On March 25, 2021 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported a corporate update and financial results for the year ended December 31, 2020 (Press release, Neoleukin Therapeutics, MAR 25, 2021, View Source [SID1234577146]).

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"Despite the challenges of the COVID-19 pandemic, our team has remained focused and committed to the advancement of our de novo technology platform, paving the way for future achievements this year and beyond," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. "In 2021, we look forward to advancing our first-in-human trials of NL-201 and expanding our de novo protein technology and pipeline."

Recent Updates

NL-201 Development

NL-201 is a computationally designed de novo protein that is a mimetic of natural cytokines IL-2 and IL-15. In the fourth quarter of 2020, Neoleukin submitted a Clinical Trial Notification ("CTN") for Phase 1 clinical testing of NL-201 in Australia, which is anticipated to be initiated at leading clinical research centers in the first half of 2021. In addition, in December 2020, Neoleukin announced submission of an Investigational New Drug ("IND") Application with the U.S. Food and Drug Administration ("FDA") to begin Phase 1 clinical testing of NL-201 in the U.S. The planned clinical trial of NL-201 in Australia and North America is expected to enroll patients with relapsed or refractory solid tumors. Patients will receive NL-201 as intravenous monotherapy to assess safety, pharmacokinetics, pharmacodynamics, and antitumor activity.

On January 7, 2021, Neoleukin received a clinical hold letter from the FDA related to its IND Application. The FDA requested that the company develop a new assay for methods-of-use testing and to demonstrate that this assay can more precisely measure the amount of NL-201 that is delivered to the patient when following the pharmacy preparation and administration instructions. The FDA also had additional requests not related to the clinical hold to be addressed by amendment of the IND. Neoleukin is working to address the FDA’s questions as quickly as possible and currently expects to resolve the clinical hold as well as to begin enrollment of patients in the first half of 2021.

In addition to the systemic trial, Neoleukin is planning a trial of NL-201 to test local administration in order to achieve higher drug concentrations in the tumor microenvironment. The company expects the local administration trial to begin by the end of 2021 and will provide further details as appropriate.

In November 2020, Neoleukin presented preclinical data on NL-201 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 35TH Anniversary Annual Meeting. These data highlighted the results of multiple experiments of NL-201 in combination with immunotherapies and demonstrate that NL-201 enhances activity of checkpoint inhibitors and tumor-targeting antibodies in preclinical models.

De Novo Protein Design for Coronavirus – NL-CVX1

In November 2020, Neoleukin announced publication in the journal Science of a manuscript describing novel molecules designed to treat or prevent infection by SARS-CoV-2, the virus that causes COVID-19. As reported, the optimized proteins act as decoys that bind to the SARS-CoV-2 spike protein with high affinity, preventing its association with the viral receptor hACE2 and blocking cellular entry. The lead molecule, NL-CVX1 (CTC-445.2d), was shown to prevent infection of multiple cell lines in vitro and, when administered intranasally, to prevent serious consequences of SARS-CoV-2 infection in hamsters. The rapid development of this targeted protein demonstrates the potential of the Neoleukin de novo protein design platform. Neoleukin is currently planning a first-in-human trial of NL-CVX1, and will continue to evaluate the program as the SARS-CoV-2 landscape evolves.

Other Research Updates

Neoleukin has multiple research projects underway evaluating the applications of de novo protein technology to develop agonists and antagonists of immune pathways. This includes development of potent and hyperstable inhibitors of inflammation that could be used to treat autoimmune conditions. Neoleukin currently plans to announce additional information about its pipeline program during the second half of 2021.

Summary of Financial Results

Cash Position: Cash and cash equivalents totaled $192.6 million as of December 31, 2020, compared to $143.1 million as of December 31, 2019. The increase was primarily driven by the completion of a public offering in July 2020 for net proceeds of $71.3 million. Based upon current internal infrastructure and pipeline initiatives, Neoleukin believes it has sufficient cash to fund operations into 2023.

