On March 15, 2022 The Jerome Canady Research Institute for Advanced Biological and Technological Sciences (JCRI-ABTS), reported that their recent article, "BCL2A1 REGULATES CANADY HELIOS COLD PLASMA-INDUCED CELL DEATH IN TRIPLE-NEGATIVE BREAST CANCER (TNBC)", has been published in Scientific Reports, a Nature Portfolio journal (Press release, JCRI-ABTS, MAR 15, 2022, View Source [SID1234610131]). This novel discovery marks a significant advancement in cold plasma technology for cancer treatment.

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JCRI-ABTS’s scientists demonstrated that a combination of Canady Helios Cold Plasma (CHCP) and anti-BCL2A1 treatment may be beneficial and a novel therapeutic option for triple-negative breast cancer and other solid tumor cancers.

BCL2A1 expression plays an important role in cell survival after CHCP treatment in breast cancer cells and is potentially regulated by TNF-alpha. Silencing BCL2A1 by siRNA treatment or by downregulating its expression by CPI203 treatment in combination with CHCP significantly increases the potency of the CHCP treatment.

Breast cancer is the leading cause of cancer death among women. Triple-negative breast cancer (TNBC) has a very poor prognosis and frequent relapses occur early compared with other cancer subtypes. CHCP is proving to be a promising therapy for a variety of prognostically poor breast cancer types and BCL2A1 could be a potential companion diagnostic biomarker.

According to Jerome Canady, MD, Chief Science Officer, "We investigated the expression profile of 48 apoptotic and 35 oxidative gene markers after CHCP Treatment during this study, and we are pleased to report Canady Helios Cold Plasma induced cell death in the TNBC cell lines".

Dr. Taisen Zhuang, CTO of USMI revealed, "These outstanding results, discovered by our scientists, provide the solid theoretical foundation and will boost the commercialization process of Cold Plasma Oncotherapeutics. Patients with TNBC will benefit from our cold plasma technology in the near future".

JCRI-ABTS and sister company USMI have recently successfully completed a Phase 1 Clinical Trial using Canady Helios Cold Plasma (CHCP) for the treatment of recurrent and stage 4 solid tumors (FDA IDE #G190195).

On March 15, 2022 Emmanuelle BETTENDORF reported that it will participate in BioEurope Spring from March 28 to 31, 2022 and will be available to meet with you on partnership opportunities (Press release, Vect-Horus, MAR 15, 2022, View Source [SID1234610700]).

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On March 15, 2022 Immedica Pharma reported that Heidi Ramstad has been offered and accepted the position as Chief Medical Officer (CMO) at Immedica Pharma (Press release, Immedica Pharma, MAR 15, 2022, View Source [SID1234610072]).

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Heidi is a Medical Doctor (MD) and Specialist in Pediatric Medicine. She has many years of academic and pharmaceutica industry experience. As an example, she has Medical Affairs experience from both big and small pharma, eg. being country and Nordic medical director for companies such as Pfizer, GSK and Roche. Recently she has held the position as CMO at the Swedish Biopharma company Oasmia.

We are very glad to bring Heidi onboard, and she will be an important contributor for the many activities and projects currently underway at Immedica.

Heidi will start her new role at Immedica at in April 2022 and she will report to Immedica CEO Anders Edvell. She will also be a member of the Immedica Executive Leadership Team.

On March 15, 2022 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, reported financial results for the three months and year ended December 31, 2021 and provided a business update (Press release, Aprea, MAR 15, 2022, View Source [SID1234610096]).

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Fourth Quarter Financial Results

Cash and cash equivalents: As of December 31, 2021, the Company had $53.1 million of cash and cash equivalents compared to $89.0 million of cash and cash equivalents as of December 31, 2020. The Company expects cash burn for the full year 2022 to be between $25.0 million and $30.0 million. The Company believes its cash and cash equivalents as of December 31, 2021 will be sufficient to meet its current projected operating requirements into 2023.

