Pembrolizumab

Porustobart, a second-generation Fc-enhanced CTLA-4 antibody, is being advanced across two clinical indications in the neoadjuvant setting, beginning with MSS clinical stage II-III colon cancer Phase 2 trial of porustobart for colon cancer will be open for enrollment early in the fourth quarter of 2026 Financing led by RA Capital Management, joined by Canaan Partners, Forbion, and other investors Sept. 09, 2026 -- Solstice Oncology, a clinical-stage immuno-oncology company focused on treating cancer early, in the neoadjuvant setting, today announced its launch and $225 million Series A financing led by RA Capital Management and joined by Canaan Partners, Forbion and other investors. Solstice is advancing its lead candidate porustobart, a differentiated, second-generation, Fc-enhanced cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, across two clinical indications, one in microsatellite-stable (MSS) colon cancer and a second, undisclosed indication. Its Phase 2 trial is evaluating porustobart in combination with pembrolizumab in the neoadjuvant setting for the treatment of MSS clinical stage II-III colon cancer, the indication with the largest segment of colon cancer patients, which has yet to benefit from immunotherapy. "We believe the greatest opportunity in oncology lies in treating disease earlier, in the neoadjuvant setting, when the tumor is still present, the immune system is still intact, and disease hasn't yet hardened its resistance to treatment," said Caroline Loew, PhD, Chief Executive Officer of Solstice Oncology. "Treating patients early with an immuno-oncology combination therapy like the one we are evaluating in our Phase 2 trial could allow the immune response to act systemically, reaching micrometastatic disease well beyond the primary tumor, which is where we see the greatest opportunity to improve cure rates and long-term survival. Since founding the company in February, our team has moved with the speed and discipline this opportunity demands, filing and clearing an IND and now advancing directly into a Phase 2 trial, for which we anticipate data in the second half of 2027." Porustobart is a second-generation, Fc-enhanced CTLA-4 antibody designed to overcome multiple facets of immunosuppression through two mechanisms of action: CTLA-4 checkpoint blockade and regulatory T cell (Treg) depletion via antibody-dependent cellular cytotoxicity (ADCC). It is being developed to be administered in combination with anti-PD-(L)1 therapy. The two agents work synergistically: anti-PD-(L)1 reawakens T cells that have already recognized the tumor, while porustobart widens that response by releasing a second, independent brake on the immune system and depleting the immunosuppressive Tregs that shield tumors from attack. MSS colon cancer has historically been unresponsive to immunotherapy, but data across this new class of Fc-enhanced CTLA-4 molecules appears to have changed that, producing not just a signal, but a true clinical synergistic effect with PD(L)-1 blockade. Porustobart's engineered, heavy-chain-only structure also gives it a markedly shorter half-life than first-generation CTLA-4 antibodies (4-5 days vs. roughly 2-3 weeks for existing CTLA-4 antibodies), which Solstice believes will enable more flexible dosing, potentially reducing the frequency and duration of immune-related adverse events, a key limitation of first-generation CTLA-4 antibodies. While the company's lead indication for porustobart is MSS clinical stage II-III colon cancer, it believes porustobart's mechanism has the potential to be effective in the neoadjuvant setting across multiple tumor types. "Solstice brings together a compelling approach to treating patients with high unmet need in a potentially curative setting, a de-risked molecule that has already demonstrated activity in late-stage patients in Phase 1/2 studies, and a team with decades of drug development experience who have led multiple approved medicines from first-in-human trials through registration,” said Josh Resnick, MD, Partner at RA Capital. “The team has rapidly designed and advanced a Phase 2 trial to generate an early, credible read on efficacy, and the size of this financing and the strength of the syndicate reflect our conviction in the science, the strategy, and this team's ability to execute." "We know that neoadjuvant approaches have great potential across a number of tumor types, and I believe that could be true for porustobart in MSS colon cancer," said Jenny Seligmann, MRCP, PhD, Professor at the University of Leeds. "Pathologic response has become a recognized signal of long-term benefit in this setting, and a study designed around that endpoint gives us a fast, meaningful way to evaluate whether this approach can change outcomes for patients with MSS colon cancer." In a Phase 2 clinical study conducted by the Company’s licensor Harbour BioMed, porustobart in combination with tislelizumab (a PD-1 inhibitor) showed a 30% objective response rate (7 of 23 patients), with strong durability, in late-line MSS metastatic colorectal cancer patients without liver metastases. Median duration of response was 8.4 months. Porustobart was shown to have a favorable safety pro supports late-stage clinical development. Porustobart is a second-generation, Fc-enhanced CTLA-4 antibody licensed from Harbour BioMed, designed to overcome multiple facets of immunosuppression by having two mechanisms of action: CTLA-4 checkpoint blockade and regulatory T cell (Treg) depletion through ADCC. When given in combination with anti-PD(L)-1 therapy, the two agents are designed to work synergistically: anti-PD(L)-1 reawakens T cells that have already recognized the tumor, while porustobart widens that response by releasing a second, independent brake on the immune system and depleting the immunosuppressive regulatory T cells that shield tumors from attack. Porustobart's engineered, heavy-chain-only structure also gives it a markedly shorter half-life than first-generation CTLA-4 antibodies, which Solstice believes will support a more favorable tolerability pro early disease, where patients are otherwise well. Solstice believes porustobart could be effective in the neoadjuvant setting across multiple early-stage cancers. Porustobart plus a PD(L)-1 blocker has already shown meaningful clinical activity in a Phase 2 clinical study conducted by Harbour BioMed: a 30% objective response rate with 8.4-month median duration of response in late-line, heavily pretreated MSS colorectal cancer patients without liver metastases, and a favorable safety pro of later-stage development. Solstice Oncology is a clinical-stage immuno-oncology company built around the neoadjuvant treatment setting, the point in a patient's disease course where the company believes the opportunity to improve cure rates and long-term survival is greatest. Founded in February 2026, Solstice is led by a team with decades of experience building and advancing successful immunotherapy drugs in oncology. The company is advancing porustobart, a second-generation Fc-enhanced CTLA-4 antibody, across two clinical indications: a Phase 2 study in combination with pembrolizumab in the neoadjuvant setting for clinical stage II-III MSS colon cancer, and a second, undisclosed clinical indication. Solstice's initial investors include RA Capital, Canaan Partners, and Forbion. The content above comes from the network. if any infringement, please contact us to modify.

