Cidara Therapeutics Presents Preclinical Data on Novel Drug-Fc Conjugate CBO421 at SITC’s 38th Annual Meeting

On November 3, 2023 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported new preclinical data on its drug-Fc conjugate (DFC) candidate, CBO421, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Annual Meeting (Press release, Cidara Therapeutics, NOV 3, 2023, View Source [SID1234638369]). The conference is taking place November 1-5, 2023, both virtually and in-person in San Diego, CA.

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"We look forward to sharing data that demonstrate the potential for CBO421 to potently inhibit tumor growth as both a monotherapy and in combination with PD-1 therapies," said Jeffrey Stein, Ph.D. president and chief executive officer of Cidara. "CD73 plays a significant role in contributing to immune evasion in solid tumors. CBO421, our CD73-targeting DFC, combines the strengths of small molecule inhibitors and monoclonal antibodies against CD73 and demonstrates the potential for best-in-class activity to fully exploit the CD73 target to inhibit immune evasion by cancer cells in-vivo. Based on these data, we’re excited to advance this candidate into clinical trials for the treatment of solid tumors."

Presentation details are summarized below:

Title: Discovery of CBO421, a first-in-class drug Fc-conjugate (DFC), targeting CD73 in cancer
Presenter: Simon Döhrmann, Ph.D., Cidara Therapeutics
Session Location: Ground Level Exhibit Halls A and B1
Date and Time: Friday, November 3, 2023, 12:00-1:30 PDT

Cidara Therapeutics Presents Preclinical Data on Novel Drug-Fc Conjugate CBO421 at SITC’s 38 ? Annual Meeting

On November 3, 2023 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported new preclinical data on its drug-Fc conjugate (DFC) candidate, CBO421, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Annual Meeting (Press release, Cidara Therapeutics, NOV 3, 2023, View Source [SID1234637014]). The conference is taking place November 1-5, 2023, both virtually and in-person in San Diego, CA.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We look forward to sharing data that demonstrate the potential for CBO421 to potently inhibit tumor growth as both a monotherapy and in combination with PD-1 therapies," said Jeffrey Stein, Ph.D. president and chief executive officer of Cidara. "CD73 plays a significant role in contributing to immune evasion in solid tumors. CBO421, our CD73-targeting DFC, combines the strengths of small molecule inhibitors and monoclonal antibodies against CD73 and demonstrates the potential for best-in-class activity to fully exploit the CD73 target to inhibit immune evasion by cancer cells in-vivo. Based on these data, we’re excited to advance this candidate into clinical trials for the treatment of solid tumors."

Presentation details are summarized below:

Title: Discovery of CBO421, a first-in-class drug Fc-conjugate (DFC), targeting CD73 in cancer
Presenter: Simon Döhrmann, Ph.D., Cidara Therapeutics
Session Location: Ground Level Exhibit Halls A and B1
Date and Time: Friday, November 3, 2023, 12:00-1:30 PDT

Orano Med and 48Hour Discovery to Develop Innovative Peptide Receptor Radionuclide Therapy for Targeted Cancer Treatment

On November 6, 2023 Orano Med, a pioneer in targeted alpha therapy, and 48Hour Discovery, a novel peptide discovery platform company, reported their strategic collaboration to advance cancer treatment through radioligand discovery and development (Press release, 48Hour Discovery, NOV 3, 2023, View Source;utm_medium=rss&utm_campaign=orano-med-and-48hour-discovery-to-develop-innovative-peptide-receptor-radionuclide-therapy-for-targeted-cancer-treatment [SID1234637006]). This partnership aims to harness the potent properties of lead-212 (212Pb), a rare alpha-emitting radioisotope, in conjunction with 48Hour Discovery’s innovative peptide discovery technology and expertise.

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Orano Med is advancing precision medicine in oncology by capitalizing on the unique properties of lead-212 and its proprietary platform to develop new radioligand therapies. Their commitment to innovation and therapeutic excellence aligns with 48Hour Discovery’s dedication to redefining drug discovery through novel peptides.

The core of the collaboration is the development of a novel peptide receptor radionuclide therapy (PRRT) capable of selectively targeting cancer cells with unparalleled precision. Lead-212, renowned for its potent alpha-emitting properties, holds the potential to deliver therapeutic payloads directly to cancer cells, minimizing collateral damage to healthy tissues. The expertise of Orano Med in harnessing the therapeutic potential of 212Pb, combined with 48Hour Discovery’s cutting-edge peptide design platform, is driving the development of novel cancer treatment modalities.

48Hour Discovery’s innovative platform has garnered significant attention for its transformative approach to peptide-based drug discovery. Their methodology, encompassing state-of-the-art phage display libraries, high-throughput screening, and chemical modifications, has enabled the identification of peptides with enhanced affinity, specificity, and therapeutic potential. The partnership with Orano Med opens doors to leverage this expertise in crafting peptides that will deliver highly cytotoxic 212Pb on cancer cells with unparalleled effectiveness.