R&D Expenses: Research and development expenses for the year ended December 31, 2020 were $24.3 million compared to $4.4 million for the year ended December 31, 2019. The increase in research and development expenses during the year ended December 31, 2020 was due to increased expenses incurred from IND-enabling activities related to our lead product candidate, NL-201, and in connection with the advancement of other Neoleukin technologies. Lower research and development costs during the year ended December 31, 2019 reflect the fact that prior to the merger between Aquinox Pharmaceuticals, Inc. ("Aquinox") and Neoleukin Therapeutics, Inc. ("Former Neoleukin") in August, 2019, all research and development activities with rosiptor had been suspended since June 2018.

G&A Expenses: General and administrative expenses for the year ended December 31, 2020 were $17.2 million compared to $18.8 million for the year ended December 31, 2019. The higher general and administrative expenses for the year ended December 31, 2019 as compared to the year ended December 31, 2020 were primarily due to severance costs and the recognition of stock-based compensation expense for certain options that vested as a result of the merger between Aquinox and Former Neoleukin in August 2019. The general and administrative expenses for the year ended December 31, 2020 reflect an increase in personnel related costs, facility-related costs, and professional service fees.

Acquired in-process R&D: The acquired in-process research and development expense of $47.7 million in 2019 arose from the merger between Aquinox and Former Neoleukin in 2019 and was expensed immediately in accordance with accounting standards.

Gain on Sale of Aquinox Canada: The gain relates to the sale of Aquinox Canada, a wholly owned subsidiary of the company, during the three months ended September 30, 2020. The gain of $7.8 million recognized is the total consideration of $8.2 million, less transaction costs of $0.4 million.

Net Loss: Net loss for the year ended December 31, 2020 was $33.3 million compared to a net loss of $69.4 million for the year ended December 31, 2019. The higher net loss in 2019 is primarily due to the acquired in-process research and development expense from the merger.

Conference Call Information

Neoleukin will host a conference call today to discuss 2020 financial results and provide a corporate update. Details as follows:

The archived audio webcast will be available on the Investor Relations section of the Neoleukin website approximately two hours after the event and will be available for replay for at least 30 days after the event.

About NL-201

NL-201 is a de novo receptor agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). Previously presented preclinical data have demonstrated the ability of NL-201 to stimulate and expand CD8+ and NK cells at low doses with minimal impact on immunosuppressive regulatory T cells.

On March 25, 2021 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading edge experimental and computational technologies, reported fourth quarter and full year 2020 financial results and operational highlights (Press release, Relay Therapeutics, MAR 25, 2021, View Source [SID1234577145]).

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"2020 was a transformational year for Relay Therapeutics. We successfully advanced multiple programs into the clinic, evolved our platform, expanded our strong team and completed a successful IPO," said Sanjiv Patel, M.D., president and chief executive officer. "While the last few years were spent validating our approach of combining leading edge experimental and computational techniques to create potentially life-saving therapies for patients, the next chapter will be about extending our platform leadership and delivering meaningful clinical results to support the success of our programs. 2021 will be a critical year of execution as we advance our mission of transforming drug discovery to address some of the most devastating diseases."

2020 Corporate Highlights

Initiated first-in-human clinical studies for RLY-1971 (SHP2 inhibitor) and RLY-4008 (FGFR2 inhibitor)
Progressed PI3Kα mutant selective program into late lead optimization
Continued to advance three additional precision oncology programs through preclinical development
Expanded research efforts into genetic diseases with two preclinical programs
Strengthened the balance sheet with $460 million gross proceeds raised in an initial public offering
Announced a worldwide license and collaboration agreement with Genentech, Inc., a member of the Roche Group, for the development and commercialization of RLY-1971
2021 Anticipated Milestones

Present preclinical data for RLY-4008 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021
Announce initial clinical data for RLY-4008 in the second half of 2021
Genentech to initiate RLY-1971 and GDC-6036 (KRAS G12C inhibitor) combination trial
Enter IND-enabling studies for PI3Kα mutant selective inhibitor and provide program update
Fourth Quarter and Full Year 2020 Financial Results

Cash, Cash Equivalents and Investments: As of December 31, 2020, cash, cash equivalents and investments totaled approximately $678.1 million, compared to $355.8 million as of December 31, 2019. The Company expects its current cash and cash equivalents, including the $75 million upfront payment received from Genentech in 2021, will be sufficient to fund its current operating plan into 2024.

