Taipei, Taiwan May 24th, 2023

· AG-73305 was found to be safe and tolerable with no severe adverse effects (SAEs) after a single intravitreal injection of 0.5 mg and 1 mg in DME patients.

· AG-73305 showed median improvements in Best Corrected Visual Accuity (BCVA) of 8.5 ETDRS letters with median Central Subfield Thickness (CST) improvements of -110 microns from baseline across the 2 doses.

· The efficacious effects in all 6 patients lasted between 12 and 24 weeks after a single injection of AG-73305.

Allgenesis Biotherapeutics Inc., a clinical-stage specialty pharmaceutical company focused on developing novel ophthalmic drugs, announces exciting preliminary data from the two initial cohorts of the on-going AG-77305 FIH Phase 2a clinical trial for the treatment of Diabetic Macular Edema (DME) in the US. In addition, Allgenesis completed dosing of the last patient in April 2023, and anticipates the release of the final topline data, including data from the latter two cohorts (the 2 and 4 mg cohorts), in 4Q23.

Preliminary data from the 0.5 mg (n=3) and 1 mg (n=3) cohorts demonstrated that AG-73305 was safe and tolerable after a single intravitreal injection. There were no dose-limiting toxicities and no SAEs related to AG-73305 in patients. The 0.5 mg cohort showed median improvement in BCVA of +8 ETDRS letters with CST reduction of -57.9 microns. The 1 mg AG-73305 cohort showed median improvement in BCVA of +14 ETDRS letters and CST reductions of -145 microns. All 6 patients responded to the treatment with efficacy lasting between 12 and 24 weeks after a single injection.

“We are thrilled to share this exciting preliminary data and anticipate continued improvements as we treat patients with higher doses of AG-73305.” said Madhu Cherukury, Ph.D., DABT., CEO of Allgenesis. “The current data for AG-73305 supports our hypothesis that blocking multiple pathways in the disease state can provide additional benefits to DME patients in the form of BCVA gains and durability.”

“We are very encouraged by the safety and efficacy outcomes after just one intravitreal injection with the low doses”, said Sunil Patel MD, PhD., Chief Medical Officer. “AG-73305, through its novel mechanism of action, has the potential to be a disease modifying therapy for retinal disease.”

“Given the positive data that we are seeing from the open label study, we are forging ahead with our plans to initiate a Ph2b study in DME patients.” said Dr. Cherukury.

In September 2021, Allgenesis announced it entered into a licensing agreement with AffaMed Therapeutics for the development and commercialization of AG-73305 in Greater China, South Korea, and multiple ASEAN markets.

For additional inquiries regarding collaboration and partnering opportunities related to AG-73305, please contact Jack Chang or Sandy Lai at info@allgenesis.com for more information.

About AG-73305

AG-73305 is a humanized, bi-specific Fc-fusion protein designed to simultaneously block VEGFs and integrins for the treatment of DME, nAMD, RVO, and other retinal diseases. AG-73305 contains a VEGF-trap and a disintegrin that blocks various key integrin receptors. AG-73305 has the potential to treat both anti-VEGF responders and non-responders.

About Allgenesis Biotherapeutics Inc.

Allgenesis is a clinical-stage biopharmaceutical company headquartered in Taipei, Taiwan. The company is focused on research and development of novel medicines for the treatment of eye diseases. Current projects in the pipeline include AG-73305, a potential blockbuster drug for the treatment of DME, nAMD, and other retinal diseases such as RVO, and AG-80308 for Dry Eye Disease.

新源生技：臨床2a 初期數據顯示AG-73305用於治療糖尿病性黃斑部水腫具良好的安全性和療效

• 在病患玻璃體內單次注射0.5毫克或1毫克AG-73305後，觀察到良好的安全性和耐受性，也無嚴重的不良反應。
• 給藥後，兩組病患(n=6)的最佳矯正視力(Best Corrected Visual Accuity, BCVA)可改善達8.5個ETDRS字母(中位數)，黃斑中心視網膜厚度(Central Subfield Thickness, CST)之修復也達 -110微米(中位數)。
• 在單次AG-73305治療後， 兩組受試者(n=6)之BCVA 和CST均有改善，且療效能維持12至24週。

專注於開發新穎眼科藥物的臨床階段生技新藥公司，新源生物科技股份有限公司(Allgenesis Biotherapeutics Inc.)宣佈，其在美國進行之 AG-77305首次人體(First-in-human, FIH)2a期臨床試驗治療糖尿病性黃斑水腫(DME)已取得初期結果並已於2023年4月完成最後一名患者給藥的重要里程碑，預計在2023年第四季發佈此2a期臨床試驗之最終主要結果(final topline data)，包括後續兩組高劑量2和4毫克之數據。 

分析低劑量0.5毫克(n=3)和1毫克(n=3)組別的結果得知，在單次玻璃體內注射後，受試者沒有劑量限制性毒性反應(Dose-limiting toxicities, DLT)，也無AG-73305藥物相關的嚴重不良反應，顯示AG-73305的安全性和耐受性。針對療效分析，在0.5毫克組別中，BCVA改善之中位數達8個ETDRS字母，CST修復之中位數達 -57.9微米。在1毫克組別中則顯示， BCVA改善可達14個ETDRS字母，CST修復也達-145微米。兩組受試者(n=6)均對AG-73305治療有反應，單次給藥後的療效至少維持了12週甚至持續到24週。 

新源生技執行長Madhu Cherukury博士(美國認證毒理學家, DABT)表示：「我們很興奮能跟大家分享AG-73305 臨床試驗初步的正向結果，在後續更高劑量的組別裡，病患有望能持續地受惠於新源藥物的治療。初步數據已支持我們的藥物設計理念，亦即在黃斑部病變時透過AG-73305的治療來同時阻斷多種致病路徑，期能在DME病人的視力(BCVA)改善和藥物耐久性方面，帶來更多治療的效益。」

新源生技醫療長Sunil Patel醫學博士則表示：「在單次低劑量玻璃體內注射後，AG-73305安全性和療效的結果，讓我們深受激勵。因為AG-73305具有新的作用機制，我們期待它能成為改善視網膜相關疾病之病程進展的療法(disease modifying therapy)。」

Cherukury博士說：「鑒於我們在這個臨床試驗(open label study)取得了正面且令人振奮的結果，我們正在推進相關計劃以啟動DME臨床2b期研究。」

2021年9月，新源生技宣佈已與與藹睦醫療(AffaMed Therapeutics)完成授權協議，於大中華區、韓國和多個東協(ASEAN)市場開發及銷售AG-73305。

如需進一步諮詢與AG-73305有關的合作機會，請聯繫Jack Chang或Sandy Lai(電子信箱：info@allgenesis.com)，以獲取更多訊息。 

關於AG-73305

AG-73305是一種人源化、雙特異性Fc融合蛋白，AG-73305分子具有一個血管內皮生長因子誘捕體(VEGF trap)以及一個可阻斷各種關鍵整合素的去整合蛋白(anti-integrin)，可用於治療DME、nAMD、視網膜靜脈阻塞(RVO)和其他視網膜疾病。AG-73305有機會應用於更廣大的患者範圍，不受限於對血管內皮生長因子療法有反應者或是無反應者。

關於新源生物科技股份有限公司

新源生技是一家總部位於台灣的臨床階段生技新藥公司，專精於研究和開發眼科新藥。新源生技目前正在推進的專案包含創新大分子藥物 AG-73305，可用於治療DME、nAMD、RVO等視網膜疾病，以及用於治療乾眼症的新穎性小分子 AG-80308。