On July 3, 2025 Thermo Fisher Scientific, the world leader in serving science, reported the U.S. Food and Drug Administration (FDA) has approved the Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer as an in vitro diagnostic (IVD) assay for use as a companion diagnostic (CDx) for Dizal’s ZEGFROVY (sunvozertinib) and in tumor profiling (Press release, Thermo Fisher Scientific, JUL 3, 2025, View Source [SID1234654241]). This approval brings rapid next-generation sequencing (NGS) to decentralized clinical settings closer to where patients receive care. With the ability to deliver essential genomic insights in as little as 24 hours*, this approval helps advance the accessibility of precision oncology tools and enables more timely decision making.

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A patient’s tumor profile has the potential to guide precision oncology care. However, delays in obtaining results can hinder clinicians’ ability to make informed decisions, potentially causing patients to miss out on targeted therapies, which can impact treatment efficacy and patient outcomes. Furthermore, a significant number of patients miss out on targeted therapies due to inefficiencies or lack of access to testing, highlighting the critical role of timely genomic profiling. The Oncomine Dx Express Test was designed to simplify the NGS workflow and connect patients everywhere to precision oncology.

Now with the Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer, laboratories across a variety of clinical settings can deliver rapid genomic profiling with exceptional accuracy and ease, helping to ensure patients can benefit from the latest advancements in precision oncology.

The Oncomine Dx Express Test is intended for use as a companion diagnostic for ZEGFROVY (sunvozertinib), a targeted therapy from Dizal, to identify patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. In addition, the test has been approved for tumor profiling in solid tumors and detects cancer mutations with evidence of clinical significance and potential clinical significance across 46 genes.

Accelerating informed precision oncology care

The Genexus Dx Integrated Sequencer automates the NGS workflow — from sample preparation to data analysis and reporting — making the technology accessible to more laboratories, including those that are smaller and without previous NGS expertise. It also enables laboratories to generate timely CDx results as well as tumor profiling reports in as little as 24 hours, helping accelerate insights and access to precision oncology.

"NGS has been instrumental in advancing precision oncology, but these insights often aren’t available early enough to inform real-world care," said Kathy Davy, president of Clinical Next-Generation Sequencing at Thermo Fisher Scientific. "With our rapid NGS solutions, we aim to deliver timely results to clinicians and their patients prior to the initiation of treatment. We’ve been leading companion diagnostics in collaboration with our pharma partners for a decade, and this approval signifies the next step in our journey bringing rapid, decentralized NGS CDx to drug development. We are proud of our collaboration with Dizal to bring ZEGFROVY to the US market."

Biodesix, one of Thermo Fisher’s collaborators in the validation of Oncomine Dx Express Test on the Genexus Dx Integrated Sequencer, will be the first lab to launch testing services.

"The Biodesix team is excited at the prospect of using the newly FDA approved Genexus Dx Integrated Sequencer for clinical testing using the Oncomine Dx Express test and for supporting our biopharma client projects," said Gary Pestano, Ph.D., chief development officer at Biodesix. "Automation of the systems for nucleic acid purification, library preparation, sequencing and report generation has the potential to significantly improve our NGS laboratory workflows by reducing hands-on time and by delivering rapid turnaround times – from sample receipt to results."

ZEGFROVY (sunvozertinib) CDx approval

ZEGFROVY, developed by Dizal, was granted FDA accelerated approval following Breakthrough Therapy designation and Priority Review for the treatment of NSCLC patients with EGFR exon 20 insertion mutations. With the approval of the Oncomine Dx Express Test on the Genexus Dx Integrated Sequencer as a companion diagnostic for this therapy, clinicians can now quickly identify eligible patients – supporting earlier intervention and expanding access to targeted therapy.

"ZEGFROVY is a highly effective and currently the only approved EGFR TKI targeting EGFR exon 20 insertion mutations. The approval of ZEGFROVY will have a significant impact on platinum-pretreated patients with NSCLC harboring EGFR exon 20 insertion mutations, a difficult-to-treat lung cancer subtype," said Susan Chen, senior vice president, head of clinical operation at Dizal. "Today’s FDA approval of the Oncomine Dx Express Test offers access to ZEGFROVY through decentralized companion diagnostic testing. The ability to match patients to our therapy quickly and accurately, regardless of mutation location, can improve outcomes for this patient population."

