On March 18, 2021 Boston Scientific Corporation (NYSE: BSX) reported it has received U.S. Food and Drug Administration (FDA) approval of the TheraSphere Y-90 Glass Microspheres, developed for the treatment of patients with hepatocellular carcinoma (HCC) (Press release, Boston Scientific, MAR 18, 2021, View Source [SID1234576844]). The approval expands access to this life-prolonging therapy for a greater number of patients, which, to date, has been utilized under a humanitarian device exemption (HDE) – an FDA classification which required institutional review board approval and limited the number of patients treated with the therapy per year. TheraSphere is now the only radioembolization technology indicated for the treatment of unresectable HCC in the U.S.

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HCC is one of the most prevalent cancers in the world and the most common type of primary liver cancer, with more than half a million new global cases diagnosed annually.i The American Cancer Society estimates that approximately 32,000 new cases of HCC will be diagnosed in the U.S. in 2021.ii It is most often treated through surgery, liver transplantation, chemotherapy or embolization, including both chemoembolization and radioembolization – also commonly referred to as selective internal radiation therapy (SIRT). TheraSphere treatment, a type of SIRT with low toxicity, is comprised of millions of microscopic glass beads containing radioactive yttrium (Y-90), which are delivered directly to liver tumors via catheter and result in minimal exposure to surrounding healthy tissue.

TheraSphere-Vial-and-Sphere

TheraSphere-Vial-and-Sphere
Approval of TheraSphere was based on results from the LEGACY study, designed to evaluate the safety and efficacy of the therapy for the treatment of early and advanced HCC. The study analyzed data from 162 patients and met both primary endpoints of objective response rate and duration of response rate (72.2% at four weeks and 76.1% at six months, respectively).iii, iv,v,vi Data demonstrated 100% complete or partial patient response up to two TheraSphere treatments – disappearance of all lesions or >/= 30% decrease in target lesion diameter – and a 93% overall survival rate in patients with transplant or resection following treatment at three years.

"I am honored to have spearheaded the LEGACY trial in which we found that patients with early and advanced HCC exhibited very high response rates as well as clinically meaningful durations of response and survival, establishing TheraSphere as a standard treatment for this patient population," said Riad Salem, M.D., M.B.A, interventional radiologist at Northwestern Memorial Hospital and principal investigator of the LEGACY trial. "The trial results, which have been accepted for publication in Hepatology, produced one of the most comprehensive databases for TheraSphere, empowering physicians to make informed, data-driven decisions for their patients."

Treatment with TheraSphere does not require hospitalization and is typically performed as an outpatient procedure in as little as an hour, potentially alleviating pressure on healthcare systems in an increasingly complex care environment. Recognition of the benefits of SIRT – both to patients and hospitals – were reflected in recently issued guidance from the National Institute for Health and Care Excellence (NICE) when they recommended the use of TheraSphere for the treatment of patients with HCC through the National Health Service (NHS) in England, Wales and Northern Ireland.

"The FDA approval and the recent NICE recommendation will expand access to TheraSphere, which has demonstrated improvement in both survivability and quality of life through 20 years of clinical trials and real-world outcomes in the more than 70,000 patients globally," said Peter Pattison, president of Interventional Oncology, Peripheral Interventions, Boston Scientific. "We expect to continue to focus our efforts on bringing this treatment to more patients, both by planning a randomized trial to study the combination of TheraSphere and immunotherapy in patients with HCC not eligible for curative treatments, as well as further investigating the therapy for different cancer segments, including prostate and brain."

On March 18, 2021 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, reported its fourth quarter and full year 2020 financial results, and provided recent corporate and program highlights (Press release, Aeglea BioTherapeutics, MAR 18, 2021, View Source [SID1234576843]).

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"2020 was a challenging year advancing our clinical trials and at the same time prioritizing the health and well-being of the rare disease patients we serve, who often have additional difficulties and vulnerabilities," said Anthony Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. "We have been focused on mitigating the impact of COVID-19 on our clinical timelines and I’m proud of the work the team has done to put patient needs first while also advancing a broad range of other impactful activities, as seen with the regulatory designations received for AGLE-177, our continuous gains in Arginase 1 Deficiency patient identification and the buildout of our commercial organization."

