Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type

Early analysis reveals clinically meaningful activity in refractory DLBCL patients Multiple confirmed complete responses observed in heavily pre-treated patients No adverse safety and tolerability signal reported, consistent with previous clinical trials DARTMOUTH, Nova Scotia, & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- IMV Inc. (Nasdaq: IMV; TSX: IMV) (“IMV” or the “Company”), a clinical-stage biopharmaceutical company developing a portfolio of immune-educating therapies based on its novel DPX® platform to treat solid and hematologic cancers, today announced positive preliminary data from the VITALIZE Phase 2B trial evaluating its lead DPX product, maveropepimut-S (“MVP-S”), in combination with pembrolizumab in patients with relapsed, refractory Diffuse Large B Cell Lymphoma (“r/r DLBCL”). Key initial findings from the ongoing VITALIZE trial: 8 Patients with an ECOG1 score of 0-1 have been enrolled in arm 1 of the study. Of these, 6 have so far been evaluable for efficacy; Of these 6 evaluable patients, 3 patients showed confirmed complete responses, 1 patient was assessed with stable disease as best response and 2 patients were assessed with progressive disease as best response; and 2 patients with poor level of baseline functionality (ECOG ≥ 2) failed to stay on study through to the first scan and therefore could not be evaluated. Overall Response Rate (“ORR”) will be communicated when the totality of stage one data are available for definitive assessment. “VITALIZE is our most advanced and rigorous trial to date, and we are encouraged by the way the data for MVP-S are trending. This is the most refractory population of patients we have treated so far, and to show complete, confirmed clinical responses is notable. These positive initial results, combined with the accelerating recruitment of the AVALON study in platinum resistant ovarian cancer add, we believe, to the growing industry enthusiasm about the potential for MVP-S in multiple tumor settings,” said Andrew Hall, CEO of IMV. About the VITALIZE Study The VITALIZE Phase 2B trial is a randomized, parallel group, Simon two-stage study designed to assess IMV’s lead candidate, MVP-S, in combination with pembrolizumab with (arm 1) or without (arm 2) cyclophosphamide. Across the arms of this study, the combination will be evaluated in up to 30 patients in stage one (two arms of 15) with the option to expand to up to a total of 102 subjects in stage two with r/r DLBCL who have received at least two prior lines of systemic therapy and who are ineligible or have failed autologous stem cell transplant (ASCT) or CAR-T therapy. About the AVALON study The AVALON study is an open label, company-sponsored phase 2b, single arm trial evaluating the efficacy and safety of MVP-S and intermittent low-dose cyclophosphamide (CPA) in patients with platinum-resistant ovarian cancer. The study is a Simon two-stage design where up to 41 subjects will be evaluated in stage one, with the option to expand to up to a total of 73 patients in stage two. Patients participating in the trial will receive two doses of subcutaneous MVP-S once every three weeks, followed by an MVP-S dose once every eight weeks, plus low-dose oral CPA on a repeating cycle of one week on/one week off. About IMV IMV Inc. is a clinical-stage immuno-oncology company advancing a portfolio of therapies based on the Company’s immune-educating platform, DPX®. Through a differentiated mechanism of action, the DPX platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. IMV’s lead candidate, maveropepimut-S (MVP-S), delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers. MVP-S also delivers an innate immune activator and a universal CD4 T cell helper peptide. These elements foster maturation of antigen presenting cells as well as robust activation of CD8 T cell effector and memory function. MVP-S treatment has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. MVP-S is currently being evaluated in clinical trials for hematologic and solid cancers, including Diffuse Large B Cell Lymphoma (DLBCL) as well as ovarian, bladder and breast cancers. IMV is also developing a second immunotherapy leveraging the DPX immune delivery platform, DPX-SurMAGE. This dual-targeted immunotherapy combines antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously. A Phase 1 clinical trial in bladder cancer, using MVP-S or DPX-SurMAGE, was initiated in early 2022. For more information, visit and connect with us on Twitter and LinkedIn. IMV Forward-Looking Statements This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements use such word as “will”, “may”, “potential”, “believe”, “expect”, “continue”, “anticipate” and other similar terminology. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In this press release, such forward-looking statements include, but are not limited to, statements regarding the potential and efficacy of MVP-S, the potential impact of the VITALIZE study and timing of availability of the ORR from the remaining stage one patients from its Phase 2B trial, the Company’s ability to advance its development strategy, and the prospects for its lead immunotherapy and its other pipeline of immunotherapy candidates. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties, and those risks and uncertainties include, but are not limited to, those related to the detailed results when presented being at least consistent with the initial results from the VITALIZE Phase 2B trial, the Company’s priorities with MVP-S and its DPX delivery platform, the potential for its delivery platform and the anticipated timing of enrollment and results for its clinical trial programs and studies as other risks detailed from time to time in our ongoing quarterly filings and annual information form. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at and on EDGAR at . 1 ECOG is a measure of patient functionality and is measured according to a standardized measure ranging from 0-5. Oken et al., Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-655. PMID: 7165009

MONROVIA, Calif.--(BUSINESS WIRE)-- Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, today announced additional clinical data from expansion cohorts in its Phase 1 study of plamotamab, a CD20 x CD3 bispecific antibody, in patients with relapsed or refractory non-Hodgkin lymphomas. Data will be presented by Krish Patel, M.D., Director of the Lymphoma Program at Swedish Cancer Institute, in a poster session today from 6:00 p.m. to 8:00 p.m. CST at the 64th American Society of Hematology (ASH) Annual Meeting in New Orleans, Louisiana. “Patients with non-Hodgkin lymphomas need further therapy options which can be efficacious, well-tolerated and importantly, administered in a variety of settings,” said Dr. Patel. “In the Phase 1 monotherapy study of plamotamab, the recommended intravenous dose was well tolerated, and we are encouraged by the responses observed in the study. This was a cohort of patients that were heavily pretreated, enriched with adverse prognostic factors, and included poor risk histology, such as high-grade B cell lymphoma and activated B-cell DLBCL.” “Our strategy is to develop plamotamab as part of multiple highly active chemotherapy-free regimens across B-cell cancers. Xencor’s first combination study, evaluating plamotamab with tafasitamab plus lenalidomide, is enrolling patients with advanced, aggressive lymphoma. Importantly, we are engineering novel B-cell targeted CD28 bispecific antibodies that may selectively enhance T-cell cytotoxic activity,” said Allen Yang, M.D., Ph.D., senior vice president and chief medical officer at Xencor. “Additionally, patients enrolling to the ongoing Phase 1 monotherapy study will now receive subcutaneous doses of plamotamab.” At data cut off on August 24, 2022, 44 patients with relapsed or refractory non-Hodgkin lymphoma (NHL) had been enrolled before June 30, 2022 and received the recommended dose. Patients had a median age of 69 years and had received a median of 4 prior therapies. At baseline, 86% had advanced stage III or IV disease. Additionally, 50% of patients received CAR-T as a prior therapy. The primary disease at enrollment for these patients was diffuse large B-cell lymphoma (DLBCL; n=26), high-grade B-cell lymphoma (HGBCL; n=6), follicular lymphoma (FL; n=10), and other lymphoma (n=2). Safety Analysis The safety pro plamotamab was consistent with previous results. The most common Grade 3 or 4 treatment-emergent adverse events (AEs) across all patients were neutropenia (25.0%), anemia (15.9%) and lymphopenia (11.4%). Grade 3 immune effector cell-associated neurotoxicity syndrome was observed in one patient (2.3%). AEs leading to plamotamab discontinuation occurred in nine patients (20.5%), including four patients (9.1%) who discontinued due to COVID-19. Cytokine release syndrome (CRS), the most common AE, was observed in 70.5% of patients, and no patients experienced Grade 3 or 4 CRS. Efficacy Analysis The efficacy analysis included both evaluable and intent-to-treat (ITT) patient populations. Responses were assessed based on the Lugano Classification. In the efficacy evaluable population of patients with DLBCL or HGBCL, the overall response rate (ORR) was 52.0% (13/25), and the complete response rate was 24.0% (6/25). For patients who received