On July 3, 2025 OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported it was granted an End of Phase 2 Meeting by the United States Food & Drug Administration ("FDA") to review the OST-HER2 program in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (Press release, OS Therapies, JUL 3, 2025, View Source [SID1234654242]). The Company expects the meeting to occur in the third quarter of 2025. The End of Phase 2 Meeting marks a pivotal point in the drug development process, and a significant milestone towards market access.

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The Company intends to seek alignment with FDA to begin a Rolling Review process for the forthcoming Biologics Licensing Application ("BLA") submission for OST-HER2. The Rolling Review process means that a company can submit completed sections of its Biologic License Application (BLA) for review by FDA, rather than waiting until every section of the BLA is completed before the entire application can be reviewed. This can contribute to augmented interactions with FDA and potentially an expedited BLA approval timeline.

OST-HER2 has received FDA Orphan Disease Designation (ODD), Fast Track and Rare Pediatric Disease Designation (RPDD) from FDA. Under the RPDD program, if the Company receives Accelerated Approval prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to sell. The most recent PRV sale, valued at $160 million, occurred in June 2025.

OST-HER2, an immunotherapy for osteosarcoma that uses a HER2-bioengineered form of the bacterium Listeria monocytogenes to trigger a strong immune response against HER2-expressing cancer cells, is featured in the movie Shelter Me: The Cancer Pioneers. The movie offers a look into canine comparative oncology, a field that compares treatment of cancers in dogs to those in people and covers developing treatments for rare forms of cancer. The trailer is available here and the movie is available via streaming on PBS’ website.

The most recent data regarding the OST-HER2 canine osteosarcoma program is available at this link. The Company has formed subsidiary OS Animal Health to advance the canine osteosarcoma program.

On July 3, 2025 Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology (IO) and Antibody Drug Conjugate (ADC)-based therapies, reported that Boehringer Ingelheim has selected a third drug candidate, which will now advance into IND-enabling studies under their ongoing collaboration (Press release, Oxford BioTherapeutics, JUL 3, 2025, View Source [SID1234656420]). The target, OB33, was identified using OBT’s proprietary OGAP-Verify discovery platform. As a result of this milestone, OBT will receive a payment from Boehringer.

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Immuno-oncological therapies have transformed the cancer treatment landscape. They are however only effective in a subset of patients, requiring the identification of novel immunotherapy targets. The collaboration with Oxford BioTherapeutics complements Boehringer Ingelheim’s development of next-generation potentially life-changing cancer immunotherapies with the identification of unique and specific cancer targets.

Dr. Christian Rohlff, Chief Executive Officer, said: "We are pleased to see our partnership with Boehringer Ingelheim reach an important preclinical milestone. It reflects the strength of our collaboration and the scientific excellence of our OGAP discovery platform. This achievement reinforces our strategy of partnering with world-class organizations to translate breakthrough science into potential new cancer therapies. We look forward to the next phase of this highly successful partnership and to continuing to work together to develop innovative first-in-class treatments for patients with difficult to treat cancers."

OBT’s recently launched enhanced OGAP-Verify discovery platform allows for enhanced sensitivity and target selection, addressing key challenges in the design of therapeutic antibodies and diagnostic tools. This has resulted in an increased overall success rate of these novel compounds transitioning into clinical development.

Under the multi-year collaboration, OBT has identified targets using the OGAP-Verify platform, while Boehringer is responsible for the development and commercialization of resulting product candidates.

The OBT–Boehringer partnership began in 2013 and has expanded through subsequent agreements in 2020 and 2022 to include additional programs. The collaboration has yielded multiple development-stage assets, with two candidates currently in clinical trials, one compound now in IND enabling studies, and a fourth target recently optioned by Boehringer Ingelheim.