Dr. Quinn continued, "With enrollment completion expected this month and data expected in the fourth quarter for our pivotal Phase 3 PEACE study of pegzilarginase in Arginase 1 Deficiency, and the potential for first-in-human data from our AGLE-177 Phase 1/2 clinical trial in Homocystinuria, 2021 is shaping up to be a transformational year and we are well positioned to evolve into a successful commercial-stage company."

Recent Highlights and Updates

Pegzilarginase in Arginase 1 Deficiency

As of mid-March, 24 patients have been enrolled and randomized in the pivotal Phase 3 PEACE clinical trial. An additional nine patients are in active screening or scheduled to begin screening in the next two weeks. Trial enrollment is expected to close in March, with completion of screening and all patients randomized by the end of April. Topline data is expected in the fourth quarter of 2021.
As of January, Aeglea has identified over 300 Arginase 1 Deficiency patients in addressable markets. The number of currently identified patients represents approximately 65% and 30% of the estimated genetic prevalence populations in the U.S. and EU4 plus the UK, respectively.
At the 2021 JP Morgan Healthcare Conference, Aeglea provided an update on the safety profile of pegzilarginase. As of September 2020, more than 1,350 doses had been administered in the Phase 1/2 clinical trial and Phase 2 open-label extension study.
AGLE-177 in Homocystinuria

In December 2020, Aeglea announced the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation to AGLE-177 for the treatment of Homocystinuria. If AGLE-177 is approved by the FDA, the company will be eligible to receive a Priority Review Voucher.
In January, Aeglea announced it will be adding clinical trial sites in Australia for its Phase 1/2 clinical trial.
In January, the Company presented the results of an analysis which determined the Classical Homocystinuria (CBS deficiency) population in global addressable markets may exceed 30,000 patients, with an estimated 15,000-18,000 of those patients to be non-responsive to the existing standard of care.
Corporate

Aeglea expanded the Company’s Board of Directors to include two new members. Alison Lawton, who previously served as president and CEO of Kaleido Biosciences, was appointed in December 2020. Sara Brownstein, a principal at Baker Bros. Advisors LP, was appointed in February 2021.
Upcoming Events

Aeglea will be attending the following virtual investor conferences:

Wells Fargo Annual Biotech Corporate Access Day, April 6
20th Annual Needham Healthcare Conference, April 12-13
Fourth Quarter and Full Year 2020 Financial Results

As of December 31, 2020, Aeglea had available cash, cash equivalents, marketable securities and restricted cash of $148.1 million. Based on Aeglea’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations into 2023.

Research and development expenses totaled $15.8 million for the fourth quarter of 2020 and $17.6 million for the fourth quarter of 2019. The decrease was primarily associated with completing certain manufacturing and pre-commercial activities for Aeglea’s lead product candidate, pegzilarginase.

Research and development expenses totaled $59.6 million for the year ended December 31, 2020 and $64.6 million for the year ended December 31, 2019. The decrease was primarily associated with completing a Phase 1/2 clinical trial in patients with Arginase 1 Deficiency and closing cancer related trials, completing certain manufacturing and pre-commercial activities for Aeglea’s lead product candidate, pegzilarginase, along with supporting toxicology studies for the Homocystinuria program.

General and administrative expenses totaled $7.0 million for the fourth quarter of 2020 and $4.3 million for the fourth quarter of 2019. This increase was primarily due to ramping-up commercial capabilities and infrastructure.

General and administrative expenses totaled $21.8 million for the year ended December 31, 2020 and $15.7 million for the year ended December 31, 2019. This increase was primarily due to ramping-up commercial capabilities and infrastructure along with additional office space to support company growth.

Net loss totaled $22.7 million and $21.5 million for the fourth quarter of 2020 and 2019, respectively, with non-cash stock compensation expense of $1.6 million and $1.2 million for the fourth quarter of 2020 and 2019, respectively. Net loss totaled $80.9 million and $78.3 million for the years ended December 31, 2020 and 2019, respectively, with non-cash stock compensation expense of $6.3 million and $4.9 million for the years ended December 31, 2020 and 2019, respectively.

