On December 5, 2020 Novartis reported analyses from two separate trials with Kymriah (tisagenlecleucel) in patients with certain advanced lymphomas. In the interim analysis of the investigational Phase II ELARA study, Kymriah led to a complete response (CR) in 65% of patients with relapsed or refractory (r/r) follicular lymphoma (FL) and an overall response rate (ORR) of 83% after at least three months of follow-up (Press release, Novartis, DEC 5, 2020, View Source [SID1234572214]). These patients continued to relapse or have refractory disease despite exposure to numerous lines of therapy (median four prior lines of therapy [range 2-13]) prior to Kymriah infusion1. The second analysis – a 40-month median follow-up from the Phase II JULIET trial – reported that the two-year progression-free survival (PFS) rate was 33% in patients with r/r diffuse large B-cell lymphoma (DLBCL), an important finding given these patients have limited treatment options that provide durable responses2. The JULIET study continued to show the effectiveness and well-characterized safety profile of Kymriah for these patients. These results were presented today during the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (ASH) (Free ASH Whitepaper).

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"For people who have follicular lymphoma that continues to relapse or does not respond after treatment with many lines of therapy, response to therapy becomes less likely with each additional treatment," said Nathan H. Fowler, MD, Department of Lymphoma and Myeloma, Division of Cancer Medicine at MD Anderson Cancer Center. "We are encouraged by these interim results from the ELARA trial, as there is a great need for potentially definitive options and an alternative to stem cell transplant. We look forward to continuing to learn more about how Kymriah may provide benefit for these patients."

In the interim analysis of the investigational ELARA clinical trial, in which 52 patients were evaluable for efficacy with a median follow-up of 9.9 months, Kymriah led to responses for the majority of patients treated. Specifically, after at least three months of follow-up, 65% (99.5% CI, 45.1-82.4) of patients achieved a complete response, meeting the primary endpoint. The overall response rate was 83% (95% CI, 69.7-91.8). For those who had a complete response, the vast majority (90%) sustained responses for six months or more.

Safety results from this analysis of the ELARA trial suggest there was no emergence of new safety signals for Kymriah in the 97 patients evaluable for safety. No patients experienced grade 3/4 CRS, as defined by the Lee Scale, and any grade CRS occurred in 49% of patients (29% grade 1; 20% grade 2). To treat CRS, 15% of patients required tocilizumab and 3% required steroids. One percent of patients experienced grade 3/4 NEs and any grade NEs occurred in 9% of patients. Median time to CRS and severe NE onset was four and 8.5 days respectively, with respective median time to resolution of four and two days. All neurological and CRS events resolved with appropriate management. Three patients died from progressive disease and no deaths were treatment-related. Kymriah was administered in the outpatient setting for 18% of patients in the ELARA trial1.

Results from the primary analysis of the ELARA study, with data from 90 patients followed up for at least 6 months, will be presented at an upcoming medical meeting.

"Novartis is dedicated to continuing to explore the safety and efficacy of Kymriah for patients with advanced blood cancers who do not achieve long-term remissions despite multiple prior lines of therapy," said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. "As we go deeper with our research in CAR-T cell therapies, these new analyses showcase the potential to rewrite cancer survival in patients with certain advanced lymphomas."

New updated efficacy results from pivotal JULIET clinical trial

New updated efficacy results from a 40-month median follow-up analysis demonstrated continued durable responses for patients with r/r DLBCL treated with Kymriah in the JULIET trial (n=115). Among the 61 patients who responded to treatment, the relapse-free probability was 60% at 24 and 36 months; median DOR was not reached (95% CI, 10-not estimable [NE])3. Two-year progression-free survival rate was 33% 2. Survival probability at 24 and 36 months was 40% and 36%, respectively. Importantly, no new safety signals were observed after more than three years of long-term follow-up observation3.

"Before the availability of Kymriah, long-term responses to treatment for those living with relapsed or refractory DLBCL were rare," said Ulrich Jaeger, MD, Medical University of Vienna, Vienna, Austria. "With these results from the JULIET trial, including biomarker analysis to better define patient subgroups who may benefit the most from CAR-T cell therapy, we are providing further evidence that Kymriah may be a definitive option for some patients. Additionally, with no new safety signals observed, physicians can continue to confidently refer their patients to certified centers to be treated with Kymriah."

