On August 13, 2025 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, reported the initiation of an investigator sponsored trial (IST) in rGBM at the DFCI with the first patient in the trial having been dosed with CUE-102 (Press release, Cue Biopharma, AUG 13, 2025, View Source [SID1234655212]). The trial (NCT06917885) is a Phase 1b, open-label study of adjuvant CUE-102, the Company’s drug product candidate targeting Wilms’ Tumor 1 protein (WT1) expressing cancers. The principal investigator of the Phase 1b trial, David A. Reardon, MD, is the Clinical Director of the Center for Neuro-Oncology at DFCI and a leader in the field of immunotherapy for the treatment of brain cancer. The goal of the study is to evaluate the tolerability and clinical activity of CUE-102 in patients with GBM at first recurrence.

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"Glioblastoma remains one of the most aggressive and hard-to-treat cancers, and as a result, there is a pressing need for more effective therapies. Investigational treatments targeting WT1 in GBM have shown a potential correlation between expansion of antigen-specific T cells and survival," said Dr. Reardon. "CUE-102 is designed to target tumor cells by activating WT1 specific T cells, which may improve clinical outcomes in recurrent GBM."

Matteo Levisetti, MD, chief medical officer at Cue Biopharma, added, "Glioblastoma is an immunologically ‘cold’ tumor representing a disadvantage for treatment with standard immunotherapies such as checkpoint inhibitors, but is known to express high levels of the Wilms’ Tumor 1 oncofetal protein. We believe the mechanism of action of CUE-102, to preferentially activate and expand WT1 tumor-specific T cells, has the potential to activate and generate an enhanced anti-tumor immune response against glioblastoma. We are highly encouraged by the clinical data generated to date from the CUE-100 series, CUE-101 and CUE-102, and look forward to reporting results from this investigator sponsored trial."

About CUE-102
CUE-102 is Cue Biopharma’s second clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand Wilms’ Tumor 1 (WT1)-specific T cells by presenting the WT1 peptide to the WT1-specific T cell receptor. WT1 is a well-recognized onco-fetal protein known to be over-expressed in a number of cancers, including solid tumors and hematologic malignancies. CUE-102 has demonstrated anti-tumor activity and a favorable tolerability profile with no dose limited toxicities observed in a Phase 1 open label, dose escalation and expansion trial (NCT05360680), for patients with late-stage colorectal, gastric/gastroesophageal junction, pancreatic and ovarian cancers that express WT1.

About Glioblastoma
Glioblastomas are the most common primary cancer of the brain and the most aggressive type of brain tumor. There are ~13,000 new cases diagnosed each year in the United States. The most common length of survival following diagnosis is ~12 to 15 months, with fewer than ~3 to 5 percent of people surviving longer than five years.

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that present two signals to T cells. Signal #1 is a tumor-specific peptide linked to a major histocompatibility complex (pMHC) to enable selectivity and specificity. Signal #2 is a rationally engineered interleukin 2 (IL-2) molecule to trigger T cell activation. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

On August 13, 2025 Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported the strategic importance of its preclinical asset APVO442-an investigational CD3-engaging bispecific antibody designed to treat prostate cancer (Press release, Aptevo Therapeutics, AUG 13, 2025, View Source [SID1234655211]). APVO442 is built on Aptevo’s next-generation ADAPTIR-FLEX platform and is engineered to selectively activate T cells within the PSMA-expressing tumor microenvironment, offering potential for precision targeting and reduced systemic toxicity.

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APVO442 is built on the same CRIS-7-derived anti-CD3 binding domain as clinical candidate mipletamig but is specifically engineered for solid tumors, with lower binding affinity and a monovalent format that reduce the risk of immune activation outside the tumor. This design helps ensure that T cells are activated only within the tumor microenvironment, improving safety while maintaining anti-tumor potency. Preclinical data show that APVO442 effectively localizes to PSMA-expressing prostate tumors, triggering a targeted immune response while potentially sparing healthy tissue. The same solid tumor-optimized architecture has also been applied to newly added pipeline candidate APVO455.

"With mipletamig performing as designed in the clinic and the addition to the pipeline of APVO455 for multiple solid tumors, we’re confident in the strength of our CD3-based bispecific approach," said Marvin White, President and CEO of Aptevo. "APVO442 is engineered for the same balance-potent immune activation precisely where it’s needed – in the tumor. It represents yet another high-conviction opportunity to expand into solid tumors, a market where the need is large and growing."

