On November 5, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported its financial results for the quarter ended September 30, 2025, and provided an update on corporate progress.

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"Our diverse clinical and preclinical RAS(ON) inhibitor programs continue to make encouraging progress and deliver on important milestones," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "Backed by robust operational capabilities and a strong financial position, we feel growing momentum in support of our goal to establish new global standards of care for people living with RAS-addicted cancers, including pancreatic, lung and colorectal cancers."

The company reported significant progress on its near-term strategic priorities:

Execute pivotal trials with daraxonrasib monotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC)

RASolute 302, a global Phase 3 clinical trial of daraxonrasib in patients with previously treated PDAC, is winding down enrollment globally as the company nears completion of enrollment at all U.S. and international sites. The trial remains on track for an expected data readout in 2026.

For daraxonrasib in pancreatic cancer, the FDA recently granted an Orphan Drug Designation as well as a Commissioner’s National Priority Voucher supporting accelerated review, in addition to the previously awarded Breakthrough Therapy Designation.

RASolve 301, a global Phase 3 trial of daraxonrasib in patients with previously treated NSCLC, is now enrolling patients in Europe and Japan in addition to the U.S.

Advance daraxonrasib into earlier line randomized pivotal trials in patients with PDAC and NSCLC

The company recently disclosed new clinical results supporting initiation of RASolute 303, a global Phase 3 registrational trial of daraxonrasib in first line metastatic PDAC. The company remains on track to initiate the trial this year. The trial will evaluate daraxonrasib as monotherapy and in combination with gemcitabine nab-paclitaxel (GnP), each compared with GnP alone. The company expects to share updated daraxonrasib monotherapy and daraxonrasib plus GnP combination data, each in patients with first line PDAC, including preliminary durability, in the first half of 2026.

The company has initiated RASolute 304, a Phase 3 trial of daraxonrasib as adjuvant treatment for patients with resectable PDAC, and is currently activating trial sites. The trial will evaluate patients who have received surgery and perioperative chemotherapy per standard of care, who will be randomized to either observation or daraxonrasib monotherapy for two years. The primary endpoint is disease-free survival, with secondary endpoints of overall survival and safety.

The company remains on track to initiate a registrational trial in 2026 evaluating daraxonrasib in patients with first line metastatic RAS mutant NSCLC in combination with pembrolizumab and chemotherapy.

Generate sufficient data to inform development priorities for the mutant-selective inhibitors elironrasib and zoldonrasib and prepare to initiate one or more pivotal trials either as monotherapy or in a drug combination

New elironrasib monotherapy data presented recently at the AACR (Free AACR Whitepaper)-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics (Triple Meeting) showed encouraging response rate and progression-free survival in patients with RAS G12C NSCLC who had previously been treated with a KRAS G12C(OFF) inhibitor. The company continues to expand enrollment in this and other elironrasib monotherapy and combination trials as it explores options for continued development of this differentiated and promising RAS(ON) G12C-selective inhibitor.

In addition, at the Triple Meeting the company presented encouraging preclinical data supporting the RAS(ON) inhibitor doublet of zoldonrasib, the company’s G12D-selective inhibitor, and daraxonrasib in models of KRAS G12D PDAC, furthering the rationale for this RAS(ON) inhibitor doublet as a therapeutic strategy.

With zoldonrasib’s differentiated profile, the company believes this G12D-selective inhibitor has the potential to contribute as a key component of combination regimens in first line PDAC with current standard of care chemotherapy and/or with daraxonrasib as a RAS(ON) inhibitor doublet. The company expects to initiate a registrational trial for a zoldonrasib combination in patients with first line metastatic PDAC in the first half of 2026 and one or more additional pivotal combination trials in 2026 that incorporate either zoldonrasib or elironrasib.

Zoldonrasib is also being evaluated in a Phase 1 monotherapy expansion cohort in patients with previously treated NSCLC as well as in combination regimens, including zoldonrasib with pembrolizumab or daraxonrasib, in NSCLC.

Progress earlier stage pipeline, including advancing next-generation innovations from the company’s highly productive discovery organization

RMC-5127, a RAS(ON) G12V-selective inhibitor, is on track toward planned initiation of a Phase 1 trial in Q1 2026.