The relationship between biomarkers, such as baseline Myc overexpression in tumors and tumor microenvironment (TME) characteristics, and response to Kymriah was also assessed in this analysis. Outcomes were better for those with negative Myc expression compared to those who had Myc overexpression, which leads to an unfavorable immunosuppressive TME with a restricted T-cell response. These results are consistent with historical outcomes for patients with Myc- and Myc+ expression4. Analyses to further identify biomarkers for response to CAR-T cell therapy are ongoing.

More information about Novartis activities at ASH (Free ASH Whitepaper) can be found on the Novartis 2020 ASH (Free ASH Whitepaper) Annual Meeting virtual portal.

About Follicular Lymphoma
Follicular lymphoma, the second most common form of non-Hodgkin lymphoma (NHL), is an indolent lymphoma, and represents approximately 22% of NHL cases5,6. Despite new treatments that improve overall survival, FL is regarded as an incurable malignancy with a relapsing and remitting pattern7,8. Throughout the lifetime of a patient with relapsing FL, they may be exposed to a median of five lines of prior treatment, with an upper range of 12 lines9,10. Although patients in third or later line treatment for FL have multiple systemic therapies available, the efficacy of these regimens drops off rapidly in later lines5. Additionally, because of this relapsing and remitting pattern, patients who are refractory to treatment or quickly relapse may exhaust available treatment options8.

About the ELARA trial
ELARA is a Phase II, single-arm, multicenter, open-label trial investigating the efficacy and safety of Kymriah in adult patients with r/r FL. This international trial has enrolled patients from over 30 sites in 12 countries worldwide. The primary endpoint is CRR based on best response by central review (Lugano 2014 criteria). Patients evaluable for efficacy had measurable disease at infusion and more than six months of follow-up from infusion or discontinued early. After infusion, disease assessments were performed every three months. Secondary endpoints include overall response rate, duration of response, progression-free survival, overall survival and safety.

In Q2 2020, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Kymriah in r/r FL, based on preliminary results from the ELARA trial. RMAT designation is intended to expedite the development and review of Kymriah as a regenerative therapy for this underserved patient population. Kymriah also has Orphan Drug designation from the FDA for this indication.

About the JULIET Trial
JULIET was the first multi-center global registration study for Kymriah in adult patients with r/r DLBCL. JULIET, led by researchers at the University of Pennsylvania, enrolled patients from 27 sites in 10 countries across the US, Canada, Australia, Japan and Europe, including Austria, France, Germany, Italy, Norway and the Netherlands.

About Kymriah
Kymriah is the first-ever FDA-approved CAR-T cell therapy, and the first-ever CAR-T to be approved in two distinct indications. It is a one-time treatment designed to empower patients’ immune systems to fight their cancer. Kymriah is currently approved for the treatment of r/r pediatric and young adult (up to 25 years of age) acute lymphoblastic leukemia (ALL), and r/r adult DLBCL11.

About Novartis Commitment to Oncology Cell & Gene
Novartis has a mission to reimagine medicine by bringing curative cell & gene therapies to patients worldwide. Novartis has a deep CAR-T pipeline and ongoing investment in manufacturing and supply chain process improvements. With active research underway to broaden the impact of cell and gene therapy in oncology, Novartis is going deeper in hematological malignancies, reaching patients with other cancer types and evaluating next-generation CAR-T cell therapies that focus on new targets and utilize new technologies.

Novartis was the first pharmaceutical company to significantly invest in pioneering CAR-T research and initiate global CAR-T trials. Kymriah, the first approved CAR-T cell therapy, developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, is the foundation of Novartis’ commitment to CAR-T cell therapy. Kymriah is currently approved for use in at least one indication in 27 countries and at more than 270 certified treatment centers, with the ambition for further expansion to help fulfill the ultimate goal of bringing CAR-T cell therapy to every patient in need.

