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Last update 28 May 2026
mRNA-4359
Last update 28 May 2026
Overview
Basic Info
Drug Type Therapeutic vaccine, mRNA vaccine |
Synonyms mRNA 4359, mRNA4359 |
Target |
Action modulators |
Mechanism IDO1 modulators(Indoleamine 2,3-dioxygenase modulators), PDL1 modulators(Programmed death-ligand 1 modulators) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhasePhase 2 |
First Approval Date- |
Regulation- |
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Related
1
Clinical Trials associated with mRNA-4359NCT05533697
Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors
The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab or ipilimumab and nivolumab.
Start Date01 Sep 2022 |
Sponsor / Collaborator |
100 Clinical Results associated with mRNA-4359
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100 Translational Medicine associated with mRNA-4359
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100 Patents (Medical) associated with mRNA-4359
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26
News (Medical) associated with mRNA-435901 May 2026
Reports first quarter revenue of $0.4 billion, with approximately 80% of revenue from international markets
Reports first quarter GAAP net loss of $(1.3) billion and GAAP EPS of $(3.40), including $0.9 billion non-recurring litigation settlement charge
Reiterates plan to deliver up to 10% revenue growth and GAAP operating expense reductions in 2026, excluding the non-recurring litigation settlement charge
Advanced infectious disease portfolio with key regulatory milestones in the EU, including approval of mNEXSPIKE and mCOMBRIAX, Moderna's flu plus COVID combination vaccine
Initiated Phase 3 clinical study evaluating intismeran autogene as monotherapy and in combination with KEYTRUDA QLEX for treatment of high-risk Stage 1 non-small cell lung cancer
CAMBRIDGE, MA /
ACCESS Newswire
/ May 1, 2026 /
Moderna, Inc. (NASDAQ:MRNA) today reported financial results and provided business updates for the first quarter of 2026.
"The Moderna team delivered a great start to the year, driving significant revenue growth and substantial cost reductions building on actions taken in 2025. We received two product approvals in Europe, including the world's first flu plus COVID combination vaccine, mCOMBRIAX. We also started a new pivotal trial for intismeran-our first Phase 3 monotherapy study for high-risk Stage 1 non-small cell lung cancer patients," said Stéphane Bancel, Chief Executive Officer of Moderna. "Building on this strong first quarter momentum, we are excited to return to sales growth in 2026 and expect several additional approvals around the world, including for our seasonal flu vaccine, which would be Moderna's fifth approved product. We also look forward to important pivotal readouts this year for our norovirus, intismeran in melanoma, and propionic acidemia programs."
Commercial Updates
During the first quarter, Moderna continued to advance its multi-year revenue growth strategy by executing on strategic partnerships and key approvals. In the UK, the Company delivered the first shipment under its long-term strategic partnership. Moderna also received regulatory approval in Europe for mNEXSPIKE
®
and its flu plus COVID combination vaccine, mCOMBRIAX
®
, as well as mRESVIA
®
for all individuals aged 18 and older.
First Quarter 2026 Financial Results
Revenue
: Total revenue for the first quarter of 2026 was $389 million, an increase of $281 million compared to the same period in 2025. Revenue was $78 million in the U.S. and $311 million in international markets. Net product sales increased due to higher COVID vaccine sales, primarily in international markets, as a result of deliveries under long-term strategic partnerships with government entities.
Cost of Sales:
Cost of sales for the first quarter of 2026 was $955 million, including third-party royalties of $895 million and inventory write-downs of $38 million. Cost of sales increased by $865 million, compared to the same period in 2025, primarily driven by litigation settlement-related expenses of $878 million recognized in the first quarter of 2026 within third-party royalties. Excluding these expenses, cost of sales decreased compared to the same period in 2025, primarily due to lower unutilized manufacturing capacity costs, losses on firm purchase commitments and inventory write-downs, partially offset by higher sales volume.