Prostate cancer is the second most common cancer in men, with over 300,000 new cases annually* in the U.S. The global treatment market-currently valued at $14 billion-is projected to reach $24 billion within the next decade**. APVO442 is differentiated in this space as a tumor-specific immunotherapy designed for combination potential and scalable manufacturing. (*American Cancer Society, **Global Data)

APVO442 is currently in preclinical studies, and supports the Company’s goal of expanding its clinical pipeline and driving long-term value through modular, platform-based innovation. The Company continues to leverage insights from its CD3 bispecific programs to accelerate future development and partnership opportunities.

On August 13, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK-pathway-driven cancers, reported positive, updated safety and efficacy data and late-breaking presentation details of partner GenFleet Therapeutics’ Phase 1/2 study in China of GFH375, an oral KRAS G12D (ON/OFF) inhibitor, known as VS-7375 outside of China, in advanced non-small cell lung cancer patients with a KRAS G12D mutation (Press release, Verastem, AUG 13, 2025, View Source [SID1234655207]). The data will be presented in a mini oral presentation at the IASLC 2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer from September 6-9, in Barcelona, Spain.

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"These data at WCLC build on the encouraging data presented at ASCO (Free ASCO Whitepaper) earlier this year, where GenFleet initially reported an ORR of 42% in 12 patients with advanced non-small cell lung cancer harboring a KRAS G12D mutation," said Dan Paterson, president and chief executive officer of Verastem Oncology. "The significant increase in patients with advanced lung cancer demonstrating a response, 68.8% ORR at the recommended Phase 2 dose, and 57.7% ORR across all dose levels, is impressive and continues to support the development and potential of VS-7375 in advanced lung cancer and across other advanced KRAS G12D solid tumors."

The late-breaking abstract was issued today by the WCLC. GenFleet reported cumulative safety data across the entire study population and preliminary efficacy data specific to patients with advanced NSCLC from the Phase 1/2 study in China. As of the data cutoff of July 15, 2025, the median follow-up time was 4.5 (range: 1.8-12.2) months. Tumor response was observed across the dose range tested. The study population includes 142 patients, including 28 with advanced NSCLC, 85 with advanced pancreatic ductal adenocarcinoma (PDAC) and 29 with other solid tumors. Amongst the patients with NSCLC, all had metastatic disease at baseline, 64.3% had received at least two prior lines of systemic therapies, and 96.4% had received an anti-PD1/PD-L1 therapy.

At the recommended Phase 2 dose of 600 mg once daily (QD), the ORR was 68.8% (11/16) (both confirmed and unconfirmed) and the disease control rate (DCR) was 93.8% (15/16). Among the 26 evaluable patients with NSCLC treated across all dose levels, the ORR was 57.7% (15/26) (both confirmed and unconfirmed) and the DCR was 88.5% (23/26).

Across all cancer types and dose levels evaluated, the most common treatment-related adverse events (TRAEs) occurring in at least 20% of patients were diarrhea, vomiting, nausea, anemia, decreased appetite, neutrophil count decreased, white blood cell count decreased, aspartate aminotransferase increased, asthenia, hypoalbuminemia, and alanine aminotransferase increased, predominately Grade 1 or 2 in severity. TRAEs and severe adverse events (SAEs), greater than Grade 3,occurred in 27.5% (39/142) and 7.7% (11/142) of patients, respectively. Of the 142 patients in the safety population, 11 patients had dose reduction, and six discontinued due to TRAEs. No TRAE-related deaths were reported.

WCLC Details

· Title: Efficacy and Safety of GFH375 in Advanced Non-Small Cell Lung Cancer Patients with KRAS G12D Mutation
· Session: MA02- New Treatment Strategies in Other Than EGFR-Positive Tumors
· Session Date/Time: Sunday, September 7, 2025 from 12:00 pm – 1:15 pm CEST

About KRAS G12D

KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancers. The KRAS G12D mutation occurs most commonly in pancreatic (37%), colorectal (12.5%), endometrial (8%), and non-small cell lung (5%) cancers. Currently, no therapies are approved by the U.S. Food and Drug Administration (FDA) specifically targeting KRAS G12D mutations in cancer.