The Novartis global CAR-T manufacturing footprint spans seven facilities, across four continents. This comprehensive, integrated footprint strengthens the flexibility, resilience and sustainability of the Novartis manufacturing and supply chain. Commercial and clinical trial manufacturing is now ongoing at Novartis-owned facilities in Stein, Switzerland, Les Ulis, France and Morris Plains, New Jersey, USA, as well as at the contract manufacturing sites at Fraunhofer-Institut for cell therapy and immunology (Fraunhofer-Institut für Zelltherapie und Immunologie) facility in Leipzig, Germany, and now FBRI in Kobe, Japan. Manufacturing production at Cell Therapies in Australia and Cellular Biomedicine Group in China is forthcoming.

Kymriah (tisagenlecleucel) US Important Safety information
Kymriah may cause side effects that are severe or life-threatening, such as Cytokine Release Syndrome (CRS) or Neurological Toxicities. Patients with CRS may experience symptoms including difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, or dizziness/lightheadedness. Patients may be admitted to the hospital for CRS and treated with other medications.

Patients with neurological toxicities may experience symptoms such as altered or decreased consciousness, headaches, delirium, confusion, agitation, anxiety, seizures, difficulty speaking and understanding, or loss of balance. Patients should be advised to call their healthcare provider or get emergency help right away if they experience any of these signs and symptoms of CRS or neurological toxicities.

Because of the risk of CRS and neurological toxicities, Kymriah is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called Kymriah REMS.

Serious allergic reactions, including anaphylaxis, may occur after Kymriah infusion. Kymriah can increase the risk of life-threatening infections that may lead to death. Patients should be advised to tell their healthcare provider right away if they develop fever, chills, or any signs or symptoms of an infection.

Patients may experience prolonged low blood cell counts (cytopenia), where one or more types of blood cells (red blood cells, white blood cells, or platelets) are decreased. The patient’s healthcare provider will do blood tests to check all of their blood cell counts after treatment with Kymriah. Patients should be advised to tell their healthcare provider right away if they get a fever, are feeling tired, or have bruising or bleeding.

Patients may experience hypogammaglobulinemia, a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is increased. It is expected that patients may develop hypogammaglobulinemia with Kymriah, and may need to receive immunoglobulin replacement for an indefinite amount of time following treatment with Kymriah. Patients should tell their healthcare provider about their treatment with Kymriah before receiving a live virus vaccine.

After treatment with Kymriah, patients will be monitored lifelong by their healthcare provider, as they may develop secondary cancers or recurrence of their cancer.

Patients should not drive, operate heavy machinery, or do other dangerous activities for eight weeks after receiving Kymriah because the treatment can cause temporary memory and coordination problems, including sleepiness, confusion, weakness, dizziness, and seizures.

Some of the most common side effects of Kymriah are difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, confusion, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, dizziness/lightheadedness, and headache. However, these are not all of the possible side effects of Kymriah. Patients should talk to their healthcare provider for medical advice about side effects.

Prior to a female patient starting treatment with Kymriah, their healthcare provider may do a pregnancy test. There is no information available for Kymriah use in pregnant or breast-feeding women. Therefore, Kymriah is not recommended for women who are pregnant or breast feeding. Patients should talk to their healthcare provider about birth control and pregnancy.

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

After receiving Kymriah, patients should be advised that some commercial HIV tests may cause a false-positive test result. Patients should also be advised not to donate blood, organs, or tissues and cells for transplantation after receiving Kymriah.

On December 5, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. The results were shared in an oral presentation at the virtual 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. BCMA (B-cell maturation antigen) is a protein that is typically over-expressed on multiple myeloma cells. REGN5458 is designed to bind to BCMA on multiple myeloma cells and the CD3 receptor on T-cells in order to bridge them together and activate T-cells to kill the cancer cells.

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"REGN5458 continues to show early, deep and durable anti-tumor responses in patients with relapsed and refractory multiple myeloma across all dose levels. This is particularly encouraging given that a majority of patients were heavily pretreated and had few options remaining. All patients were triple-refractory, with 57% being penta-refractory," said Deepu Madduri, M.D., Assistant Professor of Medicine at the Icahn School of Medicine at Mount Sinai in New York and a trial investigator. "As these data continue to mature, we look forward to assessing whether responses will further deepen and remain durable with ongoing REGN5458 treatment."

