1stOncology™: Cancer Intelligence Service – Page 61 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Pheast Therapeutics to Host Educational KOL Webinar on Emerging Role of Macrophage Checkpoint Biology for the Treatment of Solid Tumors

On August 3, 2026 Pheast Therapeutics, a clinical-stage biotechnology company advancing next-generation macrophage-directed immunotherapies for cancer, reported it will host an educational webinar on Monday, August 10, 2026 from 12:00 p.m. – 2:00 p.m. ET. The webinar will focus on the emerging role of macrophage checkpoint biology for the treatment of solid tumors as well as Pheast’s lead program, PHST001, a novel, high-affinity IgG4 anti-CD24 monoclonal antibody currently in Phase 1 clinical development for multiple solid tumor types, including ovarian cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The webinar will feature participation from key opinion leaders (KOLs) in cancer immunotherapy:

Aurélien Marabelle, M.D., Ph.D., Professor of Clinical Immunology, University of Paris Saclay; Senior Medical Oncologist in the Drug Development Department (DITEР) at Gustave Roussy Cancer Center; and Head of the Laboratory for Translational Immunotherapy Research (LRTI)
Thomas Marron, M.D., Ph.D., Professor of Immunology and Immunotherapy at the Icahn School of Medicine at Mount Sinai and Associate Director for Translational Research at Tisch Cancer Center
Please click here to register for the live webinar. A replay of the webinar will also be made available under the Presentations section of the Pheast Therapeutics website following the live event.

About PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor designed to overcome immune suppression in the tumor microenvironment. CD24 is highly expressed across many cancers, where high expression is associated with poor prognosis. Pheast has engineered PHST001 to be a potential best-in-class antibody designed to induce macrophages to phagocytose cancer cells and initiate a powerful immune response. PHST001-101 is an open-label, multicenter Phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT06840886) evaluating safety, tolerability, and dose optimization, with secondary objectives assessing pharmacokinetics and preliminary anti-tumor activity. PHST001 received FDA Fast Track Designation for the treatment of ovarian cancer in June 2025.

(Press release, Pheast Therapeutics, AUG 3, 2026, View Source [SID1234669624])

Pathos AI Enters Global Licensing Agreement with Alphamab Oncology on JSKN016, a First-in-Class TROP2/HER3 Bispecific ADC

On August 3, 2026 Pathos AI, a clinical-stage AI and technology company advancing its own pipeline of cancer therapies, reported a licensing agreement with Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Alphamab"), a wholly-owned subsidiary of Alphamab Oncology (Stock Code: 9966.HK), on JSKN016, a first-in-class (FIC) TROP2/HER3 bispecific antibody-drug conjugate (ADC) independently developed by Alphamab.

Pursuant to the licensing agreement, Alphamab granted Pathos an exclusive license to research, develop, manufacture and commercialize JSKN016 in territories outside the Chinese Mainland, Hong Kong, Macau and Taiwan, with Pathos bearing all related development and commercialization costs and expenses under the agreement. Alphamab retains its full and exclusive rights to develop, manufacture and commercialize JSKN016 in the Chinese Mainland, Hong Kong, Macau and Taiwan.

Under the terms of the agreement, Alphamab is entitled to receive a non-refundable upfront payment of US$125 million and milestone payments based on the achievement of certain development and commercialization milestones, totaling up to US$2,093 million, as well as tiered royalties at high-single digit to low-double digit percentage rates according to aggregate annual net sales in the licensed territories.

Accelerated by AI: The Foundry Advantage

JSKN016 was identified and prioritized through Foundry, Pathos’s proprietary AI-driven decision platform for oncology drug development. Foundry utilizes thousands of AI agents working in parallel, powered by the Pathos’ proprietary AI models, to analyze biological, clinical, and real-world data at scale; surfacing high-potential assets, designing clinical trials, and matching the right patients to the right therapies faster and more safely than traditional methods allow.

Every major asset-level decision at Pathos flows through Foundry. JSKN016 becomes the fourth clinical-stage program advanced into the Pathos pipeline through the platform.

"JSKN016 is a next-generation bispecific ADC with the potential to address significant unmet need across a range of solid tumors, and we are excited to advance it in partnership with Alphamab. This program was identified through Foundry, the same platform that continues to guide portfolio decisions across our clinical pipeline. This collaboration reflects our shared commitment to bringing differentiated therapies to patients."

— Iker Huerga, CEO of Pathos AI

"JSKN016 represents the best of our next-generation bispecific ADC platform, and we are excited to partner with Pathos. With Pathos’s leading capabilities in AI-driven precision development, we are confident this collaboration will accelerate the global clinical advancement of JSKN016 and bring a potential breakthrough therapy to more patients with solid tumors. This partnership reflects our shared commitment to delivering differentiated innovation to patients worldwide."

— Dr. Ting Xu, Chairman and CEO of Alphamab Oncology

A Growing Mission to Transform Oncology

The addition of JSKN016 expands Pathos’s clinical pipeline to four assets across multiple solid tumor indications. JSKN016, a TROP2/HER3 bispecific ADC, joins pocenbrodib, currently in development for metastatic castration-resistant prostate cancer (mCRPC) and relapsed/refractory multiple myeloma (RRMM); DO-2, for MET-altered non-small-cell lung cancer (NSCLC); and AZD4241, an ERα PROTAC for ER+/HER2- breast cancer being advanced under a collaboration with AstraZeneca. Every program in the Pathos pipeline has been identified, evaluated, or accelerated by the Foundry platform, reinforcing the company’s commitment to AI-native drug development.

About JSKN016

JSKN016 is a TROP2/HER3 targeting bispecific ADC developed using the proprietary single-domain antibody and bispecific antibody platforms. It is conjugated via site-specific glycosylation to generate a homogeneous and stable ADC with a drug-to-antibody ratio (DAR) of 4. JSKN016 binds to TROP2 and/or HER3 on tumor cells, blocks the corresponding signaling pathways and releases topoisomerase I inhibitors through cellular endocytosis, exerting anti-tumor effects.

JSKN016 has demonstrated superior efficacy and a favorable safety profile across multiple solid tumors. Multiple clinical studies of JSKN016 as monotherapy and in combination therapies for lung cancer, breast cancer, and other indications have been initiated. The Phase III clinical study evaluating JSKN016 for the treatment of triple-negative breast cancer (TNBC) is currently ongoing. The Phase Ib clinical study in China and the Phase I clinical study in Australia of the subcutaneous formulation of JSKN016 are both ongoing.

(Press release, Pathos AI, AUG 3, 2026, View Source [SID1234669623])

Pathos AI Enters Collaboration and Co-Exclusive Licensing Agreement to Advance Novel ERα PROTAC for ER+ Breast Cancer into the Clinic

On August 3, 2026 Pathos AI, a clinical-stage AI and technology company advancing its own pipeline of cancer therapies, reported a collaboration and co-exclusive licensing agreement with AstraZeneca. Under this agreement, the companies will advance AZD4241, a preclinical investigational therapy for patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer, with Pathos assuming responsibility for the early clinical development of the asset.

AZD4241 is an investigational oral therapy known as a PROTAC (proteolysis-targeting chimera), specifically designed to degrade the estrogen receptor, targeting both normal and mutated forms of the receptor. Mutated forms of the estrogen receptor are present in up to 30-40% of patients whose disease progresses on standard hormone therapies.

Translating the full potential of this mechanism into patient benefit requires a fundamentally different approach. By harnessing large-scale multimodal patient data and a proprietary AI platform, Pathos redesigns drug development end-to-end. The company’s capabilities span early asset identification, data driven portfolio optimization, and AI-native trial monitoring, with the specific early clinical execution for AZD4241 driven directly by its Foundry platform.

Accelerated by AI: The Foundry Advantage

In complex indications like ER+ breast cancer, identifying the exact patient subpopulation, optimal dose, and ideal treatment setting is a massive data challenge. Foundry was built to solve this problem.

Foundry utilizes thousands of AI agents working in parallel, powered by the Pathos Oncology Foundation Model. These agents analyze complex biological, clinical, and real-world data to intelligently design clinical trials, optimize dosing, and match the right patients to the right therapies faster and more safely than traditional methods allow.

"The bottleneck in oncology is not finding molecules. It is proving they work in the right patients. AZD4241 has a compelling mechanism. Foundry’s job is to design the trial that proves it — matching this drug to the patients whose biology demands it. That is how we compress time. Patients are waiting."
— Iker Huerga, CEO of Pathos AI

A Growing Mission to Transform Oncology

This collaboration and co-exclusive licence agreement to bring AZD4241 into the clinic expands Pathos’ clinical pipeline to three major assets across four distinct tumor types. AZD4241, targeting ER+/HER2- breast cancer, joins pocenbrodib, currently in development for metastatic castration-resistant prostate cancer (mCRPC) and relapsed/refractory multiple myeloma (RRMM), and DO-2 for MET-altered non-small-cell lung cancer (NSCLC). Every program in the Pathos pipeline has been identified, evaluated, or accelerated by the Foundry platform, reinforcing the company’s commitment to AI-native drug development.

(Press release, Pathos AI, AUG 3, 2026, View Source [SID1234669622])

Compugen Reports Second Quarter 2026 Results

On August 3, 2026 Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational drug target discovery powered by AI/ML, reported financial results for the second quarter of 2026 and provided a corporate update.

"Q2 2026 reflects continued execution across the business," said Eran Ophir, Ph.D., President and CEO of Compugen. "Our MAIA-ovarian trial in platinum-sensitive ovarian cancer remains on track for the interim analysis with median progression-free survival data expected by the first quarter of 2027, which would mark a potential inflection point for COM701 in a patient population with a significant unmet need. Our partnered programs also advanced during the quarter, with AstraZeneca initiating an additional Phase 3 trial with rilvegostomig and presenting new rilvegostomig data at ASCO (Free ASCO Whitepaper) 2026, and the Gilead-partnered GS-0321 Phase 1 trial progressing as planned. With cash runway expected into 2029, we believe we are well positioned to advance our immuno-oncology pipeline."

COM701

Compugen continues to advance MAIA-ovarian, its sponsored, randomized, placebo-controlled adaptive platform trial evaluating COM701, a potential first-in-class anti-PVRIG antibody, as maintenance monotherapy in patients with second- and third-line relapsed platinum-sensitive ovarian cancer, a setting with no approved treatment option. The Company anticipates the interim analysis with median progression-free survival data by the first quarter of 2027.

During the quarter, Compugen presented a trial-in-progress poster on MAIA-ovarian at the ESMO (Free ESMO Whitepaper) Gynaecological Cancers Congress in Copenhagen. The poster underscored the strong biological and clinical rationale for evaluating COM701 in this population, including the differentiated biology of the PVRIG pathway versus other checkpoints such as PD-1 and TIGIT, its high expression in ovarian cancer, and the durable responses previously observed with COM701 as mono- and combination therapy in heavily pre-treated platinum-resistant patients. The Company believes that clear prolongation of PFS in these patients versus placebo could inform a registration path for COM701 and establish it as a potential backbone for drug combinations. Clinically meaningful success could also enable a broader clinical development plan across earlier and later lines of ovarian cancer and other indications where clinical signals were previously observed.

Rilvegostomig

Rilvegostomig is a PD-1/TIGIT bispecific antibody being advanced by Compugen’s partner AstraZeneca, the TIGIT component of which is derived from Compugen’s fully owned COM902 program. At the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, AstraZeneca presented an updated analysis from the GEMINI-Hepatobiliary study of rilvegostomig in combination with chemotherapy in the first-line setting. This was the first overall survival readout for rilvegostomig, with median overall survival of 16.8 months, versus less than 13 months in historical first-line biliary tract cancer trials. The data showed encouraging efficacy together with a manageable safety profile in a setting of high unmet need, while longer follow-up and randomized data from the ongoing Phase 3 trial will ultimately be needed to validate these findings. AstraZeneca continues to advance rilvegostomig across its broad late-stage program in 12 ongoing Phase 3 trials, including the recently initiated trial of rilvegostomig in combination with Datroway in urothelial carcinoma.

GS-0321

GS-0321, formerly known as COM503, is a potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead that represents a novel antibody approach to harness cytokine biology for the treatment of cancer, potentially overcoming the limitations of direct cytokine administration. The ongoing Phase 1 dose-escalation trial continues to progress as planned.

Early Pipeline

Compugen continues to leverage Unigen, its AI/ML-powered computational discovery platform, to identify novel drug targets and biological pathways grounded in human disease biology. Unigen has already discovered the targets of COM701, COM902, and GS-0321 and we remain committed to identifying and advancing the next generation of immuno-oncology innovation.

Second Quarter 2026 Financial Highlights

Cash: As of June 30, 2026, Compugen had approximately $125.3 million in cash, cash equivalents, short-term bank deposits, and investment in marketable securities. Compugen expects that its cash and cash-related balances will be sufficient to fund its operating plans into 2029. This does not include any additional cash inflows. The Company has no debt.
Revenues for the second quarter of 2026 were approximately $2.6 million, compared to approximately $1.3 million for the comparable period in 2025. Revenues in the second quarters of 2026 and 2025 reflect the recognition of portions of both the upfront payment and the IND milestone payment from the license agreement with Gilead.
R&D expenses for the second quarter of 2026 were approximately $6.3 million, compared to approximately $5.6 million in the second quarter of 2025.
G&A expenses for the second quarter of 2026 were approximately $2.3 million, compared to approximately $2.2 million in the second quarter of 2025.
Net loss for the second quarter of 2026 was approximately $7.0 million, or $0.07 per basic and diluted share, compared to a net loss of approximately $7.3 million, or $0.08 per basic and diluted share, in the second quarter of 2025.
Full financial tables are included below.

Conference Call and Webcast Information

The Company will hold a conference call today, August 3, 2026, at 8:30 AM ET to review its second quarter 2026 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

(Press release, Compugen, AUG 3, 2026, View Source [SID1234669621])

Lilly’s olomorasib receives U.S. FDA’s Breakthrough Therapy designation for the treatment of previously treated KRAS G12C-mutant advanced pancreatic cancer

On August 3, 2026 Eli Lilly and Company (NYSE: LLY) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib as a monotherapy for the treatment of adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and have a KRAS G12C mutation, as determined by an FDA-approved test. Olomorasib is an investigational, potent and highly selective next-generation inhibitor of KRAS G12C. Olomorasib was previously granted Breakthrough Therapy designation, in combination with anti-PD-1 therapy KEYTRUDA (pembrolizumab), for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression ≥ 50%, as determined by FDA approved tests.

Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicate that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval.

Pancreatic cancer is diagnosed in approximately 60,000 people in the United States each year, with an estimated 50,000 deaths projected annually.1 Outcomes for patients with metastatic pancreatic cancer are typically poor, with a five-year survival rate under 5%.2 Growing evidence suggests outcomes for patients with KRAS G12C-mutant pancreatic cancer are worse than those without the mutation, underscoring a persistent gap in treatment and an opportunity to address a significant unmet need.3 There currently are no approved therapies that specifically target KRAS G12C-mutant pancreatic cancer.

"Pancreatic cancer has historically been one of the most difficult-to-treat cancers and people whose tumors harbor a KRAS G12C mutation face limited options once their disease progresses," said Jacob Van Naarden, executive vice president, and president of Lilly Oncology. "This Breakthrough Therapy designation reflects the early potential we’re seeing with olomorasib in this setting and the critical need for new treatment options. With now two Breakthrough Therapy designations across pancreatic and lung cancers, olomorasib continues to demonstrate broad potential clinical evidence across KRAS G12C-driven tumors and reflects our commitment to bringing meaningful new treatment options to patients living with these cancers."

The FDA Breakthrough Therapy designation is based on encouraging preliminary results from the open-label, multicenter, Phase 1/2 LOXO-RAS-20001 study (NCT04956640) of olomorasib in patients with KRAS G12C-mutant, advanced solid tumors, including those with advanced pancreatic cancer who have received at least one prior systemic therapy.

Lilly is studying olomorasib in KRAS G12C-mutant cancers in multiple studies. Details on the trials can be found by visiting clinicaltrials.gov.

About LOXO-RAS-20001
LOXO-RAS-20001 is an open-label, multicenter, Phase 1/2 study evaluating the safety, tolerability and preliminary efficacy of olomorasib in patients with KRAS G12C-mutant advanced solid tumors (NCT04956640). The study includes a Phase 1a dose escalation phase of olomorasib monotherapy in KRAS G12C-mutant solid tumors and a Phase 1b dose expansion and optimization phase which are evaluating olomorasib as a monotherapy and in combination with other treatments.

About Olomorasib
Olomorasib (LY3537982) is an investigational, oral, potent, and highly selective next-generation inhibitor of the KRAS G12C protein. KRAS mutations account for approximately 85% of RAS-associated cancers in humans, including about 90% of pancreatic cancers, and KRAS G12C mutations occur in approximately 1% to 2% of patients with pancreatic cancer.4,5 Olomorasib was specifically designed to target KRAS G12C and has pharmacokinetic properties which allow for high predicted target occupancy and high potency when used as monotherapy or in combination.6

Olomorasib is currently being studied in the LOXO-RAS-20001 Phase 1/2 trial (NCT04956640) in patients with KRAS G12C-mutant NSCLC and other advanced solid tumors and in the pivotal, registrational SUNRAY-01 global study (NCT06119581) investigating olomorasib in combination with pembrolizumab with or without chemotherapy for first-line treatment of KRAS G12C-mutant advanced NSCLC, and the SUNRAY-02 (NCT06890598) global study investigating olomorasib in combination with standard of care immunotherapy in patients with resected or unresectable KRAS G12C-mutant NSCLC. For additional information about olomorasib clinical trials, please refer to clinicaltrials.gov.

(Press release, Eli Lilly, AUG 3, 2026, View Source [SID1234669620])