On May 5, 2026 MimiVax Inc. and Roswell Park Comprehensive Cancer Center reported the launch of a phase 2 clinical trial (NCT06202066) evaluating SurVaxM in combination with temozolomide in patients with progressing neuroendocrine tumors, also known as NETs. The study is being conducted at Roswell Park in Buffalo, New York, under the direction of principal investigator Dr. Jasmeet Kaur.

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The phase 2 study compares the safety and effect of temozolomide combined with SurVaxM to temozolomide alone in patients with metastatic NETs that are progressing.

SurVaxM is a peptide vaccine that has been shown to produce an immune system response against cancer cells that express the protein survivin and may block the growth of new tumor cells. The new clinical trial builds directly on phase 1 findings from NCT03879694, in which SurVaxM was well tolerated in NET patients and demonstrated measurable clinical benefit with elevated antibody responses.

"This phase 2 trial is the result of years of careful, collaborative science between MimiVax, Roswell Park Comprehensive Cancer Center, and the neuroendocrine tumor community," said Michael Ciesielski, PhD, CEO and Co-founder of MimiVax. "NET patients deserve more options, and we are excited to see if SurVaxM can become a new treatment for them."

Neuroendocrine tumors are a rare type of cancer that arise from hormone-producing cells throughout the body, most commonly in the gastrointestinal tract and lungs. Their incidence has increased significantly over the past two decades, with an estimated 28,000 people diagnosed in the U.S. each year. While many NETs grow slowly, metastatic NET disease carries a poor prognosis, and treatment options are limited once patients progress on first-line therapy. Immunotherapy has shown limited efficacy in NETs to date, making the identification of new immunologic targets and approaches important to patient care.

The phase 2 trial builds on Roswell Park’s previous NET research, which demonstrated that survivin, the protein targeted by SurVaxM, is expressed in approximately 52 percent of NET specimens, and that its expression correlates with more aggressive tumor biology and shorter survival. Importantly, the phase 1 study demonstrated that SurVaxM was safe and generated measurable immune responses in NET patients.

"Patients need more options to treat NETs, and the phase 1 data gave us confidence this is a safe, immunologically active approach to try in a larger patient population," said gastrointestinal oncologist Jasmeet Kaur, MD, FACP, study principal investigator and Assistant Professor at Roswell Park. "We are excited to see if the next trial confirms a meaningful clinical benefit that advances patient care."

The initiation of this phase 2 trial comes as MimiVax begins data analysis from its phase 2b SURVIVE trial of SurVaxM in newly diagnosed glioblastoma. SurVaxM is also being evaluated in pediatric brain tumors and multiple myeloma.

"The phase 2 NET study underscores the breadth of cancers in which survivin is a relevant therapeutic target," noted Robert Fenstermaker, MD, Roswell Park Chair Emeritus in Neurosurgery and a co-founder of MimiVax. "Once discarded as too difficult a target, our research into survivin is yielding results that are giving hope to patients with some of the toughest cancer diagnoses."

For more information about this study or other Roswell Park clinical trials, please call 1-800-ROSWELL (1-800-767-9355) or send an e-mail to [email protected] interested in participating in this study may contact Roswell Park Comprehensive Cancer Center at 1-800-ROSWELL (1-800-767-9355) or [email protected]. Additional information is available at clinicaltrials.gov (NCT06202066).

(Press release, MimiVax, MAY 5, 2026, View Source;utm_medium=rss&utm_campaign=mimivax-and-roswell-park-open-phase-2-trial-of-survaxm-for-patients-with-metastatic-neuroendocrine-tumors [SID1234665123])

On May 5, 2026 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the first quarter of 2026 (1Q26).

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"Our first-quarter results reflect disciplined execution across the business, delivering 19% year-over-year growth alongside key pipeline advancements and positioning the company for an outstanding 2026," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "Demand for Xywav remained strong, our rare oncology launches with Modeyso and Zepzelca in 1LM ES-SCLC gained significant momentum, and Epidiolex continued to provide consistent growth. Looking ahead, we are excited about the potential launch of zanidatamab in 1L GEA later this year, as we progress our pipeline and business development efforts to bring more life-changing therapies to patients and fuel durable long-term growth."