Clinical Collaboration Updates
The company has several discovery and clinical collaborations exploring a range of combinations of a RAS(ON) inhibitor with inhibitors of novel targets, including vopimetostat (TNG462), a PRMT5 inhibitor, under an agreement with Tango Therapeutics, and ivonescimab, a bi-specific PD-1/VEGF inhibitor, under an agreement with Summit Therapeutics.

Other Corporate Updates

In support of the company’s growing late-stage development activities and commercialization plans, the company recently announced the appointment of Alan Sandler, M.D. as chief development officer, Alicia Gardner as senior vice president and general manager for the U.S. region, and Gerwin Winter as senior vice president and general manager of the European region.

Financial Highlights

Third Quarter Results

Cash Position: Cash, cash equivalents and marketable securities were $1.93 billion as of September 30, 2025. This balance includes the receipt of the first royalty monetization tranche of $250 million in June 2025 from the company’s partnership with Royalty Pharma, and there remains an additional $1.75 billion in future committed capital under this arrangement.

R&D Expenses: Research and development expenses were $262.5 million for the quarter ended September 30, 2025, compared to $151.8 million for the quarter ended September 30, 2024. The increase in expenses was primarily due to increases in clinical trial expenses and manufacturing expenses for daraxonrasib, zoldonrasib and elironrasib, and personnel-related expenses and stock-based compensation expense related to additional headcount.

G&A Expenses: General and administrative expenses were $52.8 million for the quarter ended September 30, 2025, compared to $24.0 million for the quarter ended September 30, 2024. The increase was primarily due to increases in personnel-related expenses and stock-based compensation expense associated with additional headcount, an increase in commercial preparation activities, and increased legal expenses.

Net Loss: Net loss was $305.2 million for the quarter ended September 30, 2025, compared to net loss of $156.3 million for the quarter ended September 30, 2024.

Financial Guidance
The company reiterates its full year 2025 GAAP net loss guidance of between $1.03 billion and $1.09 billion, which includes estimated non-cash stock-based compensation expense of between $115 million and $130 million.

Webcast
Revolution Medicines will host a webcast this afternoon, November 5, 2025, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

(Press release, Revolution Medicines, NOV 5, 2025, View Source [SID1234659473])

On November 5, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it has executed a data transfer agreement ("DTA") with Cleveland Clinic, as a key step in the process of transferring the breast cancer vaccine clinical trial data and sponsorship to Anixa for future clinical development.

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With enrollment completed and encouraging immune response data observed in the Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial and will assume full sponsorship of the IND. The IND, currently sponsored by Cleveland Clinic, is in the process of being transferred to Anixa. The DTA will allow for the transfer of all relevant data and information, collected and generated from the Phase 1 clinical trial, to Anixa.

Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets α-lactalbumin—a lactation-associated protein that is typically expressed only in breast tissue during lactation, but which re-emerges in many forms of breast cancer. By establising an immune response against α-lactalbumin-expressing cells, the vaccine may offer both therapeutic and preventive benefits for patients with tumors expressing this protein.

"Execution of the DTA represents a significant step in the transfer of IND sponsorship to Anixa. We look forward to completing the remaining steps with Cleveland Clinic, and eventually advancing to a Phase 2 trial under our sponsorship," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We are pleased with the progress and preliminary findings from our Phase 1 clinical trial, and are excited about the presentation of the final Phase 1 data, by Cleveland Clinic, at the San Antonio Breast Cancer Symposium on December 11."

(Press release, Anixa Biosciences, NOV 5, 2025, View Source [SID1234659490])

On November 5, 2025 Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, reported financial results and business highlights for the fiscal quarter ended September 30, 2025.

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"We are advancing a pipeline rooted in tumor-enabling ecDNA biology to bring forward innovative therapies for patients with oncogene-amplified cancers," said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. "Enrollment is underway in the BBI-355/BBI-825 combination arm of the POTENTIATE trial, and we are excited to advance BBI-940, our novel, orally bioavailable Kinesin degrader into the clinic in the first half of 2026, as we work to deliver a meaningful impact for both patients and shareholders."

Research and Development Highlights and Upcoming Milestones

POTENTIATE clinical trial of BBI-355 and BBI-825

•
The combination arm of the Phase 1/2 POTENTIATE trial evaluating BBI-355 and BBI-825 in oncogene-amplified cancers is actively enrolling. The Company expects to deliver initial proof-of-concept clinical data within its existing cash runway timeline.

