On November 30, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company that utilizes the latest biotechnology to discover and deliver novel medicines, reported that the pivotal Phase 2 TIDAL study evaluating zandelisib as a single agent for follicular lymphoma (FL) patients who received at least two prior systemic therapies demonstrated a 70.3% objective response rate (ORR) as determined by Independent Review Committee (IRC) assessment in the primary efficacy population (n=91) (Press release, MEI Pharma, NOV 30, 2021, View Source [SID1234596251]). In addition, 35.2% of patients achieved a complete response. The data are currently insufficiently mature to accurately estimate duration of response (DOR). In line with previously reported data from the Phase 1B study, zandelisib was generally well tolerated. With 9.4 months (range: 0.8-24) median duration of follow-up in the total study population (n=121), interim data demonstrated a discontinuation rate due to any drug related adverse event of 9.9%. Patients enrolled in the study will continue to be followed for safety and DOR. Zandelisib is an investigational selective phosphatidylinositol 3-kinase delta ("PI3Kδ") inhibitor in clinical development for the treatment of B-cell malignancies.

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"Our team is continuing to study this investigational medicine with our partner MEI Pharma in the hopes of understanding zandelisib’s value and bringing more hope to lymphoma patients around the world."

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Overview of Preliminary TIDAL Data in Relapsed or Refractory (r/r) FL

The ongoing TIDAL study (NCT03768505) is a global, open-label Phase 2 trial evaluating zandelisib as a single agent across two disease cohorts: the first cohort for the treatment of adults with r/r FL and the second cohort for r/r marginal zone lymphoma (MZL), in both cases after failure of at least two prior systemic therapies, including chemotherapy and an anti-CD20 antibody. Enrollment in the FL cohort is complete; enrollment in the MZL cohort is ongoing. Subject to the results and discussion with the U.S. Food and Drug Administration (FDA), TIDAL study data from each study cohort are intended to be submitted to the FDA to support accelerated approval marketing applications.

The r/r FL cohort enrolled a total of 121 patients, 91 of which were enrolled in the primary efficacy population for the evaluation of ORR and DOR. The median age of patients with FL was 64 years old. Patients enrolled in both the FL primary efficacy and total patient populations received a median of 3 prior lines of treatment (range: 2-8). Patients were administered zandelisib once daily for two 28-day cycles as response induction therapy, followed thereafter by once daily dosing for the first seven days of each subsequent 28-day cycle, a schedule called Intermittent Dosing Therapy (IDT).

Efficacy

The ORR in the 91 patients with r/r FL enrolled in the primary efficacy population was 70.3% (n=64), 95% CI=59.8, 79.5, as assessed by IRC after a minimum follow-up of 6 months; the complete response rate was 35.2%, 95% CI=25.4, 45.9. The ORR represents the primary endpoint of the TIDAL study.

As of the data cutoff date, the data are not sufficiently mature to accurately estimate the final DOR in the FL primary efficacy population, a secondary outcome measure of the TIDAL study. However, with a median follow-up time for response of 8.4 months, the median DOR had not been reached. The data cutoff date is approximately 6 months after the last patient in the primary efficacy population received their first dose of zandelisib.

Safety and Tolerability

Zandelisib appeared generally well-tolerated in the total TIDAL study population through the data cutoff date. The safety observed in TIDAL was consistent with data previously reported from the Phase 1B study (NCT02914938) evaluating zandelisib in patients with B-cell malignancies as a single agent or in combination with rituximab (Rituxan).

As of the data cutoff date, with a median follow up of 9.4 months (range: 0.8-24) in the total FL study population, the incidence of Grade ≥3 Adverse Events of Special Interest were: 1.7% ALT/AST elevation, 1.7% colitis, 5% diarrhea, 2.5% mucositis, 0.8% pneumonitis, and 3.3% rash. The discontinuation rate due to any drug related adverse event in the group was 9.9%, also as of the data cutoff date.

A more complete report of the TIDAL data as of the data cutoff date will be submitted for presentation at upcoming scientific congresses in 2022.

"The emerging zandelisib data are very promising and indicate the potential to positively impact the standard-of-care for patients with relapsed or refractory follicular lymphoma," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "The response data and interim safety data reported today support our plans to continue discussions with the FDA on timing of an accelerated approval submission, and we look forward to reporting a more comprehensive review of the data at upcoming medical conferences while continuing this trial and continuing to advance the zandelisib clinical development program in indications beyond follicular and marginal zone lymphomas with our partner, Kyowa Kirin."