R&D Expenses: Research and development expenses were $32.1 million for the fourth quarter of 2020, as compared to $22.4 million for the fourth quarter of 2019. This increase was primarily due to $7.4 million of increased employee related costs, including $5.7 million of additional share-based compensation expense, primarily due to increases in our stock price and increased headcount, and $2.3 million in increased clinical trial expenses. Research and development expenses were $99.9 million for the full year 2020, as compared to $70.3 million for the full year 2019.

G&A Expenses: General and administrative expenses were $15.5 million for the fourth quarter of 2020, as compared to $3.4 million for the fourth quarter of 2019. This increase was primarily due to $9.1 million of increased employee related costs, including $7.5 million of additional share-based compensation expense, primarily due to increases in our stock price and increased headcount, as well as $3.0 million of increased general expenses, primarily driven by public company related costs. General and administrative expenses were $38.6 million for the full year 2020, as compared to $13.7 million for the full year 2019.

Net Income/Loss: Net income was $35.3 million for the fourth quarter of 2020, as compared to a net loss of $23.9 million for the fourth quarter of 2019. Net loss was $52.4 million for the full year 2020, or a net loss per share of $5.40, as compared to a net loss of $75.3 million for the full year 2019, or a net loss per share of $21.82.

On March 25, 2021 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported corporate updates and financial results for the fourth quarter and fiscal year ended December 31, 2020 (Press release, CymaBay Therapeutics, MAR 25, 2021, View Source [SID1234577144]).

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In the fourth quarter of 2020 and through early March 2021, CymaBay made significant progress reinitiating the development program for seladelpar in primary biliary cholangitis (PBC). With multiple clinical sites activated, patient recruitment is underway in RESPONSE, a global Phase 3 registrational study evaluating seladelpar in patients with PBC. In addition, we have also initiated ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional safety data to support registration.

Sujal Shah, President and CEO of CymaBay, stated, "One year ago today, our work towards finding novel treatments for patients with chronic, inflammatory and metabolic diseases was on hold as we completed the important work of ensuring patient safety before moving forward. Today we have four active clinical studies ongoing across three programs. We continue to make great progress towards restarting our seladelpar development program with RESPONSE as we execute on a focused strategy to complete late-stage development of seladelpar for patients with PBC. Results from our previous Phase 3 study in PBC, ENHANCE, presented at The Liver Meeting 2020, highlighted the anti-cholestatic, anti-inflammatory and anti-pruritic effects of seladelpar in patients with PBC that we believe support the potential for seladelpar to address key unmet needs for patients suffering from this disease. In addition to our core focus in PBC, we continue to evaluate seladelpar for other indications and are excited about our early-stage pipeline maturing in the coming months."

Recent Corporate Highlights

Initiated RESPONSE, a 52-week, placebo-controlled, randomized, global, Phase 3 registrational study evaluating the safety and efficacy of seladelpar in patients with PBC. This study will target enrolling 180 patients, who have an inadequate response to, or intolerance to, ursodeoxycholic acid, in a 2:1 randomization to oral, once daily seladelpar 10 mg or placebo. The primary outcome measure is the responder rate at 52 weeks. A responder is defined as a patient who achieves an alkaline phosphatase level < 1.67 times the upper limit of normal with at least a 15% decrease from baseline and has a normal level of total bilirubin. Additional key outcomes of efficacy will compare the rate of normalization of alkaline phosphatase at 52 weeks and the level of pruritus at 6-months for patients with moderate to severe pruritus at baseline assessed by a numerical rating scale recorded with an electronic diary.

