On August 24, 2021 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported that Health Canada has granted Incyte, its development and commercialization partner for tafasitamab, a Notice of Compliance with conditions for Minjuvi(R) (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, who are not eligible for autologous stem cell transplant (ASCT) (Press release, MorphoSys, AUG 24, 2021, View Source [SID1234586845]).

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Incyte and MorphoSys share global development rights for tafasitamab; Incyte has exclusive commercialization rights to tafasitamab outside the United States. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi(R) in the U.S., and is marketed by Incyte under the brand name Minjuvi(R) in Canada.

"The approval of Minjuvi in Canada brings an innovative targeted immunotherapy to patients diagnosed with relapsed or refractory DLBCL, an area of significant unmet medical need, and we are confident in the ability of our partner Incyte to bring it to eligible patients who need it most. The documented safety profile and durable response shown in patients with relapsed or refractory DLBCL treated with tafasitamab plus lenalidomide, suggest the combination could potentially lead to durable remission," said Malte Peters, Chief Research and Development Officer at MorphoSys.

The conditional approval is based on data from the L-MIND study, an open label, multicenter single arm study evaluating the safety and efficacy of tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for ASCT, and is supported by the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL. Removal of the conditions from the Notice of Compliance is contingent upon verification and description of clinical benefit in a confirmatory trial(s). The results from L-MIND showed overall response rate (ORR) of 53.5% (primary endpoint), including a complete response (CR) rate of 35.2% and a partial response rate (PR) of 18.3%, as assessed by an independent review committee. The median duration of response (mDOR) was 34.6 months (secondary endpoint). Adverse events (AEs) reported included infusion-related reactions, serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia, infections and tumour lysis syndrome.

About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide[1], characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter[2], leading to a high medical need for new, effective therapies[3], especially for patients who are not eligible for an ASCT in this setting.

About L-MIND
The L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), who are not eligible for high-dose chemotherapy (HCD) or autologous stem cell transplant (ASCT). The study’s primary endpoint is best objective response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). The study reached its primary completion in May 2019.
For more information about L-MIND, visit View Source

About RE-MIND
RE-MIND, an observational retrospective study (NCT04150328), was designed to isolate the contribution of tafasitamab in combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys’ L-MIND trial. RE-MIND collected the efficacy data from 490 relapsed or refractory 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 was met and shows a statistically significant superior best ORR of the tafasitamab-lenalidomide combination compared to lenalidomide monotherapy.
For more information about RE-MIND, visit View Source

About Minjuvi(R) (tafasitamab)
Minjuvi(R) (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. The safety and efficacy of tafasitimab in other B-cell malignancies has not been established.

Minjuvi(R) and Monjuvi(R) are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi(R) in the United States, and marketed by Incyte under the brand name Minjuvi(R) in Canada.

XmAb(R) is a registered trademark of Xencor, Inc.

On August 24, 2021 Immunocore (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, reported that regulators in the United States and European Union have each accepted applications for the approval of tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma (mUM) (Press release, Immunocore, AUG 24, 2021, View Source [SID1234586844]).

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The U.S. Food and Drug Administration (FDA) has accepted for review Immunocore’s Biologics License application (BLA) for tebentafusp (IMCgp100). The FDA has granted Priority Review to the Company’s BLA submission, a designation for drugs which, if approved, may provide significant improvements in the safety and effectiveness of the treatment of serious conditions. Priority Review designation shortens the review period from the standard ten months to six months from the filing acceptance of the BLA, and therefore, an expected PDUFA target action date of February 23, 2022.

The BLA was initiated and will be reviewed under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA’s Oncology Center of Excellence which is designed to expedite the delivery of safe and effective cancer treatments to patients. Tebentafusp is also being reviewed under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. Previously, the FDA has granted Breakthrough Therapy Designation (BTD) to tebentafusp for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), accepted Immunocore’s Marketing Authorization Application (MAA). The EMA has also agreed to the Company’s request for accelerated assessment of its MAA based on the determination that tebentafusp is a product of major interest for public health and therapeutic innovation. Accelerated assessment potentially reduces the time frame for the CHMP and Committee for Advanced Therapies (CAT) to review the Company’s submitted MAA for advanced therapies. While the CHMP review period of a MAA can take up to 210 days, the accelerated assessment reduces the timeframe for review of the MAA to 150 days (excluding clock-stops).