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor

VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. Verastem announced in April 2025 that the U.S. Investigational New Drug (IND) application for VS-7375 was cleared and initiated a Phase 1/2a clinical trial in June 2025. GenFleet’s IND for VS-7375 (known as GFH375 in China) was approved in China in June 2024, and the first patient was dosed in a Phase 1/2 study in July 2024.

On August 13, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, reported its financial results for the second quarter ended June 30, 2025 (Press release, Moleculin, AUG 13, 2025, View Source [SID1234655205]).

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"The second quarter of 2025 marked a period of momentum for Moleculin. We continued to make meaningful progress in our MIRACLE trial, including a significant expansion into a number of countries, positioning ourselves to achieve our enrollment targets and, importantly, reach an expected pivotal data readout before the end of this year. In addition to progress in our AML program, we reported compelling topline data in our Phase 1B/2 soft tissue sarcoma lung metastases (STS lung mets) trial and continue to build a growing body of preclinical and clinical data showcasing the depth and breadth of the potential Annamycin has to treat a range of cancer indications," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "I am proud of the dedication our team continues to show, and we look forward to building on this progress in the second half of the year and beyond."

Recent Highlights

Annamycin for the Treatment of AML

Expanded its Phase 2B/3 MIRACLE trial with secured approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia;
Four active MIRACLE sites now screening subjects in Ukraine, Georgia, Spain and the US;
Expect to add more than 20 additional sites in the European Union (EU) and the US by the end of Q3 2025; and
Received positive FDA feedback on pediatric study plan for Annamycin in children with R/R AML, setting the start of that trial in 2027.
Other Annamycin

Announced the presentation of encouraging preclinical data for Annamycin, which demonstrated significant efficacy against various primary and metastatic liver cancers;
Bolstered Annamycin intellectual property portfolio with notice of intent to grant a new European patent;
Engaged industry veteran Adriano Treve to explore Annamycin related strategic partnerships; and
Reported positive topline efficacy results from U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of STS lung metastases (MB-107).
Clinical Development Update

Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)

The Company is currently evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") in a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) will be global, including sites in the US, Europe and the Middle East.

The MIRACLE study is a Phase 2B/3 clinical trial whereby data from the Phase 2B portion will be combined with the Phase 3 portion for purposes of measuring its primary efficacy endpoint. MIRACLE is subject to appropriate future filings with and potential additional feedback from the FDA and their foreign equivalents, and utilizes an adaptive design whereby the first 75 to 90 subjects will be randomized (1:1:1) in Part A of the trial to receive high dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin, which Annamycin doses were specifically recommended by the FDA in the Company’s end of Phase 1B/2 meeting.

The protocol for the MIRACLE trial allows for the unblinding of preliminary primary efficacy data (Complete Remission or CR) and safety/tolerability of the three arms at 45 subjects, in addition to the conclusion of Part A (at 75 to 90 subjects). The first early unblinding will yield 30 subjects treated with Annamycin (190mg/m2 and 230 mg/m2) in combination with HiDAC and 15 subjects treated with just HiDAC plus placebo. The Company expects to reach the first unblinding (45 subjects) before the end of 2025, in addition to the second unblinding, which is expected in the first half of 2026. This accelerated estimated timeline is due in part to the positive response the Company received in meetings during December with potential investigators regarding recruitment for the trial.

As previously announced regarding the EU, the clinical trial approval with EMA was granted under the condition that the Company present results of appropriate nonclinical GLP studies before initiating the Phase 3 portion (Part B) of the study. Results will be submitted as a substantial modification to the existing approved CTA.

For Part B of the trial, approximately 220 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin (randomized 1:1). The selection of the optimum dose will be based on the overall balance of safety, pharmacokinetics and efficacy, consistent with the FDA’s new Project Optimus initiative.

Patient dosing has commenced, and the initial data readout is on track for the second half of 2025. For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756. Additionally, the clinical trial in the EU is on euclinicaltrials.eu and the reference identifier there is 2024-518359-47-00.

