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PDS Biotech Completes Successful Meeting with FDA for Triple Combination of PDS0101, PDS0301 and a Commercial Immune Checkpoint Inhibitor

On February 27, 2023 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported the successful completion of a Type B meeting with the U.S. Food and Drug Administration (FDA) for a combination therapy of PDS0101, PDS0301 and an FDA-approved immune checkpoint inhibitor (ICI) for the treatment of recurrent/metastatic human papilloma virus (HPV)-positive, ICI refractory head and neck cancer (Press release, PDS Biotechnology, FEB 27, 2023, View Source [SID1234627763]). Head and neck cancers are the most common of all HPV-positive cancers and the number of cases is growing rapidly, according to the National Cancer Institute (NCI), one of the National Institutes of Health. There remains a critical unmet medical need to develop new treatment options for patients who have failed treatment with ICIs.

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In recent interactions with the FDA, PDS Biotech has confirmed the required contents of the study design for a potential registrational trial of the combination of PDS0101, PDS0301 and a commercial immune checkpoint inhibitor. PDS0101, PDS Biotech’s lead candidate, is a Versamune based investigational immunotherapy designed to stimulate a potent targeted T cell attack against HPV16-positive cancers. PDS0301 is a novel, proprietary investigational tumor-targeting fusion protein of Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment, and is designed to overcome tumor immune suppression utilizing a different mechanism from checkpoint inhibitors. The combination of Versamune and IL-12 is patented by PDS Biotech. In a NCI-led clinical trial in advanced HPV-positive ICI refractory patients, the combination of PDS0101 and PDS0301 administered with an investigational bifunctional ICI resulted in a median overall survival of 21 months, which compares favorably to the historical median survival of 3-4 months.

"We are pleased with the guidance from the FDA on key elements of a study design to progress the development of our assets, PDS0101 and PDS0301, in combination with a commercial immune checkpoint inhibitor," said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. "This concurrence to substitute an FDA-approved commercially available ICI for the investigational agent studied in the NCI trial simplifies the regulatory pathway for this triple combination."

Dr. Bedu-Addo continued, "Versamune based investigational immunotherapies in combination with PDS0301 represent a potentially transformative treatment approach for recurrent/metastatic, ICI refractory cancer patients with poor survival prognosis. We remain committed to addressing unmet needs in cancer with more effective immunotherapy."

About PDS0101

PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by a simple subcutaneous injection in combination with other immunotherapies and cancer treatments. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About PDS0301

PDS0301 is a novel investigational fusion protein of a tumor-targeting antibody and Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. Together with Versamune based immunotherapies PDS0301 works synergistically to promote a targeted T cell attack against cancers. PDS0301 is given by a simple subcutaneous injection. Clinical data suggest the addition of PDS0301 to Versamune based immunotherapies can demonstrate significant disease control by shrinking tumors and/or prolonging survival in recurrent/metastatic cancers with poor survival prognosis.

Monopar and NorthStar Announce Expanded Radiopharma Program, Positive Preclinical Results, and Visibility Toward Human Trials

On February 27, 2023 Monopar Therapeutics Inc. (Nasdaq: MNPR) (Wilmette, Ill.) and NorthStar Medical Radioisotopes, LLC (Beloit, Wis.), reported an expansion of their radiopharmaceutical collaboration along with a new radiolabeled MNPR-101 imaging candidate designated as MNPR-101-Zr (Filing, 8-K, Monopar Therapeutics, FEB 27, 2023, View Source [SID1234627762]). Based on promising recently generated preclinical imaging results with MNPR-101-Zr showing high uptake across multiple tumor types, the companies also committed to additional funding with the aim of initiating a first-in-human imaging study with MNPR-101-Zr as early as the end of this year.

