On May 10, 2024 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers, reported its financial results for the first quarter of 2024 and provided a business update (Press release, Xenetic Biosciences, MAY 10, 2024, View Source [SID1234643087]).

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"We have initiated several preclinical studies on the influence of DNase in combination with standard treatment paradigms such as chemotherapy or immune checkpoint blockade and expect to present results in the second half of this year. We anticipate that this growing body of data will have an important impact in demonstrating the promise of incorporating DNase into clinical treatment regimens for certain solid tumors, and in guiding our clinical development strategy," commented, Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "We believe we have successfully positioned 2024 to be a year of meaningful preclinical data and remain focused on executing our plans to advance development towards our first in human trial."

Summary of Financial Results for First Quarter 2024

Net loss for the quarter ended March 31, 2024 was approximately $1.2 million. Research & development expenses for the three months ended March 31, 2024 increased by approximately $0.3 million, or 58.6%, to approximately $0.9 million from approximately $0.6 million in the comparable quarter in 2023. The increase was primarily due to the Company’s increased spending in connection with our pre-clinical development efforts related to our DNase platform. General and administrative expenses for the three months ended March 31, 2024 decreased by approximately $0.1 million, or 9.8%, to approximately $0.8 million from approximately $0.9 million in the comparable quarter in 2023. The decrease was primarily due to a decrease in accounting and legal fees during the three months ended March 31, 2024 compared to the same period in 2023.

The Company ended the quarter with approximately $7.8 million of cash.

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.

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].

On May 10, 2024 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, reported financial results for the first quarter ended March 31, 2024 and provided a business update (Press release, iTeos Therapeutics, MAY 10, 2024, View Source [SID1234643088]).

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"After reviewing headline data for an interim assessment of GALAXIES Lung-201, we are thrilled to announce that belrestotug + dostarlimab exceeded our pre-defined efficacy criteria for clinically relevant activity with clinically meaningful tumor reduction at each dose. The data also indicate an acceptable safety profile in line with the TIGIT:PD-1 class," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "We believe this early interim assessment supports our view that quality of components matters and that our TIGIT:PD-1 doublet has the potential to deliver differentiated clinical data. Our GALAXIES clinical development plans remain on track, and we look forward to GSK’s update on the GALAXIES program in June. We are also excited to present data from GALAXIES Lung-201 at a medical congress later in 2024."

"Additionally, we completed enrollment with no new safety signals observed and passed the futility analysis for efficacy in both combined positive score (CPS) cohorts in the first portion of the TIG-006 trial in first-line recurrent/metastatic PD-L1 positive head and neck cancer. iTeos and GSK have agreed to not continue beyond stage 1 recruitment in the open-label TIG-006 cohorts 2C & 2D and instead focus on generating randomized, controlled data in the ongoing Phase 2 GALAXIES H&N-202 platform study to further support a path to late-stage development in this indication. We are excited to provide an update on the TIG-006 trial at a medical congress later this year," concluded Dr. Detheux.

Program Highlights

Belrestotug (EOS-448/GSK4428859A): IgG1 anti-TIGIT monoclonal antibody targeting first-line non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) in collaboration with GSK

Preparation underway to advance GALAXIES clinical program that will evaluate the belrestotug + dostarlimab doublet
GALAXIES Lung-201: Interim assessment exceeded pre-defined efficacy criteria for clinically relevant activity with clinically meaningful tumor reduction and showed an acceptable safety profile in line with the TIGIT:PD-1 class. Interim data from Phase 2 platform trial assessing belrestotug + dostarlimab doublet in first-line advanced / metastatic PD-L1 high NSCLC anticipated in second half of 2024.
GALAXIES H&N-202: Enrollment ongoing in randomized Phase 2 platform study assessing belrestotug + dostarlimab doublet and a triplet with GSK’s investigational anti-CD96 antibody, nelistotug, in first-line patients with PD-L1 positive recurrent / metastatic HNSCC.
TIG-006 HNSCC: Completed enrollment and passed futility analysis for efficacy of both CPS arms of the first portion of TIG-006 in 1L HNSCC (Cohorts 2C & 2D). iTeos and GSK have agreed to not continue beyond stage 1 recruitment in these open-label cohorts in order to focus on the randomized, controlled GALAXIES H&N-202 trial. Topline data from the first portion of TIG-006 Cohorts 2C & 2D assessing belrestotug + dostarlimab doublet in first-line PD-L1 positive advanced / metastatic HNSCC anticipated in second half 2024.
TIG-006 mNSCLC: Enrollment completed in Phase 1b expansion trial assessing belrestotug, dostarlimab, and chemotherapy triplet in first-line advanced or metastatic NSCLC.
Continued advancement of Phase 1b trials exploring two novel triplets in advanced solid tumors: belrestotug + dostarlimab and GSK’s nelistotug (anti-CD96 antibody), and belrestotug + dostarlimab and GSK’s investigational anti-PVRIG antibody (GSK’562)
Adenosine Pathway

