On March 30, 2020 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported recent business highlights and full year 2019 financial results (Press release, Beam Therapeutics, MAR 30, 2020, View Source [SID1234555977]).

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"So far in 2020, we have made strides across all aspects of our business, and despite the many uncertainties we face today amid the COVID-19 pandemic, we remain committed to moving our programs forward for patients," said John Evans, chief executive officer of Beam. "Following the successful completion of our initial public offering and the recent additions to our team, we have the resources needed to steadily advance a broad and deep portfolio of base editing programs addressing a wide range of disease areas and to invest in the science of base editing, illustrated by the recent platform technology publications. As we look ahead, we are planning for additional scientific publications throughout the year and remain on track to file an initial wave of IND applications beginning in 2021, in an effort to bring a new class of precision genetic medicines to the clinic and, ultimately, to patients."

Recent Business Highlights

Leadership Team Strengthened with Key Appointments: Since the beginning of 2020, Beam has named several appointments and promotions aimed at further supporting advancement of its pipeline and expanding its business operations. These include the promotion of Giuseppe "Pino" Ciaramella, Ph.D., to president and chief scientific officer, the promotion of Manmohan Singh, Ph.D., to senior vice president of pharmaceutical sciences and delivery technologies, and the appointment of Christine Swenson as senior vice president of regulatory affairs.

Advancements in Base Editing Technology Platforms Highlighted in Scientific Publications: New research on Beam’s novel adenine base editor (ABE) and cytosine base editor (CBE) technologies were reported in multiple scientific publications. Data from these internal and collaborator publications further support that Beam’s continued evolution of ABEs and CBEs can enhance the precision of targeted A-to-G and C-to-T DNA base changes, potentially improving the range of therapeutic applications.

In a paper entitled, "ABE8: Superior adenine base editors with expanded targeting range, higher activity, and therapeutic application", accepted for publication in Nature Biotechnology, Gaudelli, et al., highlight continued evolution of Beam’s adenine base editors. These proprietary, next-generation "ABE8 variants" demonstrated improved therapeutic potential compared to previously published versions, including increased on-target activity while maintaining low-levels of off-target editing across a number of cell types, including transformed and human primary cells.

In a paper entitled, "Next-generation cytosine base editors with minimized unguided DNA and RNA off-target events and high on-target activity," accepted for publication in Nature Communications by Yu, et al., highlighted proprietary next-generation versions of CBEs. Off-target editing rates with the first published version of CBEs, known as BE3, are low and within mutation rates that naturally occur with no consequence in somatic cells. These next-generation CBEs display comparable on-target editing to BE3 while further reducing the low levels of off-target editing seen with BE3.

Two papers published in Nature Biotechnology by Beam co-founder Dr. David Liu, highlight novel CBEs that diminish or eliminate the low levels of off-target editing observed with BE3s, and novel variants of base editors that are able to bind a wider range of genetic targets, expanding their therapeutic potential.

Oversubscribed $207M Initial Public Offering Completed: On February 11, 2020, Beam announced the closing of its initial public offering of 12,176,471 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,588,235 additional shares of common stock, at a public offering price of $17.00 per share. The net proceeds to Beam Therapeutics from the offering were approximately $188.3 million, after deducting underwriting discounts and commissions and estimated offering expenses.

Business Continuity: Beam is executing its business objectives for 2020 and beyond, while closely monitoring the impact of the COVID-19 situation. The company has established a remote operating model while prioritizing the most critical research and development activities needed to advance its portfolio of novel base editing programs.

Full Year 2019 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $91.8 million as of December 31, 2019, which does not include the $188.3 million in net proceeds from the company’s IPO completed in February 2020. In addition, cash used to fund our operations was $72.0 million for the year ended December 31, 2019.

R&D Expenses: Research and development (R&D) expenses were $54.6 million for the full year ended December 31, 2019.

G&A Expenses: General and administrative (G&A) expenses were $20.6 million for the full year ended December 31, 2019.
Net Loss: Net loss was $78.3 million for the full year ended December 31, 2019.

On March 30, 2020 ImaginAb Inc., a leading clinical stage immuno-oncology imaging company, reported it has signed a multi-year non-exclusive license agreement with AstraZeneca (Press release, ImaginAb, MAR 30, 2020, View Source;utm_medium=rss&utm_campaign=imaginab-announces-licensing-deal-with-astrazeneca-for-cd8-immunopet-technology [SID1234555974]).

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Under the terms of the agreement, ImaginAb’s CD8 ImmunoPET technology will be used in AstraZeneca’s clinical trials in North America and Europe to facilitate clinical development of AstraZeneca’s novel immunotherapies and to advance the clinical utility of ImaginAb’s CD8 ImmunoPET.

