Toripalimab

Inovio Pharmaceuticals, Inc. (Nasdaq: INO) announced a USD 17.5 million underwritten public offering on April 2, 2026, seeking to extend its cash runway as the Pennsylvania-based company advances a pipeline spanning HPV-related diseases, oncology, and infectious diseases. The capital raise comes as Inovio works toward a potential first commercial product in INO-3107 for recurrent respiratory papillomatosis, a rare HPV-driven disease for which a Biologics License Application (BLA) is under FDA review under the Accelerated Approval Program. The offering comprises 12,500,000 shares of common stock at a combined public offering price of USD 1.40 per share, accompanied by Series A warrants to purchase up to 12,500,000 shares and Series B warrants to purchase up to 12,500,000 shares, each with an exercise price of USD 1.40 per share. Pre-funded warrants are available in lieu of common stock for investors who would otherwise exceed beneficial ownership thresholds. Inovio also granted the sole underwriter, Piper Sandler, a 30-day option to purchase up to 1,875,000 additional shares of common stock along with corresponding Series A and Series B warrants at the public offering price, less underwriting discounts and commissions. The offering was expected to close on or about April 6, 2026, subject to customary closing conditions. Company overview and pipeline Inovio is focused on developing and commercializing DNA medicines for HPV-related diseases, cancer, and infectious diseases. Its platform centers on optimizing the design and delivery of DNA-based constructs intended to instruct the body to produce its own immune responses against disease targets, administered using electroporation delivery devices such as the CELLECTRA system. The nearest-term commercial catalyst is INO-3107, a DNA immunotherapy targeting recurrent respiratory papillomatosis caused by HPV types 6 and 11. Inovio submitted a BLA for INO-3107 under the US FDA’s Accelerated Approval Program with acceptance confirmed in 2025, though the US FDA flagged a potential review issue citing insufficient information to support accelerated approval eligibility. The FDA assigned INO-3107 a PDUFA goal date of October 30, 2026, as per a company press release. In oncology, VGX-3100, a DNA immunotherapy targeting HPV16/18-related cervical high-grade squamous intraepithelial lesions, is under development in China via license to ApolloBio, currently Phase III stage, however, Inovio ended US development in 2023. INO-5401, a DNA cancer immunotherapy, is being evaluated in combination with INO-9012 and the PD-1 inhibitor cemiplimab alongside radiation and temozolomide in newly diagnosed glioblastoma multiforme in a Phase I/II study listed as active but not recruiting. INO-5401 is also under evaluation in a separate Phase I study in BRCA1/2 mutation carriers. On the business development front, Inovio entered a clinical collaboration and supply agreement with Coherus BioSciences in January 2024 to evaluate INO-3112 in combination with Loqtorzi (toripalimab-tpzi), Coherus’s FDA-approved PD-1 inhibitor, in a planned Phase III trial targeting locoregionally advanced HPV16/18-positive oropharyngeal squamous cell carcinoma across North America and Europe. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

SHANGHAI & SUZHOU, China--(BUSINESS WIRE)--Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, today announced that preclinical data from its IL-15 and IL-18 programs will be presented at the 2026 AACR Annual Meeting held April 17-22, 2026 in San Diego, California. IL-15 Programs: FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein and has demonstrated best-in-class (BIC) profile as monotherapy in heavily pre-treated patients with late stage solid tumors, of which 3 patients (~10%) remain on treatment and progression-free currently at 9, 11 and 20 months respectively. Poster 7932 further elucidated mechanism of action underlying FL115 BIC profile, with Cryo-EM analysis of FL115/FcRn/β2M complex. In vivo, RNA-Seq and single-cell transcriptomics revealed FL115 reshaped the tumor microenvironment by enhancing NK and T cells infiltration without not triggering activation of neutrophils and macrophage. Poster 6459 showed significant potential of FL115 subcutaneous formulation. Compared to IV injection, subcutaneous injection of FL115 resulted in drastic lowering of Cmax (up to 26.7×) with bioavailability at ~60% as well as good linearity in PK file. FL115 at approximately 9 mg per injection site in rabbits showed no significant gross skin irritation. IL-18 Programs: using structural modeling with our AI-driven Intelligent Biomolecular Discovery Platform, we developed a series of engineered IL-18 variants (IL-18v) that fully escape IL-18BP neutralization while providing tunable IL-18R1 affinity, enabling customizable cytokine potency, as described in Poster 7779. Based on one such IL-18v, we developed FL116, a PD-1/interleukin-18 (IL-18) bispecific antibody. Poster 1777 showed FL116 achieved potent anti-tumor activities and rechallenge-confirmed immune memory while maintaining systemic immune homeostasis in multiple tumor models, and re-ignited intratumoral cytotoxic immunity while reshaping the TME toward a highly inflamed, effector-dominant state. “Forlong’s pipeline strategy is to modulate the immune system with precision via stimulation of specific immune cell subpopulation through engineered cytokines, providing new options for patients,” said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, “IL-15 and IL-18 have long been believed to be attractive cytokines for cancer immunotherapy, and we appreciate the opportunity to present initial data of FL115 and FL116 programs to leading immuno-oncology experts in this prestigious forum.” Poster Details: Title: A tunable interleukin-18 (IL-18) platform engineered for complete escape from the decoy receptor IL-18 binding protein (IL-18BP) Poster Number: 7779 Date & Time: 4/22/2026 Title: FL116, a PD-1/IL-18 bispecific antibody, enables cis-activation of PD-1⁺ T cells and reshapes the suppressive tumor microenvironment (TME) Poster Number: 1777 Date & Time: 4/20/2026 Title: FL115, a novel IL-15 superagonist rationally designed to minimize safety risks for cancer immunotherapy Poster Number: 7932 Date & Time: 4/22/2026 Title: Development of FL115, a novel IL-15 superagonist, as subcutaneous injection for cancer immunotherapy Poster Number: 6459 Date & Time: 4/21/2026 About FL-115 FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors. About Forlong Biotechnology Forlong Biotechnology is a clinical-stage biotech company focusing on developing transformative cytokine therapies for cancer patients with severe unmet needs. It has established four proprietary synthetic immunology platforms: Fbody ® Long-acting Technology Platform, Fc engineering platform, Syntokine® Synthetic Cytokine Platform and AI-driven Intelligent Biomolecular Discovery Platform. The leading candidate FL115 is interleukin-15 (IL-15) superagonist with best-in-class potential, currently being advanced to combo therapy with PD-(L)1 antibodies in Phase I for patients with solid tumors and combo therapy with BCG in Phase II for patients with NMIBC. Its second candidate FL116 is a PD-1 antibody fused with interleukin-18 (IL-18) mutein which is engineered to bind IL-18 receptor and not IL-18BP (a decoy), and has demonstrated potent tumor-killing efficacy in multiple in vivo tumor models resistant to immune checkpoint inhibitors.