On October 23, 2023 Novartis reported data from the Phase III PSMAfore trial at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (Press release, Novartis, OCT 23, 2023, View Source [SID1234636255]). Data presented at the Presidential Symposium showed that Pluvicto (lutetium (177Lu) vipivotide tetraxetan) met its primary endpoint with a clinically meaningful and statistically significant benefit in radiographic progression-free survival (rPFS) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) after treatment with androgen receptor pathway inhibitor (ARPI) therapy, compared to a change in ARPI1.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Efficacy endpoint Pluvicto vs. change in ARPI
Radiographic progression-free survival *a HR 0.41 (95% CI: 0.29, 0.56; p<0.0001)
Median rPFS* 12.0 vs. 5.6 months
≥50% decline in prostate-specific antigen levels 57.6% vs. 20.4%
Time to symptomatic skeletal event (SSE)a HR 0.35 (95% CI: 0.22, 0.57)
Objective response rate (ORR)b 50.7% vs. 14.9%
Duration of response (DOR)b 13.6 vs. 10.1 months
FACT-P scorea HR 0.59 (95% CI: 0.47, 0.72)
Brief Pain Inventory-Short Form (BPI-SF)a HR 0.69 (95% CI: 0.56, 0.85)
Prespecified crossover-adjusted overall survivala HR 0.80 (95% CI: 0.48, 1.33)
Unadjusted OSa (84% crossover) HR 1.16 (95% CI: 0.83, 1.64)
a Hazard Ratio (95% Confidence Interval). Functional Assessment of Cancer Therapy-Prostate
b In patients with measurable disease at baseline in soft tissue per RECIST v1.1.

"The rPFS data are impressive and the treatment effect is comparable with what was observed in the VISION trial," said Dr. Oliver Sartor, PSMAfore Co-Principal Investigator, Chairman of the Trial Steering Committee and adjunct professor in the Department of Urology at Tulane University School of Medicine, New Orleans, LA, one of the many sites where the trial was conducted. "We look forward to a future where Pluvicto may be a viable therapy for patients in need of alternative, earlier options."

"These promising results from PSMAfore could change the treatment paradigm for advanced prostate cancer by allowing patients to potentially avoid or delay taxane-based chemotherapy, which carries a heavy burden of side effects," said Jeff Legos, Executive Vice President, Global Head of Oncology Development at Novartis. "While data collection for overall survival continues, the consistency of the benefit observed on other clinically meaningful efficacy endpoints, together with improved quality of life and favorable safety profile, show the potential of Pluvicto for taxane-naïve patients with mCRPC."

The trial met its primary endpoint of rPFS2 with a 59% reduction in the risk of radiographic disease progression in patients with Pluvicto versus a change of ARPI1. Using a data cut off with a median of 8.6 months longer study follow-up, an updated rPFS analysis (HR 0.43; 95% CI: 0.33, 0.54) demonstrated a consistent clinical benefit in patients with Pluvicto versus a change in ARPI, more than doubling time to radiographic disease progression (12.0 months vs. 5.6 median months)1.

Patients on Pluvicto also showed improved quality of life, maintaining their FACT-P total score for 3 months longer than a change in ARPI (7.5 vs. 4.3 months), with a delay in worsening pain (BPI-SF) of 5.0 versus 3.7 months1. Other clinically meaningful efficacy endpoints also favored Pluvicto, with a PSA decline of at least 50% being >2.5X more frequent with Pluvicto than with a change in ARPI1.

At the second interim OS analysis with 45% of events, the pre-specified crossover-adjusted OS analysis demonstrated a hazard ratio of 0.80 (95% CI: 0.48, 1.33)1. The unadjusted intent-to-treat OS analysis was confounded as 84% of patients who discontinued ARPI due to radiographic progression crossed over to receive Pluvicto1. The trial will continue to assess OS, with the next interim OS analysis expected in 2024.

The trial demonstrated a favorable safety profile with 6 cycles of Pluvicto1:

Adverse events (AEs) Pluvicto vs. change in ARPIa
Grade 3–4 33.9% vs. 43.1%
Serious 20.3% vs. 28.0%
Leading to dose-adjustment 3.5% vs. 15.1%
Leading to discontinuation 5.7% vs. 5.2%
a In patients who experienced ≥1 adverse event.