Research and Development Expenses:
Research and development expenses for the first quarter of 2026 were $649 million, a 24% decrease compared to the same period in 2025. The decrease was primarily driven by lower clinical development and manufacturing costs, reflecting the wind-down of large Phase 3 respiratory programs and congenital CMV studies, as well as the timing of clinical trial activities, partially offset by higher costs related to postmarketing commitments for the Company's COVID products.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses for the first quarter of 2026 were $173 million, an 18% decrease compared to the same period in 2025. The decrease was primarily driven by lower employee-related expenses, as well as reduced marketing costs and lower consulting and external services across multiple functions, reflecting continued discipline across the organization.
Income Taxes:
Income tax provisions for both periods were not material, as the Company continues to maintain a global valuation allowance against most of its deferred tax assets.
Net Loss:
Net loss was $(1.3) billion for the first quarter of 2026, compared to net loss of $(1.0) billion for the first quarter of 2025. Litigation settlement-related expenses had an unfavorable impact of $(0.9) billion on net loss for the first quarter of 2026.
Loss Per Share:
Loss per share was $(3.40) for the first quarter of 2026, compared to loss per share of $(2.52) for the first quarter of 2025. Litigation settlement-related expenses had an unfavorable impact of $(2.22) on loss per share for the first quarter of 2026.
Cash Position:
Cash, cash equivalents and investments as of March 31, 2026, were $7.5 billion, compared to $8.1 billion as of December 31, 2025. The decrease was primarily driven by operating losses associated with continued investment in research and development and advancement of the Company's pipeline. Litigation settlement-related expenses recognized in the first quarter of 2026 did not impact cash during the period, as the related payment of $950 million is expected to be made in the third quarter of 2026.
2026 Financial Framework
Revenue:
The Company is targeting up to 10% growth from 2025 revenue and expects 2026 revenue split to be approximately 50% U.S. and approximately 50% international.
Cost of Sales:
Cost of sales for 2026 is now expected to be approximately $1.8 billion, including the $0.9 billion non-recurring litigation settlement charge.
Research and Development Expenses:
Research and development expenses for 2026 are anticipated to be approximately $3.0 billion.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses for 2026 are projected to be approximately $1.0 billion.
Income Taxes:
The Company expects its full-year tax expense to be negligible.
Capital Expenditures:
Capital expenditures for 2026 are expected to be $0.2 to $0.3 billion.
Cash and Investments:
Year-end cash and investments for 2026 are now projected to be $4.5 to $5.0 billion, which excludes any further drawdowns from the Company's remaining $0.9 billion available under its credit facility.
Recent Progress and Upcoming Late-Stage Pipeline Milestones
Infectious disease vaccines:
Seasonal flu + COVID vaccine
: Moderna recently presented mRNA-1083 data from a Japanese cohort at the 2026 European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress. The Company has received European Commission marketing authorization for mCOMBRIAX in the EU and its mRNA-1083 regulatory filings are under review in Canada and Australia. Moderna is awaiting further guidance from the U.S. FDA on refiling the submission for its flu plus COVID combination vaccine.
Seasonal flu vaccine
: Moderna recently presented mRNA-1010 revaccination data at the 2026 ESCMID Global Congress. The Company's mRNA-1010 regulatory filings are under review in Europe, Canada and Australia and potential approvals are expected to begin in 2026. The U.S. FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date for mRNA-1010 of August 5, 2026.
Norovirus vaccine
: Moderna's ongoing Phase 3 safety and efficacy study of mRNA-1403 is fully enrolled in a second Northern Hemisphere season (2025-2026) with data expected in 2026, subject to case accruals.
Oncology therapeutics:
Intismeran autogene
: The Company is advancing mRNA-4157 in collaboration with Merck, with nine total Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. This includes the recent initiation of a Phase 3 study of intismeran as monotherapy and in combination with KEYTRUDA QLEX for the treatment of high-risk Stage 1 NSCLC.
Fully enrolled studies include a Phase 3 adjuvant melanoma, a Phase 2 adjuvant renal cell carcinoma, and a Phase 2 adjuvant muscle invasive bladder cancer. Moderna expects Phase 3 adjuvant melanoma data potentially in 2026.
