Even with the ever-changing situation, technological innovation is still the most critical component for biopharmaceutical companies' long-term development. This continuous innovation keeps companies up to date and promotes the evolution of R&D and the success of commercialization.
Recently, 6 of Viva's portfolio companies have achieved significant results and progress: Mediar and QurAlis have successfully completed financing, while AmacaThera, AceLink, Basking, and TechnoDerma have made smooth progress in their R&D pipelines.
Keep reading for more details.
Mediar Therapeutics Announces $105 Million Financing to Advance Portfolio of First-in-Class Fibrosis Therapies
CAMBRIDGE, Mass., March 15, 2023 /PRNewswire/ -- Mediar Therapeutics Inc., invested and incubated by Viva BioInnovator (VBI), is a biotechnology company advancing a portfolio of first-in-class therapies that halt and even reverse the course of fibrosis. Recently they announced a $105M financing, including a recent $85 million Series A round co-led by Novartis Venture Fund and Sofinnova Partners and with participation from Pfizer Ventures, Mission BioCapital, Gimv, Pureos, Bristol Myers Squibb, Eli Lilly & Company, Ono Venture Investment and Mass General Brigham Ventures. Viva also continued to invest in this round. Mediar was founded on pioneering fibrosis research from Mass General and Brigham and Women's Hospitals in partnership with Mass General Brigham Ventures with the goal to transform the treatment of fibrotic disease by targeting the myofibroblast, the key cell type driving fibrosis progression. Mediar is led by industry veterans, Chief Executive Officer Rahul Ballal, Ph.D. and Chief Scientific Officer Paul Yaworsky, Ph.D. Dr. Ballal joins Mediar with nearly 20 years of experience in biotech and was most recently CEO of Imara, which recently merged with Enliven Therapeutics. Dr. Yaworsky joined Mediar in 2019 after a successful 21-year career at Pfizer, most recently serving as the COO of inflammation and immunology research. Joining the Mediar board is Nandita Shangari, Ph.D., from Novartis Venture Fund, Maina Bhaman, MBA, from Sofinnova Partners, and Andreas Jurgeit, Ph.D., from Gimv.
Mediar's portfolio comprises three novel targets that are readily detectible in blood and correlate to disease severity, enabling a de-risked approach to clinical development. The series A financing will support advancement of the company's portfolio of first-in-class antibody treatments, which offer unique potential to address fibrosis at varying stages of the disease, with two programs advancing into human studies in 2024.
AmacaThera Doses First Subjects in Phase 1 Clinical Trial for AmacaGel™ Therapeutic Platform, and Their Lung Cancer Applications Recognized in QuickFIre Challenge
TORONTO, March 9, 2023 /CNW/ - AmacaThera Inc, invested and incubated by Viva BioInnovator (VBI), is a clinical-stage company transforming therapeutics to make a difference in patient health. Recently they announced that the first subjects have been dosed in the company's Phase 1 first-in-human clinical investigation of the safety of AmacaGel™. AmacaGel™ is a unique injectable hydrogel platform technology. It can be injected directly into a targeted organ or incision site, where it forms a depot from which medications can achieve local benefit, thereby improving patient lives. Patients were dosed with the hydrogel alone group to demonstrate the core technology's safety.
Previously, AmcaThera also received grant funding from the Innovations for Vets QuickFire Challenge: Lung Cancer & Physical Trauma. With the support of the QuickFire Challenge funding, the company will collaborate with another biotech company to visualize and sample lung cancer tumors.
QurAlis Closes $88 Million Series B Financing to Advance Precision Medicines for Neurodegenerative Diseases
CAMBRIDGE, Mass., March 9, 2023 – QurAlis Corporation, incubated and invested by Viva BioInnovator (VBI), is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets. Recently they announced it has closed an oversubscribed $88 million Series B financing, bringing the total funds raised to $143.5 million. The financing was led by EQT Life Sciences, investing from the LSP Dementia Fund, Sanofi Ventures, and Droia Ventures, with participation from the ALS Investment Fund and existing investors LS Polaris Innovation Fund, Mission BioCapital, INKEF Capital, Dementia Discovery Fund, Amgen Ventures, MP Healthcare Venture Management, Mitsui Global Investment, Dolby Family Ventures, Mission Bay Capital, and Sanford Biosciences.