"We are encouraged by the zandelisib data reported today from the TIDAL study," said Yoshifumi Torii, PhD, Executive Officer, vice president, Head of R&D Division of Kyowa Kirin. "Our team is continuing to study this investigational medicine with our partner MEI Pharma in the hopes of understanding zandelisib’s value and bringing more hope to lymphoma patients around the world."

MEI Pharma Conference Call and Webcast

MEI will host an investor and analyst webcast event today, November 30, 2021, at 8:00 AM Eastern Time to review the TIDAL phase 2 study data reported today and to provide a corporate overview.

You can access the live webcast with slides under the investor relations section of MEI’s website on the "Events and Presentation" page at: www.meipharma.com. A replay of the webcast will be archived for at least 30 days after the conclusion of the live event.

To view additional media and investor resources from MEI Pharma click here.

About Zandelisib

Zandelisib, a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies. Clinical trials are investigating the efficacy and safety of zandelisib utilizing an Intermittent Dosing Regimen (IDT), as a single agent and in combination with other modalities for the treatment of patients with B-cell malignances. The IDT leverages molecular and biologic properties specific to zandelisib.

In March 2020 the FDA granted zandelisib Fast Track designation for treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least 2 prior systemic therapies. In November 2021 the FDA granted zandelisib Orphan Drug designation for the treatment of patients with follicular lymphoma.

In April 2020, MEI and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib. MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S., with MEI booking all revenue from the U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S.

Ongoing zandelisib studies include the cohort in TIDAL evaluating patients with r/r marginal zone lymphoma and continuing follow up in the cohort of the study evaluating patients with r/r follicular lymphoma. Also ongoing is the Phase 3 COASTAL study (NCT04745832) comparing zandelisib plus rituximab to standard of care chemotherapy plus rituximab, in patients with r/r follicular or marginal zone lymphomas who received ≥ 1 prior line of therapy, which must have included an anti-CD20 antibody in combination with chemotherapy or lenalidomide. COASTAL is intended to support marketing applications in the U.S. and globally. Pending FDA agreement, COASTAL is also intended to act as the required confirmatory study for potential U.S. accelerated approvals of zandelisib based on the TIDAL study.

Other ongoing studies include a Phase 2 pivotal study in Japan (NCT04533581) in patients with indolent B-cell non-Hodgkin’s lymphoma (iNHL) without small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), and Waldenström’s macroglobulinemia (WM) conducted by Kyowa Kirin.

About the TIDAL Phase 2 Study

The TIDAL study (Trials of PI3Kδ DeltA in Non-Hodgkin’s Lymphoma) is a global Phase 2 trial evaluating zandelisib as a single agent across two study cohorts: the first cohort for the treatment of adults with r/r FL and the second cohort for r/r MZL, in both cases after failure of at least two prior systemic therapies including chemotherapy with an alkylating agent and an anti-CD20 antibody. Subject to the results and discussions with the FDA, data from each study cohort are intended to be submitted to the FDA to support separate accelerated approval marketing applications under 21 CFR Part 314.500, Subpart H.

The study is evaluating zandelisib administered once daily at 60 mg for two 28-day cycles as response induction therapy, followed thereafter by Intermittent Dosing Therapy, or "IDT." The zandelisib IDT consists of once daily dosing for the first seven days of each subsequent 28-day cycle and was developed based on zandelisib-specific preclinical and clinical supporting evidence. The primary efficacy endpoint is the rate of objective responses to therapy and other endpoints will include duration of response and tolerability of zandelisib. The primary efficacy population sample size for r/r FL is 91 patients and the primary efficacy population sample size for r/r MZL is 64 patients. Complete enrollment of the FL primary efficacy population was announced in April 2021. The total study population in the FL cohort is 121 patients to provide additional safety data for the registration application.

More information about this trial is available at ClinicalTrials.gov (NCT03768505).

About PI3K Delta

Phosphatidylinositol 3-kinase delta (PI3Kδ) is often overexpressed in cancer cells and plays a key role in the proliferation and survival of hematologic cancers. Targeting the inhibition PI3Kδ is a validated strategy in various B cell malignancies, including follicular and marginal zone lymphomas. However, PI3Kδ inhibition can lead to immune dysregulation, including inhibition of regulatory T-cell (T-reg) activity, which is understood to contribute to immune-mediated treatment-limiting toxicities.

Strategies to minimize immune dysregulation, while maintaining tumor control with PI3K inhibitors, are required. Subject to suitable pharmacodynamic characteristics, intermittent dosing of PI3Kδ inhibitors is a promising approach to decouple the inhibitory activity on malignant B-cells from T-reg inhibition, potentially allowing T-reg recovery, improving tolerability and optimizing the therapeutic potential of this class of therapy.

