KBP Biosciences USA, Inc.

Photys Therapeutics is on deck to tackle preclinical efforts, while Novo Nordisk is slated to take the potential assets through IND-enabling studies and clinical development. \n With Novo Nordisk’s name already synonymous with treatments for diabetes and obesity, the Danish drugmaker has been making a concerted push to bolster its pipeline beyond GLP-1 stalwarts Ozempic and Wegovy, branching out into other cardiometabolic conditions like metabolic dysfunction-associated steatohepatitis (MASH) and chronic kidney disease (CKD).Now, as part of that development odyssey, the company is tapping into an emerging protein technology from Photys Therapeutics.Under a new research collaboration unveiled Wednesday, Novo will pay Photys up to $186 million in upfront, development and commercial milestone payments to help develop proximity-based therapeutics for an unnamed cardiometabolic disease target.The deal—which will also see Photys receive R&D funding and potential tiered royalties on commercial sales—hinges on the biotech’s Phosphorylation Inducing Chimeric Small molecules (PHICS) technology. The company has designed its proprietary platform to induce proximity between a kinase and a protein of interest in order to phosphorylate that target and change its biologic function, Photys explained in a release.Novo and Photys plan to work together on multiple PHICS molecules for their chosen cardiometabolic target. Photys is on deck to tackle preclinical efforts, while Novo is slated to take the potential assets through investigational new drug-enabling studies and clinical development, the partners said.“This collaboration represents a strong alignment between the desire to control a critical protein and a technology capable of doing so in a tissue-specific manner,” Alexandra Joseph, Ph.D., Photys’ chief scientific officer, said in a statement.Meanwhile, Novo’s corporate vice president and therapeutic area head of diabetes, obesity and MASH, Bei Zhang, Ph.D., said the deal could allow her company to reach important protein targets “with a high degree of efficacy and selectivity.” Photys, which is based right next to Boston in Waltham, Massachusetts, uncloaked in 2022 with $75 million in funds from Merck & Co.’s MRL Ventures Fund, Eli Lilly, Arkin Bio and Mass General Brigham Ventures, among others.The biotech has stayed relatively quiet over the last two years, with the October appointment of Joseph the most recent update on the company’s website.Novo Nordisk, for its part, has been working hard to enrich its cardiometabolic pipeline in areas beyond diabetes and obesity, where the company currently dominates the commercial market with its respective GLP-1 medicines Ozempic and Wegovy.So far, the company’s success has been somewhat mixed.Back in May, Novo unveiled full results from its FLOW trial showing that a once-weekly 1-mg dose of semaglutide—the molecule behind Ozempic and Wegovy—helped combat major kidney outcomes like kidney failure, loss of kidney function and death from kidney or cardiovascular causes in people with Type 2 diabetes and CKD.At the time, Novo’s executive medical director, Michael Radin, M.D., told Fierce Pharma the results could “really move the needle” and set a new standard for “holistic” care for many patients living with both diabetes and kidney disease.Additionally, 2.4-mg semaglutide recently excelled in a phase 3 study of MASH patients, prompting Novo to ready filings for submission to regulators in Europe and the U.S. in the first half of 2025. Still, Novo has been less fortunate with external cardiometabolic efforts, as evidenced by the drugmaker’s decision in early November to scrap a late-stage kidney drug acquired through a $1.3 billion deal with KBP Biosciences.Novo had hoped the CKD prospect, dubbed ocedurenone, could eventually rival Bayer’s Kerendia. But those hopes were dashed when the nonsteroidal mineralocorticoid receptor antagonist missed its primary endpoint at the time of a prespecified interim analysis. With ocedurenone gone, the only CKD program still listed in Novo’s pipeline is semaglutide. 

