City of Hope Researchers to Share New Immunotherapy and Precision Medicine Insights Across Cancer Types at ASCO 2026

On May 11, 2026 Researchers from City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, reported it will present 49 abstracts at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, including new findings on immunotherapy, precision medicine and emerging treatment strategies across blood cancers and solid tumors. These experts will partner with the global oncology community congregating in Chicago May 29-June 2 with the goal of shaping the future of cancer care.

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"Year after year, City of Hope researchers bring forward research that moves cancer care closer to where it needs to be — more precise, more effective and more personal for patients," said Marcel van den Brink, M.D., Ph.D., City of Hope chief physician executive. "Our strong presence at ASCO (Free ASCO Whitepaper) 2026 reflects the depth and breadth of City of Hope’s scientific leadership and our commitment to translating discovery into real progress for people facing cancer."

City of Hope’s robust presence at ASCO (Free ASCO Whitepaper) 2026 includes the below data. To see the cancer center’s complete list of abstracts, visit cityofhope.org/asco-2026.

Oral Abstract 7007: Mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) versus rituximab, gemcitabine and oxaliplatin (R-GemOx) in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL): Updated efficacy and safety from the phase 3 SUNMO study including in second-line (2L) versus third-line plus (3L+) patient subgroups
Track: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Time: May 30 at 5:12 p.m. CDT
Presenting and Last Author: Elizabeth Budde, M.D., Ph.D.

Rapid Oral Abstract 5014: A phase 1, first-in-human (FIH) study evaluating the safety, pharmacokinetics, and efficacy of ABBV-969 in patients with metastatic castration-resistant prostate cancer (mCRPC)
Track: Genitourinary Cancer – Prostate, Testicular, and Penile
Time: May 31 at 4:42 p.m. CDT
Presenting Author: Tanya Dorff, M.D., F.A.S.C.O.

Rapid Oral Abstract 4519: Microbial dysbiosis as predictor of benefit from CBM588 as an adjunct to immune checkpoint blockade (ICB)–based first line therapies in metastatic renal cell carcinoma (mRCC)
Track: Genitourinary Cancer – Kidney and Bladder
Time: June 1 at 9 a.m. CDT
Presenting Author: Rahul Winayak, M.D., postdoctoral fellow

Rapid Oral Abstract 4012: Randomized phase II trial of olaparib and pembrolizumab vs olaparib alone as maintenance therapy in metastatic pancreatic cancer patients with germline BRCA1 or BRCA2 (gBRCA1/2) mutations: SWOG S2001
Track: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Time: June 1 at 1:45 p.m. CDT
Presenting Author: Vincent Chung, M.D.

Rapid Oral Abstract 4015: Tegavivint, a downstream Wnt/β-catenin inhibitor: Dose-finding results from a phase 1/2 trial in advanced hepatocellular carcinoma (aHCC)
Track: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Time: June 1 at 2:15 p.m. CDT
Last Author: Daneng Li, M.D.

City of Hope Experts to Contribute Scientific Perspective Across Plenary, Oral and Education Sessions

Discussion of LBA3: Event-free survival with adjuvant selpercatinib in stage-IB-IIIA RET fusion-positive NSCLC: Primary results of the phase 3 LIBERTTO-432 trial
Track: Special Sessions (Plenary)
Time: May 31 at 2:25 p.m. CDT
Discussant and Panelist: Christine Lovly, M.D., Ph.D., F.A.S.C.O.

Case-Based Panel: One Patient, Many Pathways: Management Options in ALK-Positive Non–Small Cell Lung Cancer From Early Stage to Advanced Disease
Track: Lung Cancer
Time: May 30 at 3 p.m. CDT
Chair and Moderator: Kristin Higgins, M.D.

Discussion of Abstracts 7503, 7504, 7505: Raising the Bar in Newly Diagnosed Multiple Myeloma: Depth, Duration, and Risk
Track: Hematologic Malignancies – Plasma Cell Dyscrasia
Time: May 29 at 4:21 p.m. CDT
Discussant and Moderator: Amrita Krishnan, M.D.

Discussion of Abstracts 7006, 7007, 7008: Tailoring Immunotherapy for Relapsed Lymphoma
Track: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Time: May 30 at 5:36 p.m. CDT
Discussant and Panelist: Tycel Phillips, M.D., F.A.S.C.O.

Highlights of the Year II: Highlights in Prostate Cancer: Moving Towards Personalized Treatment Across the Spectrum of Prostate Cancer
Track: Special Sessions
Time: June 1 at 9 a.m. CDT
Presenting Author: Tanya Dorff, M.D., F.A.S.C.O.

Education Session: Frontline Treatment Strategies in Papillary Renal Cell Carcinoma
Track: Genitourinary Cancer- Kidney and Bladder
Time: June 1 at 5:15 p.m. CDT
Presenting Author: Charles Nguyen, M.D.

City of Hope Leaders Honored with Top ASCO (Free ASCO Whitepaper) Distinctions

John Carpten, Ph.D., City of Hope chief scientific officer, has been named the recipient of the 2026 Allen Lichter Visionary Leader Award from the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). The award honors ASCO (Free ASCO Whitepaper) members whose visionary leadership has significantly advanced cancer care and inspired progress across the oncology community. A nationally recognized expert in cancer genomics, precision medicine and health disparities research, Dr. Carpten provides strategic leadership for City of Hope’s research enterprise and in 2022 became the first African American chair of the National Institutes of Health’s National Cancer Advisory Board.

Since ASCO (Free ASCO Whitepaper) 2025, three City of Hope faculty have been named Fellow of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (FASCO), an honor recognizing extraordinary, sustained leadership and meaningful contributions to the oncology community. The distinction highlights their leadership in cancer care, research and education and City of Hope’s continued impact on oncology practice and patient outcomes worldwide.

Arjun Gupta, M.D., medical oncologist, City of Hope Cancer Center Phoenix
Tanya Dorff, M.D., division chief, City of Hope’s Genitourinary Disease Program
Walter Stadler, M.D., chief clinical officer, City of Hope Cancer Center Chicago

(Press release, City of Hope, MAY 11, 2026, View Source [SID1234665464])

Ernexa Therapeutics Releases Virtual Investor KOL Connect Segment Highlighting Ovarian Cancer Landscape and Lead Candidate ERNA-101

On May 11, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported the release of a Virtual Investor KOL Connect segment featuring Dr. Robert Pierce, Chief Scientific Officer of Ernexa.

As part of the segment, Dr. Pierce provides insight into the complexities of ovarian cancer, one of the most challenging malignancies to treat, and discusses the limitations of current therapeutic approaches. The discussion highlights the patient journey from diagnosis through treatment, emphasizing the persistent unmet need for more effective and durable treatment options.

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Dr. Pierce also outlines the evolving treatment landscape and shares his perspective on how Ernexa is approaching ovarian cancer differently at the biological level. He discusses the Company’s lead product candidate, ERNA-101, and its potential to improve outcomes and enhance the patient experience compared to existing therapies.

The Virtual Investor KOL Connect segment featuring Ernexa Therapeutics is now available here.

In addition, Ernexa announced that Sanjeev Luther, President & Chief Executive Officer, and Dr. Robert Pierce, Chief Scientific Officer, will participate in a Virtual Investor Closing Bell event on Wednesday, May 13, 2026, at 4:00 PM ET.

As part of the event, Mr. Luther and Dr. Pierce will provide a corporate overview and discuss Ernexa’s recently announced preclinical ovarian cancer data for ERNA-101, which demonstrated complete tumor elimination and 100% survival in ovarian cancer models when combined with PD-1 blockade. The discussion will also cover the potential for ERNA-101 to address immunologically "cold" tumors by reshaping the tumor microenvironment to support stronger immune responses.

For more information about ERNA-101 and the Company’s development plans, visit www.ernexatx.com

(Press release, Ernexa Therapeutics, MAY 11, 2026, View Source [SID1234665480])

Actuate Therapeutics Announces FDA Clearance of IND for Oral Elraglusib
and Strategic Initiatives to Advance the Elraglusib Development Program

On May 11, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers, reported key initiatives to advance and expand the potential of the elraglusib development program.

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Actuate is prioritizing the development of the elraglusib oral tablet formulation, which is intended to enhance patient convenience, broaden potential clinical utility, and improve the pharmacokinetic exposure of elraglusib across multiple oncology indications. This strategy is supported by an analysis of patient data from the recently completed Phase 2 study in metastatic pancreatic ductal adenocarcinoma (mPDAC), which identified a positive correlation between drug exposure and clinical outcomes, including meaningful improvement in overall survival.

To support this initiative, the Company recently received Investigational New Drug (IND) clearance from FDA to conduct a Phase 1/2 study designed to demonstrate that a higher overall exposure to elraglusib can be achieved with the oral formulation compared to the IV formulation. The study will evaluate the safety and potential efficacy of the oral formulation as a monotherapy in solid tumor patients, including those with metastatic melanoma, NSCLC, colorectal, and pancreatic cancers, based on evidence of efficacy of the IV formulation in prior clinical studies and machine learning therapeutic target analyses.

The Company has worked with the European Medicines Agency (EMA) to obtain specific guidance regarding elements of a trial design for a potential single registration study for IV treatment of mPDAC. As demonstrated by the positive Phase 2 results published in Nature Medicine, elraglusib combined with gemcitabine plus nab-paclitaxel (GnP) showed statistically significant improvement in overall survival in patients that received the IV formulation of elraglusib once weekly. Going forward, the Company will work with the EMA and FDA on specific guidance regarding elements of the trial design for a potential single registration study with the oral tablet formulation of elraglusib.

"Advancing the elraglusib oral tablet is an important element to the success of our overall development strategy," said Daniel Schmitt, President & Chief Executive Officer of Actuate. "Transitioning from an IV to an oral formulation of elraglusib, which better positions the program by improving patient convenience and broadening clinical and potential commercial utility, is supported by an analysis of the completed Phase 2 data of elraglusib in mPDAC, showing higher exposures are associated with improved clinical activity. With the IND for the oral program authorized, we are planning to advance into clinical development in the second half of 2026 with a clear focus on optimizing exposure, dose, and response."

Mr. Schmitt continued: "In parallel, we are actively exploring elraglusib’s combination potential in RAS-driven cancers, where early preclinical data show potential for synergy with RAS inhibitors. With a strong mechanistic rationale targeting key survival and resistance pathways, we believe an oral elraglusib has the potential to enhance the activity of RAS-targeted therapies and address adaptive resistance, positioning it as a potential backbone agent in combination regimens. We look forward to further maturing this data, with additional updates expected in mid-2026.

The planned Phase 1/2 study will initially evaluate oral elraglusib as a monotherapy in patients with advanced solid tumors. The study is intended to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), while also evaluating safety, pharmacokinetics (PK), and preliminary signals of antitumor activity. In the Phase 2 portion, the study will enroll patients with a higher likelihood of benefitting from elraglusib treatment, including those with melanoma, non-small cell lung cancer (NSCLC), colorectal, and/or pancreatic cancers."

Finally, the addition of new board member Martin Huber, MD, a highly experienced biotech leader with extensive experience in oncology drug development, further strengthens our strategic and execution capabilities. Dr. Huber is also currently a board member of Syndax Pharmaceuticals and, most recently, was the President and Chief Executive Officer of Mersana Therapeutics until its acquisition by Day One Pharmaceuticals in January 2026. His guidance will be instrumental as we advance the oral elraglusib program and execute on its next phase of growth. "I am excited to join a team that has successfully demonstrated improved survival in patients with pancreatic cancer who were treated with elraglusib," said Martin Huber, MD, Director, Actuate Therapeutics, Inc. "I look forward to helping the Actuate team advance the new oral formulation in the evolving pancreatic treatment landscape and potentially bring elraglusib to more patients."

(Press release, Actuate Therapeutics, MAY 11, 2026, View Source [SID1234665425])

Pliant Therapeutics Provides Corporate Update and Reports First Quarter 2026 Financial Results

On May 11, 2026 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics, reported a corporate update and announced first quarter 2026 financial results.

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"In the first quarter, our team showcased its clinical development capabilities, initiating FORTIFY, the Phase 1b trial of PLN-101095, ahead of schedule and dosing the first patient in April," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. "We were excited to highlight encouraging recent data from the Phase 1a trial of PLN-101095 at AACR (Free AACR Whitepaper) showing deepening responses and increasing time on treatment. The team continues to make progress on pipeline programs emerging from Pliant’s proprietary integrin platform while evaluating opportunities to expand our clinical-stage pipeline."
Oncology Program
PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to overcome checkpoint resistance by blocking TGF-β activation in the tumor microenvironment. Pliant is currently conducting a Phase 1a/1b open-label, dose-escalation and indication expansion trial (NCT0670706) to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095, as monotherapy and in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors.

•FORTIFY, a Phase 1b indication expansion trial, enrolling and dosing patients. In April, the Company announced the dosing of its first participant in the FORTIFY Phase 1b indication expansion trial. The Phase 1b open-label, single dose trial will enroll three cohorts of patients including non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma and a subset of tumors with high tumor mutational burden. Tumor selection was based on data from the Phase 1 trial, as well as strong mechanistic rationale for integrin inhibition. Patients will be treated for 14 days with PLN-101095 dosed at 1,000 mg twice daily as monotherapy, after which pembrolizumab will be added as combination therapy. Enrollment is underway with interim data expected in 2027.

•Oral presentation at AACR (Free AACR Whitepaper) of updated Phase 1 data from PLN-101095 highlighted deepening of confirmed responses. In April, at the Clinical Trials Mini Symposium of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 Annual Meeting, the Company announced positive updated data from its Phase 1 trial of PLN-101095. Results showed that, in a heavily pretreated patient population, PLN-101095 demonstrated anti-tumor activity in combination with pembrolizumab, an FDA-approved ICI. One confirmed overall complete response, two confirmed overall partial responses, including one patient with a complete response of baseline target lesions, and one unconfirmed partial response were reported. These clinical responses were observed in patients with cholangiocarcinoma, NSCLC, melanoma and head and neck squamous cell carcinoma, respectively. All responding patients showed large increases in plasma interferon gamma (IFN-γ) after 14 days of monotherapy with PLN-101095 prior to the addition of pembrolizumab. At Week 10, all responders maintained more than a 2-fold increase in IFN-γ. No non-responders showed meaningful increases in plasma IFN- γ. PLN-101095 was generally well tolerated across all doses tested. IFN-γ is known to play a multifaceted role in modulating anti-tumor immunity, with increased tumor expression levels having previously been linked with better outcomes from immune checkpoint blockade. In addition to IFN- γ increases, all responding patients showed elevated plasma PD-L1 levels, known to be induced by increased IFN-γ and a predictor of an improved ICI response. Additionally, PLN-101095 was spotlighted as a novel immunotherapy approach as part of AACR (Free AACR Whitepaper)’s 2026 Annual Meeting Highlights Plenary Session.

Integrin-Targeted Delivery Platform

•Utilizing cell-specific integrin receptors, Pliant has developed a platform to deliver drug payloads, including siRNAs, to selective tissue types. Current programs are focused on delivering siRNAs to skeletal muscle cells and other tissues. Preclinical proof-of-concept studies are currently ongoing. The Company believes this integrin-targeting drug-delivery platform has the potential for broad applicability across multiple disease areas utilizing a variety of drug payloads.

First Quarter 2026 Financial Results
•Research and development expenses were $13.6 million, as compared to $43.4 million for the prior-year quarter. The decrease was primarily due to completing close-out activities for BEACON-IPF, a Phase 2b/3 study of bexotegrast, in 2025 and reduced personnel-related expenses, including stock based compensation, driven by decreased headcount compared to prior year.
•General and administrative expenses were $8.2 million, as compared to $15.5 million for the prior-year quarter. The decrease was primarily due to personnel-related expenses, including stock-based compensation, driven by decreased headcount compared to prior year.
•Net loss was $20.0 million as compared to $56.2 million for the prior-year quarter. The decrease was primarily due to significantly lower operating expenses following the termination of bexotegrast development in IPF in 2025 and decreased personnel-related expenses, including stock-based compensation, driven by reduced headcount compared to prior year.
•As of March 31, 2026, the Company had cash, cash equivalents and short-term investments of $172.4 million which the Company expects to be sufficient to fund operations into the second half of 2028.