The regulatory submissions are based on data from the randomized Phase 3 IMCgp100-202 clinical trial evaluating tebentafusp in previously untreated metastatic uveal melanoma, a cancer that has historically proven to be frequently insensitive to other immunotherapies. In the final trial analysis, tebentafusp demonstrated clinically and statistically significant superior overall survival (OS) benefit as a monotherapy. The primary endpoint was achieved with the OS Hazard Ratio (HR) in the intent-to-treat population favoring tebentafusp, HR=0.51 [95% CI (0.37, 0.71); p< 0.0001] over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine).

Bahija Jallal, Chief Executive Officer of Immunocore, said: "There is an urgent need for an approved treatment for metastatic uveal melanoma, an aggressive form of cancer for which there are very limited treatment options. We are excited to work with the FDA and EMA to bring tebentafusp to patients as quickly as possible."

On August 24, 2021 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that the U.S. Food and Drug Administration (FDA) has reviewed and cleared the Investigational New Drug (IND) application for BP1002 (liposomal Bcl-2), the Company’s second drug candidate, for an initial Phase 1/ 1b clinical trial that will evaluate the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients (Press release, Bio-Path Holdings, AUG 24, 2021, View Source [SID1234586842]).

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"AML patients that fail frontline venetoclax-based therapy have very poor prognosis with a median overall survival of less than three months and a novel treatment modality is urgently needed for such patients. Preclinical studies indicate that the BP1002 and decitabine combination is effective against venetoclax-resistant cell lines, suggesting that the BP1002 and decitabine combination therapy may provide benefits to patients who have relapsed from venetoclax-based treatment," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.

By targeting Bcl-2 at the DNA level rather than the protein, BP1002 might overcome and prevent some of the mechanisms of resistance that affect venetoclax. The current standard of care for patients with AML not eligible for intensive chemotherapy is venetoclax, an oral Bcl-2 inhibitor that targets the BH3 domain of the Bcl-2 protein, in combination with a hypomethylating agent or with low-dose cytarabine. High expression of Bcl-2 has been correlated with adverse prognosis for patients diagnosed with AML. Preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and its benign safety profile should enable BP1002 combination therapy with approved agents, such as decitabine.

"We are excited to move into these advanced clinical studies and look forward to generating data that not only support the DNAbilize platform but bring us one step closer to bringing these potentially lifesaving drugs to patients," said Jorge Cortes, M.D., Director of the Georgia Cancer Center and Chairman of the Bio-Path Scientific Advisory Board.

The Phase 1/1b clinical trial is anticipated to be conducted at several leading cancer centers in the United States, including the Weill Medical College of Cornell University, The University of Texas MD Anderson Cancer Center and the Georgia Cancer Center. Initially, a total of six evaluable patients are scheduled to be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study will commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients.

Gail J. Roboz, M.D., will serve as Principal Investigator for the Phase 1/1b trial. Dr. Roboz is professor of medicine and director of the Clinical and Translational Leukemia Program at the Weill Medical College of Cornell University and the New York-Presbyterian Hospital in New York City.

The IND review process was performed by the FDA’s Office of Oncologic Diseases, Division of Hematologic Malignancies and involved a comprehensive review of data submitted by the Company covering pre-clinical studies, safety, chemistry, manufacturing and controls, and the protocol for the Phase 1/1b clinical trial.

On August 24, 2021 Fusion Antibodies and Eurofins Discovery reported that sign co-marketing agreement to support timely and cost-effective development of innovative products for the benefit of global healthcare (Press release, Fusion Antibodies, AUG 24, 2021, View Source [SID1234586841])

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Fusion Antibodies are delighted to announce that is has entered into a commercial collaboration with Eurofins, a Eurofins Scientific SE group company; a leading provider of products and services to the drug discovery industry.