Expected Milestones for Annamycin AML Development Program

Q3 2025 – Site and recruitment updates for MIRACLE trial
Q3 2025 – First patients treated in the US and the EU
Q4 2025 – Announcement of 45th subject being recruited and data readout (n=45) unblinded efficacy/safety review
Q1 2026 – Impact of data readout (n=45) on regulatory pathway; Recruitment update
1H 2026 – Interim efficacy and safety data (n=~75-90) unblinded and Optimum Dose set for MIRACLE trial
2027 – Begin enrollment of 3rd line subjects in MIRACLE2
2027 – Enrollment ends in 2nd line subjects
2027 – Prepare for the launch of an AML pediatric trial
2028 – Primary efficacy data for 2nd line subjects in MIRACLE
2028 – Begin submission of a Rolling New Drug Application (NDA) for the treatment of R/R AML for accelerated approval on primary endpoint of CR from MIRACLE
2028 – Primary efficacy data for 2nd line subjects
Soft Tissue Sarcoma (STS) Lung Metastases

As previously announced, the Company reported positive topline efficacy results from its completed U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of STS lung mets (MB-107). The final topline results of MB-107 demonstrated median overall survival (OS) of 13.5 months for subjects as median 7th line therapy (n=36). This compares to OS of 8-12 months for standard of care treatments and 13.4 months for experimental treatments for advanced STS as 2nd line.1

For more information about the MB-107 trial visit clinicaltrials.gov and reference identifier NCT04887298.

Expected Milestones for Annamycin STS Lung Mets Development Program

Q4 2025 – Identify next phase of development / pivotal IIT (investigator-initiated-trial) program
Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the EMA.

WP1066 & Brain Tumors

With regard to the Company’s WP1066 oral formula, the Company has an externally funded Phase 1B/2 in combination with radiation treating glioblastoma (GBM), a form of brain cancer, at Northwestern University (Northwestern) that is actively recruiting. This is an investigator-initiated trial where Moleculin’s main cost is supplying drug product. To date Northwestern has recruited 7 subjects, of which 5 have completed treatment and are undergoing follow-up while 2 continue with treatment. No data has been released. Also, the Company has signed an agreement with Emory University enabling Emory to study various WP1066 IV formulations in preclinical studies with the goal of selecting the best molecule to move into a clinical setting towards, most likely, brain cancers such as GBM. Study drug was delivered in April 2025 to Emory with results from such studies expected in the second half of 2025.

Summary of Financial Results for the Second Quarter 2025

Research and development (R&D) expense was $3.6 million and $4.1 million for the three months ended June 30, 2025 and 2024, respectively. The decrease of $0.5 million is mainly related to a reduction in the clinical trials activity.

General and administrative expense was $2.1 million each for the three months ended June 30, 2025 and 2024.

As of June 30, 2025, the Company had cash and cash equivalents of $7.6 million and believes that the cash on hand is sufficient to fund planned operations into the fourth quarter of 2025.

On August 13, 2025 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on the development of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported a business update and announced financial results for the second quarter ended June 30, 2025 (Press release, Mersana Therapeutics, AUG 13, 2025, View Source [SID1234655201]).

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"During the second quarter, we were excited to have Emi-Le clinical data presented in oral sessions at both ASCO (Free ASCO Whitepaper) 2025 and ESMO (Free ESMO Whitepaper) Breast Cancer 2025. These presentations highlighted Emi-Le’s encouraging clinical activity in patients with TNBC post-topo-1 treatment and those with adenoid cystic carcinoma type 1 (ACC-1)," said Martin Huber, M.D., President and Chief Executive Officer of Mersana Therapeutics. "Our team has continued to make important progress in recent months, as evidenced by the strong pace of enrollment in the two ongoing dose expansion cohorts in our Phase 1 clinical trial of Emi-Le. We look forward to reporting initial clinical data from these expansion cohorts later this year."

Emiltatug Ledadotin (Emi-Le; XMT-1660)
Mersana has continued to advance the development of Emi-Le, the company’s B7-H4-directed Dolasynthen ADC.

Medical Congress Presentations: During the second quarter of 2025, clinical data as of a March 8, 2025 data cut-off from dose escalation and backfill cohorts in the Phase 1 clinical trial of Emi-Le were included in oral presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting (ASCO 2025) in Chicago, IL and the European Society for Medical Oncology Breast Cancer 2025 Annual Congress (ESMO Breast Cancer 2025) in Munich, Germany. The ASCO (Free ASCO Whitepaper) 2025 presentation included data for patients across all enrolled tumor types, and the ESMO (Free ESMO Whitepaper) Breast Cancer 2025 presentation focused primarily on patients with post-topo-1 TNBC. These presentations can be accessed by visiting the Publications section of the Mersana website at www.mersana.com.

