Immunotherapy of HIV-infected Patients An Open, Dose-escalating Assessment of Vacc-C5 With Either GM-CSF or Alhydrogel as Adjuvant in HIV-1-infected Subjects on Antiretroviral Therapy (ART)

Background:
Despite the introduction of highly effective antiretroviral therapy (ART) regimes, which control the HIV infection and results in increases in CD4 cell counts and an undetectable viral load, many patients suffer from increased morbidity. There is evidence that presence of antibodies against the C5 region of gp120 strongly correlates with slower disease progression, and that loss of antibody responses to this region are associated with progression.
Investigational product:
Vacc-C5 is a single heterodimeric peptide-based HIV therapeutic vaccine corresponding to the C5 region on gp120 and the external domain of gp41. The vaccine is intended to create a non-neutralizing antibody against C5 region.
Study objectives:
To evaluate safety of the vaccination regimens
To evaluate C5-specific humoral immune responses (antibodies), T cell responses, T cell activation markers and other immune markers.

Start Date01 Sep 2012

Sponsor / Collaborator

Bionor Immuno AS

100 Clinical Results associated with Vacc-C5

100 Translational Medicine associated with Vacc-C5

100 Patents (Medical) associated with Vacc-C5

Literatures (Medical) associated with Vacc-C5

01 Feb 2024·Arthroscopy: The Journal of Arthroscopic & Related Surgery

Eighth Cervical Nerve Root Block During Interscalene Brachial Plexus Block Decreases Pain Caused by Posterior Portal Placement but Increases Horner Syndrome in Patients Undergoing Arthroscopic Shoulder Surgery: A Randomized Controlled Trial

Article

Author: Kim, Jonghae ; Kim, Eugene ; Choi, Chang Hyuk ; Lee, So Young ; Choi, Eunjoo ; Lim, Jung A

PURPOSETo compare the intensity of pain on posterior portal placement between a C5-C7 root block (conventional interscalene brachial plexus block [ISBPB]) and a C5-C8 root block in patients undergoing arthroscopic shoulder surgery.METHODSIn this prospective, single-blinded, parallel-group randomized controlled trial, patients were randomized to receive either a C5-C7 root block (C5-C7 group, n = 37) or a C5-C8 root block (C5-C8 group, n = 36) with 25 mL of 0.75% ropivacaine. The primary outcome was the pain intensity on posterior portal placement, which was graded as 0 (no pain), 1 (mild pain), or 2 (severe pain). The secondary outcomes were the bilateral pupil diameters measured 30 minutes after ISBPB placement; the incidence of Horner syndrome, defined as a difference in pupil diameter (ipsilateral - contralateral) of less than -0.5 mm; the onset of postoperative pain; and the postoperative numerical rating pain score, where 0 and 10 represent no pain and the worst pain imaginable, respectively.RESULTSFewer patients reported mild or severe pain on posterior portal placement in the C5-C8 group than in the C5-C7 group (9 of 36 [25.0%] vs 24 of 37 [64.9%], P = .003). Less pain on posterior portal placement was reported in the C5-C8 group than in the C5-C7 group (median [interquartile range], 0 [0-0.75] vs 1 [0-1]; median difference [95% confidence interval], 1 [0-1]; P = .001). The incidence of Horner syndrome was higher in the C5-C8 group than in the C5-C7 group (33 of 36 [91.7%] vs 22 of 37 [59.5%], P = .001). No significant differences in postoperative numerical rating pain scores and onset of postoperative pain were found between the 2 groups.CONCLUSIONSA C5-C8 root block during an ISBPB reduces the pain intensity on posterior portal placement. However, it increases the incidence of Horner syndrome with no improvement in postoperative pain compared with the conventional ISBPB (C5-C7 root block).LEVEL OF EVIDENCELevel I, randomized controlled trial.

