Cytimm Therapeutics is Selected for Company Presentation in 2024 BIO International Convention in San Diego

On May 10, 2024 Cytimm, a clinical-stage company focused on the development of IL-2 based therapeutics for cancer, autoimmune diseases, and neurodegenerative diseases, reported that Dr. Haining Huang, Co-Founder and Chief Executive Officer, would present a corporate overview next month at the 2024 BIO International Convention in San Diego (Press release, Cytimm Therapeutics, MAY 10, 2024, View Source [SID1234646047]). The presentation is set for 11:00 a.m. PDT on Wednesday, June 5, 2024 in Company Presentation Theater 1 in Hall A of the Exhibition Hall at the San Diego Convention Center.

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Dr. Huang will provide an overview of Cytimm’s strategies and innovative technologies in decoupling the two opposite functions of IL-2 and the development of the two proprietary IL-2 based drugs, CTM103 and CTM201.

CTM103 is a mRNA drug that encodes HSA-IL2v fusion protein, for the treatment of solid tumors. This intravenously delivered drug can efficiently and continuously expresses IL2v with a significantly prolonged half-life. Clinical trials of CTM103 as monotherapy or in combination with Pembrolizumab demonstrated good safety andPK profiles as well as robust immune stimulatory activity in promoting CD8 T cells and NK cells proliferation. Encouraging signs of antitumor efficacy warrants more dose escalations and cohort expansions in selected tumor indication like NSCLC, HNSCC, RCC, melanoma and others.

CTM201 is the first Treg specific long-acting PEG-IL2 without compromising its bioactivity. Cytimm, for the first time, identified the ideal PEGylation strategy for IL-2 with improved activity, stability and functionality. Based on our proprietary PEGylation technology platform, CTM201 was developed as the immune suppressor for inflammatory diseases including autoimmune diseases and neurodegenerative diseases. FIH studies in ALS volunteers demonstrated excellent safety profile and robust Treg specific amplification.

In the presentation, we will highlight our recent progress in developing next-generation IL-2 based therapies in cancer and chronic inflammatory indications. This is an exciting time for Cytimm, and we look forward to sharing our views and progresses with the community at the BIO conference in San Diego. BIO is the industry’s largest and most prestigious event and we appreciate the selection of Cytimm as a presenting company that will be featured in the partnering section of the conference.

Cytimm will also hold One-on-One meets with potential partners in the event. To schedule a meeting at the BIO International Convention with Cytimm, please submit a meeting request through the BIO One-on-One Partnering platform. For more information, please visit BIO websites or send an e-mail to Cytimm at [email protected].

Non-consolidated Financial Results for the Three Months Ended March 31, 2024

On May 10, 2024 Oncolys BioPharma reported non-consolidated Financial Results for the Three Months Ended March 31, 2024 (Press release, Oncolys BioPharma, MAY 10, 2024, View Source [SID1234644739]).

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Cure Genetics Announced Promising Safety and Efficacy Data of CAR-NKT Product CGC729 for RCC at ASGCT 2024

On May 10, 2024 Cure Genetics reported the safety and efficacy data of their CAR-NKT product, CGC729, for patients with relapsed and refractory metastatic renal cell carcinoma (R/R mRCC) in an oral presentation at the 27th Annual Meeting of the American Society for Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) in Baltimore (Press release, CureGenetics, MAY 10, 2024, View Source [SID1234643645]). This marked the first-in-human trial using CAR-NKT therapy for R/R mRCC, demonstrating a good safety profile and encouraging anti-tumor activity.

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This phase I dose-escalation clinical trial was conducted at Fudan University Shanghai Cancer Center using a single-arm, 3+3 design to evaluate the safety and efficacy of CGC729 at three dose levels (DL1: 5 x 106/m2; DL2: 1.5 x 107/m2; DL3: 4.5 x 107/m2) in the treatment of R/R mRCC patients who had at least two lines of prior therapy. As of April 2024, five patients were enrolled and received a single infusion of CGC729. All patients underwent lymphodepletion prior to CGC729 infusion.

Safety Evaluation: As of April 11, 2024, all five patients (three in DL1 and two in DL2) experienced no dose-limiting toxicities (DLTs). The most common adverse events were lymphodepletion-related neutropenia, thrombocytopenia, and leukopenia. One patient in DL1 (0102) developed grade 2 cytokine release syndrome (CRS), which resolved within 24 hours; the same patient also developed grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS), which improved rapidly after symptomatic treatment.

