This week’s Respiratory Research update highlights regulatory approvals, advancing clinical programs, novel diagnostic approaches, and continued progress across infectious, fibrotic, and critical respiratory diseases.
In Today’s Newsletter
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🫁 MiNK doses first Phase 2 patient for agenT-797 in acute lung injury [1] [Ukraine • 28 May 2026]
https://investor.minktherapeutics.com/news-releases/news-release-details/mink-therapeutics-announces-first-patient-dosed-randomized-phase
Context: C-1300-02 is a randomized Phase 2 trial of agenT-797 plus standard of care versus placebo plus standard of care in acute lung injury meeting Global ARDS criteria.
Key point: MiNK Therapeutics dosed the first patient at First Lviv Territorial Medical Union in Lviv, Ukraine, with US site expansion underway.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Precigen reports longer PAPZIMEOS response durability in RRP [2] [US • 30 May 2026]
https://investors.precigen.com/news-releases/news-release-details/precigen-presents-new-long-term-durability-data-papzimeos
Context: PAPZIMEOS (zopapogene imadenovec-drba) is FDA-approved for adults with recurrent respiratory papillomatosis.
Key point: Precigen reported that 15 of 18 complete responders had ongoing complete responses as of 30 Apr 2026, with no new safety events during long-term follow-up.
Implication: May influence prescriber choice and payer reviews pending full data.
🩻 SPECT/CT approach differentiates ILD inflammation from fibrosis [3] [US • 01 Jun 2026]
https://medicalxpress.com/news/2026-06-spect-imaging-approach-distinguishes-inflammation.html
Context: Researchers evaluated ⁹⁹ᵐTc-maraciclatide SPECT/CT in 15 participants, including idiopathic pulmonary fibrosis, fibrotic hypersensitivity pneumonitis, and healthy controls.
Key point: The approach showed distinct lung uptake in ILD cohorts versus healthy controls, supporting differentiation of inflammatory activity from fibrosis.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🦠 Invivyd completes enrollment in Phase 3 DECLARATION for VYD2311 [4] [US • 01 Jun 2026]
https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-completion-enrollment-upsized-declaration
Context: DECLARATION is a Phase 3 randomized, triple-blind, placebo-controlled trial of VYD2311 for prevention of symptomatic COVID-19.
Key point: Invivyd completed enrollment after upsizing the trial by about 500 participants, with topline results expected around late Q3 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
💪 Rejuvenate Biomed completes RJx-01 Phase 2 recruitment in COPD sarcopenia [5] [Belgium • 01 Jun 2026]
https://www.rejuvenatebiomed.com/en/news/rejuvenate-biomed-completes-recruitment-in-phase-2-trial-assessing-first-in-class-multi-pathway-therapeutic-rjx-01-in-copd-induced-sarcopenia
Context: MINT-COPD is a randomized, double-blind, placebo-controlled Phase 2 trial of RJx-01 in COPD-induced muscle weakness and sarcopenia.
Key point: Rejuvenate Biomed completed recruitment and expects topline Phase 2 data by year-end 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
🫀 Corsair reports positive Phase 1 data for TRX-248 patch in PAH [6] [US • 01 Jun 2026]
https://www.corsairpharma.com/post/corsair-pharma-announces-positive-phase-1-results-for-the-trx-248-transdermal-system-in-pulmonary-ar
Context: The first-in-human Phase 1 trial evaluated single-dose safety and pharmacokinetics of TRX-248 Transdermal System in nine female volunteers.
Key point: Corsair Pharma reported steady treprostinil plasma levels over 24 hours, dose proportionality across patch sizes, and acceptable safety and skin tolerability.
Implication: May influence prescriber choice and payer reviews pending full data.
💊 Shionogi wins FDA approval for XOCOVA COVID-19 post-exposure prophylaxis [7] [US • 01 Jun 2026]
https://www.shionogi.com/global/en/news/2026/06/20260601.html
Context: XOCOVA (ensitrelvir) is an oral SARS-CoV-2 main protease inhibitor approved for post-exposure prophylaxis in adults and adolescents 12 years and older.
Key point: FDA approval was based on SCORPIO-PEP, where XOCOVA reduced symptomatic COVID-19 risk by 67% through Day 10 versus placebo.
Implication: Introduces competition that may affect pricing and formulary access.
🌬️ MannKind advances inhaled nintedanib DPI program in IPF [8] [US • 03 Jun 2026]
https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-enters-data-rich-development-period-completion
Context: Nintedanib DPI (MNKD-201) uses MannKind’s Technosphere dry powder inhalation platform to deliver nintedanib directly to the lung.
Key point: MannKind completed patient randomization in Phase 1b INFLO-1 and enrolled the first patient in global Phase 2 INFLO-2.
Implication: May influence prescriber choice and payer reviews pending full data.
🧫 Omnix doses first Phase 2 patients with OMN6 for resistant Acinetobacter [9] [Israel • 03 Jun 2026]
https://www.biospace.com/press-releases/omnix-medical-announces-first-patients-dosed-in-phase-ii-trial-of-antimicrobial-lead-compound-omn6
Context: OMN6 is a first-in-class antimicrobial peptide targeting severe multidrug-resistant Acinetobacter baumannii infections.
