AD-214 / AdAlta - LARVOL DELTA

Second Generation I-Body AD-214 Attenuates Unilateral Ureteral Obstruction (UUO)-Induced Kidney Fibrosis Through Inhibiting Leukocyte Infiltration and Macrophage Migration. (PubMed, Int J Mol Sci) - "In a scratch assay, AD-214 also inhibited macrophage migration. To conclude, i-body AD-214 attenuates UUO-induced kidney fibrosis by inhibiting leukocyte infiltration and macrophage migration."

Journal • Chronic Kidney Disease • Fibrosis • Immunology • Nephrology • Renal Disease • CXCR4 • TGFB1

AdAlta delivers positive Phase I Extension Study results for AD-214 (Yahoo Finance) - P1 | N=8 | NCT05914909 | Sponsor: AdAlta Limited | "AdAlta Ltd (ASX:1AD) managing director Tim Oldham sits down with Proactive’s Jonathan Jackson to discuss encouraging outcomes from a Phase I extension study of their lead asset, AD-214, aimed at combating Idiopathic Pulmonary Fibrosis (IPF). This pivotal study assessed the target Phase II dose of AD-214 in healthy volunteers, marking a significant milestone in the drug's development pathway. The study's positive results have addressed the inquiries of potential partners. AD-214 exhibited a commendable safety profile, with consistent pharmacokinetics (PK) and pharmacodynamics (PD) across all doses and participants....There was no evidence of adverse effects that could undermine efficacy, even with prolonged use, highlighting AD-214's potential as a treatment for IPF."

P1 data • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

Safety, Tolerability, PK and PD Study of AD-214 Administered to Healthy Volunteers and Patients With Interstitial Lung Disease or Chronic Kidney Disease (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: AdAlta Limited | Not yet recruiting ➔ Completed | N=16 ➔ 8 | Trial completion date: Jul 2024 ➔ Feb 2024 | Trial primary completion date: Jul 2024 ➔ Feb 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Chronic Kidney Disease • Interstitial Lung Disease • Nephrology • Pulmonary Disease • Renal Disease • Respiratory Diseases • CXCR4

AdAlta completes enrolment for AD-214 fibrosis safety trial (Yahoo Finance) - P1 | N=50 | NCT04415671 | Sponsor: AdAlta Limited | "AdAlta Ltd (ASX:1AD) CEO Dr Tim Oldham tells Proactive the company has wrapped up the enrolment of healthy volunteers for its AD-214 Phase 1 extension study, and early indications are that it is well tolerated. The aim of the trial is to evaluate the safety of AD-214, the company’s flagship candidate for treating fibrotic diseases including Idiopathic Pulmonary Fibrosis."

Enrollment closed • P1 data • Idiopathic Pulmonary Fibrosis

AdAlta links AD-214 results with efficacy thanks to new data (Yahoo Finance) - P1 | N=NA | "AdAlta Ltd...CEO Tim Oldham tells Proactive’s Elisha Newell that new data on lead drug candidate AD-214 favourably links preclinical animal studies and Phase I human trial results, providing important dose frequency insights as it moves through the clinic. The findings de-risk the I-body candidate’s future move into Phase 2 clinical trials and stand to boost confidence as AdAlta progresses partnership discussions."

P1 data • Idiopathic Pulmonary Fibrosis

AdAlta receives ethics approval to extend Phase 1 clinical study for i-body AD-214 targeting fibrotic disease (Investing.com) - "AdAlta...has received Human Research Ethics Committee (HREC) approval to extend the Phase 1 clinical study of its lead product candidate AD-214 targeting fibrotic disease including idiopathic pulmonary fibrosis. 'The AD-214 Phase I extension study aims to confirm safety and pharmacokinetic and pharmacodynamic trends of multiple doses of AD-214 using higher doses than in the previous study'...'This data is important to establish the safety and to better inform the target dosing schedule of AD-214 at the doses planned for Phase II studies.'"

New P1 trial • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

Safety, Tolerability, PK and PD Study of AD-214 Administered to Healthy Volunteers and Patients With Interstitial Lung Disease or Chronic Kidney Disease (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: AdAlta Limited

New P1 trial • Chronic Kidney Disease • Interstitial Lung Disease • Nephrology • Pulmonary Disease • Renal Disease • Respiratory Diseases • CXCR4

AdAlta to support early return to clinical trials of AD-214 with rights offer (Benzinga) - "AdAlta Ltd (ASX:1AD) managing director Dr Tim Oldham tells Proactive the company is seeking an early return to clinical trials of its lead asset, AD-214, with a $3.5 million non-renounceable rights offer. AdAlta has already received commitments from investors for $2.49 million of the target amount."