"Uniting Orano Med’s expertise in targeted alpha therapy with 48Hour Discovery’s innovative approach to drug discovery creates a powerful synergy," says Julien Dodet, CEO at Orano Med. "We are excited about the potential to reshape the landscape of cancer therapy and deliver transformative treatments to patients."

Rick Finnegan, CEO of 48Hour Discovery, shares, "Our collaboration with Orano Med represents a testament to the value of cross-disciplinary partnerships. Together, we embark on a journey that can redefine the paradigms of cancer treatment, offering new hope to patients worldwide."

Replimune Presents Updated Interim Results from the ARTACUS Clinical Trial of RP1 Monotherapy in Solid Organ and Hematopoietic Cell Transplant Recipients with Skin Cancers During Oral Presentation at the 38th Annual Meeting of the SITC

On November 3, 2023 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, reported updated interim results from ARTACUS, a Phase 1/2 clinical trial evaluating RP1 monotherapy for the treatment of skin cancers in patients who have had solid organ or hematopoietic cell transplants (Press release, Replimune, NOV 3, 2023, View Source [SID1234636972]). The data were presented today by Dr. Michael R. Midgen of the University of Texas MD Anderson Cancer Center during an oral session (Abstract #777) at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in San Diego.

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Treatment with RP1 monotherapy led to an overall response rate (ORR) of 34.8 percent (8 of 23 evaluable patients, including 5 complete responses and 3 partial responses). Of the 23 evaluable patients, 20 had cutaneous squamous cell carcinoma (CSCC) and 3 had merkel cell carcinoma (MCC) with responses observed in 6 CSCC patients and 2 patients with MCC. One patient treated for CSCC also had a complete response of a new primary basal cell carcinoma which appeared post baseline that was treated with RP1. Most responses were ongoing as of the data cutoff date of September 18, 2023. There was no evidence of allograft rejection including of hepatic and lung allografts. RP1 monotherapy was well tolerated, and the safety profile was similar to the profile in non-immunocompromised patients with advanced skin cancers. The slides are available on the Replimune website under presentations.

"These data demonstrating an overall response rate of nearly 35 percent with good durability of benefit to date show that RP1 monotherapy has clinically meaningful anti-tumor activity in a difficult to treat patient population receiving chronic immunosuppressive treatment and where systemic immunotherapy may not be a viable option," said Robert Coffin, President and Chief Research and Development Officer of Replimune. "Patients receiving organ transplants are highly susceptible to skin cancer at a rate which is far higher than in the general population. Based on the data to date, we believe that RP1 monotherapy may potentially provide a safe and effective option for patients that currently have a limited number of treatments available."

About ARTACUS
ARTACUS is a multicenter, open-label, two-part Phase 1b/2 study evaluating RP1 as monotherapy for the treatment of locally advanced or metastatic cutaneous malignancies in patients who underwent a kidney, liver, heart, lung, or other solid organ transplant, or hematopoietic cell transplantation, who are on chronic immunosuppressive treatment, in whom systemic immunotherapy is typically contra-indicated. Researchers will assess the safety of RP1 and also evaluate its ability to shrink tumors.

About RP1
RP1 is Replimune’s lead product candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.

Dizal Highlights Its Advances in Hematological Portfolio at 2023 ASH, Featuring Breakthroughs in Lymphoma Treatment

On November 3, 2023 Dizal reported that it will have four presentations from its hematological oncology pipeline, including golidocitinib and DZD8586, at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (2023 ASH (Free ASH Whitepaper), San Diego) (Press release, Dizal Pharma, NOV 3, 2023, View Source [SID1234636939]). Its global multicenter pivotal study of golidocitinib (JACKPOT8 PARTB) has been selected for oral presentation.

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Golidocitinib

Golidocitinib is the first and only Janus kinase 1 (JAK1) selective inhibitor in the NDA stage for the treatment of r/r PTCL. Dizal will release the latest results from two clinical studies: the full analysis of the multinational pivotal study of golidocitinib (JACKPOT8 PARTB) in r/r PTCL and a phase 2 study evaluating golidocitinib as a maintenance therapy in patients with PTCL after first-line systemic therapy (JACKPOT26).

Golidocitinib monotherapy demonstrated superior efficacy and safety profile in the full analysis of the JACKPOT8 PARTB study, which was consistent with the preliminary findings presented at 2023 ASCO (Free ASCO Whitepaper). An IRC-assessed overall response rate (ORR) was 44.3%, nearly double the existing treatment options. The response was durable. The final data for duration of response (DOR), progression-free survival (PFS), as well as overall survival (OS) will be reported at the meeting.

Approximately 40% of patients with complete response and 80% of patients with partial response have disease relapse within 2 years following first-line standard therapy, and the prognosis of relapsed patients was typically poor. According to the results of phase 2 study of golidocitinib as maintenance therapy in patients with PTCL after first-line systemic therapy (JACKPOT26), golidocitinib showed manageable safety profile and promising efficacy in maintaining and enhancing tumor response in patients with PTCL post first-line therapies.

