On August 5, 2026 Acrivon Therapeutics, Inc. ("Acrivon" or "Acrivon Therapeutics") (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform deployed for rational drug design and predictive clinical development, reported that ACR-2316 has advanced into the randomized dose expansion portion of its ongoing Phase 1/2 study. The advancement is supported by the differentiated favorable safety profile and clinical activity observed during dose escalation, including tumor shrinkage and partial responses (PRs) with durable clinical benefit in multiple subjects. Acrivon has selected 120 mg and 160 mg administered orally once daily (QD) on a 3d on/4d off weekly schedule for further dose optimization and final dose selection.

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"Advancing ACR-2316 into dose expansion is an important milestone for Acrivon, and the exciting initial clinical activity observed represents further clinical validation of our AP3 platform," said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. "We rationally designed ACR-2316 using AP3 to overcome the resistance mechanisms that limit efficacy of single-target WEE1 and PKMYT1 inhibition, hence enabling potent tumor cell death. We are highly encouraged by the durable single-agent activity, including tumor shrinkage and PRs, and clinical benefit observed for more than a year in multiple heavily pretreated subjects with lung cancer. These data support our belief that ACR-2316 has the potential to become an important therapy across multiple high unmet need patient populations."

"ACR-2316 has demonstrated a favorable safety profile in dose escalation, with adverse events limited primarily to transient, mechanism-based hematological events, mainly neutropenia, and a notable absence of non-hematological adverse events," said Mansoor Raza Mirza, M.D., chief medical officer of Acrivon. "This promising differentiated safety profile and initial clinical activity support its rapid advancement into a randomized expansion phase, to establish the dose with the optimal benefit-risk profile to carry into subsequent development."

ACR-2316 Dose Escalation Data and Observations To Date

Two weekly (3d on / 4d off QD and 2d on / 5d off QD) oral dosing regimens have been established, while a bi-weekly (3d on / 11d off QD) oral dosing regimen was evaluated, but deprioritized.
A total of 35 subjects received ACR-2316 across 6 dose levels ranging from 30 to 240 mg QD in the two weekly oral dosing schedules.
Amongst the subjects treated with ACR-2316 at ≥120 mg QD in the weekly schedules, tumor shrinkage with long-lasting clinical benefit were observed across multiple tumor types, including PRs in lung cancer and endometrial cancer.
In the 7 efficacy-evaluable subjects (median 3 prior lines of systemic therapy) with SCLC, sqNSCLC, and adNSCLC, AP3-predicted tumor types not previously shown to be sensitive to clinical single agent WEE1 or PKMYT1 inhibitors, a disease control rate of 86% (2 PRs, 4 SD, and 1 PD) was observed.
Ongoing durable clinical benefit observed in 3 heavily pretreated lung cancer subjects remaining on treatment for over one year.
In the selected 3d on / 4d off dosing regimen, the 120 mg QD and 160 mg QD doses were well tolerated, with a favorable, differentiated safety profile; no grade ≥4 treatment-related adverse events (TRAEs) were reported, and grade 3 TRAEs were limited to primarily transient, mechanism-based hematologic events, predominantly neutropenia.
These observations support further evaluation of ACR-2316 in the selected 3d on / 4d off QD regimen in a randomized dose expansion study of AP3-informed tumor types.

The dose expansion will evaluate ACR-2316 in subjects with SCLC, sqNSCLC and adNSCLC, as well as endometrial cancer, cervical cancer, and esophago-gastric junction carcinoma, all with AP3-identified biomarker signatures associated with pathway vulnerability, including loss or mutation of TP53 or FBXW7, or overexpression or amplification of CCNE1 or CCNB1, or HPV+ in the case of cervical cancer. The expansion utilizes a 3d on / 4d off weekly administration schedule and will include stratification by lung cancer versus non-lung cancer tumor types, with 1:1 randomization within each group to the 120 mg QD or 160 mg QD dose level. The two selected doses are candidate doses for final recommended phase 2 dose selection.

The ACR-2316 dose escalation and expansion study adheres to the principles of the FDA’s Project Optimus, which emphasize dose selection based on the totality of efficacy, safety, tolerability, pharmacokinetic and pharmacodynamic data, and specifically stipulate randomized evaluation of multiple doses rather than routine selection of the maximum tolerated dose. Acrivon expects to provide further updates as the study progresses.

(Press release, Acrivon Therapeutics, AUG 5, 2026, View Source [SID1234669759])

On August 5, 2026 Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging ("TCE") bispecific antibodies for solid tumors, reported its financial results for the second quarter ended June 30, 2026, and reported on recent and upcoming business highlights.