BBI-940 novel Kinesin program targeting ecDNA segregation and inheritance

•
The Company expects to submit an investigational new drug (IND) application for BBI-940 and initiate a first-in-human Phase 1 clinical trial in the first half of 2026.
•
Initial proof-of-concept clinical data are expected within the Company’s existing cash runway timeline.

Third Quarter 2025 Financial Results

•
Cash Position: Cash, cash equivalents, and short-term investments totaled $117.6 million as of September 30, 2025.

•
Research and Development (R&D) Expenses: R&D expenses were $10.7 million for the third quarter of 2025, compared to $14.1 million for the same period in 2024.
•
General and Administrative (G&A) Expenses: G&A expenses were $4.5 million for the third quarter of 2025, compared to $4.6 million for the same period in 2024.
•
Net Loss: Net loss totaled $13.9 million for the third quarter of 2025, compared to $16.5 for the same period in 2024.

(Press release, Boundless Bio, NOV 5, 2025, View Source [SID1234659458])

On November 5, 2025 Royalty Pharma plc (Nasdaq: RPRX) reported financial results for the third quarter of 2025 and raised full year 2025 guidance for Portfolio Receipts."We delivered strong third quarter 2025 results, raised our full year guidance and are on track to deliver another year of double-digit top-line growth," said Pablo Legorreta, Royalty Pharma’s founder and Chief Executive Officer. "In addition, we had an especially active past few months for deals, expanding our portfolio with three innovative therapies and increasing our Capital Deployment to $2.0 billion for the year. Furthermore, we hosted our Investor Day in September, where we highlighted the rapid growth in the royalty market, the powerful competitive advantages that underscore our leadership, our sustainable and attractive returns and our goal to be the premier capital allocator in life sciences with consistent, compounding growth.

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"Double-digit growth in Royalty Receipts and Portfolio Receipts

•Royalty Receipts grew 11% to $811 million in the third quarter of 2025, primarily driven by Voranigo, Tremfya and the cystic fibrosis franchise. •Portfolio Receipts increased by 11% to $814 million. Significant Capital Deployment in recent months strengthens portfolio •Acquired a royalty on Amgen’s Imdelltra for up to $950 million; entered into a funding agreement on obexelimab with Zenas BioPharma for up to $300 million; and acquired a royalty on Alnylam’s Amvuttra for $310 million.•Repurchased four million Class A ordinary shares for $152 million in the third quarter, with total share repurchases of $1.2 billion in the first nine months of 2025.Positive clinical and regulatory updates across royalty portfolio•Revolution Medicines’ daraxonrasib: positive initial data in first-line metastatic pancreatic cancer supporting Phase 3 initiation in the fourth quarter of 2025; FDA awarded Commissioner’s National Priority Voucher with goal of accelerating development and review.•Roche’s trontinemab: initiated the Phase 3 program for Alzheimer’s disease. Raising financial guidance for full year 2025 (excludes contribution from future transactions)•Royalty Pharma expects 2025 Portfolio Receipts to be between $3,200 million and $3,250 million (previously $3,050 million to $3,150 million), representing expected growth of 14% to 16% (previously 9% to 12%).Financial & Liquidity Summary
Three Months Ended September 30,
(unaudited)
($ and shares in millions)
2025
2024
Change
Portfolio Receipts
814
735
11%
Net cash provided by operating activities
703
704
(0)%
Adjusted EBITDA (non-GAAP)*
779
679
15%
Portfolio Cash Flow (non-GAAP)*
657
617
6%
Weighted average Class A ordinary shares outstanding – diluted
560
593
(6)%

*See "Liquidity and Capital Resources" section. Adjusted EBITDA and Portfolio Cash Flow are non-GAAP liquidity measures calculated in accordance with the credit agreement.
2

