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Celcuity Secures $500 Million Credit Facility Following Positive Phase 3 Data for Gedatolisib in Advanced Breast Cancer

Oncology
  • Celcuity has upsized its senior secured credit facility to $500 million with Innovatus Capital Partners and Oxford Finance, including $350 million in committed capital and up to $150 million at mutual discretion.
  • The financing follows positive topline data from the PIK3CA wild-type cohort of the pivotal VIKTORIA-1 Phase 3 clinical study evaluating gedatolisib in advanced breast cancer patients.
  • The enhanced financial structure provides funding for the rolling NDA submission to FDA via the RTOR program and commercial launch preparations for gedatolisib.
  • Additional milestone-based funding includes $100 million upon FDA approval of gedatolisib for second-line wild-type advanced breast cancer patients and $120 million upon achieving commercial revenue milestones.

Daiichi Sankyo Expands Global Research Network with New San Diego Institute and $154M Shanghai ADC Manufacturing Facility

Oncology
  • Daiichi Sankyo has established its third international research institute in San Diego, joining facilities in Boston and Munich opened in 2024, to strengthen global research collaborations and access cutting-edge science.
  • The Japanese pharmaceutical company broke ground on a $154 million antibody-drug conjugate manufacturing facility in Shanghai's Zhangjiang Science City, marking China's first national pilot program for cross-border segmented production of biologics.
  • The Shanghai facility will localize ADC manufacturing for cancer treatments and expand supply of innovative therapies, supporting faster patient access through increased capacity and supply stability.
  • These strategic expansions reflect Daiichi Sankyo's commitment to embedding scientists in global life-science ecosystems while addressing growing cancer treatment needs through precise targeted delivery mechanisms.

AAVivo Advances In Vivo CAR-T Platform with PACE Technology for Precision Gene Delivery

CAR-TPrecision MedicineOncology
  • AAVivo's PACE platform transforms non-targeted AAV vectors into precise, cell-specific gene delivery systems for in vivo CAR-T therapy development.
  • The company's IntelligentAAV platform enables rapid development of precision biotherapies produced directly by patients' bodies for long-term disease control.
  • AAVivo's pipeline includes AVO-100 for B cell malignancies and AVO-200/AVO-300 for solid tumors, positioning the company as a leader in gene therapy innovation.

Phanes Therapeutics Doses First Biliary Tract Cancer Patient with Novel Bispecific Antibody Spevatamig

Oncology
  • Phanes Therapeutics has dosed the first biliary tract carcinoma patient with spevatamig, a first-in-class bispecific antibody targeting claudin 18.2 and CD47, in combination with chemotherapy.
  • Spevatamig has received FDA orphan drug designation for pancreatic cancer and Fast Track designation for metastatic claudin 18.2-positive pancreatic adenocarcinoma, highlighting its regulatory recognition.
  • The TWINPEAK Phase I/II trial is evaluating spevatamig's safety and efficacy across multiple advanced adenocarcinomas, with parallel trials recruiting patients in China.
  • The global biliary tract cancer treatment market is projected to grow at 5.7% CAGR to reach $1.28 billion by 2032, representing significant commercial opportunity.

Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or ICI, for the Treatment of Patients With Advanced Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)

NCT05482893RecruitingPhase 1
Phanes Therapeutics
Posted 3/15/2023

InnoCare's BTK Inhibitor Orelabrutinib Gains Singapore Approval for Relapsed/Refractory Marginal Zone Lymphoma

Drug ApprovalOncology
  • The Health Sciences Authority of Singapore has approved orelabrutinib (HIBRUKA) for treating adult patients with relapsed or refractory marginal zone lymphoma, marking InnoCare's second indication approval in the country.
  • Phase 2 trial data demonstrated a 58.9% objective response rate with a median duration of response of 34.3 months in 90 patients with marginal zone lymphoma at 24.3 months median follow-up.
  • The highly selective BTK inhibitor showed favorable safety profile with most common treatment-related adverse events being hematologic toxicities including anemia (27.9%) and decreased neutrophil count (23.4%).
  • This approval provides a new treatment option for marginal zone lymphoma patients in Singapore, an indolent B-cell non-Hodgkin's lymphoma with limited effective therapies after first-line treatment failure.