Key point: Omnix Medical dosed first patients in a Phase IIa trial in HABP or VABP caused by Acinetobacter baumannii complex.
Implication: May influence prescriber choice and payer reviews pending full data.
👶 MSD receives Singapore HSA approval for Enflonsia in infant RSV prevention [10] [Singapore • 03 Jun 2026]
https://www.pharmabiz.com/NewsDetails.aspx?aid=186270&sid=2
Context: Enflonsia (clesrovimab) is a long-acting monoclonal antibody for prevention of RSV lower respiratory tract disease in newborns and infants.
Key point: Singapore HSA approved Enflonsia for neonates and infants born during or entering their first RSV season.
Implication: May expand screening, initiation, and follow-up at scale.
Why it matters
- Respiratory pipelines remain active across acute lung injury, ILD, IPF, PAH, COPD-related sarcopenia, RSV, and COVID-19.
- Multiple updates are execution milestones rather than efficacy readouts, so near-term data timing matters.
- Several programs use differentiated delivery or modality strategies, including cell therapy, inhaled DPI, transdermal prodrug delivery, and long-acting antibodies.
- Regulatory wins for XOCOVA and Enflonsia add prevention-focused options in COVID-19 and RSV.
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FAQ
What did MiNK Therapeutics report for agenT-797?
MiNK dosed the first patient in randomized Phase 2 C-1300-02, evaluating agenT-797 plus standard of care in acute lung injury and critical illness. Preliminary data are expected in H2 2026. [1]
What is new for Precigen’s PAPZIMEOS?
Precigen presented long-term pivotal-study follow-up in adults with recurrent respiratory papillomatosis, including ongoing complete responses beyond 4 years in five responders. [2]
What did Shionogi’s FDA approval cover?
FDA approved XOCOVA (ensitrelvir) for post-exposure prophylaxis of COVID-19 in adults and adolescents 12 years and older after contact with an infected individual. [7]
What is MannKind testing with nintedanib DPI?
MannKind is developing an inhaled dry powder version of nintedanib for idiopathic pulmonary fibrosis, with Phase 1b data expected in Q3 2026 and Phase 2 underway. [8]
What does Singapore’s Enflonsia approval mean?
Singapore HSA approved MSD’s Enflonsia (clesrovimab) to help prevent RSV lower respiratory tract disease in newborns and infants entering their first RSV season. [10]
Entities / Keywords
MiNK Therapeutics, agenT-797, C-1300-02, allogeneic iNKT cell therapy, acute lung injury, ARDS, critical illness
Precigen, PAPZIMEOS, zopapogene imadenovec-drba, recurrent respiratory papillomatosis, RRP, HPV 6, HPV 11
⁹⁹ᵐTc-maraciclatide, SPECT/CT, interstitial lung disease, ILD, idiopathic pulmonary fibrosis, hypersensitivity pneumonitis
Invivyd, VYD2311, DECLARATION, monoclonal antibody, COVID-19 prevention, SARS-CoV-2
Rejuvenate Biomed, RJx-01, MINT-COPD, COPD-induced sarcopenia, muscle weakness
Corsair Pharma, TRX-248, treprostinil, transdermal system, pulmonary arterial hypertension, PAH
Shionogi, XOCOVA, ensitrelvir, SCORPIO-PEP, COVID-19 post-exposure prophylaxis
MannKind, nintedanib DPI, MNKD-201, INFLO-1, INFLO-2, idiopathic pulmonary fibrosis, IPF
Omnix Medical, OMN6, antimicrobial peptide, Acinetobacter baumannii, HABP, VABP, CRAB
MSD, Merck & Co., Enflonsia, clesrovimab, RSV, infant prophylaxis, Singapore HSA
References
- https://investor.minktherapeutics.com/news-releases/news-release-details/mink-therapeutics-announces-first-patient-dosed-randomized-phase
- https://investors.precigen.com/news-releases/news-release-details/precigen-presents-new-long-term-durability-data-papzimeos
- https://medicalxpress.com/news/2026-06-spect-imaging-approach-distinguishes-inflammation.html
- https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-completion-enrollment-upsized-declaration
- https://www.rejuvenatebiomed.com/en/news/rejuvenate-biomed-completes-recruitment-in-phase-2-trial-assessing-first-in-class-multi-pathway-therapeutic-rjx-01-in-copd-induced-sarcopenia
- https://www.corsairpharma.com/post/corsair-pharma-announces-positive-phase-1-results-for-the-trx-248-transdermal-system-in-pulmonary-ar
- https://www.shionogi.com/global/en/news/2026/06/20260601.html
- https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-enters-data-rich-development-period-completion
- https://www.biospace.com/press-releases/omnix-medical-announces-first-patients-dosed-in-phase-ii-trial-of-antimicrobial-lead-compound-omn6
- https://www.pharmabiz.com/NewsDetails.aspx?aid=186270&sid=2
