On January 5, 2021 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ:INCY) reported that the Swiss Agency for Therapeutic Products (Swissmedic) has accepted the marketing authorization application (MAA) for tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody (Press release, MorphoSys, JAN 5, 2021, View Source [SID1234573457]). The MAA seeks approval for tafasitamab, in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT). The MAA will now enter the formal review process by Swissmedic.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Swissmedic MAA for tafasitamab will be reviewed as part of the U.S. Food and Drug Administration’s (FDA) modified Project Orbis, which provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international collaborators. Collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries.

"Currently about 40% of DLBCL patients do not respond to initial therapy or relapse thereafter leading to a high medical need for new, effective therapies," said Peter Langmuir, M.D., Group Vice President, Targeted Therapeutics, Incyte. "The acceptance of the MAA for tafasitamab for review by Swissmedic is a pivotal step towards bringing tafasitamab in combination with lenalidomide to eligible patients in Switzerland."

"Tafasitamab in combination with lenalidomide may represent an important new targeted treatment option for patients with relapsed or refractory DLBCL," said Mike Akimov, M.D., Ph.D., Head of Global Clinical Development, MorphoSys. "We look forward to continuing to work with the regulatory authorities alongside our partners at Incyte to bring this novel therapeutic option to eligible patients with a high unmet medical need."

The Swissmedic application, submitted by Incyte in collaboration with MorphoSys, is supported by data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL and data from the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL. If approved, Incyte will hold the marketing authorization, and have exclusive commercialization rights for tafasitamab in Switzerland.

Incyte has exclusive commercialization rights for tafasitamab outside the United States.

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]. In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL[3],[4],[5].

About L-MIND
The L-MIND trial is a single arm, open-label, multicenter 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 or refuse subsequent autologous stem cell transplant. The study’s primary endpoint is Overall 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.

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 the 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 Tafasitamab
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).

Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration (FDA) 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, 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).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi(R) is a registered trademark of MorphoSys AG.

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

On January 5, 2021 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported the completion of its previously-announced sale of a portfolio of select prescription products to Cheplapharm for a total value of $562 million USD1 (Press release, Takeda, JAN 5, 2021, View Source [SID1234573437]). The portfolio includes 16 prescription pharmaceutical products sold predominantly in Europe which is part of Takeda’s Europe and Canada Business Unit. This divestment agreement was first announced in September 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The divested portfolio is comprised of non-core prescription pharmaceutical products in a variety of therapeutic categories that includes Cardiovascular/Metabolic and Anti-Inflammatory products along with Calcium. In line with Takeda’s long-term growth strategy, these products, while addressing key patient needs in these countries, are outside of Takeda’s five core business areas: Gastroenterology (GI), Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience.

Takeda remains focused on executing its long-term growth strategy to optimize our business mix around our key business areas, and simplifying our operations to better serve patients by delivering innovative treatments in these areas.

The Company intends to use the proceeds from the sale to reduce its debt and accelerate deleveraging towards its target of 2x net debt/adjusted EBITDA within Fiscal Years 2021–2023.

Takeda has sustained momentum in its divestiture strategy in 2020 and exceeded its $10 billion non-core asset divestiture target, announcing 11 deals since January 2019 to date for a total aggregate value of up to approximately $11.6 billion, including agreements to divest:

Takeda Consumer Healthcare Company Limited to Oscar A-Co KK, a company controlled by funds managed by The Blackstone Group Inc. and its affiliates for a total value of approximately JPY 242.0 billion ($2.3 billion USD).
Other non-core portfolio assets within the Growth & Emerging Markets Business Unit, totaling up to approximately $2.3 billion with five separate buyers.2
Select OTC and non-core assets in Europe to Orifarm for up to approximately $670 million.
The TachoSil Fibrin Sealant Patch to Corza Health, Inc. for approximately €350 million.

