On June 22, 2022 Alpha Tau Medical Ltd. ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that the first patient was treated in a feasibility study evaluating the Alpha DaRT as a neoadjuvant therapy in patients with prostate cancer at the Rambam Health Care Center in Haifa, Israel (Press release, Alpha Tau Medical, JUN 22, 2022, View Source [SID1234616165]).

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The primary objectives of this study are to assess the feasibility and safety of intratumoral Alpha DaRT source implantation for the treatment of local prostate cancer prior to surgery. Secondary objectives include assessing radiological and pathological objective response rate of the tumor, and changes in quality of life measures. The study involves two separate procedures, with surgical resection of the prostate 50 days following Alpha DaRT source insertion, and can recruit up to 10 patients. The surgical resection will be performed at the Carmel Medical Center in Haifa, Israel using a da Vinci surgical robot, and will be led by Dr. Yuval Freifeld and his senior team.

"This is a historic day for Alpha Tau," said Alpha Tau CEO Uzi Sofer. "After gaining a wealth of experience in treating superficial cancers such as those of the skin, head & neck, and breast, we are thrilled to have treated the first prostate patient, our first internal organ treatment. Our pre-clinical data show that the Alpha DaRT technology may have potential to address a very broad range of solid tumor types, and our strategy is to expand our clinical studies across multiple tumor types in order to evaluate the full potential of the Alpha DaRT. This study suggests our ability to deliver this promising treatment beyond superficial tumors and is an important milestone in executing on this strategy."

Alpha Tau CMO Dr. Robert Den remarked, "Since the prostate is surgically removed 50 days after the Alpha DaRT insertion, the neoadjuvant design of this trial will allow us to analyze the pathological response of tissues to the Alpha DaRT. This will hopefully provide very valuable information to our researchers and allow us to compare theoretical versus actual cell damage."

Dr. Tomer Charas, head of the GU Radiotherapy Unit in the Oncology Division at Rambam Health Care Center in Haifa, Israel, and principal investigator of the study, commented, "We are excited to be leading this trial in collaboration with the Carmel Urology team, and to be the first to evaluate Alpha DaRT in prostate cancer in patients. Based on the results from preclinical studies, it is possible that neoadjuvant treatment with the Alpha DaRT may also trigger an immune response, which could help decrease the risk of tumor recurrence. In addition, a preferable safety profile has been observed to date in treatments of other tumor types."

On June 22, 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 the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for VBI-1901, a bivalent gB/pp65 immunotherapeutic vaccine candidate for the treatment of glioblastoma (GBM) (Press release, VBI Vaccines, JUN 22, 2022, View Source [SID1234616181]). In June 2021, the FDA also granted Fast Track Designation for VBI-1901 for the treatment of recurrent GBM in patients with first tumor recurrence.

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"This orphan drug designation is another significant milestone for our VBI-1901 program, and it underscores the urgency of our effort to develop meaningful new treatment options for patients with this devastating cancer," said Jeff Baxter, President and CEO of VBI. "As recently presented at ASCO (Free ASCO Whitepaper), we continue to see strong tumor response data and improvements in overall survival data compared to historical controls in the Phase 2a study of VBI-1901. With this orphan drug status, we look forward to working closely with the FDA and clinical investigators to build on that data, advancing the potential of this program to be a valuable part of the fight against GBM."

Though classified as a rare disease, GBM is the most common primary brain cancer with approximately 14,000 new cases diagnosed in the United States each year, and a low median overall survival of 15-18 months after diagnosis of primary GBM.1 Glioblastomas are stage IV brain tumors – they are an exceptionally aggressive form of brain cancer, with high recurrence rates and a five-year survival rate around 10%.2 Standard of care in the frontline setting includes surgical resection, chemotherapy, and radiation therapy. There is no effective standard of care in the recurrent setting – median overall survival in this patient population is approximately eight months.3

About FDA Orphan Drug Designation

The FDA’s Office of Orphan Products Development grants orphan drug designation to investigational drugs and biologics intended to prevent, diagnose, or treat rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for qualified clinical trials, exemptions from certain FDA fees, and the potential for seven years of post-approval marketing exclusivity.