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"During the second quarter, we advanced our pipeline and reported interim Phase 1a data from CTIM-76 in a limited number of heavily pretreated patients with platinum-resistant ovarian cancer ("PROC") receiving weekly dosing," said Martin Lehr, Chief Executive Officer of Context. "These data demonstrated encouraging interim efficacy and safety findings. We intend to evaluate CTIM-76 with every-three-week ("Q3W") dosing in less heavily pretreated PROC patients in the second half of 2026, aiming to further characterize its clinical profile in a larger and more commercially relevant dataset."

Mr. Lehr added, "We also expect to dose the first patient in our Phase 1 clinical trial evaluating CT-202 in patients with Nectin-4-positive urothelial, colorectal, and triple-negative breast cancers in the third quarter of 2026, marking an important step in the clinical advancement of our Nectin-4 x CD3 TCE program."

Recent Pipeline Progress and Upcoming Milestones of Prioritized Clinical Programs:

CTIM-76: CLDN6 x CD3 TCE

Context is evaluating CTIM-76 as a monotherapy in a Phase 1 trial in patients with PROC.

Recent Progress:

April 2026: The U.S. Food and Drug Administration granted Fast Track Designation for the treatment of PROC in patients that have received all standard of care therapies
June 2026: Presented interim Phase 1a safety, tolerability and efficacy data with weekly dosing in PROC patients
Upcoming Expected Milestones:

Q1 2027: Initiation of Phase 1b dose expansion trial
Q2 2027: Phase 1a initial safety, tolerability and efficacy data with Q3W dosing in PROC patients
CT-202: Nectin-4 x CD3 TCE

Context is evaluating CT-202 as a monotherapy in a Phase 1 trial in patients with urothelial, colorectal, and triple-negative breast cancers.

Recent Progress:

April 2026: Human Research Ethics Committee approval and Clinical Trial Notification acknowledgement by the Australian Therapeutic Goods Administration to initiate a first-in-human Phase 1 clinical trial
May 2026: Entered into a License Agreement Amendment with BioAtla, Inc. removing all future milestones and royalty obligations owed
Upcoming Expected Milestones:

3Q 2026: First patient dosed in Phase 1 trial
2H 2027: Phase 1a initial topline safety, tolerability and early efficacy data
CT-95: MSLN x CD3 TCE

As part of a portfolio prioritization and capital allocation strategy, Context is discontinuing the development of CT-95 and will focus its development efforts on CTIM-76 and CT-202.

Second Quarter 2026 Financial Results

Cash and cash equivalents were $43.0 million at June 30, 2026, compared to $66.0 million at December 31, 2025. The Company expects its cash and cash equivalents will be sufficient to fund its operations into the fourth quarter of 2027.
Research and development ("R&D") expenses were $12.5 million for the second quarter of 2026, as compared to $7.8 million for the second quarter of 2025. The increase in R&D expenses compared to the second quarter was primarily driven by higher CT-202 expense of $4.4 million and higher CTIM-76 expense of $0.8 million. The increase in CT-202 expense was primarily a result of a higher in-process research and development charge of $6.5 million related to consideration paid to amend the BioAtla license agreement for CT-202, offset by lower contract manufacturing and preclinical expenses. These increases were partially offset by lower personnel-related costs of $0.5 million.
General and administrative expenses were $2.4 million for the second quarter of 2026, as compared to $1.9 million for the second quarter of 2025. The increase was primarily driven by higher professional fees of $0.3 million and an increase of $0.2 million in salaries and personnel-related costs, including share-based compensation as compared to the same period in 2025.
Other income was $0.4 million for the second quarter of 2026, as compared to $0.9 million for the second quarter of 2025, primarily due to lower interest income earned on cash and cash equivalent balances.
Context reported a net loss of $14.6 million for the second quarter of 2026, as compared to $8.8 million for the second quarter of 2025.

(Press release, Context Therapeutics, AUG 5, 2026, View Source [SID1234669758])

On August 5, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported financial results for the second quarter ended June 30, 2026, and provided business updates.

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"At a time when first-line pancreatic cancer patients finally have treatment options, the 17.3 month median overall survival reported at ASCO (Free ASCO Whitepaper) for atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP) in our single-arm Phase 2a study stands out as potentially best-in-class. Equally important in our Phase 2a data presented at ASCO (Free ASCO Whitepaper) is that 84% of evaluable patients treated with atebimetinib + mGnP were weight stable or gained weight at three months, and only two categories of treatment related adverse events occurred at a grade 3 or higher in at least 10% of patients. In other words, debilitating side effects may not have to be a given for patients. With over 30 study locations already posted on clinicaltrials.gov, and newly published preclinical data in the peer reviewed journal Cancer Research supporting atebimetinib’s unique mechanism of action, we believe our Phase 3 MAPKeeper 301 study represents a compelling and differentiated option for first-line pancreatic cancer patients."