About Pegzilarginase in Arginase 1 Deficiency

Pegzilarginase is a novel recombinant human enzyme, which has been shown to rapidly and sustainably lower levels of the amino acid arginine in plasma. Aeglea is developing pegzilarginase for the treatment of patients with Arginase 1 Deficiency (ARG1-D), a rare debilitating and progressive disease characterized by the accumulation of arginine. ARG1-D presents in early childhood and patients experience spasticity, seizures, developmental delay, intellectual disability and early mortality. Aeglea’s Phase 1/2 and Phase 2 open-label extension data for pegzilarginase in patients with ARG1-D demonstrated clinical improvements and sustained lowering of plasma arginine. The Company’s ongoing single, global pivotal Phase 3 PEACE trial is designed to assess the effects of treatment with pegzilarginase versus placebo over 24 weeks with a primary endpoint of plasma arginine reduction. Pegzilarginase has received multiple regulatory designations, including Rare Pediatric Disease, Breakthrough, Fast Track and Orphan Drug Designations from the FDA as well as Orphan Drug Designation from the European Medicines Agency.

About AGLE-177 in Homocystinuria

AGLE-177 is a novel recombinant human enzyme, which degrades the amino acid homocysteine and its related homocystine dimer. Aeglea is developing AGLE-177 for the treatment of patients with cystathionine beta synthase (CBS) deficiency, also known as Classical Homocystinuria, a rare inherited disorder of methionine metabolism that results in elevated levels of homocysteine and homocystine. Homocysteine accumulation plays a key role in multiple progressive and serious disease-related complications, including thromboembolic vascular events, skeletal abnormalities (including severe osteoporosis), developmental delay, intellectual disability, lens dislocation and severe near sightedness. Preclinical data demonstrated that AGLE-177 improved important disease-related abnormalities and survival in a mouse model of Homocystinuria. AGLE-177 has received U.S. Rare Pediatric Disease and Orphan Drug Designations as well as EU Orphan Drug Designation. Aeglea initiated a Phase 1/2 trial in the second quarter of 2020 and continues patient identification and administrative activities.

On March 18, 2021 ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, reported financial results for the fourth quarter and fiscal year ended December 31, 2020 and provided business updates (Press release, ADC Therapeutics, MAR 18, 2021, View Source [SID1234576842]).

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"The ADC Therapeutics team is well-positioned to execute on our goals for 2021 after a year of significant progress and achievements across the company in 2020," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "As we approach the May 21, 2021 PDUFA date and planned commercial launch of our lead therapeutic candidate, Lonca, we have recruited a team of industry veterans to advance our commercial, medical affairs and CMC goal of rapidly bringing Lonca to patients with relapsed or refractory diffuse large B-cell lymphoma who are in desperate need of new treatment options. For our second lead program, Cami, we completed enrollment in our pivotal Phase 2 trial, bringing us one step closer to potentially addressing an unmet need in heavily pre-treated Hodgkin lymphoma patients. We look forward to reporting updated interim data from the trial in the first half of this year. Finally, we continued to develop our strong research pipeline and licensed advanced technologies for next-generation ADC research and development for patients with difficult-to-treat hematologic and solid tumor cancers."

Recent Highlights from Two Lead Programs

Loncastuximab Tesirine (Lonca)

