On May 12, 2025 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported that it will webcast its presentation at the BofA Securities 2025 Healthcare Conference at 9:20 a.m. PT on Tuesday, May 13, 2025 (Press release, Sana Biotechnology, MAY 12, 2025, View Source [SID1234652888]). The presentation will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer.

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The webcast will be accessible on the Investor Relations page of Sana’s website at View Source A replay of the presentation will be available at the same location for 30 days following the conference.

On May 12, 2025 Coherus BioSciences, Inc. (Coherus or the Company, Nasdaq: CHRS), reported financial results for the quarter ended March 31, 2025 and provided an overview of recent business highlights (Press release, Coherus Biosciences, MAY 12, 2025, View Source [SID1234652873]).

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"The completion of the UDENYCA divestiture in April positions us to focus on our innovative oncology portfolio," said Denny Lanfear, Coherus Chairman and Chief Executive Officer. "This includes maximizing LOQTORZI revenues, advancing our novel immuno-oncology candidates in combination with LOQTORZI to key data milestones in 2026, and progressing label expanding indications for LOQTORZI in novel combinations. The commercial launch of LOQTORZI continues to progress with patient demand growing more than 15% in the first quarter of 2025 versus the fourth quarter of last year."

"At AACR (Free AACR Whitepaper) last month, we reported promising early clinical data from our ongoing Phase 1 clinical trial evaluating CHS-114, which supports continued evaluation of CHS-114 in combination with other therapies, including toripalimab in HNSCC," stated Theresa LaValle, Ph.D., Coherus Chief Scientific and Development Officer. "We believe CHS-114 has the potential to treat many solid tumors outside of head and neck cancer, including other large, underserved immuno-oncology indications, such as colorectal cancer. As an innovative, revenue-generating oncology company, Coherus is well positioned to fully realize the value of our pipeline focused on extending the survival of cancer patients."

RECENT BUSINESS HIGHLIGHTS

LOQTORZI RESULTS

LOQTORZI is the only FDA-approved and available treatment for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC), in all patient subsets and across all lines of therapy.
LOQTORZI net product sales for Q1 2025 were $7.3 million, with patient demand growing in excess of 15% compared to Q4 2024.
In November 2024, the National Comprehensive Cancer Network (NCCN) revised its treatment guidelines for NPC to designate LOQTORZI as the only treatment with Preferred status in NPC, both in first line (1L) with a Category 1 designation and in second line (2L) and later NPC.
ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION IMMUNO-ONCOLOGY PIPELINE

LOQTORZI (toripalimab-tpzi) is a next-generation, differentiated PD-1 marketed in the U.S. in two indications.

Coherus plans to maximize the value of this product by:

Combining LOQTORZI with internal pipeline assets, casdozokitug and CHS-114, in additional indications; and
Entering into capital-efficient external partnerships for additional label expansions. We are pursuing additional partnerships, evaluating LOQTORZI with novel, promising cancer agents in 2025.
CHS-114 is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding. Phase 1 dose escalation is complete, establishing safety and proof of mechanism.

The Company reported early clinical data at AACR (Free AACR Whitepaper) 2025 from an ongoing Phase 1 clinical trial evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, as monotherapy and in combination with toripalimab in patients with recurrent/metastatic HNSCC. The data showed a confirmed partial response in a heavily pre-treated PD-1 refractory patient, a 50% depletion in CCR8+ Treg, and an increase in CD8+ T cells, consistent with anti-tumor activity, demonstrating proof of mechanism. The safety profile was consistent with advanced disease and the known safety profile of toripalimab.
The Company initiated a Phase 1b CHS-114/toripalimab combination dose optimization study in 2L HNSCC in Q1 2025 with a first data readout expected in Q2 2026.
The Company initiated a Phase 1b CHS-114/toripalimab combination dose optimization study in 2L gastric cancer in Q1 2025 with a first data readout expected in Q2 2026.
Casdozokitug is a first-in-class, clinical-stage IL-27 antagonist, with demonstrated monotherapy activity in treatment-refractory NSCLC and clear cell renal cell carcinoma (ccRCC) and combination activity in hepatocellular carcinoma (HCC).

