Docetaxel

iStock, efks Following their blowout win in melanoma last month, Merck and Moderna are leading the way among a new crop of personalized cancer vaccines. Here are five companies with similar therapies hoping to break through where others have previously failed. Merck and Moderna’s late-stage melanoma win last month marked a triumphant turnaround for the cancer vaccine space after years of middling outcomes. The partners—whose Phase 3 data showed that their mRNA-based cancer vaccine, combined with Merck’s Keytruda, extended progression-free survival in patients with cutaneous melanoma, as compared with Keytruda alone—“finally made cancer vaccines work and it was not easy!” Christiana Bardon, co-managing partner at the investment firm MPM BioImpact, told BioSpace in an email. Early data in the space were, by contrast, underwhelming, she said. She highlighted Dendreon’s Provenge as one example. Approved by the FDA in 2010 for late stage prostate cancer, Provenge , an autologous cell therapy, is widely considered to be the first-ever cancer vaccine to hit the market. Despite blazing a trail, however, Provenge struggled to gain traction, with a survival benefit that hardly justified its $93,000 price tag . As a result, Dendreon declared bankruptcy around four years after Provenge’s approval. Another cancer vaccine casualty is IO Biotech, which closed shop in April after the FDA said last year that the company did not have enough evidence to support its product candidate Cylembio. Company closure IO Shuts Down Following Regulatory Roadblocks The FDA advised IO Biotech last year to hold off on filing an approval application for its cancer vaccine Cylembio, pointing to a failed Phase 3 study in frontline advanced melanoma. The biotech has now gone under. April 1, 2026 · 2 min read · Tristan Manalac Read more “It turns out that a vaccine with one antigen was not enough,” Bardon said. “Vaccines need multiple antigens, and those antigens are unique to each patient.” Indeed, Merck and Moderna’s approach directly confronts this individualized constellation of targets. The companies’ individualized neoantigen therapy, dubbed intismeran autogene, makes use of a patient’s own tumor, from which a “unique mutational signature” is identified—similar to a cancer “fingerprint”—that can then be used to produce a personalized mRNA-based vaccine, according to a news release from the partners. When administered, the resulting vaccine prepares the patient’s immune system to recognize this antigen fingerprint and attack cells containing it. This immune-priming action is what defines the cancer vaccine class, according to a spokesperson from BioNTech, another prominent player in this space. “The term ‘cancer vaccine’ is commonly used to describe this class because vaccines stimulate the body’s immune system,” the spokesperson explained. In the case of Merck and Moderna’s intismeran, the vaccine mechanism is therapeutic—it instructs the immune system to destroy an existing tumor, resulting in the partners’ reported survival benefits. But, according to Bardon, there is also the possibility that these therapies could prove protective in the long run. Cancer vaccines, she told BioSpace , “may generate long-term immune responses which can prevent recurrence and increase the cure rate of patients with early-stage melanoma.” With their Phase 3 win for intismeran, Merck and Moderna are leading the cancer vaccine race, but they’re hardly the only drugmakers in this space. Here are five more companies looking to break through. Cancer Moderna stock nearly doubles as Merck-partnered mRNA cancer vaccine meets Phase 3 goal Melanoma was slower to recur in patients receiving Merck and Moderna’s mRNA vaccine with Keytruda, supporting use of the combination in adjuvant treatment. The partners plan to take the data to the FDA. August 19, 2026 · 3 min read · Nick Paul Taylor Read more Roche, BioNTech succeed in pancreatic cancer, miss in colorectal At the annual American Association for Cancer Research meeting in April, Roche and BioNTech’s therapeutic vaccine candidate autogene cevumeran showed promising survival rates in patients with pancreatic cancer. Autogene cevumeran, an mRNA-based personalized cancer immunotherapy, was originally developed by BioNTech. In September 2016, Roche, through its subsidiary Genentech, paid $310 million upfront and in near-term milestones to develop and advance cancer vaccines