Executing commercial strategy for mid-2021 launch in 3L+ relapsed or refractory diffuse large B-cell lymphoma (DLBCL): The Company’s commercial and medical affairs organizations are hired, trained and finalizing launch preparations in anticipation of potential U.S. Food and Drug Administration (FDA) approval in mid-2021. From a CMC perspective, the Company has commercial drug product ready for potential launch.
FDA PDUFA date set for May 21, 2021: In November 2020, the FDA accepted the Company’s Biologics License Application (BLA) filing for Lonca for the treatment of patients with relapsed or refractory DLBCL. The FDA granted priority review status for the application and has set a Prescription Drug User Fee Act (PDUFA) target date of May 21, 2021. The BLA submission is based on data from the LOTIS 2 trial, a single-arm, open-label, 145-patient Phase 2 clinical trial of Lonca as a single agent in patients with relapsed or refractory DLBCL following ≥2 established therapies.
Initiated expanded access program (EAP) for patients in the U.S.: In January 2021, the Company initiated its EAP for Lonca for patients in the U.S. with relapsed or refractory DLBCL. The EAP is for patients who cannot be treated by currently available drugs, cell therapy, or clinical trials, and requests must be made by licensed, treating physicians in the U.S.
Presented updated Lonca clinical data at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020: Updated data from the LOTIS 2 trial continued to demonstrate Lonca’s significant, durable antitumor activity with an overall response rate (ORR) of 48.3%, a complete response rate (CRR) of 24.8% and a median duration of response of 12.58 months. Interim data from the ongoing LOTIS 3 Phase 1/2 trial evaluating Lonca in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma (MCL) also showed good exposure, manageable toxicity and encouraging efficacy with an ORR of 62.9% across all patients. Lonca continued to demonstrate a manageable toxicity profile as a single agent, as well as in combination with ibrutinib.
Enrolling patients in Phase 3 LOTIS 5 clinical trial of Lonca in combination with rituximab in 2L patients: This Phase 3 confirmatory trial will evaluate the safety and efficacy of Lonca in combination with rituximab versus standard immunochemotherapy in 2L patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant. The primary endpoint will be progression-free survival. The LOTIS 5 trial would fulfill the post-marketing approval requirement with the FDA for a confirmatory study, if accelerated approval is received for relapsed or refractory DLBCL.
Expanding addressable patients for Lonca treatment: The pivotal Phase 2 trial of Lonca combined with ibrutinib has enrolled 26 of the targeted 66 non-germinal center B-cell DLBCL patients as of February 12, 2021. This trial is intended to support the submission of a supplemental BLA for Lonca in combination with ibrutinib. The Company is also expecting to initiate a pivotal Phase 2 clinical trial in follicular lymphoma (FL) in the first half of 2021. The Company plans to initiate two additional Lonca trials this year. The first trial will evaluate Lonca in combination with multiple other drugs in non-Hodgkin lymphoma (NHL). The Company also plans to initiate a dose-finding study of Lonca in combination with R-CHOP in frontline DLBCL.
Camidanlumab Tesirine (Cami)

Completed patient enrollment in pivotal Phase 2 trial: In January 2021, the Company completed enrollment in the 117-patient pivotal Phase 2 clinical trial evaluating the efficacy and safety of Cami in patients with relapsed or refractory Hodgkin lymphoma (HL).
Presented updated pivotal Phase 2 data evaluating Cami in patients with relapsed or refractory HL at the ASH (Free ASH Whitepaper) Annual Meeting in December 2020: Interim data from 51 patients in the open-label, single-arm, 117-patient pivotal Phase 2 clinical trial in patients with relapsed or refractory HL were consistent with the Phase 1 trial. Cami demonstrated encouraging antitumor activity as a single agent, with an 83% ORR, 38.3% CRR and no new safety signals.
Announced first patient dosed in combination with pembrolizumab in ongoing Phase 1b trial in selected advanced solid tumors: In October 2020, the Company dosed its first patient with Cami in combination with pembrolizumab, a checkpoint inhibitor, in an ongoing Phase 1b clinical trial in patients with selected advanced solid tumors. The multicenter, open-label, dose-escalation and dose-expansion Phase 1b trial is evaluating the safety, tolerability, pharmacokinetics and antitumor activity of Cami in combination with pembrolizumab. Pharmacokinetic and biomarker data from the Phase 1b trial were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, and preclinical data were published in the Journal for ImmunoTherapy of Cancer.
Recent Business Updates