Key First Quarter 2026 Highlights

•Total revenues in 1Q26 grew to $1.1 billion (+19% year-over-year (YoY))
•Generated GAAP / non-GAAP1 adjusted earnings per share (EPS) of $4.43 / $6.34 with $408 million in cash from operations.
•Practice-changing Phase 3 HERIZON-GEA-01 results, presented as a late-breaker at ASCO (Free ASCO Whitepaper) GI, support zanidatamab as the HER2-targeted agent of choice in HER2+ 1L advanced gastroesophageal adenocarcinoma (GEA); additional benefit from tislelizumab irrespective of PD-L1 status.
•Supplemental Biologics License Application (sBLA) accepted by FDA under Real-Time Oncology Review (RTOR) program with potential approval and launch in 1L HER2+ GEA on or before PDUFA date.

Business Updates

Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Xywav net product sales increased 18% to $408 million in 1Q26, compared to 1Q25.
•Continued physician and patient demand for the differentiated benefits of low-sodium Xywav.

•Strong new patient growth, with approximately 425 net patient adds in 1Q26. There were approximately 16,600 active patients exiting the quarter, comprised of approximately 11,075 narcolepsy patients and approximately 5,525 idiopathic hypersomnia (IH) patients.

Epidiolex/Epidyolex (cannabidiol):
•Epidiolex/Epidyolex net product sales increased 15% YoY to $250 million in 1Q26, driven by continued strong demand.
•Announced agreement with Nippon Zoki to commercialize Epidyolex in Japan, following completion of ongoing clinical trials and potential regulatory approval.

Ziihera (zanidatamab-hrii):
•Ziihera net product sales in biliary tract cancer (BTC) were $13 million in 1Q26.
•In April 2026, FDA accepted the zanidatamab sBLA in GEA for a Priority Review, with a PDUFA date of August 25, 2026.
•Submitted HERIZON-GEA-01 data for potential National Comprehensive Cancer Network (NCCN) guideline inclusion.
•HERIZON-GEA-01 data accepted for publication by a top-tier medical journal.
•The second interim overall survival (OS) analysis for the HERIZON-GEA-01 trial doublet regimen is expected in mid-2026.
•Multiple registrational trials of zanidatamab are underway, including in metastatic breast cancer (mBC), supporting a broad development program designed to maximize patient impact and long-term shareholder value.

Modeyso (dordaviprone):
•Modeyso net product sales were $41 million in 1Q26 with ~500 patients having received Modeyso from product launch in August 2025 through the end of the first quarter.
•The company completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $200 million (50% to Jazz).
•Phase 3 ACTION trial remains on track with top-line readout expected late 2026 / early 2027.

Zepzelca (lurbinectedin):
•Zepzelca net product sales increased 60% YoY to $101 million in 1Q26, driven by continued uptake of the Zepzelca and atezolizumab combination in the 1LM ES-SCLC setting, partially offset by a decline in second line use.
•The company expects second line use to decline throughout the year.
Financial Highlights
Three Months Ended
March 31,
(In millions, except per share amounts) 2026 2025
Total revenues $ 1,068.9 $ 897.8
GAAP net income (loss) $ 293.1 $ (92.5)
Non-GAAP adjusted net income $ 419.5 $ 105.2
GAAP earnings (loss) per share $ 4.43 $ (1.52)
Non-GAAP adjusted earnings per share $ 6.34 $ 1.68

The GAAP net loss and non-GAAP adjusted net income for 1Q25 included an expense of $172 million related to Xyrem antitrust litigation settlements, which impacted our GAAP and non-GAAP results by $146 million (net of tax of $26 million), or $2.38 per share on a GAAP basis and $2.34 per share on a non-GAAP adjusted basis.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

(Press release, Jazz Pharmaceuticals, MAY 5, 2026, View Source [SID1234665121])

On May 5, 2026 Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, reported that management will be participating in fireside chats at the following upcoming investor conferences:

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Bank of America Securities Health Care Conference
Date: Tuesday, May 12, 2026
Fireside Chat Time: 3:40 p.m. PT
Location: Las Vegas

RBC Capital Markets Global Healthcare Conference
Date: Wednesday, May 20, 2026
Fireside Chat Time: 2:35 p.m. ET
Location: New York

Jefferies Global Healthcare Conference
Date: Wednesday, June 3, 2026
Fireside Chat Time: 4:55 p.m. ET
Location: New York

The fireside chats will be webcast live. To join the webcasts, please visit the Events and Presentations page of the Investors & Media section on Intellia’s website at intelliatx.com. Replays of the webcasts will be available on the same page for approximately 90 days following the events.