About FDA Fast Track Designation

The Fast Track program facilitates the expedited development and review of new drugs or biologics that are intended to: 1) treat serious or life-threatening conditions, and 2) demonstrate the potential to address unmet medical needs. A therapeutic that receives Fast Track Designation is eligible for some or all of the following: 1) more frequent meetings with FDA to discuss the development plan and data needed to support approval, 2) more frequent written communication from FDA relating to the design of the proposed clinical trials and use of biomarkers, 3) Accelerated Approval and Priority Review, if relevant criteria are met, and 4) Rolling Review, which means the company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, instead of waiting until all sections of the application are completed.

Fast Track Designation was granted to VBI-1901, adjuvanted with granulocyte macrophage colony-stimulating factor (GM-CSF), for the treatment of first-recurrent GBM in June 2021.

About VBI-1901 and GBM

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. 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.

To learn more about VBI’s ongoing Phase 1/2a study and the INSIGhT trial, visit clinicaltrials.gov (Respective Identifiers: NCT03382977 and NCT02977780).

On June 22, 2022 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported the signing of a definitive agreement for the sale of revenues from U.S. and European royalty and milestone interests in Klisyri (tirbanibulin) to Sagard Healthcare Partners and funds managed by Oaktree Capital Management, L.P. ("Oaktree") for $85 million (Press release, Athenex, JUN 22, 2022, View Source [SID1234616166]). Approximately $80 million of the proceeds from the transaction will be used toward partially paying down existing debt and operating the business, with $5 million to be placed into escrow and paid to Athenex upon the satisfaction of certain conditions. The transaction is subject to customary closing conditions.

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"We are executing on our new strategy and will continue to deliver on the objectives that we laid out to extend our cash runway by over 18 months. We are pleased to enter into this agreement, as we believe it generates meaningful benefits for our stockholders as we continue to pay down debt and extend our cash runway," said Dr. Johnson Lau, Chief Executive Officer of Athenex. "The sale of the revenues from the U.S. and European royalty and milestone interests in Klisyri represents another step in continuing to monetize non-core assets to focus on developing our potential best-in-class NKT cell platform."

Ladenburg Thalmann & Co. Inc. and Royalty/Revenue Interest Capital Advisors LLC served as financial advisors to Athenex and Cooley LLP served as legal counsel to Athenex. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as legal counsel to Sagard Holdings and Oaktree.

On June 22, 2022 ProMIS Neurosciences Inc. (TSX: PMN) (OTCQB: ARFXF) ("ProMIS" or the "Company"), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as toxic oligomers, implicated in the development of neurodegenerative diseases, reported that it has amended its articles to authorize the issuance of 70,000,000 Series 1 Preferred Shares ("Series 1 Shares") which it intends to use in settlement of its outstanding debentures (Press release, ProMIS Neurosciences, JUN 22, 2022, View Source [SID1234616182]).

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Holders of Series 1 Shares will be entitled to participate, on an as-converted basis, in dividend payments only if the Company declares, pays or sets aside any dividends on shares of any other class or series of capital stock. The Series 1 Shares are not subject to mandatory redemption or other redemption provisions and do not confer any voting rights or privileges to the holders. Holders of the Series 1 Shares shall be entitled to a liquidation preference in an amount per share equal to US$0.10.

Series 1 Shares are convertible at the option of the holder, in a 1:1 ratio, into the Company’s Common Shares ("Common Shares"). All outstanding Series 1 Shares shall automatically convert into Common Shares, at the effective conversion rate, upon the closing of one or more sales of equity securities resulting in at least US$30 million of gross proceeds to the Company.