In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. With a median follow up of 2.6 months (range: 1-13), responses generally occurred by week 4 and deepened over time. Exploratory analyses suggest that patient-reported global health status/quality of life (per EORTC QLQ-C30) also improved meaningfully at week 4 and was maintained through week 24, with assessment ongoing.

*As of data cut-off, dose level 6 patients had been followed for a median of 2 months, and responses may deepen over time.

Among all patients who responded to treatment (n=19) as of data cut-off:

95% (n=18) achieved a VGPR or better
42% (n=8) had a CR or sCR
57% of evaluable patients (4 of 7 patients) were minimal residual disease (MRD) negative
Tumor response was not correlated with BCMA expression as assessed by immunohistochemistry
In assessing durability among patients who responded to treatment and with data continuing to mature at the time of analysis:

Among responding patients with ≥6 months of follow-up, 83% (10 of 12 patients) have ongoing responses for up to 13 months at the time of analysis
74% of responders (n=14) remain on treatment
The observed median duration of response was 6 months (range: 1-13)
The most common adverse events (AEs) were cytokine release syndrome (CRS; 39%; n=19), anemia (37%; n=18), fatigue (35%; n=17), nausea (31%; n=15), pyrexia (31%; n=15) and back pain (27%; n=13). Grade ≥3 AEs occurred in 69% (n=34) of patients with the most common being anemia (22%; n=11), neutropenia (14%; n=7) and lymphopenia (12%; n=6). There were no reports of Grade ≥3 CRS or neurotoxicity. Dose-limiting toxicity was reported in 2 patients with 1 patient experiencing acute kidney injury and 1 patient experiencing elevated alanine aminotransferase (ALT)/raised aspartate aminotransferase (AST). Both cases were resolved with supportive care, and the patient that experienced elevated ALT/AST remains on REGN5458 and has since achieved a VGPR.

"REGN5458 is the second CD3 bispecific in our oncology portfolio to show clinically meaningful results. Alongside our CD20xCD3 bispecific odronextamab, REGN5458 offers additional evidence to support the potential of our bispecific platform to transform the treatment of diverse blood cancers for patients," said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President, Translational & Clinical Sciences, Hematology at Regeneron. "Regeneron continues to drive increasing momentum across our oncology and non-oncology hematology programs. We are currently enrolling patients in a potentially registrational Phase 2 portion of this REGN5458 trial. We are also expanding our odronextamab program with multiple pivotal trials in 2021."

In addition to the REGN5458 data, updated results from the Phase 1 odronextamab trial in R/R follicular lymphoma, diffuse large B-cell lymphoma and other B-cell non-Hodgkin lymphomas will also be shared in an oral presentation (Abstract 400) at ASH (Free ASH Whitepaper) and will include patient follow-up data of up to 3 years.

REGN5458 and odronextamab were invented using Regeneron’s proprietary VelocImmune technology and created using the company’s Veloci-Bi platform. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

About the Phase 1/2 Dose-escalation Trial
REGN5458 monotherapy is being investigated in an open-label, Phase 1/2 dose-escalation trial in patients with R/R multiple myeloma who are at least triple refractory to existing therapeutic options, including proteasome inhibitors, immunomodulatory drugs and CD38 antibody treatments. The Phase 1 portion of the trial is primarily assessing safety, tolerability, and dose-limiting toxicities of REGN5458, with efficacy as secondary endpoints. The Phase 2 portion is currently enrolling patients and will further assess REGN5458 anti-tumor activity and safety.

Among the patients being enrolled are those with heavily pre-treated, triple refractory and penta-exposed multiple myeloma, including those with extra-medullary (outside of the bone marrow) and non-secretory (do not secrete detectable myeloma proteins) disease.

About Multiple Myeloma
Multiple myeloma is the second most common blood cancer with approximately 30,192 and 168,765 new diagnoses in the U.S. and the world, respectively, in 2020. It is characterized by the proliferation of cancerous plasma cells (multiple myeloma cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. Multiple myeloma is not curable despite treatment advances. While current treatments are able to slow progression of the cancer, most patients will ultimately experience cancer progression and require additional therapies.

