On February 28, 2022 Thermo Fisher Scientific reported that it is calling for new proposals for its Oncomine Clinical Research Grant (Press release, Thermo Fisher Scientific, FEB 28, 2022, View Source [SID1234609168]). The latest request for submissions from the global scientific community will award funding for molecular profiling research that helps accelerate the use of genomic sequencing in oncology .

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"Next-generation sequencing is vital to match eligible patients with lung carcinomas with targeted therapies, but often this testing takes too long to inform their care"

The recipients of the grants will each be awarded up to $200,000 in reagents and general funding for independent clinical research proposals that demonstrate excellence in cancer molecular profiling. Project proposals harnessing the value of next generation sequencing (NGS) in either the context of solid or hematological cancers will be reviewed by independent and internationally recognized experts for scientific rigor and merit. Grant proposals are now being accepted through April 7, 2022.

"The Oncomine Clinical Research Grant program aims to fund research furthering our understanding of cancer at the genomic level. The identification of specific cancer biomarkers associated with response or resistance to treatment can inform clinical care and potentially help predict patient outcomes," said José Luis Costa, Ph.D., director of medical affairs for clinical next-generation sequencing and oncology, Thermo Fisher Scientific. "Thermo Fisher is committed to supporting scientists and researchers globally as we look to advance cutting-edge genetic research."

Since launching the program in 2020, Thermo Fisher has awarded Oncomine Clinical Research Grants to 16 projects worldwide in support of research in hematology-oncology, immuno-oncology, liquid biopsy, and fusion gene detection. Recipients of the last funding round, which supported clinical research programs using NGS technology in solid tumors and hematology-oncology applications, included: Myung-shin Kim, The Catholic University of Korea Seoul St. Mary’s Hospital, South Korea; Wolfram Jochum, Kantonsspital St. Gallen, Switzerland; Fernando Lopez-Rios, Hospital Universitario 12 de Octubre, Spain; Tarek Bismar, University of Calgary, Canada.

"Next-generation sequencing is vital to match eligible patients with lung carcinomas with targeted therapies, but often this testing takes too long to inform their care," said grant recipient Fernando Lopez-Rios, Hospital Universitario 12 de Octubre. "With the support from the Oncomine Clinical Research Grant, we hope to demonstrate that comprehensive genomic sequencing with very rapid turnaround times can increase patient access and advance the idea of universal testing of all patients with lung carcinomas, including those with early-stage disease."

On February 28, 2022 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported that a phase II study of Kazia’s investigational new drug, paxalisib, in combination with metformin and a ketogenic diet for the treatment of newly diagnosed and recurrent glioblastoma, has been initiated at Weill Cornell Medicine, with the first patient successfully initiated in the study and a second patient already in screening (Press release, Kazia Therapeutics, FEB 28, 2022, View Source [SID1234609185]).

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Key Points

Research by Professor Lew Cantley, who discovered the PI3K pathway, suggests that a low-insulin state may enhance the activity of PI3K inhibitors such as paxalisib. Inducing a ‘ketogenic’ state, in which the body is fueled by fats and proteins rather than by glucose, is a very effective way to reduce insulin levels.
Patients on the study will also be treated with metformin, a common anti-diabetic drug, which is intended in this case to further reduce insulin levels.
The Cornell study will explore this approach. One arm of the study will examine patients with recurrent disease, and the other will enroll newly diagnosed patients.
Dr Howard Fine, founding Director of the Brain Tumor Center at New York-Presbyterian Weill Cornell Medical Center, will serve as Principal Investigator.
The study is expected to recruit between 30 and 60 patients, and to take approximately two years to complete.
Kazia will provide support, including study drug and a financial grant.
Dr Fine, Principal Investigator on the study, commented, "We have extensive and very convincing preclinical data to support this approach. My colleagues and I believe that administering paxalisib to patients in a ketogenic state may significantly enhance its efficacy. That in turn offers the potential to make a very significant difference in the treatment of glioblastoma, which remains one of the most challenging cancers in modern medicine."

Kazia CEO, Dr James Garner, commented, "We are delighted to have this study now underway and look forward to following its progress. This important milestone kicks off an exciting year for Kazia, with at least six potential data read-outs anticipated over the course of 2022. The GBM AGILE study continues to progress well, and additional studies, such as this one, have the potential to substantially extend and enhance the use of paxalisib in clinical practice."

Ketogenesis and Glioblastoma

Cells in the human body generally rely on glucose as ‘fuel’ for their energy requirements. However, when glucose is not readily available, cells can metabolise fats and proteins to provide energy. The fats and proteins are broken down to an intermediate form known as ketones, and so this biochemical pathway is referred to as ‘ketogenesis’.

