On June 2, 2026 Greywolf Therapeutics, a clinical-stage biotech company advancing novel antigen modulation treatments for cancer and autoimmune diseases, reported clinical and translational results from six completed Phase 1b expansion cohorts of the EMITT-1 trial (NCT06923761) evaluating GRWD5769, a first-in-class oral ERAP1 inhibitor, in combination with cemiplimab in patients with secondary anti-PD-1 resistance or microsatellite stable colorectal cancer without liver metastases (MSS-CRC NLM).

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Data were presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting by Professor Fiona Thistlethwaite, Consultant Medical Oncologist at The Christie NHS Foundation Trust and Medical Director of the National Institute for Health and Care Research (NIHR) Manchester Clinical Research Facility at The Christie, and Principal Investigator of the EMITT-1 trial.

Professor Fiona Thistlethwaite, Consultant Medical Oncologist at The Christie NHS Foundation Trust and Medical Director of the National Institute for Health and Care Research (NIHR) Manchester Clinical Research Facility at The Christie said:

"What excites me about this trial is the combination of what we’re seeing – strong signals of efficacy across six tumor types that have shown great resistance to immunotherapy, with very few side effects. That’s unusual at such an early stage."

Highlights from the Phase 1b data

Objective Response Rates (ORR) of 13–36% across all six cohorts in patients with a median of 2 prior lines of therapy and documented secondary anti-PD-1 resistance (except MSS-CRC (NLM) where this therapy is not effective)
Durable Clinical Benefit of 18–55% across all cohorts (DCB — defined as complete response, partial response, or stable disease lasting ≥6 months) and Progression Free Survival duration of 33 wks in NSCLC, 16 wks in HCC and 33 wks in MSS-CRC (NLM) (with 8.8 months median follow-up and still maturing). These data are very encouraging in a setting where durable benefit is exceptionally rare.
GRWD5769 is well tolerated in cemiplimab combination, with no safety signals and most adverse events being Grade 1

Evaluable*
(n) Partial response(s) Overall response rate
(%) Durable clinical benefit
(%) Progression-free survival
(wks)
Urothelial carcinoma 14 5 36 36 8
Non-small cell lung cancer 14 3 21 55 33
Hepatocellular carcinoma (liver cancer) 14 2 14 32 16
Microsatellite stable colorectal cancer (no liver metastases) 12 2 17 51 33
Cervical 14 2 14 18 9
Head and neck squamous cell carcinoma 8 1 13 38 14

Tom Lillie, Chief Medical Officer of Greywolf Therapeutics, said:

"Seeing the combination of strong durable clinical benefit rates and sustained PFS in a population that had already failed anti-PD-1 therapy, and in MSS-CRC where it isn’t licensed, is a clinically meaningful signal. Critically, we’re seeing this alongside a tolerability profile that enables patients to remain on treatment for extended periods, providing excellent potential for GRWD5769 to be used in other combination therapies."

Peter Joyce, CEO and Co-founder of Greywolf Therapeutics, said:

"EMITT-1 has validated a mechanism that the field has long recognized as scientifically compelling but clinically unproven. We are now advancing into Stage 2 cohort expansions to inform a randomized Phase 2 study, and we believe this data positions GRWD5769 as a genuinely differentiated approach to two of the largest unmet needs in oncology — T cell exhaustion and tumor visibility to the immune system."

About GRWD5769

GRWD5769 is a first-in-class oral small molecule inhibitor of Endoplasmic Reticulum Aminopeptidase 1 (ERAP1), an enzyme that regulates tumor antigen presentation on MHC-I. By inhibiting ERAP1 on a cyclical Q3W on/off schedule, GRWD5769 aims to generate alternating antigenic repertoires to broaden T cell responses and prevent T cell exhaustion driven by chronic antigen exposure. The drug is administered as an oral capsule in combination with cemiplimab, an approved anti-PD-1 therapy.

About the EMITT-1 trial

EMITT-1 (NCT06923761) is a global Phase 1/2 study evaluating GRWD5769 in combination with cemiplimab across multiple solid tumor types. The Phase 1b expansion enrolled patients across six cohorts: non-small cell lung cancer (NSCLC), urothelial carcinoma (UC), hepatocellular carcinoma (HCC), MSS-CRC (without liver metastases), squamous cell carcinoma of the head and neck (SCCHN), and cervical cancer. All patients had secondary resistance to prior anti-PD-1 therapy, except for the MSS-CRC NLM cohort. The trial is ongoing across 28 centers in Australia, France, Spain, and the United Kingdom.

(Press release, Grey Wolf Therapeutics, JUN 2, 2026, View Source [SID1234666401])

On June 2, 2026 Lantern Pharma presented its corporate presentation.