developed through the German company’s platform. Autogene cevumeran would eventually become one of those assets. The partners are testing the vaccine in a Phase 1 study of 16 patients with pancreatic cancer who were given autogene cevumeran after surgical removal of the tumor. Trial participants were also treated with chemotherapy and a checkpoint inhibitor. Results presented earlier this year showed that eight patients responded to the personalized cancer vaccine. Autogene cevumeran was able to trigger the production of immune cells that recognized and attacked cancer cells, according to a news release from Memorial Sloan Kettering Cancer Center, which sponsored the study. Among the eight responders, seven were still alive four to six years after surgery, a survival rate of 87.5%. In contrast, the five-year survival rate for pancreatic cancer across different stages is 13% , according to the American Cancer Society. Roche and BioNTech are testing autogene cevumeran in a Phase 2 study in combination with the pharma’s checkpoint inhibitor Tecentriq and chemotherapy. The IMcode003 study is currently recruiting patients with resected pancreatic ductal adenocarcinoma. Topline data are expected in 2031. It hasn’t been completely smooth-sailing for autogene cevumeran, however. The candidate stumbled last month in colorectal cancer, as an independent data board recommended ending a Phase 2 study for futility—a setback that analysts at BMO Capital Markets at the time said could “reduce confidence in autogene cevumeran.” Cancer BioNTech halts mid-stage trial of personalized mRNA vaccine in colorectal cancer Shares of Germany-based BioNTech were down as much as 8% Friday after announcing a Phase 2 trial of autogene cevumeran would be discontinued for futility. The news follows Merck and Moderna’s Phase 3 win last week for their cancer vaccine plus Keytruda in melanoma. August 28, 2026 · 2 min read · Heather McKenzie Read more Two more shots for BioNTech Aside from autogene cevumeran, BioNTech has a handful of other cancer vaccines—though none are being positioned as personalized therapies. Instead, the company’s other assets , which it calls mRNA cancer immunotherapies, work by encoding certain tumor antigens that prime patients’ immune systems to fight off malignancies of a certain type. One of these assets is BNT113, which targets two proteins commonly found in HPV16-positive tumors. The candidate is currently being tested in combination with Merck’s mega-blockbuster PD-1 inhibitor Keytruda in the open-label Phase 2/3 AHEAD-MERIT study in newly diagnosed patients with unresectable recurrent or metastatic head and neck cancers. Phase 2 findings released in September 2024 showed that when used with Keytruda, BNT113 resulted in an unconfirmed overall response rate of 40% at 12 months. Interim data from the randomized, controlled part of the Phase 2/3 study, which is testing the combo regimen as a first-line treatment option, are expected this year, according to BioNTech’s second quarter presentation . Aside from BNT113, BioNTech is also advancing BNT116, which encodes six antigens associated with non-small cell lung cancer (NSCLC). A mid-stage study of the candidate in combination with Regeneron’s PD-1 inhibitor Libtayo in first-line NSCLC is ongoing, with data likewise set to be released this year. Early data published in November 2024 demonstrated a 10% partial response rate, with 70% of the 20 treated patients reaching stable disease. Drug Development BioNTech’s Multi-Modality Play Outpaces Moderna’s mRNA-Focused Pipeline After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape. February 3, 2026 · 5 min read · Nick Paul Taylor Read more OSE Immunotherapeutics pushes off-the-shelf vaccine Stepping up to compete against BioNTech is OSE Immunotherapeutics, which is advancing its own investigational cancer vaccine Tedopi. Tedopi is a T cell epitope–based therapy designed as an off-the-shelf vaccine that primes an immune response against five antigens commonly associated with tumors—a broad targeting pro unlike BNT116. Like BioNTech, OSE is testing Tedopi in NSCLC, in combination with Bristol Myers Squibb’s PD-1 blocker Opdivo and the chemotherapy docetaxel. This regimen is being tested in the Phase 2 Combi-TED trial, with topline data slated for later this year . The French biotech is also running the Phase 3 Artemia study, focusing on patients with metastatic disease who have