On November 12, 2021 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to elicit a potent and durable immune response in the tumor microenvironment, reported that a poster highlighting promising new preclinical data for BCA101, a bifunctional antibody designed to localize the TGF-β trap to EGFR+ tumors currently in an ongoing Phase 1/2 study, will be presented on Saturday, November 13, 2021 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2021 Annual Meeting in Washington, D.C (Press release, Bicara Therapeutics, NOV 12, 2021, View Source [SID1234595462]).

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"These data show that BCA101, our first-in-class bifunctional antibody, has strong potential to improve anti-tumor response versus historical EGFR inhibitors by leveraging the interplay between the EGFR and TGF-β signaling pathways. It also suggests synergy in combination with PD-1 inhibitors with the potential to delay and overcome PD-1 resistance," said Liviu Niculescu, M.D., Chief Medical Officer of Bicara Therapeutics. "These preclinical data are very encouraging for our ongoing clinical trial aimed at giving cancer patients a treatment option with better efficacy and safety than currently available options. We look forward to reporting data from the Phase 1/2 clinical trial in the second half of 2022."

Details of the poster are as follows:

Title: Development of BCA101, a Bifunctional Antibody Capable of Simultaneously Disabling EGFR and TGF-β Signaling, as a Novel Single-agent Immunotherapy
Poster Number: 874
Category: Novel Single-Agent Immunotherapies
Presentation Date and Time: Friday, November 12, 2021, at 7:00 a.m.
Authors: Srinivas R. Boreddy, Ph.D.; Reshmi Nair; Arindam Banerjee; Anshu Kuriakose; Prashant Kumar Pandey; Chaitali Dey; Meena Shri; Shruthi Rao; Bhadravathi Marigowda Shivakumar; Moni Abraham Kuriakose; Ram Bhupal Reddy; Amrita Suresh; Praveen Reddy Moole; Usha Bughani; Seng-Lai Tan, Ph.D.; Pradip Nair

Key findings:

Improved retention of BCA101 in tumor microenvironment compared to TGF-bRII-Fc alone
BCA101 inhibits TGF-β-induced epithelial to mesenchymal transition and rescues from TGF-β-mediated immune inhibition
BCA101 demonstrates superior anti-tumor efficacy compared to cetuximab + TGF-bRII-Fc in vivo
BCA101 demonstrates sustained tumor regression compared to cetuximab in HNSCC-PDX models
BCA101 exhibited improved efficacy in combination with anti-PD-1 inhibitor in checkpoint-resistant HuNOG-EXL humanized model
BCA101 is currently being evaluated in a Phase 1/2 study as both a monotherapy in patients with EGFR-driven tumors and in combination with pembrolizumab (anti-PD-1) in squamous cell carcinoma of the head and neck (SCCHN) and squamous cell carcinoma of the anal canal (SCCAC). The study is currently enrolling patients in dose escalation and will open dose expansions in 2022.

About BCA101

BCA101 is a first-in-class EGFR / TGF-β-trap bifunctional antibody designed to enhance both innate and adaptive immune responses directly at the site of the tumor by binding to the well-validated EGFR antigen and disabling TGF-β, a signaling molecule that plays a key role in suppressing the immune response in the tumor microenvironment. Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab in preventing tumor recurrence, as well as in restoring immune activation. An ongoing Phase 1/2 clinical trial of BCA101, initiated in July 2020, has dosed the first six cohorts of patients in a dose-escalation study with BCA101 as a single agent. A second arm of the study began enrolling patients for combination treatment with BCA101 and pembrolizumab, a PD-1 inhibitor, in January 2021. For more information, please visit www.clinicaltrials.gov.

On November 12, 2021 Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‛cytokine storm’ with its lead drug candidate, lenzilumab, reported financial results for the third quarter and nine months ended September 30, 2021 (Press release, Humanigen, NOV 12, 2021, View Source [SID1234595478]).

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Status of Application to UK’s Medicines and Healthcare Products Regulatory Agency (MHRA)

On June 11, 2021, Humanigen initiated submission of an application seeking Conditional Marketing Authorization (CMA) from the UK’s MHRA for lenzilumab in hospitalized COVID-19 patients and it was accepted for expedited COVID-related rolling review on July 9, 2021. Humanigen submitted the last of the planned modules on September 30, 2021. The company believes MHRA is actively reviewing its application.