On July 3, 2025 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, reported that on July 2, 2025 the Company granted (i) non-qualified stock options to one newly-hired non-executive employee to purchase a total of 30,000 shares of the Company’s common stock at an exercise price per share of $1.12, which was the closing price per share of the Company’s common stock as reported by NASDAQ on July 2, 2025, the options grant date, and (ii) restricted stock units (RSUs) representing 37,900 shares of its common stock to two newly-hired non-executive employees (Press release, Fate Therapeutics, JUL 3, 2025, View Source [SID1234654234]). The grants were approved by the Compensation Committee of the Company’s Board of Directors and granted under the Company’s Amended and Restated Inducement Equity Plan as an inducement material to the new employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The options will vest over four years, with 25% of the shares underlying the option vesting on the one-year anniversary of the grant date and the remaining 75% vesting in approximately equal monthly installments over the following thirty-six months, subject to the employee being continuously employed by the Company through each vesting date. The RSUs will vest over four years, with 25% of the shares underlying each RSU award vesting on each anniversary of the grant date, subject to the employees being continuously employed by the Company through each vesting date.

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On July 2, 2025 I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, reported the presentation of positive Phase 1b combination data for givastomig, in combination with nivolumab and mFOLFOX6, at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) in Barcelona (abstract #388MO) (Press release, I-Mab Biopharma, JUL 2, 2025, View Source [SID1234654218]). Givastomig is a bispecific antibody targeting Claudin 18.2 and 4-1BB. I-Mab plans to host a virtual investor event on Tuesday, July 8th (register here) to review these data.

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The Phase 1b data (NCT04900818) show a confirmed objective response rate (ORR) of 71% across all doses (12/17), and 83% (10/12) at doses selected for the ongoing dose expansion study (8 mg/kg and 12 mg/kg). Responses occurred in tumors with low levels of PD-L1 expression and/or Claudin 18.2 (CLDN18.2) expression, with favorable overall tolerability. There were no Grade 3 or greater events for nausea and vomiting, and only one Grade 3 TRAE for increased liver enzymes. The data are based on the results of the dose escalation part of a Phase 1b study evaluating the givastomig combination as first line therapy (1L) in patients with Claudin 18.2-positive gastric cancers (≥1+ IHC staining intensity in ≥1% of tumor cells). The primary endpoint is safety. The study enrolled only patients in the U.S.

"The positive Phase 1b combination data presented at ESMO (Free ESMO Whitepaper) GI bolster our confidence in givastomig’s potential to be a best-in-class Claudin 18.2 directed therapy. Givastomig has been well tolerated when combined with immuno-oncology and chemotherapy, has shown a high objective response rate, with rapid onset and durable responses that have deepened over time, supported by consistent pharmacokinetic data and soluble 4-1BB induction," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. "In addition, we are optimistic about the results from the 8 mg/kg and 12 mg/kg doses. These doses showed an ORR of 83%, with consistent responses across PD-L1 and Claudin 18.2 expression levels, and a favorable overall safety profile. These data further our conviction in the ongoing Phase 1b dose expansion study. We believe givastomig has broad potential in a number of gastric cancer settings and look forward to continued advancement of the program."

"I am encouraged by the response rates, as well as the deepening of responses over time, demonstrated by the givastomig combination regimen in the Phase 1b dose escalation study that we presented today at ESMO (Free ESMO Whitepaper) GI. Despite approved therapies, targeted treatment options for gastric cancers continue to be limited. While the data are early, givastomig combination therapy demonstrates a high response rate across Claudin18.2 and PD-L1 expression levels," said Samuel J Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital. "In addition, I have been pleased to observe that givastomig has a favorable overall tolerability profile with a low level of gastrointestinal side effects — especially important for patients with gastric cancer. I look forward to participating in the ongoing givastomig clinical development program, and hope we may be able to expand the population of patients who may benefit from Claudin 18.2 directed agents."

Virtual Investor Event:

Register (here) for the Post-ESMO GI 2025 Investor Event to be held on Tuesday, July 8th at 2:00 PM EDT. A replay of the webinar will be accessible on the Events page of the I-Mab website for 90 days.

Fireside Chat Event with Lucid Capital Markets to Recap the Presentation:

Tune in (here) for a fireside chat sponsored by Christopher Liu, PharmD, Managing Director at Lucid Capital Markets that will be accessible today at 2:00pm EDT on the Events page of the I-Mab website. A replay of the fireside chat will be available for 90 days.