Novo Nordisk's flagship obesity treatment Wegovy returned to forecast-topping growth in the company's latest financial results, sending shares up more than 8% on Wednesday. Sales of the GLP-1 product surged 79% in the third quarter to DKK 17.3 billion ($2.5 billion), well above consensus expectations of DKK 15.9 billion.While sales of Wegovy had grown 55% in the previous quarter to DKK 11.7 billion, they came in below consensus estimates of DKK 13.5 billion — a "blip" that Novo attributed to an adjustment of rebates related to estimates made on the prior year's revenue.And ahead of Novo's latest financial print, fears of a repeat in the third quarter had been stoked by Eli Lilly's disappointing sales figures for its competing GLP-1/GIP co-agonist products Mounjaro and Zepbound. Revenue for the two came in below analyst predictions, which Lilly blamed on inventory decreases in the US wholesaler channel. On Wednesday, Novo CEO Lars Fruergaard Jørgensen said that the pharma continues to see "very significant demand" for Wegovy in the US and is working hard to increase manufacturing capacity. However, the company warned that despite earmarking billions of dollars to invest in production, it still faces "capacity limitations" at some sites, along with "periodic supply constraints and related drug-shortage notifications."Weak diabetes sales"Wegovy continues to gain momentum and clearly exceeds expectations in the quarter," compensating for weaker diabetes sales, remarked Sydbank analyst Søren Løntoft Hansen. "This is good enough to provide some relief," added Emily Field of Barclays, explaining that Wegovy's beat came despite slightly worse pricing in the US than anticipated.Novo's overall sales and profit both increased 21% in the third quarter to DKK 71.3 billion and DKK 27.3 billion, respectively. However, the revenue figure came in below analyst projections of DKK 72.3 billion, partly due to lacklustre growth in its diabetes segment, including for Ozempic.In the quarter, Ozempic — which contains the same active ingredient as Wegovy — generated sales of DKK 29.8 billion, up 26% year-over-year at constant currencies, but below forecasts of DKK 30.5 billion.Guidance narrowedFor the full year, Novo said it now expects sales growth of between 23% and 27% on a constant exchange rate basis, narrowed from a prior range of 22% to 28%. Meanwhile, operating profit growth was similarly revised, and is now seen between 21% and 27%, from previous guidance of 20% to 28%.Investors had feared the drugmaker would cut its outlook, noted Terence McManus of Bellevue Asset Management. "However, we don't see these results as an all-clear signal on the stock," he added, with all eyes now set to turn to pending late-stage data for its next obesity hopeful dubbed CagriSema.The therapy, which combines semaglutide — the active ingredient in Ozempic and Wegovy — with the amylin analogue cagrilintide, is expected to lead to weight loss of over 15% when results are unveiled later this year. Martin Holst Lange, Novo's development head, reaffirmed that CagriSema has potential for up to 25% weight loss, with "no change in our confidence level."Other pipeline updatesNovo also disclosed alongside its financial print that the Phase IIIb STRIDE study of Ozempic as an adjunct to standard of care in people with type 2 diabetes and peripheral arterial disease with intermittent claudication met its primary endpoint. The drug demonstrated a clinically relevant and statistically significant improvement in maximum walking distance of 13% compared to placebo. US and EU marketing applications in this indication are targeted for the first half of 2025.Additionally, the company plans regulatory filings next year for its factor VIIIa mimetic bispecific antibody Mim8 in haemophilia A. Following up on the positive Phase IIIa FRONTIER 2 trial, Novo said Wednesday that the Phase IIIb FRONTIER 5 study has now been completed. The trial assessed switching from prophylaxis with Roche's once-weekly therapy Hemlibra (emicizumab) to Mim8 — something Novo reported was well tolerated.Elsewhere, Novo said it has now decided to bin development of the non-steroidal mineralocorticoid receptor antagonist ocedurenone across all indications. The future of the asset — gained from KBP Biosciences for up to $1.3 billion — was under review following the failure in June of the Phase III CLARION-CKD study in patients with uncontrolled hypertension and advanced chronic kidney disease.($1 = DKK 6.92889)

Flagship Pioneering’s roots in Singapore are growing less than a year after the biotech incubator first unveiled its ambitions in the Asia-Pacific. The Cambridge, MA-based investor said Wednesday evening it will jointly commit up to 100 million Singapore dollars, or about $77 million, over the next five years with Singapore’s Agency for Science, Technology and Research. Also known as A*STAR, the agency is one of the city-state’s main public sector R&D outfits, Flagship said. Research institutes affiliated with A*STAR will collaborate with Flagship portfolio companies to co-develop “technologies in strategically important areas,” the groups said. Singapore’s agency will also provide access to its scientists and facilities. Flagship Asia-Pacific chair André Andonian told Endpoints News that the partners will focus on “scientific exchange,” talent development and venture creation. They are interested in cell and gene therapies, nucleic acid therapeutics, precision medicine and using artificial intelligence for drug discovery, according to Andonian, who has led Flagship’s outpost in Singapore since last year after a 34-year career at McKinsey. The Singapore unit has four Flagship employees so far, Andonian said. In the Asia-Pacific, Flagship also has a partnership with Samsung. Flagship will likely unveil another partnership in the Asia-Pacific by the end of the year, Andonian said, and within two years, Flagship aims to have at least six partnerships in the region. Singapore, Korea and Japan are the main regions of focus, but Flagship is doing an “opportunistic assessment of other markets” like China and Australia, Andonian said in an interview last year. Singapore’s biotech scene took a big hit in 2023 when A*STAR-partnered cell therapy maker Tessa Therapeutics suddenly shuttered with little explanation. Some biotechs in the area have inked global deals in the past year, including Hummingbird Bioscience and KBP Biosciences. Endeavor BioMedicines last October licensed an antibody-drug conjugate from Hummingbird for up to $430 million. That same month, Novo Nordisk bought a kidney disease drug from KBP for up to $1.3 billion, though it wound up taking an $816 million writedown after the experimental medicine failed a late-stage test. Flagship has not yet formed a portfolio company in Singapore, a spokesperson told Endpoints via email. The firm’s most famous offshoot, Moderna, announced it would create a subsidiary in Singapore in 2022. “We want to learn from this foray. Most people looking at what other such expansions look like expect that we’re there to find new companies or new investments, and that’s not what we’re there to do,” Flagship chair Noubar Afeyan told Endpoints in July. “We’re there to connect our ecosystem of some 48 companies in Cambridge, Boston, to vibrant, growing ecosystems in the UK and in APAC.” The firm also set up operations in the UK last year and disclosed its first UK-based startup in November. “The connectivity of our ecosystem there, whether it’s based on science, intellectual property that we may be able to add to what we’re doing, clinical trials, manufacturing partnerships, financial partnerships — those are all things that can add, we think, value to each and every one of our companies,” Afeyan said in July.