On October 2, 2023 Avenge Bio, Inc. ("Avenge" or the "Company"), a biotechnology company developing the LOCOcyte Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for AVB-001 for treatment of patients with relapsed resistant/refractory ovarian cancer (Press release, Avenge Bio, OCT 2, 2023, View Source [SID1234635577]).

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"We are extremely pleased to receive the FDA Fast Track designation for AVB-001 based on FDA’s review of our preclinical and emerging clinical data. The Fast Track designation has been provided for platinum-resistant, refractory ovarian cancer, and acknowledges the potential for AVB-001 to treat this significant unmet medical need," said Michael Heffernan, CEO at Avenge Bio.

FDA Fast Track program is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need. The Fast Track designation is available not only where treatments do not exist, but also for drugs that demonstrate a potential advantage over available therapies. Once granted Fast Track designation, the FDA increases the frequency of meetings to discuss the development, trial design, clinical data, and submission of the Biologics License Application (BLA).

In January 2023, Avenge announced the initiation of an open-label, First-in-Human, Phase 1/2, multicenter study (NCT05538624) designed to evaluate the safety and efficacy of AVB-001. AVB-001 is an encapsulated cell product engineered to produce native human interleukin-2 (hIL-2) and is delivered intraperitoneally (IP) to patients.

In addition to advancing the lead clinical trial in ovarian cancer, Avenge is also developing AVB-001 for additional conditions of high unmet needs in other peritoneal malignancies and pleural cancers.

About LOCOcyte Platform
Our LOCOcyte allogeneic cell-based immunotherapy platform enables potent localized modulation of the immune system which also precipitates a systemic immune response, allowing us to treat previously intractable cancers. The technology leverages three unique advantages:

Potent immune effector molecules are generated by synthetically engineering allogeneic cells creating a ready-to-use therapy,
Therapy is localized in proximity to the primary tumor site and generates innate and adaptive immune response, and
The immunomodulator trains the patient’s immune system generating a robust immune response that seeks and eradicates distal metastasis without systemic toxicity.

On October 2, 2023 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported that it will present clinical data from its ongoing Phase I/II study investigating the safety and efficacy of autologous TAC-T cells targeting HER2 in relapsed or refractory solid tumors (TACTIC-2 /NCT04727151) at two upcoming scientific conferences: the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held October 20-24, 2023, in Madrid, Spain, and the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), being held October 11-15, 2023, in Boston (Press release, Triumvira Immunologics, OCT 2, 2023, View Source [SID1234635576]). TAC01-HER2 is a novel cell therapy based on genetically engineered autologous T cells expressing a T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2).

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Details of the presentation are as follows:

ESMO 2023 Congress

Title: A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC01-HER2 in Relapsed or Refractory Solid Tumors
Presenter: Daniel Olson, MD, Assistant Professor of Medicine, The University of Chicago Medicine
Poster Number: 1528P
Date: Monday, October 10
Location: IFEMA, Avda. Del Partenón 5, 28042, Madrid, Spain

AACR-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper)

Title: A phase I/II trial investigating safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumors
Presenter: Benjamin Schlechter MD, Senior Physician, Dana-Farber Cancer Institute, Instructor, Medicine, Harvard Medical School
Poster Number: B035
Session: Poster Session B
Date: Friday, October 13, from 12:30 p.m. to 4 p.m. EST
Location: Hynes Convention Center, Boston, MA.

On October 2, 2023 Precision Biologics, Inc. ("Precision"), a clinical-stage immunotherapy and targeted oncology company, reported that on September 26, 2023, the USPTO granted a patent for its lead clinical asset, NEO-201, which is currently being tested in Phase 2 human Clinical Trials in the US (Press release, Precision Biologics, OCT 2, 2023, View Source [SID1234635575]).

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NEO-201 is a humanized IgG1 monoclonal antibody with multiple mechanisms of action. It has been shown previously to kill cancer cells expressing its target (truncated glycans) which is expressed in numerous cancers; however, it does not bind to most normal tissues. In addition, NEO-201 binds to immune suppressor cells, including regulatory T cells (Tregs) and granulocytic myeloid-derived suppressor cells (gMDSCs), which are thought to diminish the efficacy of cancer immunotherapy.