undergone at least one prior line of treatment. This trial is currently recruiting with initial data expected late next year. Aside from NSCLC, OSE is also studying Tedopi in pancreatic and ovarian cancers, for which separate mid-stage trials are ongoing. In May, OSE toplined mid-stage ovarian cancer data for a regimen of Tedopi and Keytruda. Patients treated with the combo saw a significant 47% drop in the risk of death or disease progression as compared with supportive care. Comparing the doublet against the vaccine alone showed that Keytruda boosted Tedopi’s progression-free survival benefit by 28%, which fell short of statistical significance. Elicio rides Merck/Moderna’s tailwinds For Elicio Therapeutics, the success of Merck and Moderna’s vaccine in melanoma last month strengthened the case for the Boston biotech’s own cancer vaccine ELI-002. “Class validation is now empirical, not theoretical,” analysts at Rodman & Renshaw wrote in an Aug. 19 note. “The bull case for ELI-002 has partly rested on antigen-directed adjuvant vaccination being a viable mechanism class.” Elicio could use this additional confidence in ELI-002, after the asset in June failed to significantly improve disease-free survival in a mid-stage study of patient with KRAS-driven pancreatic cancer. At the time, however, the biotech blamed the miss on a higher proportion of patients with residual tumor cells at or within 1 mm of the surgical margin. Posthoc analyses showed better survival outcomes in the subset of patients whose tumors had been completely removed by surgery. Elicio will focus on this patient population in late-stage development. This approach of targeting specific patient groups likely to benefit from treatment “looks like an emerging field standard,” not just an Elicio-specific maneuver to improve late-stage chances, according to Rodman & Renshaw. The firm in particular pointed to Merck and Moderna’s success “in a similarly biomarker-informed, fully-resected population,” which suggests that “precision selection over broad . . . dosing is becoming the standard registrational path for adjuvant vaccines.” Designed to target lymph nodes, ELI-002 makes use of a KRAS peptide antigen that can elicit an immune response against a broad spectrum of KRAS mutations, according to Elicio’s website . The therapy also includes a proprietary adjuvant to further boost the immune response. Despite fail, Agenus advances dual-antibody therapy Capping off this list is Agenus and its immunotherapy combo BOT+BAL, which consists of the anti-CTLA-4 antibody botensilimab and PD-1 inhibitor balstilimab. While Agenus doesn’t label BOT+BAL as such, the asset works a lot like how a cancer vaccine might. A combination of the two antibodies, BOT+BAL is designed to activate the immune system and enhance activity against cancer cells. In particular, Agenus hopes to leverage this approach to awaken “cold” tumors, transforming cancers that have historically been inert to immunotherapies into an immune-responsive diseases. But the BOT+BAL bet hasn’t always played out well for Agenus. In April, the investigational combo, when used alongside a cell therapy from MiNK Therapeutics, the VEGFR2 antagonist Cyramza and chemotherapy, failed to trigger a response in any of 15 patients with gastroesophageal adenocarcinoma. Cell therapy Agenus cancer cocktail records 0% response rate, missing midstage goal An investigational cocktail was tied to a 0% overall response rate in patients with gastroesophageal cancer, but developers Agenus and MiNK Therapeutics aren’t giving up on the program just yet. April 20, 2026 · 2 min read · Gabrielle Masson Read more Agenus nevertheless has a broad development program for BOT+BAL, particularly in colorectal cancer, for which there are several studies of different stages testing various regimens of the investigational therapy. The most mature of these, the Phase 3 ROBBIN trial, is designed to test a neoadjuvant course of BOT+BAL in high-risk patients with stage II and III microsatellite-stable (MSS) colon cancer. In July, Agenus secured $85 million upfront —as well as $255 million in potential future payments—in a private placement push to help bankroll ROBBIN and push BOT+BAL’s development through key value inflection points, including an early pathologic response readout, expected in the back half of 2027. Aside from colorectal cancer, BOT+BAL is also being tested in a mid-stage study for solid tumors.