On January 5, 2021 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA), in combination with Tecentriq (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations (Press release, Genentech, JAN 5, 2021, View Source [SID1234573436]). Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the FDA, and the designation is based on randomized data from the Phase II CITYSCAPE trial. CITYSCAPE provides the first evidence that targeting both immune inhibitory receptors, TIGIT and PD-L1, may enhance anti-tumor activity by potentially amplifying the immune response.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have been researching TIGIT as a novel cancer immunotherapy target for almost 10 years and we are pleased that the FDA has acknowledged the potential of tiragolumab to substantially improve outcomes for people with certain types of lung cancer," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We look forward to advancing our tiragolumab development program, which includes chemotherapy-free combinations and trials in early stages of disease across multiple cancer types with high unmet need."

BTD is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions, with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies. This marks the 37th BTD for Genentech’s portfolio of medicines.

Tiragolumab in combination with Tecentriq has so far shown encouraging efficacy and safety in PD-L1-positive metastatic NSCLC based on data from the Phase II CITYSCAPE trial, the first randomized study in the anti-TIGIT field. Full results from CITYSCAPE, presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program, showed that at an average of 10.9 months follow-up, the combination showed an improvement in the overall response rate (ORR; 37% vs. 21% with Tecentriq alone) and a 42% reduction in the risk of disease worsening or death (progression-free survival; PFS) compared with Tecentriq alone. An exploratory analysis in people with high levels of PD-L1 (tumor proportion score; TPS ≥ 50%) showed a clinically meaningful ORR vs. Tecentriq alone (66% vs. 24%) and median PFS was not reached (vs. 4.11 months with Tecentriq alone; HR=0.30, 95% CI: 0.15–0.61). The data suggest that tiragolumab plus Tecentriq was generally well-tolerated, showing similar rates of all Grade 3 or more all-cause adverse events when combining the two immunotherapies compared with Tecentriq alone (48% vs. 44%).

Genentech is investigating the potential of tiragolumab in a broad development program that builds on the benefit observed with Tecentriq while expanding into earlier stages of disease and new areas of unmet need. This includes randomized trials in metastatic NSCLC (SKYSCRAPER-01 and SKYSCRAPER-06) and small cell lung cancer (SKYSCRAPER-02), as well as exploration of tiragolumab in earlier stages, including stage III NSCLC (SKYSCRAPER-03) and locally advanced esophageal cancer (SKYSCRAPER-07). Tiragolumab is also being investigated in metastatic esophageal squamous cancer (SKYSCRAPER-08) and cervical cancer (SKYSCRAPER-04), with early trials in other tumor types.

Biomarker analyses from the CITYSCAPE study will be presented at the IASLC 2020 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer, taking place from January 28-31, 2021 (Efficacy of Tiragolumab + Atezolizumab in PD-L1 IHC and TIGIT Subgroups in the Phase II CITYSCAPE Study in First-Line NSCLC).

Dual blockade of the TIGIT and PD-L1 pathways

TIGIT and PD-L1 are proteins that play a role in suppression of the immune system. Blocking both pathways simultaneously with tiragolumab and Tecentriq has the potential to increase anti-tumor activity by enhancing the body’s immune response to cancer cells. Targeting multiple immune pathways in this way has the potential to build upon previous advances in cancer immunotherapy, expand into earlier stages of disease and provide new treatment options in areas of high unmet need.

About the CITYSCAPE study

CITYSCAPE is a global Phase II, randomized and blinded study evaluating tiragolumab plus Tecentriq (atezolizumab) compared with Tecentriq alone in 135 patients with first-line PD-L1-positive, locally advanced unresectable or metastatic non-small cell lung cancer. Patients were randomized 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until progressive disease or loss of clinical benefit. Co-primary endpoints are overall response rate and progression-free survival. Secondary endpoints include safety and overall survival.

About tiragolumab

Tiragolumab is a monoclonal antibody designed to bind with TIGIT, a protein receptor on immune cells. Tiragolumab works as an immune amplifier, by potentially enhancing the body’s immune response. By binding to TIGIT, tiragolumab blocks its interaction with a protein called poliovirus receptor (PVR, or CD155) that can suppress the body’s immune response. Blockade of TIGIT and PD-L1 may synergistically enable the re-activation of T cells and enhance NK cell anti-tumor activity.

