Endeavor BioMedicines, Inc

Frazier Life Sciences and a cadre of well-known biotech investors are coming together for a new startup in the antibody-drug conjugates field, an area of cancer treatment R&D that has remained hot. Investors are pumping $187 million into a Series A for Callio Therapeutics, a new Seattle and Singapore biotech focused on multi-payload ADCs, according to a Monday morning announcement. Well, it’s sort of new. Callio is based on ADC technology and programs in-licensed from a decade-old Singapore biotech called Hummingbird Bioscience. Hummingbird will get equity, potential milestones and royalties in exchange for offloading its oncology ADC platform, and certain IP and pipeline assets associated with it, the companies said. And Callio is led by some of the longtime executives of Hummingbird, including CEO Piers Ingram, chief scientific officer Jerome Boyd-Kirkup and chief business officer Angèle Maki. Meanwhile, Callio’s medical chief is Naomi Hunder, who held the same post at ProfoundBio when that Seattle ADC biotech was bought by Genmab for $1.8 billion last spring . Callio and Hummingbird are independently operated, but Ingram will be running both “for now,” he said in an interview with Endpoints News . Callio has six employees so far, according to a spokesperson. Hummingbird got “very interested in the ADC space” about four years ago, “along with the rest of the field,” Ingram said. Since then, the “majority of resistance seems to be payload, rather than loss of antigen, driven,” he said. Ingram said the field has “struggled” to find good payloads. “The Topo1 inhibitors have proven to be a very, very good class of payload, but there are not many others still,” the CEO said. “The best strategy would be if you could really deliver targeted combination therapies to address these resistance mechanisms to the payloads that we do have.” To realize that potential in ADCs, it “seemed to be quite challenging to find a way to really make it work within Hummingbird,” so the investors and board decided to create a separate company focused on the ADC platform, Ingram said. The new company is a play on the original’s name. Callio is short for calliope, a tiny bird in the hummingbird family. Some of the same investors are backing both Callio and Hummingbird. Hummingbird last disclosed a $125 million Series C in May 2021 . That round and the new $187 million Series A share the following investor names: Frazier, Novo Holdings, Pureos Bioventures, SEEDS Capital and EDBI. Joining for the new round are Jeito Capital, Omega Funds, ClavystBio, Platanus and Norwest. The Series A will allow Callio to gather key clinical data on a HER2-targeted dual-payload ADC called HMBD-802, the company said. Callio also got the license to Hummingbird’s HMBD-803 and HMBD-804. Hummingbird will keep its two clinical-stage monoclonal antibodies, called HMBD-001 and HMBD-002, a spokesperson confirmed. Over the years, Hummingbird had done well with drumming up outside interest in its platform and pipeline. Amgen signed onto a co-discovery collaboration for new antibody therapies in 2019. That six-year pact included an undisclosed amount in upfront fees and research payments, plus the potential for up to $1.2 billion in biobucks across up to a dozen targets. But the California biopharma “deprioritized the targets in that collaboration,” the Callio spokesperson said. Amgen remains a shareholder in Hummingbird, they added. Hummingbird also licensed out a HER3-targeted ADC to Endeavor BioMedicines in 2023 for up to $430 million . And it licensed antibodies to Clay Siegall’s Immunome earlier this year.

SAN DIEGO--( BUSINESS WIRE )--Endeavor BioMedicines, a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, announced that the first patient has been dosed in the Phase 2b WHISTLE-PF trial evaluating the safety and efficacy of ENV-101 (taladegib), the company’s lead investigational medicine, in individuals with idiopathic pulmonary fibrosis (IPF). ENV-101 is a novel Hedgehog signaling pathway inhibitor that demonstrated potential in a Phase 2a trial to be the first disease-modifying treatment for IPF. “ Initiating the WHISTLE-PF trial is an important milestone for our company as we continue to develop ENV-101 for the treatment of IPF, a relentless disease that has a worse prognosis than most cancers," said John Hood, Ph.D., Co-founder, CEO and Chairman, Endeavor BioMedicines. “ Following the positive results from our Phase 2a trial of ENV-101, Endeavor BioMedicines is now intensely focused on efficiently advancing the WHISTLE-PF trial to get this potentially transformative drug to patients as quickly as possible.” IPF is a chronic, progressive lung disease with limited treatment options that affects approximately 150,000 adults in the United States. Although the exact cause of IPF is unknown, various environmental factors can deliver repeated injuries to lung cells that trigger abnormal wound-healing processes and life-threatening lung scarring. Current standard-of-care therapies do not address the underlying cause of IPF. They slow the decline of lung function, but do not stop or reverse it, and they have tolerability issues that limit their long-term use in most patients. ENV-101 is designed to block a cellular wound-healing pathway known as Hedgehog (Hh) that is abnormally activated in fibrotic lung diseases such as IPF and drives the continuous pathophysiologic buildup of scar tissue in the lungs. Results from the randomized, double-blind, placebo-controlled Phase 2a trial of ENV-101 showed that patients who received the investigational therapy experienced statistically significant improvements in lung function and total lung capacity, and reversal of multiple key quantitative measures of lung fibrosis through 12 weeks of treatment. There were no treatment-related serious adverse events, treatment-related grade 3 or 4 adverse events, or clinically meaningful safety findings on laboratory analyses, vital signs, electrocardiograms, or physical examination reported for ENV-101-treated patients. The Phase 2b WHISTLE-PF ( W ound-remodeling H edgehog-Inhibitor I LD S tudy T esting L ung F unction E ndpoints- PF ) clinical trial is a global, randomized, placebo-controlled study evaluating the therapeutic potential of ENV-101 in individuals with IPF ( NCT06422884 ). Endeavor BioMedicines intends to conduct the trial in 14 countries globally, including Australia, where the first patient was dosed. The WHISTLE-PF trial will evaluate the efficacy of a range of ENV-101 doses through 24 weeks of treatment, characterize the investigational compound’s safety, assess its effect on patient reported outcomes and its effects on lung capacity and lung fibrosis as measured by chest high-resolution computed tomography (HRCT). About Endeavor BioMedicines Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. Endeavor’s lead candidate, ENV-101 (taladegib), is an inhibitor of the Hedgehog signaling pathway in development for fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). The company’s second candidate, ENV-501, is a HER3 antibody-drug conjugate (ADC) in development for the treatment of HER3-positive solid tumors. More information is available at www.endeavorbiomedicines.com and on LinkedIn or X .

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.