On May 4, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) and the University Hospital Erlangen reported a partnership regarding molecular analyses of biospecimens from the German Chronic Kidney Disease ("GCKD") cohort study (Press release, Evotec, MAY 4, 2021, View Source;announcements/press-releases/p/evotec-and-the-gckd-study-enter-into-strategic-collaboration-to-build-a-unique-molecular-patient-database-6059 [SID1234579038]). Under the agreement, the research team will make use of Evotec’s proprietary EVOpanOmics and EVOpanHunter platforms to facilitate deep molecular profiling of patient samples. The Evotec platforms combine enhanced throughput proteomics, high-throughput transcriptomics and integrated data analysis.

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Initiated in 2009, GCKD was designed to be the world’s largest cohort study on chronic kidney disease. Scientists from eleven universities work together with more than 150 practicing nephrologists to monitor more than 5,000 patients with CKD with biospecimens being taken and supporting interviews being conducted multiple times during the interval. Evotec will also financially support GCKD, which will enable the extension of this important cohort study beyond the initial term of 10 years, allowing future follow-up visits and additional sample analysis.

The multi-omics analysis of the biospecimens from the GCKD cohort study is expected to lead to a deeper understanding of different kidney disease etiologies, their respective disease mechanisms, progression and potential complications. Together with Evotec’s existing molecular patient database, this systematic integrated exploitation of the GCKD biobank will open the door to novel starting points for drug discovery and the identification of biomarkers, enabling precision medicine approaches for highly effective treatment options for clearly defined patient populations.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We continue to work towards our goal to build a highly comprehensive molecular patient database. This collaboration is a major step forward towards this goal and we are very excited about the opportunity to work with this unique network. The GCKD cohort not only complements and expands our already leading kidney disease data base with well-documented long-term survey of CKD patients and corresponding patient samples. The more comprehensive the data base, the more impactful it will be in re-defining patient populations according to disease mechanisms rather than symptoms, identify suitable molecular targets for intervention and stratify patient populations for clinical trials."

Prof. Dr Kai-Uwe Eckardt, Director of the Department of Nephrology and Medical Intensive Care at the Charité – Universitätsmedizin Berlin, and Principal Investigator of the GCKD Study, said: "CKD is a severe health problem that affects 10% of the population. The underlying mechanisms are complex and strong efforts are urgently needed to better understand this complexity. We are very excited to enter this collaboration with Evotec, which creates novel synergies and provides the prospect for innovative diagnostic and therapeutic approaches that can be translated into patient care."

Prof. Dr Anna Köttgen, Head of the Institute of Genetic Epidemiology at the University of Freiburg, and Member of the GCKD Steering Committee added: "We are looking forward to expand the spectrum of molecular analyses in this cohort, which will greatly facilitate the discovery of robust associations between complex molecular phenotypes and clinical outcomes."

"One of the challenges in studying CKD is the gradual decline of kidney function that may eventually lead to kidney failure. The GCKD study is unique as a long-term observational study and its extension will further increase the value of this huge research project," added Prof. Dr Mario Schiffer, Director of the Department of Nephrology and Hypertension at the Friedrich-Alexander-Universität Erlangen-Nürnberg, and also Member of the GCKD Steering Committee.

On May 4, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that it will announce its financial results for the first quarter of 2021 on Tuesday, 11 May 2021 (Press release, Evotec, MAY 4, 2021, View Source;announcements/press-releases/p/evotec-se-to-announce-results-for-the-first-quarter-2021-on-11-may-2021-6061 [SID1234579037]).

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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.

Conference call details

Date: Tuesday, 11 May 2021

Time: 02.00 pm CET (08.00 am EST, 01.00 pm GMT)

On May 4, 2021 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that it has received a response from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application that the study for selection and treatment of Prostate-Specific Membrane Antigen (PSMA) positive prostate cancers using 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA may proceed (Press release, Clarity Pharmaceuticals, MAY 4, 2021, View Source [SID1234579036]).

