Biomea Fusion Announces Oral and Poster Presentations of Icovamenib at the 22nd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)
Biomea Fusion (NASDAQ: BMEA) presented significant preclinical findings for icovamenib, their investigational covalent menin inhibitor, at the 22nd WCIRDC. The research demonstrated that icovamenib enhanced beta cell function and improved responsiveness to GLP-1-based therapies in human islets. Key findings showed increased expression of GLP-1 receptors and intracellular insulin, with synergistic effects when combined with therapies like semaglutide and tirzepatide.
The data suggests that icovamenib's ability to increase beta cell mass could potentially allow for lower doses of GLP-1-based therapies while maintaining glycemic targets, potentially reducing side effects. Clinical case studies indicated that short-term icovamenib treatment was well-tolerated with no significant adverse events or hypoglycemia reported.
Biomea Fusion (NASDAQ: BMEA) ha presentato risultati preclinici significativi per icovamenib, il loro inibitore covalente della menina in fase di sperimentazione, al 22° WCIRDC. La ricerca ha dimostrato che icovamenib ha migliorato la funzione delle cellule beta e la risposta alle terapie basate su GLP-1 negli isole umani. Le scoperte principali hanno mostrato un aumento dell'espressione dei recettori GLP-1 e dell'insulina intracellulare, con effetti sinergici quando combinato con terapie come semaglutide e tirzepatide.
I dati suggeriscono che la capacità di icovamenib di aumentare la massa delle cellule beta potrebbe consentire dosi inferiori di terapie basate su GLP-1, mantenendo nel contempo i bersagli glicemici e riducendo potenzialmente gli effetti collaterali. Gli studi di casi clinici hanno indicato che il trattamento a breve termine con icovamenib è stato ben tollerato, senza eventi avversi significativi né ipoglicemia riportati.
Biomea Fusion (NASDAQ: BMEA) presentó hallazgos preclínicos significativos para icovamenib, su inhibidor covalente de menin en investigación, en el 22° WCIRDC. La investigación demostró que icovamenib mejoró la función de las células beta y la respuesta a terapias basadas en GLP-1 en islotes humanos. Los hallazgos clave mostraron un aumento en la expresión de receptores de GLP-1 y de insulina intracelular, con efectos sinérgicos cuando se combinó con terapias como semaglutida y tirzepatida.
Los datos sugieren que la capacidad de icovamenib para aumentar la masa de células beta podría permitir dosis más bajas de terapias basadas en GLP-1 mientras se mantienen los objetivos glucémicos, lo que podría reducir los efectos secundarios. Los estudios de casos clínicos indicaron que el tratamiento a corto plazo con icovamenib fue bien tolerado, sin eventos adversos significativos ni hipoglucemia reportados.
Biomea Fusion (NASDAQ: BMEA)는 22회 WCIRDC에서 그들의 실험적 공유 결합 멘인 억제제인 icovamenib에 대한 중요한 전임상 발견을 발표했습니다. 연구 결과 icovamenib가 인간 섬에서 베타 세포 기능을 향상시키고 GLP-1 기반 요법에 대한 반응성을 개선했음을 보여주었습니다. 주요 발견은 GLP-1 수용체와 세포 내 인슐린의 발현 증가를 보여주었으며, 세마글루타이드 및 티르제파타이드와 같은 요법과 결합했을 때 시너지 효과가 있었습니다.
데이터는 icovamenib의 베타 세포 질량 증가 능력이 GLP-1 기반 요법의 용량을 낮추면서 혈당 목표를 유지할 수 있게 할 수 있음을 시사하며, 이는 잠재적으로 부작용을 줄일 수 있습니다. 임상 사례 연구는 단기 icovamenib 치료가 잘 견뎌졌으며 중요한 부작용이나 저혈당이 보고되지 않았음을 나타냈습니다.
Biomea Fusion (NASDAQ: BMEA) a présenté des résultats précliniques significatifs pour icovamenib, leur inhibiteur covalent de la ménine en cours d'investigation, lors du 22e WCIRDC. La recherche a démontré qu'icovamenib augmentait la fonction des cellules bêta et améliorait la réactivité aux thérapies basées sur le GLP-1 dans les îlots humains. Les principales découvertes ont montré une augmentation de l'expression des récepteurs de GLP-1 et de l'insuline intracellulaire, avec des effets synergiques lorsqu'il était combiné avec des thérapies telles que la sémaglutide et le tirzepatide.
Les données suggèrent que la capacité d'icovamenib à augmenter la masse des cellules bêta pourrait potentiellement permettre des doses plus faibles de thérapies basées sur le GLP-1 tout en maintenant les cibles glycémiques, ce qui pourrait réduire les effets secondaires. Les études de cas cliniques ont indiqué que le traitement à court terme avec icovamenib a été bien toléré, sans événements indésirables significatifs ni hypoglycémie rapportée.
