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Knight Therapeutics Announces Approval of Additional Indication for MINJUVI® (tafasitamab) in Brazil

On March 17, 2026 Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, reported that its Brazilian affiliate, United Medical Ltda. has received approval from ANVISA, the Brazilian health regulatory agency, for an additional indication for MINJUVI (tafasitamab). The approval follows a supplemental regulatory filing and review by ANVISA under Project Orbis for MINJUVI, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). 1

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The approval is supported by data from clinical studies evaluating MINJUVI in combination with rituximab and lenalidomide (R2), which demonstrated meaningful response rates and durable disease control in patients with previously treated FL.

"ANVISA’s approval of the new indication for tafasitamab in combination with rituximab and lenalidomide represents an important step in expanding treatment options for patients with relapsed or refractory follicular lymphoma. As a chemotherapy-free option with a favorable risk-benefit profile, this approval broadens therapeutic alternatives for patients across Brazil," said Dr Jorge Vaz Pinto Neto, Hematologist, Member of The Board of Directors of the Brazilian Association of Hematology, Hemotherapy, and Cellular Therapy (ABHH-TC) and Coordinator of the Bone Marrow Transplant Unity at CETTRO Cancer Center/ Oncoclinicas – Brasília.

"This approval of MINJUVI delivers on our promise to bring high quality cancer care to Latin America and provides physicians and patients a new option in the treatment of relapsed or refractory lymphoma," said Samira Sakhia, President and CEO of Knight Therapeutics Inc. "The rapid review and approval under Project Orbis reflect Knight’s strong regulatory capabilities and focused execution for the benefit of Knight and our partners."

Knight entered into an exclusive supply and distribution agreement with Incyte (NASDAQ: INCY) in 2021 for tafasitamab (commercialized as MONJUVI (tafasitamab-cxix) in the United States and MINJUVI ex-USA) across Latin America. Knight has launched MINJUVI in Brazil, Mexico and Argentina for use in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLCBL arising from low grade lymphoma in Brazil, who are not eligible for autologous stem cell transplantation (ASCT).

About MINJUVI (tafasitamab)

MINJUVI (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., MONJUVI is approved by the U.S. FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

MONJUVI is not approved and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Additionally, MONJUVI received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

In Europe, MINJUVI (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by MINJUVI monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Additionally, MINJUVI is approved in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy in Europe.

In Japan, MINJUVI is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

In Brazil, MINJUVI is approved for use in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLCBL arising from low grade lymphoma in Brazil, who are not eligible for autologous stem cell transplantation (ASCT) and is also approved in MINJUVI, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). MINJUVI is not approved and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

XmAb is a registered trademark of Xencor, Inc.

MONJUVI and MINJUVI are registered trademarks of Incyte.

About Follicular Lymphoma (FL)

FL is the most common subtype of indolent non-hodgkin lymphoma (NHL).2-4 FL typically presents with generalized painless lymphadenopathy that waxes and wanes. It commonly affects the axillary, cervical, femoral, and inguinal lymph nodes. Rarely, it may appear as an asymptomatic large mediastinal mass. Roughly 20% of FL patients experience B symptoms such as night sweats, fever, and weight loss.5 Although patients usually respond to initial therapy, FL will typically relapse over time and is therefore considered incurable.6,7 Approximately a quarter of FL patients are refractory to first-line immunochemotherapy.8 Additionally, there is a risk of histologic transformation to DLBCL or high-grade B-cell lymphomas, which occurs at an estimated annual rate of 2% to 3% and is generally associated with a poor clinical outcomes.9-12

In Brazil, according to the 2023 data from the INCA Registries, the expected incidence/year of NHL (inclusive of all subtypes) was 5.57 per 100, 000 in the general population.13 It is expected that follicular lymphoma constitutes 20% to 25% of adult NHL cases.2-4 Globally it is believed to have an estimated prevalence of 1/3000 thus making it a rare disease by both Global and Brazilian regulatory standards.14

