Relmada Therapeutics Provides Corporate Update and Reports Second Quarter 2023 Financial Results
News
Palvella Therapeutics Announces Planned Pivotal Phase 3 Study Design of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations and Topline Results from Phase 2b CODY Study in Gorlin Syndrome
QTORIN™ rapamycin has potential to become first approved therapy and standard of care for Microcystic Lymphatic Malformations in U.S.; significant commercial opportunity based on an estimated more than 30,000 individuals in the U.S. with Microcystic Lymphatic Malformations
Phase 3 SELVA pivotal study to enroll approximately 50 subjects with Microcystic Lymphatic Malformations; productive FDA end-of-phase 2 meeting completed in Q1 2023
Phase 2 study of QTORIN™ rapamycin demonstrated 100% of participants with Microcystic Lymphatic Malformations were either “Much Improved” or “Very Much Improved” as rated by the Clinician Global Impression of Change following 12-weeks of QTORIN™ rapamycin
Phase 2b CODY study of QTORIN™ rapamycin for Basal Cell Carcinomas in Gorlin Syndrome did not meet primary endpoint of new Basal Cell Carcinoma prevention at 24-weeks; pre-specified secondary endpoint demonstrated nominally statistically significant reduction in existing Clinically Suspicious and Biopsy Confirmed Basal Cell Carcinoma lesion size compared to placebo
Palvella Therapeutics Reports Topline Results from Pivotal Phase 3 VAPAUS Study of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Pachyonychia Congenita
KayoThera, Inc. Strengthens Financial Position with $5.2 Million in Grant and Expanded Series A Funding, Bringing Total Financial Support to $14 Million
New funding comprised of grants from the National Institutes of Health, The Andy Hill Cancer Research Endowment (CARE) Fund, and additional Equity Funding
Additional funding will support advancement of KayoThera’s development programs in diabetes and oncology
Halo Labs Unveils Aura+ Subscription Program for Convenient and Affordable Particle Analysis
ENB Therapeutics Presents Top-line Results from Phase 1b ENBOLDEN-101 Study in Solid Tumors Refractory to Standard of Care at the Immuno-oncology Summit 2023
ENB is developing first in class small molecule ENB-003 to selectively targeting the ETB receptor – a novel immune checkpoint
– The ENB-003 in combination with KEYTRUDA® (pembrolizumab) was well tolerated
– Promising preliminary efficacy signals with 33% disease control rate (DCR) across all cohorts
– Efficacy appears to correlate with endothelin B receptor (ETBR) expression: 83% DCR in ETBR-Hi patients in cohort 6 (RP2D)
– Platinum refractory/ resistant microsatellite stable ovarian cancer patients with 80% DCR across all cohorts
SIRPant Immunotherapeutics Appoints Jelle Kijlstra, MD, MBA as Chief Medical Officer
Accomplished healthcare executive brings extensive drug development and regulatory experience from global CRO and multiple pharmaceutical companies to SIRPant Immunotherapeutics Inc
Immunome and Morphimmune Announce Definitive Merger Agreement and Simultaneous Private Placement Investment of $125 Million to Develop Targeted Cancer Therapies
– The combined company, which will operate as Immunome, will feature a synergistic platform expected to enable the development of best-in-class targeted cancer therapies across multiple modalities
– Clay B. Siegall, Ph.D., current Morphimmune President & CEO and former co-founder & CEO of Seagen, Inc., to serve as Chairman and CEO of combined company
– A concurrent $125 million private placement investment with leading institutional investors will support development of a combined pipeline expected to submit three investigational new drug applications (INDs) within 18 months of closing
ImmunoGenesis and Cancer Focus Fund Announce $4.5 Million Investment to Support First-in-Human Trial of IMGS-001 for Relapsed or Refractory Advanced Solid Tumors
First dual-specific PD-L1/PD-L2 antibody with killing function designed to treat the many immune-excluded cancers that are resistant to existing immunotherapies
Phase 1b will focus on tumors that are resistant to existing immunotherapy, which may include ovarian, colorectal, and triple negative breast cancers
Melior Is Selected as a Top 20 CRO by Pharma Tech Outlook
– Melior has cover appearance on this industry-leading magazine
– Melior is recognized for the combination of its attention to quality, culture and, innovative offering