On November 10, 2022 Medikine, Inc., a biopharmaceutical company developing transformative therapeutics for cancer, autoimmune disorders and infectious diseases using its novel PEPTIKINE technology, reported preliminary safety, tolerability, and pharmacokinetic/pharmacodynamic data from its Phase 1 clinical trial in healthy subjects for its lead program, MDK-703, a peptide-based interleukin-7 (IL-7) mimetic with an extended half-life (Press release, Medikine, NOV 10, 2022, View Source [SID1234623781]).

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The data, which were presented during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting (SITC 2022), demonstrated that MDK-703 was well-tolerated and safe after a single intramuscular administration at doses of both 10 and 30 ug/kg. Additionally, MDK-703 demonstrated drug exposure in blood consistent with high bioavailability and, as expected, produced extended elevation of CD8 and CD4 T cells compared to baseline with minimal effects on regulatory T cells (Treg) and natural killer (NK) cells. Further analysis showed that MDK-703 produced expansion of memory T cells, specifically CD8 and CD4 T-stem cell memory (Tscm), T-central memory, and T-effector memory cells, in blood.

"We are encouraged by the early trial results of MDK-703, which in this study passed the crucial proof-of-pharmacology threshold of expanding T cell populations and, most importantly, demonstrated a unique proliferative effect on the Tscm subpopulation, which is essential for T cell survival, renewal, and the avoidance of exhaustion," said Dr. Joseph Leveque, president and chief medical officer of Medikine. "We anticipate this T cell ‘stemness’ effect associated with MDK-703 will induce a potent and persistent anti-tumor response in cancer patients and look forward to further investigating its clinical utility in solid tumors beginning early next year."

A second poster presentation detailed preclinical results in peripheral blood monocytes (PBMCs) from healthy donors for MDK-1654, Medikine’s dual-acting agonist that incorporates both IL-7 and non-alpha IL-2/15 PEPTIKINES. This is the first demonstration of a synthetic peptide with agonist activity for two clinically relevant cytokine receptors.

In addition to activating both the IL-2/15Rβγc and IL-7Rαγc signaling pathways, MDK-1654 expanded all memory T cells, including CD8 Tscm. It also exhibited additive and complementary effects of IL-2/15Rβγc and IL-7Rαγc signaling among various blood immune cell populations, specifically Tscm, γδT cells, and NK cells. T cells and NK cells are important cells that have a high cytotoxic, tumor-killing, and anti-tumor capacity.

Together, the combined actions of MDK-1654 suggest it could drive deep and durable anti-tumor responses in cancer by activating cells involved in both the adaptive and innate immune systems.

"Medikine is employing a unique and versatile drug discovery platform to generate modular cytokine-mimetic ‘PEPTIKINES’ that are engineered with distinctive features and optimized therapeutic attributes not found in naturally occurring cytokines," said Ronald W. Barrett, Ph.D., chief executive officer and chairman of the board of Medikine. "To our knowledge, MDK-703 is the first peptide-based molecule that has been shown in humans to emulate the activity of a cytokine that works through a hetero-dimeric receptor. As such, it serves as important validation of Medikine’s PEPTIKINE technology. We look forward to investigating MDK-703 in solid tumors both as monotherapy and in combination with a PD-1 inhibitor and expect to enroll the first patient in the start of these studies in the first quarter of 2023. We also plan to advance our IL7/IL2 Dual PEPTIKINE program to selection of an IND candidate in 2023."

Both poster presentations are now available on the Medikine website at www.medikine.com.

ABOUT MDK-703

MDK-703 is an investigational biologic interleukin-7 (IL-7) mimetic consisting of an IL-7 PEPTIKINE fused to an immunoglobulin Fc-domain that was discovered using Medikine’s platform technology.