"We are continuing our efforts to get lenzilumab to hospitalized COVID-19 patients. The recent selection of lenzilumab by the European Commission as one of the 10 most promising treatments for COVID-19, validates our view that lenzilumab offers meaningful clinical potential.1 We appreciate the commitment MHRA has made to reviewing our application," said Cameron Durrant, Chairman and CEO, Humanigen. "The vaccination rate in the UK is 79%, yet hospitalizations due to COVID-19 continue. We continue to work with regulators in the UK, US, and European Union to potentially bring this therapy to patients."2

Recent data suggests that the protection offered to fully vaccinated individuals from infection and severe disease wanes over time and there is a continued need for additional treatment options for patients who become severely ill after infection with SARS-CoV-2.3 Despite nearly 80% of the population in the UK being fully vaccinated, there were nearly 25,000 COVID-19 patients newly admitted to hospitals for treatment in October, more than 60% of whom were fully vaccinated. 2,4,5

Timothy Morris, COO/CFO, Humanigen, noted, "We are preparing for potential launch in the UK if lenzilumab were to receive authorization from MHRA by securing a supply chain to import, release and distribute lenzilumab to UK hospitals. Separately, our agreement with Clinigen, once fully operational, will allow us to distribute lenzilumab to patients in 16 countries in the EU where regulations allow for managed access, named patient, compassionate use or similar programs. We are also pleased by the progress being made to evaluate lenzilumab in Chronic Myelomonocytic Leukemia (CMML), acute Graft versus Host Disease (aGvHD), and our own effort to conduct a Phase 3 study with commercially-approved CD19 CAR-T therapies in non-Hodgkin lymphoma (NHL)."

Third Quarter and Recent Highlights:

Lenzilumab in hospitalized COVID-19

European Commission selected Humanigen’s lenzilumab as one of the 10 most promising treatments for COVID-19.
Submitted final required modules as well as a risk management plan and pediatric investigation plan for CMA for lenzilumab in COVID-19 to the UK’s MHRA.
EMA appointed a Rapporteur and Co-Rapporteur related to the company’s planned submission of an MAA for lenzilumab in COVID-19 in the EU.
Entered into agreement with Clinigen Group to establish a Managed Access Program to enable access to lenzilumab on a case-by-case basis to patients in up to 16 European countries.
Requested and granted a Type B meeting with FDA. Included in the briefing materials for the meeting request were day 60 data as well as detailed CRP analysis from the company’s LIVE-AIR Phase 3 study.
Lenzilumab in CMML, aGvHD, and NHL

First patient dosed in Phase 2 study of lenzilumab in patients with Chronic Myelomonocytic Leukemia (CMML), sponsored by the company’s Australian partners.
Reached agreement with University of Birmingham to conduct a Phase 2/3, potentially registrational, trial to evaluate lenzilumab in the treatment of aGvHD at IMPACT Partnership stem cell transplant centers across the UK.
Scheduled a meeting in December 2021 with FDA to discuss a protocol to conduct a Phase 3 randomized, placebo-controlled, open-label trial of lenzilumab to improve the safety and efficacy of CD19 CAR-T therapies in the treatment of NHL.
Corporate

Elected John Hohneker, MD, and Kevin Xie, PhD, to Board of Directors.
Received U.S. Patent 11,130,805 protecting the method of treating CAR-T cell therapy-induced neurotoxicity using a GM-CSF inhibitor. The patent issued on September 28, 2021 and has an expected patent term through October 2, 2038.
ACTIV-5 Update

In August 2021, the National Institutes of Health (NIH) announced the advancement of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-5) and Big Effect Trial, in the "B" arm of the trial (BET-B), referred to as ACTIV-5/BET-B. Following feedback from and consultation with the company, the NIH advanced the study to a Phase 2/3 study with target enrollment of up to 400 patients with a baseline CRP<150 mg/L, or a total of up to 550 patients, and amended the protocol for ACTIV-5/BET-B in a manner that aligns with the design of the company’s LIVE-AIR trial. The trial is approximately 75% enrolled.

