AGTECH HOLDINGS LIMITED
Solis Agrosciences, created to provide R&D crop development services to
The funding will allow Solis to expand with additional talent and infrastructure to meet the needs of a growing customer base.
Hermann has known the principals at Solis for years and jumped at the opportunity to help lead this financing,' said
We are thrilled to receive this investment,' said
Solis was launched in May of 2022 as a collaboration between Ag executives
Solis began as a conversation with
Solis' Plant Pipeline as a Service is the best integrated resource imaginable for gene editing, plant transformation, plant analysis, and greenhouse operation. Working with Solis is like having our own in-house team to manage our pipeline. They are great partners dedicated to our success,' said
Solis plans to meet customer demand by continually launching new services, adding new crop species, acquiring new technologies, and building world-class infrastructure in an eco-friendly way.
To ensure Solis can meet its growing customer demand, we needed to expand our greenhouse and field capabilities,' said
About Solis Agrosciences
Solis Agrosciences is a pioneering plant sciences company offering state-of-the-art technology & research services to
About BioGenerator
BioGenerator, the startup arm of BioSTL, creates and grows innovative
About Hermann Companies
Founded in 1956, Hermann Companies combines three generations of experience to make investments across a spectrum of asset classes and industries. Hermann offer a variety of capital solutions to accomplish its goal of partnering with strong, entrepreneurial teams through meaningful direct investments.
Novartis investigational iptacopan provides clinically meaningful increases in hemoglobin levels in complement-inhibitor-naive patients with PNH
In the study, the safety profile of iptacopan monotherapy was consistent with previously reported data1,6,7. Detailed data will be presented at an upcoming medical meeting and included as part of global regulatory submissions in 2023.
We are very encouraged by the results of the complement-inhibitor-naive data from the Phase III APPOINT-PNH trial,' said
Topline results for the pivotal Phase III APPLY-PNH study were recently announced8. It met its two primary endpoints, with iptacopan demonstrating superiority over anti-C5 therapies (eculizumab or ravulizumab) in adults with PNH experiencing residual anemia despite prior anti-C5 treatment8. The study showed a statistically significant and clinically meaningful increase in the proportion of iptacopan-treated patients achieving 2 g/dL or more hemoglobin-level increases from baseline, and 12 g/dL or more hemoglobin levels, both without the need for blood transfusions at 24 weeks, compared to anti-C5 therapies8.
Novartis is grateful to the patients and clinical investigators whose time, trust and commitment made this PNH research possible, and is excited to continue to explore the potential of iptacopan as the first oral monotherapy option for patients with PNH.
Iptacopan is also being investigated in Phase III studies for the complement-mediated kidney diseases (CMKDs) C3 glomerulopathy (APPEAR-C3G [NCT04817618]), IgA nephropathy (APPLAUSE-IgAN [NCT04578834]), and atypical hemolytic uremic syndrome (APPELHUS [NCT04889430]), as well as in a number of additional indications in Phase II9-11.
About the study
APPOINT-PNH (NCT04820530) is a Phase III, multinational, multicenter, open-label, single-arm study to evaluate the efficacy and safety of twice-daily, oral iptacopan monotherapy (200 mg) in adult PNH patients who are naive to complement inhibitor therapy, including anti-C5 therapies (e.g., eculizumab or ravulizumab)12.
The primary endpoint was to assess the proportion of participants achieving an increase in hemoglobin levels from baseline of 2 g/dL or more in the absence of red blood cell (RBC) transfusions at 24 weeks12. Secondary endpoints include the proportion of participants achieving sustained hemoglobin levels of 12 g/dL or more in the absence of RBC transfusions, transfusion avoidance defined as the proportion of participants who remain free from transfusions, average change in hemoglobin levels, average percent change in lactate dehydrogenase (LDH) levels, rate of breakthrough hemolysis, average change in absolute reticulocyte counts, change in fatigue, and rates of major adverse vascular events12.
About paroxysmal nocturnal hemoglobinuria (PNH)
PNH is a rare, chronic and serious complement-mediated blood disorder2. People with PNH have an acquired mutation in some of their hematopoietic stem cells (which are located in the bone marrow and can grow and develop into RBCs, white blood cells and platelets) that causes them to produce RBCs that are susceptible to premature destruction by the complement system2,3. This leads to intravascular hemolysis (destruction of RBCs within blood vessels) and extravascular hemolysis (destruction of RBCs mostly in the spleen and liver), which cause anemia (low levels of circulating RBCs), thrombosis (formation of blood clots), fatigue and other debilitating symptoms that can impact people's quality of life2,3.
It is estimated that approx. 10-20 people per million worldwide live with PNH2. Although PNH can develop at any age, it is often diagnosed in people between 30-40 years old13,14.
PNH has a significant unmet need not addressed by anti-C5 therapies (eculizumab or ravulizumab): despite treatment with anti-C5s, a large proportion of people with PNH remain anemic, fatigued and dependent on blood transfusions2-5.
About iptacopan
Iptacopan is an investigational first-in-class, orally administered targeted factor B inhibitor of the alternative complement pathway6,7,15. It acts upstream of the C5 terminal pathway, preventing not only intravascular but also extravascular hemolysis in PNH6,7,15. In doing so, iptacopan targets a key part of the biology responsible for PNH while offering an oral monotherapy option6,7,15.
Discovered at the
Based on disease prevalence, unmet need and data from Phase II studies, iptacopan has received FDA Breakthrough Therapy Designation in PNH, orphan drug designations from the FDA and EMA in PNH and C3G,
Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as 'potential,' 'can,' 'will,' 'plan,' 'may,' 'could,' 'would,' 'expect,' 'anticipate,' 'seek,' 'look forward,' 'believe,' 'committed,' 'investigational,' 'pipeline,' 'launch,' or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in
About Novartis
Novartis is reimagining medicine to improve and extend people's lives. We deliver high-value medicines that alleviate society's greatest disease burdens through technology leadership in R&D and novel access approaches. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. About 108,000 people of more than 140 nationalities work together to bring Novartis products to nearly 800 million people around the world.
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