The Company recently announced an upcoming oral presentation on June 1 at 8 a.m. to 11 a.m. CT at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting highlighting positive five-year Phase 2b adjuvant melanoma data, which showed a sustained benefit with intismeran in combination with KEYTRUDA, reducing the risk of recurrence or death by 49% compared to KEYTRUDA alone.
mRNA-4359
: Moderna's Phase 1/2 study of mRNA-4359, an investigational wholly-owned cancer antigen therapy, is ongoing. The Company recently presented mRNA-4359 data at the American Association for Cancer Research (AACR) 2026 Annual Meeting. The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC, and the Company expects a potential Phase 2 data readout in 2026.
Rare disease therapeutics:
Propionic acidemia (PA) therapeutic
: The Company's PA candidate, mRNA-3927, is in a registrational study and target enrollment has been reached. Moderna expects potential data in 2026.
Methylmalonic acidemia (MMA) therapeutic
: The Company is deferring its decision on a pivotal trial for mRNA-3705 until PA registrational data readout.
Moderna Corporate Updates
Entered into a settlement agreement with Arbutus Biopharma Corporation and Genevant Sciences GmbH resolving all litigation worldwide
Announced the initiation of Phase 3 study of mRNA-1018, Moderna's investigational pandemic influenza vaccine in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI)
Key 2026 Investor and Analyst Event Dates
ASCO Investor Event: June 1 at 7:15 a.m. ET
Science Day: June 25
Analyst Day: November 12
Investor Call and Webcast Information
Moderna will host a live conference call and webcast at 8:00 a.m. ET on May 1, 2026. To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.
Telephone:
Webcast:
The archived webcast will be available on Moderna's website approximately two hours after the conference call and will be available for one year following the call.
About Moderna
Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.
With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.
MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, in millions, except per share data)
Three Months Ended March 31,
2026
2025
Revenue:
Net product sales
$
352
$
86
Other revenue
1
37
22
Total revenue
389
108
Operating expenses:
Cost of sales
955
90
Research and development
649
856
Selling, general and administrative
173
212
Total operating expenses
1,777
1,158
Loss from operations
(1,388
)
(1,050
)
Interest income
72
90
Other expense, net
(18
)
(4
)
Loss before income taxes
(1,334
)
(964
)
Provision for income taxes
9
7
Net loss
$
(1,343
)
$
(971
)
Net loss per share
Basic and Diluted
$
(3.40
)
$
(2.52
)
Weighted average common shares used in calculation of net loss per share
Basic and Diluted
395
386
_______
1
Includes grant, collaboration, licensing and royalty, and stand-ready manufacturing revenue.
MODERNA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, in millions)
March 31,
December 31,
2026
2025
Assets
Current assets:
Cash and cash equivalents
$
1,908
$
2,595
Investments
3,297
3,204
Accounts receivable, net
71
184
Inventory
146
153
Prepaid expenses and other current assets
348
408
Total current assets
5,770
6,544
Investments, non-current
2,251
2,336
Property, plant and equipment, net
2,086
2,134
Right-of-use assets, operating leases
706
719
Other non-current assets
675
605
Total assets
$
11,488
$
12,338
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable
$
161
$
317
Accrued liabilities
1,912
1,386
Deferred revenue
102
99
Other current liabilities
220
185
Total current liabilities
2,395
1,987
Deferred revenue, non-current
154
153
Operating lease liabilities, non-current
645
653
Financing lease liabilities, non-current
13
20
Long-term debt
590
590
Other non-current liabilities
283
285
Total liabilities
4,080
3,688
Stockholders' equity:
Additional paid-in capital
1,503
1,382
Accumulated other comprehensive income
25
45
Retained earnings
5,880
7,223
Total stockholders' equity
7,408
8,650
Total liabilities and stockholders' equity
$
11,488
$
12,338
MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in millions)
Three Months Ended March 31,
2026
2025
Operating activities
Net loss
$
(1,343
)
$
(971
)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
104
115
Depreciation and amortization
59
39
Amortization/accretion of investments
(11
)
(19
)
Loss on equity investments, net
2
8
Other non-cash items
6
2
Changes in assets and liabilities:
Accounts receivable, net
114
280
Prepaid expenses and other assets
54
46
Inventory
6
(8
)
Right-of-use assets, operating leases
11
9
Accounts payable
(120
)
(156
)
Accrued liabilities
464
(381
)
Deferred revenue
5
(29
)
Operating lease liabilities
(7
)
(5
)
Other liabilities
26
33
Net cash used in operating activities
(630
)
(1,037
)
Investing activities
Purchases of marketable securities
(1,348
)
(1,764
)
Proceeds from maturities of marketable securities
732
1,933
Proceeds from sales of marketable securities
602
688
Purchases of property, plant and equipment
(62
)
(117
)
Purchase of intangible asset
-
(10
)
Net cash (used in) provided by investing activities
(76
)
730
Financing activities
Proceeds from issuance of common stock through equity plans
19
3
Tax payments related to net share settlements on equity awards
(2
)
(1
)
Changes in financing lease liabilities
-
2
Net cash provided by financing activities
17
4
Effect of changes in exchange rates on cash and cash equivalents
1
-
Net decrease in cash, cash equivalents and restricted cash
(688
)
(303
)
Cash, cash equivalents and restricted cash, beginning of year
2,597
1,929
Cash, cash equivalents and restricted cash, end of period
$
1,909
$
1,626
Spikevax
®
, mRESVIA
®
, mNEXSPIKE
®
and mCOMBRIAX
®
are registered trademarks of Moderna.