About inMIND Study

The inMIND study (INCMOR 0208-301) was a Phase 3, randomized, double-blind, placebo-controlled, multicenter study in participants with relapsed/refractory FL or relapsed/refractory marginal zone lymphoma (MZL) who had been previously treated with at least one prior line of systemic therapy, including an anti-CD20 antibody. Patients were randomized to receive either tafasitamab + R2 (n = 273) versus placebo + R2 (n = 275). The estimated median progression free survival (PFS; primary endpoint) was 22.37 months (95% CI: 19.22, NE) in the tafasitamab + R2 group compared with 13.93 months (95% CI: 11.53, 16.39) in the placebo + R2 group, with a HR of 0.434 (95% CI: 0.324, 0.580) and a p < 0.0001. Overall, adding tafasitamab to lenalidomide plus rituximab led to a statistically significant, clinically meaningful improvement in PFS, corresponding to a 57% lower risk of progression, relapse, or death in patients with relapsed/refractory follicular lymphoma.15 The most common adverse reactions (≥ 20%) in patients with relapsed or refractory FL were respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough. The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) were decreased neutrophils and decreased lymphocytes.

(Press release, Knight Therapeutics, MAR 17, 2026, View Source [SID1234663627])

Cancer Research UK and NovalGen dose the first patient in the Phase 1 trial of T-cell engager NVG-222

On March 17, 2026 Cancer Research UK’s Centre for Drug Development (CDD) and NovalGen reported that the first patient has been dosed in a Phase 1 clinical trial evaluating NVG‑222, NovalGen’s next-generation self‑regulating T‑cell engager for the treatment of ROR1‑positive blood cancers.

NVG‑222 is a bispecific T‑cell engager targeting ROR1 and CD3 and is the first therapeutic candidate to use NovalGen’s proprietary AutoRegulation technology, a key innovation designed to mitigate excessive immune activation and cytokine-mediated toxicities, while maintaining sustained T-cell function and reducing exhaustion associated with continuous stimulation.

The trial is sponsored and delivered by Cancer Research UK’s Centre for Drug Development and is led by Chief Investigator Will Townsend at University College London Hospitals NHS Foundation Trust (UCLH), where the first patient received treatment. Cancer Research Horizons is managing the commercial partnership between NovalGen and Cancer Research UK.

The study is enrolling patients across the UK with ROR1‑positive blood cancers and uses an adaptive design to optimise dose, treatment and biomarker strategies. Dosing of the first patient marks an important step in translating AutoRegulated immune therapies from the laboratory into clinical testing.

Dr Lars Erwig, Director of the Centre for Drug Development at Cancer Research UK, said:

"Dosing the first patient is an important milestone for our collaboration with NovalGen. NVG‑222 reflects the kind of innovative, safety‑focused immunotherapy we aim to advance, and we’re proud to help bring this next‑generation treatment into the clinic."

Professor Amit Nathwani, Founder and CEO of NovalGen, said:

"The start of this Phase 1 trial is a defining moment for NovalGen and the patients we serve. With support from CRUK, we are moving towards a future of ‘intelligent’ biologics. Our AutoRegulation (AR) technology is designed to sense and respond to the biological environment in real-time, aiming to overcome the toxicity and

exhaustion hurdles that have historically limited T-cell based immunotherapies. NVG-222 marks the beginning of our mission to set a new standard for precision, potency and safety in next-generation immunotherapy."

Dr William Townsend, Consultant Haematologist at University College London Hospitals NHS Foundation Trust, said:

"This represents the start of the next chapter in the story of T-cell engaging strategies to treat blood cancers. It is exciting to be part of this Phase 1 clinical trial which shows the best of UK research and clinical trial delivery. I hope it will translate into tangible benefits for our patients."

(Press release, NovalGen, MAR 17, 2026, View Source [SID1234663625])

Revolution Medicines to Showcase Progress Across RAS(ON) Targeted Oncology Pipeline with Multiple Presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting

On March 17, 2026 Revolution Medicines, Inc. (Nasdaq:RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that nine oral and poster presentations highlighting advances across its RAS(ON) inhibitor pipeline will be featured at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 17–22, 2026 in San Diego.

