Pfizer Completes Licensing Agreement with 3SBio

On July 24, 2025 Pfizer Inc. (NYSE: PFE) reported the completion of a global, ex-China, licensing agreement with 3SBio, Inc. (01530.HK) granting Pfizer exclusive rights for the development, manufacturing and commercialization of 3SBio’s SSGJ-707, a bispecific antibody targeting PD-1 and VEGF developed using 3SBio’s proprietary CLF2 platform (Press release, Pfizer, JUL 24, 2025, View Source [SID1234654518]). This agreement solidifies Pfizer at the forefront of innovative cancer research and further enhances the company’s robust oncology pipeline.

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"We are excited to contribute our significant expertise and resources to advance rapidly the development of the SSGJ-707 program including novel combination strategies across a number of our major tumor areas of focus," said Chris Boshoff, M.D., Ph.D., Chief Scientific Officer and President, Research & Development, Pfizer. "This is an important candidate that combines two key targets in a promising class of medicines, complementing our antibody-drug conjugate portfolio and further demonstrates our commitment to advancing pioneering science to deliver transformative cancer medicines and new hope to people living with cancer."

SSGJ-707 is currently undergoing several clinical trials in China for non-small cell lung cancer (NSCLC), metastatic colorectal cancer, and gynecological tumors. Positive interim Phase 2 results evaluating the safety and efficacy of SSGJ-707 as monotherapy in patients with advanced NSCLC were recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Pfizer plans to manufacture drug substance for SSGJ-707 in Sanford, North Carolina, and drug product in McPherson, Kansas. The clinical development plan for SSGJ-707 moving forward will include trial sites across the U.S. and rest of world with priority to the Phase 3 global development plan for NSCLC and other solid tumors. The first Phase 3 global studies will initiate enrollment in the U.S.

Under the terms of the agreement, 3SBio will receive a payment of $1.25 billion. Pfizer will also make a $100 million equity investment in 3SBio. Additionally, the agreement provides Pfizer the option to extend the license to include exclusive development and commercialization rights to SSGJ-707 in China. In exchange for the exclusive rights in China, Pfizer will pay 3SBio up to $150 million in option payments.

Novocure Reports Second Quarter 2025 Financial Results

On July 24, 2025 Novocure (NASDAQ: NVCR) reported financial results for the second quarter that ended June 30, 2025 (Press release, NovoCure, JUL 24, 2025, View Source [SID1234654517]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

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"With the first half of 2025 complete, I am pleased to report continued progress towards our clinical, regulatory and commercial milestones. In Q2, we grew our glioblastoma and non-small cell lung cancer businesses and advanced our efforts to bring Tumor Treating Fields therapy to new patient populations," said Ashley Cordova, CEO, Novocure. "With one launch ongoing and two more on the horizon, we are well-positioned in both the near and long term. This is a pivotal period for Novocure."

Financial updates for the second quarter ended June 30, 2025:

Total net revenues for the quarter were $158.8 million, an increase of 6% compared to the same period in 2024. This increase is primarily driven by active patient growth across our major markets.
The U.S., Germany, France and Japan contributed $94.3 million, $19.1 million, $18.4 million and $9.5 million, respectively, with other active markets contributing $13.0 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.6 million.
Recognized revenue from Optune Lua in the quarter was $2.4 million, including $1.1 million from non-small cell lung cancer (NSCLC) and $1.3 million from malignant pleural mesothelioma (MPM).
Gross margin for the quarter was 74% compared to 77% in the prior year. The reduction of gross margin was primarily driven by the roll out of our Head Flexible Electrode (HFE) transducer array for use with Optune Gio, the NSCLC launch where we are treating on-label patients at risk prior to establishing broad reimbursement, and increased tariffs.
Research, development and clinical studies expenses for the quarter were $55.8 million, an increase of 2% from the same period in 2024. This was primarily driven by increased direct clinical trial expenses related to the ramp of the LUNAR-2 and KEYNOTE D58 trials.
Sales and marketing expenses for the quarter were $57.1 million, an increase of 1% compared to the same period in 2024. This primarily reflects higher costs associated with the expansion of our NSCLC sales force.
General and administrative expenses for the quarter were $44.0 million, an increase of 17% compared to the same period in 2024. This increase was primarily driven by higher share-based compensation expenses and higher personnel and professional service expenses to support the NSCLC launch and general company build-out, particularly on the enterprise technology side.
Net loss for the quarter was $40.1 million with loss per share of $0.36.
Adjusted EBITDA* for the quarter was $(9.9) million.
Cash, cash equivalents and short-term investments were $911.5 million as of June 30, 2025.
Operational updates for the second quarter ended June 30, 2025:

As of June 30, 2025, there were 4,331 total active patients on TTFields therapy globally.
Optune Gio
1,598 prescriptions for Optune Gio for the treatment of glioblastoma were received in the quarter, a decrease of 1% from the same period in 2024. The U.S., Germany, France and Japan contributed 963; 199; 179 and 101 prescriptions, respectively, with the remaining 156 prescriptions contributed by other active markets.
As of June 30, 2025, there were 4,194 Optune Gio active patients on therapy, an increase of 7% from the same period in 2024. The U.S., Germany, France and Japan contributed 2,177; 581; 453 and 451 Optune Gio active patients, respectively, with the remaining 532 active patients contributed by other active markets.
Optune Lua
143 total prescriptions for Optune Lua were received in the quarter. 121 Optune Lua prescriptions were received for the treatment of NSCLC and 22 prescriptions were received for the treatment of MPM.
As of June 30, 2025, there were 137 active Optune Lua patients on therapy, including 94 patients treated for metastatic NSCLC and 43 patients treated for MPM.
Quarterly updates and achievements:

In May 2025, Novocure presented the results of the Phase 3 PANOVA-3 clinical trial at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. PANOVA-3 met its primary endpoint, demonstrating a statistically significant extension in overall survival in patients treated with TTFields therapy together with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel alone. Patients treated with TTFields therapy also exhibited a statistically significant extension in pain-free survival (secondary endpoint) and distant progression-free survival (post hoc analysis). The presentation was selected for inclusion in ‘Best of ASCO (Free ASCO Whitepaper)’ program and the data were simultaneously published in the Journal of Clinical Oncology.
In July 2025, Novocure presented final quality of life data from the PANOVA-3 trial at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025. Patients treated with TTFields therapy demonstrated a statistically significant and clinically meaningful benefit across multiple quality of life measures of pain (secondary endpoint) and significantly delayed the need for opioid pain medication (post hoc analysis) for patients with unresectable, locally advanced pancreatic adenocarcinoma. A significant delay in deterioration across measures of health status was observed, preserving quality of life longer in patients treated with TTFields therapy.
Anticipated clinical and regulatory milestones:

Novocure plans the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the treatment of unresectable, locally advanced pancreatic cancer based on results of the Phase 3 PANOVA-3 clinical trial in Q3 2025.
Novocure plans the submission of a PMA application to the FDA for the treatment of brain metastases from NSCLC based on results of the Phase 3 METIS clinical trial in H2 2025.
The topline data readout from the Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer is expected in H1 2026.
The topline data readout from the Phase 3 TRIDENT clinical trial in newly diagnosed glioblastoma is expected in H1 2026.
Conference call details

Novocure will host a conference call and webcast to discuss second quarter 2025 financial results at 8:00 a.m. EDT today, Thursday, July 24, 2025. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Vir Biotechnology Announces First Patient Dosed in Phase 1 Clinical Trial of EGFR-Targeting PRO-XTEN™ Dual-Masked T-Cell Engager VIR-5525 for the Treatment of Solid Tumors

On July 24, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR) reported that the first patient has been dosed in the Company’s Phase 1 clinical trial evaluating VIR-5525, an investigational dual-masked T-cell engager (TCE) targeting EGFR (epidermal growth factor receptor) (Press release, Vir Biotechnology, JUL 24, 2025, View Source [SID1234654516]). VIR-5525 will be evaluated for the treatment of a variety of EGFR-expressing solid tumors in areas of high unmet need such as non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), and cutaneous squamous cell carcinoma (cSCC).