About Follicular Lymphoma

Follicular lymphoma (FL) is the most common indolent lymphoma, comprising about 20-30% of all non-Hodgkin lymphomas (NHL). The disease also forms on B-cells, is chronic in most cases and tends to progress slowly. Follicular lymphoma is most common in the elderly, having a median age at diagnosis of approximately 65 years old. Sometimes follicular lymphomas can transform into a more aggressive form of large B-cell lymphoma, a fast-growing type of NHL.

On November 30, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported positive top-line data from the pivotal SORAYA trial evaluating the safety and efficacy of mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab) (Press release, ImmunoGen, NOV 30, 2021, View Source [SID1234596271]).

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"Despite advances in the platinum-sensitive setting, most patients with ovarian cancer eventually develop platinum-resistant disease, for which there are limited treatment options, especially for those patients who have previously received bevacizumab," said Robert Coleman, MD, Chief Scientific Officer of US Oncology Research and SORAYA Co-Principal Investigator. "Data from SORAYA have the potential to redefine the standard of care for patients with FRα-high platinum-resistant ovarian cancer, as this trial has demonstrated that mirvetuximab delivers clinically meaningful benefit in this setting, with significant and durable responses and a favorable tolerability profile."

SORAYA is a single-arm study of mirvetuximab in patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα and who have been treated with up to three prior regimens – at least one of which included bevacizumab. The primary endpoint for the study is confirmed objective response rate (ORR) as assessed by investigator, including complete and partial responses, and the key secondary endpoint is duration of response (DOR). ORR was also assessed by blinded independent central review (BICR). The study is designed to rule out a 12% ORR, based on expected outcomes with available single agent chemotherapy from the AURELIA study in patients with platinum-resistant ovarian cancer and one to two prior lines of therapy.

Key Findings from SORAYA

SORAYA enrolled 106 patients with a median of three prior lines of therapy (range one to four); 51% had three prior lines of therapy and 48% had one to two prior lines of therapy. All patients received prior bevacizumab; 48% of patients received a prior PARP inhibitor. As of the data cutoff on November 16, 2021, the median follow-up time was 8.1 months.

ORR by investigator was 32.4% (95% confidence interval [CI]: 23.6%, 42.2%), including five complete responses (CRs). ORR by BICR was 31.6% (95% CI: 22.4%, 41.9%), including five CRs. Responses were observed regardless of prior PARP inhibitor or number of prior lines of therapy.
The median DOR is currently 5.9 months (95% CI: 5.6, 7.7). With nearly half of responders continuing on therapy, the duration of response continues to evolve and, with longer follow-up, median DOR could range from 5.7 to just above 7 months.
Mirvetuximab was well-tolerated, consistent with the known safety profile seen in more than 700 patients treated in the broader mirvetuximab program. Treatment-related adverse events led to dose reductions in 19% of patients, dose delays in 32% of patients, and discontinuations in 7% of patients. The most common treatment-related adverse events included blurred vision (41% all grade; 6% grade 3+), keratopathy (35% all grade; 9% grade 3+), and nausea (29% all grade; 0% grade 3+).
"These data have the potential to be transformative for ovarian cancer patients and their physicians," said Ursula Matulonis, MD, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, Professor of Medicine at the Harvard Medical School, and SORAYA Co-Principal Investigator. "In the platinum-resistant setting and particularly in later-line treated patients, response rates with available therapy are in the single digits with significant toxicities. With an ORR above 30%, a duration of response of around six months, and a treatment-related discontinuation rate below 10%, mirvetuximab shows impressive activity and tolerability for patients with platinum-resistant ovarian cancer. If approved, mirvetuximab will become a critical therapeutic option for patients with FRα-high ovarian cancer."

"We are extremely pleased with the top-line data from SORAYA, which support our strategy to position mirvetuximab as the standard of care for patients with FRα-high ovarian cancer," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "Mirvetuximab’s efficacy far exceeds that which is expected with available therapies. This is particularly encouraging given the majority of patients in SORAYA were fourth-line, and the safety profile and anti-tumor activity replicate those previously generated in the program. We are deeply grateful to all of the patients and physicians who participated in this study, and we look forward to presenting the full SORAYA data at a medical meeting next year."

