On September 9, 2025 Tagworks Pharmaceuticals BV ("Tagworks"), a clinical-stage precision oncology company using its proprietary Click-to-Release treatment platform to develop a new standard of care for patients suffering from solid tumors, reported the third dose level has been initiated in the ongoing Phase 1 clinical trial evaluating TGW101, a first-in-class antibody-drug conjugate (ADC) targeting tumor associated glycoprotein 72 (TAG-72) with a monomethyl auristatin E (MMAE) payload, in patients with advanced solid tumors (Press release, Tagworks Pharmaceuticals, SEP 9, 2025, View Source [SID1234655885]).

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"We are pleased to report continued progress in our Phase 1 clinical trial of TGW101 which reflects our strong operational execution and commitment to advancing our pioneering Click-to-Release technology," said Ken Mills, Chief Executive Officer of Tagworks. "The Safety Oversight Committee’s decision to proceed to the third dose level highlights TGW101’s favorable safety profile to date. We are encouraged by the potential of TGW101’s highly differentiated profile to address significant unmet needs in the treatment of advanced solid tumors, while overcoming limitations seen with other ADC therapies. We look forward to sharing preliminary data from the study, including safety, pharmacokinetics, and potential early signs of clinical activity, in early to mid-2026."

The ongoing Phase 1 trial is a multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of TGW101 in patients with relapsed or refractory solid tumors. The primary objectives are to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and dose regimen for cohort expansion.

To date, the trial has initiated three dose levels following favorable safety reviews by the Safety Oversight Committee (SOC). Up to seven dose levels are currently planned, and the maximum dose to be evaluated may be updated based on evolving clinical safety and pharmacokinetic data. The study aims to enroll up to 50 patients across sites in the United States, with potential expansion to additional regions.

Tagworks expects to share preliminary safety and pharmacokinetic data, along with any early signals of efficacy, in early to mid-2026.

About TGW101
TGW101 is an antibody-drug conjugate (ADC) targeting TAG-72, a non-internalizing marker found on the surface of many solid tumor cells. TGW101 consists of a TAG-72-binding diabody conjugated with monomethyl auristatin E (MMAE) toxin. TGW101 is administered intravenous (IV) first and allowed to bind to TAG-72 in the tumor. Then a small molecule trigger is administered IV, resulting in selective chemical cleavage of the linker of the tumor-bound TGW101, release of the MMAE in the extracellular tumor microenvironment and diffusion into surrounding tumor cells. TGW101 is being studied in an open-label, multicenter, Phase 1 dose-escalation clinical trial designed to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors.

On September 9, 2025 Celcuity Inc. ("Celcuity"), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported that it has entered into an amendment to its existing senior secured credit facility with an affiliate of Innovatus Capital Partners, LLC ("Innovatus") and Oxford Finance LLC ("Oxford") (Press release, Celcuity, SEP 9, 2025, View Source [SID1234655918]). The amendment increases the total term loan facility size to $500 million, including $350 million in committed capital and up to $150 million at the mutual discretion of Celcuity and its lenders. At the closing of the Amendment, the initial funding under the amended credit facility was in a principal amount of $30 million, bringing the total term loan outstanding to $130 million.

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Highlights of the amended credit facility include:

● Increased Capital Availability: Adds $170 million in new committed capital, including an additional $50 million for a total of $100 million available upon U.S. Food and Drug Administration ("FDA") approval of gedatolisib in second-line wild-type advanced breast cancer ("ABC") patients post-CDK4/6 inhibitor therapy, and $120 million upon achievement of certain commercial revenue milestones. An additional up to $150 million is also available at the mutual discretion of Celcuity and its lenders.
● Improved Structure and Financial Flexibility: Extends the interest-only period by 14 months, with an additional seven-month extension available upon FDA approval. The maturity date of the facility was also extended by six months.

The amendment significantly enhances Celcuity’s financial flexibility and access to capital following the positive topline data from the PIK3CA wild-type cohort of the pivotal VIKTORIA-1 Phase 3 clinical study. The upsized facility strengthens Celcuity’s ability to manage its capital structure efficiently while providing additional funding to support the rolling submission to FDA of its New Drug Application ("NDA") via FDA’s RTOR program, commercial launch preparations for gedatolisib, and other strategic initiatives.

On September 9, 2025 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported the presentation of new findings on its leading assets, ZEGFROVY (sunvozertinib) and golidocitinib, in non-small cell lung cancer (NSCLC) at the 2025 World Conference on Lung Cancer (WCLC), held September 6–9 in Barcelona, Spain (Press release, Dizal Pharma, SEP 9, 2025, View Source [SID1234655886]).

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ZEGFROVY: Targeting EGFR exon20ins and a wide spectrum of EGFR mutations

The latest data from the multinational pivotal WU-KONG1 Part B (WU-KONG1B) study for ZEGFROVY were presented in an oral session at the conference and simultaneously published in the Journal of Clinical Oncology. Based on results from WU-KONG1B, ZEGFROVY received accelerated approval from the U.S. Food and Drug Administration (FDA) in July 2025 as the only targeted oral therapy for NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins).

ZEGFROVY demonstrated a favorable benefit/risk profile in patients with platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The study showed robust and durable antitumor activity with a manageable safety profile. (#MA08.01).