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 statements regarding: Moderna's 2026 financial framework, including its plan to deliver up to 10% revenue growth and GAAP operating expense reductions, and its projected year-end cash balance; Moderna's multi-year revenue growth strategy, including geographic expansion and new product launches; Moderna's continued cost discipline; Moderna's international strategic partnerships; expectations regarding mRNA-4157 Phase 3 adjuvant melanoma data in 2026; the potential of intismeran as monotherapy and in combination with KEYTRUDA QLEX; the potential of Moderna's expanded oncology portfolio; pending and anticipated regulatory filings and potential approvals, including timing of approvals; Moderna's PDUFA date in the U.S. for mRNA-1010; and anticipated progress and milestones for Moderna's pipeline programs, including potential near-term data and other catalysts. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "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 neither promises nor guarantees, and 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 Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at Except as required by law, Moderna 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. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.
###
Moderna Contacts
Media:
Chris Ridley
Vice President, Head of Global Communications
+1 617-800-3651
Chris.Ridley@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com
SOURCE:
Moderna, Inc.
View the original
press release
on ACCESS Newswire
28 Apr 2026
iStock,
Wirestock
Cancer cocktails pairing Moderna’s mRNA-4359 with Merck’s Keytruda and Marengo’s invikafusp alfa with Gilead Sciences’ Trodelvy showed promising results, while a complex combination by Agenus and MiNK Therapeutics failed to elicit an overall response.
Combinations continue to be a primary focus in cancer drug development, as researchers seek out therapeutic cocktails that target tumor cells with optimum efficiency while also mitigating side effects and potential drug resistance.
Indeed, the next wave of combo therapies was on display at the American Association for Cancer Research’s annual meeting in San Diego last week. Companies including Moderna, Marengo Therapeutics and Akeso presented new data at AACR showcasing new uses for existing combinations, as well as blends of experimental therapies with tried-and-true treatments like chemotherapy and more recently approved drugs.
A combination approach is “very, very important,” Zhen Su, a physician-scientist and CEO of Marengo, told
BioSpace
, pointing as an example to the “transformative care” now available to patients with certain types of lung cancer and multiple myeloma thanks to high-powered drug combos.
“For frontline cancer, the treatment’s oftentimes a combination therapy because tumors are not easy to tackle, and sometimes you need a multi-modality approach to really hit tumors from different angles,” Su said.
Such combos might include a chemotherapy or antibody-drug conjugate (ADC) that can give a tumor “a big hit from the get-go,” he said, alongside an immunotherapy capable of activating cancer-fighting T cells.
When experimental meets approved
At AACR, Marengo shared
initial data
from a
Phase 2 study
of invikafusp alfa, an investigational dual T cell agonist, in combination with Gilead Sciences’ ADC Trodelvy, which is FDA-approved for certain forms of heavily pretreated breast cancer. Of 10 patients with heavily pretreated metastatic breast cancer, two had confirmed complete responses to the combo, two had confirmed partial responses and six saw their disease remain stable.
