INT301 / Intrommune Therap - LARVOL DELTA

Intrommune Therapeutics Announces Publication of OMEGA Study in Peanut Allergic Adults in Annals of Allergy, Asthma & Immunology (GlobeNewswire) - P1 | N=32 | OMEGA (NCT04603300) | Sponsor: Intrommune Therapeutics | "The findings demonstrated that OMIT with INT301 achieved an exceptional safety profile, with 100% of participants tolerating the highest dose they received. Encouragingly, there were no reports of anaphylaxis or severe systemic reactions in any of the treated participants and none of the study participants opted to withdraw from the study due to this novel treatment. Moreover, the non-systemic reactions that did occur were mostly mild, transient and localized to the mouth and lips. The robust safety profile coupled with an adherence rate of 97%, illustrates the patient-centric nature of this innovative approach."

P1 data • Food Hypersensitivity

Randomized, Placebo-Controlled, Phase 1 Safety Study of Oral Mucosal Immunotherapy in Peanut Allergic Adults. (PubMed, Ann Allergy Asthma Immunol) - "In the OMEGA trial, INT301 met all primary and secondary endpoints of safety, tolerability, and adherence. OMIT appears to be a safe and convenient option for individuals with food allergies. These results support its further evaluation in the pediatric population."

Journal • P1 data • Allergy • Food Hypersensitivity • Immunology • Pediatrics

A Randomized, Placebo-Controlled Phase 1 Safety Study of OMIT in Adults with Peanut Allergy (ACAAI 2023) - "Immunologic response to treatment suggests further evaluation. These results support continued development of INT301 in the pediatric population."

Clinical • IO biomarker • Late-breaking abstract • P1 data • Allergy • Food Hypersensitivity • Immunology • Pediatrics • Pruritus

OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Intrommune Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Allergy • Food Hypersensitivity • Immunology

OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Intrommune Therapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2022 ➔ Aug 2023 | Trial primary completion date: Sep 2022 ➔ Jul 2023

Enrollment closed • Trial completion date • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology

OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Intrommune Therapeutics | Trial completion date: Aug 2022 ➔ Nov 2022 | Trial primary completion date: Jun 2022 ➔ Sep 2022

Trial completion date • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology

Intrommune Therapeutics (BIO 2022) - "INT301 is the initial product in development by Intrommune specifically designed to help those who suffer from peanut allergy. The product is intended to significantly raise a patient’s immune threshold through daily use of OMIT toothpaste beyond what has triggered a potentially dangerous allergic reaction via accidental exposure."

Allergy • Dermatology • Food Hypersensitivity • Immunology • Urticaria

Intrommune Reports Positive Update from Ongoing Phase 1 Study in Peanut Allergy (GlobeNewswire) - P1, N=32; NCT04603300; Sponsor: Intrommune Therapeutics; "INT301 Met Safety Goals Across Four Dose Levels in Cohort 1...Intrommune Therapeutics, Inc...announced an initial update from its ongoing Phase 1 OMEGA Trial of INT301 in patients with peanut allergy. INT301 is a novel peanut desensitization immunotherapy formulated as a fully-functioning toothpaste and conveniently administered during a patient’s daily toothbrushing routine....Cohort 2 has been fully enrolled at this time....'The momentum demonstrated in the clinic has enabled the initiation of the company’s Series B fundraising process. The proceeds of this financing will accelerate the growth of Intrommune by expanding our operations, clinical research, and regulatory efforts, while moving INT301 aggressively towards registration...'"

Enrollment status • Financing • P1 data • Food Hypersensitivity

A Phase 1 Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut. (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Intrommune Therapeutics | Trial completion date: Dec 2021 ➔ Aug 2022 | Trial primary completion date: Oct 2021 ➔ Jun 2022

Trial completion date • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology

A Phase 1 Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut. (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: Intrommune Therapeutics; Trial completion date: Aug 2021 ➔ Dec 2021; Trial primary completion date: Jul 2021 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology

Intrommune Therapeutics Presents at Next Generation Food Allergy Drug Summit (GlobeNewswire) - "Intrommune Therapeutics...is participating in the Next Generation Food Allergy Drug Summit. This annual event takes place July 20-22, 2021....'We are very excited about the currently enrolling phase 1B trial of INT301, and we hope to escalate our development program based on results of this study,'...'The successful development of INT301 will demonstrate that food allergy immunotherapy can be accurately and effectively dispensed in order to ensure comprehensive patient-safety.'"