Inupadenant (EOS-850): insurmountable small molecule antagonist targeting adenosine A2A receptor in second-line NSCLC

A2A-005: Completed enrollment of Phase 2 A2A-005 dose escalation. Data from the dose escalation portion of the Phase 2 trial with inupadenant and platinum-doublet chemotherapy in post-IO metastatic non-squamous NSCLC anticipated in late 2024.
EOS-984: potential first-in-class small molecule inhibiting ENT1, a dominant transporter of adenosine on lymphocytes involved in T cell metabolism, expansion, effector function, and survival

Topline data from the Phase 1 trial anticipated in the second half of 2024
First Quarter 2024 Financial Results

Cash and Investment Position: The Company’s cash, cash equivalents, and investments position, which included $13.0 million of receivables from matured investments recorded in prepaid expense and other current assets on the balance sheet, was $595.0 million as of March 31, 2024, as compared to $706.6 million as of March 31, 2023. Pro forma cash, cash equivalents, and investments position were $715.0 million as of May 10, 2024, inclusive of approximately $120 million in proceeds from the May 2024 registered direct offering. The Company expects its cash balance to provide runway through 2027, which includes the potential initiation of multiple Phase 3 registrational trials assessing the belrestotug + dostarlimab doublet.

Research and Development (R&D) Expenses: R&D expenses were $34.5 million for the quarter ended March 31, 2024, as compared to $25.6 million for the same quarter of 2023. The increase compared to the comparative period was primarily due to increases in activities related to the belrestotug, inupadenant, and EOS-984 programs, and included the addition of new R&D employees hired to help advance these programs.

General and Administrative (G&A) Expenses: G&A expenses were $12.7 million for the quarter ended March 31, 2024, as compared to $11.9 million for the same quarter of 2023. The increase was primarily due to increases in headcount and related costs and an increase in stock-based compensation compared to the prior year. The increases were partially offset by a decrease in recruiting costs.

Net Income/Loss: Net loss attributable to common shareholders was $38.2 million, or net loss of $1.07 per basic and diluted share for the quarter ended March 31, 2024, as compared to a net loss of $15.6 million, or a net loss of $0.44 per basic and diluted share for the quarter ended March 31, 2023.

On May 10, 2024 iTeos Therapeutics, Inc. (Nasdaq: ITOS) ("iTeos"), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, reported that it has entered into a securities purchase agreement to sell 1,142,857 shares of the Company’s common stock (the "Common Stock") at a price of $17.50 per share, representing a premium of approximately 44% to iTeos’ closing price on May 9, 2024 and pre-funded warrants to purchase up to 5,714,285 shares of the Common Stock (the "Pre-Funded Warrants") at a price of $17.499 per pre-funded warrant, in a registered direct offering (Press release, iTeos Therapeutics, MAY 10, 2024, View Source [SID1234643089]). Each pre-funded warrant will have an exercise price of $0.001 per share, will be exercisable immediately, and will be exercisable until exercised in full. The aggregate gross proceeds from the offering are expected to be approximately $120 million, before deducting offering expenses payable by iTeos. The financing is expected to close on or about May 14, 2024, subject to the satisfaction of customary closing conditions.

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The financing is being led by existing investors, RA Capital Management and Boxer Capital.

iTeos expects to use net proceeds from the financing to advance its clinical programs and preclinical pipeline, and for working capital and other general corporate purposes.

The shares of Common Stock, Pre-Funded Warrants and the shares of Common Stock issuable upon the exercise of the Pre-Funded Warrants were offered pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") on May 10, 2023 (File No. 333-271793) and was declared effective on May 19, 2023. A final prospectus supplement containing additional information relating to the offering, will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

This press release shall 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.