The deal is an opportunity for ImaginAb to support AstraZeneca’s project teams on imaging CD8 cells in patients and both teams will be committed to analysing and interpreting the data for their respective research and development activities.

ImaginAb will receive license fees and other contingent payments.

This agreement follows the recently signed pre-competitive alliance between AstraZeneca, ImaginAb and other global pharmaceutical companies, announced on October 14, 2019.

Commenting on the news, Ian Wilson, Chief Executive Officer of ImaginAb said: "We are very pleased that AstraZeneca is expanding our relationship. Under the new agreement, ImaginAb will provide AstraZeneca with clinical doses of ImaginAb’s CD8 ImmunoPET minibody, as well as technical support, to AstraZeneca clinical trials involving novel immunotherapies. ImaginAb’s CD8 ImmunoPET technology is the clinically most advanced CD8 PET tracer. It is a powerful diagnostic approach for measuring non-invasively the effect of immunotherapies, which we believe will ultimately be used to predict therapeutic efficacy."

On March 30, 2020 ISA Pharmaceuticals reported that Just weeks after International Human Papilloma Virus (HPV) Awareness Day, new results from two long-time Cancer Research Institute (CRI) scientists highlighted the promise of immunotherapy against HPV-associated cervical cancer (Press release, ISA Pharmaceuticals, MAR 30, 2020, View Source [SID1234555973]).

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In a phase 1/2 study, women with advanced, recurrent, or metastatic cervical cancer were treated with the combination of an HPV-targeting vaccine and standard-of-care chemotherapy. Of 72 evaluable patients, 43 percent had their tumors shrink.

Led by Cornelis J. M. Melief, M.D, Ph.D., and Sjoerd H. van der Burg, Ph.D., this clinical breakthrough was the latest fruit borne by the duo, both of whom have been supported by CRI during their time at Leiden University Medical Center in the Netherlands. In addition to being a member of the CRI Scientific Advisory Council, Melief was the recipient of the 2019 AACR (Free AACR Whitepaper)-CRI Lloyd J. Old Award in Cancer Immunology and is currently the chief scientific officer at ISA Pharmaceuticals. Van der Burg, who earned his doctorate in Melief’s lab in 1998, is also affiliated with ISA as a member of their Scientific Advisory Board, as well as the Oncode Institute.

In 2002, CRI-funded preclinical work by Melief and van der Burg provided an early proof of principle that therapeutic HPV vaccines could eliminate HPV-associated cancers. To do so, they used synthetic long peptide (SLP) vaccines to target the E6/E7 oncoproteins produced by the HPV16 strain.

Next, they demonstrated that HPV-targeting vaccines could clear pre-malignant lesions. However, vaccination wasn’t effective against advanced cancers because of the presence of immunosuppressive myeloid cells. By adding chemotherapy to the treatment regimen, the current study sought to decrease the number of myeloid cells and thereby enable more potent anti-tumor immune responses after vaccination, especially by the immune system’s "killer" T cells.

In many patients, the combination appears to have done just that.

Two weeks after chemotherapy, when patients’ myeloid cells were at their lowest point, varying doses of the ISA-101 vaccine were administered. Half of them also received a molecule called pegylated type 1 interferon that may help boost adaptive immune responses. Overall, about one-third of patients analyzed had low levels of HPV-targeting T cells after chemotherapy alone and prior to vaccination. Post-vaccination, HPV-specific T cell responses were detected at all dose levels, and "the patients with higher than median strength responses survived the best," Melief told CRI.

"These results, provided they are validated in larger trials, could lead to significantly improved care for patients with cervical cancer."

In another ongoing study, this vaccine paired well with checkpoint blockade immunotherapy in patients with advanced head and neck cancer—another cancer linked to HPV infection. A similar trial will soon be testing that approach in cervical cancer, according to Melief, who believes we might benefit from going even further with vaccine combinations.

"Last year, we demonstrated the synergy between vaccination and anti-PD-1 checkpoint immunotherapy in patients with recurrent or metastatic HPV+ head and neck cancer. It is therefore tempting to combine all three therapeutic measures—anti-PD-1, vaccination, and chemotherapy—for additional synergy because chemotherapy and anti-PD-1 act by non-overlapping mechanisms. This chemotherapy combination also pinches in nicely with other types of immunotherapy because many types of late-stage cancer induce this kind of myeloid cell-mediated immunosuppression in patients."

On March 30, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for chimeric antigen receptor (CAR) T cell therapy axicabtagene ciloleucel for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma and related lymphomas (Press release, Daiichi Sankyo, MAR 30, 2020, View Source [SID1234555972]).

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In January 2017, Daiichi Sankyo received exclusive development, manufacturing and commercialization rights for axicabtagene ciloleucel in Japan from California-based Kite, a Gilead Company.