ESMO GI Presentation Details:

A full copy of the ESMO (Free ESMO Whitepaper) GI presentation is available on the Publications and Presentations page of the I-Mab website here.

Givastomig Phase 1b Dose Escalation Data Summary in 1L Gastric Cancers

•
17 advanced metastatic gastric cancer patients were treated with givastomig across the 5 mg/kg (n=5), 8 mg/kg (n=6), and 12 mg/kg (n=6) dose levels as of the May 15, 2025 data cutoff. All patients were efficacy evaluable

Patient Characteristics:

•
The 17 patients enrolled in the study were treatment naïve metastatic gastric, esophageal or gastroesophageal adenocarcinomas
•
Patients were HER2-negative, Claudin 18.2-positive (defined as ≥1+ IHC staining intensity in ≥1% of tumor cells), regardless of PD-L1 expression levels
•
All patients were enrolled at sites within the United States

Efficacy Results:

•
Confirmed Objective Response Rates (ORRs):
o
71% of patients (12/17) achieved a partial response (PR) per RECIST v1.1
▪
5 mg/kg (2/5)
▪
8 mg/kg (5/6)
▪
12 mg/kg (5/6)
o
At the doses selected for dose expansion (8 and 12 mg/kg), 83% (10/12) of patients achieved PRs
o
80% of patients (4/5) with CLDN18.2 expression below 75% (CLDN-Low) achieved a PR. The CLDN-Low response rate increased to 100% of patients (3/3) in the doses selected for expansion (8 and 12 mg/kg)
•
The disease control rate (DCR) was 100% across the three dose levels
•
Dose-dependent pharmacokinetics (PK) were observed, similar to monotherapy PK
•
Patients also experienced a dose dependent induction of soluble 4-1BB, a positive indicator of T cell activation and engagement

ORR: % (n)

All

(n=17)

Cohorts Chosen for Expansion

(8 and 12 mg/kg)

(n=12)

PD-L1

Any

71 (12/17)

83 (10/12)

≥5

82 (9/11)

89 (8/9)

<5

50 (3/6)

67 (2/3)

≥1

73 (11/15)

82 (9/11)

<1

50 (1/2)

100 (1/1)

CLDN18.2

≥75

67 (8/12)

78 (7/9)

<75

80 (4/5)

100 (3/3)

ORR: % (n)

PD-L1 ≥ 5

PD-L1 < 5

CLDN18.2 ≥ 75

80 (8/10)

0 (0/2)

CLDN18.2 < 75

100 (1/1)

75 (3/4)

Durability:

•
8 of 17 patients remained on study treatment and the longest treatment duration was 13.3 months as of the data cutoff
•
Median follow-up was 9.0 months across all dose levels as of the data cutoff

Safety:

•
Treatment-related adverse events (TRAEs) leading to discontinuation of any treatment were 12% (two patients), five patients had progressive disease, two patients withdrew from the study for social reasons
•
No dose limiting toxicities (DLT) were observed and a maximum tolerated dose (MTD) was not reached
•
Common TRAEs (≥10% of patients) were generally Grade 1 or Grade 2 including nausea, vomiting, infusion related reaction, fatigue, decreased appetite, diarrhea, abdominal pain, chills, dyspepsia and gastritis
•
Grade 3 TRAEs attributed to givastomig were rare, with single cases of abdominal pain, ALT/AST increases, gastritis, and infusion related reaction
•
Four cases of Grade 3 and two cases of Grade 4 treatment-related neutropenia were observed driven by an early restriction on prophylaxis use of G-CSF, which has been subsequently lifted. The neutropenia cases were primarily attributed to mFOLFOX6 in the 8 mg/kg cohorts
•
No Grade 5 TRAEs were reported

About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first line (1L) metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

An ongoing Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation and dose expansion cohorts. Dose escalation is complete, and enrollment in the first dose expansion cohort (n=20) finished ahead of schedule. Enrollment continues to progress ahead of schedule in the second dose expansion cohort (n=20). The study builds on positive Phase 1 monotherapy data.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.