The proceeds from the financing will fund clinical development of QRL-201 and QRL-101, the Company’s lead product candidates in ALS. In addition, the financing will support ongoing and planned research, as well as the advancement of QurAlis’ pipeline with therapeutic candidates that target specific components of ALS and genetically related frontotemporal dementia (FTD) pathology and defined ALS patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.
AceLink Presented Phase I Clinical Data of AL01211 and AL00804 During the 2023 WORLD Symposium
NEWARK, Calif.--(BUSINESS WIRE)--AceLink Therapeutics, Inc. (AceLink), invested and incubated by Viva BIoInnovator (VBI), is an innovative biopharmaceutical company developing transformative therapies for genetic diseases. Recently they presented positive data from a Phase 1 trial of AL01211 in healthy volunteers and preclinical data on the development of AL00804, a novel brain penetrant glucosylceramide synthase inhibitor.
AL01211 is a novel, oral, non-brain penetrant glucosylceramide synthase inhibitor (GCSi) being developed for the treatment of Fabry disease.
Here are some highlights Data:
- AL01211 was safe and well-tolerated, showing no significant or serious adverse events in healthy volunteers.
- Treatment with AL01211 resulted in dose-dependent PK and PD (reduction of plasma GL1 and GL3) properties.
- In preclinical studies, AL01211 was widely distributed in peripheral organs and lacked blood-brain barrier penetration. This makes AL01211 an excellent choice for treating diseases that primarily affect peripheral tissues.
- The increased potency and low brain penetration make AL01211 a potentially safer and more efficacious molecule for treating Fabry disease patients, especially in younger patients seeking a convenient and lifelong treatment option.
AL00804, a highly brain penetrant GCS inhibitor, efficiently reduced GL1 accumulation in the brain of preclinical models. Currently, it is eligible for IND new drug clinical application. Its data highlights include:
- Pharmacokinetics studies support once daily, oral administration of AL00804.
- AL00804 is highly brain penetrant that efficiently reduced brain GL1 and lyso-GL1 accumulation in preclinical disease models.
- AL00804 reduced CNS disease symptoms, significantly delayed motor function decline and extended survival.
- When tested head-to-head in a neuronopathic model of Gaucher disease, AL000804 performed better than Venglustat.
- The increased potency and superior brain penetration compared to Venglustat make AL00804 a potentially safer and more efficacious molecule for treating neuronopathic GSL storage disorders.
Basking Biosciences Presents Positive Clinical Results from Safety and Dose-Escalation Study for First Reversible Thrombolytic Agent at ISC 2023
COLUMBUS, OH (February 9, 2023): Basking Biosciences (Basking), a clinical-stage biopharmaceutical company developing the first reversible thrombolytic therapeutic for ischemic stroke, today presented positive results of a Phase 1 single ascending dose safety study in healthy volunteers of the company’s novel von Willebrand Factor (vWF)-targeting thrombolytic agent, BB-031. BB-031 demonstrated safety and tolerability following a single intravenous dose ranging from 0.1 mg/kg to 4.0 mg/kg and dose-dependent patterns of vWF binding and changes in platelet function.
In the Phase 1 study, healthy volunteers received BB-031 or placebo (in a 6:2 ratio) by intravenous bolus at single ascending doses ranging from 0.1 mg/kg to 4.0 mg/kg. The study found that BB-031 was safe and well tolerated throughout the 28-day study period, with no significant or treatment-emergent adverse events. BB-031 demonstrated an apparent mean terminal half-life ranging from 18 minutes at 0.1 mg/kg to 61 minutes at 4.0 mg/kg. Dose-dependent changes in vWF binding were observed. An analysis of platelet function showed complete inhibition of clot formation at all doses tested and dose-dependent duration of clotting inhibition and time to return to normal clotting.