Enrollment is ongoing in the Phase 2 randomized trial of casdozokitug/toripalimab/bevacizumab in 1L HCC, with the first data readout expected in 1H 2026.
The Company reported final data at ASCO (Free ASCO Whitepaper)-GI 2025 from a Phase 2 trial of casdozokitug/atezolizumab/bevacizumab in 1L HCC. The data showed an overall response rate (ORR) increased to 38% compared to 27%1 initially announced, and complete responses per RECIST v1.1 increased to 17.2% compared to 10.3%2 previously announced and the initial assessment of 0%1. These data demonstrate both an increase in ORR and a deepening of responses compared to previous datasets. Importantly, responses were seen in viral and nonviral disease, and toxicity was consistent with the known safety profiles of atezolizumab and bevacizumab, with no new safety signals identified.
UDENYCA RESULTS (DISCONTINUED OPERATIONS)

UDENYCA net product sales for Q1 2025 were $31.5 million.
In April 2025, Coherus announced the completion of the previously announced divestiture of its UDENYCA franchise for up to $558.4 million. At the closing of the transaction, Coherus received an upfront payment of $483.4 million, including $118.4 million for UDENYCA inventory, and is eligible to receive potential milestone payments of up to $75 million.
DISCONTINUED OPERATIONS FINANCIAL STATEMENT PRESENTATION

In accordance with the relevant accounting rules, the biosimilar business, inclusive of the UDENYCA, YUSIMRY and CIMERLI franchises, has been classified as discontinued operations for all periods presented. The results of the discontinued operations have been reported as a separate component of income on the condensed consolidated statements of operations, and the assets and liabilities of the discontinued operations have been presented separately in the condensed consolidated balance sheets.

FIRST QUARTER 2025 FINANCIAL RESULTS

Net revenue from continuing operations was $7.6 million and $2.3 million for the three months ended March 31, 2025 and 2024, respectively. The increase of $5.3 million was primarily due to higher volume of LOQTORZI, which launched in December 2023.

Cost of goods sold (COGS) from continuing operations was $2.7 million and $1.4 million during the three months ended March 31, 2025 and 2024, respectively. The increase was primarily due to higher volume of LOQTORZI, which launched in December 2023.

Research and development (R&D) expenses from continuing operations were $24.4 million and $28.4 million for the three months ended March 31, 2025 and 2024, respectively. The decrease was primarily due to the reduction in co-development costs for toripalimab, termination of the TIGIT Program announced in January 2024 and savings in personnel and stock-based compensation from reduced headcount, partially offset by increased costs for development of casdozokitug and CHS-114.

Selling, general and administrative (SG&A) expenses from continuing operations were $26.0 million and $40.2 million during the three months ended March 31, 2025 and 2024, respectively. The decrease was driven primarily by the net $6.8 million charge in the first quarter of 2024 associated with the full write-off of the out-license intangible asset and associated release of the contingent value right liability related to NZV930, which was acquired in the Surface Oncology, Inc. acquisition, as well as lower average headcount and decreased operating costs following Coherus’ recent divestitures.

Interest expense from continuing operations was $2.2 million and $3.1 million during the three months ended March 31, 2025 and 2024, respectively. The decrease was primarily due to prepaying the remaining $75.0 million of the principal amount due under the 2027 Term Loans on May 8, 2024, partially offset by interest on the $38.7 million senior secured term loan facility and the LOQTORZI portion of the Revenue Participation Right Purchase and Sale Agreement among Coherus and Coduet Royalty Holdings, LLC (Revenue Purchase and Sale Agreement), which each commenced May 8, 2024.

Net loss from continuing operations for the first quarter of 2025 was $47.4 million, or $(0.41) per share on a diluted basis, compared to $68.0 million, or $(0.60) per share on a diluted basis, for the same period in 2024.

Non-GAAP net loss from continuing operations for the first quarter of 2025 was $40.9 million, or $(0.35) per share on a diluted basis, compared to $53.6 million, or $(0.48) per share for the same period in 2024. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss from continuing operations and a reconciliation to the most directly comparable GAAP measures.

Net income (loss) from discontinued operations, net of tax was a net loss of $9.2 million, or $(0.08) per share on a diluted basis, for first quarter of 2025 compared to net income of $170.9 million, or $1.52 per share on a diluted basis, for the same period in 2024. The change was primarily due to the $153.6 million gain on sale of the CIMERLI ophthalmology franchise in March 2024 and the negative impacts on UDENYCA revenues in Q1 2025 following the temporary supply interruption experienced that occurred in Q4 2024, including supply allocations to wholesalers which were not removed until the end February 2025.