The Japan NDA submission is based on previous pivotal trial data conducted globally by Kite for axicabtagene ciloleucel in addition to results from a phase 2 bridging study conducted by Daiichi Sankyo in Japan. Both trials included patients with four aggressive types of relapsed/refractory B-cell lymphomas including diffuse large B cell lymphoma (DLBCL); primary mediastinal B-cell lymphoma (PMBCL); transformed follicular lymphoma (TFL); and high-grade B cell lymphoma. The Japanese trial met its primary endpoint for objective response rate, and data will be presented at an upcoming medical meeting.

"We are pleased to confirm submission of the NDA for axicabtagene ciloleucel following positive topline results from the phase 2 bridging study in Japan," said Wataru Takasaki, PhD, Corporate Officer, Head of Oncology Function and Head of R&D Division in Japan, Daiichi Sankyo. "We will continue to work with regulatory authorities to develop this important new cell therapy for eligible patients in Japan who need additional treatment options for relapsed or refractory DLBCL and related lymphomas."

About Axicabtagene Ciloleucel
Axicabtagene ciloleucel is a CAR T cell therapy directed against CD19 (a cell membrane protein), which harnesses a patient’s own immune system to fight B-cell lymphoma. Axicabtagene ciloleucel received Orphan Drug Designation from the Japan Ministry of Health, Labour and Welfare (MHLW) in 2018 for the treatment of DLBCL, PMBCL, TFL and high-grade B-cell lymphoma.

Axicabtagene ciloleucel is approved in the U.S. and Europe for patients with certain types of relapsed or refractory B-cell lymphoma based on the results of the pivotal ZUMA-1 study.

Unmet Treatment Need in NHL/B-Cell Lymphoma
There were an estimated 509,000 new cases and about 248,000 deaths globally from non-Hodgkin lymphoma (NHL) in 2018.[1] In Japan, there were nearly 21,000 new cases of NHL reported in 2012.[2]

About 85 percent of NHLs are B-cell lymphomas. DLBCL is the most commonly diagnosed NHL, representing about one in five cases.[3] Treatment advances have led to improved outcomes for patients with certain types of NHL, but relapsed or refractory disease has remained a significant treatment challenge.[4] DLBCL is considered an aggressive form of the disease; however, the majority of DLBCL patients do achieve complete and sustained remission on initial treatment (chemotherapy plus targeted therapy).[5] Approximately 40 percent of patients experience relapse or resistance and may subsequently receive additional chemotherapy and/or stem cell transplant (ASCT) if eligible; those who are ineligible for ASCT or who relapse after transplantation have a poor prognosis.5

New and novel treatments such as CAR T cell therapies are providing additional options for some patients with relapsed/refractory DLBCL after two or more lines of treatments have been tried.[6]

About the Japan Phase 2 Study
The phase 2 multicenter, open-label, single-arm study was planned to evaluate efficacy and safety of axicabtagene ciloleucel in Japanese patients with several aggressive types of large B-cell lymphoma that is refractory or relapsed following one or more lines of standard treatment including drug therapy or stem cell transplant (ASCT). The study enrolled patients with DLBCL, PMBCL, TFL and high-grade B cell lymphoma.

The primary efficacy endpoint is investigator-assessed objective response rate (ORR). Secondary efficacy endpoints include centrally evaluated ORR, duration of response, progression-free survival and overall survival. The study will also measure safety and pharmacokinetics. Enrollment has completed and the study is ongoing at several institutions in Japan. For more information, visit ClinicalTrials.jp.

About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our DXd antibody drug conjugate (ADC) technology, our powerful research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.

On March 30, 2020 AstraZeneca reported that Imfinzi (durvalumab) has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care (SoC) chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide) (Press release, AstraZeneca, MAR 30, 2020, View Source [SID1234555971]).

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The approval by the Food and Drug Administration was based on positive results from the Phase III CASPIAN trial showing Imfinzi in combination with SoC platinum-etoposide demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus SoC alone.

SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy.1,2

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "The US approval of Imfinzi brings a new medicine to extensive-stage small cell lung cancer patients in urgent need of new options. Imfinzi is the only immunotherapy to show both a significant survival benefit and improved response rate in combination with chemotherapy for these patients, an important step forward in treating this devastating disease."

Jonathan Goldman, MD, Associate Professor of Hematology & Oncology, UCLA Medical Center, Santa Monica, California and a lead investigator in the Phase III CASPIAN trial, said: "Patients with extensive-stage small cell lung cancer continue to face a poor prognosis, and finding new medicines to improve outcomes in this setting has been a formidable challenge. The CASPIAN trial enables clinicians to choose durvalumab in combination with etoposide and either carboplatin or cisplatin, making this an important new 1st-line treatment option for patients that is both effective and well-tolerated."