Efficacy Evaluation: Among four eligible patients, the overall response rate (ORR) reached 50% (2/4). Among CD70 positive patients (n=3),ORR was 66.7% (2/3), with two patients achieving partial response (PR). CGC729 demonstrated promising efficacy with deep anti-tumor activity. The longest duration of response (DOR) is continuing at nine-month after treatment. Furthermore, pharmacokinetic measurements showed robust expansion of CGC729 in all subjects, regardless of the CD70 expression level in the tumor, with prolonged persistence in the blood up to 20 weeks.

Conclusion: The interim analysis of this first-in-human trial shows that anti-CD70 CAR-NKT (CGC729) has a good safety profile and robust anti-tumor activity. It may provide a promising treatment option for R/R mRCC in the future.

About the ASGCT (Free ASGCT Whitepaper) Presentation

Title:Interim Safety and Efficacy Evaluation of Anti-CD70 CAR-NKT (CGC729) Phase I Study for Patients with Relapsed and Refractory Metastatic Renal Cell Carcinoma (R/R mRCC)
No:Late-breaking Abstract No. 10
Format:Oral presentation
Room:Ballroom 4
Time:2024/5/10 8:30 am – 8:45 am
Presenter:Dr. Yuanyuan Qu, Fudan Univeristy Shanghai Cancer Center

About AIMS CAR-NKT

The challenge of treating solid tumors is compounded by tumor heterogeneity and a suppressive tumor microenvironment (TME), which are major barriers to successful CAR-T cell therapy. Addressing this, Natural Killer T (NKT) cells, a subset of multifactorial innate-like T cells, offer new possibilities in solid tumor therapy due to their multifactorial anti-tumor capabilities and TME modulation properties.

Cure Genetics’ innovative AIMS CAR-NKT platform is based on these NKT cell features, aimed at enhancing solid tumor infiltration, modulating the TME, and prolonging sustained expansion. This platform has demonstrated good safety and promising efficacy in our lead product, CGC729, and is concurrently being expanded to other autologous/allogeneic products.

About CGC729

CGC729 is an autologous anti-CD70 CAR-NKT with a differentiated mechanism of action from T cells and NK cells. First, CGC729 combines adaptive and innate immunity with multiple tumor-killing mechanisms targeting CD70, CD1d, and stress ligands frequently expressed in RCC. Additionally, CGC729 has the capability to modulate the TME through skewing macrophage differentiation and resisting TGF-β inhibition.

Entry into a Material Definitive Agreement

On May 10, 2024, Propanc Biopharma, Inc. (the "Company") reported to have entered into a Maturity Extension Agreement (the "Extension Agreement") with Ionic Ventures, LLC (the "Ionic"), pursuant to which the Ionic agreed to extend the maturity date of original 10% OID Promissory Note issued on August 15, 2023 (the "Original Note") to September 30, 2024 (Press release, Propanc, MAY 10, 2024, View Source [SID1234643402]). The maturity date of the Original Note shall be amended retroactively as of November 15, 2023 and both the Company and Ionic acknowledged and agreed that no event of default shall be deemed to have occurred solely by virtue of the Company failing to pay all principal and interest on or before November 15, 2023. All other terms of the Original Note shall continue in full force and effect after the date of the Extension Agreement

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The foregoing description of the Extension Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Extension Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K (this "Form 8-K") and is incorporated herein by reference.

Pacira BioSciences, Inc. Announces Pricing of $250.0 Million Aggregate Principal Amount of 2.125% Convertible Senior Notes due 2029

On May 10, 2024 Pacira BioSciences, Inc. (Nasdaq: PCRX) reported the pricing of $250.0 million aggregate principal amount of convertible senior notes due 2029 (the "notes") in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Pacira Pharmaceuticals, MAY 10, 2024, View Source [SID1234643234]). Pacira also granted the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional $37.5 million aggregate principal amount of notes. The sale of the notes to the initial purchasers is expected to settle on May 14, 2024, subject to customary closing conditions.