Preparing state-of-the-art ADC research center at the Imperial College Translation & Innovation Hub (I-HUB): In January 2021, the Company entered into an agreement to open a new state-of-the-art ADC research center for ADC Therapeutics in Imperial College’s new Translation & Innovation Hub (I-HUB) in central London. The research center will enable further platform and pipeline innovation for the Company and is expected to open in the summer of 2021.
Formed Overland ADCT BioPharma to develop and commercialize Lonca, ADCT-601, ADCT-602 and ADCT-901 in greater China and Singapore: In December 2020, the Company announced the launch of Overland ADCT BioPharma (CY) Limited (Overland ADCT BioPharma) in partnership with Hillhouse-backed Overland Pharmaceuticals to develop and commercialize four of ADC Therapeutics’ ADC product candidates for difficult-to-treat hematologic and solid tumors in greater China and Singapore. Under the terms of the agreement, ADC Therapeutics licensed exclusive development and commercialization rights to Lonca, ADCT-602, ADCT-601 and ADCT-901 for greater China and Singapore to Overland ADCT BioPharma. ADC Therapeutics received a 49% stake in the company and may also earn milestone payments and royalties. Overland Pharmaceuticals invested $50 million to fund operations. The Board of Directors includes an equal number of nominees from ADCT and Overland.
Cash balance of $439.2 million as of December 31, 2020.
2021 Expected Milestones

PDUFA target date for Lonca is May 21, 2021 and the Company is on track to launch quickly following approval (if and when received).
Initiate a pivotal Phase 2 trial of Lonca in FL in the first half of 2021.
Report updated data from the Phase 1 trial of Lonca in combination with ibrutinib in relapsed or refractory DLBCL in the first half of 2021, as well as complete enrollment in the pivotal Phase 2 expansion in the first half of this year.
Initiate dose finding study of Lonca in first-line with R-CHOP in the first half of 2021.
Report data from the 20-patient safety run-in of LOTIS 5, the Phase 3 confirmatory study of Lonca in combination with rituximab, in the second half of 2021.
Report interim results from the pivotal Phase 2 trial of Cami in HL in the first half of 2021.
Initiate a Phase 1b combination study of ADCT-601, targeting AXL, in multiple solid tumors in the second half of 2021.
File Investigational New Drug (IND) application for ADCT-901, targeting KAAG1, in the first half of 2021.
Fourth Quarter and Full Year 2020 Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $439.2 million as of December 31, 2020, compared to $115.6 million as of December 31, 2019.

Research and Development (R&D) Expenses

R&D expenses were $48.6 million for the quarter and $142.0 million for the full year ended December 31, 2020, compared to $30.4 million and $107.5 million for the same quarter and year-end 2019. R&D expenses increased as we continue to expand the potential market opportunities for Lonca in earlier lines of therapies and multiple indications, advance Cami to support BLA submission, and build our pipeline. As a result of these initiatives, employee headcount and share-based compensation increased.

Selling and Marketing (S&M) Expenses

During the fourth quarter of 2020, the Company began to present S&M expenses as a separate line item in its Consolidated Statement of Operation in anticipation for its commercial launch of Lonca. S&M expenses were $9.4 million for the quarter and $22.1 million for the full year ended December 31, 2020. The Company did not incur a material amount of S&M expenses, which were classified within general and administrative expenses, during the quarter and full year ended December 31, 2019. The increase in S&M expenses related to the build-out of the Company’s commercial organization and preparation activities for the anticipated launch of Lonca in 2021.

General and Administrative (G&A) Expenses

G&A expenses were $20.1 million for the quarter and $55.1 million for the full year ended December 31, 2020, compared to $5.3 million and $14.2 million for the same quarter and year-end 2019. The increase was primarily due to increased share-based compensation expense and costs of being a public company.