Unlike healthy cells, most tumour cells are poorly able to metabolise ketones, and so depend on glucose for their energy needs. Consequently, many researchers have experimented with ‘ketogenic diets’ as a potential treatment for cancer.[1]

In addition, scientists in Professor Cantley’s lab have shown that insulin has the potential to counteract the anti-tumor effects of PI3K inhibitors[2]. In follow-up, Dr Fine’s lab has shown that insulin can reverse the anti-tumor effects of PI3K inhibitors specifically in glioblastoma cells. Insulin is a hormone produced by the body in response to high levels of glucose. When the body is in a state of ketosis, glucose is absent, and so insulin falls to very low levels.

For these reasons, there is a sound rationale to explore a combination of ketogenic diet and paxalisib in glioblastoma. In this study, patients will also receive metformin, a common anti-diabetic drug, which will help to further lower fasting insulin levels.

Clinical Trial Design

This study will comprise two arms. The first will contain patients with newly diagnosed glioblastoma who have unmethylated MGMT promotor status. These patients have historically responded poorly to the current standard of care, temozolomide. The second arm will contain patients with recurrent disease, regardless of the methylation status of their MGMT promotor, who have progressed after taking standard-of-care therapy.

In each arm, paxalisib will be combined with metformin and with a ketogenic diet. The diet will be overseen by expert clinical dieticians to ensure that it is scientifically appropriate and that patients are compliant.

An initial cohort of approximately 16 patients will be recruited to each of the two study arms. If there are signals of activity in a given arm, that arm will be expanded to approximately 30 patients. The primary endpoint will be progression-free survival at six months (PFS6). In addition to efficacy and safety, the study will examine a range of metabolic, pharmacodynamic, and novel radiographic imaging biomarkers to inform future research and clinical practice. The study is expected to take around two years to complete.

Principal Investigator

Dr Howard Fine will serve as Principal Investigator to the study. Dr Fine is the founding Director of the Brain Tumor Center at New York-Presbyterian Weill Cornell Medical Center, Feil Professor of Medicine a Professor of Neurology at Weill Cornell Medicine. He is an internationally recognized leader in the field of neuro-oncology, with more than 30 years of experience in both laboratory and clinical research as well as in the care of patients with brain tumors. Dr Fine has built large multidisciplinary brain tumor programs at top academic institutions such as the Dana Farber Cancer Institute / Harvard Medical School and the National Institutes of Health, has cared for nearly 20,000 patients with brain and spinal cord tumors in his career, has conducted over 100 clinical trials, published over 250 papers and book chapters on brain tumors, and for over two decades has run a continuously operating translational genetic / molecular laboratory devoted to a better understanding of, and better therapies for, brain tumors.

Weill Cornell Medical Center

The Joan and Sanford I. Weill Medical College of Cornell University, known generally as Weill Cornell Medicine, is the medical school of Cornell University, based in New York, NY, and is one of the leading medical research centers in the United States. Its notable alumni include Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Disease.

Paxalisib Clinical Program

The initiation of this trial in glioblastoma brings the number of ongoing clinical studies of paxalisib in brain cancer to eight.

On February 27, 2022 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported the successful dosing of first patient in China Phase IIa Study of TST001, a Claudin18.2 monoclonal antibody, combined with Cisplatin and Gemcitabine for the first line treatment of systemic treatment-naïve locally advanced or metastatic biliary tract cancer patients (Press release, Transcenta, FEB 27, 2022, View Source [SID1234609084]). Globally Transcenta is the first company exploring the potential of Claudin 18.2 targeting agent in biliary tract cancer.

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Biliary tract cancer is a relatively rare malignancy, which includes cholangiocarcinoma and gallbladder carcinoma. Cholangiocarcinoma is further classified into extrahepatic and intrahepatic cholangiocarcinoma. In the treatment of biliary tract cancer, radical resection is the standard and only approach for patients at the early stage. However, most of the patients cannot receive surgical resection, as the cancer has stepped into the metastatic stage by the time of diagnosis. For biliary tract cancer, few effective therapies are available for these patients, which leaves significant unmet clinical needs.

This Phase IIa clinical trial is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and anti-tumor efficacy of TST001 in patients with systemic treatment-naïve locally advanced or metastatic biliary tract cancer. These patients will be screened using an immunohistochemistry assay developed by Transcenta and validated by central lab that specifically detects Claudin18.2 but not Claudin 18.1.

"Biliary tract cancer has poor prognosis and the combination of Cisplatin and Gemcitabine is the standard of care for first line treatment." said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta." Using our proprietary IHC antibody, Transcenta has shown that Claudin18.2 is over-expressed in the tumor of a subset of biliary tract cancer patients. As the combination of Claudin18.2 targeting agent with chemo backbone has shown promising activity in first line gastric cancer, the addition of TST001 to the first line chemotherapy regimen may also provide better treatment benefit to biliary tract cancer patients with Claudin18.2-expressing tumor."

About TST001
TST001 is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities and potent anti-tumor activities in tumor xenograft models. TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally. TST001 is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 kills Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001. Clinical trials for TST001 are ongoing in China and US (NCT04396821, NCT04495296/CTR20201281). TST001 was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).