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Portfolio Receipts Highlights
Three Months Ended September 30,
(unaudited)
($ in millions)
2025
2024
Change
Products:
Marketers:
Therapeutic Area:
Cystic fibrosis franchise
Vertex
Rare disease
222
207
7%
Trelegy
GSK
Respiratory
96
91
6%
Tysabri
Biogen
Neuroscience
68
68
(0)%
Evrysdi
Roche
Rare disease
52
48
8%
Xtandi
Pfizer, Astellas
Cancer
50
43
15%
Tremfya
Johnson & Johnson
Immunology
49
34
44%
Imbruvica
AbbVie, Johnson & Johnson
Cancer
41
46
(11)%
Promacta
Novartis
Hematology
38
42
(9)%
Voranigo
Servier
Cancer
33
—
n/a
Cabometyx/Cometriq
Exelixis, Ipsen, Takeda
Cancer
21
19
15%
Spinraza
Biogen
Rare disease
14
14
(4)%
Erleada
Johnson & Johnson
Cancer
12
10
23%
Trodelvy
Gilead
Cancer
12
11
6%
Other products(5)
102
98
3%
Royalty Receipts
811
732
11%
Milestones and other contractual receipts
3
3
0%
Portfolio Receipts
814
735
11%

Amounts shown in the table may not add due to rounding.Royalty Receipts was $811 million in the third quarter of 2025, an increase of 11% compared to $732 million in the third quarter of 2024. The increase was primarily driven by Voranigo, Tremfya and the cystic fibrosis franchise. Portfolio Receipts was $814 million in the third quarter of 2025, an increase of 11% compared to $735 million in the third quarter of 2024, primarily driven by the same Royalty Receipts increases noted above. Liquidity and Capital ResourcesRoyalty Pharma’s liquidity and capital resources are summarized below:As of September 30, 2025, Royalty Pharma had cash and cash equivalents of $939 million and total debt with principal value of $9.2 billion, primarily comprised of $8.8 billion of unsecured notes with a weighted average duration of approximately 13 years and an attractive weighted-average cost of debt of 3.75%. This outstanding total debt includes $2.0 billion of senior unsecured notes (2025 Notes) issued in September 2025 with a weighted average coupon rate of 5.16%. Additionally, Royalty Pharma repaid $1.0 billion of senior unsecured notes upon maturity in August 2025.In January 2025, Royalty Pharma announced a new share repurchase program under which it may repurchase up to $3.0 billion of its Class A ordinary shares. Royalty Pharma repurchased approximately four million Class A ordinary shares for $152 million in the third quarter and 35 million shares for $1.2 billion for the first nine months of 2025. The weighted-average number of diluted Class A ordinary shares outstanding for the third quarter of 2025 was 560 million as compared to 593 million for the third quarter of 2024.

Three Months Ended September 30,
(unaudited)
($ in millions)
2025
2024
Portfolio Receipts
814
735
Payments for operating and professional costs
(34)
(55)
Adjusted EBITDA (non-GAAP)
779
679
Interest paid, net
(123)
(62)
Portfolio Cash Flow (non-GAAP)
657
617

Amounts may not add due to rounding.•Adjusted EBITDA (non-GAAP) was $779 million in the third quarter of 2025. Adjusted EBITDA is calculated as Portfolio Receipts minus payments for operating and professional costs.•Portfolio Cash Flow (non-GAAP) was $657 million in the third quarter of 2025. Portfolio Cash Flow is calculated as Adjusted EBITDA minus interest paid or received, net. This measure reflects the cash generated by Royalty Pharma’s business that can be redeployed into value-enhancing royalty acquisitions, used to repay debt, returned to shareholders through dividends or share purchases, or utilized for other discretionary investments. Refer to Table 4 for Royalty Pharma’s reconciliation of each non-GAAP measure to the most directly comparable GAAP financial measure, net cash provided by operating activities.Capital Deployment reflects cash payments during the period for new and previously announced transactions. Capital Deployment was $1.0 billion in the third quarter of 2025, consisting primarily of upfront payments for the Imdelltra and obexelimab funding agreements (see ‘Royalty Transactions’) and research and development funding for litifilimab. Capital Deployment for the first nine months of 2025 amounted to $1.7 billion.The table below details Capital Deployment by category:Capital Deployment
Three Months Ended September 30,
Nine Months Ended September 30,
(unaudited)
(unaudited)
($ in millions)
2025
2024
2025
2024
Purchases of available for sale debt securities
—
—
(75)
(150)
Acquisitions of financial royalty assets
(962)
(1,195)
(964)
(2,009)
Acquisitions of other financial assets
—
—
—
(18)
Development-stage funding payments
(51)
(1)
(402)
(2)
Milestone payments
—
—
(269)
(50)
Investments in equity method investees
—
—
—
(11)
Contributions from legacy non-controlling interests – R&D
(0)
0
0
1
Capital Deployment
(1,013)
(1,195)
(1,709)
(2,239)