(Press release, Intellia, MAY 5, 2026, View Source [SID1234665120])

On May 5, 2026 INmune Bio Inc. (NASDAQ: INMB) ("INmune Bio"), a clinical-stage biotechnology company, and Anthony Nolan, a pioneering UK-based charity that set up the world’s first stem cell register and is now driving forward cell therapy advancements, reported the signing of an amended and restated Material Transfer and License Agreement. This expanded collaboration secures the long-term provision of high-quality umbilical cord tissue to power INmune Bio’s CORDStrom platform, the industry’s most advanced Mesenchymal Stromal Cell (MSC) technology designed to deliver consistent, scalable, and "off-the-shelf" cellular therapies which are suitable for supply in UK, EU and US, as well as other global regions.

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The restated agreement, effective April 29, 2026, solidifies the partnership between Anthony Nolan’s Cell Therapy and Laboratory Services, which draws on 50 years of pioneering innovation, research and expertise, and INmune Bio’s international and domestic entities to support the development of human medicinal products subject to global regulatory oversight, including the FDA, EMA, and MHRA.

Solving the MSC Consistency Challenge

While MSCs have long shown therapeutic promise, the industry has struggled with donor variability and manufacturing inconsistency. CORDStrom addresses these hurdles by utilizing umbilical cord-derived MSCs which are tested, screened and pooled to create standardized "MSC Banks". By leveraging Anthony Nolan’s Cell Therapy & Laboratory Services’ world-class procurement and screening infrastructure, INmune Bio ensures that every CORDStrom product meets rigorous "Materials Acceptance Criteria," including precise neonatal weight and maternal age specifications, to ensure the highest reproducibility whilst ensuring regulatory compliance.

A Robust Pipeline: From RDEB to Oncology

The collaboration is initially focused on several high-impact "Initial Indications" and next-generation therapeutic candidates:

● Recessive Dystrophic Epidermolysis Bullosa (RDEB): Development of CORDStrom as a transformative treatment for this devastating skin-fragility disorder.

● CORDStrom-col7a: A next-generation systemic treatment for EB designed to address the underlying genetic deficiencies of the disease.

● CORDStrom-TRAIL (Oncology): Targeted expansion into solid tumors, utilizing the platform’s immunomodulatory capabilities to combat cancer.

● Inflammatory & Degenerative Diseases: The platform will also be deployed to address the massive unmet needs in Osteoarthritis and Systemic Lupus Erythematosus (SLE).

Management Commentary

"We view CORDStrom as a tremendous platform that finally solves the fundamental challenge of understanding MSCs as a drug," said David Moss, CEO of INmune Bio. "By partnering with Anthony Nolan’s Cell Therapy & Laboratory Services, we are combining the most advanced MSC cell platform with the most reliable source of cellular starting material. This collaboration allows us to move beyond the limitations of traditional cell therapy and provide consistent, high-potency treatments for patients suffering from RDEB, cancer, and chronic inflammatory conditions. We remain hugely grateful to the volunteer donors who provide the UC for our program and who consent to UK and US testing to make CORDStrom universally available".

"Anthony Nolan is committed to supporting the development of innovative cell and gene therapies to help more patients survive and thrive," said Nicola Alderson, COO of Anthony Nolan. "This partnership with our Cell Therapy and Laboratory Services allows our donor materials to reach their full potential within a cutting-edge manufacturing platform, facilitating the development of medicinal products that meet the highest ethical and regulatory standards for patients worldwide".