In the Phase I clinical trial, NEO-201 was found to reduce immune suppressive cells that may be responsible in diminishing cancer-killing activity for checkpoint inhibitors. Based on the safety and activity of NEO-201 in its Phase I completed study, a Phase II study is currently enrolling patients with metastatic Non-Small Cell Lung Cancer (NSCLC), Head and Neck Cancer, Endometrial Cancer and Cervical Cancer, whose disease has previously progressed through prior checkpoint inhibitor therapy (including prior Keytruda.) (View Source) This ongoing Phase 2 trial is testing to see if combining NEO-201 with Keytruda can reactivate the effectiveness of checkpoint inhibitors when they no longer work.

Data from the ongoing Phase 2 trial was recently presented at CRI-ENCI-AACR 7th International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) Sept 22, 2023, Milan, Italy. This data demonstrated that NEO-201 reduces the quantity of regulatory T cells in PBMCs of cancer patients and this reduction is associated with stabilization of disease. (click here).

Additional data regarding the effects of NEO-201 on reducing gMDSCs will be presented at the upcoming SITC (Free SITC Whitepaper) Annual Meeting in San Diego in early November.

On October 2, 2023 GT Medical Technologies, Inc., a medical device company dedicated to improving the lives of patients with brain tumors, reported interim findings of a multi-institutional study that demonstrates high local control for the treatment of recurrent brain metastases in patients, adding to the growing evidence of the efficacy and safety of its FDA-approved GammaTile Therapy at the American Society for Radiation Oncology’s (ASTRO) 65th Annual Meeting (Press release, GT Medical Technologies, OCT 2, 2023, View Source [SID1234635574]).

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The meeting is taking place October 1 to 4, 2023, at the San Diego Convention Center.

At this interim timepoint, 48 patients with 51 brain metastases at 14 U.S. sites were treated with GammaTile, a treatment that provides immediate radiation where it is needed most after brain tumor removal surgery. None of the patients experienced adverse effects from the radiation treatment in follow-ups, which had a median time of four months post-surgery.

"We could not have achieved these interim clinical results without the support of the doctors and patients who were part of this registry study from across the nation," said study author David Brachman, MD, Co-founder and the Chief Technology Officer of GT Medical Technologies. "This robust emerging scientific data reinforces the impact GammaTile Therapy has on local control for patients with brain metastases. It builds upon an already strong body of evidence that shows just how effective and safe GammaTile is for patients with brain tumors."

Dr. Brachman, MD presented the clinical findings of GammaTile during a poster viewing Q&A session on Monday, October 2, 2023. The poster, titled: "Surgically Targeted Radiation Therapy (STaRT) for Brain Metastases: Initial Experience from a Prospective Multi-institutional Registry" will be available on the ASTRO Annual Meeting Portal.

"As an enrolling institution in the GTM-101 registry, we are excited by these initial interim results demonstrating the feasibility of GammaTile brachytherapy for patients with brain metastases – with a median implantation time of 3 minutes – and no patients experiencing any radiation-attributed adverse effects," said Rupesh Kotecha, MD, lead study author and Chief of Radiosurgery for the Department of Radiation Oncology at Miami Cancer Institute, Baptist Health South Florida, Miami, FL.

GammaTile is a Surgically Targeted Radiation Therapy (STaRT) for patients with newly diagnosed malignant intracranial neoplasms and patients with recurrent intracranial neoplasms, including primary (benign or malignant) and metastatic tumors.

In addition to the poster presented at the ASTRO Annual Meeting, three recently published clinical studies from Memorial Sloan Cancer Center, Barrow Neurological Institute and Miami Cancer Institute further demonstrated that GammaTile leads to durable local control for the treatment of recurrent brain metastases.

Among these three publications, Miami Cancer Institute’s findings were recently published in Brachytherapy on September 16, 2023. The results showed that GammaTile for operable recurrent brain metastases was associated with superior local control compared to the first course of external beam radiotherapy in the series. Study authors found the initial clinical experience demonstrated that GammaTile is associated with a high local control rate, modest surgical complication rate, and low radiation necrosis risk in the reirradiation setting.

Members of GT Medical Technologies team will be available to discuss the study’s implications for patients along with the recent published studies on GammaTile at Booth 2723.

Since its initial FDA clearance in 2018 for recurrent brain tumors and subsequent FDA clearance in 2020 for newly diagnosed brain tumors, GammaTile Therapy has helped more than 1,000 people with operable brain tumors.

The incidence of brain metastasis is increasing with an estimated 98,000 to 170,000 cases each year. And is likely increasing as a result of patients with systemic metastatic disease are surviving longer as a result of new innovations like immunotherapy.

