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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.

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.

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.

Fulgent Reports Third Quarter 2023 Financial Results

On November 3, 2023 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, reported financial results for its third quarter ended September 30, 2023 (Press release, Fulgent Genetics, NOV 3, 2023, View Source [SID1234636938]).

Third Quarter 2023 Results:

Total Revenue of $85 million
Core Revenue1 grew 17% year-over-year to $66 million
GAAP loss of $13.1 million, or $0.44 per share
Non-GAAP loss of $11.7 million, or $0.39 per share
Adjusted EBITDA of $18.1 million
Generated cash flow from operations of $10.2 million
Cash, cash equivalents, and investments in marketable securities of $851 million as of September 30, 2023
Note:

1) Core Revenue excludes revenue from COVID-19 testing products and services including COVID-19 NGS testing revenue.

Non-GAAP income (loss), non-GAAP income (loss) per share, and adjusted EBITDA income (loss) are described below under "Note Regarding Non-GAAP Financial Measures" and are reconciled to the most directly comparable GAAP financial measure, GAAP income (loss), in the accompanying tables.

Commenting on the results, Ming Hsieh, Chairman of the Board and Chief Executive Officer, said, "We continue to see good momentum in our core business, with particular strength in precision diagnostics. I am pleased with the trajectory of the business and our ability to use our resources efficiently as we continue to grow our core revenue. At the same time, we are advancing our therapeutics development business, Fulgent Pharma, with ongoing clinical data of our lead drug candidate, FID-007, being presented tomorrow at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in San Diego. We believe these data continue to support our program, and we are excited to initiate Phase 2 studies of FID-007 in head and neck cancer in the first quarter of 2024."

Paul Kim, Chief Financial Officer, added, "We are pleased with our performance as we near the end of 2023, with momentum in the business and a strong financial profile. Even as we continue to invest in our business and repurchase shares, we are maintaining an enviable cash position with which to execute our strategy in 2024 and beyond."

Outlook

For the full year 2023, Fulgent expects:

Core Revenue of approximately $260 million
GAAP loss of approximately $2.15 per share
Non-GAAP loss of $0.95 per share
Cash, cash equivalents, and investments in marketable securities of approximately $830 million as of December 31, 2023*
*Cash expenditures may be higher or lower than currently estimated due to a variety of facts and circumstances, including as a result of the Company’s ongoing stock repurchase program or other expenditures outside of ordinary course.

Conference Call Information

Fulgent will host a conference call for the investment community today at 8:30 AM ET (5:30 AM PT) to discuss its third quarter 2023 results. The call may be accessed through a live audio webcast on the Investor Relations section of the Company’s website, View Source An audio replay will be available at the same location.

Calidi Biotherapeutics (NYSEAM: CLDI) Presents Data on CLD-201 Demonstrating Inhibition of Tumor Growth and Induction of Robust Anti-Tumor Immunity at the Society for Immunotherapy of Cancer’s 38th Annual Meeting (SITC 2023)

On November 3, 2023 Calidi Biotherapeutics, Inc. (NYSE American: CLDI or "Calidi"), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, reported the presentation of new preclinical data from the company’s CLD-201 (SuperNova) allogeneic stem cell-based platform and announces readiness for clinical trial launch in 2024 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting (Press release, Calidi Biotherapeutics, NOV 3, 2023, View Source [SID1234636937]). The meeting is taking place in San Diego from November 1-5, 2023.

CLD-201 builds on decades of stem cell and oncolytic virus research and is a novel allogeneic solution with potential advantages over an autologous approach including enhanced potency, improved manufacturing reproducibility, lower cost, and the ability to treat multiple cancer types. CLD-201 consists of allogeneic mesenchymal stem cells loaded with the oncolytic vaccinia virus CAL1, which has the potential to target a variety of solid tumors.

The poster presentation details the evaluation of CLD-201 in in vitro and animal models in the presence of complement and neutralizing antibodies, and the assessment of immune cell infiltration in treated and untreated tumors. Tumor growth inhibition and induction of anti-tumor immunity were compared in mice treated with unprotected CAL1 virus and CLD-201. Additionally, the poster presents the readiness of the product and plans to launch clinical trial in 2024.

"This new CLD-201 data further supports the potential of our stem-cell based platform to effectively target a variety of solid tumors while exhibiting promising anti-tumor effects in multiple animal models," said Antonio F. Santidrian, PharmD, Ph.D., Chief Scientific Officer of Calidi Biotherapeutics. "We believe that CLD-201 is a very promising immunotherapy platform, based on its observed inhibition of tumor growth in multiple tumor types and its powerful anti-tumor immune effects, as well as its superiority to existing autologous therapies as an allogeneic alternative. We look forward to initiating a Phase 1 clinical trial in 2024 and generating additional data on the potential of CLD-201 to treat advanced solid tumors."

Key highlights from the poster presentation are below:

Multiple allogeneic adipose tissue-derived mesenchymal stem cell banks were generated, and one was selected for GMP manufacturing and loaded with the oncolytic vaccinia virus CAL1, creating CLD-201.
CLD-201 demonstrated greater resistance to inactivation by the humoral immune system compared to the unprotected CAL1 virus.
CLD-201 significantly inhibited the growth of the tumors even at the very low dose of 1.5×103 cells containing 1.6×104 viral plaque forming units (PFU).
CLD-201 has been successfully GMP manufactured, and its safety profile has been analyzed in both immunocompetent and immunocompromised pre-clinical models.
Full details for the poster presentation are below:

Title: A Novel Stem Cell-based Platform for Delivery and Potentiation of Oncolytic Virotherapies
Presenting Authors: Antonio F. Santidrian, PharmD, Ph.D., Chief Scientific Officer, Calidi Biotherapeutics
Boris R. Minev, MD. President, Medical & Scientific Affairs, Calidi Biotherapeutics
Abstract Number: 1419
Date: Friday, November 3, 2023
Time: 9:00 AM – 7:00 PM PDT

Following the meeting, a copy of the poster will be available on the Scientific Publications page of Calidi’s website at: View Source