01 Dec 2017·BMC Infectious DiseasesQ3 · MEDICINE

The therapeutic HIV Env C5/gp41 vaccine candidate Vacc-C5 induces specific T cell regulation in a phase I/II clinical study

Q3 · MEDICINE

ArticleOA

Author: Brekke, Kristin ; Kvale, Dag ; Ökvist, Mats ; Sommerfelt, Maja ; Dyrhol-Riise, Anne Margarita

BACKGROUNDLevels of non-neutralising antibodies (AB) to the C5 domain of HIV Env gp120 are inversely related to progression of HIV infection. In this phase I/II clinical study we investigated safety of Vacc-C5, a peptide-based therapeutic vaccine candidate corresponding to C5/gp41^732-744 as well as the effects on pre-existing AB levels to C5/gp41^732-744, immune activation and T cell responses including exploratory assessments of Vacc-C5-induced T cell regulation. Our hypothesis was that exposure of the C5 peptide motif may have detrimental effects due to several of its HLA-like features and that enhancement of non-neutralising anti-C5 AB by vaccination could reduce C5 exposure and thereby chronic immune activation.METHODSThirty-six HIV patients on effective antiretroviral therapy were randomised to one of three dose levels of Vacc-C5 administered intramuscularly with Alhydrogel or intradermally with GM-CSF as adjuvant through initial immunisation and two booster periods over 26 weeks. Vacc-C5-specific AB were measured by ELISA and T cell responses by both IFN-γ ELISPOT and proliferative assays analysed by flow cytometry. Immune regulation was assessed by functional blockade of the two inhibitory cytokines IL-10 and TGF-β in parallel cultures. Non-parametric statistical tests were applied.RESULTSVacc-C5 was found safe and well tolerated in all patients. Only marginal changes in humoral and cellular responses were induced, without any effect on immune activation. Overall, anti-Vacc-C5 AB levels seemed to decrease compared to pre-existing levels. Whereas Vacc-C5-specific CD8⁺ T cell proliferative responses increased after the first booster period (p = 0.020; CD4⁺, p = 0.057), they were reduced after the second. In contrast, Vacc-C5-induced T cell regulation increased after completed vaccination (p ≤ 0.027) and was lower at baseline in the few AB responders identified (p = 0.027).CONCLUSIONSThe therapeutic HIV vaccine candidate Vacc-C5 safely induced only marginal immune responses, whereas Vacc-C5-induced T cell regulation markedly increased. Our data support further attention on immune regulation during therapeutic HIV vaccination studies.TRIAL REGISTRATIONNCT01627678 .

01 Jan 1983·Cancer detection and prevention

Surface antigens defined by monoclonal antibodies as tumor markers in human leukemia.

Article

Author: Lutz, D ; Majdic, O ; Liszka, K ; Knapp, W ; Bettelheim, P

The detection of surface-linked antigenic determinants by heteroantisera has greatly contributed to a better understanding of the heterogeneity of benign and malignant hematopoietic cells. The difficulties encountered in rendering these heteroantisera specific for a unique cell surface component have been a major drawback to a more rapid development of immunologic cell typing. With the introduction of hybridoma technology, it became possible to obtain monoclonal antibodies and markedly improve immunologic cell typing. We have, therefore, used this new technology for the production of monoclonal antibodies against human leukocyte surface antigens. This paper describes four cell type-specific monoclonal antibodies, which turned out to be very useful reagents in leukemia diagnosis. One of these antibodies, VIM-D5, is directed against a myeloid cell surface antigen. VIL-A1 is specific for the common acute leukemia associated antigen. VIB-C5 recognizes B-cell differentiation antigen and VIE-G4 is specific for glycophorin A, and thus detects erythroid precursor cells.

News (Medical) associated with Vacc-C5

24 Aug 2022

·www.prnewswire.com

Argenx's Vyvgart and Alexion's Ultomiris Go Toe-to-Toe in Generalized Myasthenia Gravis, According to Spherix Global Insights

Positive perceptions for both brands will drive expansion of patient share and prescriber base EXTON, Pa., Aug. 24, 2022 /PRNewswire/ -- Competition in the generalized myasthenia gravis (gMG) market is heating up with the launches of argenx's Vyvgart and Alexion's Ultomiris earlier this year. Both brands have the same approved indication but differ on mechanism of action, dosing profiles, and safety (among other factors). Spherix recently carried out a deep dive into neurologists' use and perceptions of the disease modifying therapies as part of the ongoing Launch Dynamix™: Vyvgart (argenx) and Ultomiris (Alexion) in gMG (US) service. Six months into the launch of Vyvgart, neurologists identified (unaided) the brand's efficacy and safety as its greatest advantages for the treatment of gMG. For Ultomiris, efficacy is also as a top advantage of the drug, in addition to its convenient dosing schedule. One interviewed neurologist reported, "I definitely like the every-eight-week dosing interval. It takes the guesswork out of it." Indeed, neurologists report a slight edge for Ultomiris over Vyvgart on favorable dosing, and at this early stage of Vyvgart's launch, some have questions on the drug's treatment schedule. As noted by one respondent, "The bad thing is it's kind of like an as-needed medication. After you give the first cycle, then you have to wait and see if there's deterioration. Sometimes patients get nervous. I can get nervous, especially in a patient who when they do deteriorate, they immediately go into crisis. That's why I choose my patients as to who I should give it to." Conversely, argenx's neonatal fragment crystallizable receptor (FcRn) blocker well outperforms Ultomiris on overall safety, with Alexion's C5 complement inhibitor having a black box warning for serious meningococcal infections – a feature not shared by Vyvgart. Interestingly, some interviewed neurologists did not perceive Ultomiris' black box warning or its REMS program to be a major deterrent to use of the brand – in part because of their previous experience with Alexion's Soliris. However, other neurologists did acknowledge that patients' comfort level with Ultomiris' safety risks does influence their prescribing decisions and not all patients are willing to accept those risks. With some neurologists' expectation that Vyvgart dosing in clinical practice will be more frequent than in the ADAPT Phase III clinical, one respondent noted that Vyvgart's safety in the real world might not mirror trial safety data: "The biggest concern I have is about the safety: we are absolutely, 100% going to be giving the drug [Vyvgart] more often than what was given in the clinical trial because I think they didn't conduct their studies the way they should have. The re-treatment criteria were way too strict…Therefore the safety data is not valid for the way it's going to be used." Despite these concerns, neurologists have overall welcomed the addition of Vyvgart as a new treatment option for gMG and view the brand's unique mechanism of action as fulfilling an unmet need for patients. Indeed, Vyvgart's patient share is expected to increase significantly in the next six months, coupled by expansion in its prescriber base. The launch of a subcutaneous version, expected in 2023, will likely further drive argenx's gMG franchise. About Launch Dynamix™ Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand. About Spherix Global Insights Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets. All company, brand or product names in this document are trademarks of their respective holders. For more information contact: Emma McFadden, Senior Insights Director, Neurology Email: [email protected] SOURCE Spherix Global Insights

16 Aug 2022

·www.globenewswire.com

FDA accepts supplemental Biologics License Application for Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma

First new treatment regimen in more than 20 years to significantly improve outcomes in people with this fast-growing type of lymphoma Application is based on pivotal data from the phase III POLARIX study showing Polivy plus R-CHP significantly reduced the risk of disease progression, relapse or death with comparable safety versus the standard of care, R-CHOPVarious combination studies with Polivy and the company's CD20xCD3 bispecifics in diffuse large B-cell lymphoma are ongoing Basel, 16 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). The FDA is expected to make a decision on approval by 2 April 2023.“The POLARIX study results suggest that Polivy plus R-CHP could transform the treatment of this aggressive malignancy, and we are working with the FDA to bring this combination to newly diagnosed DLBCL patients as soon as possible,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We hope it will become the new standard of care for the first-line treatment of DLBCL, potentially reducing the need for subsequent treatments and limiting patient burden.”DLBCL is an aggressive blood cancer. Although DLBCL often responds to initial treatment, it is not cured with the current standard of care in four out of 10 people. Most relapses occur within two years of starting treatment and the majority of those who require subsequent lines of therapy have poor outcomes.The sBLA is based on results from the pivotal phase III POLARIX trial, which is the first in two decades to show a clinically meaningful improvement in progression-free survival (PFS) compared to the current standard of care Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP). The risk of disease progression, relapse or death was reduced by 27% with Polivy plus R-CHP compared with R-CHOP after a median follow-up of 28.2 months (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57–0.95; p<0.02). Safety outcomes were consistent with those seen in previous clinical trials, and the safety profile was comparable for Polivy plus R-CHP versus R-CHOP, including rates of Grade 3-4 adverse events (AEs; 57.7% versus 57.5%), serious AEs (34.0% versus 30.6%), Grade 5 AEs (3.0% versus 2.3%), and AEs leading to dose reduction (9.2% versus 13.0%).Based on pivotal data from the POLARIX study, the European Commission approved Polivy in combination with R-CHP in May 2022 for the treatment of adult patients with previously untreated DLBCL. Polivy is currently approved as a readily available, fixed-duration treatment option for relapsed or refractory (R/R) DLBCL in combination with bendamustine and Mabthera/Rituxan in more than 70 countries worldwide, including in the EU and in the United States.Roche continues to explore areas of unmet need where Polivy has the potential to deliver additional benefit, including in ongoing studies investigating combinations of Polivy with the company’s CD20xCD3 T-cell engaging bispecific antibodies Lunsumio® (mosunetuzumab) and glofitamab, and with Rituxan in combination with gemcitabine and oxaliplatin in the phase III POLARGO study.About the POLARIX studyPOLARIX [NCT03274492] is an international phase III, randomised, double-blind, placebo- controlled study evaluating the efficacy, safety and pharmacokinetics of Polivy® (polatuzumab vedotin-piiq) plus Rituxan® (rituximab), cyclophosphamide, doxorubicin, and prednisone (R-CHP) versus rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in people with previously untreated diffuse large B-cell lymphoma. Eight-hundred and seventy-nine patients were randomised 1:1 to receive either Polivy plus R- CHP plus a vincristine placebo for six cycles, followed by rituximab for two cycles; or R-CHOP plus a Polivy placebo for six cycles, followed by two cycles of rituximab. The primary outcome measure is progression-free survival (PFS) as assessed by the investigator using the Lugano Response Criteria for malignant lymphoma. POLARIX is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC). Other clinical investigators from around the world also participated in the trial.About diffuse large B-cell lymphoma (DLBCL)DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for about one in three cases of NHL.[1] DLBCL is an aggressive (fast-growing) type of NHL. [1] While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.[2,3] Approximately 150,000 people worldwide are estimated to be diagnosed with DLBCL each year.[4]About Polivy® (polatuzumab vedotin-piiq)Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B-cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to minimise the effects on normal cells. Polivy is being developed by Roche using Seagen ADC technology and is currently being investigated for the treatment of several types of NHL. Polivy is currently marketed in the EU for the treatment of relapsed or refractory diffuse large B-cell lymphoma.About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of hematological diseases. Our approved medicines include MabThera/Rituxan® (rituximab), Gazyvaro/Gazyva® (obinutuzumab), Polivy® (polatuzumab vedotin-piiq), Venclexta/Venclyxto® (venetoclax) in collaboration with AbbVie, and Hemlibra® (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and Lunsumio®( mosunetuzumab), targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1 and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.In recognising our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.All trademarks used or mentioned in this release are protected by law.References[1] Cancer.Net. Leukemia – Lymphoma –Non-Hodgkin: Subtype. [Internet; cited 2022 July]. Available from: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes. [2] Maurer MJ, Ghesquières H, Jais JP, et al. Event-free survival at 24 months is a robust end point for disease- related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol. 2014;32(10):1066-1073.[3] Sehn LH, Gascoyne RD. Diffuse large B-cell lymphoma: optimizing outcome in the context of clinical and biologic heterogeneity. Blood. 2015;125(1):22-32.[4] Globocan 2020. World Fact Sheet. [Internet; cited 2022 July]. Available from: http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.[5] The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC) https://lymphoma-research-experts.org/ Roche Group Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 61 687 41 47 Nathalie AltermattPhone: +41 61 687 43 05 Karsten KleinePhone: +41 61 682 28 31 Nina MählitzPhone: +41 79 327 54 74 Dr. Barbara von SchnurbeinPhone: +41 61 687 89 67 Sileia Urech Phone: +41 79 935 81 48 Roche Investor Relations Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com Dr. Sabine BorngräberPhone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr. Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.com Dr. Gerard Tobin Phone: +41 61 68-72942 e-mail: gerard.tobin@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com Attachment 16082022_MR_Polivy

AntibodyFirst in ClassADCLicense out/in

05 Jul 2022

·www.globenewswire.com

FDA grants Priority Review to Roche’s Lunsumio for people with relapsed or refractory follicular lymphoma

Lunsumio® (mosunetuzumab) could be the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA for the treatment of any type of non-Hodgkin lymphoma Application is based on results from the pivotal phase I/II study showing Lunsumio induced high and durable complete response rates in people with follicular lymphoma who received two or more prior therapiesLunsumio is a fixed-duration treatment option with the potential to be administered in an outpatient setting Basel, 6 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for Lunsumio® (mosunetuzumab), a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies. FL is the most common indolent (slow growing) form of non-Hodgkin lymphoma (NHL), a type of blood cancer, which often returns after initial therapy. The FDA is expected to make a decision on approval of this novel cancer immunotherapy by 29 December 2022. “New therapeutic options are needed for follicular lymphoma, which often relapses after initial therapy and becomes increasingly difficult to treat each time it returns. Clinical trial results have demonstrated durable responses with Lunsumio in advanced follicular lymphoma, representing a step toward shifting the treatment paradigm,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Since Lunsumio does not require the collection or genetic modification of patient cells, it could become an effective, fixed-duration outpatient option without the barriers of travelling to a major academic centre.” The BLA is based on positive results from the pivotal phase I/II GO29781 study of Lunsumio, which showed high complete response (CR) rates, with the majority of responders (57% [95% CI: 49-70]) maintaining responses for at least 18 months, and manageable tolerability in people with heavily pretreated FL. After a median follow-up of 18.3 months, the CR rate was 60% (n=54/90) and the objective response rate was 80% (n=72/90). The median duration of response among those who responded was 22.8 months (95% CI: 9.7-not estimable). The most common adverse event (AE) was cytokine release syndrome (39%; n=86/218), which was generally low grade (grade 1: 25.6%; grade 2: 14%; grade 3: 2.3%; grade 4: 0.5%), and all events resolved. Other common AEs (>20%) included fatigue, headache, neutropaenia, fever and hypophosphataemia. Treatment was administered without mandatory hospitalisation. Results were presented for the first time in December 2021 at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition. Priority Review designation is granted to medicines that the FDA considers to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. The FDA granted Breakthrough Therapy designation (BTD) to Lunsumio for the treatment of adults with R/R FL who have received at least two prior systemic therapies in June 2020 and Orphan Drug Designation in December 2018. BTD is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence that indicates they may demonstrate substantial improvement over existing therapies. The European Commission granted conditional marketing authorisation for Lunsumio for the treatment of people with R/R FL who have received at least two prior systemic therapies in June 2022. A robust development programme for Lunsumio is ongoing including two phase III studies: CELESTIMO investigating Lunsumio plus lenalidomide in second line plus (2L+) FL, and SUNMO, investigating Lunsumio plus Polivy® (polatuzumab vedotin) in 2L+ diffuse large B-cell lymphoma (DLBCL). About the GO29781 studyThe GO29781 study [NCT02500407] is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Lunsumio® (mosunetuzumab) in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Outcome measures include complete response rate (best response) by independent review facility (primary endpoint), objective response rate, duration of response, progression-free survival, safety, and tolerability (secondary endpoints). About follicular lymphomaFollicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases. It typically responds well to treatment but is often characterised by periods of remission and relapse. The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis. In the United States, it is estimated that approximately 13,000 new cases of FL will be diagnosed in 2022. About Lunsumio® (mosunetuzumab)Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, diffuse large B-cell lymphoma, and other blood cancers. About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera® (rituximab), Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclyxto® (venetoclax) in collaboration with AbbVie, and Hemlibra® (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and Lunsumio® (mosunetuzumab), targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1 and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognizing our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. Roche Group Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 61 687 41 47Karsten KleinePhone: +41 61 682 28 31Nina MählitzPhone: +41 79 327 54 74Nathalie Meetz Phone: +41 79 771 05 25Dr. Barbara von SchnurbeinPhone: +41 61 687 89 67Sileia Urech Phone: +41 79 935 81 48 Roche Investor Relations Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.comDr. Sabine BorngräberPhone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.comDr. Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.comDr. Gerard Tobin Phone: +41 61 68-72942 e-mail: gerard.tobin@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com Attachment 06072022_MR_Lunsumio_FilingAcceptance_en

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