On October 2, 2023 Vascular Biogenics Ltd. ("VBL") reported the following the execution of the term sheet with Wellbeing Group Ltd. ("Wellbeing") on June 30, 2023 (as amended on July 25, 2023) (the "Term Sheet"), the parties negotiated a definitive asset purchase agreement (the "Asset Purchase Agreement") for the sale of VB-601 and MOSPD2 related assets (the "VB-601 Asset") (Filing, 8-K, VBL Therapeutics, OCT 2, 2023, View Source [SID1234635570]). VBL entered into the Asset Purchase Agreement on October 1, 2023. The proxy statement/prospectus/information statement of VBL dated September 5, 2023 (the "Original Prospectus") is therefore supplemented such that VBL Proposal No. 10: Advisory Approval of the VB-601 Asset Sale hereby would approve the sale of the VB-601 Asset on the basis of the Asset Purchase Agreement, the material terms of which are summarized below, in lieu of the Term Sheet.

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The following summary of the Asset Purchase Agreement is not intended to be a complete discussion of the Asset Purchase Agreement and is qualified in its entirety by reference to the full text of the Asset Purchase Agreement, attached hereto as Exhibit 10.1.

Under the Asset Purchase Agreement, Immunewalk Therapeutics Inc. ("Immunewalk") an assignee of Wellbeing, agreed to pay an upfront cash payment of $250,000 to VBL at the closing and additional payments of up to $4.75 million upon the achievement of clinical and commercial milestones by Immunewalk, its Affiliates or Licensees (as such terms are defined in the Asset Purchase Agreement). Immunewalk also agreed to pay a low to mid-single digit percentage tiered royalty on aggregate annual Net Sales by Immunewalk or any of its Affiliates above $50 million, for the sale of Covered Products (as defined in the Asset Purchase Agreement). The Asset Purchase Agreement also clarified that in cases where Immunewalk licenses any of the VB-601 Assets, VBL is entitled to receive a low-teen digit percentage of the License Fees actually received by Immunewalk from a Licensee with respect to Net Sales of such Licensee and adjusted the definition of Net Sales in the Asset Purchase Agreement. In addition, the parties further agreed that in the event of an asset sale by Immunewalk, the royalty rates shall be adjusted as set forth in the Asset Purchase Agreement.

Capitalized terms used and not otherwise defined herein shall bear the respective meanings ascribed to them in the Asset Purchase Agreement.

Shareholders of VBL who have already cast their vote with respect to VBL Proposal No. 10: Advisory Approval of the VB-601 Asset Sale, and who following the filing of this supplement, wish to change their original vote, are hereby requested to follow the instructions set forth under the Original Prospectus.

Additional Information about the Proposed Merger and Where to Find It

This communication may be deemed to be solicitation material in respect of the proposed merger transaction between VBL and Notable Labs, Inc. ("Notable"). In connection with the proposed merger transaction, VBL has filed relevant materials with the Securities and Exchange Commission ("SEC"), including a registration statement on Form S-4 that contains a proxy statement (the "Proxy Statement") and prospectus. This communication is not a substitute for the Form S-4, the Proxy Statement or for any other document that VBL may file with the SEC and or send to VBL’s shareholders in connection with the proposed merger transaction. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS OF VBL ARE URGED TO READ THE FORM S-4, THE PROXY STATEMENT AND OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT VBL, THE PROPOSED MERGER TRANSACTION AND RELATED MATTERS. Investors and security holders can obtain free copies of the Form S-4, the Proxy Statement and other documents filed by VBL with the SEC through the website maintained by the SEC at View Source Copies of the documents filed by VBL with the SEC are also available free of charge on VBL’s website at www.vblrx.com, or by contacting VBL’s Investor Relations at [email protected]. VBL, Notable and their respective directors and certain of their executive officers may be considered participants in the solicitation of proxies from VBL’s shareholders with respect to the proposed merger transaction under the rules of the SEC. Information about the directors and executive officers of VBL is set forth in its Annual Report on Form 10-K for the year ended December 31, 2022 as filed with the SEC on March 14, 2023, and in subsequent documents filed with the SEC. Additional information regarding the persons who may be deemed participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, are or will be included in the Form S-4, the Proxy Statement and other relevant materials to be filed with the SEC when they become available. You may obtain free copies of this document as described above.

No Offer or Solicitation

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor a solicitation of any vote or approval with respect to the proposed transaction or otherwise. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.