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On December 4, 2020 Magenta Therapeutics (NASDAQ: MGTA) and bluebird bio, Inc. (NASDAQ: BLUE) reported an exclusive clinical trial collaboration to evaluate the utility of MGTA-145, in combination with plerixafor, for mobilization and collection of stem cells in adults and adolescents with sickle cell disease (SCD) (Press release, Magenta Therapeutics, DEC 4, 2020, View Source [SID1234639033]). The data from this clinical trial could provide proof-of-concept for MGTA-145, in combination with plerixafor, as the preferred mobilization regimen for patients with SCD. bluebird bio’s experience with plerixafor as a mobilization agent in sickle cell disease aligns with Magenta’s combination therapy approach, utilizing MGTA-145 plus plerixafor with potential to achieve safe, rapid and reliable mobilization of sufficient quantities of high-quality stem cells to improve outcomes associated with stem cell transplantation. Under the collaboration, the stem cells will be fully characterized, and Magenta will undertake preclinical studies to evaluate the ability of these cells to be gene corrected and engrafted in mouse models. The companies will co-fund the clinical trial and Magenta will retain all rights to its product candidate.

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This press release features multimedia. View the full release here: View Source

"We are excited to build upon our leading position in the field of ex-vivo gene therapy and the promising clinical data with LentiGlobin in SCD with a collaboration focused on achieving improved stem cell mobilization," said Dave Davidson, M.D., chief medical officer, bluebird bio. "In this initial study, we hope to establish whether the combination of plerixafor with MGTA-145 can generate appropriate CD34+ stem cells with a single round of mobilization. If successful, we hope to evaluate this novel mobilization regimen with LentiGlobin to make another step forward in the treatment of patients with SCD."

"Achieving reliable and rapid stem cell mobilization and a simplified collection process can ensure the entire patient experience is optimal with respect to therapeutic outcome. The incorporation of bluebird bio’s experience in this area of treatment will be immensely valuable in further developing MGTA-145 plus plerixafor to address the remaining unmet needs in gene therapy approaches for diseases like sickle cell disease," said John Davis Jr., M.D., M.P.H., M.S., Head of Research & Development and Chief Medical Officer, Magenta Therapeutics. "We look forward to collaborating with bluebird bio to evaluate MGTA-145 as the preferred mobilization option for people with sickle cell disease."

SCD is a serious, progressive and debilitating genetic disease caused by a mutation in the β-globin gene that leads to the production of abnormal sickle hemoglobin (HbS), causing red blood cells (RBCs) to become sickled and fragile, resulting in chronic hemolytic anemia, vasculopathy and painful vaso-occlusive events (VOEs). For adults and children living with SCD, this means unpredictable episodes of excruciating pain due to vaso-occlusion as well as other acute complications—such as acute chest syndrome (ACS), stroke, and infections, which can contribute to early mortality in these patients.

Currently available mobilization drugs, including granulocyte-colony stimulating factor (G-CSF), a commonly used mobilization agent administered over the course of five to seven days in other transplant settings, is not used in sickle cell disease because it can trigger vaso-occlusive crises and even death in adults and adolescents. Plerixafor is used to mobilize a patient’s stem cells for collection prior to transplant and while an available treatment option, multiple cycles of apheresis and collection may sometimes be required to generate sufficient stem cells for gene therapy. Magenta is developing MGTA-145, in combination with plerixafor, to be the preferred mobilization regimen for rapid and reliable mobilization and collection of hematopoietic stem cells (HSCs) to improve stem cell transplantation outcomes in multiple disease areas, including genetic diseases such as sickle cell disease, as well as blood cancers and autoimmune diseases.

About Magenta Therapeutic’s MGTA-145

MGTA-145, in combination with plerixafor, has demonstrated, in a recently completed Phase 1 study in healthy volunteers, it can rapidly and reliably mobilize high numbers of functional stem cells in a single day, without the need for G-CSF. MGTA-145 works in combination with plerixafor to harness a physiological mechanism of stem cell mobilization to rapidly and reliably mobilize HSCs for collection and transplant across multiple indications.