The drug cocktail is one of the first to combine a precision immunotherapy with a precision ADC, Su said, bringing “two of the most potent modalities into a tumor and [lighting] up a fire in their cancer.” The results so far, he continued, are a sign of “the next frontier,” an exciting new phase in the industry after his nearly three decades as a drug developer.
Marengo plans to continue expanding the trial and, “if we continue to see the benefits we’re seeing,” will potentially seek FDA Fast Track designation for the combo in breast cancer before moving into a pivotal trial. Invikafusp alfa already holds the designation as a monotherapy in advanced colorectal cancer.
Also unveiling combo data at AACR last week was Moderna, specifically, early results from a
Phase 2 trial
of its investigational antigen therapy mRNA-4359 in combination with Merck’s blockbuster immunotherapy Keytruda as a first-line treatment for locally advanced and metastatic melanoma. As of Dec. 1, 2025, two of 12 patients achieved a complete response, while eight had a partial response, for an overall response rate of 83%.
Cancer
AACR 2026: Moderna, Revolution, Zymeworks and BeOne showcase new data
Moderna, Revolution Medicines and Zymeworks record wins in melanoma, lung and breast cancers, while BeOne swings and misses at head and neck cancer.
April 21, 2026
·
4 min read
·
Tristan Manalac
Read more
There are several reasons for mRNA-4359’s promise in melanoma, David Berman, Moderna’s recently appointed chief development officer, told
BioSpace
via email. For one, he said, “this is a novel dual mechanism therapy where we activate T cells to kill cancer cells and recalibrate the tumor microenvironment to a more immune favorable state.”
Berman also pointed to the benefits shown in a study of the combo among patients previously treated with immune checkpoint inhibitors and in late-stage data “from another company using a similar approach.”
Following Monday’s AACR presentation, in a
video
posted to Moderna’s website, Berman called the early trial results “quite intriguing,” while noting that “it’s hard to tease apart” the contributions of each component of the drug cocktail. Therefore, the next steps will be to determine if, in the larger cohort of patients who have progressed on checkpoint inhibitors, there is sufficient reason to believe that mRNA-4359 is bringing additional activity, he said. Those data should arrive “over the next year.”
In a Monday note to investors, Leerink Partners said that while the patient sample is very small, the 83% ORR “represents a promising signal,” though the analysts cautioned that it is “unlikely to garner meaningful investor enthusiasm.”
Hits and misses
Another promising drug is a combination of Akeso’s PD-1/CTLA-4 bispecific antibody cadonilimab with chemotherapy. The Chinese biotech is evaluating the combo in the
Phase 2
Compassion-26 study as a first-line treatment for advanced cases of pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer.
Data presented at AACR
showed
an objective response rate of just under 34% and disease control rate of 96.4% among 56 patients. The drug combination appeared to be especially effective in patients with locally advanced disease, with a median overall survival rate of more than 23 months and median progression-free survival of 11.1 months, compared to 10.5 months and 7.2 months, respectively, among those with metastatic disease.
“The efficacy of cadonilimab in hard-to-treat tumors is driven by its innovative molecular design and novel mechanism of action,” a company spokesperson told
BioSpace
via email. “It harnesses the therapeutic benefits of both PD-1 and CTLA-4 pathways while overcoming the traditional efficacy and safety limitations of each target.” This translates into breakthrough clinical value, the spokesperson continued. “For example, it addresses the toxicity challenges that have historically limited the use of CTLA-4 agents and improves response in PD-L1 low/negative populations where PD-1/L1 inhibitors often underperform.”
With these attributes, Akeso’s spokesperson added, “cadonilimab is well-positioned as a backbone agent to combine with novel therapies.”
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
Less successful, meanwhile, were results from a
Phase 2 study
of Agenus’ experimental immunotherapies botensilimab and balstilimab plus MiNK Therapeutics’ allogeneic cell therapy agenT-797, alongside the approved VEGFR2 antagonist Cyramza and chemotherapy. The cocktail elicited a 0% response rate among the study’s 15 eligible gastroesophageal adenocarcinoma patients.
Despite missing the study’s primary endpoint, Agenus remained optimistic, suggesting in an April 17
press release
that the secondary factors of durability and survival may in fact “be the most clinically relevant endpoints” among the study’s particular population. The combo was tied to a 73% stable disease rate, while three patients experienced overall survival of more than 20 months.
