On February 4, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported the launch of an Expanded Access Program (EAP) in the USA for tafasitamab, an anti-CD19 antibody currently under development (Press release, MorphoSys, FEB 4, 2020, View Source [SID1234553831]). Under certain conditions, patients with relapsed or refractory diffuse large B-cell lymphoma (r / r DLBCL) can have access to tafasitamab in combination with lenalidomide via the EAP. Tafasitamab is an active ingredient in development (investigational product), the safety and efficacy of which have not been established.

According to the FDA, programs for expanded access , sometimes referred to as "compassionate use", offer patients an opportunity to gain access to an investigational medication for the treatment of a serious illness. They are often provided when there are no comparable or satisfactory alternative therapies to treat the disease, when the patient cannot be enrolled in a clinical trial, when the potential benefit to the patient justifies the potential treatment risk, and when it is made available of the investigational medicinal product does not affect studies that could support the marketing authorization of the drug for the corresponding treatment indication.

To be eligible for the Tafasitamab EAP, r / r DLBCL patients must meet the EAP inclusion / exclusion criteria that correspond to those in the MorphoSys L-MIND study. Treatment of DLBCL patients under the EAP is recommended with tamasitamab in combination with lenalidomide according to the L-MIND treatment plan. The EAP will be available for a limited time while the FDA is reviewing MorphoSys’s application for a Biologics License Application (BLA) for Tamasitamab. Applications for inclusion in the Tafasitamab EAP must be made by a medical doctor approved in the United States.

The Tafasitamab EAP is from Clinigen Healthcare Ltd. managed. Questions or inquiries regarding the Tafasitamab EAP should be directed to [email protected] .

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About tafasitamab
Tafasitamab is a humanized Fc-modified monoclonal antibody against CD19. In 2010, MorphoSys licensed Xencor, Inc.’s worldwide development and marketing rights for tafasitamab. Tafasitamab has an Fc part modified with the XmAb (R) technology, which is said to lead to a significant increase in antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), and thus to improve a key mechanism of tumor cell killing. MorphoSys is investigating tafasitamab as a therapeutic option for malignant B-cell disorders in a number of ongoing combination studies. An open phase 2 combination study (L-MIND study) examined the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed / refractory DLBCL who were not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) Question come. Based on preliminary data from L-MIND, the FDA granted therapeutic breakthrough status for tafasitamab plus lenalidomide in this patient population in October 2017.

On February 4, 2020 Boundless Bio, a company interrogating and targeting extrachromosomal DNA (ecDNA) in aggressive cancers, reported presentations at the following upcoming conferences this month (Press release, Boundless Bio, FEB 4, 2020, View Source [SID1234553847]):

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5th Annual Biomarker and Companion Diagnostics Conference: Jason Christiansen, Ph.D., Chief Technology Officer of Boundless Bio, will give a presentation titled: "Targeting extrachromosomal DNA (ecDNA), a new approach to treating cancers with high copy number gene amplification." The presentation will take place at 3:25 p.m. PST on Friday, February 7, 2020 in San Diego, California.

BIO CEO & Investor Conference: Zachary Hornby, President and Chief Executive Officer of Boundless Bio, will provide an overview of the company’s efforts to pioneer novel cancer therapeutics directed to ecDNA. The presentation will take place at 1:30 p.m. EST on Monday, February 10, 2020 in New York, New York.
About ecDNA

Extrachromosomal DNA, or ecDNA, are large circles of DNA containing genes that are outside the cells’ chromosomes and can make many copies of themselves. ecDNA can be rapidly replicated within the cell, causing high numbers of oncogene copies, a trait that can be passed to daughter cells in asymmetric ways during cell division. Cells have the ability to upregulate or downregulate ecDNA and resulting oncogenes to ensure survival under selective pressures, including chemotherapy, targeted therapy, immunotherapy, or radiation, making ecDNA one of cancer cells’ primary mechanisms of recurrence and treatment evasion. ecDNA are rarely seen in healthy cells but are found in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.

On February 4, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported the initiation of an expanded access program (EAP) in the U.S. for tafasitamab, an investigational anti-CD19 antibody (Press release, MorphoSys, FEB 4, 2020, View Source [SID1234553831]). The EAP may provide access to tafasitamab for use in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) in combination with lenalidomide. Tafasitamab is an investigational medicine and its safety and efficacy have not been established.

According to the FDA, expanded access programs – sometimes called "compassionate use" – provide a pathway for a patient to receive an investigational medicine for a serious disease or condition. They are often made available when there are no comparable or satisfactory alternative therapies to treat the disease or condition; patient enrollment in clinical trials is not possible; potential patient benefit justifies the potential risk of treatment and providing the investigational medicine will not interfere with investigational trials that could support the medicine’s marketing approval for the treatment indication.

