Centers for Medicare & Medicaid Services open NCD review process for Epi Pro Colon

On March 2, 2020 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that the U.S. Centers for Medicare & Medicaid Services (CMS) have opened the National Coverage Determination (NCD) review of Epi proColon, Epigenomics’ blood test for colorectal cancer screening (Press release, Epigenomics, MAR 2, 2020, View Source [SID1234555014]). The NCD is one of two options to obtain CMS coverage for Epi proColon, which would represent a major U.S. market breakthrough for the company. The opening of the review process obliges CMS by statute to take a decision on the reimbursement of Epi proColon within a maximum period of nine months.

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Greg Hamilton, CEO of Epigenomics AG: "The opening of the NCD review process is a milestone for our company. For nearly four years since FDA approval of Epi proColon, there has been uncertainty as to when and whether CMS will reimburse Epi proColon. Now we know that a reimbursement decision will be made within the next nine months. We hope that the findings of the microsimulation model developed by experts at Harvard Medical School along with the key studies supporting FDA-approval of the product will result in CMS making a positive reimbursement decision."

The microsimulation model demonstrates that Epi proColon administered annually can reduce the incidence and mortality of colorectal cancer nearly equivalent or better than other approved methods. Additionally, when adherence is included as a variable in the model, the blood test can outperform all other CRC screening strategies in terms of long-term benefits including the reduction in CRC incidence and mortality rates.

With the opening of the NCD, a 30-day period for public comments begins. This comment period is part of a six-month review period during which CMS is required by legal statute to publish a proposed decision. If this proposed coverage decision is positive, another 30-day comment period follows. A final decision on the reimbursement will then be published by CMS within 90 days of the initial proposed decision.

FDA Accepts MorphoSys’ Biologics License Application (BLA) and Grants Priority Review for Tafasitamab and Lenalidomide for the Treatment of Relapsed/Refractory DLBCL (news with additional features)

On March 2, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported that the U.S. Food and Drug Administration (FDA) accepted filing of MorphoSys’ Biologics License Application (BLA) and granted priority review for tafasitamab, the Company’s investigational anti-CD19 antibody, under review in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) (Press release, MorphoSys, MAR 2, 2020, View Source [SID1234555011]).The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 30, 2020. The FDA has informed MorphoSys that they are not currently planning to hold an advisory committee meeting to discuss the application.

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"We are extremely pleased that the FDA has accepted filing of our application and granted priority review, as we believe that the combination of tafasitamab and lenalidomide may provide an additional treatment option for patients suffering from DLBCL, who have relapsed after or are refractory to the current standard of care," said Dr. Malte Peters, Chief Development Officer of MorphoSys. "We would like to thank all patients participating in our clinical studies and we will continue to work relentlessly towards making tafasitamab available to patients."

The BLA submission is based on the primary analysis data from the L-MIND trial of tafasitamab in combination with lenalidomide in patients with r/r DLBCL and the retrospective observational matched control cohort Re-MIND evaluating efficacy outcomes of r/r DLBCL patients who received lenalidomide monotherapy. MorphoSys announced the submission of the BLA at the end of December 2019.

Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. This designation shortens the FDA review period following the acceptance of the BLA to six months compared to ten months under Standard Review.

MorphoSys was granted Breakthrough Therapy Designation by the FDA for the combination of tafasitamab and lenalidomide in r/r DLBCL in 2017.

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. Under the terms of the collaboration and licensing agreement, FDA acceptance of MorphoSys’ BLA submission triggers an undisclosed milestone payment from MorphoSys to Xencor.

About L-MIND
L-MIND is a single arm, open-label phase 2 study, investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) after up to two prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy and subsequent autologous stem cell transplantation. The study’s primary endpoint is objective response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). In May 2019, the study reached its primary completion. Primary analysis data with a cut-off date of November 30, 2018 included 80 patients enrolled into the trial who had received tafasitamab and lenalidomide and had been followed-up as per protocol for at least one year. Efficacy results in this update were based on response rates assessed by an independent review committee for all 80 patients.

About Re-MIND
Re-MIND, an observational retrospective study, was designed to isolate the contribution of tafasitamab in the combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory DLBCL who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys’s L-MIND trial. Re-MIND collected the efficacy data from 490 r/r DLBCL patients in the U.S. and EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible Re-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective response rates (ORR) were validated based on this subset of 76 patients in Re-MIND and L-MIND, respectively. The primary endpoint of Re-MIND has been met and shows a statistically significant superior best ORR of the tafasitamab/lenalidomide combination compared to lenalidomide monotherapy.

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.
In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. In the U.S., MorphoSys and Incyte will co-commercialize tafasitamab, outside the U.S., Incyte will have exclusive commercialization rights. The agreement is subject to clearance by the U.S. antitrust authorities under the Hart-Scott-Rodino Act as well as by the German and Austrian antitrust authorities and will become effective as soon as these conditions have been met.
Tafasitamab is being clinically investigated 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). The ongoing phase 3 study B-MIND assesses the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. In addition, tafasitamab is currently being investigated in patients with relapsed/refractory CLL/SLL after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

3SBIO makes investment in MPM’s $100M Oncology Innovations Fund and donation to Dana-Farber cancer research

On March 1, 2020 MPM Capital (MPM) and Dana-Farber Cancer Institute have jointly reported on February 26, 2020 the successful closing of the MPM Oncology Innovations Fund (INV) with $100M in capital, and the Dana-Farber Innovations Research Fund (IRF) with more than $26M in pledged donations (Press release, MPM Capital, MAR 1, 2020, View Source [SID1234555005]). 3SBIO, a leading biopharmaceutical company in China, is a limited partner in the INV and has agreed to make donation to the IRF, to support early-stage oncology research at Dana-Farber. The collaboration of INV and IRF is a unique, first of its kind, impact investing collaboration.

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Through INV, MPM intends to create and invest in early-stage companies developing innovative therapeutic technologies in oncology. MPM expects 50% of the capital from INV to be invested in new companies generated from Dana-Farber research. As part of the collaboration, MPM, through INV, has the right of first offer to license certain Dana-Farber technologies that have been identified for commercialization.

"With innovative new funding structures, such as the collaboration between MPM and Dana-Farber, we believe we can expand and accelerate important research efforts while putting in place a path for developing this research into novel therapeutics. We are honored to partner with one of the world’s leading cancer research centers to execute on this strategy and, having partnered before to bring groundbreaking science to patients, we are excited to continue working with our esteemed colleagues at Dana-Farber to advance the search for cancer cures," said Ansbert Gadicke, co-founder and Managing Director at MPM Capital.

"We are thrilled to have partnered with MPM on this innovative venture philanthropy model. We have generated substantial philanthropic support for exciting areas of cancer research at Dana-Farber, and MPM will support the creation of biotech companies that seek to bring new and advanced treatments to our patients," said Laurie H. Glimcher, MD, President and Chief Executive Officer of Dana-Farber.

"3SBIO is pleased to invest in MPM’s INV as a limited partner and to make donation to IRF to support Dana-Farber, a top cancer research and treatment center in the world. We are looking forward to this collaboration to develop many promising oncology therapies that address the unmet medical needs of cancer patients," said Dr. Jing Lou, Chairman and CEO of 3SBIO.

MPM’s partnership with Dana-Farber comes as biotechnology venture investors seek access to the most-promising academic discoveries and as medical institutes pursue new ways to fund research and propel their innovations into the market