Research and Development (R&D) expenses: R&D expenses were $4.5 million for the quarter ended December 31, 2021, compared to $9.3 million for the comparable period in 2020. The decrease in R&D expenses was primarily due to decreases in clinical trial costs for the Company’s pivotal Phase 3 clinical trial of eprenetapopt with azacitidine for the frontline treatment of TP53 mutant MDS and the Company’s Phase 2 post-transplant MDS/AML clinical trial. These decreases were partially offset by increases in clinical trial costs for other ongoing clinical trials.

General and Administrative (G&A) expenses: G&A expenses were $3.4 million for the quarter ended December 31, 2021, compared to $4.9 million for the comparable period in 2020. The decrease in G&A expenses was primarily due to a decrease in pre-commercialization development activities which was partially offset by increased non-cash stock-based compensation.

Net loss: Net loss was $7.8 million, or $0.36 per share for the quarter ended December 31, 2021, compared to a net loss of $13.1 million, or $0.73 per share for the quarter ended December 31, 2020. The Company had 21,859,413 shares of common stock outstanding as of December 31, 2021.
Business Operations Update:

Myeloid Malignancy Program

The Company’s myeloid malignancy program includes fully enrolled and completed clinical trials in MDS, AML and post-transplant maintenance therapy in MDS/AML. In August 2021, the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on the clinical trials of eprenetapopt in combination with azacitidine in the Company’s Phase 3 frontline MDS clinical trial, the Company’s Phase 2 MDS/AML Post-Transplant clinical trial and the Company’s Phase 1/2 AML clinical trial. In December 2021 the Company discussed with FDA the requested data and analyses from the Phase 3 frontline MDS clinical trial and reached agreement on the Company’s proposals for new clinical trials in myeloid malignancies. In the first quarter of 2022 the Company received clearance from FDA to proceed under its existing myeloid malignancy IND with a new clinical trial in relapsed/refractory MDS and AML.

Lymphoid Malignancy Program

The Company’s lymphoid malignancy program includes a clinical trial evaluating eprenetapopt in patients with non-Hodgkin lymphomas (NHL). In August 2021, FDA placed a clinical hold on this trial. In October 2021, the Company discussed with FDA the requested data and analyses from the Phase 3 frontline MDS clinical trial and proposed amendments for clinical trials to proceed in its lymphoid malignancy program. Following interaction with the FDA, the clinical hold was lifted in December 2021.

The Company is in the planning phase for new clinical trials in both myeloid and lymphoid malignancies and is continuing to evaluate other development opportunities. The Company plans to provide updates on progress on all programs throughout 2022.

APR-548 Phase I Trial

The Company’s second product candidate, APR-548, is a next generation p53 reactivator that is being developed in an oral dosage form. The Company initiated a Phase 1 clinical trial testing APR-548 in relapsed/refractory MDS and AML. Enrollment in the first dosing cohort was completed and pharmacokinetic and adverse event data will be collected and analyzed. The Company does not plan to enroll additional patients into the trial.

Solid Tumor Program

The Company’s solid tumor program includes its clinical trial evaluating eprenetapopt with anti-PD-1 therapy in advanced solid tumors. The Company completed enrollment in its Phase 1/2 clinical trial in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing eprenetapopt with anti-PD-1 therapy. The Company is in the planning phase for a future clinical trial to further evaluate orally-administered eprenetapopt with immunotherapy checkpoint inhibitors.

On March 15, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that Jeff Baxter, VBI’s President and CEO, will participate in an analyst-led fireside chat at the 32nd Annual Oppenheimer Healthcare Conference on Wednesday, March 16, 2022 (Press release, VBI Vaccines, MAR 15, 2022, View Source [SID1234610116]).

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Presentation Details

Event: 32nd Annual Oppenheimer Healthcare Conference
Date: Wednesday, March 16, 2022
Time: 10:00-10:30 AM ET
Webcast Link: View Source
A live webcast of the presentation will also be available on the Investors page of VBI’s website at: View Source A replay of the webcast will be archived on the Company’s website following the presentation.