"This is an exciting moment, both for the field of ovarian cancer and for ImmunoGen, and the outcomes from SORAYA further validate our longstanding history of innovation in ADCs," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "We are moving forward expeditiously to complete the BLA for mirvetuximab, with the goal of submitting the application to FDA for accelerated approval in the first quarter of 2022. In parallel, commercial preparations are well underway to support the potential launch of mirvetuximab next year. To this end, we recently hired our Chief Commercial Officer and are focused on having the right talent, resources, and infrastructure in place to maximize the potential impact of mirvetuximab for women living with ovarian cancer. Beyond SORAYA, we expect to generate top-line data from our confirmatory MIRASOL trial in the third quarter of 2022 to support the potential full approval of mirvetuximab. We are also working to expand mirvetuximab monotherapy into later-line platinum-sensitive disease and, as part of our efforts to establish mirvetuximab as the combination agent of choice, evaluating mirvetuximab doublets in earlier lines of treatment, all with the goal of furthering our mission to offer more patients more good days."

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 7577328. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

ABOUT MIRVETUXIMAB SORAVTANSINE

Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells.

On November 30, 2021 GE Healthcare reported collaborations with SOPHiA GENETICS, The University of Cambridge and Optellum as part of its vision to advance care, make precision health more accessible, and ultimately improve outcomes for cancer patients (Press release, GE Healthcare, NOV 30, 2021, View Source [SID1234596290]).

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These alliances are intended to help GE Healthcare support integrated health systems at the local level by providing the technology to deploy software across imaging networks and helping to make the newest innovations accessible across the broader population. It is hoped this will enable local oncologists and medical experts to deliver earlier diagnoses and more accurate treatments — a crucial component in achieving positive health outcomes with cancer patients.

"Cross-functional partnerships between organizations are key to the creation of new approaches and intelligent tools that enable cancer to be detected as early as possible and with the greatest degree of accuracy," said Dr. Ben Newton, Global Head of Oncology Solutions at GE Healthcare. "By partnering with SOPHiA GENETICS, Optellum, and the University of Cambridge, we’re looking to create a more powerful oncology care pathway that promotes high-quality, personalized, and effective medical care."

GE Healthcare’s comprehensive diagnostic imaging and monitoring portfolio can be deployed throughout the patient’s cancer journey, from initial screening and diagnosis, through therapy guidance facilitating minimally invasive treatment, to monitoring patient progress.

As cases of cancer continue to rise and are predicted to reach 29.5 million new cases per year by 20401 there is a growing demand for data-driven medicine, both for clinical practice and clinical trials. GE Healthcare is utilizing its Edison platform to integrate data from diverse sources, such as electronic health records (EHR) and radiology information systems (RIS), imaging and other medical device data. This integrated data can be used to develop and deploy AI enabled solutions to help simplify oncology patient workflows, better understand increasingly complicated clinical patient data, and compare data from patient to patient.

SOPHiA GENETICS and GE Healthcare will be collaborating on opportunities in the healthcare market, including various initiatives and projects in the fields of digital oncology and radiogenomic analysis. The companies will initially work together on the creation of infrastructure to integrate data between GE’s Edison platform and the SOPHiA DDM platform, as well as co-marketing and pilot site recruitment across oncology and radiogenomics.

The companies will be deploying GE Healthcare’s extensive medical imaging and monitoring capabilities and Edison platform-enabled data aggregation with the SOPHiA DDM cloud-based software-as-a-service analytics genomic insights platform and related solutions, which are available in more than 750 hospitals, laboratories and biopharma companies.

The University of Cambridge, Cambridge University Hospitals and GE Healthcare have agreed to collaborate on developing an application aiming to improve cancer care, with Cambridge providing clinical expertise and data to support GE Healthcare’s development and evaluation of an AI-enhanced application that integrates cancer patient data from multiple sources into a single interface.

Building on research supported by The Mark Foundation for Cancer Research and Cancer Research UK, the collaboration aims to address the problems of fragmented or siloed data and disconnected patient information, which is challenging for clinicians to manage effectively and can prevent cancer patients receiving optimal treatment.

UK-based company Optellum is a leader in AI- decision support for the early diagnosis and optimal treatment of lung cancer. Together, the companies are seeking to address one of the largest challenges in the diagnosis of lung cancer, helping providers to determine the malignancy of a lung nodule: a suspicious lesion that may be benign or cancerous. The majority of incidentally detected pulmonary nodules present an indeterminate cancer risk, which are incredibly challenging for clinicians to diagnose and manage, leading to delayed treatment for cancer patients and invasive procedures on healthy people.

