On February 17, 2022 At the 2022 ASCO (Free ASCO Whitepaper) GU Cancers Symposium Bayer reported that results from the Phase III ARASENS trial which demonstrated that the use of the oral androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) and docetaxel significantly increased overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to ADT plus docetaxel. Darolutamide plus ADT and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel (HR=0.68, 95% CI 0.57-0.80; P<0.001) (Press release, Bayer, FEB 17, 2022, View Source;ref=irrefndcd [SID1234608324]). At the data cutoff date for the primary analysis (October 25, 2021), the median treatment duration was longer for darolutamide plus ADT and docetaxel (41.0 months) versus ADT plus docetaxel (16.7 months).

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Amid these positive results Bayer raised peak sales expectation for Nubeqa (darolutamide) to exceed €3 billion.

"Subject to regulatory approval, the team at Bayer is excited to be able to offer even more patients suffering from prostate cancer an additional treatment option backed by strong clinical data," said Stefan Oelrich, Member of the Board of Management of Bayer and President of the Pharmaceuticals Division. "With the confirmation of darolutamide’s clinical profile and expansion into the metastatic setting as well as the investments that we are making in clinical trials in other potential indications, we feel that Nubeqa has the potential to generate peak sales of more than 3 billion euros".

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. Based on results from the pivotal Phase III ARAMIS trial, the compound is already approved for the treatment of patients with nmCRPC, who are at high risk of developing metastatic disease, in more than 60 markets worldwide. Results from the second Phase III ARASENS trial evaluating darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC) were presented yesterday as an oral presentation at the 2022 ASCO (Free ASCO Whitepaper) GU Cancer Symposium and simultaneously published in The New England Journal of Medicine. Bayer is already in discussions with health authorities worldwide regarding the submission for marketing authorization in this additional indication.

Darolutamide is being investigated in a broad development program with additional three ongoing or planned large clinical studies, to investigate its potential across prostate cancer patients from the early- to the late-stage of this disease. This includes 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). Information about these trials can be found at www.clinicaltrials.gov. In addition, a study to explore the potential of darolutamide in the early setting for patients who have been treated with surgery or radiation and now see a rise in their prostate specific antigen (PSA) levels is also planned.

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 and ARASENS Phase III trials 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 currently 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). Information about these trials can be found at www.clinicaltrials.gov.

On February 16, 2022 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company focused on developing and commercializing innovative vaccines, reported that it will report fourth quarter and full year 2021 financial results on Monday, February 28, 2022, after the U.S. financial markets close (Press release, Dynavax Technologies, FEB 16, 2022, View Source [SID1234608185]).

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Dynavax will host a conference call and live audio webcast on Monday, February 28, 2022 at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source Alternatively, participants may dial (866) 420-4066 or (409) 217-8237 and refer to conference ID 4678925. A replay of the webcast will be available for 30 days following the live event.

On February 16, 2022 Invitae (NYSE: NVTA), a leading medical genetics company, reported the availability of FusionPlex Dx and LiquidPlex Dx in Europe, part of its industry-leading Anchored Multiplex PCR chemistry in-vitro diagnostic (IVD) products (Press release, Invitae, FEB 16, 2022, View Source [SID1234608168]). Invitae is delivering essential high quality innovation for precision oncology in the fight against cancer.

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With this announcement, Invitae provides the highest quality CE-IVD products to enable European pathologists and oncologists to efficiently provide vital information, in a timely manner, to guide cancer therapy for patients.

"This is a major step toward our mission to bring comprehensive genetic information into mainstream medicine," said Vishal Sikri, President of Oncology at Invitae. "Our best in class FusionPlex and LiquidPlex tests will enable more patients access to the right cancer therapies at the right time, which is especially critical in Europe where the majority of molecular testing is performed locally in decentralized hospital settings."

In line with ESMO (Free ESMO Whitepaper) guidelines for non-small cell lung cancer (NSCLC), Invitae’s FusionPlex Dx and LiquidPlex Dx allow comprehensive genomic profiling (CGP) and companion diagnostic (CDx) use for solid tumor neoplasms including NSCLC in tissue biopsy and where tissue is a limiting factor. The panels are intended to be used on Illumina’s Next Generation Sequencing (NGS) platforms for IVD testing.

"Increasing patient access to content on our instrument fleet through partnerships such as those with Invitae speaks to our mission to improve human health by unlocking the power of the genome," said Joydeep Goswami, Chief Strategy and Corporate Development Officer at Illumina. "We congratulate Invitae on its first CE-IVD cancer testing kits, a significant milestone."

FusionPlex Dx identifies structural variants including fusions in RNA derived from formalin-fixed, paraffin-embedded tumor specimens. FusionPlex Dx covers multiple actionable variants in a 41-gene panel to provide CGP for patients with solid malignant neoplasms. FusionPlex Dx is intended to be used as a CDx to aid in identifying patients diagnosed with NSCLC with mesenchymal-epithelial transition factor (MET) exon 14 (METex14) skipping alterations, anaplastic lymphoma kinase (ALK) fusions, ros proto-oncogene 1, receptor tyrosine kinase (ROS1) fusions, ret proto-oncogene (RET) fusions, neurotrophic receptor tyrosine kinase 1-3 (NTRK1, NTRK2, NTRK3) fusions, and for whom treatment with a targeted therapy may be beneficial.

LiquidPlex Dx identifies substitutions and insertion-deletion mutations in cell-free circulating tumor DNA (ctDNA) isolated from plasma derived from whole blood of cancer patients (liquid biopsy). LiquidPlex Dx interrogates 29 genes to provide CGP for patients with solid malignant neoplasms. LiquidPlex Dx is intended to be used as a CDx to aid in identifying patients diagnosed with NSCLC with METex14 skipping alterations, and for whom treatment with a targeted therapy may be beneficial.