MNPR-101-Zr is a zirconium-89 labeled version of MNPR-101, a highly selective antibody against the urokinase plasminogen activator receptor (uPAR). Positron emission tomography (PET) imaging of preclinical mouse models for triple-negative breast, colorectal, and pancreatic tumors displayed high and selective uptake of MNPR-101-Zr in these uPAR-expressing tumors.

These proof-of-concept studies provide support for a first-in-human PET imaging study with MNPR-101-Zr and a future therapeutic study using the previously announced actinium-225 labeled radioimmunotherapeutic version of MNPR-101. Overall, the imaging results demonstrate the potential utility of MNPR-101 as a precision targeting agent for both imaging and therapy in multiple cancer indications.

"We are excited about these recent developments, about our expanded partnership with NorthStar, and about our increasing involvement in the radiopharma space. The Monopar team believes this personalized medicine and precision approach to imaging and treating cancer patients holds tremendous promise," said Chandler Robinson, MD, CEO of Monopar Therapeutics.

"Our continued partnership with Monopar shows our commitment to being a leader in the radiopharmaceutical field through the supply of advanced radionuclides as well as specialized development support for promising precision radiopharma programs like MNPR-101," said Stephen Merrick, CEO of NorthStar Medical Radioisotopes.

About Radiopharmaceuticals

Radiopharmaceuticals are an emerging class of cancer drugs designed to target a tumor and deliver radiation directly while minimizing damage to normal tissue. Radiopharmaceuticals are formed by attaching radioactive isotopes, a process also known as radiolabeling, to targeting molecules (e.g., an antibody) that bind specifically to tumors. Depending on the radioactive isotope selected, the radiopharmaceutical can image or treat the targeted cancers.

Entry into a Material Definitive Agreement

On February 27, 2023 In connection with the note purchase agreement entered into by Kiromic BioPharma, Inc. (the "Company") on January 20, 2023, the Company pursuant to the Agreement issued a 25% Senior Secured Convertible Promissory Note (the "Note") to the Investor (as defined in the Agreement) (Filing, Kiromic, FEB 27, 2023, View Source [SID1234627761]). The Note has a principal amount of $2,000,000, bears interest at a rate of 25% per annum (the "Stated Rate") and matures on February 21, 2024 (the "Maturity Date"), on which the principal balance and accrued but unpaid interest under the Note shall be due and payable. The Stated Rate will increase to 27% per annum or the highest rate then allowed under applicable law (whichever is lower) upon occurrence of an event of default, including the failure by the Company to make payment of principal or interest due under the Note on the Maturity Date, and any commencement by the Company of a case under any applicable bankruptcy or insolvency laws.

The Note is convertible into shares (the "Conversion Shares") of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at an initial conversion price of $0.25 per share (the "Conversion Price"), subject to a beneficial ownership limitation equivalent to 9.99% (the "Beneficial Ownership Limitation") and a share cap of 5,771,547 shares (the "Share Cap"), representing 19.9% of the total issued and outstanding shares of Common Stock as of February 21, 2023, in the event that the Conversion Price is lower than $0.1540 per share, representing the lower of the closing price immediately preceding the Issuance Date or the average closing price of the Common Stock for the five trading days immediately preceding the Issuance Date.

The unpaid principal of and interest on the Note constitute unsubordinated obligations of the Company and are senior and preferred in right of payment to all subordinated indebtedness and equity securities of the Company outstanding as of the Issuance Date; provided, however, that the Company may incur or guarantee additional indebtedness after the Issuance Date, whether such indebtedness are senior, pari passu or junior to the obligations under the Note, which are secured by all of the Company’s right, title and interest, in and to, (i) all fixtures (as defined in the Uniform Commercial Code, the "UCC") and equipment (as defined in the UCC), and (ii) all of the Company’s intellectual property as specified in the Note, subject to certain exclusions as described in the Note.

The foregoing description of the Note is qualified in its entirety by reference to the full text of such Note, a copy of which is attached hereto as exhibit 10.1 and incorporated herein by reference.

Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

Reference is made to the disclosure set forth under Item 1.01 above, which disclosure is incorporated herein by reference.

Item 3.02 Unregistered Sales of Equity Securities

Reference is made to the disclosure set forth under Item 1.01 above, which disclosure is incorporated herein by reference. The issuance of the Note was made in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended.

Entry into a Material Definitive Agreement.

On February 27, 2023 Genprex, Inc. (the "Company") reported that it has entered into a securities purchase agreement (the "Securities Purchase Agreement") with an accredited healthcare-focused institutional investor (the "Purchaser") pursuant to which the Company agreed to issue and sell to the Purchaser 3,809,524 shares (the "Shares") of its common stock, par value $0.001 per share (the "Common Stock") and common warrants to purchase an aggregate of 3,809,524 shares of Common Stock (the "Warrants"), in a registered direct offering (the "Offering") (Filing, 8-K, Genprex, FEB 27, 2023, View Source [SID1234627758]).

The Warrants are exercisable immediately upon issuance, expire 5 years from the date of issuance and have an exercise price of $1.10 per share. The combined offering price is $1.05 per share of common stock and accompanying Warrant. The aggregate gross proceeds to the Company from the Offering are expected to be approximately $4.0 million, before deducting placement agent fees and other estimated Offering expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the Warrants issued in the Offering. The closing of the Offering is expected to occur on or about March 1, 2023, subject to the satisfaction of customary closing conditions.

The Warrants may only be exercised on a cashless basis if, at the time of exercise, there is no registration statement registering, or the prospectus contained therein in not available for, the issuance or resale of shares of common stock underlying the Warrants to or by the holder. In the event of certain fundamental transactions, holders of the Warrants will have the right to receive the Black Scholes Value of their Warrant calculated pursuant to a formula set forth in the Warrant and payable in the form of consideration set forth in the Warrant.

The Securities Purchase Agreement contains customary representations, warranties and agreements by the Company and customary conditions to closing. The representations, warranties and covenants contained in the Securities Purchase Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to the Securities Purchase Agreement and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Securities Purchase Agreement is incorporated herein by reference only to provide investors with information regarding the terms of the Securities Purchase Agreement and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the Commission.

The Company engaged A.G.P./Alliance Global Partners to act as placement agent in the Offering. The Company has agreed to pay the placement agent a cash fee equal to 7.0% of the aggregate gross proceeds generated from the Offering and to reimburse certain expenses of the placement agent in connection with the Offering in an amount not to exceed $20,000.

The Offering is being made pursuant to the Company’s registration statement on Form S-3 (No. 333-239134), as previously filed with the Securities and Exchange Commission on June 12, 2020, as amended on July 1, 2020 and declared effective on July 17, 2020, and a related base prospectus and prospectus supplement.

The foregoing descriptions of the material terms of the Warrant and the Securities Purchase Agreement do not purport to be complete and are qualified by the forms of the Warrant and the Securities Purchase Agreement, copies of which are filed herewith as Exhibits 4.1 and 10.1, respectively, and are incorporated herein by reference.

This Current Report on Form 8-K does not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Transactions in connection with share buy-back program

On February 27, 2023 Genmab A/S (Nasdaq: GMAB), reported the initiation of a share buy-back program to honor our commitments under our Restricted Stock Units program (Press release, Genmab, FEB 27, 2023, View Source [SID1234627757]).

The share buy-back program is expected to be completed no later than March 31, 2023 and comprises up to 220,000 shares.

The following transactions were executed under the program from February 23, 2023, to February 24, 2023:

No. of shares Average price (DKK) Total value (DKK)
Accumulated through last announcement – –
February 23, 2023 12,000 2,645.86 31,750,320
February 24, 2023 10,000 2,648.18 26,481,800

Total 22,000 58,232,120
Accumulated under the program 22,000 58,232,120
Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 565,416 shares as treasury shares, corresponding to 0.86% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 06 dated February 22, 2023.