Third Quarter and Nine Months Ended September 30, 2021 Financial Results

Net loss for the three months ended September 30, 2021 was $66.7 million or $1.12 per share as compared to $30.8 million or $0.71 per share for the three months ended September 30, 2020. The net loss for the nine months ended September 30, 2021 was $203.1 million or $3.56 per share as compared to $57.2 million or $1.79 per share for the nine months ended September 30, 2020. The increase in net loss for both periods was largely due to an increase in total expenses, mainly Research and Development ("R&D") expense which rose significantly as the company accelerated its efforts to manufacture lenzilumab for potential commercialization upon receipt of a regulatory authorization. R&D expense increased $38.4 million from $22.4 million for the three months ended September 30, 2020, to $60.8 million for the three months ended September 30, 2021, and increased $139.6 million from $44.2 million for the nine months ended September 30, 2020, to $183.8 million for the nine months ended September 30, 2021. The manufacturing expense included in R&D was $55.8 million for the third quarter of 2021 as compared to $10.9 million for the prior year quarter, and $162.9 million for the nine months ended September 30, 2021, as compared to $28.3 million for the prior year period. Manufacturing expense is comprised of technical transfer, start-up and production expenses for bulk drug substance (BDS) and drug product (DP). The company has built an extensive network of contract manufacturing organizations (CMOs) to produce lenzilumab BDS, to fill DP, and to establish a supply chain for lenzilumab.

On September 8, 2021, FDA declined the company’s Emergency Use Authorization (EUA) request for lenzilumab in hospitalized COVID-19 patients. Subsequently, the company has amended, and in some cases canceled, certain of its manufacturing agreements, some of which were contingent on EUA, in an effort to reduce its future spending on lenzilumab production until and if authorization is received in the UK, EU, or US. In the event of authorization by MHRA, EMA, or FDA, the company anticipates that the demand for commercial product could exceed the in process and planned production of lenzilumab through 2022. The company intends to seek additional manufacturing capacity if authorization is obtained. Production beyond 2022 would require the company to secure capacity at our CMOs and acquire the necessary supplies and components. The Company expects to use a portion of the revenues generated from commercial sale of lenzilumab following receipt of a regulatory authorization to support its efforts to expand production capacity in 2023 and beyond.

Certain of the company’s CMOs have been unsuccessful in their efforts to manufacture some batches of lenzilumab to the company’s specifications for various reasons. The company is working with these CMOs to determine if batches of BDS manufactured by them may be usable in the future or, if not, whether other financial recompense will be offered to the company.

Cash and Cash Equivalents

Net cash used in operating activities, net of balance sheet changes, was $48.0 million for the three months ended September 30, 2021, and $151.8 million for the nine months ended September 30, 2021. During the nine months ended September 30, 2021, the company raised net proceeds of $40.0 million from the sale of shares of common stock under its At-the-Market offering program, drew $25.0 million under its credit facility with Hercules Capital, providing net proceeds of $24.4 million, and completed a public offering of common stock with net proceeds of $94.2 million. As of September 30, 2021, the company had cash and cash equivalents of $76.5 million. Subsequent to September 30, 2021, the company received net proceeds of approximately $24.5 million under its At-the-Market offering program.

A summary of key financial highlights as of and for the three and nine months ended September 30, 2021 and 2020 is as follows ($ in thousands):

On November 12, 2021 Nektar Therapeutics (Nasdaq: NKTR) reported three data presentations for its I-O pipeline at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Nektar Therapeutics, NOV 12, 2021, View Source [SID1234595494]).

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Initial clinical results were presented from the dose-escalation stage of a Phase 1/2 study of NKTR-255 in combination with cetuximab in a late-breaking abstract presented by Mehmet Altan, MD, Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center on Friday, November 12th. Collaborator presentations of translational data for bempegaldesleukin in combination with nivolumab and bempegaldesleukin in combination with NKTR-262 data were also featured in two poster presentations by Arika S. Feils at the Department of Human Oncology, University of Wisconsin School of Medicine and Public Health and Annah Rolig, PhD, Earle A. Chiles Research Institute, Providence Cancer Institute, respectively, on Friday, November 12th.

"The data presented at this year’s SITC (Free SITC Whitepaper) meeting highlight the strength of our cytokine portfolio and in particular the potential of NKTR-255 in the treatment of patients with solid tumors," said Jonathan Zalevsky, Ph.D., Senior Vice President and Chief Research & Development Officer at Nektar. "We were excited to see early evidence of clinical benefit in the first patients treated in the dose-escalation portion of the study for NKTR-255 in combination with cetuximab which reinforces the promising synergy of IL-15 in combination with an antibody-dependent cellular cytotoxicity agent for the treatment of solid tumors."

2021 SITC (Free SITC Whitepaper) presentations are available for download at View Source

Highlights from the presentations are as follows:

Abstract 957: "NKTR-255 Plus Cetuximab in Patients with Solid Tumors: Interim Safety and Efficacy Results from the Phase 1b Dose Escalation Study", Altan, M., et al.