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Clinical ResultPhase 2Immunotherapy
21 Apr 2026
iStock,
otman lazrak
Moderna, Revolution Medicines and Zymeworks record wins in melanoma, lung and breast cancers, while BeOne swings and misses at head and neck cancer.
The American Association for Cancer Research annual meeting is in full swing, featuring some of the latest developments in biopharma’s most dynamic therapeutic area. Experts from all over the world have congregated in the San Diego Convention Center to present cutting-edge research that could push the field forward and potentially change clinical practice.
BioSpace
rounds up some of the most interesting presentations here.
Moderna presents “competitive” first-line data for melanoma antigen therapy
Moderna’s investigational antigen therapy mRNA-4359, when used alongside Merck’s anti-PD-1 blockbuster Keytruda, elicited an 83% overall response rate (ORR) in patients with locally advanced or metastatic melanoma who hadn’t been exposed to prior treatments.
Two patients in the Phase 1/2 study achieved a complete response (CR)—the total absence of any signs of remaining cancer—while eight experienced partial responses, according to an
oral presentation
at AACR. Disease control rate hit 92%.
“The encouraging data looks competitive to approved 1L options offering a differentiated off-the shelf-approach,” Jefferies analysts told investors in a Monday note.
In terms of competition, the firm pointed to Bristol Myers Squibb’s Opdualag—a combination of the anti-LAG-3 antibody relatlimab and the pharma’s PD-1 blocker Opdivo—which according to its
label
generated an ORR of 43% and a CR of 16%. Opdualag was approved in 2022 for unresectable or metastatic melanoma. Jefferies also referred to Regeneron’s Libtayo plus fianlimab, a combo regimen that in a Phase 2 study demonstrated an
ORR of 57%
.
MRNA-4359 plus Keytruda has been granted the FDA’s fast track designation for unresectable or metastatic melanoma, Moderna said in a
news release
on Friday. The company “is targeting a potential drug launch by 2028,” Jefferies added in its note.
Revolution updates lung cancer data after epic pancreatic cancer win
Following its
knockout late-stage victory
in pancreatic cancer, Revolution Medicines presented a detailed breakdown of Phase 1 data for its lung cancer drug zoldonrasib at AACR.
The results showed a 52% confirmed ORR with a 93% disease control rate. This outcome “decreased slightly” from a prior readout, analysts at Leerink Partners told investors in a Monday note, pointing to an April 2025 readout that showed a
61% ORR
. “This data cut included more patients,” Leerink said by way of an explanation, “and a longer follow-up time.”
The study, dubbed RMC-9805-001, also found that median progression-free survival (PFS) reached 11.1 months, with 48% of patients being free of disease progression at 12 months. Overall survival rate were not yet mature by the time of the AACR readout, but the study hit an estimated survival rate of 73% at 12 months, “suggesting encouraging early survival outcomes,” according to a Monday
press announcement
.
Zoldonrasib is a tri-complex inhibitor that works by binding to and creating a complex with cyclophilin A, in turn selectively blocking the active form of a certain cancer-causing RAS mutant. Around 29% of all RAS cancers are linked to this specific genetic anomaly, according to Revolution’s release, with no approved targeted therapy. Aside from lung cancer, the biotech is
also studying
zoldonrasib in pancreatic cancer and other solid tumors.
Lung cancer
Merck’s early PD-1/VEGF data competitive in lung cancer, but Summit ‘looms large’
While Merck’s PD-1/VEGF asset appears to match the performance of Summit Therapeutics’ ivonescimab, the pharma’s Phase 1/2 readout in non-small cell lung cancer still leaves analysts with some questions moving into later-stage development.
April 20, 2026
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2 min read
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Tristan Manalac
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‘Encouraging’ win for Zymeworks, BeOne and Jazz’s bispecific backs cutting chemo in early breast cancer
A neoadjuvant course of Zymeworks’ bispecific antibody zanidatamab can help minimize or eliminate the need for chemotherapy in patients with early-stage HER2-positive breast cancer.
