VBI Vaccines Announces Dosing of First Patients in Phase 2b Study of VBI-1901 in Recurrent GBM

On September 7, 2023 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported the first patients have been dosed in the randomized, controlled Phase 2b study of VBI’s cancer vaccine immunotherapeutic candidate, VBI-1901, in patients with first recurrent glioblastoma (rGBM) (Press release, VBI Vaccines, SEP 7, 2023, View Source [SID1234634996]). The study will assess the safety, tolerability, tumor response rates, and survival following treatment with VBI-1901, as a monotherapy, at 10 leading neuro-oncology centers across the United States.

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Andrew B. Lassman, M.D., Chief of Neuro-Oncology at Columbia University Vagelos College of Physicians and Surgeons, Associate Director for Clinical Trials at the NCI-designated Herbert Irving Comprehensive Cancer Center, and principal investigator of the study, commented, "Based on the pre-clinical and clinical data seen in earlier stages of this study, I look forward to demonstrating the potential value of VBI-1901, relative to current standard of care, in my patients in this next phase of clinical development, with the hope to provide meaningful benefit against a brain tumor that is notoriously aggressive with a high mortality rate."

Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer, commented, "Median overall survival in the recurrent GBM setting is just eight months, making any advancement in patient care critical. As we work to offer new hope to the patients, family members, and caretakers who are battling this devastating and historically treatment-resistant brain tumor, we are excited to kick-off this next phase of development for VBI-1901."

In the Phase 1/2a study of VBI-1901 in the rGBM setting, extensive biomarker panels suggested normal baseline CD4+/CD8+ T-cell ratios, which is a measure of immunological fitness, along with boosting of cytomegalovirus (CMV) gB specific antibody responses were correlated with tumor and clinical responses. These learnings have been incorporated into patient enrollment eligibility criteria for the Phase 2b study to help identify patient populations that may be more likely to respond to treatment with VBI-1901.

Phase 1/2a Study Data Highlights – VBI-1901 10µg + GM-CSF Study Arms

(n=16)

44% disease control rate achieved (n=7/16) – disease control rate is defined as stable disease (SD) + partial tumor response (PR) + complete tumor response (CR)
2 partial responses (PR) were observed – 1 patient was on treatment for more than 28 months (2.33 years), surviving at least 40 months (3.33 years) as of August 1, 2023, with a maximum tumor reduction of 93% relative to baseline
5 additional patients demonstrated stable disease (SD) for a sustained period of time
All patients with a tumor response (PR or SD) (n=7/16) reached a minimum survival of 12 months
Median overall survival (mOS) was 12.9 months, comparing favorably to 8-month mOS for monotherapy standard-of-care2
Phase 2b Study Design

Multi-center, randomized, controlled, open-label study in up to 60 patients with first recurrent GBM

Patients will be randomized in a 1:1 ratio across two study arms:
Intradermal VBI-1901 + GM-CSF: 10 µg dose every 4 weeks until clinical disease progression
Monotherapy standard-of-care: either intravenous carmustine or oral lomustine, every 6 weeks until disease progression or intolerable toxicity
Endpoints include:
Safety and tolerability
Overall survival (OS) – median and overall
Tumor response rate (TRR)
Progression-free survival (PFS)
Immunologic responses
Reduction in corticosteroid use relative to baseline
Change in quality of life compared to baseline
The U.S. Food and Drug Administration (FDA) has considered demonstration of a statistically significant improvement in overall survival relative to a randomized control arm to be clinically significant and has recognized this as criteria to support the approval of new oncology drugs.1

For more information about the Phase 2b study, visit clinicaltrials.gov and reference trial identifier: NCT03382977.

About GBM and VBI-1901

Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 14,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. The FDA has granted VBI-1901 Fast Track Designation and Orphan Drug Designation for the treatment of recurrent glioblastoma. These designations are intended to provide certain benefits to drug developers, including more frequent meetings with the FDA, and Accelerated Approval and Priority Review, if relevant criteria are met, among other benefits.

TG Therapeutics to Participate in the H.C. Wainwright 25th Annual Global Investment Conference

On September 7, 2023 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in the H.C. Wainwright 25th Annual Global Investment Conference, being held at the Lotte New York Palace Hotel, in New York City on September 11 – 13, 2023 (Press release, TG Therapeutics, SEP 7, 2023, View Source [SID1234634995]). The fireside chat is scheduled to take place on Monday, September 11, 2023, at 10:30 AM ET.

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A live webcast of the fireside chat will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

PharmaMar to participate at the 21st Morgan Stanley Annual Global Healthcare Conference

On September 7, 2023 PharmaMar (MSE:PHM), world leader in the research, development and commercialization of marine-derived anticancer drugs, reported that the Company will participate in person at the 21st Morgan Stanley Annual Global Healthcare Conference, taking place in New York from September 11-14, 2023 (Press release, PharmaMar, SEP 7, 2023, View Source [SID1234634993]).

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During the Conference, the management team will have the opportunity to present the Company to US and international analysts and institutional investors.

Palatin to Present at the H.C. Wainwright 25th Annual Global Investment Conference

On September 7, 2023 Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, reported that management will present at H.C. Wainwright 25th Annual Global Investment Conference taking place September 11-13, 2023 in New York, NY (Press release, Palatin Technologies, SEP 7, 2023, https://palatin.com/palatin-to-present-at-the-h-c-wainwright-25th-annual-global-investment-conference/ [SID1234634992]).

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The Company presentation will be held on Wednesday, September 13, 2023 at 10:00 a.m. ET. A live webcast of the presentation will be available on the Investors section of Palatin’s website at View Source A replay of the webcast will be available for 30 days following the presentation.

Iovance Biotherapeutics to Present at 2023 Wells Fargo Healthcare Conference

On September 7, 2023 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that senior leadership plans to present at the 2023 Wells Fargo Healthcare Conference (Press release, Iovance Biotherapeutics, SEP 7, 2023, View Source [SID1234634991]):

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2023 Wells Fargo Healthcare Conference
Fireside Chat: September 7, 2023 at 12:45 p.m. ET
Boston, MA
The live and archived webcast, and along with the most recent Iovance corporate presentation, will be available at View Source