Gotistobart continues to show potential as chemotherapy-free monotherapy to reignite anti-tumor immunity in previously treated patients with squamous non-small cell lung cancer, where median survival with current standard of care treatments is less than one year 1 Gotistobart demonstrated a median overall survival of 18.5 months compared to 10.0 months with standard-of-care chemotherapy in updated data from stage 1 of the PRESERVE-003 Phase 3 clinical trial, nearly doubling median survival in this patient population Findings are consistent with gotistobart’s differentiated mechanism of action as an investigational immunomodulator that selectively enhances regulatory T cell depletion through CTLA-4-targeting in the tumor microenvironment MAINZ, Germany, and ROCKVILLE, USA, September 14, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”) today announced the first median overall survival (“OS”) data from the non-pivotal stage 1 of the global randomized PRESERVE-003 Phase 3 clinical trial ( NCT05671510 ) of gotistobart (also known as BNT316 or ONC-392), in patients with squamous non-small lung cancer (“NSCLC”) whose disease progressed on prior immunotherapy and chemotherapy. Gotistobart is an investigational CTLA-4-targeting immunotherapy designed to selectively deplete regulatory T cells (“Tregs”) within the tumor microenvironment and restore anti-tumor immune activity. The data showed that treatment with gotistobart led to a statistically significant and clinically meaningful OS benefit, nearly doubling survival compared with standard-of-care chemotherapy in this patient population. The data were presented at the International Association for the Study of Lung Cancer (“IASLC”) 2026 World Conference on Lung Cancer (“WCLC”). “Patients with squamous NSCLC continue to face limited treatment options after progression on immunotherapy. Current survival expectations with established therapies remain less than a year, and despite numerous development efforts, chemotherapy has remained the standard of care in this setting for more than a decade,” said Rama Balaraman, M.D., Principal Investigator and medical oncologist at Ocala Oncology Center, Florida, United States. “The magnitude of the survival benefit observed with gotistobart as a chemotherapy-free treatment approach in the PRESERVE-003 clinical trial is highly encouraging. If confirmed in the pivotal portion of the Phase 3 trial, these findings could transform the standard of care in a setting where new therapies are urgently needed.” At the data cut-off on July 17, 2026, with a median follow-up of 25.4 months, 87 patients with metastatic squamous NSCLC had been randomized to receive either gotistobart monotherapy 6 mg/kg with two 10 mg/kg loading doses (N=45) or docetaxel 75 mg/m 2 (N=42) in the second-line or later treatment setting. The median OS was 18.5 months for patients treated with gotistobart compared to 10.0 months for patients treated with docetaxel (HR: 0.56; nominal p-value=0.0295). The safety pro gotistobart was consistent with previously reported data and remained manageable. Grade ≥3 treatment-related adverse events (“AEs”) were reported in 20/45 (44.4%) patients receiving gotistobart and 20/42 (48.8%) patients receiving docetaxel. “These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “In second- and later lines of treatment, the clinical relevance of novel therapeutic options depends on the ability to re-engage a suppressed or exhausted anti-tumor immune response and overcome acquired resistance. This update highlights gotistobart’s unique mode of action and our ambition to translate our deep understanding of the immune system into meaningful survival benefit for patients with lung cancer – particularly in areas where patients still need more. We look forward to continuing our work with our colleagues at OncoC4 to further explore and realize gotistobart’s full potential.” “The data support the differentiated mechanism of action of gotistobart as a tumor microenvironment-selective Treg modulator and reinforce our confidence in the therapeutic potential of this distinct CTLA-4-targeting approach to meaningfully shift the treatment landscape in this indication,” said Pan Zheng, M.D., Ph.D., Co-Founder and Chief Medical Officer at OncoC4. “We are encouraged by the clinical activity and safety pro to date and remain focused on advancing gotistobart for patients with this difficult-to-treat disease.” The pivotal stage 2 portion of PRESERVE-003 is currently ongoing at more than 160 sites globally. Gotistobart previously demonstrated a clinically meaningful OS benefit and durable anti-tumor activity versus docetaxel in stage 1 of the PRESERVE-003 Phase 3 trial in patients with squamous NSCLC who had progressed on PD-(L)1 inhibitors. This data was published in Nature Medicine and presented at the 2026 European Lung Cancer Congress (“ELCC”) and the IASLC ASCO 2025 North America Conference on Lung Cancer (“NACLC”). About the PRESERVE-003 clinical trial PRESERVE-003 ( NCT05671510 ; EUCT:2023-505311-20-01 ; CTR20232927 ) is a two-stage, open-label Phase 3 trial evaluating the efficacy and safety of gotistobart as monotherapy compared to the standard-of-care chemotherapy (docetaxel) in squamous NSCLC patients, who have progressed on PD-(L)1 inhibitors and platinum-based chemotherapy. The non-pivotal stage of the trial included all NSCLC patients. The ongoing pivotal stage enrolled patients with squamous NSCLC. The primary endpoint is overall survival. Secondary endpoints include overall response rate, progression-free survival, and safety profile. About gotistobart (BNT316/ONC-392) Gotistobart (BNT316/ONC-392) is an investigational immunotherapy that enhances Treg depletion within the tumor microenvironment through targeting ​CTLA-4 to reignite antitumor ​immunity and which is being jointly developed by BioNTech and OncoC4. 