The most frequently reported all-grade AEs for Pluvicto were primarily Grade 1–2 and included dry mouth (57.3%), asthenia (31.7%), nausea (31.3%), anemia (24.2%) and fatigue (22.9%)1.
Currently, patients diagnosed with metastatic prostate cancer have a 5-year survival rate of approximately 30%3 and there remains an urgent need for treatment options for patients who have disease progression despite the current standard of care4-7.

*Pluvicto met its primary endpoint of rPFS at the primary analysis based on centrally confirmed rPFS events with an October 2022 data cut off1. The updated exploratory rPFS analysis was based on the latest data cut off of June 2023 and only nominally significant1.

About the PSMAfore Study
PSMAfore (NCT04689828) is a Phase III, open-label, multi-center, 1:1 randomized study comparing the efficacy and safety of Pluvicto to a change in ARPI (abiraterone or enzalutamide) in patients with PSMA-positive mCRPC who have not been exposed to a taxane-containing regimen8. Patients enrolled must have progressed only once after receiving a second-generation ARPI (abiraterone, enzalutamide, darolutamide or apalutamide)8.

Patients randomized to the change in the ARPI arm were allowed to crossover to receive Pluvicto upon confirmation of radiographic progression by blinded independent central review (BICR). There were 469 participants enrolled in the study8.

The primary endpoint is rPFS, defined as the time from randomization to radiographic progression by PCWG3-modified RECIST v1.1 (as assessed by BICR) or death8. The key secondary endpoint of OS is defined as the time from date of randomization until the date of death due to any cause8. The pre-specified crossover-adjusted OS analysis was performed using the rank-preserving structural failure time (RPSFT) model to adjust for crossover8.

About Pluvicto (lutetium (177Lu) vipivotide tetraxetan)
Pluvicto is an intravenous radioligand therapy (RLT) combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177)9,10. After administration into the bloodstream, Pluvicto binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein9,10. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death10.

Pluvicto is approved in the U.S., the E.U. and other countries to treat adults with a type of advanced cancer called PSMA-positive mCRPC and who have already been treated with other anticancer treatments (ARPI and taxane-based chemotherapy)11-15. These regulatory decisions are supported by the results from the pivotal Phase III VISION trial, where Pluvicto met both primary endpoints of OS and rPFS, reducing the risk of death by 38% and the risk of radiographic progression or death by 60% compared to standard of care9.

As part of our goal to move into earlier stages of disease, we have two additional Phase III studies to evaluate Pluvicto in earlier lines of treatment for PSMA-positive prostate cancer: PSMAddition (NCT04720157) is ongoing in the metastatic hormone-sensitive setting and PSMA-DC (NCT05939414) in the oligometastatic setting is in preparation. More information on these studies may be found at www.clinicaltrials.gov

On October 23, 2023 NanOlogy LLC, a clinical-stage oncology company, reported that an abstract has been accepted for poster presentation at the 38th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting being held November 1-5 at the San Diego Convention Center (Press release, NanOlogy, OCT 23, 2023, View Source;utm_medium=rss&utm_campaign=nanology-announces-an-abstract-has-been-accepted-for-presentation-at-the-38th-sitc-annual-meeting [SID1234636254]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The abstract (#1084) entitled: "Local administration of large surface area microparticle docetaxel is associated with anti-tumor immunomodulation across multiple tumor types" will be presented in Exhibit Hall B of the convention center during poster sessions throughout the day on Saturday, November 4th.

A press release summarizing presentation data will be issued following the conference.

On October 23, 2023 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported updated data from two presentations at the 2023 Annual Congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) (Press release, Nanobiotix, OCT 23, 2023, View Source [SID1234636253]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

POSTER #1631P: Phase 1 Study of Endoscopic Ultrasound (EUS)-guided NBTXR3 delivery activated by Radiotherapy (RT) for Locally Advanced or Borderline Resectable Pancreatic Cancer (LAPC or BRPC)

The 5-year overall survival rate for patients with unresectable locally advanced pancreatic cancer (LAPC) remains less than 5%. Normally, these patients receive the combination of cytotoxic chemotherapy followed by concurrent chemoradiation if no metastatic progression has occurred. Innovative new treatments that might extend survival and avoid additional harmful side effects are an urgent unmet need for this patient population.

