On October 25, 2024 Egle Therapeutics, a biotechnology company focused on advancing the next generation of regulatory T cell-focused therapies for oncology and auto-immunity, reported that it will present at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting taking place in Houston, Texas from November 6th to 10th, 2024 (Press release, Egle Therapeutics, OCT 25, 2024, View Source [SID1234647434]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The presentation, entitled "Preferential tumor retention of EGL-001, a CTLA-4/CD25 antagonist fusion protein, to selectively deplete tumor Tregs and minimize peripheral toxicities: towards a first-in-human clinical study", will highlight the development and promising preclinical results of EGL-001, a humanized antibody designed to selectively target regulatory T cells (Tregs) within the tumor microenvironment. The data showcases EGL-001’s potential as single-agent and to enhance the effectiveness of immune checkpoint blockade therapies by depleting tumor-associated Tregs, leading to increased CD8+ T cell activation and anti-tumor responses in preclinical models.

The SITC (Free SITC Whitepaper) presentation will include key findings from studies in mouse models and cynomolgus monkeys, demonstrating the safety, tolerability, and efficacy of EGL-001, as well as its preferential tumor accumulation and rapid clearance from peripheral organs. These promising results leading Egle Therapeutics to conduct a first-in-human open-label, phase I/II trial evaluating the safety, tolerability, PK and preliminary activity of EGL-001 in patients with selected solid tumors, with the goal to address the critical need for more effective immunotherapies in cancer treatment.

Session Date Saturday, Nov. 9 ; Location: George R. Brown Convention Center – Level 1 – Exhibit Halls AB ; Poster Board Number: 674

On October 25, 2024 enGene Holdings Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage genetic medicines company whose non-viral lead investigational product detalimogene voraplasmid (also known as detalimogene, and previously EG-70) is in an ongoing pivotal study in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis), reported that it has agreed to sell 6,758,311 of its common shares at a price per share of $8.90 (Press release, enGene, OCT 25, 2024, View Source [SID1234647433]). The financing is expected to close on October 29, 2024, subject to customary closing conditions. enGene anticipates the gross proceeds from the private placement to be approximately $60 million, before deducting any offering-related expenses.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The financing included participation from new and existing investors, including Deep Track Capital, Cormorant Asset Management, Forbion, OrbiMed, Sphera Healthcare, Vestal Point Capital and Venrock Healthcare Capital Partners.

enGene intends to use the net proceeds from this financing to fund the continued development of detalimogene, pre-commercial activities, the potential expansion of the DDX platform, and for working capital and general corporate purposes. The proceeds from this financing, combined with current cash and cash equivalents, are expected to be sufficient to fund the current operating plan into 2027.

Leerink Partners, Piper Sandler & Co., Guggenheim Securities and Wells Fargo Securities are acting as placement agents to the Company in connection with the private placement.

The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. enGene has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the common shares issued in this private placement. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

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.

On October 25, 2024 Traverse Biotech, Inc., a privately held biotechnology company specializing in innovative immunotherapy solutions, reported that it will present a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 39th Annual Meeting, taking place November 6-10, 2024, in Houston, TX (Press release, Traverse Biotech, OCT 25, 2024, View Source [SID1234647431]). The presentation will showcase preclinical results on TB-Bs1, Traverse’s T-cell engaging product candidate targeting ROR2-positive solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Poster Presentation Details:

Title: ROR2-targeted T-cell engager as a novel therapeutic approach in solid tumors
Abstract Number: 1065
Location: Exhibit Halls A-B, George R. Brown Convention Center
Date: Friday, November 8, 2024
Attending from Traverse Biotech:

Brandy Houser, Ph.D., Co-Founder & Chief Executive Officer
Jing Gong, Ph.D., Director of Strategy and Operations
About TB-Bs1
TB-Bs1 is a first-in-class T-cell Engaging (TCE) bispecific antibody built on the DuoBody platform targeting ROR2. ROR2 is a receptor that has been shown to cause cancer cell proliferation and that has also been identified as a negative prognostic indicator. ROR2 is a member of the receptor tyrosine kinase-like orphan receptor family associated with Wnt signaling. We and others have confirmed ROR2 protein expression in liquid and solid cancers, with TB-Bs1 demonstrating consistent cytotoxic activity against ROR2-positive cancer cell lines. In a humanized mouse model, TB-Bs1 significantly inhibited tumor growth in a dose-dependent manner with minimal adverse effects. These results highlight the potential of TB-Bs1 as a targeted immunotherapy for ROR2-positive cancers.

On October 25, 2024 RiboX Therapeutics Ltd. (RiboX), a pioneering biopharmaceutical company, focused on discovering and developing fully engineered circular RNA therapeutics, reported that the US Food and Drug Administration (FDA) has cleared its IND application for the Phase I/IIa Study of RXRG001 (SPRINX-1 Study) on October 25th, 2024 (Press release, RiboX Therapeutics, OCT 25, 2024, View Source [SID1234647430]). RXRG001 is the first-ever circular RNA therapy to receive FDA IND clearance. This important advancement marks a significant milestone as circular RNA drugs advance into the clinical development phase. The first-in-human SPRINX-1 study is designed to evaluate the safety and efficacy of RXRG001 in patients with radiation-induced-xerostomia (RIX) (dry mouth) and hyposalivation (low saliva secretion).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Xerostomia and hyposalivation are common side effects of radiation therapy in head and neck cancer (HNC) patients. The incidence of HNC is increasing and has become the sixth most common malignant tumor worldwide. Radiation therapy, a main treatment for HNC, often results in damage to salivary glands and a significant decrease in saliva secretion, frequently leading to dry mouth, difficulties in chewing and swallowing, impaired oral health, and diminished quality of life. It has been two decades since the last xerostomia treatment was approved by the FDA. Patients reported that current treatments are ineffective, temporary, and costly. There is a significant unmet medical need to develop a new treatment for xerostomia and hyposalivation.

RXRG001 is a proprietary product developed using innovative circular RNA technology. In recent years, circular RNA has emerged as the next generation mRNA therapy due to its high protein expression efficiency, low immunogenicity, and manufacture stability. RXRG001 consists of the circular RNA coding human aquaporin 1 (hAQP1, a water channel protein of cell membrane), encapsulated in lipid nanoparticles (LNPs). RXRG001 increases saliva production by restoring water permeability via overexpression of hAQP1, therefore it alleviates dry mouth symptoms. Non-clinical studies demonstrated a favorable risk and benefit profile of RXRG001 in animal models. For instance, a single administration of RXRG001 led to a significant increased salivary flow which was sustained for about four weeks.

"RIX is a devastating life-long health issue for patients with HNC. Although radiation therapy improves patients’ survival, its damage to the salivary glands leads to an impaired quality of life of many cancer survivors," said Dr. Yizhen Xu, Chief Medical Officer of RiboX. "RXRG001 may offer a potential effective and sustained therapeutic option for RIX patients. We are excited to conduct clinical trials to further evaluate its efficacy and safety in patients."

"The FDA’s clearance of the IND application for RXRG001 is an acknowledgment of our innovative capabilities, robust technology, and competitiveness in the field of circular RNA therapeutics." Dr. Weiyi Zhang, Chief Executive Officer of RiboX, stated "RiboX will advance the clinical development of RXRG001, continue leveraging the unique advantages of circular RNA technology in therapeutic applications, and introduce more pioneering treatments to patients around the world."

