On October 27, 2020 Redx Pharma plc (AIM: REDX), the drug discovery and development company focused on cancer and fibrosis, reported that it has appointed Dr Jane Robertson as Chief Medical Officer (Press release, Redx Pharma, OCT 27, 2020, View Source [SID1234573528]). Jane is a well respected UK haemato-oncologist with over 17 years’ experience of clinical development in oncology and has a breadth of experience investigating multiple tumours and agents including VEGF inhibitors, anti-hormonals, PARP inhibitors, nucleotide analogs and most recently cell therapies. She will commence her role at Redx on 1 March 2021.

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Jane joins Redx from her position as Chief Medical Officer at Achilles Therapeutics Ltd, a biotech company focused on the creation of a personalized T cell therapy directed against clonal tumour neoantigens. During her tenure at Achilles, the Company progressed its lead candidate into two clinical trials. Prior to Achilles, Jane served as the Chief Medical Officer at Nucana Biomed Ltd and at Kesios Therapeutics Ltd. She has previously also held a number of senior R&D leadership roles at AstraZeneca Oncology, notably leading the development of the first in class PARP inhibitor, olaparib. Jane originally trained in general medicine and haematology, working in clinical practice and translational research settings, and sub-specialising in haemato-oncology; she remains General Medical Council registered.

Lisa Anson, Chief Executive Officer of Redx Pharma commented: "We are absolutely delighted that Jane has chosen to join our team at this exciting stage in Redx’s development. As our Chief Medical Officer, her extensive and varied experience in big pharma, biotech and clinical practice, will be invaluable as we further progress our pipeline into clinical development."

Jane Robertson, incoming Chief Medical Officer, Redx Pharma commented: "I have been very impressed by Redx and its outstanding scientific team, and am really looking forward to the opportunity to progress the Company’s promising pipeline into differentiated clinical stage programmes in the treatment of fibrotic diseases and cancer. With data expected from Redx’s Phase 1 RXC004 study in H1 2021, this feels like a particularly exciting time to be joining the Company." Following a handover, Dr Andrew Saunders will leave Redx after 3 years as Chief Medical Officer to pursue other opportunities. Lisa Anson added, "On behalf of all of Redx and the Board, I would like to thank Andrew for his great work in overseeing the transition of RXC004 into phase 1 and his strategic guidance in our planned future development plans for RXC004."

On October 27, 2020 Genome & Company (KONEX: 314130), a global pioneer company of microbiome therapeutics, reported that it initiated clinical trial of GEN-001, an anti-cancer microbiome therapeutic (NCT04601402) (Press release, Genome & Company, OCT 27, 2020, View Source [SID1234571039]).

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GEN-001 is an oral microbiome therapeutic candidate of Genome & Company, and in this clinical trial, it will be administered to patients with cancer in combination with an immune checkpoint inhibitor, which is the first among Asian microbiome development companies.

The phase 1 study aims to determine the RP2D (recommended Phase 2 dose) of GEN-001 in combination with BAVENCIO (avelumab). Avelumab is an anti-PD-L1 checkpoint inhibitor co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc. In the phase 1b study, the safety and preliminary efficacy of the combination therapy at the RP2D of GEN-001 in combination with BAVENCIO for patients with specific solid tumors will be investigated.

A total of three clinical sites including OHSU Knight Cancer Institute located in Portland, Oregon will complete the dose-escalation cohort within the first half of 2021. The OHSU Knight Cancer Institute is one of the globally renowned cancer centers and is one of the 51 National Cancer Institute (NCI) designated Comprehensive Cancer Center in the U.S. Amid harsh conditions due to COVID-19 since the beginning of 2020, close collaboration among OHSU, contract research organization and Genome & Company enabled this clinical trial to be initiated just six months after its IND to FDA went into effect.

"We are pleased to offer our patients access to a new clinical trial of the drug GEN-001 in combination with avelumab," said Shivaani Kummar, M.D., head of the division of hematology and medical oncology in the OHSU School of Medicine, and co-director of the OHSU Knight Cancer Institute Center for Experimental Therapeutics. "Our goal is to learn more about whether this combination therapy will be effective in overcoming acquired resistance to anti-PD-(L)1 therapy in patients with advanced solid tumors whose disease has progressed on prior anti-PD-(L)1 therapy."

Dr. Jisoo Pae, CEO of Genome & Company also stated, "The study outcome of GEN001-101 will investigate the preliminary efficacy of GEN-001 in patients with various cancers. We hope to see clinically meaningful results fairly soon which in turn would allow us to continue making progress GEN-001 clinical trials, with the potential to eventually become an alternative therapeutic option in the immuno-oncology market."

In December 2019, Genome & Company entered into the Clinical Trial Collaboration and Supply Agreement with Merck KGaA and Pfizer Inc. (this "Agreement") to evaluate the safety, tolerability, and biological and clinical activities of GEN-001 therapy in combination with avelumab, a human anti-PD-L1 therapy, in multiple cancer indications. Under the terms of this Agreement, Genome & Company will be the sponsor of the study, and Merck and Pfizer will supply avelumab for the phase 1/1b clinical trial.