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The Phase 1 clinical trial (NCT06960395) is a first-in-human open-label, non-randomized study designed to assess the safety, pharmacokinetics, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab. VIR-5525 is Vir Biotechnology’s third dual-masked TCE in clinical trials. It incorporates the Company’s clinically validated in-licensed PRO-XTEN masking technology, which is designed to enable the selective activation of the TCEs in the tumor microenvironment, mitigating damage to healthy cells and reducing toxicity.

EGFR is a clinically validated target known to play a key role in cancer.1 Although EGFR-targeting therapies are available, they often face limitations due to the development of resistance mechanisms2 and high toxicities associated with treatment.3

"We are excited to bring our third PRO-XTEN dual-masked T-cell engager VIR-5525 to the clinic as we further our mission of transforming the lives of people living with hard-to-treat solid tumors," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "This achievement is a testament of Vir Biotechnology’s commitment to advancing innovative therapies that address substantial unmet needs in oncology."

"EGFR has been well characterized as a key oncogenic driver and a marker of poor prognosis in cancer. Traditional therapies have significant limitations, creating a substantial unmet need for highly efficacious and well-tolerated options," said Mark Eisner, MD, MPH, Chief Medical Officer, Vir Biotechnology. "VIR-5525 harnesses the anti-tumor power of T-cell engagers with a dual-masking approach designed to unlock an expanded therapeutic index. We look forward to evaluating the potential of this clinical candidate in our Phase 1 trial."

The first patient dosing of VIR-5525 triggers a $75 million milestone payment as part of the Company’s 2024 exclusive worldwide license agreement with Sanofi for the PRO-XTEN platform and clinical-stage T-cell engagers. This anticipated milestone payment has been held as restricted cash since the transaction closing and was excluded from the Company’s $1.02 billion in cash, cash equivalents and investments reported as of March 31, 2025. The payment will be recognized as a research and development expense in the third quarter of 2025.

Dose escalation continues for Vir Biotechnology’s dual-masked TCEs VIR-5818 (targeting a variety of HER2-expressing solid tumors) and VIR-5500 (targeting PSMA in metastatic castration-resistant prostate cancer). Initial Phase 1 data presented in January 2025 showed compelling early clinical response signals and promising safety profiles for both clinical candidates in heavily pretreated patients.

The Company is advancing multiple preclinical dual-masked TCEs against clinically validated targets with potential applications across a variety of solid tumors with high unmet need. These undisclosed candidates integrate the PRO-XTEN masking technology with novel TCEs discovered and engineered using Vir Biotechnology’s antibody discovery platform and the Company’s proprietary dAIsY (data AI structure and antibody) artificial intelligence engine.

About VIR-5525

T-cell engagers (TCEs) are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. VIR-5525 is an investigational dual-masked TCE currently being evaluated in an open-label, non-randomized Phase 1 clinical trial (NCT06960395) designed to assess the safety, pharmacokinetics and preliminary efficacy of VIR-5525 alone or in combination with pembrolizumab.

VIR-5525 combines a bispecific EGFR and CD3 binding TCE with the PRO-XTEN masking technology. The PRO-XTEN masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By confining the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with unmasked TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing for less frequent dosing regimens.