New trial • Idiopathic Pulmonary Fibrosis

AdAlta granted second Japanese patent for lead i-body AD-214 (Investing.com) - "AdAlta...has extended the range and diversity of sequences analogous to its lead program AD-214 with the grant of a second patent in Japan by the Japanese Patent Office. The clinical-stage biotechnology company developing novel therapeutic products from its i-body platform has been advised that Patent Number 2020-121974, which is entitled 'CXCR4 binding molecules', has an expiry date of January 8, 2036. It is the second patent granted in Japan for AD-214, adding to existing patent protection....It includes the lead indication of idiopathic pulmonary fibrosis as well as cancer, viral infections, inflammatory diseases, sclerosis, kidney disease, eye disorders and immune deficiency disorders and wounds."

Patent • Idiopathic Pulmonary Fibrosis

AdAlta eyes AD-214 application in kidney and lung fibrosis (Proactiveinvestors) - "The company will prioritise injectable delivery of AD-214 for lung, kidney or eye fibrosis for development. AdAlta Ltd...is eyeing the application of AD-214 - its lead program and a first-in-class antifibrotic - to kidney and eye fibrosis, areas of significant unmet need with major commercial opportunity....'We have chosen to proceed with an injectable format for AD-214. While we spent time evaluating the inhaled format through the year, it became clear that, despite being feasible, it would cost too much and take too long for us to get to the appropriate point with this formulation in time to start our next clinical trial - this time in Phase 2'....The Australian Government Medical Research Future Fund’s Biomedical Translation Bridge program part-funded the research by contributing about $1 million."

Financing • Fibrosis

AdAlta receives European patent protection until 2036 (Proactiveinvestors) - "AdAlta Ltd...has been granted its first European patent relating to lead program, AD-214, by the European Patent Office...Patent Number EP3242685, known as 'CXCR4 binding molecules', will now not expire until January 8, 2036....Validation is anticipated to be complete by August 2022. This European Patent adds to existing patent protection for AD-214 in Australia (two patents), China, India, Japan, Singapore and US (two patents)....AdAlta has completed Phase I clinical studies for its lead i-body candidate, AD-214, that is being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF)..."

Patent • Trial completion • Idiopathic Pulmonary Fibrosis

Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy Volunteers (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: AdAlta Limited | Active, not recruiting ➔ Completed | Trial completion date: Jul 2022 ➔ Feb 2022 | Trial primary completion date: Jul 2022 ➔ Oct 2021

Trial completion • Trial completion date • Trial primary completion date • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

AdAlta finalises preclinical development program for inhaled version of anti-fibrotic drug, AD-214 (Proactiveinvestors) - "AdAlta Ltd...has finalised its preclinical development program to develop an inhaled version of AD-214, the company’s first-in-class therapeutic for fibrotic diseases including Idiopathic Pulmonary Fibrosis (IPF) and other Interstitial Lung Diseases (ILDs)....Looking ahead, work to optimise a formulation of AD-214 for nebulisation and inhalation is expected to be completed in parallel with preclinical studies, enabling large animal toxicology studies to be initiated in the March quarter of next year....'As the data becomes available progressively over the next two quarters, inhaled AD-214 will be further de-risked, enabling additional partnering discussions.'"

Preclinical • Idiopathic Pulmonary Fibrosis

AdAlta granted Chinese patent protecting idiopathic pulmonary fibrosis therapy AD-214 (Proactiveinvestors) - "AdAlta Ltd...has secured a first Chinese patent relating to its lead idiopathic pulmonary fibrosis (IPF) program, AD-214, from the China National Intellectual Property Administration.The clinical stage biotechnology company developing novel therapeutic products from its i-body platform has secured Patent Number CN 107427574 B, named 'CXCR4 binding molecules', which expires on January 8, 2036."

Patent • Idiopathic Pulmonary Fibrosis

INHALED AD-214 PASSES FIRST DEVELOPMENT MILESTONE (HotCopper) - "AdAlta Limited...is pleased to announce that initial testing of AD-214 in nebulisation devices has exceeded expectations...Efficacy studies of AD-214 delivered by microsprayer in a bleomycin mouse model of IPF have now commenced at PharmaLegacy Laboratories (Shanghai) Co Ltd, with initial results expected early in 2022...AD-214 has successfully completed Phase I safety studies by intravenous administration and clinical supplies of drug substance for the next clinical trials are scheduled to be available in mid-2023."