iStock, Nadzeya_Dzivakova With multiple drug pricing initiatives like Most Favored Nation now in force, drugmakers have to reinvent their commercial strategies to stay ahead of the fast-moving policy environment, according to a new report from Numerof & Associates. No more is launching a drug a “straight math exercise,” as Most Favored Nation drug pricing pressures drugmakers to reconsider launch sequences to ensure the best price can be achieved in the main global market: the United States. That’s according to pharmaceutical executives interviewed as part of healthcare consulting firm Numerof & Associates’ Thursday report titled “ Pharma’s Commercial Reset .” The firm surveyed 157 pharma leaders from 67 companies to come up with the analysis. When Numerof last conducted the survey in 2024, the industry was coming off the COVID-19 pandemic, when patients rushed to digital and virtual options to access healthcare. This forced drug manufacturers to look beyond traditional boots-on-the-ground sales forces. At this time, price control measures like the Inflation Reduction Act were just being introduced. Now, the impact of that policy—and MFN—have hit, forcing another upset in commercial strategies. “Interviewees reported that the current era of policy change is unlike anything they have experienced before—and is unlikely to be temporary,” Numerof wrote. Beyond the U.S., the European Commission has rolled out the Joint Clinical Assessments, a new regulatory framework that assesses the clinical efficacy and safety of new therapies and medical devices. The region is also working on its own drug pricing initiatives. Drug pricing 9 midsize drugmakers climb aboard Trump’s MFN train Astellas Pharma, BridgeBio, BeOne Medicines and six other large biotechs join the 17 Big Pharmas that previously signed on to President Donald Trump’s Most Favored Nation (MFN) drug pricing program, representing some 89% of the branded drug market. September 1, 2026 · 2 min read · Tristan Manalac Read more This means drugmakers can no longer escape regulatory pressures to keep prices down, nor can they justify the high cost of new medicines. One interviewee wrote: “The policy environment is like an earthquake; it’s not going to settle down soon.” Drugmakers previously treated regions separately. But now, setting a price in one region could affect the potential cost elsewhere. Rather than set the same price across the board, drugmakers are deeply considering where they launch first and what evidence they will use to support the set price. “It used to be a straight math exercise, but now there are a lot of qualitative inputs involved,” one interviewee stated. “To this end, launch sequencing is particularly important,” Numerof wrote. “Companies are evaluating whether, and when, to launch in individual countries based on the potential downstream implications in other markets, including whether launching in a lower-price market could affect the price achievable elsewhere.” The firm continued: “In some cases, the implications are significant enough to influence whether a company launches in a market at all.” This decision-making goes beyond the commercial stage, too, Numerof found. Companies are considering pricing controls in clinical decisions as well, from the specific endpoints for clinical trials to the indications to go after. The interviewees also wondered if the “multi-indication blockbuster drug model”—think Merck’s Keytruda or AbbVie’s Humira—might not be viable going forward. More targeted therapies for smaller populations “may offer a stronger value proposition and therefore justification for premium pricing,” the firm wrote. Drug pricing Trump’s MFN Pricing Expected To Delay More European Drug Launches Following Insmed’s decision to hold off on launching a newly approved lung disease drug in Europe, experts anticipate more companies will do the same as they seek to avoid price erosion in the U.S. Will Chinese biotechs fill the void? April 1, 2026 · 3 min read · Nick Paul Taylor Read more That means drugmakers must reinvent their commercialization strategies. Previously, companies would aim to get across the regulatory approval threshold with less thought toward building evidence of the medicine’s value that payers and health systems will consider before offering coverage. Teams across the pharma drug development were fairly siloed as they focused on their own goals. This is what needs to change, with one interviewee stating: “We’re currently operating in a world where the commercial engine is often turned on too late in the clinical process. I believe we must flip this model entirely so that the most critical phase of commercialization occurs during Phase 1 and Phase 2, because if you get that foundation right, the backend of the process will be much more streamlined.” Pharmas have been responding to this new reality by bringing together teams to address commercialization earlier in the process. Several interviewees noted this has changed, with market access and distribution teams brought in earlier than before. “Market access, for instance, used to be a secondary component tacked on to a brand plan. Today, it’s evolved into one of our core strategic pillars,” one person responded. These changes must be established policy, rather than offering a loose directive to the teams to collaborate more, Numerof noted. The fast-moving policy environment is also forcing companies to be nimbler, with more communication than ever before. Pharma must be more agile, Numerof argued. As one interviewee put it: “Every morning it feels like there is another tweet, announcement, policy statement, or market development; and organizations are constantly evaluating how those changes could impact the business and what they ultimately mean strategically and operationally. That pace is forcing teams to communicate more closely, coordinate more quickly, and react in a much more integrated way than in the past.” Drug pricing BIO 2026: Biopharma dealmakers seek to protect ‘premium pricing’ from Trump’s MFN policy With drug pricing now embedded in U.S. policy, business development teams in biotech and pharma are changing the way they strike deals, including acknowledging policy uncertainties with renegotiation clauses. June 23, 2026 · 2 min read · Annalee Armstrong Read more