Royalty TransactionsDuring 2025, Royalty Pharma has announced new transactions of up to $3.8 billion. The announced transactions amount reflects the entire amount of capital committed for new transactions year to date, including potential future milestones. Recent transactions include:•In November 2025, Royalty Pharma acquired a royalty interest in Alnylam’s Amvuttra from Blackstone for $310 million. Amvuttra is an approved RNAi therapeutic for the treatment of transthyretin (TTR) amyloidosis with cardiomyopathy and for hereditary TTR amyloidosis with polyneuropathy.•In September 2025, Royalty Pharma acquired a synthetic royalty on obexelimab from Zenas BioPharma for an upfront payment of $75 million and up to $225 million in milestone payments contingent on the achievements of certain clinical and regulatory events. Obexelimab is in Phase 3 development for the treatment of immunoglobulin G4-related disease and in Phase 2 development for relapsing multiple sclerosis and systemic lupus erythematosus.•In August 2025, Royalty Pharma acquired a royalty interest in Amgen’s Imdelltra from BeOne Medicines for an upfront payment of $885 million. BeOne Medicines has the option to sell to Royalty Pharma additional royalties on Imdelltra for up to $65 million within twelve months from the acquisition date. Imdelltra is approved for the treatment of extensive-stage small cell lung cancer.The information in this section should be read together with Royalty Pharma’s reports and documents filed with the SEC at www.sec.gov and the reader is also encouraged to review all other press releases and information available in the Investors section of Royalty Pharma’s website at www.royaltypharma.com.Key Developments Relating to the Portfolio The key developments related to Royalty Pharma’s royalty interests are discussed below based on disclosures from the marketers of the products.
litifilimab
In October 2025, Biogen announced that both litifilimab Phase 3 studies for systemic lupus erythematosus are fully enrolled with expected data readout for both studies now accelerated to the second half of 2026.
obexelimab
In October 2025, Zenas BioPharma announced positive results from the Phase 2 trial of obexelimab in relapsing multiple sclerosis, which demonstrated a highly statistically significant 95% relative reduction in new gadolinium (Gd)-enhancing T1 lesions over week 8 and week 12 compared with placebo. Zenas anticipates reporting 24-week data in relapsing multiple sclerosis in the first quarter of 2026.
trontinemab
In September 2025, Roche announced that it initiated its Phase 3 program for trontinemab in early symptomatic Alzheimer’s disease. Additionally, Roche announced plans to initiate a Phase 3 study in preclinical Alzheimer’s disease, in people at high risk of cognitive decline.
Airsupra
In September 2025, AstraZeneca announced that the FDA approved a supplemental New Drug Application (sNDA) for Airsupra to reflect the statistically significant severe exacerbation risk reduction in patients with mild asthma compared to albuterol.
daraxonrasib
In September 2025, Revolution Medicines announced positive Phase 1 results from its clinical trials evaluating daraxonrasib as a monotherapy and daraxonrasib in combination with chemotherapy in first-line (1L) metastatic pancreatic ductal adenocarcinoma (PDAC). These data support Revolution Medicines’ plan to initiate a Phase 3 trial for daraxonrasib in 1L metastatic PDAC in the fourth quarter of 2025. In October 2025, the FDA granted a non-transferrable voucher for daraxonrasib under the Commissioner’s National Priority Voucher (CNPV) pilot program, which accelerates review times to 1-2 months.
Skytrofa
In July 2025, Ascendis announced the FDA approved Skytrofa for the once-weekly treatment of adults with growth hormone deficiency.
Cabometyx
In July 2025, Ipsen announced that the European Commission (EC) approved Cabometyx for previously treated advanced neuroendocrine tumors.

deucrictibant
In July 2025, Pharvaris announced that it anticipates topline data for the Phase 3 study (RAPIDe-3) evaluating deucrictibant for the on-demand treatment of hereditary angioedema attacks in the fourth quarter of 2025 and, pending positive data, expects to submit a New Drug Application (NDA) to the FDA in the first half of 2026.
CF Franchise
In July 2025, Vertex announced that the EC approved Alyftrek for people with cystic fibrosis ages 6 years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