IL-7 is a cytokine critical for the development and maintenance of T cells, including enhancing generation, function, and survival of memory T cells. By emulating these effects of IL-7 on T cells, MDK-703 may enhance the rate, depth, and durability of clinical responses, alone or in combination with other immune-based therapies. Additionally, MDK-703 has the beneficial property that it may not generate anti-drug antibodies (ADAs) that neutralize native IL-7, an issue previously observed with IL-7 agents that have been studied in humans.

Medikine has presented preliminary results from a Phase 1 study of MDK-703 in healthy volunteers and plans to investigate MDK-703 in solid tumors both as monotherapy and in combination with a PD-1 inhibitor in clinical studies in 2023.

On November 10, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported that financial results for the three and six months ended June 30, 2022 and provides a business update (Press release, Biocept, NOV 10, 2022, View Source [SID1234623780]).

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"Today we are reporting strong progress in positioning Biocept as a leader in neurological tumor diagnostics," said Samuel D. Riccitelli, Biocept’s Chairman, and interim President and CEO. "During the second quarter, we reported the first revenue of $58,000 from a biopharma company using CNSide to support their therapeutics clinical trial. More recently, we opened enrollment in our FORESEE trial, the goal of which is to generate evidence of CNSide’s clinical utility in support of higher reimbursement and faster adoption into patient care guidelines. In October of 2022, we also expanded the commercial availability of CNSide to include metastatic melanoma, the third most common tumor type involved in central nervous system (CNS) metastasis with more than 60% of stage IV melanoma patients developing CNS metastasis. We look for diminishing but cash-flow positive revenue from RT-PCR COVID-19 testing services as demand continues to decline and we do not anticipate COVID-19 testing revenue beyond December 2022," said Mr. Riccitelli.

Biocept expects to report financial results for the third quarter of 2022 in the coming weeks and to hold an investment community conference call at that time.

Second Quarter Financial Results

Net revenues for the second quarter of 2022 consisted of commercial test revenue of $10.6 million, which included $9.8 million in RT-PCR COVID-19 test revenue. Excluding a $1.1 million increase in reserves for aged accounts receivables in the second quarter of 2021 that reduced net revenues, revenues were $13.1 million and included $12.0 million in RT-PCR COVID-19 test revenue.

Biocept accessioned 77,779 commercial samples during the second quarter of 2022, compared with 104,061 commercial samples during the second quarter of 2021, with the decline due primarily to lower RT-PCR COVID-19 testing volume. The average value per commercial accession for the second quarter of 2022 was $135, up 17% from $115 for the second quarter of 2021, with the increase due to payor mix.

Cost of revenues for the second quarter of 2022 was $8.0 million, compared with $7.5 million for the prior-year period, with the increase related to off-site staffing resources related to our RT-PCT-COVID-19 testing business.

Research and development (R&D) expenses for the second quarter of 2022 were $1.7 million, compared with $1.1 million for the second quarter of 2021. The increase was primarily attributable to additional costs associated with preparing for the FORESEE trial, which opened enrollment during the third quarter of 2022. General and administrative (G&A) expenses for the second quarter of 2022 were $4.3 million, compared with $3.3 million for the second quarter of 2021, with the increase due primarily to legal fees and other costs associated with the sales commission settlement, as well as audit and accounting related fees. Sales and marketing expenses for the second quarter of 2022 were $1.7 million, compared with $1.9 million for the second quarter of 2021, with the decrease due primarily to a reduction in commissions expense.

Net loss attributable to common stockholders for the second quarter of 2022 was $5.3 million, or $0.31 per share on 16.9 million weighted-average shares outstanding. This compares with net loss attributable to common stockholders for the second quarter of 2021 of $1.8 million, or $0.14 per share on 13.5 million weighted-average shares outstanding.

Six Month Financial Results

Net revenues for the first six months of 2022 were $30.6 million, which included $28.4 million of RT-PCR COVID-19 test revenue, compared with net revenues for the first six months of 2021 of $29.8 million, which included $29.0 million of RT-PCR COVID-19 test revenue. Net revenues for the first six months of 2021 includes a $1.1 million increase in reserves for age accounts receivables, which reduced net revenues.

