On July 31, 2025 Alphamab Oncology (stock code: 9966.HK) reported that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical study in the United States (study number: JSKN003-202) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, not restricted to HER2 expression levels.

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JSKN003 is an anti-HER2 biparatopic ADC developed inhouse which can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exerting anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated significant differentiated advantages including better serum stability and stronger bystander effect, which effectively expands the therapeutic window. In multiple clinical studies at various stages in China and Australia, JSKN003 has shown promising tolerability, safety, and significant antitumor activity.

In China, three Phase III clinical studies of JSKN003 for the treatment of HER2-low expressing breast cancer (BC), platinum-resistant ovarian cancer (PROC), and HER2-positive BC are currently undergoing smoothly. In March 2025, JSKN003 was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) for the treatment of PROC, not restricted to HER2 expression levels.

JSKN003-202 is a randomized, open-label, multi-center Phase II clinical study aimed at evaluating the safety and efficacy of JSKN003 in the treatment of patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, and determine the recommended phase III dose (RP3D). The FDA approval of this U.S. Phase II trial marks a significant milestone in Alphamab Oncology’s global development strategy for its innovative pipeline, which will further strengthen the Company’s competitive edge in oncology therapeutics.

About JSKN003

JSKN003 is a bispecific ADC developed based on KN026 using Alphamab’s proprietary glycan-specific conjugation platform. JSKN003 can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exerting anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window.

Results of multiple clinical studies at various stages of JSKN003 in China and Australia have demonstrated favorable safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with platinum-resistant ovarian cancer (PROC), HER2-expressing breast cancer (BC), or high HER2-expressing solid tumors. JSKN003 was granted breakthrough therapy designation by CDE for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. It has also been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and gastroesophageal junction cancer (GC/GEJ). Three Phase III clinical studies of JSKN003 for the treatment of HER2-low expressing BC, PROC, and HER2-positive BC as well as multiple exploratory Phase II clinical studies are currently undergoing smoothly.

In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), pursuant to which, JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the "Field") in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Alphamab retains the sole right to supply JSKN003.

(Press release, Alphamab, JUL 31, 2025, View Source [SID1234657000])

On July 31, 2025 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the second quarter of fiscal year 2025 (Press release, Illumina, JUL 31, 2025, View Source [SID1234654681]).

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"The Illumina team again delivered results that exceeded our guidance, driven by the continued ramp in X consumables, as well as accelerating growth in clinical, our largest customer segment" said Jacob Thaysen, Chief Executive Officer. "In research, we are actively helping our customers navigate a constrained funding environment. Even in these challenging conditions, the team’s focus on operational excellence helped drive margin expansion, enabling us to increase our expectations for the year."

Second quarter Core Illumina segment results

GAAP Non-GAAP (a)
Dollars in millions, except per share amounts
Q2 2025 Q2 2024 Q2 2025 Q2 2024
Revenue (b) $ 1,059 $ 1,092 $ 1,059 $ 1,092
Gross margin (c) 65.6 % 68.0 % 69.4 % 69.4 %
Research and development (R&D) expense $ 247 $ 241 $ 243 $ 241
Selling, general and administrative (SG&A) expense $ 234 $ 60 $ 241 $ 275
Operating profit
$ 214 $ 442 $ 252 $ 242
Operating margin 20.2 % 40.5 % 23.8 % 22.2 %
Tax provision $ 71 $ 35 $ 54 $ 55
Tax rate 23.4 % 35.0 % 22.2 % 24.2 %
Net income $ 235 $ 66 $ 187 $ 174
Diluted EPS $ 1.49 $ 0.41 $ 1.19 $ 1.09

1

(a)See tables in "Results of Operations – Non-GAAP" section below for GAAP and non-GAAP reconciliations.
(b)Revenue for Q2 2024 included intercompany revenue of $9 million prior to the spin-off of GRAIL.
(c)Non-GAAP gross margin remained flat primarily due to higher freight and duties costs related to tariffs and an increase in field service costs, partially offset by lower strategic partnership revenue, that is lower margin, and a more favorable product mix. The decrease in GAAP gross margin was primarily due to a $23 million impairment of an acquired intangible asset.

Capital expenditures for free cash flow purposes were $30 million for Q2 2025. Cash flow provided by operations was $234 million, compared to $243 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $204 million for the quarter, compared to $213 million in the prior year period. Depreciation and amortization expense was $68 million for Q2 2025. At the close of the quarter, the company held $1.16 billion in cash, cash equivalents and short-term investments.