With safety, feasibility, and the recommended Phase 2 dose (RP2D) previously determined and reported, this presentation from The University of Texas MD Anderson Cancer Center (MD Anderson) explored additional preliminary signals of efficacy from the ongoing Phase 1 study evaluating RT-activated NBTXR3 after cytotoxic chemotherapy for patients with LAPC to potentially inform next steps in clinical trial development.

An MD Anderson historical review of 243 patients treated with LAPC at the same center showed:

Normalization of the biomarker CA19-9, a surrogate indicator for longer survival, in approximately 17% of patients treated with the standard of care who had elevated CA19-9 levels at diagnosis (n=183)
Median Overall Survival (mOS) of 19.2 months in 144 patients who received cytotoxic chemotherapy followed by RT with or without concurrent or maintenance chemotherapy (80% received RT with concurrent chemotherapy)
Comparatively, preliminary data from 17 patients treated with cytotoxic chemotherapy followed by RT-activated NBTXR3 in the Phase 1 LAPC study show:

Normalization of CA19-9 in 42% of patients who had elevated levels at diagnosis (n=12)
An mOS of 23 months from diagnosis
The investigator concluded that these results suggest promising anti-tumor efficacy for NBTXR3 in LAPC.

"As we continue to execute our global development program for NBTXR3 across tumor types and therapeutic combinations in parallel with our collaborators, we view the consistently favorable safety profile for our localized therapeutic innovation as critical to the product candidate’s potential," said Louis Kayitalire, MD, chief medical officer at Nanobiotix. "Patients with locally advanced pancreatic cancer are faced with poor survival and quality of life outcomes, and these preliminary efficacy and favorable safety data are an exciting indicator that NBTXR3 may present a promising new option."

ABSTRACT #5222: Antitumor Activity of the Radioenhancer NBTXR3 on Injected Lesions to Estimate Overall Survival: Exploratory Analyses from a Phase 1 in Cisplatin-Ineligible Locally Advanced HNSCC Patients

The previously reported final efficacy analysis of Study 102—a Phase 1 dose escalation and dose expansion study evaluating RT-activated NBTXR3 for elderly, frail patients with locally advanced head and neck cancer found that therapy was feasible, well tolerated with a favorable safety profile, and showed both prolonged Progression-Free Survival (PFS) and OS in a population characterized by negative prognostic factors.

This new exploratory analysis showed an mOS of 42.8 months in the 36 evaluable patients who had complete or partial response to NBTXR3 in the injected lesion (81.8%), compared to an mOS of 18.1 months observed in All Patients Treated (n=56), and 23.1 months in the total evaluable population (n=44), respectively. In addition, a positive correlation between Objective Response to RT-activated NBTXR3 in the injected lesion, Local Progression-Free Survival, and the extension of Overall Survival was observed.

These data suggest that the high rate of Objective Response to RT-activated NBTXR3 could potentially extend PFS and OS for elderly, frail patients with locally advanced head and neck cancer.

"With the Phase 1 study now complete, our focus is to ensure that we learn everything we can to anticipate the potential results of NANORAY-312. Of particular note were the data we observed regarding the positive correlation between Objective Response to NBTXR3 in the injected lesion, Local Progression Free Survival, Duration of Response in the injected lesion, and extension of Overall Survival," said Professor Christophe Le Tourneau, MD, PhD, principal investigator for Study 102 and co-principal investigator for NANORAY-312. "Given the directional signals we observed in the exploratory analysis, the additional option to inject involved lymph nodes included in the design of the Phase 3, and the expected resemblance of the Phase 3 population to the evaluable population in the Phase 1, we see a strong opportunity to improve treatment outcomes for elderly patients with head and neck cancer in our ongoing registrational study."

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2021, the Company announced an agreement with LianBio to expand development of NBTXR3 into Greater China and other Asian Markets, and in July 2023 Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV.