Enrollment status • Food Hypersensitivity

Intrommune Therapeutics to Present at BIO Digital 2021 (GlobeNewswire) - "Intrommune Therapeutics...announced today that it will be presenting at BIO Digital 2021. The event will be live June 10-11 & 14-18, 2021....Michael Nelson, JD, Co-Founder and CEO will provide an overview of Intrommune’s core technology for the treatment of peanut and other food allergies. The presentation will focus on lead product INT301, Intrommune’s peanut allergy treatment administered daily through the brushing of teeth, and the oral mucosal immunotherapy (OMIT) platform upon which the treatment is based....'The initiation of our phase I trial of INT301 for peanut allergic patients marks a significant accomplishment in our timeline, and represents a milestone toward our ultimate goal of developing safe and effective options for food allergy sufferers so they and their loved ones can live their lives without fear."

Review • Food Hypersensitivity

Intrommune Therapeutics Publishes Peanut Allergy and Immunotherapy Report (GlobeNewswire) - "Intrommune Therapeutics...partnered with The Solution Lab ('TSL') to publish the 'Peanut Allergy and Immunotherapy – Treatment Landscape & Future Outlook' white paper....Researchers are now exploring the utility of oral mucosal immunotherapy (OMIT). An OMIT modality that delivers allergens to a wider area of the oral cavity than other immunotherapies could dramatically increase efficacy. According to this white paper, Intrommune’s OMIT product, INT301, is a toothpaste formulated with peanut allergens, thus emerging as a strong contender to OIT."

Clinical • Food Hypersensitivity

A Phase 1 Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut. (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: Intrommune Therapeutics; Not yet recruiting ➔ Recruiting; Initiation date: Nov 2020 ➔ Feb 2021

Clinical • Enrollment open • Trial initiation date • Allergy • Food Hypersensitivity • Immunology

Intrommune Receives IND Clearance From U.S. Food and Drug Administration for INT301 (GlobeNewswire) - "Intrommune Therapeutics...today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug application (IND) for its lead product, INT301. INT301 is an oral mucosal immunotherapy (OMIT) in development for the treatment of peanut allergies...The active IND enables Intrommune to initiate its clinical program to assess the tolerability, safety, and efficacy of INT301 in peanut allergic patients."

IND • Food Hypersensitivity

Intrommune to Participate in BIO @ JPM During “J.P. Morgan Week 2021” (GlobeNewswire) - "Intrommune...will participate in BIO’s one-on-one virtual partnering meeting during the 39th annual J.P. Morgan Healthcare Conference taking place January 11 – 14, 2021...Intrommune’s lead product, INT301, is an oral mucosal immunotherapy (OMIT) product under development for the treatment of peanut allergies...INT301 has the potential to be the first allergy immunotherapy treatment that easily integrates into a person’s daily routine as both first line and long-term maintenance therapy for peanut allergy."

Clinical • Food Hypersensitivity

A Phase 1 Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut. (clinicaltrials.gov) - P1; N=32; Not yet recruiting; Sponsor: Intrommune Therapeutics

Clinical • New P1 trial • Allergy • Food Hypersensitivity • Immunology

Intrommune Therapeutics Strikes Deal with Circuit Clinical (GlobeNewswire) - "Intrommune Therapeutics has announced an expanded partnership with Circuit Clinical, a leading Integrated Research Organization (IRO). Based on this deal, Circuit Clinical will oversee the early clinical development of Intrommune’s lead drug, INT301, including a Phase 1b study planned for Q4 2020 and Q1 2021....INT301 is being developed for the treatment of peanut allergies...Circuit Clinical will support Intrommune as INT301 progresses through its IND process and throughout the phase 1b clinical trial."