Operating expenses for the first six months of 2022 were $38.4 million, and included cost of revenues of $18.4 million, R&D expenses of $3.6 million, G&A expenses of $11.1 million and sales and marketing expenses of $5.3 million. Operating expenses for the first six months of 2021 were $28.9 million, and included cost of revenues of $16.5 million, R&D expenses of $2.2 million, G&A expenses of $6.4 million and sales and marketing expenses of $3.9 million.

Net loss attributable to common stockholders for the first six months of 2022 was $8.0 million, or $0.48 per share on 16.9 million weighted average shares outstanding. This compares with net income attributable to common stockholders for the first six months of 2021 of $772,000, or $0.06 per diluted share on 13.6 million weighted-average shares outstanding.

Biocept reported cash and cash equivalents as of June 30, 2022 of $22.9 million, compared with $28.9 million as of December 31, 2021.

The U.S. Health Resources and Services Administration (HRSA) informed providers that after March 22, 2022 it would stop accepting claims for COVID-19 testing and treatment for uninsured individuals and that claims submitted prior to that date would be subject to eligibility and availability of funds. HRSA’s procedure for recouping credits due from service providers had been to net these amounts against reimbursements for services provided. Given that no further payments are expected from HRSA, there is no longer a mechanism for recoupments. The Company has therefore recorded a $5.7 million liability for outstanding HRSA credits that were previously netted against accounts receivable.

On November 10, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that it will present preclinical research demonstrating the potential of its Cell Squeeze technology to multiplex engineer a diverse set of cell types, including hematopoietic stem cells (HSCs) and induced pluripotent stem cells (iPSCs), to potentially support the creation of new therapeutic candidates (Press release, SQZ Biotech, NOV 10, 2022, View Source [SID1234623778]). This capability builds upon the GMP capable system and SQZ Point-of-Care system that can process more than 10 billion cells per minute. The data will be presented at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held November 8-12, 2022, in Boston, MA.

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"Our presentation at SITC (Free SITC Whitepaper) demonstrates the broad potential of our Cell Squeeze technology to reliably deliver materials into cells without disrupting cell function, reduce manufacturing times, improve the safety of cell therapies, and support the creation of new therapies," said Jonathan Gilbert, Ph.D., Vice President of Exploratory Research at SQZ Biotechnologies.

The company will also present a COMMANDER-001 Phase 1/2 Trial in Progress poster demonstrating how its Enhanced Antigen Presenting Cell (eAPC) therapeutic candidate is designed to leverage the delivery of five mRNAs encoding for proteins stimulating the key T cell activation signals required to generate an immune response against tumors, including membrane-bound IL-2 and IL-12. By presenting all three canonical signals, the eAPC approach can potentially amplify the T cell response. Additionally, the ability to deliver E6 and E7 mRNA encoding full-length proteins to eAPCs removes the HLA restriction for trial screening, increasing the addressable patient population by two-to-three times when compared to the company’s Antigen Presenting Cell (APC) program.

Lastly, the company will present preclinical research outlining a potential new therapeutic approach linking multiple antigens together to create a single mRNA and delivering it into eAPCs to generate a personalized neoantigen medicine for mutations like the KRAS mutation.

"One of the latest examples of our platform’s potential is its capability to deliver multiple linked antigens to eAPCs, which could potentially be used to develop bespoke vaccines for patients based on their cancer’s specific mutations or vaccines for a larger set of patients with a shared mutation such as KRAS," said Marshelle Warren, M.D., Chief Medical Officer at SQZ Biotechnologies. "Additionally, we are presenting our eAPC Trial in Progress and look forward to sharing our initial data by the end of the year."