Agreement Terms

The agreement includes rigorous provisions for traceability and quality management, ensuring that all materials are handled in accordance with Good Manufacturing Practice (GMP) and Human Tissue Authority (HTA) standards as INmune Bio prepares for commercial approval of CORDStrom.

(Press release, INmune Bio, MAY 5, 2026, View Source [SID1234665119])

On May 5, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported it will present new treatment comparison results evaluating ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) versus nadofaragene firadenovec-vncg and TAR-200 in patients with non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS), with or without papillary disease, at the American Urological Association Annual Meeting (AUA 2026) in Washington, DC, May 15-18. An additional oral presentation will include new insights into research of intravesical recombinant BCG (rBCG) in BCG-naïve patients.

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These analyses are clinically relevant for urologists managing an increasingly complex NMIBC treatment landscape, particularly among patients with BCG-unresponsive disease. In the context of limited direct comparative data, cross-trial analyses may provide important context to inform treatment selection and sequencing. By evaluating ANKTIVA + BCG relative to other available options, these data may help characterize comparative efficacy and durability of response within current treatment paradigms.

Dr. Soon-Shiong will be presenting on "The Role of IL15 in the Urological Setting" where he will discuss the mechanisms driving T cell and NK cell activation, examine current clinical evidence, and outline emerging combination approaches in bladder and prostate cancer.

"At AUA 2026, we are advancing the conversation around bladder cancer treatment with new comparative analyses that help contextualize the clinical value of ANKTIVA plus BCG in BCG-unresponsive NMIBC CIS with or without papillary disease," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "These findings, along with emerging insights into recombinant BCG, reflect our commitment to expanding treatment options and addressing critical challenges such as BCG supply constraints. We also continue to prioritize research advancing next-generation immunotherapies for patients with urological cancers, including bladder and prostate cancers, and look forward to sharing this research at the upcoming AUA Annual Meeting."

Oral Presentations

The phase 1/2 ResQ133A-NMIBC trial: A study of intravesical recombinant Mycobacterium Bacillus Calmette Guérin (rBCG) in BCG naïve participants with non-muscle invasive bladder cancer
Meeks J. Oral Podium Presentation: Clinical Trials in Progress: Bladder Cancer, Sunday, May 17, 9:16 am – 9:24 am EDT, The Square, Learning Lab, Hall B, Walter E. Washington Convention Center
Indirect Treatment Comparison of Nogapendekin Alfa Inbakicept-pmln plus Bacillus Calmette–Guérin (NAI+BCG) and Nadofaragene Firadenovec-vncg in patients with BCG-unresponsive Non-Muscle Invasive Bladder Cancer CIS ± Papillary (NMIBC)
Edwards B. Oral Podium Presentation PD25-15. Session PD25: Bladder Cancer: Non-invasive V, Monday, May 18, 8:52 am – 9:00 am EDT, Room 206, Walter E. Washington Convention Center
Poster Presentation

An Indirect Treatment Comparison (ITC) of Nogapendekin Alfa Inbakicept-pmln plus Bacillus Calmette–Guérin (NAI+BCG) and TAR-200 in patients with BCG-unresponsive, Non-Muscle Invasive Bladder Cancer CIS ± Papillary (NMIBC)
Flanders S. Poster IP50-12. Session IP50: Bladder Cancer: Non-invasive IV, Sunday, May 17, 7:00 am – 9:00 am EDT, Room 146A, Walter E. Washington Convention Center
ImmunityBio Product Theater Presentation

Dr. Soon-Shiong will provide an update on the company’s efforts to expand BCG access and advance research in the BCG naïve setting, and will discuss the role of IL-15 in urological oncology, including mechanisms driving T cell and natural killer (NK) cell activation, current clinical evidence, and emerging combination approaches in bladder and prostate cancer.

The Role of IL15 in the Urological Setting
Dr. Patrick Soon-Shiong, ImmunityBio Product Theater, Saturday, May 16, 1:30 pm EDT, Product Theater booth 2701, Walter E. Washington Convention Center
About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor superagonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the dendritic cell membrane-bound IL-15 receptor alpha driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

(Press release, ImmunityBio, MAY 5, 2026, View Source [SID1234665118])