In addition to the oral presentation, multiple studies of ZEGFROVY were presented at the WCLC, highlighting its potential across a broad range of NSCLC patients, including those with EGFR exon20ins across all lines of therapy, uncommon EGFR and HER2 mutations, EGFR-sensitive mutation and co-mutations, and EGFR mutations resistant to EGFR TKIs. Both monotherapy and combination regimens were evaluated.

In EGFR exon20ins NSCLC, ZEGFROVY demonstrated promising antitumor efficacy and a tolerable safety profile across first- and second- line, as well as adjuvant and neoadjuvant treatment settings.

ZEGFROVY combined with anlotinib achieved an objective response rate (ORR) of over 80% and a disease control rate (DCR) of 100% in treatment-naïve EGFR exon20ins NSCLC (#P3.12.43).
In previously treated patients, ZEGFROVY combined with bevacizumab achieved a DCR of 100%, with target tumor lesion shrinkage observed in 85.7% of patients. With a median follow-up of 15.2 months, the median duration of response (DoR) was 19.1 months, and three patients (3/14) remained in response at the data cut-off (#P2.10.13).
Real-world cases supported the potential of ZEGFROVY in early- and advanced- stage NSCLC patients with EGFR exon20ins.

As a neoadjuvant therapy, ZEGFROVY showed encouraging clinical benefit, with all 3 patients achieving an obvious partial response (PR) before surgery. (#EP.07.49).
In the adjuvant setting, ZEGFROVY showed sustained efficacy and tolerable safety profiles, helping patients successfully pass the 1-year after surgery, a peak period for disease recurrence (#EP.07.55).
In the first-line maintenance setting, ZEGFROVY showed sustained efficacy and safety in lung adenocarcinoma patients who were intolerant to immunotherapy and chemotherapy (#EP.12.47).
In NSCLC patients harboring uncommon EGFR mutations, ZEGFROVY combined with anlotinib demonstrated promising efficacy, including one patient who achieved complete remission of intracranial lesions (#P3.12.43). In a separate real-world case series, ZEGFROVY exhibited clinical efficacy in advanced NSCLC with HER2 exon20ins, with tumor shrinkage obviously observed post-prior treatment failures (#EP.12.46).

In treatment-naïve NSCLC patients with EGFR-sensitive mutation and co-mutations, ZEGFROVY in combination with anlotinib achieved an ORR of 77.8% and a DCR of 100% (#P3.12.22). In NSCLC patients with EGFR mutations who failed prior EGFR-TKI therapies, ZEGFROVY, both as monotherapy (#EP.12.43) and in combination with chemotherapy (#P3.12.47), was well tolerated and demonstrated encouraging antitumor activity.

Golidocitinib: Janus kinase 1 (JAK1) only inhibitor Plus Anti-PD-1 in Anti-PD-1 Treated Advanced NSCLC

Resistance to first-line immune checkpoint inhibitors (ICIs) in non-small cell lung cancer (NSCLC) leads to limited treatment options and poor prognosis. Preclinical and early clinical data have shown synergistic effects between JAK inhibitors and anti-PD-1, suggesting a promising therapeutic strategy in this population. Golidocitinib in combination with anti-PD-1 was being evaluated in immune-resistant NSCLC patients. The study showed a well-tolerated profile, with no DLTs observed in the dose-escalation phase. Ongoing enrollment and data collection will provide deeper insights into clinical utility of golidocitinib (#P1.11.74).

Dr. Xiaolin Zhang, CEO of Dizal, remarked, "Dizal is advancing therapies for patients with NSCLC across EGFR exon 20 insertion, uncommon and EGFR-sensitizing mutations to address significant unmet medical needs. Through scientific innovation, we aim to deliver safe, effective and transformative treatments to patients worldwide."

On September 8, 2025 Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company"), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, reported the entry into a definitive agreement for the immediate exercise of certain outstanding common warrants (the "Existing Warrants") to purchase up to an aggregate of 1,439,126 shares of the Company’s common stock at a reduced exercise price of $2.21 (the closing price of the Company’s shares of common stock on September 5, 2025) (Press release, Beyond Air, SEP 8, 2025, View Source [SID1234655837]). The gross proceeds to the Company from the exercise of the warrants are expected to be approximately $3.25 million, prior to deducting placement agent fees and estimated offering expenses.

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Laidlaw & Company (UK) Ltd., is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the Existing Warrants for cash, the Company will issue new unregistered warrants to purchase up to 719,561 shares of common stock ("New Warrants"), at a purchase price of $0.0625 per New Warrant. The New Warrants will have an exercise price of $2.21 per share, will be exercisable immediately and will have a term of five years from the issuance date.

The offering is expected to close on or about September 9, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from this offering to advance its clinical and pre-clinical programs and for continuing operating expenses and working capital.

The new warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the new warrants issued in the private placement and the shares underlying the new warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On September 8, 2025 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that the first patient has been dosed in the clinical study of spevatamig in combination with chemotherapy for the treatment of biliary tract carcinoma (BTC) (Press release, Phanes Therapeutics, SEP 8, 2025, View Source [SID1234655838]).

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Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with Merck’s anti-PD-1 therapy, pembrolizumab.

The multi-center Phase I/II clinical trial of spevatamig (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of spevatamig in patients with advanced gastric, gastroesophageal junction, pancreatic ductal or biliary tract adenocarcinomas. The Phase I (CTR20241655) and Phase II (CTR20252758) clinical trials of spevatamig in China are currently recruiting patients.