2025 Financial OutlookRoyalty Pharma has provided guidance for full year 2025, excluding new transactions and borrowings announced after the date of this release, as follows:
Provided November 5, 2025
Previous
Portfolio Receipts
$3,200 million to $3,250 million(Growth of ~+14% to 16% year/year)
$3,050 million to $3,150 million(Growth of ~+9% to 12% year/year)
Payments for operating and professional costs
~9% to 9.5% of Portfolio Receipts
~9% to 9.5% of Portfolio Receipts
Interest paid
$275 million
$275 million

The above Portfolio Receipts guidance represents expected growth of 14% to 16% in 2025. Royalty Pharma’s full year 2025 guidance reflects a negligible estimated foreign exchange impact to Portfolio Receipts, assuming current foreign exchange rates prevail for the rest of 2025.Payments for operating and professional costs in the second half of 2025 are expected to decrease due to extinguishment of the management fee following the completion of the internalization transaction on May 16, 2025. Payments for operating and professional costs in 2025 include one-time payments amounting to approximately $70 million (>2% of 2025 Portfolio Receipts), comprised of transaction costs for the Internalization and other one-time items.Total interest paid is based on the semi-annual interest payment schedule of Royalty Pharma’s existing notes and the quarterly interest payment schedule for the term loan assumed as part of the internalization transaction. In 2025, total interest paid is anticipated to be approximately $275 million, including $7 million in the fourth quarter of 2025. These projections assume no additional debt financing in 2025. In the third quarter of 2025, Royalty Pharma collected interest of $7 million on its cash and cash equivalents, which partially offset interest paid. In 2026, Royalty Pharma anticipates interest paid to be approximately $350 – $360 million(7), including interest payments on the $2.0 billion of senior unsecured notes issued in September 2025.

(Press release, Royalty Pharma , NOV 5, 2025, View Source [SID1234659474])

On November 5, 2025 Lunai Bioworks (NASDAQ: LNAI), an AI-powered drug discovery and biodefense company, reported a major scientific breakthrough: its next-generation immune cell therapy led to complete regression of both primary and metastatic pancreatic tumors in humanized mouse models.

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The study was published in a new Brief Report in Vaccines on November 2, 2025. The peer-reviewed Brief Report details the development of a second-generation, clinical-grade DC construct that achieved complete regression of both primary and metastatic pancreatic tumors in preclinical humanized models. Pancreatic cancer is one of the deadliest cancers, often diagnosed late and resistant to conventional treatments. Lunai’s therapy uses engineered dendritic cells — specialized immune cells created from stem cells — that are genetically enhanced to activate the body’s immune system against cancer. This publication details a second-generation, clinical-compliant version of this platform, with the provided evidence critical in advancing ongoing partnering conversations for the therapy.

This new publication builds on Lunai’s earlier study (Vaccines 2025 Jul 12;13(7):749; doi:10.3390/vaccines13070749), which first demonstrated potent anti-tumor activity of CD34+ hematopoietic stem cell (HSC)-derived DCs engineered to overexpress CD40L, CD93, and CXCL13 in humanized mouse models of pancreatic cancer. While the initial study utilized a research-grade lentiviral vector, the latest report describes an optimized, clinically compliant construct that preserves equivalent efficacy while improving design and manufacturing attributes to support future clinical translation.

The second-generation construct features a strong mammalian promoter and enhanced genetic elements to drive expression of key immune-modulating molecules. In preclinical humanized models, Lunai’s next-generation DC therapy triggered robust activation of cytotoxic T cells and NK cells and led to complete regression of both primary and metastatic pancreatic tumors. These findings mirrored the outcomes achieved with the original research-grade product. While the allogeneic DC product has been evaluated in pancreatic cancer models, its therapeutic potential extends to a broad range of solid tumors.

"These findings demonstrate that our vector optimization strategy maintains therapeutic potency while bringing our allogeneic DC platform to the threshold of IND-enabling studies," said David Weinstein, CEO of Lunai Bioworks. "This represents an important inflection point as we move from research innovation to clinical translation—positioning Lunai at the forefront of next-generation cell-based immunotherapies."

The full article, titled "Modified Hematopoietic Stem Cell-Derived Dendritic Cell Therapy Retained Tumor-Inhibitory Function and Led to Regression of Primary and Metastatic Pancreatic Tumors in Humanized Mouse Models," is available in Vaccines (View Source).

(Press release, Lunai Bioworks, NOV 5, 2025, View Source [SID1234659491])