BAVENCIO is a trademark of Merck KGaA, Darmstadt, Germany.

▶Avelumab Approved Indications

Avelumab (BAVENCIO) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions as a single agent or in combination with axitinib [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity in combination with axitinib, major adverse cardiovascular events (MACE) in combination with axitinib [which can be severe and have included fatal cases], and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction peripheral edema, decreased appetite, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 hematology laboratory value abnormalities reported in at least 10% of patients with Merkel cell carcinoma treated with BAVENCIO monotherapy include lymphopenia; in patients receiving BAVENCIO in combination with axitinib, grade 3-4 clinical chemistry abnormalities include blood triglyceride increased and lipase increased.

On October 7, 2020 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based therapeutic formulations and medicines, reported that it has been informed by the European Patent Office that the examining division intends to grant the company a European Patent for the Company’s application titled "A System and Method for High Throughput Screening of Cancer Cells (Press release, Cannabics Pharmaceuticals, OCT 27, 2020, View Source [SID1234570699])."

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Drug Sensitivity Heatmap of Multiple Cannabinoids and Cancer Cells

This patent application relates to the company’s CANNABICS CDx companion diagnostic drug sensitivity test, whereby a patient’s biopsy is screened to match the optimal cannabinoid combination available using the company’s high throughput screening of cancer cells proprietary technology.

Outside the European territory, this patent is also currently being reviewed in other territories including the US and Canada. The decision of the European examiner is significant in that it could also accelerate the review process in other territories who offer a Patent Prosecution Highway such as Canada, India, Mexico and Brazil.

Gabriel Yariv, Cannabics Pharmaceuticals’ President and COO said: "This patent exemplifies our pioneering vision to bring Cannabinoid-based therapies and treatments to cancer patients worldwide and will strengthen our position as we concentrate on penetrating the European market".

Dr. Eyal Ballan, Cannabics Pharmaceuticals’ CTO, said:" As pioneers in Cannabinoid-based Cancer diagnostics, we have always believed in the novelty and uniqueness of our vision to personalize cannabinoid treatments. The intention of the European examiner to grant our patent is certainly a positive vindication for our efforts".

On October 27, 2020 Bayer reported that Nubeqa has scored backing from the UK’s National Institute for Health and Care Excellence (NICE) for treating non-metastatic castration-resistant prostate cancer (nmCRPC) (Press release, PharmaTimes, OCT 27, 2020, View Source [SID1234569473]).

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Nubeqa (darolutamide) has been authorised for use alongside androgen deprivation therapy (ADT). According to Bayer, it is the first treatment NICE has recommended in this indication.

The NICE recommendation is based on results from the phase III ARAMIS trial, which evaluated the efficacy and safety of Nubeqa plus ADT in nmCRPC patients.

In this trial, Nubeqa plus ADT demonstrated a statistically significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median 40.4 months compared to 18.4 months for placebo plus ADT.

The final overall survival (OS) data – a secondary endpoint in the ARAMIS trial – demonstrated a significant improvement in OS compared to placebo plus ADT, with a 31% reduction in the risk of death.

"Bayer welcomes NICE’s positive recommendation for Nubeqa, ensuring men with nmCRPC who are at high risk of developing metastatic disease have access to therapeutic options that delay disease progression, whilst improving overall survival, when compared to placebo and ADT alone," said Melissa Rowe, director of medical affairs for specialty medicine at Bayer UK.

"Bayer is dedicated to research that aims to address the unmet need in the way cancer is treated, with a particular focus on prostate cancer," she added.

Prostate cancer is the most common cancer in men in the UK, with over 48,000 new cases each year on average.

Approximately a third of men with nmCRPC develop metastases within two years, highlighting the need for treatment which delay the development of metastases in this patient population.

On October 27, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported an increase in its financial guidance for the financial year 2020 after preliminary completion of the latest evaluation of MorphoSys’ financial performance (Press release, MorphoSys, OCT 27, 2020, View Source [SID1234569206]).

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Based on the preliminary unaudited consolidated results for the first nine months 2020, MorphoSys now expects Group revenues in the range of €317 to €327 million (previously: €280 to €290 million) and an EBIT in the range of €10 to €20 million (previously: €-15 to €+5 million). R&D expenses are expected to remain unchanged in the range of €130 to €140 million.

The updated guidance reflects higher revenues from partnerships and collaborations and Tremfya royalties are expected to be at the upper end of guidance. In addition, it now also includes revenues from product sales of Monjuvi following its approval and subsequent launch in the U.S.

In the first nine months of 2020, MorphoSys recorded Group revenues of €291.7 million and an EBIT of €101.8 million. Further details will be published in the Company’s Q3 report on November 11, 2020.