prior CAR-T therapy, the ORR was 50.0% (8/16), and the CR rate was 25.0% (4/16). In the ITT population, the ORR was 43.8% (14/32), and the complete response rate was 18.8% (6/32). The median duration of response (mDOR) for both populations was 126 days. In the efficacy evaluable population of patients with FL, the ORR was 87.5% (7/8), and the CR rate was 50.0% (4/8). In the ITT population, the ORR was 80.0% (8/10), and the CR rate was 40.0% (4/10). The mDOR for both populations had not been reached. Dose Exposure-Response Analysis An analysis of the plamotamab exposure-response (ER) relationship from the dose-escalation portion of the Phase 1 study examined IL-6 levels, CRS incidence, high-grade AEs and overall response. First-dose CRS was related to maximum plamotamab concentration (Cmax). The probability of CRS with step-up dosing, however, was better modeled using the magnitude of the step-up increment, as measured by the ratio of Cmax after dosing to the concentration prior to that dosing (Ctrough). Once the target dose was reached, there was no relationship of exposure to high-grade CRS. This analysis indicates the potential for a wide therapeutic window at the target dose and provides guidance for improving dosing regimens in future clinical studies of plamotamab. The poster will be archived under "Events & Presentations" in the Investors section of the Company's website located at . About Plamotamab Plamotamab is an investigational tumor-targeted XmAb® bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3). CD20 is highly expressed across a range of B-cell tumors, including non-Hodgkin lymphoma (NHL). Engagement of CD3 by plamotamab activates T cells for highly potent and targeted killing of CD20-expressing tumor cells. Safety and anti-tumor activity from the ongoing Phase 1 clinical study has indicated that plamotamab was generally well tolerated and demonstrated encouraging clinical activity as a monotherapy. Plamotamab is also being evaluated in a Phase 2 study, in combination with tafasitamab plus lenalidomide, in patients with relapsed or refractory diffuse large B-cell lymphoma. The study consists of two parts, a safety run-in intended to establish the safety of the triple combination and a two-arm, open-label cohort where patients will be randomized to receive either the triple combination or tafasitamab plus lenalidomide. Xencor has entered an exclusive collaboration and worldwide license agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize plamotamab and novel XmAb B-cell targeting bispecific antibodies that are designed to conditionally activate T cells through co-stimulation. About Xencor Xencor is a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases. More than 20 candidates engineered with Xencor's XmAb® technology are in clinical development, and three XmAb medicines are marketed by partners. Xencor's XmAb engineering technology enables small changes to a protein's structure that result in new mechanisms of therapeutic action. For more information, please visit . Forward-Looking Statements Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by the use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” and similar terms, or by express or implied discussions relating to clinical trial data for plamotamab generally, planned clinical trials, the quotations from Xencor management and study investigator and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks, including the ability of publicly disclosed preliminary clinical trial data to support continued clinical development and regulatory approval for specific treatments, in each case as described in Xencor's public securities filings. For a discussion of these and other factors, please refer to Xencor's annual report on Form 10-K for the year ended December 31, 2021 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended to date. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

Sept. 30, 2022 11:05 UTC Enrollment has accelerated in the last quarter, reflecting enthusiasm for this novel treatment option Data to be presented at a scientific conference in early 2023 DARTMOUTH, Nova Scotia, & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company developing a portfolio of immune-educating therapies based on its novel DPX® platform to treat solid and hematologic cancers, today provided an update on the open-label VITALIZE study evaluating its lead product maveropepimut-S (MVP-S) in combination with pembrolizumab and intermittent low-dose cyclophosphamide (CPA) in patients with relapses, refractory diffuse large B cell lymphoma (r/r DLBCL). “There is growing enthusiasm for the VITALIZE trial and for the active and