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Indications (pronounced ‘tē-SEN-trik’)

Tecentriq is a prescription medicine used to treat adults with:

A type of bladder and urinary tract cancer called urothelial carcinoma.

Tecentriq may be used in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery, and if they have any one of the following conditions:

They are not able to take chemotherapy that contains a medicine called cisplatin and their cancer tests positive for "PD-L1" or
They are not able to take chemotherapy that contains any platinum regardless of the levels of "PD-L1" status or
They have tried chemotherapy that contains platinum and it did not work or is no longer working.
The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

A type of lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq may be used alone as the first treatment in patients with lung cancer if:

Their cancer has spread or grown and
Their cancer tests positive for "high PD-L1", and
Their tumor does not have an abnormal "EGFR" or "ALK" gene.
Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as the first treatment in patients with lung cancer if:

Their cancer has spread or grown, and
Is a type called "non-squamous NSCLC", and
Their tumor does not have an abnormal "EGFR" or "ALK" gene.
Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as the first treatment in patients with lung cancer if:

Their cancer has spread or grown, and
Is a type called "non-squamous NSCLC", and
Their tumor does not have an abnormal "EGFR" or "ALK" gene.
Tecentriq may be used alone in patients with lung cancer if:

Their cancer has spread or grown and
They have tried chemotherapy that contains platinum, and it did not work or is no longer working.
If a patient’s tumor has an abnormal EGFR or ALK gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
A type of breast cancer called triple-negative breast cancer (TNBC).

Tecentriq may be used with the medicine paclitaxel protein-bound in patients with TNBC when their breast cancer:

Has spread or cannot be removed by surgery and
Their cancer tests positive for "PD-L1".
The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

A type of lung cancer called small cell lung cancer (SCLC).

Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as the first treatment in patients with SCLC when their lung cancer is a type of lung cancer called "extensive-stage small cell lung cancer," which means that it has spread or grown.
A type of liver cancer called hepatocellular carcinoma (HCC).

Tecentriq may be used with the medicine bevacizumab when a patient’s liver cancer:

Has spread or cannot be removed by surgery, and
The patient has not received other medicines by mouth or injection through their vein (IV) to treat their cancer.
A type of skin cancer called melanoma.

Tecentriq may be used with the medicines cobimetinib and vemurafenib when a patient’s melanoma:

Has spread or cannot be removed by surgery, and
Their cancer has a certain type of abnormal "BRAF" gene. Their healthcare provider will perform a test to make sure this Tecentriq combination is right for them.
It is not known if Tecentriq is safe and effective in children.

Important Safety Information

The most important information about Tecentriq is:

Tecentriq can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.

Tecentriq can cause serious side effects, including:

Lung problems (pneumonitis)–signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath and chest pain
Liver problems (hepatitis)–signs and symptoms of hepatitis may include yellowing of the skin or the whites of the eyes, severe nausea or vomiting, pain on the right side of the stomach area (abdomen), drowsiness, dark urine (tea-colored), bleeding or bruising more easily than normal and feeling less hungry than usual
Intestinal problems (colitis)–signs and symptoms of colitis may include diarrhea (loose stools) or more bowel movements than usual; blood or mucus in stools or dark, tarry, sticky stools; and severe stomach area (abdomen) pain or tenderness
Hormone gland problems (especially the thyroid, adrenal glands, pancreas, and pituitary)–signs and symptoms that the hormone glands are not working properly may include headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior (such as decreased sex drive, irritability, or forgetfulness), feeling cold, constipation, the voice gets deeper, urinating more often than usual, nausea or vomiting and stomach area (abdomen) pain
Problems in other organs–signs and symptoms may include severe muscle weakness, numbness or tingling in hands or feet, confusion, blurry vision, double vision, or other vision problems, changes in mood or behavior, extreme sensitivity to light, neck stiffness, eye pain or redness, skin blisters or peeling, chest pain, irregular heartbeat, shortness of breath or swelling of the ankles
Severe infections–signs and symptoms of infection may include fever, cough, flu-like symptoms, pain when urinating and frequent urination or back pain
Severe infusion reactions–signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, swelling of the face or lips, dizziness, fever, feeling like passing out and back or neck pain
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if patients have severe side effects.

Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:

Have immune system problems (such as Crohn’s disease, ulcerative colitis, or lupus); have had an organ transplant; have lung or breathing problems; have liver problems; have a condition that affects the nervous system (such as myasthenia gravis or Guillain-Barre syndrome); or are being treated for an infection.
Are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq.
Females who are able to become pregnant:
Should have a healthcare provider do a pregnancy test before they start treatment with Tecentriq and
Should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq.
Are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq.
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used alone include:

Feeling tired or weak
Nausea
Cough
Shortness of breath
Decreased appetite
The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

Feeling tired or weak
Nausea
Hair loss
Constipation
Diarrhea
Decreased appetite
The most common side effects of Tecentriq when used in TNBC with paclitaxel protein-bound include:

Hair loss
Tingling or numbness in hands and feet
Feeling tired
Nausea
Diarrhea
Low red blood cells (anemia)
Constipation
Cough
Headache
Low white blood cells
Vomiting
Decreased appetite
The most common side effects of Tecentriq when used in hepatocellular carcinoma with bevacizumab include:

High blood pressure
Feeling tired or weak
Too much protein in the urine
The most common side effects of Tecentriq when used in melanoma with cobimetinib and vemurafenib include:

Skin rash
Pain in the joint muscle or bone
Feeling tired or weak
Liver injury
Fever
Nausea
Itching
Swelling of legs or arms
Swelling of the mouth (sometimes with sores)
Underactive thyroid gland
Skin sensitivity to sunlight
Tecentriq may cause fertility problems in females, which may affect their ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects of Tecentriq.

Report side effects to the FDA at (800) FDA-1088 or View Source Report side effects to Genentech at (888) 835-2555.

Please visit View Source for the full Tecentriq Prescribing Information for additional Important Safety Information.

About Genentech in cancer immunotherapy

Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.

In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit View Source

On January 4, 2021 Biocure Technology Corp. (CURE or the Company) (CSE:CURE; OTCQB: BICTF) BiocurePharm, Korea (BPK), a subsidiary of Biocure Technology Inc. (CURE) reported that BPK has entered into a MOU with Symbasis GmbH. They have expressed a common interest in developing a CAR-T Therapy for Chronic Lymphocyte Leukemia (CLL) and wish to sign this MOU for the purpose of confirming their intention in respect to the development (Press release, Biocure Technology, JAN 4, 2021, View Source [SID1234628749]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The purpose of this MOU is to establish a Joint Venture in Germany under the name "Oncocart" for clinical trials, production and marketing in Europe, (potentially, including other regions of the world) of ROR1-based products for the CAR-T therapy the target indication of which is CLL.

The MOU is intended to form the basis of discussions and negotiations between the Parties for the purpose of entering into final agreements without creating any obligation to do so.

Both parties agree that this Joint Venture will enable them to bring together an extremely experienced group of experts and professionals, allowing for all phases of the development to advance more effectively.

"Oncocart" is advised by renowned hemato-oncological experts. Among others Prof. Dr. Karl-Anton Kreuzer and Prof. Dr. Christoph Scheid are providing their in-depth knowledge for the development of CAR-T therapy. Both are consultant physicians at the University of Cologne Medical Center, which hosts the world’s largest study group for Chronic Lymphocytic Leukemia (CLL), is a leading institution for clinical CAR-T trials and serves as a National Cancer Center in Germany.

Goldberg Consulting will act as advisors for the newly formed Oncocart. Goldberg supports companies in the health and social economy sector with an interdisciplinary network of qualified exprerts. (View Source)

Dr. Sang Mok Lee, CEO and President of Biocure and BPK, states "This MOU is an important milestone for the Company to advance it’s entrance into the European market with its CAR T technology. With clinical trials commencing in Korea, we are confident, that with the right positive outcomes, we can expedite the process into the European market, allowing patients access to an affordable CAR T Therapy and ultimately saving more lives. We continue to work hard to make this happen as soon as possible."