Major Findings from Research:

Poster #224: Generation of Cell Therapies for Diverse Applications Using Microfluidic Cell Squeeze Manufacturing Technology
Date: Friday, November 11, 2022

The Cell Squeeze system can be leveraged to engineer a diverse set of cell types, including HSCs and iPSCs, and potentially allows for improved product quality and manufacturing cost relative to other common cell therapy approaches. Advantages include limited required rest time after the engineering step, faster proliferation, and fewer operator hours needed
Transient engineering of a broad set of cell types with membrane-bound cytokines could lead to new therapeutic approaches for cell therapy. Preclinically, we show the ability to potentially improve safety by eliminating cytokine support as well as increase the frequency of a desirable cell phenotype
SQZ Point-of-Care (POC) system enables more cell engineering possibilities while demonstrating a >90% reduction in operator hours with total process time under six hours. The POC system also offers the potential to eliminate the need for an ISO 7 clean room
Poster #321: Single mRNA Constructs Encoding Multiple Linked Antigens Allow for a Multiantigen-Specific CD8+ T Cell Response Driven by SQZ eAPCs
Date: Thursday, November 10, 2022

Using Cell Squeeze technology, investigators successfully generated SQZ eAPCs with mRNA encoding for up to 10 linked antigen fragments, including E6, E7, KRAS G12V, and KRAS G12D
SQZ eAPCs engineered with linked antigen mRNA constructs containing KRAS antigens drove KRAS-specific T cell responses in vitro, suggesting a potential model for a personalized neoantigen medicine for KRAS mutations
mRNA constructs encoding multiple linked antigens drove increased CD8+ T cell response, further enhancing the versatility of the Cell Squeeze technology to potentially target multiple tumor-associated neoantigens in a single mRNA construct
Poster #638: COMMANDER-001: A Phase 1/2, First-in-Human, Multicenter, Open Label Study of SQZ-eAPC-HPV as Monotherapy and with Pembrolizumab in Patients with HPV16+ Recurrent, Locally Advanced, or Metastatic Solid Tumors (Trial in Progress)
Date: Friday, November 11, 2022

SQZ-eAPC-HPV is an enhanced SQZ clinical therapeutic candidate with no HLA restrictions, which increases the eligible patient population by 2-3 times compared to the company’s SQZ-PBMC-HPV clinical candidate
SQZ Enhanced Antigen Presenting Cells (eAPCs) are engineered by using the Cell Squeeze technology to simultaneously deliver five mRNAs encoding for full-length HPV16 E6 and E7 proteins (signal 1), CD86 (signal 2), and membrane-bound (mb) IL-2 and mbIL-12 cytokines (signal 3)
Eligible patients undergo a single leukapheresis, from which all doses have been manufactured in under 24 hours. Patients do not require a preconditioning regimen prior to receiving the therapeutic candidate
About SQZ-eAPC-HPV
SQZ Enhanced Antigen Presenting Cells (eAPC) are derived from peripheral blood mononuclear cells (PBMCs), which are primarily composed of monocytes, T cells, B cells, and NK cells, and engineered with various mRNA encoding for multiple target antigens and immuno-stimulatory signals, including CD86 and membrane-bound IL-2 and IL-12. The company has presented preclinical findings showing that SQZ eAPCs have generated robust T cell responses in human in vitro and in vivo models. Additionally, it was demonstrated that HPV16-encoding mRNA delivery to PBMCs stimulated CD8+ T cells across a range of HLA haplotypes, supporting eAPC clinical development in broader HPV16+ patient populations.

COMMANDER-001 Trial Design
SQZ-eAPC-HPV is being evaluated in a Phase 1/2 clinical trial (COMMANDER-001) for the treatment of HPV16+ advanced or metastatic solid tumors. The clinical candidate, which targets E6 and E7 oncoproteins, is being studied as a monotherapy and in combination with pembrolizumab, an immune checkpoint inhibitor. The study consists of two parts. The first part is designed to assess safety and tolerability of multiple doses of SQZ-eAPC-HPV in treatment-experienced patients, following a dose-escalation scheme for monotherapy, and a dose de-escalation for the combination with pembrolizumab. The second part of the study will assess clinical response of SQZ-eAPC-HPV in combination with pembrolizumab in immune checkpoint inhibitor treatment-naïve patient populations.