New trial • Preclinical • Idiopathic Pulmonary Fibrosis

AdAlta granted second US patent for i-body platform treatment AD-214 (Proactiveinvestors) - "AdAlta Ltd...has further bolstered its patent portfolio with a second US patent for its AD-214 treatment from the company’s flagship i-body platform, granted by the US Patent and Trademark Office....The awarded patent, Number 11,142,588, is entitled 'Polypeptides which bind C-X-C chemokine receptor type 4 (CXCR4) and methods of treating or reducing the risk of fibrosis and cancer' and is directly tied to AdAlta’s first US patent, Number 10,538,596, with the same expiration date of January 8, 2036."

Patent • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

AdAlta building pipeline with target of 10 programs by 2023 for lead asset, proprietary i-body technology AD-214 (Proactiveinvestors) - “AdAlta Ltd...is building its pipeline with additional programs and is targeting 10 programs by 2023 for its lead asset – its proprietary i-body technology AD-214 – to generate a promising new class of single-domain antibody-protein therapeutics to treat some of today’s most challenging medical conditions….Lead asset AD-214 is preparing for an inhaled version for Phase II in Idiopathic Pulmonary Fibrosis (IPF), targeting a US$3 billion IPF market today.”

New P2 trial • Idiopathic Pulmonary Fibrosis • Respiratory Diseases

Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy Volunteers (clinicaltrials.gov) - P1; N=50; Active, not recruiting; Sponsor: AdAlta Limited; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

AdAlta (ASX:1AD) commences multiple-dosing in phase one clinical trial (The Market Herald) - "...AdAlta (1AD) has administered the first three doses of its AD-214 lead candidate to a cohort of healthy volunteers in a phase one clinical trial....Eight participants received either five milligrams per kilogram of AD-214 or a placebo in part B of the trial, reporting no dose-limiting adverse events....'The excellent safety profile and high receptor occupancy observed in the single-dose part A of our study facilitated rapid ethics approval of part B of the phase one program'...'We also remain on track to begin our multi-dose study in interstitial lung disease patients in the third quarter of 2021'...The company expects to complete part B of the trial by the end of the year with the phase one data set to support phase two clinical trial applications in 2022."

New P2 trial • Trial status • Idiopathic Pulmonary Fibrosis

Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy Volunteers (clinicaltrials.gov) - P1; N=68; Recruiting; Sponsor: AdAlta Limited; N=98 ➔ 68

Clinical • Enrollment change • Interstitial Lung Disease • Respiratory Diseases

AdAlta (ASX:1AD) share price rockets 31% on United States FDA update (The Motley Fool) - “The AdAlta Ltd…share price is rocketing today following the positive news on its drug trials. In mid-morning trade, the biotech company’s share price is soaring 31.4% higher to 23 cents….AdAlta utilises a range of unique compounds, known as i-bodies, to create a pipeline of drugs to treat serious diseases. This includes idiopathic pulmonary fibrosis (IPF) and other human fibrotic diseases….AdAlta advised it has been granted Orphan Drug Designation (ODD) from the United States Food and Drug Administration (FDA). In particular, this is for its lead product candidate AD-214.”

Orphan drug • Stock price • Idiopathic Pulmonary Fibrosis

".@AdAlta1AD : @US_FDA IPF Orphan Status For AD-214 - subscribe to Biotech Daily https://t.co/4E9331THtC" (@biotech_daily)

A Study to Compare PK, PD and Safety of the AD-214 10/600mg and Rabeprazole (clinicaltrials.gov) - P1; N=40; Active, not recruiting; Sponsor: Addpharma Inc.; Not yet recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Gastroenterology • Gastroesophageal Reflux Disease

A Study to Compare PK, PD and Safety of the AD-214-02 and Rabeprazole (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Addpharma Inc.

Clinical • New P1 trial • Gastroenterology • Gastroesophageal Reflux Disease

AdAlta (ASX:1AD) maintains cash burn, boosts reserves over Q1 FY21 (The Market Herald) - "In its accompanying activity statement, the company said progress in its phase 1a clinical trial for AD-214 was a highlight of the September quarter. So far, during the study, four of seven trial patients have been given the drug, reporting no adverse events over four dosage levels."

Trial status • Idiopathic Pulmonary Fibrosis