Cash and cash equivalents totaled $82.4 million as of March 31, 2025, compared to $126.0 million as of December 31, 2024. The upfront, all-cash consideration of $483.4 million for the divestiture of the UDENYCA franchise was received in April 2025 and thus will be reflected as part of Coherus’ Q2 2025 financial information, when reported. Also to be reflected as part of the Q2 2025 financial information, will be the use of a portion of the divestiture proceeds in April 2025 to pay $47.7 million to buy out the portion of the Revenue Payments rights with respect to UDENYCA in accordance with the Revenue Purchase and Sale Agreement, and the April 2025 payments to repurchase approximately $170 million aggregate principal amount of Coherus’ 1.5% Convertible Senior Subordinated notes due 2026 (2026 Convertible Notes). Coherus further expects to repurchase the remaining approximately $60 million aggregate principal amount of 2026 Convertible Notes on May 15, 2025 pursuant to the Fundamental Change Repurchase Right (as defined in the indenture, dated as of April 17, 2020, between Coherus and U.S. Bank Trust Company, National Association).

Conference Call Information
When: Monday, May 12, 2025, starting at 5:00 p.m. Eastern Daylight Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: View Source

Please dial in 15 minutes early to ensure a timely connection to the call.

Webcast: View Source
An archived webcast will be available on the "Investors" section of the Coherus website at View Source

On May 12, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported financial results for the first quarter ended March 31, 2025, and provided an overview of recent developments (Press release, UroGen Pharma, MAY 12, 2025, View Source [SID1234652889]).

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"We are entering a pivotal and exciting period for UroGen as we approach the anticipated FDA approval of our lead pipeline product, UGN-102, in June for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer," said Liz Barrett, President and Chief Executive Officer of UroGen. "This milestone has the potential to mark the first major advancement in treatment for this patient population in decades, delivering a much-needed novel and innovative treatment option that may offer meaningful disease and treatment-free intervals. With momentum building across the organization, we are entering the final phase of launch readiness. If approved, UGN-102 represents a significant commercial opportunity, with a total addressable market of over $5 billion. Backed by a strong balance sheet and a growing pipeline, we are well-positioned to build a long-term, sustainable growth company. We remain steadfast in our mission to transform the treatment paradigm in uro-oncology and see a great opportunity to advance patient care and deliver value for shareholders."

Q1 2025 and Recent Business Highlights:

UGN-102 (mitomycin) for intravesical solution

UroGen’s New Drug Application (NDA) for investigational drug UGN-102 (mitomycin) for intravesical solution as a treatment for recurrent low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC), is currently under review at the U.S. Food and Drug Administration (FDA). The FDA granted a Prescription Drug User Fee Act (PDUFA) target action date of June 13, 2025. The FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting on May 21, 2025 to discuss the UGN-102 NDA.
Updated 18-month Duration of Response (DOR) data from the Phase 3 ENVISION trial evaluating UGN-102 in patients with recurrent LG-IR-NMIBC were featured in a podium presentation by Dr. Sandip Prasad at the American Urological Association (AUA) 2025 Annual Meeting on April 26 in Las Vegas. The data are consistent with prior Kaplan-Meier estimates, with the probability of remaining in complete response (CR) of 80.6% (95% CI: 74.0, 85.7) at 18-months after achieving CR at 3 months (N=101) compared to 82.5% (95% CI: 76.1, 87.3) at 12-months after 3-month CR (N=146). Median follow-up time at 18 months was 18.7 months after the three-month CR.
The results of a patient reported outcomes analysis from three UGN-102 studies (OPTIMA II, ATLAS and ENVISION) were presented in a poster at the AUA meeting. The results showed that UGN-102 did not have a negative impact on symptom burden, patient function, or quality of life.
Long-term outcomes of the OPTIMA II LT study of UGN-102 were also presented at the meeting and demonstrated median DOR of 24.2 months (95% CI 9.72, 47.18) with a median follow-up time of 33.6 months (95% CI 10.78, 42.94) in the 41 patients who achieved a CR in the parent study.
Results from a post-hoc sub-analysis of the ENVISION trial, showing that tumor burden and the number of tumors did not significantly affect the CR rate or durability of response for patients treated with UGN-102, were presented at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO-GU 2025) in February 2025.
Results from the ENVISION trial were published in the February 2025 issue of The Journal of Urology.
JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract urothelial cancer (LG-UTUC)