On June 22, 2022 The Company reported that entered into a Securities Purchase Agreement (the "Blue Lake Purchase Agreement"), with Blue Lake Partners, LLC ("Blue Lake"), pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $335,000 (the ‘Blue Lake Note") (Filing, 8-K, Mateon Therapeutics, JUN 22, 2022, View Source [SID1234616285]). The Blue Lake Note is convertible into shares of the Company’s common stock, par value $0.01 per share ("Common Stock"). The Blue Lake Purchase Agreement and Blue Lake Note are part of a cumulative debt financing of $1 million through JH Darbie and Co., Inc. ("JH Darbie"), of which the Company raised $605,000 from Mast Hill Fund, LP ("Mast Hill") in May 2022.

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The Mast Hill and Blue Lake Purchase Agreements and the Mast Hill and Blue Lake Notes were entered into for aggregate gross proceeds to the Company of up to $1 million (the "Financing"), undertaken by the Company pursuant to a Finder’s Fee Agreement between the Company and JH Darbie, dated October 26, 2021 (the "Agreement"). Pursuant to the Agreement, JH Darbie will be entitled to a finder’s fee of: (a) 10% of the gross proceeds received by the Company in cash; and (b) warrants equal 10% warrant coverage of the amount raised, with a purchase price equal to the Conversion Price, with such warrants to expire five years from the date of issuance. For this Financing, JH Darbie has agreed to accept a lower cash finder’s fee of 4.5% of the gross proceeds and warrant coverage of 10%. The Blue Lake Purchase Agreement and the Blue Lake Note contain identical terms to the securities purchase agreements (and promissory notes issued thereunder), to the Mast Hill funding from May 27, 2022 (the "Prior Issuance"), except with reference to the name of the holders, the use of proceeds, which included repayment of certain debt, general corporate expenses and payroll, as applicable, and the law governing the terms of the Prior Issuance. The Prior Issuance was previously reported on our Current Report on Form 8-K filed with the Securities and Exchange Commission ("SEC") on June 3, 2022.

The Notes carry an interest rate of 12% per annum and matures on the earlier of (a) the one-year anniversary of the date of the Purchase Agreements, or (b) the acceleration of the maturity of the Notes by the applicable holder upon occurrence of an Event of Default (as defined below). The Notes contain a voluntary conversion mechanism whereby the applicable holder may convert the outstanding principal and accrued interest under the terms of the Notes into shares of Common Stock (the "Conversion Shares"), at a fixed price of $0.10 per share (the "Conversion Price"), subject to adjustments upon the occurrence of certain corporate events. The Company also issued 3,025,000 warrants to purchase shares of Common Stock of the Company at an exercise price of $0.20. Prepayment of the Notes may be made at any time upon three trading days’ prior written notice to the respective holder, by payment of the then outstanding principal amount plus accrued and unpaid interest and reimbursement of such holder’s administrative fees. The Notes contains customary events of default (each an "Event of Default"). If an Event of Default occurs, at the respective holder’s election, the outstanding principal amount of the Notes, plus accrued but unpaid interest, will become immediately due and payable in cash. The Purchase Agreements require the Company to use the proceeds for general working capital, and not for (i) the repayment of any indebtedness owed to officers, directors or employees of the Company or their affiliates, (iii) any loan to or investment in any other corporation, partnership, enterprise or other person (except in connection with the Company’s currently existing operations), (iv) any loan, credit, or advance to any officers, directors, employees, or affiliates of the Company, or (v) in violation or contravention of any applicable law, rule or regulation.

The issuance of the Notes are exempt from the registration requirements of the Securities Act of 1933, as amended ("Securities Act"), in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act. The shares of Common Stock issuable upon conversion of the Notes have not been registered under the Securities Act or any other applicable securities laws, and unless so registered, may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act.

The foregoing descriptions of the Purchase Agreements and the Notes are qualified in their entirety by reference to the full text of the form of such agreements, copies of which are attached as Exhibit 10.1 and 10.2, respectively and each of which is incorporated herein in its entirety by reference.