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.

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.

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

On July 24, 2025 Targepeutics, a biotech company dedicated to developing targeted therapies for aggressive pediatric brain cancers, reported a strategic financing round led by the Yuvaan Tiwari Foundation (Press release, Targepeutics, JUL 24, 2025, View Source [SID1234654513]). This investment will directly support the advancement of GB13, Targepeutics’ lead drug candidate, into clinical trials for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG) — one of the deadliest pediatric brain tumors.

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"We are honored to welcome the Yuvaan Tiwari Foundation into the Targepeutics community," said Sil Lutkewitte, CEO of Targepeutics. "Their support is more than just financial — it represents a deep, shared commitment to pushing forward the science and bringing hope to families facing DIPG."

GB13 is a first-in-class precision therapy designed to target a key molecular driver of DIPG. Preclinical data have shown promising efficacy, and the new funding will accelerate the operational steps required to initiate a first-in-human trial. The FDA’s Rare Pediatric Disease Designation (RPDD) for GB13 earlier this year underscores its potential impact and makes Targepeutics eligible for a Priority Review Voucher (PRV), which could expedite regulatory review and further support clinical development.

The Yuvaan Tiwari Foundation, created in memory of Yuvaan Tiwari who lost his life to Diffuse Midline Glioma (DMG) at the age of 3, is committed to accelerating breakthrough research and clinical solutions for pediatric brain cancer.

"We lost our son to this disease, and we know what’s at stake. This is more than an investment — it’s a direct action toward changing the outlook for children with DMG," said Parvati Tiwari, President and Co-Founder of the Yuvaan Tiwari Foundation. "Our foundation is proud to support Targepeutics’ bold and innovative treatment approach. This investment reflects our focus on advancing therapies with real potential to impact the lives of children facing this devastating disease."

Targepeutics remains focused on pushing the boundaries of what’s possible in pediatric oncology, and this new partnership brings it one step closer to delivering transformative care to the patients who need it most.

On July 24, 2025 TriSalus Life Sciences Inc. (Nasdaq: TLSI), a company focused on improving outcomes for patients with solid tumors, reported the completion of its previously disclosed exchange offer and consent solicitation for its Preferred Stock (Press release, TriSalus Life Sciences, JUL 24, 2025, View Source [SID1234654512]).

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The offer expired one minute after 11:59 p.m. EDT on July 23, 2025. Under the terms of the offer, TriSalus provided holders of its Preferred Stock the option to exchange each preferred share for 3.3 shares of its common stock. As previously disclosed, parties representing approximately 55% of the shares of Preferred Stock have agreed to tender their shares of Preferred Stock in the Offer and to consent to the Preferred Stock Amendment in the Consent Solicitation pursuant to tender and support agreements

The company has been advised that the shares of Preferred Stock tendered represented approximately 98.82% of the outstanding shares of Preferred Stock. All validly tendered shares will be accepted, with settlement expected by August 1, 2025.

Because a sufficient percentage of preferred shareholders agreed to the offer, TriSalus received approval to amend the terms of the Preferred Stock. As a result, the remaining outstanding preferred shares will be automatically converted to common stock at a slightly lower exchange rate (11.3% less than the offered rate).

The SEC declared the company’s Registration Statement on Form S-4 (Registration No. 333-288250), originally filed with the SEC on June 23, 2025, registering the shares issuable in the offer and pursuant to the amendment to Preferred Stock was declared effective by the SEC on July 22, 2025.

TriSalus was assisted in the process by Sodali LLC (Information Agent) and Continental Stock Transfer & Trust Company (Exchange Agent).