Biomea Fusion (NASDAQ: BMEA) stellte auf dem 22. WCIRDC bedeutende präklinische Ergebnisse für icovamenib, ihren experimentellen kovalenten Menin-Inhibitor, vor. Die Forschung zeigte, dass icovamenib die Funktion der Betazellen verbesserte und die Reaktion auf GLP-1-basierte Therapien in menschlichen Inseln verbesserte. Schlüsselbefunde zeigten eine erhöhte Expression von GLP-1-Rezeptoren und intrazellulärem Insulin mit synergistischen Effekten in Kombination mit Therapien wie Semaglutid und Tirzepatid.
Die Daten deuten darauf hin, dass die Fähigkeit von icovamenib, die Betazellmasse zu erhöhen, potenziell niedrigere Dosen von GLP-1-basierten Therapien ermöglichen könnte, während die glykämischen Ziele aufrechterhalten werden, was potenziell Nebenwirkungen reduzieren könnte. Klinische Fallstudien zeigten, dass die kurzfristige Behandlung mit icovamenib gut vertragen wurde, ohne signifikante unerwünschte Ereignisse oder berichtete Hypoglykämie.
- Preclinical data showed synergistic effects when combining icovamenib with GLP-1-based therapies
- Clinical case studies demonstrated good tolerability with no treatment-related adverse events
- Showed 2.5-fold improvement in HbA1c reduction in SIDD and MARD subgroups
- Potential to modify disease progression in uncontrolled T2D patients
- None.
Insights
The preclinical data for icovamenib shows promising potential in diabetes treatment through multiple mechanisms. The drug demonstrates synergistic effects with GLP-1 based therapies by increasing both GLP-1 receptor expression and intracellular insulin levels in human islets. The ability to enhance beta cell mass and function addresses a fundamental issue in diabetes progression. Key findings include 2.5-fold greater HbA1c reduction in SIDD and MARD subgroups compared to SIRD and MOD subgroups, suggesting targeted efficacy in specific diabetes subtypes.
The potential to reduce required doses of GLP-1 therapies while maintaining efficacy could significantly improve the side effect profile and patient compliance. Clinical case studies also indicate good tolerability with no treatment-related adverse events or hypoglycemia, critical factors for diabetes medication adoption.
This preclinical data strengthens Biomea Fusion's market position in the lucrative diabetes treatment space. The synergistic potential with GLP-1 drugs like semaglutide (Ozempic) and tirzepatide (Mounjaro) is particularly significant, as these represent a rapidly growing
The differentiated mechanism targeting beta cell preservation and the promising subgroup analysis suggest a viable path to market entry. With a relatively modest market cap of
- In preclinical experiments, icovamenib enhanced beta cell function and responsiveness of human islets to GLP-1-based therapies. These effects were associated with an increase in the expression levels of both the GLP-1 receptor (GLP-1R) as well as intracellular insulin.
- Overall results showed synergy of the combination therapy, which may allow lower doses of GLP-1-based therapies to achieve glycemic targets, potentially reducing side effects and improving tolerability of GLP-1 based therapies.
REDWOOD CITY, Calif., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced the Company will present one oral presentation, one poster presentation, and host an oral symposium at the 22nd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) taking place in Los Angeles, California on December 12-14, 2024.
“The data we will present during the WCIRDC this year show that there may be complementary mechanisms of action between icovamenib and approved GLP-1-based therapies that have the potential to provide a synergistic response and improved efficacy for patients. We observed in preclinical experiments that icovamenib not only increased beta cell mass but also enhanced the responsiveness to the GLP-1-based therapies. These complementary effects may ultimately have the potential to increase the effectiveness of current GLP-1 based agents,” said Juan Pablo Frias, Biomea Fusion’s Chief Medical Officer. “The increase in beta cell mass from icovamenib may also potentially allow for lower doses of approved GLP-1-based therapies to achieve glycemic targets, potentially reducing side effects and improving tolerability of these agents. Icovamenib also has a proposed mechanism of action that has been shown to be complementary to metformin and SGLT2 inhibitors, two very commonly used agents in type 2 diabetes (T2D). We look forward to further exploring clinically the potential benefits icovamenib may provide to persons with diabetes.”
Oral Presentation Abstract #0069
Combination of Icovamenib and GLP-1-Based Therapeutic Agents Improves Beta Cell Function and Insulin Secretion
Presentation Time
Oral Presentation: December 13th, 2024, at 7:30pm – 9:00pm PST
Poster Presentation Abstract #0063
Investigating the Effects of Icovamenib on Poorly Managed Severe Insulin-Deficient Diabetes (SIDD): Insights from COVALENT-111 Case Studies
Presentation Time
Poster Presentation: December 12, 2024, at 6:30pm – 7:30pm PST
Breakfast Symposium
Unlocking the Potential of Menin Inhibition: Icovamenib and a look into the Future of Diabetes Management
Presentation Time
December 13, 2024, at 7:00am – 7:45am PST
Please find a link here to our website where the poster and presentations will be available.