“Strategies are needed to de-escalate treatment” in these patients, according to the
abstract
of an investigator-initiated trial presented at AACR. At six weeks, zanidatamab treatment before surgery significantly reduced tumor size and volume, as measured by ultrasound and magnetic resonance imaging.
Six patients achieved a pathologic complete response, while four had limited residual cancer burden.
These results are “encouraging but early,” Leerink analysts wrote on Monday, noting that zanidatamab’s activity “appeared enriched in patients with HER2+” tumors. Zymeworks
is advancing
zanidatamab along with BeOne Medicines and Jazz Pharmaceuticals for a variety of malignancies, including gastroesophageal adenocarcinoma, biliary tract cancer and different types of breast cancer.
Zanidatamab is a bispecific antibody that targets two sites on the HER2 protein. This mechanism of action facilitates the immune system’s anticancer response, in turn preventing the tumor’s growth and triggering its death. The drug was approved by the FDA in 2024 for unresectable or metastatic HER2-positive biliary tract cancer, for which it is marketed as
Ziihera
.
BeOne’s experimental Tevimbra combos show no added benefit over PD-1 monotherapy
BeOne is proposing a clutch of cancer combination regimens based on its PD-1 inhibitor Tevimbra—but
data
presented at AACR did not show improved efficacy over monotherapy.
In a Phase 2 study, BeOne combined Tevimbra with the anti-TIM-3 antibody surzebiclimab and/or the anti-LAG-3 therapy alcestobart. The biotech treated 160 patients with recurrent and/or metastatic head and neck squamous cell carcinoma.
Over a median follow-up of 13.1 months, ORR reached 27.5% in patients on Tevimbra plus surzebiclimab and those given all three therapies. Participants on Tevimbra plus alcestobart had an ORR of 25%. Meanwhile, Tevimbra monotherapy yielded an ORR of 27.5%—not significantly different than the three investigational arms.
Clinical benefit rate and disease control rate were likewise comparable across all four study groups.
While the combo arms didn’t show added benefit over Tevimbra monotherapy, the discussant during the data presentation “did point out that this was a heterogenous population and there might be more benefit in the PD-L1 low tumors,” Leerink Partners wrote in an investor note on Monday.
Clinical ResultPhase 1Phase 2Fast TrackDrug Approval
100 Deals associated with mRNA-4359
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Advanced Malignant Solid Neoplasm | Phase 2 | Australia | 01 Sep 2022 | |
| Advanced Malignant Solid Neoplasm | Phase 2 | Italy | 01 Sep 2022 | |
| Advanced Malignant Solid Neoplasm | Phase 2 | Spain | 01 Sep 2022 | |
| Advanced Malignant Solid Neoplasm | Phase 2 | United Kingdom | 01 Sep 2022 |
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Clinical Result
Clinical Result
Indication
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| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 1/2 | Locally Advanced Melanoma First line | 12 | nywpttzskp(ivlrfwwede) = ahgzaniurm pdzlnoypzr (nfvhoqrjxf, 62 - 100) View more | Positive | 20 Apr 2026 | ||
(PD-L1 TPS ≥1%) | nywpttzskp(ivlrfwwede) = szecsoujgi pdzlnoypzr (nfvhoqrjxf, 47 - 100) View more | ||||||
NCT05533697 (ESMO2025) Manual  | Phase 1/2 | 29 | mRNA-4359 + pembrolizumab (400 μg) | utgxjnkuhh(iwhtxvslfx) = mRNA-4359 AEs were mostly Grade 1/2 injection site reactions and self-limited systemic AEs. Pembrolizumab AEs were consistent with its known safety profile. ytakobrhof (osphzbriqm ) View more | Positive | 17 Oct 2025 | |
mRNA-4359 + pembrolizumab (1000 μg) | |||||||
Phase 1/2 | 196 | (first-line advanced NSCLC with PD-L1 tumor proportion score (TPS) ≥50% and EGFR/ALK-negative) | qvhezhtycd(ccpvfwqfpz) = uquootkxgw bxurhtsglk (qhgbuhhysb ) | Positive | 12 Oct 2025 | ||
(first-line advanced melanoma) | inymyyroic(osbeymgcsl) = zjjikvviqs lpsizslyog (qndgrigywc ) |
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