Generated net product revenue of $20.3 million in the quarter ended March 31, 2025, an increase of 8% over the $18.8 million reported for the same quarter in 2024. Underlying demand grew by 12% year-over-year.
A poster featuring long-term outcomes of patients with recurrent and new-onset LG-UTUC who achieved CR in the Phase 3 trial of JELMYTO was presented at AUA 2025. As previously reported, the median DOR of all patients achieving CR in the JELMYTO Phase 3 study was 47.8 months, irrespective of whether their cancer was new onset or recurrent.
A long-term study on JELMYTO titled, "Durability of Response of UGN-101: Longitudinal Follow-Up of Multicenter Study," was published online in Urologic Oncology: Seminars and Investigations in January 2025. The results showed 68% recurrence-free survival rate at three years across a broad patient population with LG-UTUC.
UGN-301 (zalifrelimab) intravesical solution, an anti-CTLA4 antibody for use in high-grade non-muscle invasive bladder cancer (NMIBC)

Enrollment is complete in the multi-arm dose escalation Phase 1 clinical study of UGN-301 in patients with high-grade NMIBC, alone and in combination with fixed dose UGN-201 or gemcitabine. The investigational treatments demonstrated an acceptable safety profile and were generally well tolerated across dose levels. Responses were observed in both monotherapy and combination therapy arms, and patient follow-up is ongoing to further assess the durability of these responses.
Next-generation investigational oncolytic virus UGN-501 (ICVB-1042)

In February 2025, UroGen expanded its nonclinical oncology portfolio with the purchase of product candidate UGN-501 from IconOVir Bio, Inc (IconOVir). UGN-501 is a potent and fast-replicating investigational next generation oncolytic virus therapy, being developed as a locally administered treatment for bladder cancer and other specialty cancers. UroGen hosted a webinar to discuss UGN-501 (ICVB-1042) on February 20, 2025, and a replay can be accessed on the Company’s website here.
Next-generation novel mitomycin-based formulation for urothelial cancers

Enrollment is ongoing in the Phase 3 UTOPIA clinical trial of investigational drug UGN-103 (mitomycin) for intravesical solution in patients with LG-IR-NMIBC and enrollment is expected to be completed by mid-2025. UGN-103 is a next generation product that combines UroGen’s RTGel technology with a novel mitomycin formulation licensed from medac GmbH. UGN-103 is planned to follow the potential FDA approval and launch of UGN-102 for recurrent LG-IR-NMIBC. To learn more about the UTOPIA trial, refer to clinicaltrials.gov/NCT06331299.
UroGen plans to initiate a Phase 3 trial to explore the safety and efficacy of UGN-104 by mid-2025. UGN-104 is a next generation investigational product for LG-UTUC.
First quarter 2025 Financial Results

JELMYTO Revenue: JELMYTO net product revenues were $20.3 million for the three months ended March 31, 2025, compared with $18.8 million for the same quarter of 2024. Year-over-year revenue growth of 8% was driven by underlying demand growth of 12%, partially offset by higher 340B chargebacks.

R&D Expenses: R&D expenses for the first quarter of 2025 were $19.9 million, including non-cash share-based compensation expense of $0.6 million as compared to $15.5 million, including non-cash share-based compensation expense of $0.5 million, for the same period in 2024. The increase in R&D expenses of $4.4 million was primarily driven by the equity consideration issued to IconOVir for the acquisition of UGN-501 (ICVB-1042) which was expensed in the first quarter of 2025, higher manufacturing costs, and costs associated with the Phase 3 UTOPIA trial for UGN-103, partially offset by lower clinical trial costs and regulatory expenses in connection with UGN-102.

SG&A Expenses: SG&A expenses for the first quarter of 2025 were $35.0 million, including non-cash share-based compensation expense of $2.5 million. This compares to $27.3 million, including non-cash share-based compensation expense of $2.2 million, for the same period in 2024. The increase in SG&A expenses of $7.7 million was primarily driven by UGN-102 commercial preparation activities.

Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $4.6 million in the first quarter of 2025, compared to $5.7 million in the same period in 2024. The decrease was primarily driven by changes in underlying assumptions for remeasuring the effective rate.

Interest Expense on Long-Term Debt: Interest expense related to the $125 million term loan facility with funds managed by Pharmakon Advisors was $4.1 million in the first quarter of 2025, compared to $2.4 million in the same period in 2024. The increase was primarily attributable to the interest expense on the third tranche of the loan that was funded in September 2024.

Net Loss: UroGen reported a net loss of $43.8 million or ($0.92) per basic and diluted share in the first quarter of 2025 compared with a net loss of $32.3 million or ($0.87) per basic and diluted share in the same period in 2024.