About Human Papillomavirus Positive Cancers
Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years, often leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer, HPV+ tumors account for 4.5% of all cancers worldwide resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.

On November 10, 2022 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, reported that it will present a Trial in Progress poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, being held in Boston and virtually from November 8 –12, 2022 (Press release, Immune-Onc Therapeutics, NOV 10, 2022, View Source [SID1234623777]).

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The poster presentation will highlight the trial design, dosing regimen, and study protocol for the company’s ongoing Phase 1 clinical trial of IO-202, a first-in-class myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B4 (LILRB4, also known as ILT3) for the treatment of patients with advanced solid tumors (NCT05309187).

"Our Phase 1 study of IO-202 supports a differentiated myeloid checkpoint inhibitor with best-in-class potential to provide benefit for patients with solid tumors," said Paul Woodard, M.D., chief medical officer of Immune-Onc. "IO-202 blocks the LILRB4 pathway – specifically, interaction with its multiple ligands including apolipoprotein E and fibronectin – enabling the potential to reactivate or enhance anti-tumor T cell immune responses in patients with solid tumors."

"In addition, we are able to study IO-202 at a higher starting dose in solid tumors by leveraging safety data from our Phase 1 trial of IO-202 in AML and CMML. We plan to combine IO-202 with various anti-PD-1s such as pembrolizumab and tislelizumab, among others. We look forward to continuing to build a strong body of evidence to support IO-202 as a novel immunotherapy with broad potential across multiple oncology indications," he added.

This study consists of two parts: a dose escalation portion to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IO-202 alone and in combination with pembrolizumab, an anti-PD-1; and a dose expansion portion using the recommended Phase 2 dose of IO-202 in combination with pembrolizumab or other anti-PD-1s in multiple solid tumor types. Various biomarkers will be explored to enable a mechanistic understanding of clinical data and inform future trials. This study may also provide an opportunity to identify preliminary efficacy signals for IO-202 as a monotherapy and as a combination with a PD-1 inhibitor in patients with advanced solid tumors.

Details of the presentation are as follows:

Title: A Phase 1 Trial of IO-202, An Antagonist Antibody Targeting Myeloid Checkpoint LILRB4 (ILT3), as Monotherapy and in Combination with Pembrolizumab in Adult Patients with Advanced Relapsed or Refractory Solid Tumors
Abstract #: 747
Presentation Session: Clinical Trials in Progress
Session Date and Time: Thursday, November 10, 2022, 9:00 AM – 9:00 PM ET
Location: Boston Convention & Exhibition Center, Hall C

Poster presentations will be accessible in person and virtually. All accepted abstracts will be available in a Journal for ImmunoTherapy of Cancer (JITC) supplement. For more information about the 37th SITC (Free SITC Whitepaper) annual meeting, please visit View Source

ABOUT LILRB4 (also known as ILT3)

LILRB4, also known as ILT3, is an immune inhibitory transmembrane receptor expressed by monocytic myeloid cells, including dendritic cells, monocytes, monocytic myeloid-derived suppressor cells and tumor-associated macrophages. LILRB4 inhibits antigen-presenting cell function, resulting in immune tolerance. LILRB4 is also expressed on certain hematologic cancer cells. Immune-Onc and The University of Texas published pioneering research in Nature illuminating the role of LILRB4 in immune suppression and tumor infiltration in acute myeloid leukemia (AML) and presented the rationale for targeting LILRB4 in solid tumors at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

ABOUT IO-202

IO-202 is a humanized IgG1 monoclonal antibody with high affinity and specificity towards LILRB4 (also known as ILT3). It blocks the interaction of LILRB4 with multiple ligands, including ApoE and Fibronectin, and has broad potential as an immunotherapy in both blood cancers and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 converts a "don’t kill me" to a "kill me" signal by activating T cell killing and converts a "don’t find me" to a "find me" signal by inhibiting infiltration of blood cancer cells. In the context of solid tumors, preclinical data presented at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrate that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in an immune competent model in vivo.

