S., EU, Japan, China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The compound is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801). Information about these trials can be found at www.clinicaltrials.gov.

About Prostate Cancer at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. Prostate cancer is the second most commonly diagnosed cancer in men1 and a key area of focus for Bayer. The company’s franchise includes two products on the market (Nubeqa and Xofigo) and several compounds in development, including a unique approach of advancing targeted alpha therapies. Bayer is focused on addressing the unique needs of prostate cancer patients, providing treatments that extend their lives throughout the different stages of the disease and allowing them to continue their everyday activities, so that they can live longer, better lives.