The presentations will include new Phase 1 data for zoldonrasib, a RAS(ON) G12D-selective inhibitor, in patients with previously treated KRAS G12D mutant non-small cell lung cancer, which will be featured in a plenary session.

The company will also present two Phase 1/2 datasets evaluating daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with first line metastatic pancreatic ductal adenocarcinoma (PDAC), including monotherapy data and daraxonrasib plus chemotherapy combination data, the latter of which will be featured in a mini-symposium session.

Additional presentations will highlight preclinical research supporting a new class of mutant-targeted catalytic RAS(ON) inhibitors, designed to maintain antitumor activity in the setting of emergent resistance.

Together, these presentations reflect the breadth of Revolution Medicines’ RAS(ON)-focused development strategy, spanning clinical studies across multiple tumor types and ongoing discovery efforts to address resistance and expand therapeutic opportunities for patients with RAS-driven cancers.

Details of the presentations are listed below.

Revolution Medicines Invited Presentation:

Title: Targeting the Oncogenic State of RAS: Lessons from Tri-Complex Inhibitors
Presenter: Mallika Singh, Ph.D., Revolution Medicines
Session: How KRAS Inhibitors Got to the Clinic: From Discovery to Patient Benefit
Date/Time: April 18; 3:00 p.m. – 3:20 p.m. PST

Revolution Medicines Oral Presentation:

Title: Preliminary Safety and Clinical Activity of Zoldonrasib (RMC-9805), an Oral, RAS(ON) G12D-Selective, Tri-Complex Inhibitor in Patients with Previously Treated KRAS G12D Non-Small Cell Lung Cancer (NSCLC)
Presenter: Jonathan Reiss, M.D., UC Davis Comprehensive Cancer Center
Abstract
Number: CT021
Session: New Frontiers in Precision Oncology
Date/Time: April 19; 1:30 p.m. – 1:45 p.m. PST

Revolution Medicines Mini Symposiums:

Title: Daraxonrasib plus Chemotherapy as First Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma (mPDAC)
Presenter: Brian Wolpin, M.D., Dana-Farber Cancer Institute
Abstract
Number: LB407
Session: Late-Breaking Research
Date/Time: April 21; 4:05 p.m. – 4:20 p.m. PST

Title: Discovery of a New Class of Mutant-Targeted Catalytic RAS(ON) Inhibitors with Retained Antitumor Activity in Setting of Emergent Resistance Due to Elevated RAS Flux
Presenter: Jacqueline (Jan) Smith, Ph.D., Revolution Medicines
Abstract
Number: 6782
Session: Targeted Protein Degradation and Non-canonical Oncogenic Signaling
Date/Time: April 21; 4:05 p.m. – 4:20 p.m. PST

Revolution Medicines Posters:

Title: RAS(ON) Inhibition in both Cancer and Immune Cells by Daraxonrasib Drives Antitumor Immunity
Presenter: Nataliya Shifrin, Ph.D., Revolution Medicines
Abstract
Number: 2831
Session: Immune Mechanisms Invoked by Other Therapies and Exposures
Date/Time: April 20; 2:00 p.m. – 5:00 p.m. PST

Title: RASolve 301: A Phase 3 Study of Daraxonrasib (RMC-6236) vs. Docetaxel in Patients with Previously Treated RAS-mutant NSCLC
Presenter: Ferdinandos Skoulidis, M.D., Ph.D., MRCP, MD Anderson Cancer Center
Abstract
Number: CT215
Session: Late-Breaking Research
Date/Time: April 21; 9:00 a.m. – 12:00 p.m. PST

Title: Daraxonrasib Monotherapy as First Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma
Presenter: Eileen O’Reilly, M.D., Memorial Sloan Kettering Cancer Center
Abstract
Number: LB337
Session: Late-Breaking Research: Clinical Research 3
Date/Time: April 21; 2:00 p.m. – 5:00 p.m. PST