On October 23, 2023 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on rare diseases, reported an update on recent program developments and third quarter 2023 financial information (Press release, Mereo BioPharma, OCT 23, 2023, View Source [SID1234636252]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Program Developments

Setrusumab (UX143)

On October 14, 2023, Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) and Mereo BioPharma Group plc ("Mereo" or the "Company") announced interim data from the Phase 2 portion of the Phase 2/3 Orbit study demonstrating that treatment with setrusumab (UX143) achieved a 67% reduction in annualized fracture rate in patients with osteogenesis imperfecta (OI) with at least 6 months of follow-up and continues to demonstrate ongoing and meaningful improvements in lumbar spine bone mineral density (BMD). The Phase 3 portion of the study is currently enrolling approximately 195 patients at 50 sites across 12 countries.

Alvelestat (MPH-966)

University of Alabama at Birmingham (UAB) and the Company are reporting on the ATALANTa study, a multi-center, double-blind, placebo-controlled, proof-of-concept investigator-led study run by Professor Mark Dransfield, Director of the Division of Pulmonary, Allergy and Critical Care, UAB, in collaboration with Mereo. ATALANta investigated the safety and efficacy of alvelestat 120 mg, or matched placebo, twice daily, for 12 weeks in a broad range of individuals with Alpha-1 Antitrypsin Deficiency-Associated Lung Disease, including subjects with less severe phenotypes (Pi*SZ) than were enrolled in the Company-sponsored ASTRAEUS Phase 2 study, and those receiving augmentation therapy. The study randomized 63 patients, 32 in the 120 mg alvelestat arm (44% on augmentation therapy) and 31 in the placebo arm (48% on augmentation therapy).

The results demonstrated with the 120 mg dose of alvelestat (the lower dose used in the Phase 2 ASTRAEUS study) are consistent with those observed in ASTRAEUS on blood neutrophil elastase activity and changes in the biomarkers desmosine and Aα-val360. The data from ATALANTa also show the significant effect of alvelestat on the SGRQ-activity domain in patients not on augmentation (p=0.0106 versus placebo).

There was no difference in the proportion of patients with treatment-related Adverse Events (AEs) between the alvelestat and placebo arms. There were no Serious Adverse Events (SAEs) and no Adverse Events of Special interest (AESIs) of liver, QTC prolongation or neutropenia observed. AESIs of infection were more frequent in the placebo arm, driven by an increased number of acute exacerbations of COPD (one in the alvelestat arm in a patient on augmentation, and seven exacerbations in the placebo arm in seven patients, five of whom were on augmentation). There were two discontinuations in the alvelestat group due to mild and moderate headache. The data demonstrate that the 120 mg dose of alvelestat is safe on top of augmentation and support Mereo’s selection of the 240 mg dose to be studied in the planned Phase 3 pivotal trial. Additional data are expected to be presented by UAB at future medical conferences.

The ATALANTa study was funded by the National Center for Advancing Translational Sciences (NCATS) through the National Institutes of Health (NIH)-Industry Program for discovering new therapeutic uses for existing molecules.

In Europe, the Company has received guidance from the European Medicines Agency (EMA) that a Phase 3 primary endpoint of lung density by computed tomography (CT) scan with a relaxed p value (p<0.1) may, if the study is successful, be sufficient for full approval. In the US, the Company is continuing its interactions with the FDA and the Division of Clinical Outcomes Assessment (DCOA) regarding the use of a Patient Reported Outcome (PRO) as a primary Phase 3 endpoint.

The data from the ATALANTa study are expected to further support the ongoing partnering process for the alvelestat Phase 3 program.

Etigilimab (MPH-313)

On October 21, 2023, an update on the Company’s Phase 1b/2 study investigating the safety and efficacy of etigilimab (anti-TIGIT) in combination with nivolumab (anti-PD1) in recurrent/advanced solid tumors (ACTIVATE) was presented in a mini-oral session at the ESMO (Free ESMO Whitepaper) 2023 Congress in Madrid, Spain by Dr. Meredith McKean, Sarah Cannon Research Institute, USA. Of 40 evaluable patients presented in select cohorts, three complete responses (CRs), seven partial responses (PRs) and eleven stable disease (SDs) beyond 112 days (3.7 months) were noted. Seven patients showed clinical benefit for ≥ 335 days (11 months). The data show promising efficacy in PDL1 low patients with six of seven on study ≥ 335 days (11 months) being PDL1 negative or low and all having high PVR tumoral expression. Etigilimab in combination with nivolumab continues to be safe and well tolerated with no new safety signals noted. The last patient last dose was completed at the end of June 2023. The cervical cancer and uveal melanoma cohorts cleared the protocol Simon 2 Stage design interim futility monitoring bar for expansion to Stage 2 and were endorsed by an independent data monitoring committee for expansion.