On October 25, 2024 Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, reported the dosing of first patients in global clinical trials involving two pipeline programs: Phase I/II clinical trial of JBI-802 in heme-oncology and Phase I clinical trial for JBI-778 in solid tumors (Press release, Jubilant Therapeutics, OCT 25, 2024, View Source [SID1234647429]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are excited to take this significant step forward in our mission to transform the lives of patients through the development of easy to administer precision oral medicines with enhanced safety and therapeutic efficacy," said Hari S Bhartia, Chairman, Jubilant Therapeutics Inc.

JBI-802 is a first-in-class, orally administered, small-molecule dual inhibitor of LSD1 (Lysine-specific histone demethylase 1A) and HDAC6 (Histone deacetylase 6) within the CoREST (Co-repressor of Repressor Element-1 Silencing Transcription) complex. In the earlier Phase I study conducted in advanced solid tumor patients, JBI-802 showed a dose-proportional increase in exposure across cohorts and a strong correlation between exposure and the on-target effect of platelet decrease. There were no reports of Dysgeusia and Anemia, typical adverse events seen with LSD1only inhibitors. The Phase I trial also showed anti-tumor activity in Non-Small Cell Lung Cancer (NSCLC) patients including a confirmed partial response. Overall, the study results provided human proof-of-principle for expanding the development of JBI-802 in Essential Thrombocythemia and Myelodysplastic Syndrome/Myeloproliferative Neoplasms (MDS/MPN) with thrombocytosis.

Essential Thrombocythemia is a chronic disease of excessive platelets with over 100,000 patients in the United States for whom the primary treatment is hydroxyurea, a therapy that poses severe limitations for patients in terms of both safety and efficacy.

The second clinical trial is to assess both safety and the recommended Phase II dose for JBI-778, an oral brain-penetrant inhibitor of PRMT5 (Protein arginine N-methyltransferase 5) in mEGFR Tyrosine Kinase Inhibitor (TKI) resistant NSCLC, IDH+ high-grade glioma (HGG) and Adenoid Cystic Carcinoma (ACC).

PRMT5, although a proven pathway for multiple cancers, has produced mixed results in terms of drug development due to safety concerns surrounding SAM competitive approach to PRMT5 inhibition and patient segment limitations of MTAP null tumor-focused approach PRMT5 inhibition. JBI-778 is a unique substrate competitive brain penetrant PRMT5 inhibitor that has shown no adverse effects in preclinical setting and can address both MTAP null and wild type tumors as well as brain tumors, catering to a larger patient segment including those with brain metastases.

"The two most advanced novel drug candidates at Jubilant Therapeutics Inc. were discovered in-house using our TIBEO (Therapeutic Index and Brain Exposure Optimization) Discovery Engine. It is our unique approach of structure-based drug design to generate novel pharmacophores with improved therapeutic index compared to existing agents. We are excited to advance both JBI-802 and JBI-778 in genetically-defined subsets of patients with select hematological and solid tumor indications with high unmet medical needs. Initial clinical data are expected to read out in 2025," said Syed Kazmi, Chief Executive officer, Jubilant Therapeutics Inc.

About JBI-802

JBI-802 is novel, oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6. It targets stem cell modulation by inhibiting LSD1 and modulates immune suppression with isoform selective HDAC6 inhibition. Preclinical research has demonstrated its synergistic anti-tumor activity, which is superior compared to either target alone and with a favorable safety profile. JBI-802 is under evaluation in both hematological cancers such as acute myeloid leukemia, myelodysplastic syndrome and other myeloproliferative cancers as well as solid tumors, such as non-small cell lung cancer and small cell lung cancer.

About JBI-778

JBI-778 is novel, oral, potent and brain penetrant inhibitor of PRMT5. JBI-778 targets the substrate site and stabilizes SAM bound to PRMT5, providing high biological selectivity and has shown a superior safety profile as seen in animals. Preclinical research has demonstrated significant activity in Tyrokinase-Inhibitor resistant cell lines, brain tumor and NSCLC. JBI-778 is under evaluation in solid tumors such as NSCLC, High Grade Glioma and Adenoid Cystic Carcinoma.