Title: RAS(ON) Multi-Selective Inhibitors Stimulate the Hydrolysis of RAS-GTP to RAS-GDP and Drive Synergistic Combination Benefit with KRAS(OFF) Inhibitors in G12 Mutant Tumors
Presenter: Kyle Seamon, Ph.D., Revolution Medicines
Abstract
Number: 5696
Session: Mechanisms of Anticancer Drug Action
Date/Time: April 21; 2:00 p.m. – 5:00 p.m. PST

Collaborator Mini Symposium:

Title: Active RAS Inhibition Intercepts Pancreas Cancer in Mice
Presenter: Ben Stanger, M.D., Ph.D., Penn Pancreatic Cancer Research Center
Abstract
Number: LB406
Session: Late-Breaking Research
Date/Time: April 21; 3:50 p.m. – 4:05 p.m. PST

(Press release, Revolution Medicines, MAR 17, 2026, View Source [SID1234663624])

Outrun Therapeutics unveils lead programme targeting HPV positive head and neck cancer and appoints renowned E3 ligase experts to Scientific Advisory Board (SAB)

On March 17, 2026 Outrun Therapeutics ("Outrun" or "the Company"), a biotech developing protein stabilising therapeutics identified by its proprietary XL discovery platform, reported the selection of its lead programme for the treatment of HPV positive head and neck cancer. It also announced the formation of its Scientific Advisory Board comprising world-class experts in E3 ligase biology and head and neck cancer.

Outrun has selected an E6AP inhibitor strategy as the lead programme from its first-in-class therapeutic pipeline developed through the application of its proprietary XL discovery platform. This platform has been used to profile over 45 diverse E3 ligases across a wide range of indications in oncology, neurology, cardiovascular and auto-immune diseases. The Company expects to announce a development candidate later this year.

E6AP is an E3 ubiquitin ligase that regulates the expression of a key tumour suppressor protein in HPV positive cancers, such as head and neck cancer. Inhibiting this enzyme represents a first-in-class strategy to directly stabilise tumour suppressor protein levels, paving the way to a meaningful impact on patients’ lives. HPV positive cancers account for around 4.5% of cancers worldwide, with the global market size expected to exceed $14 billion by 2031.

To help drive the advancement of the programme and the Company’s wider pipeline of first-in-class small molecule E3 ligase inhibitors, Outrun has appointed leading experts Glenn Hanna, Kevin Harrington, Gigi Lozano, Donald Ogilvie, and Martin Scheffner to its SAB. They join Outrun’s Founder, Non-executive Director, and Chair of the SAB, Professor Satpal Virdee.

These international experts bring extensive expertise in E3 ligase biology and head and neck cancer and will provide critical translational insights as Outrun advances its lead programme towards the clinic.

Dr Tony Johnson, Board Chair and Interim CEO of Outrun Therapeutics, said: "Outrun’s mission is to develop protein stabilising therapeutics to treat disease, and the selection of our lead programme, for the treatment of HPV positive head and neck cancer, is an important milestone in our journey. This is a massively underserved patient population, and we are confident that our novel approach to protein stabilisation offers a breakthrough route to bringing meaningful treatments to those in need."

Professor Satpal Virdee, Founder, Non-executive Director, and Chair of the SAB at Outrun Therapeutics, added: "Attracting such high-profile and experienced figures to our SAB is tremendous validation of the novel nature of our technology, and we are grateful for their commitment. Their expertise will be invaluable as we develop the translational strategy, clinical design, and biomarker validation to support our goal of establishing efficacy and differentiation in the HPV-induced head and neck cancer field, and transition to a clinical stage company."

(Press release, Outrun Therapeutics, MAR 17, 2026, View Source [SID1234663623])

ORIC® Pharmaceuticals Announces Preclinical Rinzimetostat (ORIC-944) Presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting

On March 17, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that multiple abstracts highlighting the potential of rinzimetostat (ORIC-944), a potent and selective allosteric inhibitor of PRC2 to treat prostate cancer, have been accepted for poster presentations at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 17-22, 2026 in San Diego, CA. All regular abstracts are available for viewing via AACR (Free AACR Whitepaper)’s online itinerary planner located here.