Share repurchases for Q2 2025 were $380 million and the company intends to repurchase incremental shares over the course of the year as part of our approximate $800 million authorization remaining at the end of the quarter.

Key announcements since our last earnings release
•Launched TruSight Oncology 500 version 2 (TSO 500 v2), an updated version of Illumina’s comprehensive genomic profiling assay for cancer research
•TIME named Illumina to its World’s Most Sustainable Companies list for the second year in a row, and U.S. News & World Report named Illumina to its Best Companies to Work For list
•Entered into a definitive agreement with Standard BioTools under which Illumina will acquire SomaLogic and other specified assets
•Unveiled PromoterAI, a new AI algorithm that accurately deciphers pathogenic regulatory genetic variants in the noncoding regions of the human genome
•Received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for TruSight Oncology (TSO) Comprehensive for Class III/IV Medical Device (Specially Controlled Medical Device)
•Launch of DRAGEN v4.4 software, the industry’s most comprehensive secondary analysis solution powering clinical oncology research and multiomic applications

A full list of recent announcements can be found in the company’s News Center.

Financial outlook and guidance
The company provides forward-looking guidance on a non-GAAP basis, including on a constant currency basis for revenue and revenue growth rates. The company is unable to provide a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures because it is unable to predict with reasonable certainty the impact of items such as acquisition-related expenses, fair value adjustments to contingent consideration, gains and losses from strategic investments, potential future asset impairments, restructuring activities, the ultimate outcome of pending litigation, and currency exchange rate fluctuations without unreasonable effort. These items are uncertain, inherently difficult to predict, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the company is unable to address the significance of the unavailable information, which could be material to future results.

Conference call information
The conference call will begin at 1:30 pm Pacific Time (4:30 pm Eastern Time) on Thursday, July 31, 2025. Interested parties may access the live webcast via the Investor Info section of Illumina’s website or directly through the following link – View Source To ensure timely connection, please join at least ten minutes before the scheduled start of the call. A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On July 31, 2025 Instil Bio, Inc. (Nasdaq: TIL, "Instil") noted that ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK) ("ImmuneOnco"), reported preliminary safety and efficacy data from the Phase 2 open-label, multicenter study of IMM2510/AXN-2510 (‘2510) in combination with chemotherapy for front-line patients with advanced non-small cell lung cancer (NSCLC) conducted in China by ImmuneOnco (Press release, ImmuneOnco Biopharma, JUL 31, 2025, View Source [SID1234654682]).

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As of July 1, 2025, 33 patients were dosed at 10 mg/kg, with 21 patients having at least one tumor assessment (efficacy evaluable). Partial responses were observed in 62% of efficacy evaluable patients, comprising partial responses in 80% (8/10) of patients with squamous NSCLC and 46% (5/11) of patients with non-squamous NSCLC. The majority of efficacy evaluable patients had only one tumor assessment at data cut-off. ImmuneOnco expects to present safety and efficacy data in the ‘2510 chemotherapy combination trial in front-line NSCLC at a future medical conference.

The ‘2510 safety profile supports further clinical development, with no dose-limiting toxicities observed in the 33 safety evaluable patients. In these patients, there were no treatment-related adverse events (TRAE) leading to dose reduction or death, and only one TRAE leading to drug discontinuation. The most common Grade 3+ TRAEs were hematologic, with uncommon clinical sequelae. Adverse events typically associated with VEGF inhibition (e.g., hypertension, proteinuria, hemoptysis) and immune-related adverse events were uncommon and generally low-grade, and infusion-related reactions were nearly all low-grade.

"‘2510 has demonstrated early but compelling activity in front-line NSCLC patients," said Professor Caicun Zhou, M.D., Ph.D., director of the Department of Oncology at Shanghai East Hospital, Tongji University, and lead investigator on the study of ‘2510 in 1L NSCLC. "The PD-(L)1xVEGF bispecific class has the potential to become the new standard of care for front-line NSCLC, and I look forward to the generation of additional data with ‘2510 in this setting."

Dr. Tian Wenzhi, CEO of ImmuneOnco, said "We are delighted to witness the progress of ‘2510 in front-line non-small cell lung cancer (NSCLC). This data paves the way for its advancement into Phase 3 clinical studies and provides valuable insights to support further research across multiple indications."

