Results presented at ASCO demonstrating the synergy of PharmaMar’s combination of lurbinectedin with irinotecan in patients with relapsed small cell lung cancer

On June 4, 2024 PharmaMar (MSE:PHM) reported data from a Phase II trial evaluating PharmaMar’s lurbinectedin in combination with irinotecan in patients with relapsed Small Cell Lung Cancer (SCLC) after prior platinum-based treatment at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting, which took place from 31st May to 4th June in Chicago, United States (Press release, PharmaMar, JUN 4, 2024, View Source [SID1234644032]).

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The results show that combining these two drugs produces a synergy that enhances the activity of lurbinectedin, resulting in high and durable response rates in populations that are sensitive, with a chemotherapy-free interval greater than 90 days (CTFI> 90 days), and platinum-resistant with a chemotherapy-free interval of less than 90 days (CTF< 90 days).

Particularly encouraging are the data drawn from the subgroup of 74 patients with a chemotherapy-free interval greater than 30 days (CTFI>30 days) with a response rate of 52.7% and a median response duration of 7.6 months. Among the study data within this subgroup, the overall survival (OS) data is also encouraging, with a median of 12.7 months. The safety profile has proven to be manageable with a low percentage of treatment interruptions.

Dr. Luis Paz-Ares Rodríguez, Head of Medical Oncology at the "Hospital Universitario 12 de Octubre" commented: "although both irinotecan and lurbinectedin have demonstrated activity separately in monotherapy in SCLC, these compounds with different mechanisms of action have shown an important synergy when combined". The encouraging results in the population referenced in the LAGOON trial (sensitive and resistant patients, CTFI>30d) reinforce the rationale for including this combination as an experimental arm with this type of patient in the ongoing pivotal trial.

Entry into a Material Definitive Agreement

On June 3, 2024 Kiromic BioPharma, Inc. (the "Company") reported to have issued a 25% Senior Secured Convertible Promissory Note (the "Note") to an accredited investor. 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 June 3, 2025 (the "Maturity Date"), on which the principal balance and accrued but unpaid interest under the Note shall be due and payable (Press release, Kiromic, JUN 3, 2024, View Source [SID1234644615]). 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.

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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 $2.50 per share (the "Conversion Price"), subject to a beneficial ownership limitation equivalent to 19.99% (the "Beneficial Ownership Limitation").

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.

Entry into a Material Definitive Agreement

On June 3, 2024, Propanc Biopharma, Inc. (the "Company") reported to have entered into and closed a loan agreement (the "First Loan") with an investor (the "First Investor"), pursuant to which the First Investor loaned the Company an aggregate principal amount of $20,000 AUD (Filing, 8-K, Propanc, JUN 3, 2024, View Source [SID1234644284]). The Company intends to use the net proceeds therefrom for general working capital purposes.

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The maturity date of the First Loan is June 3, 2025, or sooner at the discretion of the Company, and the First Loan bears an interest rate of twelve percent (12%) per annum. The Company has the right to prepay in full at any time with no prepayment penalty.

Effective June 5, 2024, Propanc Biopharma, Inc. (the "Company") entered into and closed a loan agreement (the "Second Loan") with an investor (the "Second Investor"), pursuant to which the Second Investor loaned the Company an aggregate principal amount of $100,000 AUD. The Company intends to use the net proceeds therefrom for general working capital purposes.

The maturity date of the Second Loan is June 5, 2025, or sooner at the discretion of the Company, and the Second Loan bears an interest rate of twelve percent (12%). The Company has the right to prepay in full at any time with no prepayment penalty.

The foregoing descriptions of each of the Loan do not purport to be complete and are qualified in their entirety by reference to the full text of each of the Purchase Agreements and the Loans, which are filed as Exhibits 4.1, and 4.2 to this Current Report on Form 8-K (this "Form 8-K") and are incorporated herein by reference.

LadRx and ImmunityBio Mutually Agree to Terminate Aldoxorubicin License Aldoxorubicin Returns to LadRx

On June 3, 2024 LadRx Corporation (OTCQB: LADX) ("LadRx" or the "Company"), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, is pleased to announce that the Company and NantCell, Inc. ("NantCell"), together with NantCell’s parent company ImmunityBio, Inc. ("ImmunityBio"), have agreed to a mutual termination of the license of aldoxorubicin entered into in 2017 (Press release, ImmunityBio, JUN 3, 2024, View Source [SID1234644163]).

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With the termination of the license agreement between LadRx and NantCell, LadRx regains control of aldoxorubicin. In 2023, LadRx transferred the royalty and milestone rights of arimoclomol and aldoxorubicin to XOMA Corporation (NASDAQ: XOMA) ("XOMA") in exchange for $5 million in upfront gross proceeds, up to an additional $2 million for milestones related to arimoclomol and $5 million for milestones related to aldoxorubicin. XOMA consented to the mutual termination of the LadRx-NantCell agreement in order to facilitate the return of the program to LadRx. In parallel, LadRx and XOMA have amended their 2023 Royalty Purchase Agreement to provide XOMA with a low-single-digit synthetic royalty on aldoxorubicin and a mid-single-digit percentage of any economics derived by LadRx from future out-license agreements related to aldoxorubicin. The agreement between LadRx and XOMA regarding future royalties and milestones associated with arimoclomol is not affected by the termination of the aldoxorubicin license between LadRx and NantCell.

Stephen Snowdy, PhD, CEO of LadRx commented, "We are excited to have aldoxorubicin back in-house. Aldoxorubicin is the first LADR-based drug to reach the clinic and was shown in multiple clinical studies to have lower cardiotoxicity compared to doxorubicin while showing promise of efficacy in a Phase II trial in advanced soft tissue sarcoma. Aldoxorubicin also proved the premise of LADR-based drugs that targeting chemotoxins via the LADR backbone allows for several-fold higher dosing of chemotherapeutic drugs."

Dr. Snowdy continued, "We congratulate ImmunityBio on their recent successes with their immunity-based products and certainly understand their going-forward focus on those modalities. Over the coming months, we will be reviewing the pre-clinical and clinical data for aldoxorubicin and plotting a path forward for its continued clinical development. Meanwhile, we continue to march LADR-7 towards the clinic and remain on track for filing an IND application for LADR-7 in the third or fourth quarter of 2024."

Entry into a Material Definitive Agreement

On June 3, 2024, Royalty Pharma plc (the "Issuer") reported to have entered into an underwriting agreement (the "Underwriting Agreement"), by and among the Issuer, Royalty Pharma Holdings Ltd (the "Guarantor"), RP Management, LLC (the "Manager") and BofA Securities, Inc., Citigroup Global Markets Inc., J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC and TD Securities (USA) LLC, as representatives of the several underwriters listed on Schedule I thereto (the "Underwriters"), pursuant to which the Issuer has agreed to issue and sell to the Underwriters $500 million aggregate principal amount of its 5.150% Senior Notes due 2029, $500 million aggregate principal amount of its 5.400% Senior Notes due 2034 and $500 million aggregate principal amount of its 5.900% Senior Notes due 2059 (collectively, the "Notes") in a registered public offering pursuant to an effective shelf registration statement on Form S-3 (Registration File No. 333-279905) (Filing, 8-K, Royalty Pharma , JUN 3, 2024, View Source [SID1234644140]). The Notes will be guaranteed on a senior unsecured basis by Royalty Pharma Holdings Ltd. The offering is expected to close on June 10, 2024, subject to the satisfaction of customary closing conditions. The description of the Underwriting Agreement contained herein is qualified in its entirety by reference to the Underwriting Agreement, a copy of which is included as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

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