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(Presentation, Lantern Pharma, JUN 2, 2026, View Source [SID1234666370])

On June 2, 2026 Cycle Pharmaceuticals (Cycle) reported the FDA approval of CAVHANZA (nilotinib) Orally Disintegrating Tablets. Launching soon, the CAVHANZA formulation is specifically designed to improve solubility and dissolution rate, enabling maintained bioavailability with concomitant use of acid-reducing agents such as proton pump inhibitors (PPIs) and/or H₂ antagonists (H₂RAs) without timing restrictions.

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This will be a first in the nilotinib market, addressing a known challenge in Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) treatment, where 25% of patients are co-prescribed PPIs or H₂RAs – medications that can compromise treatment efficacy.3 In clinical trials, CAVHANZA demonstrated no food effect and can be taken without regard to meals, reducing food-related burden and supporting more flexible dosing, potentially improving treatment outcomes.1,2,4 Additionally, as an orally disintegrating tablet, CAVHANZA may support patients who have difficulty swallowing while also offering flexibility to take the treatment with or without water.1

CAVHANZA is indicated for the treatment of:

Newly diagnosed adults with Ph+ CML in chronic phase; and1
Adults with chronic and accelerated phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib.1
"We’re excited to be able to offer the CML community another TKI option that may better suit their needs," said Victoria Dickinson, Chief Product Officer at Cycle. "Finding the right treatment that fits a patient’s needs and lifestyle can be a stressful step in a patient’s treatment journey. Bringing another option to market – backed by Cycle VitaTM, our dedicated patient support* program – is an exciting prospect for Cycle."

To prepare CAVHANZA for market, Cycle partnered with Flex Pharma (Flex), who specialize in advanced formulation solutions and has developed an improved formulation of the second-generation TKI – built on years of established nilotinib efficacy.

Christian Wertz, PhD, President of Flex, added "This collaboration reflects Flex’s strategy as a technology-driven company advancing differentiated 505(b)(2) oncology therapies. Leveraging our proprietary ElectroNanoSpray (ENS) platform, we reformulate established oncology molecules to enhance bioavailability and optimize dosing performance. Together with Cycle’s rare-disease commercialization expertise, we aim to efficiently deliver improved treatment options for patients with rare leukemias."

Cycle has been delivering patient-focused treatments since 2017. The approval, and upcoming launch, of CAVHANZA represents the 10th product in Cycle’s portfolio and the 2nd product to enhance treatment options for patients living with Ph+ CML.

Learn more about CAVHANZA at View Source

Warning: QT Prolongation and Sudden Deaths

Nilotinib prolongs the QT interval. Monitor for hypokalemia or hypomagnesemia and correct deficiencies. Obtain ECGs to monitor the QTc at baseline on day 7, and periodically thereafter, and following any dose adjustments.

Sudden deaths have been reported. Avoid use in patients with hypokalemia, hypomagnesemia or long QT syndrome.

Avoid concomitant drug use with QT-prolonging drugs and strong CYP3A4 inhibitors.

Indications

CAVHANZA (nilotinib) is a kinase inhibitor indicated for the treatment of:

Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).

Adults with CP Ph+ CML or accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy.

Contraindications

CAVHANZA is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome.

Important Safety Information

Warnings and Precautions:

Substitution between nilotinib products requires dose conversion to avoid medication errors.
Monitor for myelosuppression; manage with dose adjustments or interruptions.
Cardiovascular and arterial occlusive events have been reported; assess and monitor cardiovascular risk.
Pancreatitis risk: monitor serum lipase; interrupt dosing if abdominal symptoms occur with lipase elevations.
Hepatotoxicity has been reported, with higher risk in pediatrics. Monitor liver function tests regularly.
Correct and monitor electrolyte abnormalities throughout treatment.
Tumor lysis syndrome has been reported; ensure hydration and correct uric acid before initiating treatment.
Serious hemorrhage may occur; advise patients to report signs and symptoms of bleeding.
Monitor for fluid retention and manage accordingly.
Growth retardation has been reported in pediatric patients. Monitor growth and development.
Can cause fetal harm; advise use of effective contraception during and 14 days after treatment.
Monitor BCR-ABL transcript levels in patients discontinuing treatment and manage loss of response appropriately.
Adverse Reactions:

Common non-hematologic adverse reactions include rash, pruritus, headache, nausea, fatigue, alopecia, myalgia, abdominal pain, constipation, diarrhea and vomiting. Hematologic adverse reactions include thrombocytopenia, neutropenia, and anemia. Serious adverse reactions include QT prolongation, sudden deaths, febrile neutropenia, and intracranial hemorrhage. Postmarketing reports include thrombotic microangiopathy, facial paralysis, and osteonecrosis.