The Phase III CASPIAN trial had two primary endpoints comparing experimental arms to SoC. In the Imfinzi plus SoC arm, the risk of death was reduced by 27% (equal to a hazard ratio of 0.73; 95% CI 0.59-0.91; p=0.0047), with median OS of 13.0 months versus 10.3 months for SoC alone. Results also showed an increased confirmed objective response rate in the Imfinzi plus SoC arm (68% versus 58% for SoC alone). The safety and tolerability for Imfinzi plus SoC was consistent with the known safety profiles of these medicines. The Imfinzi plus SoC data from the CASPIAN trial were published in The Lancet.3

The second experimental arm testing tremelimumab added to Imfinzi and SoC recently completed, but did not meet its primary endpoint. Details will be presented at a forthcoming medical meeting.

The CASPIAN trial used a fixed dose of Imfinzi (1500mg) administered every three weeks for four cycles while in combination with chemotherapy and then every four weeks until disease progression. As part of a broad development programme, Imfinzi is also being tested following concurrent chemoradiation therapy in patients with limited-stage SCLC in the Phase III ADRIATIC trial with data anticipated in 2021.

Imfinzi received its first approval based on the Phase III CASPIAN trial in Singapore for patients with ES-SCLC in February 2020. Imfinzi in combination with etoposide and either carboplatin or cisplatin is currently under regulatory review for the treatment of ES-SCLC in the 1st-line setting based on the Phase III CASPIAN trial in the EU and Japan.

Small cell lung cancer

Lung cancer is the leading cause of cancer death among both men and women and accounts for about one fifth of all cancer deaths.4 Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and SCLC, with about 15% classified as SCLC.5 About two thirds of SCLC patients are diagnosed with ES-SCLC, in which the cancer has spread widely through the lung or to other parts of the body.6 Prognosis is particularly poor, as only 6% of all SCLC patients will be alive five years after diagnosis.6

CASPIAN

CASPIAN was a randomised, open-label, multi-centre, global, Phase III trial in the 1st-line treatment of 805 patients with ES-SCLC. The trial compared Imfinzi in combination with etoposide and either carboplatin or cisplatin chemotherapy, or Imfinzi and chemotherapy with the addition of a second immunotherapy, tremelimumab, versus chemotherapy alone. In the experimental arms, patients were treated with four cycles of chemotherapy. In comparison, the control arm allowed up to six cycles of chemotherapy and optional prophylactic cranial irradiation. The trial was conducted in more than 200 centres across 23 countries, including the US, in Europe, South America, Asia and the Middle East. The primary endpoint was OS in each of the two experimental arms.

Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is approved in the curative-intent setting of unresectable, Stage III NSCLC after chemoradiation therapy in the US, Japan, China, across the EU and in many other countries, based on the Phase III PACIFIC trial. Imfinzi is approved for the 1st-line treatment of ES-SCLC in combination with SoC chemotherapy in the US and Singapore. Imfinzi is also approved for previously treated patients with advanced bladder cancer in the US and a small number of other countries.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, cervical cancer and other solid tumours.

Tremelimumab

Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, SCLC, bladder cancer, head and neck cancer and liver cancer.

AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action. We aim to address the unmet needs of patients with EGFR-mutated tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with the approved medicines Iressa (gefitinib) and Tagrisso (osimertinib), and its ongoing Phase III trials ADAURA, LAURA, and FLAURA2.7-9 We are also committed to addressing tumour mechanisms of resistance through the ongoing Phase II trials SAVANNAH and ORCHARD which test Tagrisso in combination with savolitinib, a selective inhibitor of c-MET receptor tyrosine kinase, along with other potential new medicines. Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate is in development for metastatic non-squamous HER2-overexpressing or HER2-mutated NSCLC including trials in combination with other anticancer treatments.

An extensive late-stage Immuno-Oncology programme focuses on lung cancer patients without a targetable genetic mutation which represents up to three-quarters of all patients with lung cancer.10 Imfinzi, an anti-PDL1 antibody, is in development for patients with advanced disease (Phase III trials POSEIDON and PEARL) and for patients in earlier stages of disease including potentially-curative settings (Phase III trials AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC) both as monotherapy and in combination with tremelimumab and/or chemotherapy. Imfinzi is also in development in the Phase II combination trials NeoCOAST, COAST and HUDSON in combination with potential new medicines from the early-stage pipeline.

AstraZeneca’s approach to Immuno-Oncology (IO)

Immuno-oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. AstraZeneca believes that IO-based therapies offer the potential for life-changing cancer treatments for the clear majority of patients.

The Company is pursuing a comprehensive clinical-trial programme that includes Imfinzi as a monotherapy and in combination with tremelimumab in multiple tumour types, stages of disease, and lines of therapy, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine the IO portfolio with radiation, chemotherapy, small targeted molecules from across AstraZeneca’s Oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With six new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.