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The SECuRE trial (Systemic Cu theranostics in prostate cancer) is a Phase I/IIa study for identification and treatment of PSMA-expressing metastatic castrate resistant prostate cancer (mCRPC), which will be conducted in the U.S. (NCT04868604)1. It is a theranostic multi-centre, single arm, dose escalation study with a cohort expansion planned for up to 44 patients. The trial employs diagnostic Positron Emission Tomography imaging with 64Cu-SAR-bisPSMA for selection of patients suitable for therapy cycles with 67Cu-SAR-bis-PSMA.

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of death worldwide2. The American Cancer Society estimates in 2021 there will be 248,530 new cases of prostate cancer in the U.S. and around 34,130 deaths from the disease3. For metastatic prostate cancer, the 5-year relative survival rate is 30%, indicating a high unmet need for early detection and better treatment options for mCRPC. Annually, there are around ~34,000 men in the U.S. who are diagnosed with mCRCP3, ~90% of whom have tumours which express PSMA4.

Although there are some new therapeutic radiopharmaceutical agents for prostate cancer in late phase clinical trials, given the large patient population, product supply for therapeutic radiopharmaceuticals presents a constraint as they rely on the production of therapeutic isotopes from a small number of nuclear reactors, with reactor shutdowns often causing isotope shortages around the globe.

Clarity’s SAR-bisPSMA product utilises two isotopes of copper, which do not have the same constraints:

The therapeutic product utilises copper-67, which is being produced domestically in the USA on electron accelerators, avoiding the issues commonly associated with the production of isotopes on nuclear reactors.
The diagnostic product utilises copper-64, which is regularly produced in significant volumes on cyclotrons in the U.S., and has a half-life of 12.7 hours, avoiding the short half-life issues of other diagnostic isotopes.
The diagnostic and therapeutic products can be centrally manufactured and shipped as finished product direct to the treatment centres, which removes the need for dedicated radiopharmacy facilities at treatment centres.
Dr Alan Taylor, Clarity’s Executive Chairman, commented on the IND approval, "The FDA response suggests not only the importance of developing novel treatments for men with late-stage prostate cancer, whose prognosis is currently very poor, but also validates Clarity’s copper pairing paradigm and the centralised manufacturing concept, which differentiates it from the competitor products and enables product supply to the levels suitable for use in large patient indications."

"We are very excited to commence the SECuRE trial in mCRCP patients and have engaged a world class group of key opinion leaders in the prostate cancer space to support the development of 64/67Cu SAR-bisPSMA. Clarity’s Global Clinical Development Group has unrivalled experience in the commercialisation of the only currently approved radiotherapeutic for prostate cancer. The FDA response is a crucial milestone in the development of SAR-bisPSMA theranostics and we are looking forward to progressing this trial at some of the leading cancer centres in the U.S. as part of our ultimate goal of developing better treatments for children and adults with cancer," said Dr Taylor.

Reference List
National Institute of Health, U.S. National Library of Medicine, View Source
World Cancer Research Fund, Prostate Cancer Statistics, View Source
American Cancer Society, Cancer Statistics Center, View Source!/cancer-site/Prostate
A. Silver, I. Pellicer, W. R. Fair, W. D. Heston and C. Cordon-Cardo 1997. "Prostate-specific membrane antigen expression in normal and malignant human tissues." Clinical Cancer Research. vol. 3, 81-85, January 1997

On May 4, 2021 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Arvinas, MAY 4, 2021, View Source [SID1234579035]).

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"Last quarter we reinforced our leadership position in the targeted protein degradation space by sharing the discovery and chemical structures of ARV-110 and ARV-471 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, the first such disclosure of our clinical-stage PROTAC degraders," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. "We look forward to further demonstrating the potential of our PROTAC platform to change the lives of patients with few or no therapeutic options."