Net Loss and Adjusted Net Loss

Net loss was $55.9 million, or a net loss of $0.73 per basic and diluted share, for the quarter and $246.3 million, or a net loss of $3.77 per basic and diluted share, for the full year ended December 31, 2020, compared to $35.3 million, or a net loss of $0.69 per basic and diluted share, and $116.5 million, or a net loss of $2.36 per basic and diluted share, for the same quarter and year-end 2019. Net loss included share-based compensation expense of $15.4 million for the quarter and $42.9 million for the full year ended December 31, 2020, compared to $0.8 million and $1.1 million for the same quarter and year-end 2019. The Company recognized a gain of $24.5 million during the quarter and full year ended December 31, 2020 related to its contribution of intellectual property for its equity interest in the Overland ADCT BioPharma joint venture. The net loss for the full year ended December 31, 2020 includes a non-cash charge of $45.4 million related to the changes in fair value of derivatives associated with the convertible loans under the Facility Agreement with Deerfield. The year-to-date increase in fair value was driven by the increase in the Company’s share price from its initial public offering.

Adjusted net loss was $63.0 million, or an adjusted net loss of $0.82 per basic and diluted share, for the quarter and $176.1 million, or an adjusted net loss of $2.69 per basic and diluted share, for the full year ended December 31, 2020, compared to $34.5 million, or an adjusted net loss of $0.68 per basic and diluted share, and $115.4 million, or an adjusted net loss of $2.34 per basic and diluted share, for the same quarter and year-end 2019. The increase in adjusted net loss was primarily driven by higher employee headcount across the organization, costs associated with the expanding clinical portfolio and the preparation for the anticipated launch of Lonca in 2021.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss fourth quarter and full-year 2020 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the live call, please dial 833-303-1198 (domestic) or +1-914-987-7415 (international) and provide conference ID 4985202. A live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

On March 18, 2021 Acacia Pharma Group plc ("Acacia Pharma" or the "Company") (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or chemotherapy, reported that it will report its results for the full year 2020 and provide an update on progress with the commercialization of BARHEMSYS and BYFAVO on Monday, 29 March 2021 at 07.00 CEST (Press release, Acacia Pharma, MAR 18, 2021, View Source [SID1234576841]).

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A presentation by Acacia Pharma’s senior management team will be webcast live the same day at 14.30 CEST (08.30 EST).

The webcast can be accessed from www.acaciapharma.com and a recording will be available after the event.

The results report and presentation will be available at www.acaciapharma.com in the Investors section from 07.00 CEST the same day.

On March 17, 2021 FUJIFILM Cellular Dynamics, Inc., a leading global developer and manufacturer of human induced pluripotent stem cells (iPSC) technologies, and Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that Sana has been granted a non-exclusive right to use FUJIFILM Cellular Dynamics’ iPSC platform for the development of commercial cell therapies (Press release, Sana Biotechnology, MAR 17, 2021, View Source [SID1234584002]). As a treatment modality, cell therapies have the potential to augment, repair, or replace human biology, including organs, tissues and cells.

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Under the agreement, FUJIFILM Cellular Dynamics grants Sana a non-exclusive license under intellectual property rights owned or controlled by FUJIFILM Cellular Dynamics, and will provide iPSC cell lines (including research-grade and/or Good Manufacturing Practices (GMP)-grade iPSC lines) to Sana. Sana may use the iPSC cell lines, and exercise the licensed intellectual property rights, for the research and development, and with respect to GMP-grade cell lines, clinical and commercial manufacture, and commercialization, of cell therapies derived from such lines. Terms of the agreement were not disclosed.

"FUJIFILM Cellular Dynamics is a leading global player in the field of iPSCs. Our history in manufacturing iPSCs for research-purposes has provided us with the foundational expertise to manufacture quality GMP-grade iPSC lines," said Takeshi Yamamoto, chief executive officer, FUJIFILM Cellular Dynamics. "Sana is developing a broad and compelling pipeline of iPSC-derived cellular therapies, and we are pleased to grant them the rights to our iPSC platform with a vision of providing more treatment options for patients."

"Sana is committed to the development of engineered cells as medicines that can be manufactured at scale and supplied to patients globally," said Stacey Ma, executive vice president, technical operations, Sana. "FUJIFILM Cellular Dynamics is a long-standing innovative leader in this field, and we are thrilled to have the opportunity to combine their expertise in GMP-grade iPSC cell lines with our investment in differentiating and manufacturing cells at scale for patients across a number of diseases."