Initiated ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional long-term safety data to support registration. The first subjects will consist of patients who have participated in CymaBay’s prior studies of seladelpar in PBC, including the patients who completed the open-label Phase 2 study and enrolled into the previous long-term study and ENHANCE. Patients who complete RESPONSE, and potentially other future PBC studies with seladelpar, will also have the opportunity to enroll in ASSURE.

Presented results from two separate studies of seladelpar in patients with PBC and NASH at The Liver Meeting 2020 as follows:

Oral, late-breaking presentation by Professor Gideon Hirschfield, MD, on November 16 highlighting results from ENHANCE, a Phase 3 study of seladelpar in patients with PBC
"Poster of Distinction" presentation by Dr. Stephen Harrison, MD, featuring results from a Phase 2 paired-liver biopsy study of seladelpar in patients with NASH

In November 2020, we announced a Phase 2a proof-of-pharmacology study to evaluate the potential for MBX-2982, a GPR119 agonist, to prevent hypoglycemia in patients with type 1 diabetes (T1D). The study is being conducted by the AdventHealth Translational Research Institute (TRI) in Orlando, Florida and fully funded by The Leona M. and Harry B. Helmsley Charitable Trust with CymaBay retaining full rights to MBX-2982. TRI commenced startup activities in early 2021 and topline results are currently anticipated in late 2021.

Initiated a single and multiple ascending dose study of CB-0406 in healthy subjects to establish its pharmacokinetics, safety and maximum tolerated dose. CB-0406 is a non-agonist ligand of PPARγ that attenuates the expression of inflammatory genes.

Held $146.3 million in cash, cash equivalents and short-term investments on December 31, 2020. We believe that cash and investments are sufficient to fund CymaBay’s current operating plan into mid-2022.

Due to the ongoing effects of the global coronavirus pandemic, CymaBay continues to conduct its operations remotely for all employees, which has allowed business activities to continue as seamlessly as possible. CymaBay continues to closely monitor pandemic developments and their associated risks to the business, including the restarting of its clinical development of seladelpar, and will continue to take actions available to mitigate them where possible. Further, all CymaBay’s actions will continue to be guided by a commitment to ensuring the health and safety of its employees as well as patients enrolled in its clinical studies.
Fourth Quarter and Year Ended December 31, 2020 Financial Results

Research and development expenses for the three and twelve months ended December 31, 2020 were $10.7 million and $35.9 million, respectively. This compared to R&D expenses of $20.9 million and $83.8 million for the three and twelve months ended December 31, 2019, respectively. Research and development expenses in the three and twelve months ended December 31, 2020 were lower than the corresponding periods in 2019 primarily due to a decline in clinical trial activities related to the termination of our Phase 3 PBC, Phase 2b NASH, and Phase 2 PSC clinical trials, and other studies, after the seladelpar development program was placed on hold from November 2019 through July 2020. Clinical development of seladelpar in PBC was resumed in late 2020, and these clinical expense reductions were offset in part by increases in clinical trial costs associated with the commencement of RESPONSE and ASSURE, our two new global late-stage clinical trials in PBC.

General and administrative expenses for the three and twelve months ended December 31, 2020 were $5.2 million and $17.4 million, respectively. This compared to $4.5 million and $19.2 million for the three and twelve months ended December 31, 2019, respectively. General and administrative expenses in the year 2020 were lower than in 2019 due to lower employee compensation costs following the completion of a reduction-in-force plan in late 2019. General and administrative expenses in the three months ended December 31, 2020 were higher than the corresponding period in 2019 due to higher employee compensation associated with the hiring of additional personnel upon resumption of development of seladelpar in the second half of 2020.