Cash and Equivalents: As of March 31, 2025, cash, cash equivalents and marketable securities totaled $200.4 million.

For further details on the Company’s financials, refer to Form 10-Q, filed with the SEC.

2025 JELMYTO Revenue and Company Operating Expense Guidance: Guidance for full-year 2025 net product revenues for JELMYTO remains unchanged and is expected to be in the range of $94 to $98 million. This implies a year-over-year growth rate of approximately 8% to 12% over the $87.4 million in demand driven JELMYTO sales in 2024, which excludes the $3.0 million in CREATES Act sales reported in 2024. Continue to expect full-year 2025 operating expenses to be in the range of $215 to $225 million, including non-cash share-based compensation expense of $11 million to $14 million.

Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review UroGen’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

On May 12, 2025 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, reported first quarter 2025 financial results (Press release, Cue Biopharma, MAY 12, 2025, View Source [SID1234652874]).

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"We made notable and encouraging progress during the first quarter of 2025 and believe we are well positioned to further our corporate objectives," said Daniel Passeri, chief executive officer of Cue Biopharma. "We believe the strategic collaboration with Boehringer Ingelheim for CUE-501 combined with our capital raise, places us in a position of strength to advance CUE-401 toward the clinic while exploring additional portfolio optimization and partnering opportunities."

Upcoming Event

Novel Biologics Portfolio Virtual Event planned for May 15, 2025 at 11 AM ET: Cue Biopharma’s virtual event will feature two key opinion leaders (KOLs): Richard DiPaolo, PhD (Saint Louis University) and Andrew Cope, MD, PhD (Centre for Rheumatic Diseases, King’s College London). The event will highlight new preclinical data for CUE-401, as well as provide an overview of the CUE-500 program and include key updates on the CUE-100 series clinical oncology programs.

The live and archived virtual event will also be available in the News + Publications section of the Company’s website. The webcast will be archived for 30 days.First Quarter 2025 Financial Results
The Company reported revenue of $0.4 million and $1.7 million for the three months ended March 31, 2025 and 2024, respectively, related to the agreement with Ono Pharmaceutical, which was terminated in March 2025.

Research and development expenses were $8.5 million and $10.2 million for the three months ended March 31, 2025 and 2024, respectively. The decrease was primarily due to decreases in clinical trial costs, and employee compensation, which includes stock-based compensation.

General and administrative expenses were $4.2 million for both the three months ended March 31, 2025 and 2024.

As of March 31, 2025, the Company had $13.1 million in cash and cash equivalents. Subsequently, the Company received approximately $18 million in net proceeds in April 2025 from an underwritten public offering, and the Company received an upfront fee of $12 million pursuant to the Collaboration and License Agreement with Boehringer Ingelheim announced on April 14, 2025.

Cue Biopharma, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited, In thousands, except share and per share amounts)

Three Months Ended
March 31,

2025

2024

Collaboration revenue

$

421

$

1,717

Operating expenses:

General and administrative

4,173

4,186

Research and development

8,547

10,199

Total operating expenses

12,720

14,385

Loss from operations

(12,299

)

(12,668

)

Other income (expense):

Interest income

170

562

Interest expense

(128

)

(241

)

Total other income, net

42

321

Net loss

$

(12,257

)

$

(12,347

)

Comprehensive loss

$

(12,257

)

$

(12,347

)

Net loss per common share – basic and diluted

$

(0.17

)

$

(0.25

)

Weighted average common shares outstanding – basic and diluted

74,254,700

49,466,711

On May 12, 2025 Lantern Pharma Inc. (Nasdaq: LTRN), an artificial intelligence company developing targeted and transformative cancer therapies using its proprietary AI platform, RADR, reported that the U.S. Food and Drug Administration (FDA) has cleared the amendment to its Investigational New Drug (IND) application to initiate a Phase 1b/2 clinical trial of LP-184 in a genomically defined patient population of non-small cell lung cancer (NSCLC) where there is a need to improve patient outcomes (Press release, Lantern Pharma, MAY 12, 2025, View Source [SID1234652890]).

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"This study represents a potential therapeutic opportunity to improve outcomes for patients diagnosed with advanced non-small cell lung cancer with KEAP1, and STK11 alterations independent of KRAS status. Historically, these co-alterations may lead to worse outcomes for patients, due to resistance to treatments such as single agent immunotherapy, chemotherapy, or chemoimmunotherapy. Research to date suggests that dual immunotherapy is the best approach for this disease type, but many patients still progress on treatment, highlighting an area of unmet need that we can potentially improve on by the addition of LP-184 to this combination," said Misty Dawn Shields, M.D. Ph.D. — Division of Hematology/Oncology, Thoracic Oncology, Indiana University: Melvin & Bren Simon Comprehensive Cancer Center, and Lead Investigator for the planned Study.