The combination of NKTR-255 + cetuximab was well tolerated at NKTR-255 doses of 1.5 and 3.0 μg/kg every three weeks (Q21D) and treatment-related adverse events were generally low-grade, transient, and easily managed.
Early evidence of on-target biological activity was observed with treatment with NKTR-255 leading to expansion and proliferation of Natural Killer (NK) cells and CD8+ T cells.
Early evidence of clinical activity was observed in 9 patients that were evaluable for efficacy [6 colorectal (CRC) patients, 3 squamous cell carcinoma of head and neck (SCCHN) patients] with 1 CRC patient achieving a confirmed partial response (PR) with 52% tumor reduction by RECIST and 5 patients experiencing stable disease (SD) by RECIST [3 CRC, 2 SCCHN] in this heavily pre-treated and highly refractory patient population. 8 of the 9 patients evaluable for efficacy had also received prior treatment with an EGFR-targeted therapy and/or a checkpoint inhibitor.
The maximum tolerated dose and recommended Phase 2 dose have not been reached yet and dose escalation of NKTR-255 + cetuximab is ongoing in patients with R/R SCCHN and CRC.
Abstract 59: "Associations between KIR/KIR-ligand genotypes and clinical outcome for patients with advanced solid tumors receiving BEMPEG plus nivolumab combination therapy in the PIVOT-02 trial", Feils, AS., et al.

Individuals who were positive for KIR2DL2 and its HLA-C1 ligand had significantly greater TS (p=0.01) and longer PFS (p=0.04) with a trend towards increased ORR (p=0.07).
No significant associations were found between an individual’s clinical outcome and their KIR3DL1 and HLA-Bw4 ligand status.
Individuals who were positive for both KIR2DL2 and KIR3DL1 with their HLA-C1 and HLA-Bw4 ligands, respectively, had significantly greater TS (p=0.04) and increased ORR with a trend towards longer PFS (p=0.07).
No significant associations were found between an individual’s clinical outcome and their KIR/KIR-ligand present versus missing status.
Abstract 596: "Combining Bempegaldesleukin (CD122-preferential IL-2 pathway agonist) and NKTR-262 (TLR7/8 agonist) pairs local innate activation with systemic CD8+ T cell expansion to enhance anti-tumor immunity", Rolig, A., et al.

BEMPEG+NKTR-262 preclinical efficacy is superior to BEMPEG+RT efficacy and relies on CD8+ T cells.
BEMPEG+NKTR-262 combination therapy produces a higher fraction of activated, tumor antigen-specific cytotoxic CD8+ T cells systemically, correlating with superior anti-tumor efficacy relative to BEMPEG+RT in preclinical models.
In preclinical models, BEMPEG+NKTR-262 therapy induces active (GzmA+, Ki-67+) AH1-A5-CD8+ T cell that are supported by type 1 IFN signaling, suggesting bystander T cell activity.
In preclinical models, BEMPEG+NKTR-262 combination therapy induces intratumoral CD8+ T cells that have increased activity as demonstrated by increased granzyme expression, increased cytolytic capacity, and reduced conversion to an exhausted phenotype (PD-1+).
Analyst Call with Cancer Specialist:

Nektar management will host an analyst and investor conference call to review the data presentation for NKTR-255 at SITC (Free SITC Whitepaper) 2021. The call will also include two invited speakers:

Mehmet Altan, MD, Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center
Alan Tan, MD, Director of GU Medical Oncology and Assistant Professor in the Division of Hematology, Oncology and Cell Therapy at Rush University Medical Center
Date and Time: Friday, November 12, 2021 at 12:00 p.m. EST

Dial-in: 877-881-2183 (toll-free) or 970-315-0453 (enter access code 1769208)

Investors and analysts can also view slides and listen to the live audio webcast of the presentation at View Source The event will also be available for replay for two weeks on the company’s website, www.nektar.com.

Biography for Mehmet Altan, MD

Mehmet Altan, MD, is an Assistant Professor in the Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. Dr. Altan is one of the lead investigators in the phase 1/2, dose-escalation and dose-expansion study of NKTR-255 in combination with cetuximab in patients with refractory 2nd and 3rd line metastatic colorectal cancer or metastatic head and neck cancer. His current research areas include identification of mechanisms for primary and secondary resistance to immunotherapies and predictive markers for immunotherapy toxicities. He also works on translational research projects for identification of spatiotemporal dynamics of the tumor microenvironment in response to immunotherapy to define potential therapeutic targets.