Net loss for the three and twelve months ended December 31, 2020 was $15.8 million, or ($0.23) per diluted share, and $51.0 million, or ($0.74) per diluted share, respectively. This compared to net loss of $29.4 million, or ($0.43) per diluted share, and $102.8 million, or ($1.53) per diluted share, in the three and twelve months ended December 31, 2019, respectively. Net loss was lower largely due to decreases in clinical operating expenses which resulted from the temporary clinical hold placed on the seladelpar development program. With development of seladelpar restarted during the second half of 2020, we expect our operating expenses to increase in 2021 as we continue to execute on our clinical development plans.
Conference Call Details

CymaBay will host a conference call today at 4:30 p.m. ET to discuss fourth quarter and fiscal year end 2020 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13715944. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On March 25, 2021 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that Shehnaaz Suliman, M.D., MBA, M.Phil., president and chief operating officer of Alector, will participate in a fireside chat at Stifel’s 3rd Annual CNS Day on Thursday, April 1, 2021, at 9:30 a.m. ET (Press release, Alector, MAR 25, 2021, View Source [SID1234577143]).

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A live webcast of the fireside chat will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 30 days following the event.

On March 25, 2021 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported financial results for the fourth quarter and year ended December 31, 2020 (Press release, Nkarta, MAR 25, 2021, View Source [SID1234577142]).

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"We continue our work to supercharge the distinctive tumor-killing power of healthy donor-derived natural killer cells and advance our co-lead development programs in allogeneic, off-the-shelf, engineered cell therapy," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "Our goal remains to report early clinical data from the dose finding portion of our ongoing clinical trial of NKX101 by the end of this year. In addition, we are on track to file the IND application for NKX019 this month and begin patient dosing in a multi-center clinical trial for patients with B cell malignancies in the second half of 2021. Nkarta remains committed to the transformative potential of CAR NK cell therapy for cancer patients and we strive to keep patients at the center of all that we do."

Anticipated Clinical Milestones

In the first quarter of 2021, Nkarta plans to file an Investigational New Drug (IND) application for NKX019, a CAR (chimeric antigen receptor) NK cell therapy candidate engineered to target tumors expressing CD19 antigen for the treatment of B-cell malignancies. Following the regulatory clearance of the IND, Nkarta expects patient dosing in a Phase 1 clinical trial of NKX019 to initiate in the second half of 2021.
Nkarta expects to manufacture NKX019 clinical supply for the Phase 1 clinical trial at its in-house cGMP clinical manufacturing facility located in South San Francisco, California.
Nkarta aims to present initial clinical data from its ongoing clinical trial of NKX101 in patients with r/r AML and MDS by year end. In the Phase 1 study, patients receive multiple doses of NKX101 during a 28-day treatment cycle and are eligible to receive a second cycle of treatment upon evidence of tolerability and disease response.
2022 milestones are expected to include an IND amendment for NKX101 for the treatment of solid tumors and an IND application for Nkarta’s third engineered CAR NK cell product candidate that is designed to target solid tumors and hematologic malignancies.
Fourth Quarter and Full Year 2020 Financial Highlights

Cash and Cash Equivalents: As of December 31, 2020, Nkarta had cash, cash equivalents, restricted cash and short-term investments of $315.3 million, which includes proceeds from the Company’s July 2020 IPO of $265.1 million, net of underwriting discounts and commissions and other offering costs.

R&D Expenses: Research and development expenses were $36.2 million for the full year 2020 and $11.3 million for the fourth quarter of 2020. Non-cash stock-based compensation expense included in R&D expense was $1.9 million for the full year 2020 and $0.8 million for the fourth quarter of 2020.

G&A Expenses: General and administrative expenses were $15.3 million for the full year 2020 and $6.7 million for the fourth quarter of 2020. Non-cash stock-based compensation expense included in G&A expense was $4.9 million for the full year 2020 and $3.3 million for the fourth quarter of 2020.

