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.

On April 22, 2022 Amgen (NASDAQ:AMGN) reported that it will report its first quarter financial results on Wednesday, April 27, 2022, after the close of the U.S. financial markets (Press release, Amgen, APR 22, 2022, View Source [SID1234612822]). The announcement will be followed by a conference call with the investment community at 2:00 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

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Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On April 22, 2022 Genoscience Pharma reported that it is enthusiastic, after having selected , about presenting the company during the Company Showcase Presentation Oncology session during Biotrinity on Tuesday morning 26th April (Press release, GenoScience, APR 22, 2022, View Source [SID1234612806]).

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Several Investors and pharma companies will be present during this Business Convention.

Date: 26-27th April 2022

Location: London

On April 22, 2022 Alligator Bioscience will host a conference call (in English) for investors, analysts and media on Wednesday, April 27, 2022, at 15:30 CET (Press release, Alligator Bioscience, APR 22, 2022, View Source [SID1234612805]). Alligator will publish the company’s interim report on Wednesday, April 27, 2022, at 8:00 CET.

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CEO, Søren Bregenholt and CFO, Marie Svensson will present the interim report for the period January – March 2022 Report followed by a Q&A session.

The conference call will be broadcast live on the web and can be accessed via the link: Alligator Bioscience , Audiocast with teleconference, Q1, 2022 | Financial Hearings

On April 21, 2022 Race Oncology reported The March 2022 quarter (Q3 FY 2022) was highlighted by positive preclinical findings that Zantrene (bisantrene dihydrochloride) was found to kill kidney cancer cells both on its own and synergistically in combination with known anti-cancer drugs (ASX announcement: 10 March 2022) (Press release, Race Oncology, APR 21, 2022, View Source [SID1234613998]).

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A second highlight was the results of preclinical work in extramedullary AML, where Zantrene in combination with decitabine was shown to be highly effective in killing a diverse range of AML cells as well as in a mouse model of extramedullary AML (ASX announcement: 17 March 2022).

These results support the planned AML Phase 1 / 2 clinical trial (RAC-006) in extramedullary AML. Our planned extramedullary AML clinical trial was further enhanced with news that Astex Pharmaceuticals has partnered via a supply agreement, under which its oral decitabine and cedazuridine formulation ASTX727 will be provided free of charge to Race (ASX announcement: 30 March 2022). In sum, while the quarter saw some minor delays to planned programs, considerable progress has been made including post quarter Human Ethics approval and governance submission for the extramedullary AML clinical trial (ASX announcement: 6 April 2022)Key events of the quarter

 On 18 January 2022, Race announced that it had received a $708,000 R&D tax refund for the financial year ended 30 June 2021. This reflects investment in Australian based R&D projects and encourages us to utilise Australian based resources, where possible.

 On 23 February 2022, Race announced that MD Anderson Cancer collaborators had published an AML Preclinical study on Zantrene in the Journal Leukemia & Lymphoma. The study confirmed that Zantrene, when used in combination with the AML drugs venetoclax, panobinostat, decitabine and olaparib showed synergies in killing AML cells. This work further supports our extramedullary AML clinical trial plans where Zantrene will be used in combination with decitabine and cytarabine, with the objective of treating extramedullary AML more effectively.

 On 10 March 2022, Race announced results of a preclinical study that confirmed compelling kidney cancer results for Zantrene, both on its own and in combination with known cancer agents. Greater cell killing synergies were observed when Zantrene was combined with lenvatinib, cabozantinib and pazopanib. These results support advancing Zantrene into human kidney cancer trials.

 On 17 March 2022, Race announced AML mouse model results, that showed excellent effectiveness for Zantrene when used in combination with Decitabine, to target extramedullary tumours as well as in the bone marrow and spleen. The results showed that low dose Zantrene used in combination with decitabine killed AML tumours and this supports the planned extramedullary AML trial and possibilities for improved treatment for extramedullary AML patients.