2 ,3,4,5,6,7,8,9 As a pH-sensitive monoclonal antibody, gotistobart is designed to enable CTLA-4 protein recycling. After binding to the CTLA-4 receptor on the cell surface, the complex is internalized, and the pH change causes the antibody to unbind, allowing CTLA-4 to return to the surface to preserve the immune checkpoint function at peripheral organs and to enhance anti-tumor immunity in the tumor microenvironment. 9 Gotistobart is currently in late-stage clinical development as a monotherapy and as a component of combination therapy in various cancer indications. Gotistobart received Fast Track Designation from the U.S. Food and Drug Administration (“FDA”) in 2022 for the treatment of patients with metastatic NSCLC whose disease progressed on prior anti-PD-(L)1 therapy and Orphan Drug Designation for the treatment of patients with squamous NSCLC in 2025. The candidate also received Breakthrough Therapy Designation from China’s National Medical Products Administration (“NMPA”) in 2025. About squamous non-small cell lung cancer With a 5-year relative survival rate of 15% and a median overall survival of 11 months in the United States (2000-2017), squamous NSCLC is a devastating disease with limited treatment options. 1 Current standard-of-care includes surgery and radiotherapy in combination with chemotherapy. 10 Treatment options for second-line therapy after first-line immunotherapy and chemotherapy are limited to chemotherapy or palliative therapy in advanced/metastatic squamous NSCLC and remain more limited than for non-squamous NSCLC. About BioNTech BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer. For more information, please visit . BioNTech Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the collaboration with OncoC4; BioNTech and OncoC4’s ability to successfully co-develop and co-commercialize gotistobart (also known as BNT316 or ONC-392), if approved; the rate and degree of market acceptance of gotistobart, if approved; the initiation, timing, progress, and results of BioNTech’s research and development programs, including data from the non-pivotal stage 1 of the global randomized Phase 3 trial PRESERVE-003 and statements regarding the expected timing of initiation, enrollment, and completion of trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations, including expectations regarding the potential indications in which gotistobart may be approved, if at all; the targeted timing and number of additional potentially registrational trials, and the registrational potential of any trial BioNTech may initiate; and discussions with regulatory agencies. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control, and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the impact of tariffs and escalations in trade policy; competition related to BioNTech’s product candidates; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s development candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments in the United States and other countries; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended June 30, 2026, and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at . These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. About OncoC4 Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologics for the treatment of cancer and immunological diseases. OncoC4’s pipeline features assets with first-in-class and best-in-class potential targeting both novel and well-validated targets across oncology and immunological diseases. Among them, AI-081 is a wholly owned bispecific antibody candidate targeting PD-1 and VEGF that is currently in phase 2 trial for oncology indications. ONC-841 is a first-in-class anti-SIGLEC-10 antibody currently in a Phase 2 trial for oncology indications and a Phase 1 trial for neurodegenerative diseases. OncoC4 has a strategic collaboration with BioNTech to co-develop gotistobart (BNT316/ONC-392), a tumor microenvironment-selective Treg depletion candidate targeting CTLA-4, in multiple solid tumor indications, including an ongoing pivotal clinical trial in squamous non-small cell lung cancer. More information: . CONTACTS BioNTech: Investor Relations Douglas Maffei, Ph.D. Investors@BioNTech.de Media Relations Jasmina Alatovic Media@BioNTech.de OncoC4: Investor Relations Ryan Cui ir@oncoc4.com Media Relations Helen Schiltz hschiltz@oncoc4.com 1 Hu, Sheng et al. (2021) Prognosis and Survival Analysis of 922,217 Lung Cancer Patients from the US Based on the Most Recent Data from the SEER Database (April 15, 2021), International Journal of General Medicine, Volume 14, 9567-9588. 2 Du X, et al. Cell Res. 2018;28:433–47 3 Du X, Cell Res. 2018;28:416–32 4 Gao H, et al. Cell Discov. 2020;6:79 5 Hale G, et al. MAbs. 2024;16:2406539 6 Liu R, et al. bodies (Basel). 2020;9:64 7 Simpson TR, et al. J Exp Med. 2013;210:1695–710 8 Mellman I, et al. Immunity. 2023;56:2188–205 9 Zhang Y et al. (2019). Cell Res. 29:609-627 10 American Cancer Society (2025) Treatment Choices for Non-small Cell Lung Cancer, by Stage, online at: