On August 27, 2026 Knight Therapeutics Inc. ("Knight") (TSX: GUD), a pan-American (ex-US) pharmaceutical company, reported that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.

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"This supplemental submission to ANVISA marks an important step in our efforts to expand MINJUVI’s potential in earlier lines of therapy in Brazil," said Samira Sakhia, President and Chief Executive Officer of Knight. "Patients with previously untreated DLBCL and HGBL continue to face significant unmet medical needs. We are encouraged by the clinical data supporting the addition of tafasitamab and look forward to working with regulators under Project Orbis to bring this potential new first-line treatment option to patients as quickly as possible."

In September 2021, Knight entered into an exclusive supply and distribution agreement with Incyte (NASDAQ:INCY), for the exclusive rights to distribute tafasitamab (commercialized as MONJUVI in the United States and MINJUVI ex-U.S.). 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 DLBCL, who are not eligible for autologous stem cell transplantation (ASCT). In March 2026, Knight announced the approval and launch of MINJUVI in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) in Brazil.1 Also in March 2026, Knight submitted MINJUVI for the same indication in Argentina and Mexico.

This supplemental submission to ANVISA builds on those approvals, seeking a first-line indication for MINJUVI based on results from the Phase 3 frontMIND trial.

About MINJUVI

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 for use in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).2

Additionally, MONJUVI received approval in the U.S. 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).2 This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

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

In Japan, MINJUVI is approved for use in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).4 MINJUVI is also approved for use in Japan in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory FL (2L+ FL).5

XmAb is a registered trademark of Xencor, Inc.

MONJUVI and MINJUVI are registered trademarks of Incyte. All other trademarks are the property of their respective owners.

About Diffuse Large B-Cell Lymphoma (DLBCL)

Diffuse Large B-Cell Lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) in adults worldwide, accounting for a third of all NHLs and ranging between 20%−50% by country.6 DLBCL commonly presents with enlarged lymph nodes or rapidly growing mass along with B symptoms, which include fever, night sweats, and weight loss. The B symptoms can be seen in 30% of patients. Bone marrow involvement is more common in indolent disease and can be seen in up to 50% of the cases.7 Each year, approximately 25,000 people in the U.S. and up to projected 28,000 people in Western Europe are diagnosed with DLBCL.8,9 In Brazil, data from The Department of Information Technology of the Brazilian Public Unified Healthcare System (DataSUS) reported DLBCL as the most frequently diagnosed NHL with 39,012 cases reported between 2008 – 2017. With about 40% of DLBCL patients not responding to initial therapy or relapsing thereafter,10,11 there is a high medical need for new, effective therapies, particularly for high-risk patients.

About High-grade B-Cell Lymphoma (HGBL)

High-grade B-Cell Lymphoma (HGBL) is a rare and aggressive category of B-cell non-Hodgkin lymphoma (NHL) defined by the World Health Organization (WHO).12 It comprises two principal subtypes based on specific genetic characteristics: DLBCL/HGBL with MYC and BCL2 rearrangements, which encompasses most lymphomas previously known as double- or triple-hit lymphoma, and HGBL, not otherwise specified (NOS), a heterogeneous subtype defined by high-grade morphology in the absence of these genetic rearrangements.12,14 HGBL shares clinical features with DLBCL, including rapidly enlarging lymph nodes and B symptoms such as fever, night sweats, and weight loss, and accurate diagnosis requires expert pathologic review incorporating cytomorphology, immunohistochemistry, and fluorescence in situ hybridization (FISH).12,15 The aggressive nature of HGBL and the failure of intensified therapy to improve overall survival underscore the significant unmet need for more effective treatment options.12,13

About frontMIND trial

The frontMIND trial (NCT04824092) is a randomized, double-blind, placebo-controlled, global Phase 3 study in patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).16

The study enrolled 899 adults (≥18 to ≤80 years) and is evaluating the efficacy and safety of tafasitamab and lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) compared with R-CHOP.16

The primary endpoint of the study is investigator-assessed progression-free survival (PFS) using the Lugano 2014 criteria. Key secondary endpoints include event-free survival (EFS) by investigator assessment and overall survival (OS).16

For more information about the frontMIND trial, please visit View Source

(Press release, Knight Therapeutics, AUG 27, 2026, View Source [SID1234670386])

On August 27, 2026 Biogen Inc. (Nasdaq: BIIB) reported that Christopher A. Viehbacher, President and Chief Executive Officer, will participate in a fireside chat during the Morgan Stanley 24th Annual Global Healthcare Conference. The webcast will be live on Monday, Sept 14, 2026, at 9:15 a.m. ET. To access the live webcast, please visit the Investors section of Biogen’s website at investors.biogen.com. An archived version of the webcast will be available for at least 30 days following the presentation.

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(Press release, Biogen, AUG 27, 2026, View Source [SID1234670385])

On August 27, 2026 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR T cell and in vivo CAR T therapies for autoimmune diseases, hematologic malignancies and solid tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The Company plans to initiate Phase 1 enrollment in patients with mCRPC in the fourth quarter of 2026.

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"ADI-212 marks an important milestone in Adicet’s strategy to address the complexity of solid tumors and represents an important addition to our portfolio of allogeneic gamma delta 1 cell therapies and in vivo CAR T programs," said Blake Aftab, Ph.D., Chief Scientific Officer of Adicet Bio. "Designed as a single off-the-shelf product, ADI-212 incorporates multiple platform enhancements by combining gene-editing and the expression of novel immune-stimulating molecules intended to strengthen anti-tumor potency, including improved antigen engagement, capacity for durable tumor-killing and active modulation of tumor microenvironment. The successful IND clearance reinforces our commitment to advancing innovative therapies for patients with cancer."

About ADI-212

ADI-212 is a next-generation gene-edited, armored cell therapy candidate targeting prostate-specific membrane antigen (PSMA), engineered to express a novel CAR binder designed to enhance tolerability and tumor specific recognition. The program combines membrane-tethered IL-12 armoring and CRISPR/Cas9-mediated disruption of subunit 12 of the mediator complex (MED12) designed to improve potency in solid tumors and enable multiple anti-tumor mechanisms within the tumor microenvironment.

(Press release, Adicet Bio, AUG 27, 2026, View Source [SID1234670384])

On August 27, 2026 Affibody AB ("Affibody"), a clinical stage radiopharmaceutical company developing next generation Radioligand Therapies (RLTs), reported participation in two upcoming investor conferences, delivering an update on clinical data from the ongoing Phase 1 study evaluating the RLT candidate, ABY-271, in patients with HER2-positive metastatic breast cancer.

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Morgan Stanley 24th Annual Global Healthcare Conference (New York City)

Presentation and 1×1 Investor Meetings
Tuesday, September 15
4th Annual Oppenheimer Targeted Radiopharmaceutical Therapies Summit (New York City)

1×1 Investor Meetings
Thursday, September 17

(Press release, Affibody, AUG 27, 2026, View Source [SID1234670383])

On August 27, 2026 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported the publication of peer-reviewed final data from its Phase 1/1b trial of soquelitinib in patients with T cell lymphoma. The publication in Blood, the journal of the American Society of Hematology (ASH) (Free ASH Whitepaper), provides the medical and scientific community with clinical and immunologic data supporting the development of soquelitinib in oncology and immune and inflammatory diseases.

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"The publication of these data in Blood brings our soquelitinib findings to a wide audience of clinicians and researchers," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "In patients with advanced, aggressive and difficult-to-treat T cell lymphomas, soquelitinib demonstrated durable responses, including complete responses, maintained for more than two years in some patients and a median overall survival exceeding two years. This compares favorably to currently available therapies, providing the rationale for our ongoing registration Phase 3 trial in relapsed/refractory PTCL. The peer-reviewed data also detail soquelitinib’s mechanism of action, with selective ITK inhibition driving Th1 skewing and blocking of Th2 and Th17 differentiation. We believe these data support soquelitinib’s broad potential across immune and inflammatory diseases, reinforcing our development strategy including our ongoing SIERRA1 Phase 2 trial in atopic dermatitis and planned trials in hidradenitis suppurativa and asthma."

The Phase 1/1b trial enrolled 75 heavily pre-treated patients (27 in dose escalation portion and 48 in dose expansion portion) with various T cell lymphomas, including peripheral T cell lymphoma (PTCL), T follicular helper cell lymphoma (TFHC), natural killer cell T cell lymphoma (NKTCL), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and adult T cell lymphoma/leukemia (ATLL). The median number of prior therapies was three (range 1-18), with only 31% achieving an objective response to their most recent prior therapy. In the dose escalation portion, patients received a twice-daily dose of soquelitinib of 100 mg, 200 mg, 400 mg or 600 mg, and the 200 mg twice-daily dose was selected for the dose expansion portion based on biomarker studies which demonstrated that doses of 200 mg or higher achieved complete occupancy of the ITK target with the drug.

Soquelitinib was well tolerated across all dose cohorts up to 600 mg twice-daily, with no dose-limiting toxicities or significant adverse events and, notably, no myelosuppression or immunosuppression. In the 200 mg twice-daily cohort (N=36), there were objective and durable tumor responses, including six complete responses. Within this group, patients with one to three prior therapies were determined to be most likely to respond to therapy (N=24) and achieved the following results: objective responses in 9 of 24 patients (six complete and three partial), a median progression-free survival of 6.2 months with 30% of patients progression-free at 18 months, and a median overall survival of 28.1 months with 67% of patients alive at 24 months.

The publication also characterizes soquelitinib’s mechanism of action. In vitro studies showed that appropriate doses resulted in Th1 skewing by blocking Th2 differentiation, and biomarker analyses of patient blood and tumor samples also demonstrated this effect in vivo, with increased Th1 cells and reduced serum IL-5. In six patients with paired tumor biopsies analyzed by RNA sequencing, treatment increased intratumoral Th1 cells by day 8, which Corvus believes reflects the direct linkage between the drug’s clinical activity and its underlying immunobiology. These findings are consistent with an anti-tumor mechanism of action involving both direct effects on the tumor (tumor intrinsic) as well as a tumor extrinsic effect on the tumor microenvironment leading to an enhanced host immune response against the tumor.

The publication is available online at the Blood website and on the Publications and Presentations page of the Corvus website. It will also be published in an upcoming print edition of the journal.

Corvus is currently enrolling patients in a registration Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is progression-free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy.

About Blood
Blood is the flagship journal of the American Society of Hematology (ASH) (Free ASH Whitepaper), providing an international forum for the publication of original articles describing basic laboratory, translational, and clinical investigations in hematology.

(Press release, Corvus Pharmaceuticals, AUG 27, 2026, View Source [SID1234670382])