Business Highlights and Recent Developments

Presented preclinical data describing the discovery of Arvinas’ two clinical-stage PROTAC degraders, ARV-110 and ARV-471, including the first disclosures of their structures at AACR (Free AACR Whitepaper)
Anticipated Milestones and Expectations

ARV-471

Completion of the Phase 1 dose escalation (1H21)
Presentation of completed Phase 1 dose escalation data (2H21)
Interim review of safety and dose finding data from the Phase 1b trial in combination with Ibrance (palbociclib) (2H21)
Initiation of a window of opportunity study in early breast cancer (2H21)
Initiation of a combination trial of ARV-471 and another targeted therapy in 2L/3L metastatic breast cancer (2H21)
ARV-110

Completion of the Phase 1 dose escalation (1H21)
Presentation of completed Phase 1 dose escalation data (2H21)
Presentation of interim data from the ARDENT Phase 2 dose expansion at 420 mg (2H21)
Initiation of combination trial(s) with standard(s)-of-care (2021)
Other Clinical Milestones

Initiation of first-in-human study of ARV-766, an androgen receptor (AR) degrader with a differentiated profile from ARV-110, in patients with metastatic castration-resistant prostate cancer (1H21)
Financial Guidance

Based on its current operating plan, Arvinas expects its cash, cash equivalents, and marketable securities will be sufficient to fund its planned operating expenses and capital expenditures into 2024.

First Quarter Financial Results

Cash, Cash Equivalents and Marketable Securities Position: As of March 31, 2021, cash, cash equivalents and marketable securities were $651.3 million as compared with $688.5 million as of December 31, 2020. The decrease primarily related to cash used to fund operations of $43.9 million, cash used to purchase fixed assets and leasehold improvements of $1.0 million and unrealized losses of $0.8 million, partially off-set by proceeds from two collaborators of $4.0 million and proceeds from the exercise of stock options of $4.5 million.

Research and Development Expenses: Research and development expenses were $34.9 million for the quarter ended March 31, 2021 as compared with $21.7 million for the quarter ended March 31, 2020. The increase in research and development expenses for the quarter of $13.2 million primarily related to Arvinas’ continued investment in its platform, exploratory and lead optimization programs of $8.3 million, its AR program of $1.5 million and estrogen receptor program (ER) of $3.4 million.

General and Administrative Expenses: General and administrative expenses were $12.3 million for the quarter ended March 31, 2021 as compared with $7.9 million for the quarter ended March 31, 2020. The increase in general and administrative expenses for the quarter of $4.4 million related to an increase of $3.6 million in personnel and facility related costs, including $1.8 million related to stock compensation expense, and insurance, taxes and professional fees of $0.8 million.

Revenues: Revenues were $5.5 million for the quarter ended March 31, 2021 as compared with $6.2 million for the quarter ended March 31, 2020 and was generated from the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer that was initiated in July 2019, the collaboration and license agreement with Pfizer that was initiated in January 2018, and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017. The decrease in collaboration revenue of $0.7 million for the quarter was primarily related to a collaborator adding new targets that extended the period of revenue recognition for that collaboration agreement.

Net Loss: Net loss was $41.0 million for the quarter ended March 31, 2021 as compared with $21.7 million for the quarter ended March 31, 2020. The increase in net loss for the quarter ended March 31, 2021 of $19.3 million primarily related to Arvinas’ continued investment in its platform, exploratory and lead optimization programs, its AR program, its ER program, and an increase in general and administrative costs.

About ARV-110
ARV-110 is an investigational orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.

ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

About ARV-471
ARV-471 is an investigational orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.

About ARV-766
ARV-766 is an investigational orally bioavailable PROTAC protein degrader designed to selectively target and degrade AR. In preclinical studies, ARV-766 degraded all resistance-driving point mutations of AR, including L702H, a mutation associated with treatment with abiraterone and other AR-pathway therapies.

ARV-766 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer, and ARV-766 may also have applicability in other AR-driven diseases both in and outside oncology. ARV-766 has demonstrated activity in preclinical models of resistance to currently available AR-targeted therapies.