Poster presentations details:

Date & Time: Wednesday, April 22, 2026, 9:00 a.m. – 12:00 p.m. PT
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Strategies to Reverse Drug Resistance
Location: Poster Section 14

Title: Rinzimetostat, an allosteric EED inhibitor with best-in-class properties for the treatment of prostate cancer, is effective in PRC2 methyltransferase-resistant settings in preclinical studies
Abstract Number: 7120
Poster Number: Board Number 9

Abstract Highlights
Rinzimetostat is a potent and highly selective next-generation allosteric PRC2 inhibitor targeting the EED subunit that has demonstrated potential best-in-class efficacy and safety in a dose exploration trial in combination with androgen receptor (AR) inhibitors. To further evaluate the possible benefits of inhibiting PRC2 activity through EED targeting, preclinical studies investigated rinzimetostat versus EZH2- or EZH1/2-targeting agents in the context of proposed acquired resistance mechanisms. Biochemical assays demonstrated that rinzimetostat maintained potent inhibition of PRC2 complexes containing either EZH1 or EZH2 as the enzymatic subunit, while EZH2 or EZH1/2 dual inhibitors showed reduced activity in EZH1-containing complexes. Consistent with the biochemical data, rinzimetostat retained antitumor activity in prostate cancer cells overexpressing EZH1, while EZH2 inhibitors mevrometostat and tazemetostat lost potency in this context. Rinzimetostat also maintained inhibition of H3K27me3 in prostate cancer cells expressing the clinically reported EZH2-inhibitor acquired resistance mutation EZH2 Y666N, while EZH2 inhibitors did not reduce H3K27me3. In addition, in prostate cancer cells expressing the acquired resistance mutation EED-H213R, which is associated with clinical resistance to dual EZH1/2 inhibition, rinzimetostat equally inhibited H3K27me3 in both mutant and wild-type settings, while an EZH1/2 inhibitor did not. Together, these data suggest that rinzimetostat, as an EED inhibitor, has the potential for superiority in resistance context of EZH1 overexpression, as well as in acquired resistance mutant contexts of EZH2 and EZH1/2 inhibitors. A global phase 1b trial of rinzimetostat in combination with AR inhibitors is ongoing in metastatic prostate cancer (NCT05413421).

Title: Rinzimetostat blockade of PRC2 activity, a key mechanism of treatment resistance, improves response of androgen receptor pathway inhibition across a spectrum of prostate cancer models
Abstract Number: 7132
Poster Number: Board Number 21

Abstract Highlights
Rinzimetostat is a potent and highly selective next-generation allosteric PRC2 inhibitor targeting the EED subunit that has demonstrated potential best-in-class efficacy and safety in a dose exploration trial in combination with AR inhibitors. Transcriptome analyses of more than 1,000 prostate cancer patient samples spanning primary prostate cancer, metastatic castration-resistant prostate cancer (mCRPC), and neuroendocrine prostate cancer (NEPC) revealed gene expression patterns driving prostate cancer progression. Pseudotime analysis of tumor transcriptomes highlighted the eventual reduction in AR expression, AR signaling and luminal identity during mCRPC that may reflect lineage plasticity and cell state reprogramming. Integrated analysis across treatment lines identified epigenetic regulators, including PRC2, whose activity signatures increase during disease progression and may contribute to tumor heterogeneity and resistance to androgen receptor pathway inhibitors (ARPIs), further supporting the rationale for PRC2 inhibition. Rinzimetostat in combination with the AR inhibitor darolutamide demonstrated antitumor activity across a broad spectrum of in vivo prostate cancer models representing the treatment continuum, including castration-sensitive and castration-resistant disease, ARPI-sensitive and ARPI-resistant settings, and tumors harboring both AR-mutant and AR wild-type backgrounds. Together, these findings suggest that targeting PRC2 with rinzimetostat re-sensitizes ARPI-resistant tumors to AR pathway inhibition and blocks prostate tumor adaptation. A global phase 1b trial of rinzimetostat in combination with AR inhibitors is ongoing in metastatic prostate cancer (NCT05413421).

(Press release, ORIC Pharmaceuticals, MAR 17, 2026, View Source [SID1234663622])