On August 11, 2026 Laekna (2105.HK) reported that the New Drug Application (NDA) for LAE002 (afuresertib) has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer (LA/mBC) with PIK3CA/AKT1/PTEN alterations, following recurrence or progression on or after endocrine therapy(-ies) (with or without a CDK4/6 inhibitor).

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The NDA is supported by positive results from the Phase III Clinical Trial (AFFIRM-205) conducted in the aforementioned patient population. This pivotal study successfully met its primary endpoint of progression-free survival (PFS), demonstrating a highly statistically significant and clinically meaningful improvement over the control arm. LAE002 (afuresertib) also showed a favorable safety and tolerability profile. The detailed study results will be presented at an upcoming international scientific conference. We are collaborating with our strategic partner, Qilu Pharmaceutical, to expedite the regulatory approval and commercialization of LAE002 (afuresertib) in China.

"The NDA submission for LAE002 would not have been possible without the trust and support of every investigator, study participant, and partner. It is the result of the unwavering dedication and perseverance of the Laekna team over the years," said Dr. Chris Lu, Chairman and CEO of Laekna. "As a potential Class I novel drug for breast cancer and the first domestically developed AKT inhibitor in China, the clinical results of LAE002 (afuresertib) have demonstrated a best-in-class efficacy and safety profile. We look forward to its approval and commercial launch as soon as possible, bringing hope to patients and families affected by advanced breast cancer, and offering clinicians a novel therapeutic option."

Dr. Chris Lu further noted that, beyond breast cancer, the clinical development of LAE002 (afuresertib) for prostate cancer is also advancing rapidly. Laekna is actively pursuing strategic partnerships in ex-China regions to accelerate development and commercialization of LAE002 (afuresertib) in international markets, aiming to bring benefits to more patients overseas as soon as possible. He emphasized, "LAE002 (afuresertib) marks the first breakthrough of our innovative pipeline, as well as a significant milestone in our transition to the commercial stage. Across major therapeutic areas, including metabolic diseases and oncology, we will continue to develop innovative drugs that offer significant clinical value and global competitiveness, bringing greater benefits to patients and shareholders".

Laekna and Qilu Pharmaceutical entered into an exclusive licensing agreement for the China region in November 2025. Under the License Agreement, Laekna is eligible to receive up to RMB2,045 million in total in upfront and milestone payments and is also entitled to receive tiered royalties on future net sales of LAE002 (afuresertib) in the licensed territory, at percentages ranging from the low teens to the low twenties. Laekna plans to pursue strategic partnerships in ex-China regions to accelerate development and commercialization of LAE002 (afuresertib) in international markets.

About AKT Inhibitor

Capivasertib (Truqap‌) was the first approved AKT inhibitor from AstraZeneca, which was approved by the U.S. FDA for HR+/HER2- breast cancer in November 2023. In June 2026, the U.S. FDA further approved capivasertib (Truqap) in combination with abiraterone and prednisone for the treatment of PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC). This approval significantly broadens the therapeutic scope of AKT inhibition and highlights its potential to address unmet needs across multiple tumor types.

LAE002 (afuresertib) is a potent AKT inhibitor internally developed by Laekna that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3). It is one of the two most advanced AKT inhibitors globally in development for breast and prostate cancer. The Phase III clinical trial (AFFIRM-205), a multi-center, randomized, double-blind, placebo-controlled pivotal study, has met its primary endpoint of progression-free survival. It showed statistically significant and clinically meaningful benefits to patients with HR+/HER2- breast cancer and demonstrated a best-in-class efficacy and safety profile.

About Breast Cancer

Breast cancer has become the leading cause of death for women globally, with approximately 2.43 million new cases diagnosed each year and around 694,000 lives lost to the disease. In China, breast cancer ranks the second most common cancer among women, with approximately 70% of the patients found to be HR+/HER2-*.

Collectively, genetic alterations in PIK3CA, AKT1 and PTEN affect approximately 50% of patients with breast cancer. Although most patients with this subtype of breast cancer can initially benefit from first/second-line treatment by endocrine therapy + CDK4/6 inhibitors and/or chemotherapy, they may gradually develop drug resistance and result in treatment failure. Novel therapeutic options are urgently needed for patients after drug resistance. As an innovative therapy for drug-resistant patients with this subtype of breast cancer, AKT inhibitors offer new hope for them and their families.

(Press release, Laekna Therapeutics, AUG 11, 2026, View Source [SID1234669967])

On August 11, 2026 Oncoinvent, a biotech company developing a receptor-independent alpha radiopharmaceutical to eradicate cancer cells in the abdominal cavity after surgery with a single, targeted dose, reported the publication of clinical dosimetry data for Radspherin in the Journal of Nuclear Medicine, one of the leading peer-reviewed journals in the field.