About Symbasis GmbH was founded in 2001 and supports organizations in the health care sector. Symbasis has a strong focus on strategy; access to market; quality assurance, and cost control specifically in Germany and India.

About Dr. Karl-Anton Kreuzer
Dr. Karl-Anton Kreuzer studied medicine at the Universities of Bonn, Munich (TU), Pittsburgh / USA and Zurich / Switzerland. He completed his scientific training with research grants at the Wistar Institute in Philadelphia / USA and the Weizmann Institute of Science in Rehovot / Israel. He completed his internistic training with Dr. Dieter Huhn at the Charité Virchow Clinic in Berlin. Dr. Kreuzer has been working at Clinic I for Internal Medicine at Cologne University Hospital since 2004 and was habilitated in 2006 on the topic of "Molecular Diagnostics in Hematology". At the local clinic, he is responsible for the treatment of acute leukemia (AML / ALL) and myelodysplastic syndrome (MDS). He also runs the clinic’s coagulation clinic and is a consultant in this regard. Dr. Kreuzer heads the interdisciplinary oncological project group (IOP) "Acute Leukemia and MDS" of the Center for Integrated Oncology (CIO) Cologne. In addition, he heads the routine laboratory for special hematological diagnostics at the clinic with a focus on hematological diagnostics. In this laboratory there is also a scientific working group that deals with the molecular pathogenesis and experimental therapy of malignant hematopoietic systemic diseases. Dr. Kreuzer is a member of national and international specialist societies in the field of hematology / oncology and is also an expert for domestic and foreign research funding institutions as well as for numerous specialist journals. Dr. Kreuzer is also the editor and co-editor of various hematological-oncological journals and standard internal works. – His research priorities cover acute leukemia and myelodysplastic syndromes. He is also a medical examiner for therapy studies on lymphomas and solid tumors. In addition to the routine diagnosis of leukemia and lymphoma, Dr. Kreuzer is also researching new molecular and immunological markers for the initial and follow-up diagnosis of hematological neoplasia.

About Dr. Christoph Scheid.
Dr. Christoph Scheid studied medicine at the universities of Bonn, Cologne and Clermont-Ferrand. After completing his doctorate and medical examination in 1991, he was a scholarship holder of the German Cancer Aid at the Paterson Institute for Cancer Research in Manchester and dealt with the research of changes in the immune system through experimental tumor therapies e.g. Interleukin-6 or the protein kinase C activator bryostatin-1. In addition, he examined the recovery of immune function after transplantation of autologous peripheral blood stem cells, a method that was still very new at the time. After moving to Clinic I for Internal Medicine at the University Hospital Cologne in 1994, he brought his experience into the development of an autologous and later also allogeneic transplant program in Cologne and later took over the management of the laboratory for stem cell transplantation and stem cell production. Dr. Scheid has been a specialist in internal medicine since 2001 and has had the additional qualification of hematology and internal oncology since 2004. Since 2002, he has headed the ward and transplant outpatient clinic (KMT), haemapheresis and the focus on stem cell transplantation (KMT). In addition, he is transfusion officer at Clinic I for internal medicine. In 2005 Professor Scheid habilitated in internal medicine. His research priorities include optimization of autologous stem cell transplantation and stem cell extraction, research into the role of stem cells in the context of ischemic heart diseases, and allogeneic stem cell transplantation. Dr. Scheid is clinically responsible for stem cell transplantation, the treatment of chronic myeloid leukemia and multiple myeloma. He is a member of numerous national and international specialist societies and is the author and co-author of a number of publications.