Licensing / partnership • New P1 trial • Food Hypersensitivity

Recent Peer-Reviewed Publication Supports Immunotherapy for the Treatment of Food Allergies (GlobeNewswire) - "A recent publication in the journal Immunotherapy reviews a variety of immunotherapy platforms for the treatment of food allergies. The article, 'Sublingual immunotherapy for food allergy and its future directions,' reviews the potential of Sublingual Immunotherapy (SLIT) options...Phase II studies have shown SLIT for treatment of peanut allergy increases the tolerated dose of peanut by a substantial margin with fewer and less severe side effects than other modalities....Intrommune’s lead OMIT product, INT301, is being developed for the treatment of peanut allergies."

Review • Food Hypersensitivity

The cost effectiveness of treating Burkitt lymphoma in Uganda. (PubMed, Cancer) - "This study demonstrates that treating BL with locally tailored protocols is very cost-effective by international standards. Studies of this kind will furnish crucial evidence to help policymakers prioritize the allocation of LMIC health system resources among noncommunicable diseases, including childhood cancer."

HEOR • Journal

Survey confirms physician interest in peanut allergy immunotherapy (GlobeNewswire) - "Intrommune Therapeutics...announces results from a survey fielded by Allergy & Asthma Network, a nonprofit advocacy organization....Results from this survey confirmed that nearly nine out of ten (87%) physicians confirmed their desire to prescribe an FDA-approved immunotherapy treatment for peanut allergy...Additional results from this survey showed that 90% of patients and parents said they were likely to try an oral mucosal immunotherapy toothpaste, such as Intrommune’s Peanut INT301."

Retrospective data

Intrommune’s food allergy toothpaste therapy to advance to clinical trials (SnackSafely.com) - "Intrommune’s CEO Michael Nelson presented at the Biotech Showcase 2020 investor’s conference and sat for an interview with Christine Corrado of Proactive Investors...During the interview, Nelson disclosed that Intrommune had a successful pre-IND meeting with the Food and Drug Administration (FDA) and that phase 1B trials of the peanut therapy will take place this year with phase 2 trials following next year. An IND (Investigational New Drug) application is an early step toward FDA approval of a new drug."

IND • New P2 trial • Trial status

Cutting edge immunotherapy for peanut allergy presented at Biotech Showcase 2020 (AccessWire) - "Intrommune Therapeutics presented an update today on their oral mucosal immunotherapy (OMIT) technology at the Biotech Showcase™, which occurs during the annual J.P. Morgan Healthcare Conference....'The use of a patented toothpaste delivery platform is expected to improve allergy immunotherapy by increasing the precision of treatment delivery and promoting treatment adherence,' said Erick Berglund, PhD, Chief Scientific Officer."

Clinical

Intrommune to present at Biotech Showcase 2020 (GlobeNewswire) - "Intrommune Therapeutics will attend and present at the upcoming Biotech Showcase™, which occurs during the annual J.P. Morgan Biotechnology Healthcare Conference....Overview of Intrommune’s Oral Mucosal Immunotherapy (OMIT) treatment for food allergies. Intrommune’s lead product, INT301, is being developed for the treatment of peanut allergy. INT301’s unique formulation is designed to desensitize an individual with peanut allergy and is delivered via a fully-functional toothpaste."

Review

POISED Study Supports Risk of Cessation of Oral Immunotherapy for Peanut Allergy; PACE Study Indicates Safer Peanut Allergy Treatment Approaches are Needed (GlobeNewswire, Intrommune Therapeutics) - "A major study recently published in The Lancet, 'Sustained outcomes in oral immunotherapy for peanut allergy (POISED study),' further validates the benefit of oral immunotherapy (OIT) for peanut allergy treatment and highlights the potential risks of allergy immunotherapy discontinuation. 'The POISED study validates the strategy behind INT301, our lead oral mucosal immunotherapy (OMIT) treatment product for peanut allergy,' said Michael Nelson, CEO, Intrommune."

Clinical data