"With Invitae’s simplified workflow and reporting solutions, both tests will enable any facility with sequencing technology, combined with our solutions, to accurately profile solid tumors using tissue or blood samples for therapy selection," said Sikri. "Precision medicine has increasingly delivered better outcomes for many cancer patients over the last several years. Molecular pathology has never been more important as the fight against cancer shifts towards precision oncology and targeted therapies based on genomic testing. Yet globally, access to the exponentially increasing therapy options is not guaranteed."

On February 16, 2022) CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported preliminary and unaudited revenues for the fourth quarter and full-year 2021 and provided an update on key highlights for 2022 (Press release, CASI Pharmaceuticals, FEB 16, 2022, View Source [SID1234608186]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented "In March 2021, we in licensed CB-5339, a first-in-class VCP/p97 inhibitor for the greater China market. In June 2021, we dosed our first patient in our CID-103 program, a fully human IgG1 anti-CD38 monoclonal antibody’s Phase 1 study; and in December 2021, we received CTA approval from CDE for BI-1206, a first-in-class novel anti-FcγRIIB antibody. Thanks to the efforts of the global CASI team, we have been able to successfully advance our pipeline initiatives during 2021 and position ourselves for continued progress during 2022."

"With EVOMELA as our primary commercial product, we have built a commercial group of more than 100 hematology sales and medical marketing specialists in China. We believe that we have significantly increased the value of our commercial franchise and that our commercial franchise brings us closer to the key opinion leaders in the Chinese hematology-oncology space. We believe that the value of our commercial franchise is also is a key reason many global innovators choose to partner with us due to our access to the market and local clinical development resources. In 2021, our commercial franchise has thoroughly prepared for the anticipated China NDA filing of CD19 CAR-T program, which we currently expect to be in late 2022 or early 2023" Dr. He commented.

Dr. He continued, "Our achievements in 2021 form a great foundation from which we plan to build upon throughout 2022 and beyond. We continue preparations for the commercialization of CNCT-19. During 2022, we anticipate that EVOMELA will continue to be the core of our commercial operation, while we further progress our other pipeline assets. During 2022, we anticipate the start of the BI-1206 phase I trial in China; CB-5339 is expected to receive CTA approval from NMPA during 2022; and CID-103’s Phase I study will continue. We are excited by our momentum and will continue to execute on several key milestones across our broad portfolio in the quarters ahead."

Preliminary and Unaudited Fourth Quarter and Unaudited Full-Year 2021 Revenues, Cash Position, and 2022 EVOMELA (melphalan for injection) Revenue Guidance

·The Company anticipates that it will report EVOMELA revenue of approximately $9.12 million for the fourth quarter ended December 31, 2021, and approximately $30 million for the full-year ended December 31, 2021, exceeding the projected $27 million guidance, and representing a 100% percent increase over the 2020 revenue of $15 million.

·The Company is targeting full-year 2022 revenue guidance of more than 30% growth over 2021 for EVOMELA.

·CASI expects to report approximately $38.7 million of cash and cash equivalents as of December 31, 2021.

·The Company’s fourth quarter and full-year 2021 revenues are preliminary and are subject to the completion of the Company’s 2021 audit. Complete fourth quarter and full-year 2021 financial results will be reported in March 2022.

Key Highlights for 2021

CASI continues to advance pipeline products through clinical trial stages in China and globally.

·Our partner, Juventas Cell Therapy Ltd ("Juventas"), continues the development of CNCT19, an autologous CD19 CAR-T investigative product for which CASI has co-commercial and profit-sharing rights. CNCT19 is being developed as a potential treatment for patients with hematological malignancies which express CD19 including, B-cell acute lymphoblastic leukemia ("B-ALL") and B-cell non-Hodgkin lymphoma ("B-NHL"). The Phase 1 studies in B-ALL and B-NHL in China have been completed by Juventas. The Phase 2 B-ALL and B-NHL registration studies are both currently enrolling.

·Along with our partner, BioInvent, we continue to progress the development and regulatory framework for BI-1206 in China. The National Medical Products Administration (NMPA) granted BI-1206 Clinical Trial Application (CTA) approval in December 2021. EC approval from a leading investigational site was granted in January 2022. BI-1206 is BioInvent’s lead drug candidate and is currently being investigated in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of non-Hodgkin lymphoma, which includes patients with FL, MCL and marginal zone lymphoma (MZL) who have relapsed or are refractory to rituximab. A second Phase 1/2 trial is investigating BI-1206 in combination with anti-PD1 therapy Keytruda (pembrolizumab) in solid tumors.

·CB-5339 CTA application for the Multiple Myeloma indication is in preparation after receiving pre-IND feedback from NMPA in January 2022. Cleave Therapeutics is responsible for the ex-China development of CB-5339, an oral second-generation, small molecule VCP/p97 inhibitor, and is evaluating the molecule, in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

·CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. CASI maintains exclusive global rights and is developing CID-103 for the treatment of patients with multiple myeloma. The Phase 1 dose escalation and expansion study of CID-103 in patients with previously treated relapsed or refractory multiple myeloma is ongoing in France and the UK.

On February 16, 2022 Oasmia Pharmaceutical reported that it will publish its year-end report for 2021 on February 24, 2022, at 08.00 am CET (Press release, Oasmia, FEB 16, 2022, View Source [SID1234608169]). The company will hold a conference call and an online presentation on the same day at 10.00 am CET. The call will be hosted by CEO Francois Martelet and CFO Fredrik Järrsten. The presentation will be in English and followed by a question-and-answer session.

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