DZD8586

DZD8586 is a rationally designed, oral, non-covalent, LYN and BTK dual inhibitor with excellent blood-brain barrier (BBB) penetration. Dizal will report its preclinical data as well as the ongoing clinical study results in B-NHL.

While Bruton’s Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can emerge due to various mechanisms, including acquired mutations at residue C481 of BTK and non BTK-driven mutations. Currently, there is no targeted therapy available to address both resistance mechanisms, highlighting an urgent need for a safe and effective treatment option for patients with r/r B-NHL.

Preclinical studies have shown that DZD8586 can overcome resistance mutations observed with approved covalent and non-covalent BTK inhibitors. DZD8586 has exhibited potent inhibition of cell growth by blocking both BTK-dependent and BTK-independent signaling pathways.

Key highlights of DZD8586 are as follows:

Potent inhibition of LYN and BTK, with good selectivity against other kinases.
Significant inhibitory effects on mutations at residue C481 of BTK, as well as BTK mutations associated with resistance to Pirtobrutinib (LOXO-305).
Potent cell growth inhibition observed in diffuse large B-cell lymphoma (DLBCL) cell lines.
Excellent BBB penetration, as evidenced by a CSF-to-plasma concentration ratio (Kpuu,CSF) greater than 1 in animal models, suggesting potential effectiveness in humans.
Currently, DZD8586 is conducting two global phase 1 studies (TAI-SHAN1 and TAI-SHAN5) for the treatment of r/r B-NHL. The preliminary results of the studies have shown encouraging pharmacokinetic (PK) properties, safety profile and antitumor efficacy. The pooled analysis results from these two studies will be presented for the first time at 2023 ASH (Free ASH Whitepaper).

Dizal’s Presentation at 2023 ASH (Free ASH Whitepaper)

Lead Author

Abstract Title

Presentation Details

Prof. Yuqin Song

Golidocitinib in Treating Refractory or Relapsed Peripheral T- Cell Lymphoma: Full Analysis of the Multinational Pivotal Study Results (JACKPOT8)

Abstract #305

Session Type: Oral

Oral Abstract Session

Date and Time: December 9, 2023, 5 PM PST

Location: Hall B

Prof. Jie Jin

Phase 2 Study of Golidocitinib, a JAK1 Selective Inhibitor, As Maintenance Therapy in Patients with Peripheral T Cell Lymphomas after First-Line Systemic Therapy (JACKPOT26)

Abstract #4430

Poster Session

Date and Time: December 11, 2023, 6 PM – 8 PM PST

Location: Hall G-H

Dr. Yu Bai

Preclinical Study of DZD8586, a Non-Covalent LYN/BTK Dual Inhibitor with Excellent BBB Penetration, for the Treatment of B-Cell Non-Hodgkin Lymphoma (B-NHL)

Abstract #2822

Poster Session

Date and Time: December 10, 2023, 6 PM – 8 PM PST

Location: Hall G-H

Prof. Yuqin Song

First Report of Phase 1 Studies of DZD8586, a BBB Penetrant LYN/BTK Dual Inhibitor, in Patients with B-Cell Non-Hodgkin Lymphoma (B-NHL)

Abstract #4465

Poster Session

Date and Time: December 11, 2023, 6 PM – 8 PM PST

Location: Hall G-H

About golidocitinib (DZD4205)

Golidocitinib is the first-in-class Janus kinase 1 (JAK1) only inhibitor currently being evaluated in a global, multicenter pivotal study (JACKPOT8 PARTB) in r/r PTCL. At the data cut-off date of February 16, 2023, Golidocitinib has demonstrated robust and durable anti-tumor activity, with an ORR of 44.3%. More than 50% of the patients with tumor remission achieved a complete response. The median relative dose intensity was 100%. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted the NDA and granted the Priority Review status for the treatment of r/r PTCL. And the Phase I clinical data of golidocitinib for the treatment of r/r PTCL (JACKPOT8 PARTA) was published in Annals of Oncology (Impact Factor: 51.8).

About DZD8586

DZD8586 is an orally available, highly selective small molecule inhibitor to target both BTK-dependent and BTK-independent B-cell receptor (BCR) signaling pathways, with full blood-brain barrier penetration. Pre-clinical research revealed that DZD8586 demonstrated good safety profile and could effectively inhibit the growth of B-NHL cells. A healthy volunteer study of DZD8586 has been conducted to investigate the clinical safety and PK/PD correlation. Additionally, a global phase I/II study is ongoing to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of DZD8586 in patients with r/r B-NHL. Preliminary results from the clinical trial suggest that DZD8586 exhibits favorable PK properties, good safety profile, and preliminary anti-tumor activity in patients with B-NHL.