Net Loss. Net loss was $91.4 million, or $5.44 per basic and diluted share, for the full year 2020. This net loss includes a non-recurring $40.2 million non-cash change in fair value of preferred stock purchase liability. Net loss was $17.9 million, or $0.55 per basic and diluted share, for the quarter ended December 31, 2020.
Financial Guidance

Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into at least the second half of 2023.
About NKX101
NKX101 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with membrane-bound IL15 and a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. By engineering NKX101 with the proprietary NKG2D-based CAR, the ability of NK cells to recognize and kill tumor cells in pre-clinical models is increased significantly compared to non-engineered NK cells. The addition of membrane-bound IL15, a proprietary version of a cytokine for activating NK cell growth, has been shown in pre-clinical models to enhance the proliferation, persistence and sustained activity of NK cells. A multi-center Phase 1 clinical trial of NKX101 in patients with relapsed/refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndromes (MDS) is currently enrolling. Additional information about the clinical trial is available on ClinicalTrials.gov, identifier NCT04623944.

About NKX019
NKX019 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with a chimeric antigen receptor (CAR) targeting the CD19 antigen and membrane-bound IL15. CD19 antigen is a B-cell marker and validated target for B-cell cancer therapies. NKX019 uses the CAR to target and bind to CD19, leading to an immune response that eliminates CD19-expressing cells in preclinical studies. The addition of membrane-bound IL15, a proprietary version of a cytokine for activating NK cell growth, has been shown in preclinical models to enhance the proliferation, persistence and activity of NK cells. Nkarta plans to file an IND application with the FDA in the first quarter of 2021. Initiation of a Phase 1 clinical trial of NKX019 in patients with advanced relapsed/refractory B cell malignancies is planned for the second half of 2021.

About Nkarta’s Platform and Natural Starting Materials
Nkarta’s engineering platform utilizes healthy adult donors as the source for NK cells. By enlisting this natural source of NK cells, Nkarta starts with bona fide NK cells already endowed with inherent tumor-recognizing and cytotoxic potencies, as compared to other more complex cell sources where these basic therapeutic features must be painstakingly designed and synthetically added to the cells. Healthy donor-derived NK cells are also available in abundance, providing a large quantity of cells with which to begin the efficient two-week manufacturing process. Finally, healthy donor-derived adult cells consist of a diverse repertoire of NK cells. By utilizing a cell source that contains the broad and naturally occurring gamut of NK cells, Nkarta has the potential to capitalize on the inherent diversity of the innate immune system and select for different NK cell sub-populations with desired characteristics.

About Nkarta’s NK Cell Technologies
Nkarta has pioneered a novel discovery and development platform for the engineering and efficient production of allogeneic, off-the-shelf natural killer (NK) cell therapy candidates. The approach harnesses the innate ability of NK cells to recognize and kill tumor cells. To enhance the inherent biological activity of NK cells, Nkarta genetically engineers the cells with a targeting receptor designed to recognize and bind to specific proteins on the surface of cancerous cells. This receptor is fused to co-stimulatory and signaling domains to amplify cell signaling and NK cell cytotoxicity. Upon binding the target, NK cells become activated and release cytokines that enhance the immune response and cytotoxic granules that lead to killing of the target cell. All of Nkarta’s NK current cell therapy candidates are also engineered with a membrane-bound IL15, a proprietary version of a cytokine known for activating NK cell growth, to enhance the persistence and activity of the NK cells.

Nkarta’s manufacturing process generates an abundant supply of NK cells that, at commercial scale, is expected to be significantly lower in cost than other current allogeneic and autologous cell therapies. Key to this efficiency is the rapid expansion of donor-derived NK cells using a proprietary NKSTIM cell line, leading to the production of hundreds of individual doses from a single manufacturing run. The platform also features the ability to freeze and store CAR NK cells for an extended period of time and is designed to enable immediate, off-the-shelf administration to patients at the point of care.