On April 22, 2024, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (referred to as "ImmuneOnco"), HKEX stock code: 01541.HK) reported that the Phase Ib clinical trial of IMM0306 in combination with lenalidomide for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) completed the first patient enrollment, marking another milestone in the company’s rapid development (Press release, ImmuneOnco Biopharma, APR 22, 2024, View Source [SID1234655700]).

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IMM0306 is a global first CD47xCD20 bi-specific molecule to enter the clinical trial stage. The company carries out a comprehensive layout of this product to explore multiple indications. Recently, two clinical research results of IMM0306 were selected for the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. IMM0306 for the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma (B-NHL) Phase I preliminary study results will be presented in the form of abstract; Another Phase Ib clinical study of IMM0306 combined with lenalidomide for the treatment of relapsed/refractory follicular lymphoma (FL) and marginal band lymphoma (MZL) was published online.

At present, In IMM0306 monotherapy appeared to have outstanding efficacy in multiple indications (including the inert lymphoma dominated by FL and MZL and DLBCL, the most common aggressive lymphoma in clinical practice). In a Phase I clinical study for relapsed or refractory B-cell lymphoma, IMM0306 monotherapy showed encouraging efficacy and a good safety profile, with no DLT observed in any of the eight dose groups and cytokine storm toxicity was not reported in all patients. In higher four dose groups (ranging from 0.8mg/kg to 2.0mg/kg), 5 cases of CR and 5 cases of PR were observed, and the ORR for treatment of relapsed refractory FL reached 41%.

In June 2023, the Phase Ib/IIa clinical trial of IMM0306 combined with lenalidomide in the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma (B-NHL) completed the first enrollment of subjects. In March this year, after discussion by the Safety Review Committee (SRC), it was unanimously approved that 1.6mg /kg QW as the RP2D dose of IMM0306 combined with lenalidomide for the treatment of advanced relapsed/refractory follicular lymphoma (FL). In addition, IMM0306 obtained patent authorization in China, the United States, Japan and Europe, consolidating leading position of ImmuneOnco in CD47/SIRPa-related drug development.

Dr. Tian Wenzhi, founder and Chairman of ImmuneOnco, said: "We are very pleased to have the first enrollment of our Phase Ib clinical trial of IMM0306 in combination with lenalidomide in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Phase I clinical study data showed good safety and clinical efficacy in monotherapy and combination with lenalidomide. In the enrolled 11 FL/MZL patients with at least 1 line of prior treatment failure, ORR reached 81.8% (3 CR, 6 PR patients). We firmly believe that IMM0306 has significant market competitiveness in late-line follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). We will continue to promote the research of IMM0306 project and strive to bring benefits to cancer patients as soon as possible."

Dr. Lu Qiying, Chief Medical Officer/Senior Vice President of ImmuneOnco, said: "It is of great significance for our company today to complete the first enrollment of the Phase Ib clinical trial of IMM0306, one of our key products, in combination with lenalidomide in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). At present, the outstanding efficacy of monotherapy has been observed in multiple indications (including the inert lymphoma dominated by FL and MZL and the most common aggressive lymphoma in clinical practice DLBCL), the data indicates that IMM0306 has broad clinical development prospects. This year, IMM0306 also had two clinical innovation research results selected for the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. At present, we are carrying out a comprehensive layout. In the current lenalidomide-combined escalation study, ORR reaches 81.8% (3 CR, 6 PR patients) in FL/MZL patients who failed at least first-line treatment. The company will accelerate the clinical development of this product for R/R DLBCL indications. We look forward to bringing new treatment options to patients with unmet medical need for R/R DLBCL."

On April 22, 2024 Xspray Pharma AB reported the strategic decision to advance its fourth product candidate XS015 into clinical trials (Press release, Xspray, APR 22, 2024, View Source [SID1234649582]). The decision follows the successful scale-up of its innovative amorphous solid dispersion (ASD) formulation of the active substance cabozantinib, used in renal cell carcinoma and other cancers. This initiative targets the U.S. market for cabozantinib, projected to reach approximately USD 2.3 billion by 2026.

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Using its proprietary HyNap technology, Xspray has enhanced the solubility and bioavailability of drugs, improving efficacy and patient outcomes for treatments like cabozantinib. The technology enables the delivery of products with better therapeutic outcomes, increased patient compliance, and fewer side effects. Today’s announcement of the decision to advance the product candidate XS015 into clinical trials has been made possible by the successful scale-up of the company’s ASD-formulation of cabozantinib.

Xspray is currently in the final phase of preparation for the anticipated launch of its first product, Dasynoc, on September 1, 2024 pending final FDA approval. This launch marks a pivotal moment as the first output from Xspray’s development pipeline and reflects significant de-risking achievements for upcoming products such as cabozantinib, notably due to synergies found in the development processes of similar PKI class of compounds.

After today’s announcement, Xspray’s product candidate portfolio has four announced product candidates based on the company’s HyNap platform: XS004 dasatinib and XS003 nilotinib for treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), and XS008 axitinib and XS015 cabozantinibn used for treatment of kidney cancer. These are improved, amorphous versions of established and marketed protein kinase inhibitors. [CH1]

As Xspray has decided to take a new product candidate to clinical trials and the portfolio moves towards commercial launch, these developments underscore the company’s commitment to innovating cancer treatment, potentially transforming standards of care in oncology.