Expansion Update: Mersana continues to enroll patients with TNBC who have received one to four prior lines of therapy, including at least one topo-1 ADC. This stage of the trial is enrolling patients in two cohorts:

A "Dose A" cohort, in which patients are receiving 67.4 mg/m2 of Emi-Le every four weeks (Q4W), and
A "Dose B" cohort, in which patients are receiving 80 mg/m2 Q4W following a loading dose of 44.5 mg/m2 on days 1 and 8 of the first four-week cycle.
Collectively, more than 45 patients with TNBC have been enrolled across the two cohorts. Mersana plans to report initial clinical data from the expansion portion of its Phase 1 clinical trial in the second half of 2025.

XMT-2056
The dose escalation portion of Mersana’s Phase 1 clinical trial of XMT-2056, the company’s lead Immunosynthen ADC candidate targeting a novel HER2 epitope, is ongoing. Additionally, in July 2025, Mersana achieved a $15 million development milestone under its agreement with GSK plc, which has an exclusive global license option to co-develop and commercialize XMT-2056. Payment of the milestone is due in the third quarter of 2025. Mersana expects to present initial clinical pharmacodynamic STING activation data for XMT-2056 in the second half of 2025.

Collaborations
Mersana continues to support its collaborations with both Johnson & Johnson (Dolasynthen research collaboration) and Merck KGaA, Darmstadt, Germany (Immunosynthen research collaboration).

Reverse Stock Split
A 1-for-25 reverse stock split of the issued and outstanding shares of Mersana’s common stock (the Reverse Stock Split) became effective at 5:00 p.m. ET on July 25, 2025, and the company’s common stock began trading on a split-adjusted basis on July 28, 2025. The Reverse Stock Split reduced the number of outstanding shares of the company’s common stock from approximately 124.8 million shares to approximately 5.0 million shares. The shares outstanding and per share amounts below have been adjusted to reflect the Reverse Stock Split.

On August 11, 2025, the company received formal notification from The Nasdaq Stock Market, LLC (Nasdaq) confirming that the company has regained compliance with Nasdaq’s minimum bid price requirement. The regaining of compliance is a result of the closing bid price per share of the company’s common stock being at least $1.00 for a minimum of 10 consecutive business days prior to the August 25, 2025 compliance deadline, as described in the initial notice from Nasdaq to the company dated February 25, 2025.

Second Quarter 2025 Financial Results and Recent Updates

Net cash used in operating activities for the second quarter of 2025 was $22.6 million, which included $2.4 million in severance-related payments.

Cash and cash equivalents as of June 30, 2025 were $77.0 million.

In July 2025, Mersana made a payment of approximately $17.9 million to satisfy in full its indebtedness and obligations under the company’s previous loan and security agreement. The company continues to expect that its capital resources will be sufficient to support its current operating plan commitments into mid-2026.
Collaboration revenue for the second quarter of 2025 was $3.1 million, compared to $2.3 million for the same period in 2024. The year-over-year change was primarily related to increased revenue recognized under the company’s collaboration and license agreements with Johnson & Johnson and Merck KGaA, Darmstadt, Germany, partially offset by reduced revenue recognized under its agreement with GSK.

Research and development (R&D) expense for the second quarter of 2025 was $16.2 million, compared to $17.2 million for the same period in 2024. Included in the second quarter of 2025 R&D expense was $0.9 million in non-cash stock-based compensation expense. The year-over-year change in R&D expense was primarily related to lower headcount and related employee compensation costs, partially offset by an increase in costs related to Emi-Le and XMT- 2056 clinical development activities and manufacturing activities associated with the company’s collaborations.
General and administrative (G&A) expense for the second quarter of 2025 was $7.4 million, compared to $10.5 million during the same period in 2024. Included in the second quarter of 2025 G&A expense was $1.1 million in non-cash stock-based compensation expenses. The year-over-year change in G&A expense was primarily related to lower headcount and related employee compensation costs and a reduction in consulting and professional services fees.
Mersana incurred $3.9 million in restructuring expenses for the second quarter of 2025 related primarily to severance and benefit payments, outplacement services and related expenses.

Net loss for the second quarter of 2025 was $24.3 million, or $4.87 per share, compared to a net loss of $24.3 million, or $4.96 per share, for the same period in 2024.

Conference Call Reminder

Mersana will host a conference call today at 8:00 a.m. ET to discuss business updates and its financial results for the second quarter of 2025. To access the call, please dial 833-255-2826 (domestic) or 412-317-0689 (international). A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for approximately 90 days.