Janux Therapeutics Highlights Pipeline Progress and Best-in-Class Potential of Novel Bispecific Platform for Autoimmune Diseases at Virtual R&D Day

On July 24, 2025 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, reported it will host its virtual R&D Day today at 1:30 PM PT (Press release, Janux Therapeutics, JUL 24, 2025, View Source [SID1234654515]). The event will highlight the company’s continued momentum in advancing its novel immunotherapy platforms—TRACTr and TRACIr, as well as ARM—designed to address significant unmet needs in oncology and autoimmune diseases.

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"At Janux, we are guided by a deep commitment to scientific excellence and a belief that innovation should translate into meaningful outcomes for patients," said David Campbell, Ph.D., President and CEO of Janux Therapeutics. "The progress we’ve shared today across our TRACTr, TRACIr, and ARM platforms reflects our disciplined strategy to focus first on maximizing the benefit and value of our clinical program JANX007, second to harness the value of our clinical experience by bringing forward TRACTrs where we can potentially be first- and/or best-in-class, and third to utilize our T cell engager development expertise to enable platform technologies that address other clear gaps in the treatment landscape."

Creating an Opportunity to Further Differentiate JANX007 with TRACIr Combination

Janux is advancing its CD28-based TRACIr platform designed to enhance T cell activation and durability of its CD3-based TRACTr platform. TRACIr was built on the same technology with the same tumor-activation and PK design features as TRACTr and combines tumor targeting with immune costimulation. The TRACIr platform represents a strategic extension of Janux’s tumor-activated approach, designed to complement and enhance the clinical potential of its TRACTr portfolio, beginning with PSMA-TRACTr JANX007.

While JANX007 has already demonstrated differentiated clinical activity in late-stage metastatic castration-resistant prostate cancer (mCRPC) patients, the addition of a PSMAxCD28-TRACIr introduces a costimulatory signal that may further enhance durability of response within the tumor microenvironment. This combination has the potential to drive more prolonged anti-tumor effects without increasing systemic toxicity, positioning Janux to further differentiate JANX007 in the mCRPC treatment landscape. IND-enabling studies are underway for the PSMA-TRACIr, with clinical trials in combination with JANX007 expected to begin in the second half of 2026.

Expanding the TRACTr Platform into High-Value Oncology Indications

Building upon learnings from the JANX007 and JANX008 clinical programs, Janux introduced its latest trophoblast cell surface antigen 2 (TROP2) TRACTr program. This next-generation TROP2-TRACTr was engineered for potential best-in-class safety and efficacy across a broad range of TROP2-expressing tumors, including breast, lung and bladder cancers. Janux’s TROP2-TRACTr exemplifies the TRACTr technology’s ability to create high-value T cell engager (TCE) product candidates directed at tumor targets that contemporary TCE technologies have been unable to access due to broad healthy tissue expression.

Janux’s TROP2-TRACTr product candidate demonstrated strong potency across multiple tumor types, activity at low TROP2 expression levels, and was well tolerated in non-human primates with no signs of cytokine release syndrome (CRS) or healthy tissue toxicity. This preclinical data also displayed the ability to overcome limitations of existing TROP2-targeted therapies, including antibody drug conjugates. These findings support a wide therapeutic window and the potential for best-in-class performance in TROP2-expressing solid tumors. IND-enabling activities are planned in the second half of 2025.

ARM Platform Redefines T-Cell Engagers for Autoimmune Disease and Oncology

Janux also introduced its Adaptive Immune Response Modulator (ARM) bispecific platform, designed to overcome the limitations of conventional TCEs in autoimmune diseases and oncology.

Builds upon Janux’s expertise to redesign bispecific TCEs.
Differentiated non-clinical profile provides best-in-class opportunity in autoimmune diseases.
Potential broad applicability across multiple disease areas.
Large safety window and off-the-shelf format position it for higher dosing, rapid development and potential best-in-class performance.
The lead program, a CD19-ARM, has displayed rapid, deep and durable B-cell depletion in periphery and tissues with a prolonged memory B cell reset while maintaining a large safety window in non-human primates, supporting a potential best-in-class profile.