Technoderma Medicines Initiates TDM-180935 Atopic Dermatitis Clinical Program with Phase 1 Dose Escalation Trial
SAN DIEGO, Feb. 9, 2023 /PRNewswire/ -- Technoderma Medicines, Inc. ("the Company"), invested and incubated by Viva BioInnovator (VBI), is a clinical stage biopharmaceutical company. They were pleased to report the Company has begun dosing healthy volunteer subjects in its Phase 1 clinical trial of topical TDM-180935 ointment. This first clinical trial in the Atopic Dermatitis (AD) program includes single dose and multidose escalation cohorts in a study entitled, "A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-180935 Following Topical Administration in Healthy Male Subjects". Study objectives are to evaluate the safety and pharmacokinetics of topical TDM-180935. One U.S. clinical site is currently participating in this study under an open IND with FDA.
About Mediar Therapeutics
Mediar Therapeutics is a biotechnology company pioneering a new approach to fibrosis treatment that halts the disease at a different source – the fibrotic mediators that drive disease progression. Mediar was founded based on a deep understanding of the complex science underlying fibrosis onset and progression. By combining novel targets with reliable, easily detectable blood biomarkers and familiar modalities, Mediar is derisking the path forward for fibrosis therapies in clinical development. For more information, contact firstname.lastname@example.org or follow us on LinkedIn.
AmacaThera is a clinical-stage biotechnology company transforming therapeutics to make a difference in patient health. Our unique, injectable hydrogel platform provides localized, sustained drug delivery to improve patient outcomes across multiple therapeutic areas, including post‑surgical pain management, cancer and other hard‑to‑reach target areas. To learn more, visit amacathera.ca.
About QurAlis Corporation
QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets with next-generation precision medicines. QurAlis’ proprietary platforms and unique biomarkers enable the design and development of drugs that act directly on disease-causing genetic alterations. Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is advancing a deep pipeline of antisense oligonucleotides and small molecule programs including addressing sub-forms of ALS that account for the majority of ALS patients. For more information, please visit www.quralis.com or follow us on Twitter @QurAlisCo.
About AceLink Therapeutics, Inc.
Founded in 2018, AceLink Therapeutics is an innovative biopharma startup focusing on developing safe and effective medicines to address genetic diseases with high unmet needs. The company’s initial focus is to develop novel therapeutics for Fabry disease. For more information, please visit www.acelinktherapeutics.com.
About Basking Biosciences
Basking Biosciences is a clinical-stage company founded to solve the biggest need in ischemic stroke therapy – for a rapid-onset, short-acting thrombolytic drug capable of reopening blocked arteries within a significantly extended therapeutic window than currently approved therapies, and whose activity can be quickly reversed in the event of bleeding. The company is developing BB-031, a first-in-class RNA aptamer targeting von Willebrand Factor (vWF), an important structural component of blood clots and driver of the clotting process. The company is also developing BB-025 in tandem, a complementary rapid-acting reversal oligonucleotide capable of quickly neutralizing BB-031 pharmacological activity. Non-clinical research in multiple gold-standard animal models demonstrated that BB-031 quickly recanalized blocked blood vessels in the brain, as late as six hours after stroke onset. Basking has successfully completed a Phase 1 single-ascending dose safety study with BB-031 and is initiating a Phase 2 clinical proof-of-concept study in patients suffering from an acute ischemic stroke with the ultimate goal of extending the therapeutic window for thrombolysis compared to currently approved therapies.
About Technoderma Medicines
Technoderma Medicines, Inc. is a privately held clinical stage biopharmaceutical company located in Jiaxing Xiuzhou Biomedicine Guoqian Park, China. Its current core programs focus on development of innovative therapies for Androgenetic Alopecia, Atopic Dermatitis, Psoriasis and Lupus Erythematosus. Its "first-in-class" small molecule thyromimetic drug candidate TDM-105795 for Androgenetic Alopecia is currently entering Phase 2a clinical testing. Technoderma's novel JAK1/TYK2 inhibitor TDM-180935 for Atopic Dermatitis has now begun Phase 1 clinical testing. The pipeline targets dermatologic indications.