lenvatinib gel suspension (AIV007) / AiViva BioPharma - LARVOL DELTA

Periocular Administration of AIV007 in the Treatment of Diabetic Macular Edema: Preliminary Phase 1 Trial Results (ARVO 2025) - P1 | "Testing this product in humans is providing information that may show it is doing something in the patient's eye that will help in vision. This product is under investigation and not approved for public use at this time."

P1 data • Diabetic Macular Edema • Ophthalmology

Periocular Administration of AIV007 Demonstrates Depot Formation for Prolonged Drug Release in Rabbits and Humans (ARVO 2025) - P1 | "Reducing this fluid may improve the patient's ability to see better and reduce the number of treatments each year to treat their buildup of fluid in the eye. This product is under investigation and not approved for public use at this time."

Preclinical • Diabetic Macular Edema • Ophthalmology • FGFR

AIV007-E02: Effect of AIV007 by Periocular Administration in Subjects With Macular Edema Secondary to Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: AiViva BioPharma, Inc. | Recruiting ➔ Active, not recruiting | N=30 ➔ 19

Enrollment change • Enrollment closed • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Gustave Roussy & Friends Invite - "09:30 - 10:00 am, Keynote speech; 15:30 - 16:00 pm, Conclusion."

Live event

Systemic and Ocular Pharmacokinetic Profile Following Periocular Administration of AIV007 Gel Formulation (AAO 2024) - "Conclusion Following a single periocular injection, AIV007 in ocular tissues remained at therapeutically relevant levels over 6 months, with low systemic exposure. AIV007 gel demonstrated a slow and prolonged drug release."

PK/PD data • Ophthalmology

AiViva Biopharma Completes Enrollment in a Phase 1 Clinical Trial of AIV007 for Age-Related Macular Degeneration and Diabetic Macular Edema (GlobeNewswire) - "AiViva Biopharma...announced that it has fully enrolled and completed dosing the last patient in a Phase 1 trial with wet age-related macular degeneration (wAMD), and/or diabetic macular edema (DME)....'We are on target to have the study completed, and full results Q1 2025'. This Phase 1 trial is a multicenter, open-label, dose-escalation safety clinical trial, with 18 subjects, who have received a single periocular injection of AIV007 and will undergo monthly evaluation for up to 6 months to assess safety, tolerability, biological activity, and the reduction of treatment burden."

P1 data • Trial status • Diabetic Macular Edema • Wet Age-related Macular Degeneration

Periocular injection of AIV007 in the Treatment of Macular Edema due to Neovascular Age-related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME): Preliminary Results of the Phase 1 Clinical Trial (ARVO 2024) - P1 | "AIV007 holds the potential as a safe and effective treatment for patients with nAMD and DME through a less invasive and durable treatment approach. Our approach in clinical development is to leverage the AIV007's novel mechanism of action, simple route of administration, and sustained release formulation to improve visual outcomes and eliminate the need for frequent intravitreal injections."

Clinical • P1 data • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

AIV007 Is a Potent Anti-angiogenic Agent with Anti-fibrotic Effect (ARVO 2024) - "AIV007 demonstrated significant inhibition of neovascularization and granulomatous inflammation, and reduction of subretinal fibrosis in multiple ocular pharmacology animal models. These findings support the clinical development of AIV007 for retinal diseases associated with these clinical symptoms such as edema and fibrosis. AIV007's broad spectrum inhibition of VEGF, FGF and PDGF pathways may offer therapeutic benefits over current anti-VEGF agents."

Age-related Macular Degeneration • Glaucoma • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

AiViva Biopharma Initiates Phase 1 Clinical Trial of AIV007 for Age-Related Macular Degeneration and Diabetic Macular Edema (GlobeNewswire) - "AiViva Biopharma...announced that it has begun a Phase 1 trial and completed dosing the first cohort of patients diagnosed with wet age-related macular degeneration (wAMD), and/or diabetic macular edema (DME)....'We are very excited to have initiated this U.S. trial,'..."

Trial status • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration

Effect of AIV007 by Periocular Administration in Subjects With nAMD or DME (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: AiViva BioPharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Effect of AIV007 by Periocular Administration in Subjects With nAMD or DME (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: AiViva BioPharma, Inc.

New P1 trial • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

LEAP-002 Trial Results Support Use of Lenvatinib Monotherapy in uHCC, Despite Missing Co-Primary End Points (Targeted Oncology) - "'The median OS of 19.0 months with lenvatinib supports its role as a standard of care in first-line advanced HCC,' Finn said....Invited discussant, R. Kate Kelley, MD...noted that prognosis has improved for patients with first-line, advanced HCC. 'The advent of multiple first- and later-line treatment options marks enormous progress in HCC and provides new opportunity to individualize treatment decisions,' she said."