To qualify for the tafasitamab EAP, patients with r/r DLBCL need to meet the EAP inclusion/exclusion criteria that are aligned with the MorphoSys’ L-MIND study. Treatment of DLBCL patients in the EAP is recommended with tafasitamab in combination with lenalidomide according to the treatment schedule in L-MIND. The EAP will be available for a limited time while the FDA reviews MorphoSys’ Biologics License Application (BLA) for tafasitamab. Requests for expanded access to tafasitamab must be made by a U.S. licensed, treating physician.

The tafasitamab EAP will be administered by Clinigen Healthcare Ltd. Questions or inquiries regarding the tafasitamab EAP should be directed to [email protected].

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About Tafasitamab
Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. MorphoSys is clinically investigating tafasitamab as a therapeutic option in B cell malignancies in a number of ongoing combination trials. An open-label phase 2 combination trial (L-MIND study) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). Based on interim data from L-MIND, in October 2017 the U.S. FDA granted Breakthrough Therapy Designation for tafasitamab plus lenalidomide in this patient population.

On February 4, 2020 Emtora Biosciences, a privately-held, clinical stage life science company developing eRapaTM for the prevention of cancer progression reported a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Clinical Immuno-Oncology Symposium to be held in Orlando, FL, February 6-8 (Press release, Emtora Biosciences, FEB 4, 2020, View Source [SID1234553848]). Emtora’s core technology incorporates submicron rapamycin particles into a pH-sensitive polymer, improving bioavailability and allowing for consistent and lower dosing than generic rapamycin. Emtora was awarded a grant from the Cancer Prevention and Research Institute of Texas (CPRIT) in 2019 to continue the advancement of eRapa in a Phase 2a trial, which is scheduled to begin in April 2020.

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"We are pleased to share data from our first-in-human trial of eRapa at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium this year," commented George Peoples, MD, Chief Medical Officer of Emtora Biosciences. "The trial results are an important validation of eRapa’s potential to positively impact the immune system at low and/or intermittent doses and provide valuable safety, tolerability, and dosing information for the company’s upcoming Phase 2a efficacy study."

The poster features results of the company’s Phase 1b trial of eRapa in 14 low grade prostate cancer (PCa) patients. eRapa capitalizes on the potential of partial and/or intermittent inhibition of the mechanistic target of rapamycin (mTOR) to act as a cancer immuno-oncology and chemopreventative agent. In patients with low-grade PCa, treatment with low dose eRapa was found to be safe and well-tolerated. The dose of 0.5mg daily produced predictable, low, and stable blood concentration levels through the duration of treatment and resulted in a positive immune impact by enhancing CD8+ memory T cells. Further investigation with low dose and/or intermittent dosing of eRapa as a preventive agent in PCa and other indications will be required to establish clinical benefit. The poster is currently available on the conference website.

Poster Presentation Details
Title: Results of a Phase 1b Trial of Encapsulated Rapamycin in Prostate Cancer Patients Under Active Surveillance to Prevent Progression
Presenting Author: Phillip Kemp Bohan, MD
Session Information: Poster Session A
Abstract Number: 34
Date: February 6, 2020, 11:30AM-1:00PM and 6:00PM-7:00PM

On February 4, 2020 The National Cancer Research Institute (NCRI) reported that cancer research funding by NCRI partners has reached £700m for the first time, following five years of increased spending (Press release, NCRI, FEB 4, 2020, View Source [SID1234554062]).

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Analysis of the NCRI’s 18 partner organisations shows that cancer research funders in the UK have increased their collective spend, for the first time spending over £700m in the year 2018/19. This follows five years of spending increases and the highest level of funding since NCRI started collecting data in 2002.

This increase in funding was driven by a 9% increase in spend in Early Detection, Diagnosis and Prognosis research . Research into Treatment and Cancer Control, Survivorship, and Outcomes Research received less funding than in previous years.

The cancers that have some of the worst one- and five-year survival rates in the UK include stomach, oesophageal, lung, brain, liver and pancreatic cancers. Funding for each of these cancers has increased compared to the year 2017/18. Lung cancer now is second only to breast cancer in research spend.

Commenting on these findings, Dr Iain Frame, CEO of NCRI said:

"I am hugely encouraged to see that the trend for increasing cancer research spend continues. At NCRI we are excited about the increase in spend in Early Detection, Diagnosis and Prognosis research and we expect that our Screening, Prevention and Early Diagnosis Group will drive high quality research in this area.

Looking to the future we hope to see the work of the NCRI Living With and Beyond Cancer Group translate into more funding being available in this area, particularly in areas such as palliative and end of life care which currently receives very little funding.

We hope that our partners and the cancer research community can use these data to identify trends and gaps in funding across a range of research areas."

NCRI continues to work with funders of all cancer types to maximise the value and benefits of cancer research for patients and the public. NCRI involves patients, carers and others affected by cancer (also known as ‘consumers’) at all stages of its activities, including developing clinical trials and high-quality NCRI data studies.