Other news from the quarter  Race expanded the preclinical team through the employment of Emily Ryan as a Research Assistant. Emily is based at the University of Wollongong and is developing new formulations of Zantrene.  Race signed a new supply contract signed with Laurus Laboratories (India) for the large-scale production of Zantrene over the next 2 years.  Dr Daniel Tillett, Race CSO, visited the University of Wollongong (UOW) to formally launch the research collaboration between Race and UOW. This visit was covered by WIN Television News.  Race signed an additional preclinical breast cancer research program with Nikki Verrills of the University of Newcastle exploring novel combinations of Zantrene and breast cancer drugs. The results of this program is expected in Q3 CY 2022. Race initiated of a number of preclinical animal studies exploring the use of Zantrene in AML, multiple myeloma, kidney cancer and breast cancer models with a range of international and Australian contract research organisations. The results of these studies are expected to be reported over the following two quarters. Summary of cash flow and quarterly activity As of 31 March 2022, Race held cash and equivalents of $35.68 million, compared with $37.10 million on 31 December 2021.

The change in cash reserves reflects planned higher research expenditure, offset by an R&D grant of $708k (net change of $1.43m vs $1.79m in the prior quarter). There was a reduction in this quarter’s administrative expense driven by timing differences. Listing rule 4.7C.3 Payments during the quarter to Related Parties amounted to $153k, comprising payments of salaries and superannuation to executive directors of $110k and board fees to non-executive directors of $43k. Shareholders by holding range Race is pleased to report that shareholders totalled 9,423 as of 31 March 2022, showing continued shareholder interest in Race’s progress.

Post quarter news
 On 6 April 2022, Race announced receiving Human Ethics approval and submitting its governance application for its extramedullary AML & Myelodysplastic syndromes (MDS) trial. governance approval is the final step required before initiating the clinical trial and treating the first patient. Approval is expected Q2 CT 2022.
 On 12 April 2022, Race executives Mr Phillip Lynch (CEO & MD) and Dr Daniel Tillett (CSO & ED) agreed to increase their formal time commitment to 75% reflecting an increased in Race related workload over the last 12 months.Expected news In the current quarter, shareholders can expect updates on the following activities:  Pre-clinical in vitro – cell-based programs in breast cancer, multiple myeloma, melanoma, and kidney cancer, as well as in cardioprotection are underway and will report over the next two quarters.

 Pre-clinical in vivo – the melanoma animal study will report during this quarter, with results to be shared as soon as the relevant IP protection process is in place. Animal work assessing cardioprotection and how Zantrene may offset anthracycline and carfilzomib induced heart damage are underway with results to be reported in Q2/3 CY 2022.  Clinical – an update on the relapsed / refractory AML trial in Israel which is in the dose escalation phase (6-12 patients) can be expected this quarter. Governance approval and first patient enrolment expected in Q2 CY 2022 for the extramedullary AML trial. Management commentary Race CEO Phillip Lynch said: "We are moving through CY 2022 with a comprehensive program of activities that will increasingly move into the clinic with expected AML results from Israel and commencement of the RAC-006 trial in Australia.

Our preclinical work is advancing to animal models, and we can expect this to support and guide clinical decisions. Importantly we remain well-resourced financially and in human capability to support our plans." Race CSO Daniel Tillett said: "It has been another busy quarter for Race, building on the new Three Pillar strategy. Zantrene continues to surprise us with positive results and I am looking forward to seeing its potential as we move to treating additional patients in the clinic." Race Chairman John Cullity said: "The strategy for Zantrene continues to form as the drug talks to us through our preclinical and clinical programs. We are coming up to an exciting time, reporting the first glimpses of data from the AML trial in Israel. My thanks goes to our clinical collaborators who continue to strongly support our efforts to bring Zantrene back to market, and to the Race team who are working overtime to realise the drug’s potential."