Biography for Alan Tan, MD

Alan Tan, MD, is an Assistant Professor in the Division of Hematology, Oncology and Cell Therapy at Rush Medical College. He specializes in kidney cancer, bladder cancer, prostate cancer and melanoma. He also has an extensive background in hematologic malignancies. Dr. Tan has clinical research interest in designing and implementing clinical trials to test novel immunotherapies and targeted therapies for renal cell carcinoma and GU malignancies. He also has interest in precision genomic cancer medicine, identifying molecular alterations that will serve as targets for individualized treatment strategies.

On November 12, 2021 Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported financial results for the third quarter ended September 30, 2021 (Press release, Applied Therapeutics, NOV 12, 2021, View Source [SID1234595517]).

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"This quarter we announced positive data in both the Galactosemia pediatric study as well as our pilot SORD Deficiency study, highlighting our execution across programs and expansion into additional indications with AT-007," said Shoshana Shendelman, PhD, CEO, Founder and Chair of the Board of Applied Therapeutics. "We are excited to launch our registrational study in SORD later this year and remain focused on preparations for our anticipated commercial launch in Galactosemia in 2022."

Recent Highlights

Reported biomarker data from pilot trial of AT-007 in SORD deficiency. In October 2021, the Company highlighted results from a pilot open-label study in 8 SORD Deficiency patients. In the study, AT-007 reduced blood sorbitol levels by approximately 66% from baseline through 30 days of treatment with a range of reduction from baseline of 54%-75%. AT-007 was safe and well tolerated in all patients. The Company plans to initiate a registrational study by the end of 2021.

Reported pediatric biomarker data from ACTION-Galactosemia Kids. In October 2021, the Company reported pediatric biomarker data from the ACTION-Galactosemia Kids study. The results demonstrated a substantial reduction in plasma galactitol of approximately 40%, which was statistically significant (p<0.001) vs. placebo. Additionally, analysis of the 47 children in the ACTION-Galactosemia Kids study demonstrated a clear correlation between baseline galactitol level and baseline clinical functional outcomes. Children with higher plasma galactitol levels displayed greater disease severity vs. children with lower plasma galactitol levels at baseline. This data is the first demonstration of correlation of a biochemical biomarker with severity of disease in Galactosemia patients. This data will be presented as a late-breaking abstract at the 14th International Congress on Inborn Errors of Metabolism (ICIEM) November 21-24, 2021.
Financial Results

Cash and cash equivalents and short-term investments totaled $108.8 million as of September 30, 2021, compared with $125.6 million at June 30, 2021.

Research and development expenses for the three months ended September 30, 2021 were $17.6 million, compared to $19.9 million for the three months ended September 30, 2020. The decrease of $2.3 million was related to a decrease in drug manufacturing and formulation costs of $5.2 million primarily related to the completion and release of AT-001 and AT-007 drug product batches in the three months ended March 31, 2021; an increase in clinical and pre-clinical expense of $2.1 million, primarily related to the progression of the AT-007 ACTION-Galactosemia adult extension study and the AT-007 ACTION-Galactosemia Kids pediatric registrational study; an increase in personnel expenses of $0.6 million due to the increase in headcount in support of our clinical program pipeline; and an increase in regulatory and other expenses of $0.2 million.

General and administrative expenses were $10.8 million for the three months ended September 30, 2021, compared to $10.0 million for the three months ended September 30, 2020. The increase of $0.8 million was primarily related to an increase in commercial expenses of $0.8 million related to the expansion of the commercial department; an increase in other expenses of $0.3 million relating to increased costs of rent and other office expenses; an increase in stock-based compensation of $0.2 million; an increase in insurance expenses of $0.1 million related to increased insurance costs; and a decrease in legal and professional fees $0.6 million due to lower external legal fees.

Net loss for the third quarter of 2021 was $28.4 million, or $1.09 per basic and diluted common share, compared to a net loss of $29.8 million, or $1.33 per basic and diluted common share, for the third quarter 2020.

On November 12. 2021 Thyas reported that it has raised JPY 300 million in Series A3 financing with participation from Kyoto University Innovation Capital Co., Ltd., and D3 LLC (Press release, Thyas , NOV 12, 2021, View Source [SID1234629207]).

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The funds will be used for accelerating the research and development including preclinical studies of iPS cell-derived immune cell therapy and discovery research of new pipelines for the treatment of solid cancers and infectious diseases. In addition to R&D, Thyas further strives for business development and aims to deliver the early clinical applications to patients as soon as possible.