Kiromic Biopharma Inc - KRBP STOCK NEWS

Kiromic BioPharma (OTCQB: KRBP) reports positive results from its Deltacel-01 Phase 1 clinical trial for advanced non-small cell lung cancer (NSCLC). The first patient showed a 33.33% tumor volume reduction at 12-month follow-up, achieving partial response. The seventh patient demonstrated a 9.5% tumor reduction at two-month follow-up.

Both responding patients are being treated at Beverly Hills Cancer Center. The eighth patient has completed treatment with results expected in February 2025, while the ninth patient has started treatment at Virginia Oncology Associates. The company expects to enroll the 10th and 11th patients by end of January.

Deltacel™ (KB-GDT-01) is an allogeneic, off-the-shelf, Gamma Delta T-cell therapy for patients with stage 4 metastatic or locally-advanced NSCLC who failed standard therapies. This marks the second partial response in the trial, following similar results in the fourth patient.

Kiromic BioPharma (OTCQB: KRBP) reports positive results from its Deltacel-01 Phase 1 clinical trial, evaluating Deltacel™ (KB-GDT-01), an allogeneic GDT cell therapy for stage 4 metastatic NSCLC patients. The fourth patient showed a 32% decrease in tumor volume at eight months post-treatment with no adverse events. The first patient maintained stable disease with a 27% tumor reduction and reached 11 months progression-free survival. Patient #7 completed treatment with results expected in January 2025, while Patient #8 was recently enrolled at the Beverly Hills Cancer Center's Koreatown location.

Kiromic BioPharma (OTCQB: KRBP) has reached a settlement agreement with the SEC regarding an investigation into the non-disclosure of FDA clinical holds by former management. The investigation concerned IND applications for ALEXIS-PRO-1 (Procel™) and ALEXIS-ISO-1 (Isocel™) filed in May 2021. Due to the company's self-reporting, prompt remediation, and cooperation, the SEC decided not to impose civil penalties, and there are no ongoing obligations related to the settlement.

Kiromic BioPharma (OTCQB: KRBP) reports favorable ongoing clinical results from its Deltacel-01 Phase 1 trial, evaluating Deltacel™ (KB-GDT-01) in stage 4 metastatic non-small cell lung cancer (NSCLC) patients. Key highlights:

• Patient 4: Maintained stable disease with a 5.3% tumor size reduction at 6-month follow-up
• Patient 6: Demonstrated stable disease with no new lesions at 2-month follow-up
• Median progression-free survival (PFS) increased to 6 months
• Median follow-up duration for all patients is 7.7 months

These results support Deltacel's potential to delay disease progression in advanced lung cancer patients and validate the therapeutic potential of gamma-delta T cells in advanced cancer treatment.

Kiromic BioPharma (OTCQB: KRBP) reports favorable 10-month follow-up results for the first patient in its Deltacel-01 Phase 1 clinical trial. The trial evaluates Deltacel™ (KB-GDT-01), an allogeneic, off-the-shelf, Gamma Delta T-cell therapy, in stage 4 metastatic non-small cell lung cancer patients who failed standard therapies. Key findings include:

• 27% tumor size reduction compared to pre-treatment
• No new disease sites identified
• 10-month progression-free survival (PFS)
• No reported adverse events

These results follow earlier observations of 20% tumor reduction at eight months and 13% at six months post-treatment. The patient is being treated at Beverly Hills Cancer Center. Kiromic's CEO and the trial's Principal Investigator expressed optimism about Deltacel's potential as a safe and effective treatment for late-stage cancers.

Kiromic BioPharma (OTCQB: KRBP) has activated the University of Arizona Cancer Center (UACC) as the fifth clinical trial site for its ongoing Phase 1 Deltacel-01 trial. The trial is evaluating Deltacel™ (KB-GDT-01), Kiromic's allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

UACC is one of 57 NCI-Designated Comprehensive Cancer Centers in the U.S. Dr. Ricklie Ann Julian, Assistant Professor of Medicine at UACC, will serve as Principal Investigator at the site. The site initiation visit has been completed, and patient enrollment is expected to begin in the coming weeks.

Kiromic BioPharma (OTCQB: KRBP) has received unanimous approval from the Safety Monitoring Committee (SMC) to advance its Deltacel-01 clinical trial into the expansion phase. The trial is evaluating Deltacel™ (KB-GDT-01), an allogeneic, off-the-shelf, Gamma Delta T-cell therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed standard therapies.

The SMC's recommendation follows a favorable review of safety data from the first two cohorts, including the 40-day follow-up of the sixth patient, which showed a positive safety and tolerability profile with no dose-limiting toxicities. The expansion phase will enroll approximately nine patients, with screening expected to begin later this month. This phase aims to further assess Deltacel's effectiveness in treating solid tumors.

Kiromic BioPharma (OTCQB: KRBP) has received Fast Track designation from the FDA for Deltacel™ (KB-GDT-01), its allogeneic, off-the-shelf, Gamma Delta T-cell therapy. This designation is for Deltacel in combination with low-dose radiation therapy for treating metastatic non-small cell lung cancer (NSCLC) patients who have progressed on at least two lines of standard therapy.

The Fast Track status allows for more frequent FDA communication, potential priority review, and rolling submission of applications. Deltacel is currently in a Phase 1 study (Deltacel-01) for stage 4 NSCLC patients who failed standard therapies. Recent data from this trial has shown a favorable safety profile and preliminary clinical efficacy. Kiromic plans to activate a fifth clinical trial site on August 30th.

Kiromic BioPharma (OTCQB: KRBP) has reported interim results for Part 1 of its Deltacel-01 Phase 1 clinical trial, evaluating Deltacel™ (KB-GDT-01) in stage 4 metastatic non-small cell lung cancer (NSCLC) patients. Key findings include:

- Progression-Free Survival (PFS) ranging from 2 to 8 months, with an average of 4.8 months for five evaluated patients
- No dose limiting toxicities (DLTs) reported for patients completing full therapy
- One patient withdrawn due to unrelated adverse event
- Sixth and final patient in Part 1 started treatment on August 6th

The company is on track to initiate Part 2 of the Deltacel-01 trial in September, with early safety and tolerability outcomes expected in September and efficacy results in early October.