On May 4, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that the European Commission (EC) has approved an additional indication for the oral once-daily therapy XTANDI (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC) (Press release, Astellas, MAY 4, 2021, View Source [SID1234579030]). Men diagnosed with mHSPC tend to have a poor prognosis, with a median survival of approximately 3-4 years,1 underscoring the need for new treatment options.

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With this indication, enzalutamide is now the only oral treatment approved by the EC to treat three distinct types of advanced prostate cancer — non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mHSPC.2 The EC approval is based on results from the pivotal Phase 3 ARCHES trial which evaluated enzalutamide in men with mHSPC.3

"Metastatic hormone-sensitive prostate cancer patients have limited options and, unfortunately, there is a poor prognosis for many men," said Andrew Armstrong, M.D., Professor of Medicine, Surgery, Pharmacology and Cancer Biology, Director of Research in the Duke Cancer Institute’s Center for Prostate and Urologic Cancers and lead investigator of ARCHES. "The research supporting this approval provides clinical evidence showing how enzalutamide can help improve outcomes for men with mHSPC, which gives healthcare professionals in Europe the option to offer the treatment across the advanced prostate cancer disease continuum."

Data from the ARCHES trial showed enzalutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 61% versus placebo plus ADT in men with mHSPC (n=1,150; hazard ratio [HR]=0.39 [95% confidence interval (CI): 0.30-0.50]; P<0.0001).3

"Enzalutamide has been an established standard of care for men with advanced prostate cancer and has been prescribed to more than 610,000 patients worldwide since it was first approved in 2012," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development, Astellas. "This new indication for enzalutamide provides men with mHSPC a much-needed, additional therapy option earlier in their treatment journey. We look forward to working with health authorities across Europe to ensure men with mHSPC have access to enzalutamide as soon as possible."

The safety analyses of the ARCHES trial appear consistent with the safety profile of enzalutamide in previous clinical trials in CRPC. In ARCHES, Grade 3 or greater adverse events (AEs) (defined as severe/disabling or life-threatening) were similar for patients receiving both enzalutamide plus ADT and those who received placebo plus ADT (24.3% vs. 25.6%).3

The EC marketing authorization for enzalutamide in men with mHSPC is applicable to European Union (EU) member countries, and is also valid in Iceland, Norway and Liechtenstein.4

This approval will have no impact on the financial forecasts of the current fiscal year ending March 31, 2022.

About metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
In men with prostate cancer, the disease is considered metastatic once the cancer has spread outside of the prostate gland to other parts of the body.5 Men are considered hormone- (or castration-) sensitive if their disease still responds to medical or surgical treatment to lower testosterone levels.6 mHSPC has a median survival of approximately 3-4 years for men starting treatment with ADT.1

About XTANDI (enzalutamide)
Enzalutamide is an androgen receptor signaling inhibitor indicated in the EU for the treatment of adult men with:2

Metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC) in combination with ADT.
High-risk non-metastatic castration-resistant prostate cancer (CRPC).
Metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. It is also indicated in adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Important Safety Information
For important Safety Information for enzalutamide please see the full Summary of Product Characteristics at: View Source

About ARCHES
The company-sponsored, Phase 3, randomized, double-blind, placebo-controlled, multinational ARCHES trial (NCT02677896) enrolled 1,150 patients with mHSPC at sites in the U.S., Canada, Europe, South America, and the Asia-Pacific region. Patients in the trial were randomized to receive enzalutamide 160 mg daily or placebo and continued on a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist or had a history of bilateral orchiectomy. The primary endpoint of the trial was radiographic progression-free survival (rPFS) assessed by blinded independent central review. rPFS was defined as the time from randomization to radiographic disease progression at any time or death within 24 weeks after study drug discontinuation. Radiographic disease progression was defined by identification of two or more new bone lesions on a bone scan with confirmation (Prostate Cancer Working Group 2 criteria) and/or progression in soft tissue disease. Patients were stratified by volume of disease (low vs high) and prior docetaxel therapy for prostate cancer (no prior docetaxel, 1-5 cycles, or 6 prior cycles).3