Additionally, as shown in preclinical studies, stem cells mobilized with MGTA-145 can be efficiently gene-modified and are able to engraft, potentially allowing for safer and more efficient mobilization for gene therapy approaches to treat sickle cell disease and other genetic diseases.

Magenta completed its Phase 1 trial of MGTA-145 in healthy volunteers, demonstrating MGTA-145 was well tolerated and enables same-day dosing, mobilization and simplified collection of sufficient stem cells for transplant, meeting all primary and secondary endpoints.

On December 4, 2020, Atara Biotherapeutics, Inc. (the "Company" or "Atara") reported that it entered into a Research, Development and License Agreement (the "License Agreement") with Bayer AG ("Bayer") (Filing, 8-K, Atara Biotherapeutics, DEC 4, 2020, View Source [SID1234572309]). Pursuant to the License Agreement, the Company grants to Bayer an exclusive, field-limited license under the applicable patents and know-how owned or controlled by the Company and its affiliates covering or related to ATA2271 and ATA3271, the Company’s next-generation CAR T immunotherapy programs targeting mesothelin, of which the Company is currently developing ATA2271 in collaboration with Memorial Sloan Kettering Cancer Center ("MSK"), to develop, manufacture and commercialize products comprising ATA2271 and ATA3271 and certain derivatives thereof ("Licensed Products"), in each case targeting mesothelin.

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Under the terms of the License Agreement, the Company will be responsible at its cost for all mutually agreed pre-clinical and clinical activities for ATA2271 through the first in human Phase 1 clinical study, following which Bayer will be responsible for the further development of ATA2271 at its cost. Bayer will be responsible for the development of ATA3271, except for certain mutually agreed pre-clinical, translational, manufacturing and supply chain activities to be performed by the Company relating to ATA3271, in each case at Bayer’s cost. Bayer will also be solely responsible for commercializing the Licensed Products at its cost. The Company will own any intellectual property rights developed solely by the Company under the collaboration, and Bayer will own any intellectual property rights developed solely by Bayer or jointly by the parties under the collaboration. Such Bayer-developed or jointly-developed intellectual property rights are subject to the Company’s rights to certain manufacturing and process development-related intellectual property. The Company has agreed to not develop or commercialize (or assist any third party to develop or commercialize) any cell therapy targeting mesothelin outside of the collaboration with Bayer for a period of three years from the first commercial sale of a Licensed Product.

Bayer will pay the Company an upfront cash payment of $45.0 million for the exclusive license grant, and will make an additional $15.0 million reimbursement payment to the Company for certain research and process development activities to be performed by the Company under the License Agreement. The Company is also entitled to receive (i) up to an additional $5.0 million for additional, specified pre-clinical and translational activities under the License Agreement, (ii) an aggregate of up to $610.0 million in milestone payments upon achieving certain development, regulatory and commercial milestones relating to Licensed Products and (iii) additional amounts for manufacturing services and product supply. In addition, the Company is eligible to receive tiered royalties at percentages up to low double digits on worldwide net product sales of Licensed Products on a country-by-country and product-by-product basis until the later of 12 years after the first commercial sale in such country or the expiration of specified patent rights in such country, subject to certain reductions and aggregate minimum floors. The License Agreement includes (i) various representations, warranties, covenants, indemnities, and other customary provisions and (ii) contains customary provisions for termination by Bayer for convenience, by the Company upon a challenge of the Company’s licensed patents, and by either party, including in the event of breach of the License Agreement (subject to cure), subject, in each case, to certain reversion rights, or upon the other party’s bankruptcy.

Pursuant to the License Agreement, for a limited period of time and only if the Company pursues a potential out-license of an additional Atara CAR T product candidate, the Company also grants Bayer a non-exclusive right to negotiate a license of such additional Atara CAR T product candidate on mutually agreed terms. The foregoing right granted to Bayer will expire upon certain change of control events of the Company.

The foregoing summary is qualified in its entirety by reference to the License Agreement. The License Agreement will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.