Strategic Trial Design to Address Critical Treatment Gap in Advanced NSCLC

The biomarker focused Phase 1b/2 clinical trial is designed to target high-risk NSCLC subtypes by evaluating LP-184 in combination with the immune checkpoint inhibitors nivolumab and ipilimumab in patients with advanced NSCLC harboring KEAP1 and/or STK11 mutations and low PD-L1 expression—a population with limited response to existing first-line therapies. The study is designed to assess safety, preliminary efficacy, and biomarker correlations, potentially paving a path toward accelerated development in this genetically defined patient segment that is treatment resistant to many existing approved chemo and immunotherapies.1 Lantern Pharma expects to prepare an application for a Fast Track or Accelerated Approval Designation for this patient population based on data from the planned trial and ongoing analysis from existing models.

This unique trial is aimed at addressing a critical unmet clinical need in lung cancer care: the median overall survival in newly diagnosed, advanced NSCLC patients with KEAP1 and/or STK11 mutations treated with chemo-immunotherapy averages 15 months, substantially lower than outcomes in mutation negative populations. For patients that fail earlier lines of therapies the overall survival tends to skew even lower at approximately 6.3 months.2 This represents a market opportunity exceeding $2 billion annually, given the prevalence and poor prognosis for patients with these mutations.

Mechanistic Rationale for LP-184 in NSCLC

LP-184 is a next-generation, synthetically lethal small molecule that induces DNA double-strand breaks upon activation by prostaglandin-reductase 1 (PTGR1). This enzyme is notably overexpressed in KEAP1-mutant tumors. Preclinical studies demonstrate that LP-184’s cancer-killing potency directly correlates with PTGR1 expression levels in NSCLC cell lines. The company’s proprietary RADR platform-driven in silico analyses and preclinical studies suggest that LP-184 is particularly effective in DNA damage repair (DDR)-deficient cancers, including NSCLC with KEAP1 and STK11 alterations3. An additional advantage of LP-184 is its selective toxicity mechanism: PTGR1 enzymatically converts LP-184 from a prodrug to its bioactive, cytotoxic form specifically within tumor cells where PTGR1 is elevated, while normal tissues with low PTGR1 expression remain largely unaffected. This selective toxicity has been observed pre-clinically and in Lantern’s AI modeling. This tumor-selective activation creates a significant therapeutic window that may enable robust anti-tumor activity while minimizing systemic toxicities.

Another key competitive advantage of LP-184 is its mechanism, which in preclinical models has been demonstrated to remain effective regardless of TP53 status—a common co-mutation that contributes to resistance against current therapies2. Individual or co-occurring KEAP1, STK11, and TP53 mutations are found in approximately 20-30% of NSCLC patients and define molecular subsets unresponsive to standard immune checkpoint blockade4.

Targeting The Right Patients – Combining Potential Clinical Benefit & Likelihood of Response to LP-184 in a Combination Regimen

Clinical data analysis conducted by Lantern Pharma in 517 lung cancer patients from a major cancer database (TCGA) revealed a clear target population for LP-184. About 35% of these patients had high levels of PTGR1 – the enzyme that has been hypothesized to activate LP-184 inside the cancer cell. (Figure 1)

Among these PTGR1-high lung cancer patients, 40% also had KEAP1 mutations, which are linked to poor responses to current immunotherapies and chemotherapies. KEAP1 mutations actually cause higher PTGR1 expression, essentially making these difficult-to-treat tumors more vulnerable to LP-184 based on preclinical observations.

"This clinical trial and the FDA clearance represents a pivotal milestone in our mission to develop precise, data-driven cancer therapies for patients with limited treatment options," said Panna Sharma, President and CEO of Lantern Pharma. "The STK11 and KEAP1 mutant NSCLC population represents an important market opportunity and, a group of patients desperately awaiting better treatment options. By combining our AI-driven approach with a deep understanding of cancer biology, we’ve identified LP-184 as a potential breakthrough for these patients. The clearance of this trial advances our precision oncology strategy while demonstrating the power of our RADR platform to accelerate development timelines and reduce costs, as part of our mission to create value for both patients and shareholders as we work to transform oncology drug development."