Optellum’s Virtual Nodule Clinic identifies and scores the probability of malignancy in a lung nodule, which is key to determining whether biopsy is necessary, and accelerating diagnosis. It is the only FDA-cleared AI-assisted diagnosis software for early-stage lung cancer2, and has been shown to improve the sensitivity and specificity of malignancy assessments of indeterminate nodules 3 ­— enabling pulmonologists and radiologists to make optimal clinical decisions4.

On November 30, 2021 Akoya Biosciences, Inc., (Nasdaq: AKYA), The Spatial Biology Company, reported that its Advanced Biopharma Solutions (ABS) laboratory, located in Marlborough, Massachusetts, has received its Certificate of Registration from the Clinical Laboratory Improvement Amendments (CLIA) program, following the receipt of a Massachusetts Department of Public Health clinical laboratory license (Press release, Akoya Biosciences, NOV 30, 2021, View Source [SID1234596308]). This certification enables Akoya’s ABS lab to support later stage clinical trial studies with its biopharmaceutical partners.

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CLIA certification affirms that Akoya’s ABS lab processes and services operate under high quality standards and provides a framework for assay development and validation that consistently meets guidelines for accuracy, precision, specificity, sensitivity, and reproducibility. This milestone is an important step towards advancing the company’s platforms toward clinical use. It further positions Akoya Biosciences as an attractive partner for biopharmaceutical companies seeking to incorporate its ground-breaking spatial biology technologies into their clinical research, most notably in the expanding field of cancer immunotherapy.

"Securing CLIA certification for ABS demonstrates our commitment to meeting the highest quality standards," said Brian McKelligon, Chief Executive Officer of Akoya Biosciences. "This is an important step in support of our effort to work with our biopharmaceutical partners to identify biomarkers that lead to better clinical decision making and improved patient outcomes."

Spatial biology, a rapidly emerging field of science, allows researchers to discover and validate biomarker signatures that map the interactions of tumor and immune cells across an entire tumor tissue section by retaining the spatial context. Published studies have demonstrated that spatial phenotypic signatures, based on Akoya’s platform, are more accurate at predicting response to immunotherapy than biomarkers currently being used in the clinic.

The certification will enable Akoya to expand its collaborations with key partners like AstraZeneca and other biopharmaceutical companies working with Akoya’s ABS Program. The goal of this program is to enable biopharma partners to leverage Akoya’s deep spatial biology expertise and technological innovations from the early stages of clinical trials, potentially, through full companion diagnostic approval.

The CLIA certification is the latest milestone in Akoya’s ongoing efforts to ensure consistency and standardization of its laboratory processes and results. Important prior milestones include a recent publication in the Journal of Immunotherapy for Cancer on the MITRE Study, demonstrating for the first time a spatial biology workflow with the throughput, accuracy and reproducibility required to serve the translational and clinical markets.

On November 30, 2021 PCI Biotech Holding ASA (OSE: PCIB), a cancer focused biopharmaceutical company with a unique intracellular delivery technology via Photochemical Internalisation and Immunicum AB (publ; IMMU.ST), a biopharmaceutical company focused on hard-to-treat established tumors and the prevention of cancer recurrence, reported an extension of their current collaboration (Press release, PCI Biotech, NOV 30, 2021, View Source [SID1234596457]).

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The companies jointly research the possibility to overcome current hurdles in cancer immunotherapy by introducing tumor independent immune targets into the tumor microenvironment, in combination with vaccination or adoptive immunotherapies. The so-called Tumor Independent Antigen concept, which has been invented by Immunicum, could benefit from PCI Biotech’s antigen delivery technologies based on Photochemical Internalisation. Following the encouraging results of the first set of in vitro experiments, during which the delivery protocol of the combination treatment has been optimized, the companies have decided to move ahead to evaluate the novel therapeutic concept in animal models. While the first experiments were conducted by Immunicum, this further in vivo evaluation will be carried out by PCI Biotech.

Commenting on the announcement PCI Biotech’s CEO, Per Walday said: "The results of the initial collaborative experiments are encouraging, supporting the immune response enhancing capability of the fimaVacc platform technology. We are committed to this collaboration and are looking forward to the next series of experiments in animal models, which are aimed to generate data that could pave the way to a potential joint development program."

Erik Manting, CEO of Immunicum added: "At Immunicum, we are continuously studying novel immunotherapy concepts aimed to address hard-to-treat established tumors and to overcome the limitations of currently available cancer therapies. In this collaboration, we are combining our know-how and technology basis with that of PCI Biotech to design potential novel therapeutic concepts and we look forward to advancing the collaboration through in vivo studies as an important next step."