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The publication, titled ‘Normal Tissue Dosimetry of Intraperitoneal Radium-224-Microparticle Therapy: Data from First-in-Human Studies in Patients with Peritoneal Metastases’, reports results from nine patients enrolled in the dosimetry cohorts of the Phase 1 Radspherin studies in ovarian and colorectal cancer. Positive final data from these studies, previously reported by Oncoinvent, demonstrated a favorable safety profile and encouraging efficacy signals.

"In early-phase clinical studies, dosimetry is essential to understand how radiation exposure relates to potential toxicity and identify potential dose-limiting tissues," said Caroline Stokke, senior author of the publication, Head of Nuclear Medicine Physics at Oslo University Hospital and Chair of the European Association of Nuclear Medicine Dosimetry Committee. "This work also reflects the methodological complexity of dosimetry for alpha therapies, where imaging cannot always be directly applied. To address these challenges, we were able to use a combination approach, also including blood sampling and biokinetic modeling, to estimate normal tissue radiation exposure and provide a basis for evaluating safety."

The dosimetry study, conducted at The Norwegian Radium Hospital, part of Oslo University Hospital, evaluated how radiation from Radspherin is distributed to normal tissues following treatment. Results showed that absorbed radiation doses to normal organs were below levels commonly associated with risks for complications, including for organs typically regarded as activity-limiting such as the kidneys and red bone marrow.

"We are pleased to report the results from the outstanding work performed together with Oslo University Hospital published in the prestigious Journal of Nuclear Medicine," said Kari Myren, Chief Medical Officer at Oncoinvent. "Unintended radiation exposure to normal organs, especially for the kidneys and red bone marrow, frequently represents a limitation for obtaining therapeutic doses of radiopharmaceuticals. Our results indicate very low radiation exposure to healthy organs after treatment, which is consistent with the favorable safety profile observed in our clinical trials and supports the further development of Radspherin to provide hope for patients for whom very limited treatment options exist."

(Press release, Oncoinvent, AUG 11, 2026, View Source [SID1234669966])

On August 11, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage biotechnology company developing immuno-oncology therapeutics based on its proprietary INTASYL gene-silencing technology, reported the receipt of a U.S. Notice of Allowance for a patent covering PH-894, further strengthening the Company’s intellectual property portfolio.

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The patent allowance represents a critical milestone in protecting Phio’s strategic interest in the Company’s INTASYL platform. PH-894, designed to selectively silence BRD4, is a key regulator of gene expression associated with proliferative and infectious disease.

"Robust intellectual property protection is a continuous focus in our development strategy to advance novel immuno-oncology therapies and maximize the long-term value of the INTASYL platform," said Robert Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals. "This patent advancement solidifies our commitment to advance PH-894 in the U.S. and pursue strategic collaborations internationally."

Phio has built a comprehensive patent estate supporting its INTASYL technology and therapeutic pipeline. The Company’s portfolio currently includes 54 issued patents covering INTASYL chemistry, specific gene targets, immuno-oncology compounds, and therapeutic applications across major global markets.

The newly allowed patent further reinforces Phio’s commitment to protecting its proprietary innovations and advancing next-generation cancer therapies based on targeted gene silencing.

(Press release, Phio Pharmaceuticals, AUG 11, 2026, View Source [SID1234669965])

On August 11, 2026 Theriva Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

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"We have successfully converted last quarter’s regulatory achievements into clinical progress in the VCN-01 program," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Dosing of the first patients in the VIRAGE2 trial brings us closer to refining a VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial in first-line metastatic PDAC patients when coadministered with chemotherapy. A repeated VCN-01 dosing regimen may also improve outcomes when combined with other cancer interventions, including immuno-oncology products, RAS inhibitors, and other emerging classes of cancer treatments. If more frequent repeated administration of VCN-01 is feasible and well-tolerated, use of this dosing regimen may further derisk future Phase 3 clinical trials."

Recent Highlights and Anticipated Milestones

VCN-01

Metastatic PDAC:

As recently announced, the first patients have been dosed in the VIRAGE2 Phase 2a clinical trial entitled "A Phase IIa, single-arm, single-center, open-label, proof-of-concept trial evaluating increased frequency dosing of zabilugene almadenorepvec (VCN-01) in combination with gemcitabine/nab-paclitaxel in patients with newly-diagnosed metastatic pancreatic cancer" (EUCT: 2026-525566-21-00; NCT07701486).
The VIRAGE2 study design incorporates feedback from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) recognizing improved survival outcomes in the VIRAGE Phase 2b trial in metastatic PDAC patients treated with 2 doses of VCN-01 (in combination with standard-of-care chemotherapy), highlighting the possibility that more frequent repeated dosing of VCN-01 may provide additional clinical benefit.
The VIRAGE2 trial will evaluate the safety and feasibility of administering at least 3 doses of VCN-01 given approximately 2 months apart in combination with standard-of-care chemotherapy. The trial is expected to enroll 6 evaluable patients. Results from the VIRAGE2 study will inform the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial.
VIRAGE2 is expected to complete enrollment during the second half of 2026, and initial pharmacodynamic and safety/tolerability data are anticipated by Q3 2027.
Retinoblastoma:

Undertook extensive discussions with key opinion leaders and completed the design of a proposed Phase 2/3 clinical trial of intravitreal VCN-01 in combination with intravitreal topotecan in children with retinoblastoma with vitreous seeds that are refractory/resistant to the use of current intravitreal chemotherapy.
Proposed clinical trial protocol builds on compelling Phase 1 clinical data in this ultra rare population for which there is no current treatment.
Plan to discuss the proposed clinical trial protocol with the FDA in Q3 2026.
VCN-01 has Orphan Drug Designation from both the FDA and EMA and Rare Pediatric Disease Designation from the FDA for the treatment of retinoblastoma; if a Biologics License Application (BLA) for VCN-01 for the treatment of retinoblastoma is approved by the FDA by September 30, 2029, the Company may be eligible to receive a Priority Review Voucher.
Head & Neck Squamous Cell Carcinoma:

Clinical and translational results from the Phase 1 clinical trial of VCN-01 in refractory or metastatic head & neck squamous cell carcinoma (HNSCC) patients (whose disease progressed despite previous therapies, including anti-PD-(L)1 immune checkpoint inhibitors) were published in the journal Clinical Cancer Research in an online first article titled "Phase I trial of intravenous VCN-01 oncolytic adenovirus and durvalumab in patients with head and neck metastatic squamous cell carcinoma refractory to immunotherapy".
In the Phase 1 trial, prolonged overall survival (OS) was observed in these heavily pre-treated refractory HNSCC patients administered intravenous VCN-01 prior to the immune checkpoint inhibitor durvalumab (sequential delivery).
Pharmacokinetic, tissue biopsy, radiomic and transcriptomic results all support the proposed VCN-01 stroma-degrading and immune enhancing modes-of-action, resensitizing refractory tumors to durvalumab.
These findings support further clinical development of VCN-01 with immune checkpoint inhibitors or other immune modulating anticancer therapies in HNSCC and potentially other cancer indications.
Second Quarter Ended June 30, 2026 Financial Results

General and Administrative Expenses

General and administrative expenses decreased to $2.0 million for the three months ended June 30, 2026, from $11.2 million for the three months ended June 30, 2025. This decrease of 82% is primarily comprised of the prior year increase in fair value of the contingent consideration adjustment of $9.2 million due to the VIRAGE Phase 2b clinical trial of VCN-01 in PDAC achieving its primary survival and safety endpoints, offset set by current year increase in legal fees. The charge related to stock-based compensation expense was $110,000 for the three months ended June 30, 2026, compared to $97,000 for the three months ended June 30, 2025.

Research and Development Expenses

Research and development expenses decreased to $1.3 million for the three months ended June 30, 2026, from $2.0 million for the three months ended June 30, 2025. This decrease of 35% is primarily the result of lower indirect cost related to compensation expense and lower direct clinical trial expenses related to the Company’s Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients and lower expenses related to SYN-020, offset by higher direct expenses related to VCN-01 manufacturing activities and expenses associated with the planning for the Phase 2a study in metastatic PDAC patients evaluating more frequent VCN-01 dosing for a longer period.

Other Income/Expense

Other income was $78,000 for the three months ended June 30, 2026, compared to other income of $74,000 for the three months ended June 30, 2025. Other income for the three months ended June 30, 2026 is comprised of interest income of $79,000 and an exchange loss of $1,000. Other income for the three months ended June 30, 2025 is comprised of interest income of $54,000 and an exchange gain of $20,000.

Cash and Cash Equivalents

Cash and cash equivalents totaled $11.3 million as of June 30, 2026, a decrease of $1.7 million from December 31, 2025. During the year ended December 31, 2025 and the quarter ended June 30, 2026, the primary use of cash was for working capital requirements and operating activities, which resulted in a net loss of $23.7 million and $5.3 million for the year ended December 31, 2025 and the six months ended June 30, 2026, respectively.

(Press release, Theriva Biologics, AUG 11, 2026, View Source [SID1234669964])

On August 11, 2026 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported that Gilead Sciences, Inc. has exercised its option to obtain an exclusive license for a preclinical bispecific program under the companies’ 2022 collaboration agreement. The option exercise triggers a $10 million payment to MacroGenics.

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The licensed program incorporates MacroGenics’ TRIDENT platform and is directed against two undisclosed targets for the treatment of solid tumors. Under the 2022 collaboration agreement, MacroGenics and Gilead Sciences are advancing three programs: MGD024, a clinical-stage CD123 × CD3 bispecific DART molecule, and two preclinical bispecific programs.

MacroGenics remains eligible to receive up to approximately $1.6 billion in additional development, regulatory and commercial milestone payments across the collaboration, as well as royalties on worldwide net sales of products resulting from the programs.

(Press release, MacroGenics, AUG 11, 2026, View Source [SID1234669963])