Recent Corporate Highlights:

Dosing patients in the Company’s pivotal Phase 3 MAPKeeper 301 trial of atebimetinib + mGnP in first-line pancreatic cancer. In June, Immuneering announced it had dosed the first patient in MAPKeeper 301, a global, randomized, open-label pivotal Phase 3 clinical trial evaluating atebimetinib + mGnP in first-line metastatic pancreatic cancer patients.

Presented compelling Phase 2a data at the ASCO (Free ASCO Whitepaper) 2026 Annual Meeting, demonstrating 17.3 month median overall survival and a favorable tolerability profile in 55 first-line pancreatic cancer patients, together with 84% of evaluable patients weight stable or gaining weight at 3 months. The Phase 2a trial is evaluating atebimetinib in combination with mGnP with results reported as of an April 24, 2026 data cutoff.

Appointed Andrew Gengos as Chief Financial Officer. In June, Immuneering announced the appointment of Andrew Gengos as Chief Financial Officer. Mr. Gengos most recently served as Chief Financial Officer and Head of Corporate Development at Terns Pharmaceuticals, which Merck & Co., Inc. acquired for $6.7 billion. Mr. Gengos will oversee financial strategy, capital allocation, investor relations, business development, and corporate development activities.

Published new findings in Cancer Research detailing atebimetinib’s broad, durable preclinical activity and favorable tolerability across RAS- and RAF-mutant tumors via Deep Cyclic Inhibition. In July, Immuneering announced the publication of an article in Cancer Research, a leading peer-reviewed journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), characterizing the differentiated mechanism and broad preclinical activity of atebimetinib. The article, "Dual-MEK Inhibitor Atebimetinib Displays Broad Activity in RAS- and RAF-Mutant Tumors via Deep Cyclic Inhibition and Resisting RAF-Bypass," reports that atebimetinib demonstrated broad antitumor activity across RAS- and RAF-mutant models while resisting RAF-mediated bypass signaling, a key mechanism associated with resistance to other MEK inhibitors. Atebimetinib’s ability to preserve body mass in a preclinical model of cancer cachexia was also highlighted in the article.

Presented Genetic Data at AACR (Free AACR Whitepaper) demonstrating mechanism to improve durability and survival, supporting use of atebimetinib in first-line pancreatic cancer and beyond. In April, Immuneering presented new genetic data in a poster presentation demonstrating a key mechanism that may improve durability and survival, supporting the use of atebimetinib as a first-line treatment in pancreatic cancer and beyond. The circulating tumor DNA (ctDNA) data from 123 atebimetinib-treated patients showed that acquired MAPK pathway alterations were rarely seen. These findings suggest that Deep Cyclic Inhibitors have the potential to overcome the limitations of conventional MAPK inhibition and provide a more sustained clinical benefit for patients, while potentially preserving sensitivity to subsequent treatments.
Anticipated Upcoming Milestones

2H 2026: Dose the first patient in Phase 2 trial of atebimetinib + anti-PD-1 (cemiplimab) in non-small cell lung cancer, with a preliminary data readout expected in late-2027.
Q4 2026: Additional preclinical data of atebimetinib in combination with anti-PD-1 in non-small cell lung cancer.
Mid-2027: Begin IND-enabling studies for our next DCI product candidate program.
Mid-2028: Topline data readout from the MAPKeeper 301 trial.
Second Quarter 2026 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2026 were $182.7 million, compared with $217.0 million as of December 31, 2025.

Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were $14.0 million, compared with $10.5 million for the second quarter of 2025. The change in R&D expenses was primarily attributable to increased clinical costs related to the Company’s lead atebimetinib program and spend related to other preclinical programs, partially offset by reduced spend related to the envometinib program.

General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2026 were $5.0 million, compared with $4.3 million for the second quarter of 2025. The increase in G&A expenses was primarily attributable to employee related costs and increased software costs supporting the general and administrative functions of the business.

Net Loss: Net loss attributable to common stockholders was $17.3 million, or $0.27 per share, for the second quarter ended June 30, 2026, compared to $14.4 million, or $0.40 per share, for the second quarter ended June 30, 2025. 

2026 Financial Guidance

Based on cash, cash equivalents and marketable securities as of June 30, 2026, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2029.

(Press release, Immuneering, AUG 5, 2026, View Source [SID1234669757])

On August 5, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that the U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug (IND) application for Bria-PROS+ and issued a Study May Proceed letter, clearing the way for clinical evaluation of Bria-PROS+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for prostate cancer.

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"We are pleased to announce FDA clearance of the IND for Bria-PROS+, our next-generation personalized immunotherapy for prostate cancer," stated Dr. William V. Williams, BriaCell’s President & CEO. "Bria-PROS+ is designed to activate multiple components of the immune system, which we believe has the potential to support meaningful therapeutic benefit with a favorable safety profile. We look forward to advancing Bria-PROS+ into the clinic as we work to develop new treatment options for patients with advanced prostate cancer."