"We are pleased with the preliminary clinical results of the combination of ‘2510 with chemotherapy in patients with front-line NSCLC, which suggest the potential for best-in-class efficacy in the promising PD-(L)1xVEGF bispecific antibody class," said Bronson Crouch, CEO of Instil. "We look forward to further public updates from ImmuneOnco on these data, as well as the initiation of our previously announced US phase 1 clinical trial before the end of this year."

About IMM2510/AXN-2510
IMM2510/AXN-2510 is a PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumors. IMM2510/AXN-2510 is differentiated from other PD-(L)1xVEGF bispecific antibodies by its VEGF trap, which binds multiple VEGF receptor ligands beyond VEGF-A, a bispecific structure which leverages PD-L1 as an anchor in the tumor microenvironment (TME), and enhanced antibody-dependent cellular cytotoxicity (ADCC) to direct killing of PD-L1-positive tumor cells.

About ImmuneOnco
ImmuneOnco is a clinical-stage biotech company focused on discovery and development of biologics to treat cancers, autoimmune diseases and metabolic diseases. With 10+ assets all originated in-house and the most advanced asset in phase III right now, ImmuneOnco is pursuing innovative therapies to improve patients’ health. For more information visit www.immuneonco.com.

On July 31, 2025 Ipsen S.A. publishes its 2025 Half-Year Report (half-year ended 30 June 2025) (Press release, Ipsen, JUL 31, 2025, View Source [SID1234654683]).

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On July 31, 2025 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor for the treatment of neurofibromatosis type 1 (NF1) and other MAPK pathway driven indications, reported the Company has completed enrollment and initial dosing of three subjects in Cohort 1 (4mg tablet) from its ongoing Phase 1/1b multicenter, open-label clinical trial evaluating PAS-004 in adult NF1 patients with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas (Press release, Pasithea Therapeutics, JUL 31, 2025, View Source [SID1234654686]).

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"Completion of enrollment and initial dosing of Cohort 1 marks a key milestone in our mission to develop PAS-004 as a potential best-in-class, next-generation MEK inhibitor for the treatment of NF1," stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "PAS-004 is a once-daily dosed MEK inhibitor in development for the treatment of NF1 patients with plexiform neurofibromas, as opposed to the current FDA-approved therapies that require twice-daily dosing. This may potentially offer a best-in-class advantage in terms of patient compliance. Based on the initial encouraging safety profile observed to date in our ongoing Phase 1 trial in advanced cancer patients, we are optimistic about the potential of PAS-004 to offer the NF1 population a better-tolerated MEK inhibitor and look forward to presenting initial NF1 proof-of-concept data in Q1 2026."

About the Phase 1/1b Clinical Trial in Adult NF1 Patients

The primary objective of the Phase 1/1b study (NCT06961565) is to evaluate the safety and tolerability of PAS-004 when administered for one 28-day treatment cycle in adult NF1 participants with at least one and up to two additional target plexiform neurofibromas (PNs) that are symptomatic and inoperable, incompletely resected, or recurrent. Secondary objectives are (i) to identify the recommended Part B dose (RPBD) or Maximum Tolerated Dose (MTD) of PAS-004, (ii) to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) profile of PAS-004, (iii) to evaluate the preliminary efficacy of PAS-004 on target PN volume, (iv) to evaluate the preliminary efficacy of PAS-004 on the size, appearance, and associated symptoms of cutaneous neurofibromas (CNs), and (v) to evaluate the impact of PAS-004 on quality of life ("QOL") and any physical symptoms attributed to the target PN. Experimental objectives are (i) to evaluate the impact of PAS-004 on QOL and any physical symptoms attributed to CNs, (ii) to evaluate the impact of PAS-004 on pain and function attributed to PNs, and (iii) to investigate PAS-004 effects on CN tumor cellular and molecular biology.

The trial will be conducted in two parts. In Part A, following a screening period of up to 28 days, up to 24 eligible participants will be enrolled sequentially to receive one of four planned dose levels of PAS-004 tablets (4mg, 8mg, 12 mg, and 18mg) in a modified 3+3 design. Part A will identify the recommended RPBD. During Part B, up to 24 eligible participants will be enrolled in parallel to receive one of two planned dose levels of PAS-004 tablets. Participants will be dosed at the RPBD level and at a dose level below the RPBD for up to six continuous 28-day treatment cycles. Part B will identify the recommended phase 2 dose (RP2D).

The study is planned to be conducted at five clinical trial sites in Australia, South Korea and the U.S.