well-tolerated treatment option MVP-S represents for patients with relapsed or refractory DLBCL,” said Dr. Matthew J. Matasar, Section Head for aggressive B cell lymphoma at the Memorial Sloan Kettering Cancer Center, and primary investigator for the VITALIZE trial. Dr. Matasar added: “Both site activation and enrollment have increased substantially in the last few months, despite there being a number of competitive trials in this space. This reflects the therapeutic potential of MVP-S in combination with pembrolizumab and cyclophosphamide in relapsed or refractory DLBCL. We look forward to sharing maturing clinical response data at a scientific conference early next year.” “As previously committed, the company is providing an update on our VITALIZE Phase 2b trial. The results of this trial will be an important validation for both MVP-S and, more broadly, the DPX platform,” said Andrew Hall, CEO IMV. “To be able to confirm that a survivin-targeted vaccine provides meaningful efficacy in a refractory DLBCL population through a company sponsored, multi-national study would be significant for the whole class of therapeutic vaccines.” In the investigator-initiated SPiReL trial (NCT03349450), the combination of MVP-S, pembrolizumab and low-dose, intermittent cyclophosphamide provided clinical benefit (complete and partial responses by Cheson criteria) in r/r DLBCL patients. Moreover, translational analyses showed that clinical benefit was most notable in patients showing survivin-specific T cell responses (data presented by Berinstein et al., ASH 2020). The VITALIZE study is an open label, multi-centric, international phase 2b trial designed to explore further the clinical benefit of MVP-S combined with pembrolizumab with and without low-dose, intermittent cyclophosphamide in patients with r/r DLBCL. About IMV IMV Inc. is a clinical-stage immuno-oncology company advancing a portfolio of therapies based on the Company’s immune-educating platform, DPX®. Through a differentiated mechanism of action, the DPX platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. IMV’s lead candidate, maveropepimut-S (MVP-S), delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers. MVP-S also delivers an innate immune activator and a universal CD4 T cell helper peptide. These elements foster maturation of antigen presenting cells as well as robust activation of CD8 T cell effector and memory function. MVP-S treatment has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. MVP-S is currently being evaluated in clinical trials for hematologic and solid cancers, including Diffuse Large B Cell Lymphoma (DLBCL) as well as ovarian, bladder and breast cancers. IMV is also developing a second immunotherapy leveraging the DPX immune delivery platform, DPX-SurMAGE. This dual-targeted immunotherapy combines antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously. A Phase 1 clinical trial in bladder cancer, using MVP-S or DPX-SurMAGE, was initiated in early 2022. For more information, visit and connect with us on Twitter and LinkedIn. IMV Forward-Looking Statements This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements use such word as “will”, “may”, “potential”, “believe”, “expect”, “continue”, “anticipate” and other similar terminology. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In this press release, such forward-looking statements include, but are not limited to, statements regarding the potential impact of the VITALIZE and AVALON studies and the anticipated date data from such studies will be available; the anticipated rate of enrollment in IMV’s studies and clinical trial programs, the anticipated upcoming milestones and clinical trial outcomes with respect to IMV’s product candidates, in particular MVP-S and DPX-SurMAGE, the date to which IMV’s current cash position is expected to sufficiently fund operations; the Company’s ability to advance its development strategy, the prospects, for its lead immunotherapy and its other pipeline of immunotherapy candidates, as well as, IMV’s ability to maintain its Nasdaq listing beyond the Compliance Period. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties, and those risks and uncertainties include, but are not limited to, those related to the Company’s expected timeline associated with its cash runway; the Company’s priorities with MVP-S and its DPX delivery platform, the potential for its delivery platform and the anticipated timing of enrollment and results for its clinical trial programs and studies as other risks detailed from time to time in our ongoing quarterly filings and annual information form. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at and on EDGAR at .