A Study to Evaluate ICP-022 in Patients With R/R Marginal Zone Lymphoma (MZL)

NCT03797456CompletedPhase 2
Beijing InnoCare Pharma Tech Co., Ltd.
Posted 4/1/2019

Nuvation Bio Surges 14.9% on Analyst Upgrades and Oncology Pipeline Progress

OncologyTargeted Therapy
  • Nuvation Bio Inc. stock surged 14.9% driven by promising clinical trial results and positive analyst sentiment from major investment firms.
  • Wedbush raised its price target to $6 while RBC increased its target to $7, reflecting growing confidence in the company's diverse oncology pipeline.
  • The company's strategic focus includes next-generation treatments such as a ROS1 inhibitor and brain-penetrant IDH1 inhibitor for cancer therapy.
  • Despite current profitability challenges with significant net losses, strong liquidity position and increased investor conference participation signal potential growth trajectory.

Lila Biologics Partners with Eli Lilly for AI-Driven Radioligand Therapy Development

OncologyAI
  • Lila Biologics announced a global licensing and multi-target research collaboration with Eli Lilly focused on discovering and developing novel radioligand therapies for solid tumor imaging and treatment.
  • The Seattle-based biotech company launched two AI/ML-powered protein therapeutic platforms: a targeted radiotherapy platform for oncology and a long-acting injectables platform for non-oncology diseases.
  • Under the collaboration agreement, Lila will design precision-targeted proteins through development candidate selection, while Lilly will handle IND-enabling studies, clinical development, and commercialization.
  • The company spun out from Nobel Laureate David Baker's lab at the University of Washington's Institute for Protein Design and utilizes proprietary LILADD™ framework for rapid protein optimization.

Legend Biotech Explores Dual Listing Strategy to Accelerate CAR-T Therapy Expansion

CAR-TOncology
  • Legend Biotech is considering a second listing outside the US, potentially on Hong Kong Stock Exchange or NASDAQ, to diversify its investor base and access new capital sources.
  • The company reported strong revenue growth of 134.73% driven by its flagship CAR-T therapy CARVYKTI, though profitability challenges persist with a net margin of 14.09%.
  • Analysts estimate the company's fair value at $44.9 per share, representing a 23.9% premium to current trading levels, with 12-month price targets averaging $75.8.
  • The dual listing strategy aligns with industry trends, as cross-border listings accounted for 62% of US IPOs in the first half of 2025.

HUTCHMED Presents Clinical Data for Multiple Cancer Therapies at Major Oncology Conferences

Targeted TherapyOncology
  • HUTCHMED will present updated clinical data for savolitinib, a selective MET tyrosine kinase inhibitor, at the 2025 World Conference on Lung Cancer, including results from SACHI, SAVANNAH, and Phase IIIb studies in non-small cell lung cancer patients.
  • The company will showcase first-in-human Phase I data for HMPL-653, a novel CSF-1R inhibitor for tenosynovial giant cell tumor, at the Chinese Society of Clinical Oncology Annual Meeting 2025.
  • Multiple investigator-initiated studies will be presented featuring fruquintinib and surufatinib combination therapies across various cancer types including colorectal, pancreatic, and biliary tract cancers.
  • The presentations span two major conferences from September 6-14, 2025, highlighting HUTCHMED's diverse oncology pipeline and collaborative research efforts.

Huadong Medicine's ROR1-Targeting ADC HDM2005 Shows Promising Phase I Results in Relapsed Lymphomas

Oncology
  • Huadong Medicine's HDM2005, a ROR1-targeting antibody-drug conjugate, demonstrated a 50% objective response rate in mantle cell lymphoma patients and 100% response rate in classical Hodgkin lymphoma patients in Phase I trials.
  • The drug showed a favorable safety profile with no severe gastrointestinal adverse reactions or peripheral neuropathy reported, addressing common toxicity concerns associated with ADC therapies.
  • HDM2005 has received orphan drug designation from the FDA for mantle cell lymphoma, providing regulatory advantages including expedited review and seven years of market exclusivity upon approval.

A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor

NCT06615193RecruitingPhase 1
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Posted 8/12/2024

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