Etigilimab, in combination with nivolumab, is in an ongoing investigator-led single-arm, two-stage, open-label Phase 1b/2 trial in a subtype of platinum-resistant recurrent ovarian cancer (clear cell ovarian cancer) at The University of Texas MD Anderson Cancer Center, financed by the Cancer Focus Fund. This trial is being led by Dr. Shannon Westin. Enrollment is currently being expanded from the initial 10 patients to 20 patients.

The Company continues to seek a partner for further development of etigilimab.

Third Quarter 2023 Financial Information

As of September 30, 2023, the Company had cash and short-term deposits of £51.2 million ($62.4 million). Cash and short-term deposits, net of expenditures, increased by £9.1 million ($11.1 million) during the third quarter of 2023.

In July 2023, the Company received a $9.0 million (£7.1 million) milestone payment from its partner, Ultragenyx, and gross proceeds of $12.0 million (£9.3 million) from the issuance of 9,673,419 ADSs representing 48,367,095 ordinary shares through an "at-the-market" offering pursuant to its Open Market Sale Agreement with Jefferies LLC. The Company expects its existing cash and short-term deposits, excluding income from existing or potential partnerships, will enable it to fund its currently committed clinical trials, operating expenses and capital expenditure requirements into 2026.

On October 23, 2023 Kiromic BioPharma, Inc. (OTC PINK: KRBP) ("Kiromic" or the "Company"), a clinical-stage, fully-integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell therapies with a focus on immuno-oncology, reported the execution of a clinical trial agreement with Beverly Hills Cancer Center (BHCC) to conduct its Deltacel-01 Phase 1 Study (Press release, Kiromic, OCT 23, 2023, View Source [SID1234636251]). Pursuant to the agreement, BHCC, one of Southern California’s esteemed private cancer centers, is anticipated to serve as the inaugural clinical site for the evaluation of Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with non-small cell lung cancer (NSCLC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The collaboration between Kiromic BioPharma and BHCC underscores the shared commitment between the two organizations to advance the fight against cancer through innovative therapeutic approaches. BHCC is a private, comprehensive facility which includes a radiation oncology center, an infusion center, a full-service diagnostic imaging center (featuring MRI, CT, PET/CT), and a diagnostic laboratory, and has a distinguished history of conducting clinical trials across multiple cancer types.

"As our clinical research program embarks on this groundbreaking clinical journey, we envision a future where patients have access to pioneering therapies and renewed hope in their battle against cancer. For years, BHCC has remained at the forefront of medical excellence, continually seeking innovative approaches to redefine the future of cancer treatment. We are very excited about this collaboration with Kiromic, a very forward-thinking and innovative company, and about this new therapeutic approach and the potential to contribute to science with the ultimate goal of improving the lives of cancer patients worldwide," said Afshin Eli Gabayan, MD, Medical Director and Principal Investigator at Beverly Hills Cancer Center and Assistant Clinical Professor at UCLA-David Geffen School of Medicine.

"The clinical trial agreement is a momentous first step in the development of this important treatment. BHCC is our first clinical site from a timeline perspective and has a history of high-quality clinical research and exceptional patient care, and it represents an ideal setting for a rigorous evaluation of our cell therapy candidate," stated Pietro Bersani, Kiromic Chief Executive Officer. "We are also actively engaging and making continued progress with other prestigious clinical trial sites to expand the reach and the impact of this study across a total of up to four sites. We intend to provide updates on the progress of the Deltacel-01 clinical study, including subsequent site activations, as the trial advances."

NSCLC is the most prevalent type of lung cancer, representing about 80% to 85% of lung cancer cases. Lung cancer is by far the leading cause of cancer death in the U.S., accounting for about 1 in 5 of all cancer deaths.