LCB-84

TORL plans to use the funds to finance multiple ongoing Phase I trials. Image Credit: Olivier Le Moal / Shutterstock. TORL BioTherapeutics has raised $158m in Series B-2 financing to advance the clinical development of its lead antibody-drug conjugate (ADC), TORL-1-23, for the treatment of solid tumours. The financiers included multiple venture capital firms Deep Track Capital, Goldman Sachs Alternatives, UC Investments, and Vertex Ventures HC, among others. Bristol Myers Squibb was also one of the investors. The current funding round, in addition to previous Series B funding , brings to total funds raised so far to exceed $350m. The Series B-2 funds are planned to finance the ongoing Phase I (NCT05103683) and a pivotal Phase II trial of TORL-1-23. The Phase II study is expected to aid in regulatory review and potential approval for TORL-1-23 as a treatment of claudin (CLDN) 6-positive, platinum-resistant ovarian cancer. The trial is slated to start in H2 this year. The US-based company also plans to use the proceeds to fund the ongoing Phase I trials for multiple ADC therapies in the company’s pipeline. TORL-2-307 is an ADC composed of an unnamed tumour-associated antigen (TAA) linked to an as-of-yet undisclosed cytotoxic agent. It is being evaluated in a Phase I trial (NCT05159440) in patients with CLDN 18.2 positive advanced solid tumours with adequate organ function. TORL-3-600 is an ADC that targets the cadherin 17 (CDH17) protein, which plays a role in cell-to-cell adhesion. It is currently in Phase I trial (NCT05948826) as a treatment for CDH17-positive advanced colorectal cancer. TORL-4-500 is another ACD in TORL’s pipeline. It is being evaluated in a Phase I trial (NCT06005740) as a treatment for Delta-like non-canonical Notch Ligand 1 (DLK1) positive solid tumours. See Also: Innate Pharma plans IND of ADC candidate after positive preclinical data ADCs have been identified as a key innovation area by GlobalData, with multiple companies investing in these therapies . In December 2023, Johnson & Johnson (J&J) signed a licensing agreement potentially worth $1.7bn with South Korean LegoChem Biosciences to develop and commercialise LCB84. In November, Prelude Therapeutics and AbCellera partnered to jointly discover, develop, and commercialise ADCs for cancer treatment. In October, Merck & Co (MSD) partnered with Daiichi Sankyo to develop and commercialise three of the latter’s DXd ADC candidates, potentially spending up to $22bn on the partnership. In March, Pfizer paid approximately $43bn to acquire Seagen, which specialised in  ADCs. GlobalData is the parent company of Pharmaceutical Technology .

Nipocalimab is the only therapy in the clinics for haemolytic disease of the foetus and newborn. Credit: Iryna Inshyna / Shutterstock.com. The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to Johnson & Johnson ’s (J&J) nipocalimab for alloimmunised pregnant people at increased risk of increased severe haemolytic disease of the foetus and newborn (HDFN), which can cause life-threatening anaemia. This investigational therapy is the only one in the clinics for the condition, which occurs when the blood types of the pregnant individual and the foetus are incompatible. Nipocalimab is a fully human, aglycosylated, effectorless, monoclonal antibody designed to hinder the neonatal fragment crystallisable receptor (FcRn) and reduce levels of circulating immunoglobulin G antibodies. The regulator granted BTD based on findings from the proof-of-concept, open-label Phase II UNITY clinical trial of the therapy. The multicentre, international, non-blinded trial assessed nipocalimab’s efficacy, safety, pharmacodynamics and pharmacokinetics. See Also: FDA grants fast track status to GSK’s bepirovirsen for hepatitis B Takeda’s EOHILIA receives FDA approval for EoE treatment Its primary endpoint was a live birth at or later than a gestational age of 32 weeks, without requiring an intrauterine transfusion throughout the pregnancy. The study met this primary endpoint with 54% of pregnant subjects. A small number of severe adverse events were reported in the study. These were found to be in line with events linked to pregnancy, HDFN and gestational age of the infant at birth. Nipocalimab for HDFN treatment received fast track status in July 2019, orphan drug status in June 2020 from the US regulator and orphan medicinal product designation from the European Medicines Agency in October 2019. The Phase III AZALEA trial is underway and is enrolling pregnant patients with a history of the condition. J&J autoantibody and maternal foetal immunology disease area leader and vice-president Katie Abouzahr stated: “Nipocalimab represents a novel approach for the treatment of patients at risk of severe HDFN who need proven, safe, non-surgical solutions to help address the serious health consequences of this condition. “We are committed to addressing the substantial unmet need in this devastating disease.” In December 2023, the company signed a licensing agreement with LegoChem Biosciences for the development and marketing of LCB84 in a $1.7bn. deal.