IO-202 has two ongoing clinical studies in the U.S.: Its first Phase 1 trial is currently enrolling patients with acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML) as a monotherapy and in combination with azacitidine (NCT04372433). The U.S. Food and Drug Administration granted IO-202 Orphan Drug designation for treatment of AML in 2020 and Fast Track designation for relapsed or refractory AML in 2022. The second Phase 1 trial of IO-202 is currently enrolling patients with advanced solid tumors to evaluate IO-202 as a monotherapy and in combination with an anti-PD-1 (NCT05309187).

On November 10, 2022 CytoImmune Therapeutics, a clinical-stage immuno-oncology company that is developing a novel class of engineered natural killer (NK) cell-based cancer therapies, reported new preclinical data highlighting the potential of the company’s tumor-reactive NK (TRACK-NK) cell program, CYTO-102, to potently and selectively kill tumor cells with the mechanism of action of antibody-dependent cellular cytotoxicity (Press release, CytoImmune Therapeutics, NOV 10, 2022, View Source [SID1234623776]). The data are being presented today during a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, being held November 10-13, 2022, virtually and in Boston.

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CytoImmune has engineered its TRACK-NK (CYTO-102) cells for clinical use by inducing expression of soluble IL-15 that is designed to activate and expand the endogenous immune response in patients. Further, these cells are designed to act as "serial killer" cells, making them capable of attacking multiple tumor cell targets in a short period of time. CytoImmune is currently advancing CYTO-102 in a Phase 1 clinical trial in patients with non-small cell lung cancer (NSCLC).

"Serial killer NK cells are rare in the immune system but have immense potential to deliver rapid anti-tumor responses through direct cell killing for the treatment of a number of challenging cancers," said Michael Caligiuri, M.D., co-founder and chief scientific officer of CytoImmune. "Combined with the ability of these cells to stimulate the patient’s own immune system to fight cancer cells, we’ve designed our TRACK-NK cells to deliver the most potent anti-tumor response possible, while maintaining good tolerability. We look forward to sharing these exciting data with the scientific community at SITC (Free SITC Whitepaper) and the opportunity to bring meaningful treatments forward for patients with cancer."

The findings to be presented highlight the dual mechanism of these cells to both induce tumor-reactivity by activating and expanding immune response as well as serial killing of multiple target cells. To evaluate their potential, CytoImmune conducted several in vitro and in vivo studies with TRACK-NK (CYTO-102). Findings showed:

TRACK-NK (CYTO-102) cells led to serial killing of both hematologic tumor cells (lymphoma) and solid tumor cells (NSCLC) in vitro
Further, when combined with tumor antigen directed monoclonal antibodies, TRACK-NK (CYTO-102) cells led to enhanced serial killing and conversion of an NK-insensitive cell line to sensitive in vitro
TRACK-NK (CYTO-102) cells effectively "cycle" the expression of CD16 and as is common for serial killers, expression is rapidly restored following resting or cryopreservation of the cells
"We are very excited to present these new preclinical data with our TRACK-NK cells, demonstrating the potential dual tumor-reactive and serial killing mechanism, aimed at providing potent and durable anti-tumor responses," said Christina Coughlin, M.D., chief executive officer of CytoImmune. "With CYTO-102, we have the potential to offer an off-the-shelf therapy for patients with cancer and these data support its continued evaluation. Our Phase 1 trial with CYTO-102 is ongoing, and we look forward to building a further understanding of its full potential in humans with initial clinical data expected in 2023."