Media quote

Advances in Frontline Treatment for Advanced Renal Cell Carcinoma - Episode 2 (Targeted Oncology) - "Nizar Tannir, MD: This is a busy slide that shows a summary of data regarding efficacy. Side by side, the data relate to the 4 regimens that have been approved from the 4 phase 3 trials in the first line: CheckMate 214, KEYNOTE-426, CheckMate 9ER, and the CLEAR study. We'll go into more detail about each phase 3 trial when we focus."

Video

CIO Abstract: Transarterial Chemoembolization ± (Tremelimumab and Durvalumab ± Lenvatinib) in Hepatocellular Carcinoma: EMERALD-3 (CIO 2022) - No abstract available.

Emerging Treatment Considerations in HCC: An Expert Case-Based Discussion - Episode 15: Selecting Therapy for Advanced HCC Following Atezo-Bev Failure (OncLive) - "Tanios Bekaii-Saab, MD: So, if you want to avoid diarrhea, you're thinking I'll go with lenvatinib. Anthony, I hear a lot about how atezo-bev is now line-minus-1, which I have no idea what that means but apparently it's coined specially in the northeast, not necessarily in Baltimore....Anthony El-Khoueiry, MD: We are limited by the absence of data and by the amount of extrapolation we're doing. If I want to be a purist again, I agree with you that I would go with an agent that has shown activity in previously systemically treated patients such as cabozantinib....Pierre Gholam, MD: I would say to your point, about this line minus one. I've heard this mentioned many times and I call this the amnesia strategy."

Video

Effect of Intravitreally Administered AIV007 in Subjects With nAMD (clinicaltrials.gov) - P1 | N=3 | Completed | Sponsor: AiViva BioPharma, Inc. | Recruiting ➔ Completed | N=24 ➔ 3 | Trial completion date: Sep 2021 ➔ Feb 2022

Enrollment change • Trial completion • Trial completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

The Evolving Landscape of Differentiated Thyroid Cancer Treatment - Episode 14: Second-Line Treatment Approaches for DTC (OncLive) - "Marcia Brose, MD, PhD, FASCO: I'd like to just add one thing about that which is that the data that came out from the SELECT study is really interesting. The dose-finding study, the 211 Study that followed the SELECT study, because we always assume that quality of life would be better if we gave lower doses....I think that was not necessarily what we would have predicted but I do think at the end of the day it says, no matter what drugs we're talking about, the importance of the physician in proactively managing the side effects....Lori Wirth, MD: And Marcia, you're talking about the lenvatinib Study 211."

Video

Renal Cell Carcinoma -- Lessons in Diversity, Breakthroughs, and Challenges (MedPageToday) - "The evolution of therapies in RCC and associated improved patient outcomes is awe-inspiring. However, multiple ambiguities in patient management still exist. Careful consideration of unique tumor histology and molecular features, individual patient characteristics and preferences as well as treatment cost should take place when selecting optimal therapies for patients with RCC."

Adding TACE to Lenvatinib Improves Survival in Liver Cancer (Medscape) - P3, N=NA; "In his discussion of the abstract, El-Khoueiry noted that the LAUNCH trial had several limitations, one being the heterogeneity of the patient population and potential imbalance. 'There is limited information regarding extrahepatic disease burden and distribution,' he explained. 'Another limitation is that the younger population - with the majority having hepatitis B - limits the broad applicability of the result and has a potential impact on the low rate of treatment discontinuation.'"

Media quote • P3 data

Phase 3 IMbrave150 Trial in Patients with Unresectable Hepatocellular Carcinoma: 2021 Update - Episode 2: Unresectable HCC: Selecting the Optimal Frontline Therapy (Targeted Oncology) - "Richard Kim, MD: In terms of the management of first-line treatment for advanced hepatocellular carcinoma [HCC], in the past, sorafenib was the only drug available. Sorafenib is a TKI [tyrosine kinase inhibitor] that blocks many pathways and has been around for over 10 years....However, in those subsets of patient who are not candidates for atezolizumab plus bevacizumab because of Child-Pugh B status, giving a TKI such as sorafenib or lenvatinib, or a single-agent checkpoint inhibitor, is definitely reasonable."

Video

Phase 3 IMbrave150 Trial in Patients with Unresectable Hepatocellular Carcinoma: 2021 Update - Episode 5: Looking Toward the Future Management of Unresectable HCC (Targeted Oncology) - "Richard Kim, MD: With atezolizumab plus bevacizumab being the standard first-line treatment, there are other phase 3 studies underway in the first line. Most of the studies are comparing to the control arm of a TKI [tyrosine kinase inhibitor], whether it’s lenvatinib or sorafenib....That’s a trial that’s already finished accrual. We’ll wait to hear what the results of that trial show."

Video

Effect of Intravitreally Administered AIV007 in Subjects With nAMD (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: AiViva BioPharma, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration