On May 20, 2026 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported it has been informed by the CHMP of the EMA of a "negative trend" opinion on its conditional Marketing Authorization Application (MAA) for MaaT013 (Xervyteg) for the treatment of acute Graft-versus-Host Disease (aGvHD), following its recent CHMP oral explanation.

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 CHMP formal vote is expected at the upcoming June Meeting, and subject to the formal vote, the Company intends to request a re-examination of the application, a standard procedure enabling a new independent scientific assessment by a different set of reviewers. The EMA’s procedure provides that the CHMP shall re-examine its opinion within 60 calendar days following receipt of the Company’s official request for re-examination.

"We continue to strongly believe in the potential for registration of MaaT013 (Xervyteg). We remain committed to working closely with the EMA to progress this application, encouraged by the therapy’s potential to address the significant unmet medical need in patients with aGvHD and by the continued support from the hematology community," said Hervé Affagard, CEO and co-founder of MaaT Pharma. "Our application remains under review, and we are fully committed to engaging constructively in the re-examination process."

For context, the CHMP feedback shared during the Oral Explanation reflects challenges, in the Company’s view, expected for first-in-class therapies based on a novel therapeutic approach, particularly those based on a single-arm pivotal trial. The application for MaaT013 (Xervyteg) is assessed under the Conditional Marketing Authorization (CMA) pathway, which is designed to facilitate earlier access to medicines addressing unmet medical needs while confirmatory data is generated post-approval.

The Company is taking cash management measures to extend its financial visibility into November 2026 (vs August 2026), covering the upcoming regulatory milestones including the re-examination process, while continuing to advance its pipeline.

MaaT013 (Xervyteg) is supported by clinical data from the pivotal ARES study, and real-world data with the ongoing Early Access Program active in 13 countries and with 300+ patients globally treated to date since 2019. Data supporting MaaT013 (Xervyteg) has previously been presented at major international congresses and in peer-reviewed publications. The Company remains committed to advancing MaaT013 (Xervyteg) through the European regulatory process, expanding patient access and progressing its broader pipeline in microbiome-based in oncology.

(Press release, MaaT Pharma, MAY 20, 2026, View Source [SID1234665894])

On May 20, 2026 Ichnos Glenmark Innovation, Inc. (IGI), a global clinical-stage biotechnology company focused on developing Multispecific antibodies in oncology, reported a new development candidate, ISB 2301, a first-in-class, multispecific immune cells (T and NK) activator, for the potential treatment of multiple solid tumor indications. ISB 2301 targets three tumor-associated antigens to trigger tumor cell death and engages both T cells and NK cells to ignite the immune system.

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!

"We engineered ISB 2301 to match the biological complexity of solid tumors in a way that conventional immunotherapies have not been able to address," said Lida Pacaud, M.D., President and Chief Executive Officer (CEO). "By simultaneously targeting three tumor-associated antigens and engaging both T cells and NK cells, it deploys a level of multi-mechanistic precision that we believe sets a new benchmark for what multispecific antibodies can achieve in solid tumors."

IGI designed ISB 2301 to induce potent antibody-dependent cellular cytotoxicity (ADCC), potent checkpoint inhibition, and a sustained type 1 immune response. IGI’s proprietary BEAT technology enabled the development of this next-generation multispecific antibody, which can be manufactured with a standard multispecific antibody process. ISB 2301 demonstrates excellent pharmacokinetics, tolerability, and a favorable safety profile in non-human primates. IGI intends to file an IND submission by the end of this year and begin clinical studies in 2027.

"The early-stage clinical success of our prior lead investigational asset, ISB 2001, was a defining moment for IGI in that it attracted a collaboration with AbbVie, validating not just the science, but the platform behind it," Pacaud added. "It’s this same platform that provided the engineering capability to develop such a highly complex molecule as ISB 2301. We look forward to advancing ISB 2301 into clinical studies and exploring the potential of this novel therapeutic approach for cancer patients with solid tumors."

(Press release, Ichnos Glenmark Innovation, MAY 20, 2026, View Source [SID1234665910])

On May 17, 2026 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, reported that the Company’s CEO, Mr. James Nathanielsz, forecasts new medical breakthroughs in the fight against pancreatic cancer over the next decade. Recent developments in treatment reflect a level of progress that has been difficult to achieve in this field. Clinical stage companies like Revolution Medicines Inc. and Erasca Inc. have demonstrated significant advancements in this field.

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!

New clinical data from a late-stage trial targeting KRAS mutations, which are present in many pancreatic cancer cases, showed a meaningful improvement in overall survival. Patients receiving the targeted therapy lived approximately 13 months compared to about 7 months with standard treatment. For a disease where outcomes have remained largely unchanged for decades, this represents an important step forward.

At the same time, additional data from combination therapy approaches are reinforcing a broader trend. In one study, a treatment designed to improve tumor penetration and support immune response increased one year survival rates to roughly 42%, compared to 22% with chemotherapy alone. These types of results are beginning to show that progress is more likely when multiple biological mechanisms are addressed together rather than in isolation. What stands out across these developments is not only the improvement in outcomes, but also what they reveal about the nature of pancreatic cancer. This is a disease driven by complex signaling pathways and supported by a highly resistant tumor environment. Targeting a single pathway, even one as important as KRAS, may not be sufficient on its own.

"From a broader perspective, these findings reinforce the importance of continuing to deepen our understanding of the underlying biology that drives both growth and resistance. While these advances are encouraging, survival outcomes remain limited, and there is still significant work to be done," said Mr. Nathanielsz. "At Propanc, we view this progress as part of a larger shift toward more biologically informed treatment strategies. Continued research into the mechanisms that support tumor persistence and recurrence will be critical in improving outcomes for patients facing this disease."

Propanc’s lead asset, PRP, achieved Orphan Drug Designation status from the US Food and Drug Administration (USFDA) for the treatment of pancreatic cancer in 2017. Compassionate use data published in Scientific Reports, an online Nature journal, administering a once daily suppository of trypsinogen and chymotrypsinogen in a fixed combination of 8.92mg ea., resulted in 3 out of 4 patients significantly exceeding life expectancy from terminal pancreatic cancer with no severe or even serious side effects observed from treatment (2017).

The Company plans to file a Clinical Trial Application (CTA) in Australia for a Phase 1b, First-In-Human, Maximum Tolerated Dose study in 30 – 40 advanced cancer patients suffering from solid tumors using PRP in an I.V. formulation administered once weekly later this year. It will be at significantly higher doses than the compassionate use study based on non-clinical safety and tolerability data translating to a safe starting dose in humans. After Phase 1 completion, the Company plans to then undertake two, Phase 2, 60 patient studies in pancreatic and ovarian cancers to establish proof of concept for each therapeutic indication.

(Press release, Propanc, MAY 20, 2026, View Source [SID1234665895])

On May 20, 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. Elena Ratner, Professor in the Department of Obstetrics, Gynecology and Reproductive Sciences at Yale University School of Medicine and a member of Ernexa’s Board of Directors.
 
As part of the segment, Dr. Ratner discusses ovarian cancer, one of the most difficult malignancies to treat, and highlights the significant challenges patients continue to face throughout diagnosis and treatment. The discussion explores limitations of current therapeutic approaches and the persistent unmet need for more effective and durable treatment options.

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!

Dr. Ratner also discusses the evolving ovarian cancer treatment landscape and shares her perspective on Ernexa’s differentiated biological approach to addressing immunologically "cold" tumors. The segment highlights Ernexa’s lead product candidate, ERNA-101, and recently announced preclinical data demonstrating complete tumor elimination and 100% long-term survival in ovarian cancer models when combined with PD-1 blockade.

The discussion also highlights the potential advantages of Ernexa’s engineered allogeneic induced mesenchymal stem cell (iMSC) platform, including the opportunity to develop scalable, off-the-shelf cell therapies designed to improve accessibility and overcome manufacturing challenges associated with traditional autologous approaches.

The Virtual Investor KOL Connect segment featuring Ernexa Therapeutics is now available here. For more information about ERNA-101 and the Company’s development plans, visit www.ernexatx.com

(Press release, Ernexa Therapeutics, MAY 20, 2026, View Source [SID1234665911])

On May 20, 2026 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology company committed to advancing transformative therapies for the treatment of cancer and rare diseases, reported that management will participate in a virtual fireside chat at the TD Cowen 7th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper) on Tuesday, May 26, 2026, at 9:30 am ET.

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!

A live webcast of the presentation can be accessed by visiting the Events and Presentations section of the Company’s website: View Source The webcast will be archived for a limited time following the presentation.

(Press release, Protara Therapeutics, MAY 20, 2026, View Source [SID1234665896])