On January 4, 2021 Charles River Laboratories International, Inc. reported that it acquired of Distributed Bio, Inc. on December 31, 2020 (Press release, Charles River Laboratories, JAN 4, 2021, View Source [SID1234577812]). The acquisition marks the culmination of an exclusive partnership between these companies that was initiated in October 2018.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Based in South San Francisco, California, Distributed Bio is a next-generation antibody discovery company. Distributed Bio’s SuperHuman antibody libraries and integrated antibody optimization technologies help to enhance the probability of success for delivering high-quality, readily formattable antibody fragments to support antibody and cell and gene therapy candidates to biopharmaceutical clients. Distributed Bio’s libraries are computationally optimized for both sequence diversity and immuno-engineering fitness through the analysis of thousands of human antibody repertoires and all known monoclonal therapeutics in clinical trials, which can generate many unique binders against every antigen tested. This large molecule discovery platform improves the chance of successful hit finding, reduces optimization requirements, and thereby expedites the antibody discovery process by several months. Distributed Bio’s computational immunology expertise also enables optimization of existing client antibodies generated through more traditional platforms, such as hybridoma or traditional phage display.

The acquisition of Distributed Bio expands Charles River’s scientific capabilities with an innovative, large-molecule discovery platform. The transaction combines Distributed Bio’s antibody libraries and immuno-engineering platform with Charles River’s extensive drug discovery and non-clinical development expertise to create an integrated, end-to-end platform for therapeutic antibody and cell and gene therapy discovery and development.

James C. Foster, Chairman, President and Chief Executive Officer of Charles River Laboratories, commented, "The addition of Distributed Bio’s next-generation antibody discovery capabilities further enhances Charles River’s unique ability to serve as a single-source partner to support our clients’ early-stage research. Our successful partnership has already generated significant client interest and we believe our broader platform will continue to attract new discovery business opportunities. Distributed Bio’s large-molecule discovery platform fills a gap in our portfolio and expands our early discovery expertise in a complex drug modality that few CROs can successfully offer. With its focus on speed and design efficiency, we believe the acquisition of Distributed Bio will enable us to build upon the more than 80 novel small molecule candidates that we have discovered for our clients and meet our goal of eliminating an additional year from our clients’ early-stage development timelines. We are pleased to welcome Distributed Bio to the Charles River family."

"We believe our clients’ willingness to outsource more of their discovery programs will be predicated on our ability to continue to add innovative capabilities to meet our clients’ critical research needs, which we are accomplishing through strategic acquisitions and our partnership strategy. Distributed Bio is an example of our selective technology investments potentially becoming acquisitions after working with the target company for a meaningful period of time to provide its services to our clients. By adding innovative capabilities like large molecule discovery, we are enabling our clients to remain with one scientific partner from target identification through IND filing, and solidifying our position as the leading, early-stage contract research organization," Mr. Foster concluded.

Financial and Transaction Details

The purchase price was $83 million in cash, subject to customary closing adjustments. In addition to the initial purchase price, the transaction includes contingent additional payments of up to $21 million based on future performance. The proposed acquisition and associated fees have been financed through Charles River’s existing revolving credit facility and cash.

Distributed Bio’s estimated annual revenue in 2020 was approximately $15 million. The transaction is not expected to have a material impact on Charles River’s GAAP or non-GAAP financial results in 2021. Distributed Bio will become part of the Company’s Discovery and Safety Assessment segment.

Caution Concerning Forward-Looking Statements

This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "expect," "will," "may," "estimate," "plan," "outlook," and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements include statements in this news release regarding the acquisition of Distributed Bio and Charles River’s expectations with respect to the impact of Distributed Bio on the Company, its product and service offerings, client perception, revenue, revenue growth rates, and earnings per share; Charles River’s projected future performance including revenue and earnings per share; as well as Charles River’s future growth for discovery services. Forward-looking statements are based on Charles River’s current expectations and beliefs, and involve a number of risks and uncertainties that are difficult to predict and that could cause actual results to differ materially from those stated or implied by the forward-looking statements. Those risks and uncertainties include, but are not limited to, the ability to successfully integrate the acquisition of Distributed. A further description of these risks, uncertainties, and other matters can be found in the Risk Factors detailed in Charles River’s Annual Report on Form 10-K as filed on February 11, 2020 and the Quarterly Report on Form 10-Q as filed on October 29, 2020, as well as other filings we make with the Securities and Exchange Commission. Because forward-looking statements involve risks and uncertainties, actual results and events may differ materially from results and events currently expected by Charles River, and Charles River assumes no obligation and expressly disclaims any duty to update information contained in this news release except as required by law.