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Pacira estimates that the net proceeds from the offering will be approximately $242.0 million (or approximately $278.4 million if the initial purchasers fully exercise their option to purchase additional notes), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses. Pacira expects to use (i) approximately $191.4 million of the net proceeds to repurchase $200.0 million aggregate principal amount of its outstanding 0.750% Convertible Senior Notes due 2025 (the "2025 Notes") concurrently with the note offering in privately negotiated transactions effected through one of the initial purchasers of the notes or its affiliate, as Pacira’s agent, (ii) approximately $23.2 million (or approximately $26.7 million if the initial purchasers exercise their option to purchase additional notes), of the net proceeds to fund the cost of entering into the capped call transactions described below and (iii) approximately $25.0 million of the net proceeds to repurchase 837,240 shares of Pacira’s common stock concurrently with the pricing of the note offering in privately negotiated transactions. Pacira intends to use the remainder of the net proceeds from the offering for general corporate purposes, including working capital, and research and development expenditures. Holders of the 2025 Notes that are repurchased in the concurrent repurchases described above may purchase shares of Pacira’s common stock in the open market to unwind any hedge positions they may have with respect to the 2025 Notes. These activities may affect the trading price of Pacira common stock and the initial conversion price of the notes.

The notes will be general unsecured senior obligations of Pacira and will mature on May 15, 2029, unless earlier repurchased, redeemed or converted in accordance with their terms. The notes will bear interest at a fixed rate of 2.125% per year, payable semi- annually in arrears on May 15 and November 15 of each year, beginning on November 15, 2024.

Prior to the close of business on the business day immediately preceding November 15, 2028, the notes are convertible at the option of the holders only under certain conditions. On or after November 15, 2028, until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert their notes at their option, irrespective of these conditions. Pacira will settle conversions of the notes by paying or delivering, as applicable, cash or a combination of cash and shares of its common stock, at its election, based on the applicable conversion rate.

The conversion rate will initially be 25.2752 shares of common stock per $1,000 principal amount of notes, subject to adjustment in certain circumstances. This represents an initial conversion price of approximately $39.56 per share, representing a conversion premium of approximately 32.5% over the closing price of $29.86 per share of Pacira common stock on May 9, 2024.

On or after May 17, 2027, Pacira may redeem for cash all or part of the notes under certain circumstances at a redemption price equal to the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any. In addition, calling any note for redemption will constitute a make-whole fundamental change (as defined in the indenture governing the notes) with respect to that note, in which case the conversion rate applicable to the conversion of that note, if it is converted in connection with the redemption, will be increased in certain circumstances.

In connection with the pricing of the notes, Pacira entered into privately negotiated capped call transactions with one or more of the initial purchasers and/or their respective affiliates and/or other financial institutions (the "option counterparties"). The capped call transactions are expected to cover, subject to anti-dilution adjustments substantially similar to those applicable to the notes, the number of shares of Pacira’s common stock underlying the notes.

The capped call transactions are expected generally to reduce the potential dilution to Pacira’s common stock upon any conversion of the notes and/or offset any potential cash payments Pacira is required to make in excess of the principal amount of converted notes, as the case may be, upon any conversion of the notes, with such reduction and/or offset subject to a cap. The cap price of the capped call transactions will initially be approximately $53.75 per share, representing a premium of approximately 80% over the closing price of $29.86 per share of Pacira common stock on May 9, 2024, and is subject to certain adjustments under the terms of the capped call transactions.

In connection with establishing their initial hedges of the capped call transactions, the option counterparties or their respective affiliates expect to enter into various derivative transactions with respect to Pacira’s common stock and/or purchase shares of Pacira’s common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Pacira’s common stock or the notes at that time.

In addition, the option counterparties and/or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Pacira’s common stock and/or purchasing or selling Pacira’s common stock or Pacira’s other securities in secondary market transactions from time to time prior to the maturity of the notes (and (x) are likely to do so during any observation period related to a conversion of notes or following redemption of the notes by Pacira or following any repurchase of the notes by Pacira in connection with any fundamental change and (y) are likely to do so following any repurchase of the notes by Pacira other than in connection with any such redemption or fundamental change if Pacira elects to unwind a corresponding portion of the capped call transactions in connection with such repurchase). This activity could also cause or avoid an increase or a decrease in the market price of Pacira’s common stock or the notes, which could affect the ability to convert the notes and, to the extent the activity occurs during any observation period related to a conversion of notes, it could affect the number of shares of Pacira’s common stock and value of the consideration that noteholders will receive upon conversion of such notes.

The offering of the notes is being made to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the notes and the shares of Pacira common stock, if any, issuable upon conversion of the notes have not been and will not be registered under the Securities Act or any state securities laws, and, unless so registered, the notes and such shares may not be offered or sold in the United States or to U.S. persons except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall it constitute an offer, or the solicitation of any sale, of any securities in any jurisdiction in which such offer, solicitation or sale is unlawful.