Drug Interactions:

Avoid concomitant use with strong CYP3A inhibitors or inducers. Dose reduction is recommended if strong CYP3A inhibitors cannot be avoided. Avoid drugs that prolong the QT interval, including anti-arrhythmics.

Use in Specific Populations:

Pregnancy: CAVHANZA can cause fetal harm when administered to a pregnant woman.

Lactation: Breastfeeding is not recommended during treatment with CAVHANZA and for 14 days after the last dose.

Pediatric use: CAVHANZA is not approved for use in pediatric patients. Monitor growth and development if used.

Due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Geriatric use: No major differences for safety were observed in patients ≥65 years taking CAVHANZA.

For more detailed information, please refer to the full Prescribing Information at View Source

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at 1-855-831-5413, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

(Press release, Cycle Pharmaceuticals, JUN 2, 2026, View Source [SID1234666386])

On June 2, 2026 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech or the Company), a global leader in cell therapy, reported that promising preliminary clinical data for LB2501, its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL), will be presented during a late-breaking session at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, taking place June 11-14, 2026, in Stockholm, Sweden.

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"The upcoming presentation of Phase 1 LB2501 data in patients with B-cell malignancies represents an important step in advancing in vivo CAR-T approaches," said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. "By generating CAR-T cells directly within the patient, this approach has the potential to simplify treatment delivery and expand access for patients who may not be able to receive traditional CAR-T cell therapies. LB2501 is built on the TaVec platform, which is a proprietary lentiviral vector engineered to enhance T-cell specificity, transduction efficiency, and safety, while restricting transduction of non-T cells."

LB2501: Promising Phase 1 Trial of In Vivo CAR-T Data Demonstrate High Response Rates in B-cell Malignancies

Data from 12 patients across two dose cohorts in an ongoing Phase 1 study evaluating LB2501 in patients with R/R B-NHL provide early clinical evidence supporting the potential of an in vivo CAR-T approach in B-cell malignancies. LB2501 is designed to generate CAR-T cells directly within the patient following a single intravenous infusion, eliminating the need for cell manufacturing and lymphodepletion.

As of April 1, 2026, 12 patients with R/R B-NHL were treated across two dose levels (DL1 and DL2). Additional details will be presented at EHA (Free EHA Whitepaper) 2026. Key findings from the abstract include:

Efficacy Results

At DL2 (median follow-up for DL2 was 2.2 months [range, 2.0 to 3.8])
Objective response rate (ORR): 100% (6/6)
Complete response rate (CR): 83.3% (5/6)
All responses were ongoing at data cutoff

Pharmacokinetics

Dose-dependent in vivo CAR-T expansion observed
CAR-T cells detected in peripheral blood for up to 116 days

Safety Results

No dose-limiting toxicities (DLTs), serious adverse events (SAEs), or deaths were observed
Infusion-related reactions occurred in 75% of patients, all of which were ≤ Grade 2
Cytokine release syndrome (CRS) occurred in 66.7% of patients, all of which were ≤ Grade 2
No immune effector cell-associated neurotoxicity syndrome (ICANS) was reported
Grade ≥3 lentiviral vector-related and CAR-T-related adverse events were limited to decreased lymphocyte count and decreased neutrophil count

EHA Presentation (June 11-14, 2026)

Abstract No. Title Information
Abstract #LB5006
Late-Breaking Oral Presentation First-in-human trial of LB2501, an in vivo CD19/CD20 dual targeting CAR-T therapy, in relapsed/refractory B-Cell NHL

Session ID: s204
Date/Time: Sunday, June 14, 2026, 9:15-10:45 AM CEST
Location: Nobel Hall

ABOUT LB2501
LB2501 is an investigational, potential first-in-class CD19/CD20 dual-targeting in vivo CAR-T therapy designed to generate CAR-T cells directly within the patient following a single intravenous infusion. It is being evaluated in an ongoing Phase 1, open-label study NCT07002112) in patients with relapsed/refractory B-cell malignancies to assess safety, tolerability, and preliminary efficacy.i

ABOUT B-CELL NON-HODGKIN LYMPHOMA
Non-Hodgkin lymphoma (NHL) is a group of cancers that originate in lymphocytes, a type of white blood cell that plays a key role in the body’s immune system.ii B-cell lymphomas account for approximately 85% of NHL cases and arise from abnormal growth of B lymphocytes (B cells), which are responsible for producing antibodies. These malignancies include a range of subtypes that vary in aggressiveness, from slow-growing to highly aggressive disease.

(Press release, Legend Biotech, JUN 2, 2026, View Source [SID1234666402])

On June 2, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reproted that Robert M. Davis, chairman and chief executive officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Goldman Sachs 47th Annual Global Healthcare Conference on Tuesday, June 9, 2026, at 11:20 a.m. ET.

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

(Press release, Merck & Co, JUN 2, 2026, View Source [SID1234666371])