(Press release, Pliant Therapeutics, MAY 11, 2026, View Source [SID1234665442])

CEL-SCI Enters Strategic Agreement with Amarox for the Registration, Commercialization, and Distribution of Multikine in Saudi Arabia

On May 11, 2026 CEL-SCI Corporation (NYSE American: CVM) reported it has signed a strategic partnership, distribution, and revenue sharing agreement with Amarox for regulatory affairs, marketing and potential commercialization of *Multikine (Leukocyte Interleukin, Injection) in the treatment of head and neck cancer in Saudi Arabia, with an optional extension for the Gulf Cooperation Council (GCC) countries including Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates.

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Amarox will support and coordinate the local regulatory process with SFDA, including seeking the SFDA’s Breakthrough Medicine Designation which, upon granting, would make Multikine rapidly available to patients in Saudia Arabia, representing a pivotal shift in CEL-SCI’s commercial trajectory.

The companies will share net revenue from sales of Multikine in Saudi Arabia on a 50%/50% basis.

Upon SFDA approval, Amarox will receive exclusive rights to distribute Multikine for the treatment of head and neck cancer in Saudi Arabia. CEL-SCI retains full ownership of all Multikine intellectual property, manufacturing know-how and global rights.

"Our collaboration with Amarox marks a transformative milestone for CEL-SCI as we advance Multikine toward commercialization in Saudi Arabia and potentially throughout the GCC region," said Geert Kersten, Chief Executive Officer of CEL-SCI. "This agreement establishes an attractive long-term revenue-sharing structure for CEL-SCI and aligns us with one of the region’s most respected pharmaceutical and regulatory organizations."

"Amarox’s excellent track record with the SFDA, combined with its deep commercial infrastructure and oncology expertise, significantly strengthens our ability to bring Multikine to patients in a region prioritizing rapid access to breakthrough cancer therapies. We believe this partnership could position Saudi Arabia as one of the first market globally to commercialize Multikine and represents an important step in CEL-SCI’s broader international commercialization strategy," Kersten concluded.

Dr. Abdullah Alzomaie, Chief Executive Officer of Amarox noted: "Saudi Arabia is rapidly advancing its position as a regional hub for innovative healthcare and advanced therapies. We are pleased to collaborate with CEL-SCI in exploring the regulatory pathway for Multikine and evaluating its potential role in addressing unmet needs in oncology care across Saudi Arabia and the GCC region."

Strong Validation from Leading Regional Oncology Partner

Amarox, one of the fastest growing pharmaceutical companies in Saudi Arabia, is engaged in manufacturing, marketing, and supply of best-in-class therapies. The company is expanding its portfolio of oncology products with a special emphasis on serving the unmet and poorly met needs of countries in the Middle East. As one of the most agile and rapidly expanding pharmaceutical companies in Saudi Arabia, Amarox is focused on regulatory excellence, oncology, specialty pharmaceuticals, and innovative therapies across Saudi Arabia and the GCC region. This strategic partnership reflects Amarox’s interest in exploring the regulatory and commercial potential of innovative oncology therapies in the region.

Amarox has demonstrated strong engagement with the SFDA to address unmet needs, and ranks #1 for applications in the SFDA’s shortage and unregistered medicines initiative for three consecutive years—2022, 2023, and 2024.

Strategic Alignment with Saudi Vision 2030

The SFDA Breakthrough Medicine Program, among other accelerated pathways, aims to facilitate and accelerate development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions in alignment with Saudi Arabia’s Vision 2030 initiative. By targeting this designation, CEL-SCI and Amarox are aligning Multikine with a high-priority national health initiative, potentially making Saudi Arabia the first region in the world to commercialize this neoadjuvant immunotherapy.

First Berlin, a leading corporate finance and investment boutique based in Berlin, Germany, specializing in independent research, capital market advisory, and investment banking services for small- and mid-cap companies across various sectors, acted as CEL-SCI’s sole advisor in structuring and executing the strategic partnership with Amarox.

About Multikine

Multikine is a cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system.

About Head and Neck Cancer

Head and neck cancer is the 6th most common cancer, with approximately 900,000 newly diagnosed cases per year globally. The newly diagnosed stage 3 and 4 patients with this cancer represent a severe unmet need.

(Press release, Cel-Sci, MAY 11, 2026, View Source [SID1234665465])