In August 2025, BriaCell was awarded a $2 million non-dilutive grant from the US National Cancer Institute to support the manufacturing and planned clinical evaluation of Bria-PROS+.

As reported in BriaCell’s preclinical poster presentation, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, Bria-PROS+ demonstrated activation of both adaptive and innate immune responses including activation of naïve (resting) T-cells, dendritic cells and natural killer (NK) cells. BriaCell believes this multipronged immune activation may enhance clinical efficacy and help prevent immune escape in patients with prostate cancer.

BriaCell’s Bria-PROS+ builds on the Company’s oncology platform with its Bria-IMT program, currently in its Phase 3 pivotal trial for metastatic breast cancer, its Bria-OTS breast cancer clinical program, in which the first patient dosed experienced sustained complete resolution of a lung metastasis, and its Bria-BRES+ program, which recently received FDA clearance to initiate clinical evaluation of its enhanced, personalized, off-the-shelf cellular immunotherapy for breast cancer. Bria-PROS+, Bria-OTS and Bria-BRES+ programs are personalized immunotherapies, based on HLA matching between patients and the respective immunotherapy cell lines.

(Press release, BriaCell Therapeutics, AUG 5, 2026, View Source [SID1234669756])

On August 5, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that its Phase II clinical study evaluating Opamtistomig (LBL-024), a proprietary PD-L1/4-1BB bispecific antibody, in combination with bevacizumab for the treatment of first-line hepatocellular carcinoma (HCC) has successfully completed the safety run-in phase assessment following expert review and has advanced into the expansion phase. The study is led by Professor Zhou Jian, President of Zhongshan Hospital, Fudan University, and Academician of the Chinese Academy of Sciences.

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Preliminary clinical data demonstrated that Opamtistomig in combination with bevacizumab has shown encouraging anti-tumor activity and a favorable safety profile in patients with HCC, supporting further clinical evaluation in the expansion phase.

HCC represents a significant global health burden and is the fourth most common malignant tumor and the second leading cause of cancer-related mortality in China, with approximately 368,000 new cases and 317,000 deaths recorded annually. Due to its often insidious onset, fewer than 30% of patients are eligible for potentially curative treatment at diagnosis, making systemic anti-tumor therapies essential for patients with intermediate-to-advanced disease.

Currently, PD-1/PD-L1 inhibitors in combination with bevacizumab have become one of the first-line standard treatments for advanced HCC both in China and globally; however, median overall survival is only approximately 19 to 20 months, median progression-free survival is less than 7 months, and the objective response rate does not exceed 30%. These limitations highlight the urgent need for more effective and durable treatment strategies.

Opamtistomig has demonstrated promising efficacy signals and broad therapeutic potential across multiple tumor types, including extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and biliary tract cancer (BTC). Powered by the proprietary X-body platform, which enables tumor-localized activation of 4-1BB signaling, Opamtistomig has maintained a favorable safety profile across nearly 800 treated patients, further supporting its potential as a next-generation IO 2.0 pan-tumor immunotherapy platform. The encouraging clinical findings in HCC further strengthen the clinical validation of Opamtistomig’s differentiated mechanism and therapeutic potential.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: "Advancing this Phase II study of Opamtistomig in first-line HCC into expansion phase is an important milestone in validating its potential as a pan-tumor immunotherapy. While PD-1/PD-L1-based combination therapies have become the standard of care for first-line HCC, significant unmet medical needs remain. The encouraging efficacy signals observed with Opamtistomig in combination with bevacizumab provide further confidence in its potential to improve treatment outcomes for patients with HCC. We will continue to accelerate clinical development and global registration efforts to bring this innovative therapy to patients worldwide as quickly as possible."

About HCC
According to data published by the World Health Organization ("WHO"), the global annual number of new HCC cases reached 865,000 in 2022, ranking sixth among malignant tumors, with 758,000 deaths, ranking third among malignant tumors. HCC is particularly prevalent in China, where it is the fourth most common malignant tumor and the second leading cause of cancer-related deaths. Although China’s population accounts for only 18.4% of the global population, the country accounts for 368,000 new HCC cases and 317,000 deaths annually, representing 42.5% and 41.8% of the global totals, respectively.

HCC is the predominant type of primary liver cancer, accounting for approximately 85% to 90% of cases. It has an insidious onset and is highly aggressive, with most patients diagnosed at an intermediate to advanced stage and a correspondingly poor prognosis. The five-year survival rate is 15% to 19% in North America, compared with only 12.1% in China, posing a serious threat to the health and lives of the Chinese population and making the reduction of the HCC disease burden a major public health issue requiring urgent attention in China.

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

(Press release, Nanjing Leads Biolabs, AUG 5, 2026, View Source [SID1234669755])