ARMs exhibit differentiated durable T cell activity with reduced T cell exhaustion preclinically.
The program demonstrated prolonged memory B-cell depletion and immune reset from a single subcutaneous dose, reflecting the durability seen with CD19 CAR-T therapies but with greater safety and convenience.
ARMs displayed potential to dose to maximum efficacy while enabling safer, outpatient-friendly dosing.
In non-human primates, CD19-ARM achieved deep and durable B-cell depletion in both blood and lymphoid tissues with a >100x CRS safety window.
The CD19-ARM is on track for first-in-human studies to begin in the first half of 2026.

Event Information

To join the webcast, please visit this link, or the Events & Presentations page of the Investors section on the Company’s website View Source A replay of the webcast will be archived and available following the event.

Participant Dial-In Numbers:
USA / International Toll +1 (646) 307-1963
USA – Toll-Free (800) 715-9871
Conference ID 9235403

Janux’s TRACTr, TRACIr and ARM Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is also advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials.

Incyte To Present Initial Data for its TGFβR2×PD-1-directed Bispecific Antibody (INCA33890) and its Selective Inhibitor of G12D-mutated KRAS (INCB161734) at the European Society of Medical Oncology (ESMO) Congress 2025

On July 24, 2025 Incyte (Nasdaq:INCY) reported that the Company will present key data from its oncology portfolio at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, to be held October 17-21 in Berlin (Press release, Incyte, JUL 24, 2025, View Source [SID1234654514]).

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"We’re looking forward to presenting the latest findings across our oncology portfolio at this year’s congress, including initial data for our TGFβR2×PD-1-directed bispecific antibody, INCA33890, and our novel, selective and orally bioavailable inhibitor of G12D-mutated KRAS, INCB161734," said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. "These data underscore the importance of establishing treatment options for advanced solid tumors and speak to the potential of INCA33890 and INCB161734 as personalized therapies to enhance outcomes for patients with cancer across a range of tumor types."

Details on the abstracts accepted for oral presentation at ESMO (Free ESMO Whitepaper) include:

INCB161734 (KRAS G12D)​

Preliminary Phase 1 Results Of INCB161734, A Novel Oral KRAS G12D Inhibitor, In Patients With Advanced Or Metastatic Solid Tumors​
(Session Title: Proffered paper session: Developmental therapeutics. [October 19, 8:45 – 10:15 a.m. ET [2:45 – 4:15 p.m. CEST]. Abstract #916O.)

INCA33890 (PD-1/TGFβR2)​

A Phase 1 Study Of INCA33890, A PD-1/Tgfβr2 Bispecific Antibody, For Advanced Solid Tumours​
(Session Title: Mini oral session: Investigational immunotherapy. [October 17, 8:00 – 9:30 a.m. ET [2:00 – 3:30 p.m. CEST]. Abstract #1522.)

INCAGN2385 (LAG-3)​

Retifanlimab (Anti–PD-1 Mab) Alone Or In Combination With Anti-LAG3 ± Anti-TIM3 Mabs In Previously Untreated, Recurrent And/Or Metastatic (R/M) PD-L1+ HNSCC: A Double-Blind Randomised Controlled Phase 2 Trial
(Session Title: Mini oral session: Head and neck cancer. [October 19, 10:30 a.m. – 12:00 p.m. ET [4:30 – 6:00 p.m. CEST]. Abstract #1325.)

All regular abstracts accepted for presentation at the ESMO (Free ESMO Whitepaper) Congress 2025 will be published online via the ESMO (Free ESMO Whitepaper) website on Monday, October 13 at 6:05 p.m. ET (12:05 a.m. CEST). All accepted abstracts will be published online in the ESMO (Free ESMO Whitepaper) Congress 2025 Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal, Annals of Oncology.

More information regarding the 2025 ESMO (Free ESMO Whitepaper) Congress can be found at: View Source