Data Highlights for Presentations at WCIRDC
Icovamenib is an investigational covalent menin inhibitor in development to address the root cause of diabetes: the progressive decline in beta cell mass and function. The data published at the WCIRDC annual meeting showed a selective proliferation of beta cells and an increase in the expression levels of both GLP-1 receptors and intracellular insulin in human islets treated ex-vivo with icovamenib, effects reproducible in multiple donors.
Menin has been shown to regulate GLP-1R expression and, consequently, the GLP-1R pathway. Effects on GLP-1R and insulin gene expression were evaluated in islet cultures from 8 independent healthy donors. Icovamenib enhanced the responsiveness of human islets to the GLP-1-based therapies, semaglutide and tirzepatide and induced enhancement in beta cell function correlated with an increase in the expression levels of both the GLP-1R as well as intracellular insulin. Both transcript and protein levels were increased. In these experiments, icovamenib promoted controlled proliferation and enhanced insulin content in beta cells in human islet microtissues ex vivo, in a glucose- and dose- dependent manner. The overall results showed synergy of the combination therapy utilizing icovamenib together with a GLP-1 based therapy. We believe the increase in beta cell mass and improved beta cell function induced by icovamenib may allow lower doses of GLP-1-based therapies to achieve glycemic targets, potentially reducing side effects and improving tolerability of these agents.
In addition, data from earlier presentations were published at the 22nd WCIRDC, showing how covalently inhibiting menin may be particularly relevant for diabetes patients with a depleted pool of beta cells. Whereby the severe insulin-deficient diabetes (SIDD) and mild age-related diabetes (MARD) subgroups in relevant dose escalation cohorts reviewed, showed approximately a 2.5-fold improvement in HbA1c reduction versus the insulin resistant diabetes (SIRD) and the mild obesity related diabetes (MOD) subgroups. T2D subtyping reveals distinct risk profiles and provides a framework for precision medicine. In addition, data presented from clinical case studies showed the potential of short-term icovamenib treatment to modify disease progression and provide lasting effects in patients with uncontrolled T2D. In these case studies icovamenib was generally well tolerated, there were no treatment related adverse events, no dose discontinuations or modifications reported, and no symptomatic or clinically significant hypoglycemia was observed.
About Menin’s Role in Diabetes
Loss of functional beta cell mass is a core component of the natural history in both types of diabetes — type 1 diabetes (mediated by autoimmune dysfunction) and T2D (mediated by metabolic dysfunction). Beta cells are found in the pancreas and are responsible for the synthesis and secretion of insulin. Insulin is a hormone that helps the body use glucose for energy and helps control blood glucose levels. In patients with diabetes, beta cell mass and function have been observed to be diminished, leading to insufficient insulin secretion and hyperglycemia. Menin is thought to act as a brake on beta cell turnover and growth, supporting the notion that inhibition of menin could lead to the regeneration of normal, healthy beta cells. Based on these and other scientific findings, Biomea is exploring the potential for icovamenib-mediated menin inhibition as a viable therapeutic approach to potentially halt or reverse progression of T2D.
About Type 2 Diabetes
Diabetes is considered a chronic health condition that affects how the body turns food into energy and results in excessive glucose in the bloodstream. Over time, this can cause serious health problems and damage vital organs. Most people with diabetes have a shorter life expectancy than people without this disease. The Centers for Disease Control and Prevention estimates about two in five adults in the United States are now expected to develop diabetes during their lifetime. More than 37 million people of all ages (about
About Icovamenib
Icovamenib is an investigational, orally bioavailable, potent, and selective covalent inhibitor of menin. The molecule was built using Biomea Fusion’s FUSION™ System and is designed to regenerate insulin-producing beta cells with the aim to cure diabetes. Icovamenib’s proposed mechanism of action in diabetes is to enable the proliferation, preservation, and reactivation of a patient’s own healthy, functional, insulin-producing beta cells. As the potentially first disease-modifying therapy for T1D and T2D, icovamenib could become an important addition and complement to the diabetes treatment landscape once it has successfully completed its ongoing clinical studies.
About Biomea Fusion
Biomea Fusion is a clinical-stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to improve the lives of patients with diabetes, obesity, and genetically defined cancers. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response.
We are utilizing our proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small-molecule medicines designed to maximize clinical benefit for patients. We aim to have an outsized impact on the treatment of disease for the patients we serve. We aim to cure.
Visit us at biomeafusion.com and follow us on LinkedIn, X and Facebook.
Forward-Looking Statements
Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of our product candidates and development programs, their mechanism of action, and their potential relative to approved products marketed by third parties; the potential benefits to future trial design and program development of subtyping diabetes patients; our research, development and regulatory plans, the progress of our ongoing and upcoming clinical trials and the timing of such events may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that preliminary or interim results of preclinical studies or clinical trials may not be predictive of future or final results in connection with future clinical trials and the risk that we may encounter delays in preclinical or clinical development, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. These risks concerning Biomea Fusion’s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (SEC), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Contact:
Ramses Erdtmann
COO & President of Biomea Fusion
re@biomeafusion.com
FAQ
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