On April 22, 2024 Alltrna, a Flagship Pioneering company unlocking transfer RNA (tRNA) biology and pioneering tRNA therapeutics to regulate the protein universe and resolve disease, reported a poster presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 27th Annual Meeting taking place May 7-11 in Baltimore and a talk and two poster presentations at TIDES USA 2024 taking place May 14-17 digitally and in-person in Boston (Press release, Alltrna, APR 22, 2024, View Source [SID1234646023]).

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Details of the presentations are as follows:

ASGCT 27th Annual Meeting

Poster Title: tRNA Therapeutics to Treat Stop Codon Disease

Session Date & Time: May 9, 12:00 PM to 7:00 PM ET

Presenter: Stephen Eichhorn, Ph.D., Head of Computational and Molecular Biology, Alltrna

Presentation Room: Exhibit Hall

Session Title: Oligonucleotide Therapeutics

Abstract Number: 1221

TIDES USA 2024

Talk Title: Manufacturing Strategies for Chemically Modified tRNAs

Session Date & Time: May 17, 5:00 PM to 5:30 PM ET

Presenter: William Kiesman, Ph.D., Chief Technology Officer, Alltrna

Session Title: Oligonucleotide Chemistry, Manufacturing, and Controls

Poster Title: Building 3-D homology models to support tRNA structure-based drug design

Presenter: Audrey Hughes, Ph.D., Scientist II, Computational Chemistry, Alltrna

Poster Title: Quantification of Tissue Delivery for tRNA Therapeutics in LNP Formulations

Presenter: W. George Lai, Ph.D., Head of DMPK, Drug Safety and Clinical Pharmacology, Alltrna

Posters will be displayed onsite in the exhibit hall throughout TIDES USA 2024.

About Stop Codon Disease
Stop Codon Disease encompasses thousands of rare and common diseases that stem from premature termination codons (PTC) also called nonsense mutations, where the code for an amino acid has been mutated into a premature "stop" codon. This results in a truncated or shortened protein product with no or altered biological activity that causes disease. Approximately 10% of all people with a genetic disease have Stop Codon Disease, representing approximately 30 million people worldwide. Alltrna is engineering tRNA medicines that can read these PTC mutations and deliver the desired amino acid, thereby restoring the production of the full-length protein.

On April 22, 2024 Pacylex Pharmaceuticals Inc. (Pacylex) is a clinical-stage pharmaceutical company focused on the development of a new class of targeted therapies, N-myristoyltransferase inhibitors (NMTi) for the treatment of hematologic cancers and solid tumors, reported that CEO Michael Weickert will present Phase 1 safety and efficacy results for zelenirstat and evidence supporting advancing it into clinical development in the Orphan Drug indication of Acute Myeloid Leukemia (AML) at the World Orphan Drug Congress USA 2024, Apr 23-25, 2024, at the Boston Convention and Exhibition Center, Boston, MA, United States (Press release, Pacylex Pharmaceuticals, APR 22, 2024, View Source [SID1234645051]).

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Details for the presentation are below. The Company’s CEO, Dr. Michael Weickert, will also be available during the conference for one-on-one meetings.

The Phase 1 dose escalation safety and tolerability study was conducted in 29 heavily pre-treated (median of 4 prior lines of drug therapy) solid tumor and lymphoma patients. Treatment related adverse events were observed in a minority of patients, and were self-limited mild to moderate gastrointestinal side effects. A recommended Phase 2 dose (RP2D) for expansion studies was established. Zelenirstat prolonged progression free and overall survival in Phase 1 solid tumor patients receiving the RP2D, compared to those receiving lower doses. Prolonged Stable Disease of 6 months or longer was observed in 57% (4/7) of the solid tumor patients receiving RP2D, including a patient with metastatic colorectal cancer who continues on treatment for more than 14 months with ongoing reductions of approximately 50% in CEA (carcinoembryonic antigen) and tumor volumes.

Preclinical studies including in vitro, ex vivo, and in vivo animal studies indicate NMT inhibition disrupts prosurvival signal initiation and oxidative phosphorylation in AML cells and completely regresses AML xenografts. Additional in vivo evidence indicates AML stem cells are even more sensitive to zelenirstat than blasts. This strongly suggests that AML patients are excellent candidates for zelenirstat, a once per day oral investigational therapy. Orphan and Fast Track designations have been granted for AML by the US FDA, and a US IND has cleared the FDA for an AML Phase 1/2 clinical study.

"Advancing zelenirstat into a second hematologic indication, AML, is a top priority for the company", said Dr. Michael Weickert, CEO of Pacylex. "AML is among the cancers most likely to respond to NMT inhibition. The high mortality of patients who have failed other available therapies makes it urgent for us to bring zelenirstat to people with AML."

On April 22, 2024 Oncopeptides reported its annual report for year 2023 (Presentation, Oncopeptides, APR 22, 2024, View Source [SID1234644675]).

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