As leading global innovation-driven and customer-focused providers of antibody development services, Fusion Antibodies and Eurofins share common values in the culture of collaboration and the pursuit of scientific excellence and together, they aim to provide laboratories worldwide with high-quality, cost-effective and efficient services that work seamlessly with one another to support biotherapeutic discovery.

Under the agreement, Fusion Antibodies will provide comprehensive pre-clinical antibody development services from discovery, engineering, and critical reagent supply to Eurofins so that together they can provide a complete workflow solution for busy researchers. This includes Fusion Antibodies services for antibody generation, characterization, sequencing, engineering and expression, and Eurofins Discovery’s in vivo and in vitro services, such as efficacy models, bioanalytical services, biomarker development, phenotypic assays and safety assessment.

Commenting on the partnership, Dr Richard Jones, CEO of Fusion Antibodies, said:

"We are delighted to enter into this commercial collaboration with Eurofins which leverages the respective expertise of both partners, delivering on both our strategic objectives as well as providing a full client service package.

Eurofins are an established global provider of testing and laboratory services, and this partnership is a natural fit with Fusion’s mission to enable pharmaceutical and diagnostic companies to develop innovative products in the most efficient and cost-effective way."

Dr Julie Gormley, Commercial Senior Director of Fusion Antibodies, said: "This partnership brings together two world leaders in their respective fields and will enable scientists to focus on their research while our services ensure efficient and robust results. I look forward to working closely with colleagues at Eurofins Discovery throughout 2021 and beyond."

The collaboration between Fusion Antibodies and Eurofins Discovery will last for an initial two-year period and is a commitment to provide world-class scientific expertise, next-generation technology, and guidance to accelerate the delivery of the best possible antibody against a broad range of targets and therapeutic areas into the clinic.

On August 24, 2021 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Arbor Biotechnologies (Arbor) reported a new collaboration to enhance efforts in developing ex vivo engineered cell therapies, using Arbor’s proprietary CRISPR gene-editing technology for select diseases (Press release, Vertex Pharmaceuticals, AUG 24, 2021, View Source [SID1234586840]).

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The new agreement between Arbor and Vertex builds upon the companies’ first partnership established in 2018. Under this new partnership, Vertex will receive rights to use Arbor’s technology to research and develop ex vivo engineered cell therapies towards Vertex’s goal of generating fully differentiated, insulin-producing hypoimmune islet cells for the treatment of type 1 diabetes, for next-generation approaches in sickle cell disease and beta thalassemia, and for the treatment of other diseases.

"This new collaboration further expands our toolkit in cell and genetic therapies and, specifically, our work to discover and develop cell therapies for the treatment of multiple serious diseases," said Bastiano Sanna, Ph.D., Executive Vice President and Chief of Cell and Genetic Therapies at Vertex. "We are excited to bring Arbor’s technology together with Vertex’s ongoing programs and capabilities in diabetes, hemoglobinopathies and other diseases to create improved cell replacement therapies for broad populations of patients."

"Arbor and Vertex share a common goal to improve the lives of people with life-threatening diseases through the discovery and development of innovative therapies, and Vertex has proven to be an ideal partner in that effort," said Devyn Smith, Ph.D., CEO of Arbor. "This agreement demonstrates the versatility and strength of Arbor’s platform and reinforces our strategic vision of expanding our engineered cell therapy capabilities through partnerships with leading organizations in our industry, while we focus our internal portfolio efforts on genetic medicines."

About the Collaboration
Under the terms of the agreement, Arbor will receive an upfront cash payment and is eligible to receive up to $1.2 billion in potential payments based upon the successful achievement of specified research, development, regulatory and commercial milestones across up to seven potential programs. In addition, Vertex will pay tiered royalties on future net sales on any products that may result from this collaboration. Vertex will also make an investment in Arbor in the form of a convertible note.