On February 27, 2022 JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported that the National Medical Products Administration (NMPA) of China accepted the supplemental New Drug Application (sNDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) (Press release, JW Therapeutics, FEB 27, 2022, View Source [SID1234609085]). This is the second marketing application on Carteyva submitted by JW Therapeutics, and is expected to be the first cell therapy product approved in China for the treatment of r/r FL patients. Carteyva was granted Breakthrough Therapy Designation by NMPA in September 2020.

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The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China. The study results were presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021. The cohort B results showed that Carteyva demonstrated very high rates of durable disease response (Best Complete Response Rate and Overall Response Rate at 3 months was 92.6% and 100%, respectively) and controllable CAR-T associated toxicities in patients with r/r FL (42.9% and 17.9% of the patients had any grade Cytokine Release Syndrome (CRS) and Neurotoxicity (NT), while 0% and 3.6% of the patients experienced CRS and NT of Grade 3 or above).

Professor Yuqin Song, Chief Physician of Lymphoma Department at Peking University Cancer Hospital, Director of China Society of Clinical Oncology (CSCO), noted at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting: "The RELIANCE study results show that Carteyva demonstrated very excellent efficacy and safety profile in patients with r/r FL and we are looking forward to the sNDA approval in China."

About Relmacabtagene Autoleucel Injection (trade name: Carteyva)

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.

About RELIANCE Study (NCT04089215)

RELIANCE study was a single-arm, multi-center, pivotal study to evaluate the efficacy and safety of Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma (cohort A: relapsed or refractory large B-cell lymphoma, cohort B: relapsed or refractory follicular lymphoma) in China.

RELIANCE cohort B study enrolled 28 patients with r/r FL who had failed the second-line (or above) therapy, including an anti-CD20 agent and anthracycline. Patients received 100*106 CAR-T or 150*106 CAR-T cell of Carteyva infusion, and followed up until 2 years or above for long term outcomes. As of the cut-off date of September 10, 2021, of 27 evaluable patients, the Complete Response Rate (CRR) and Overall Response Rate (ORR) at 3 months were 85.19% and 100%, and the Best Complete Response Rate and Overall Response Rate was 92.6% and 100%, respectively. Of 28 treated patients, 42.9% and 17.9% of the patients had any grade Cytokine Release Syndrome (CRS) and Neurotoxicity (NT), Among these AEs, no CRS of Grade 3 or above occurred, and only 3.6% of the patients experienced NT of Grade 3 or above.

On February 25, 2022 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter and year ended December 31, 2021 (Press release, ImmunoGen, FEB 25, 2022, View Source [SID1234609037]).

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"2021 was a productive year for ImmunoGen, highlighted by positive pivotal data for our lead program, advances across our earlier-stage portfolio, and further strengthening our balance sheet and management team," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "The top-line SORAYA data provide the opportunity to establish mirvetuximab soravtansine as the new standard of care for patients with FRα-positive platinum-resistant ovarian cancer, and we look forward to presenting detailed results from SORAYA during the plenary session at SGO next month."

Enyedy continued, "We also formalized our plans to expand mirvetuximab into platinum-sensitive disease as a monotherapy and in combinations to serve a broader population of ovarian cancer patients, presented promising initial data for IMGN632, now known as pivekimab sunirine, in relapsed/refractory AML and frontline BPDCN at ASH (Free ASH Whitepaper), continued dose-escalation for IMGC936, and submitted the IND for IMGN151. Together with the appointment of key leadership positions and an oversubscribed follow-on offering in the fourth quarter, this progress positions us for success in 2022 and beyond. We have an exciting year ahead, with the potential launch of our first product, top-line data for our second pivotal program, advancement of our earlier-stage portfolio, and further building our pipeline and research capabilities."

RECENT PROGRESS

●Reported positive top-line data from SORAYA, a pivotal single-arm study of mirvetuximab soravtansine (mirvetuximab) in folate receptor alpha (FRα)-high platinum-resistant ovarian cancer in patients previously treated with Avastin (bevacizumab).
●Continued patient enrollment in the confirmatory MIRASOL study.
●Initiated accrual in PICCOLO, a single-arm study of mirvetuximab monotherapy in FRα-high recurrent platinum-sensitive ovarian cancer.
●Aligned with the US Food and Drug Administration (FDA) on the design for GLORIOSA, a randomized Phase 3 study of mirvetuximab in combination with bevacizumab maintenance in FRα-high platinum-sensitive ovarian cancer.
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●Supported investigator-sponsored trials of mirvetuximab plus carboplatin in a single-arm study in the neoadjuvant setting and a randomized study in patients with recurrent platinum-sensitive ovarian cancer.
●Continued the pivotal Phase 2 CADENZA study of pivekimab sunirine (pivekimab, formerly IMGN632) in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).
●Presented initial data from the Phase 1b/2 study of pivekimab in combination with Vidaza (azacitidine) and Venclexta (venetoclax) in R/R acute myeloid leukemia (AML) in an oral session, and initial frontline BPDCN data in a poster session, at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
●Opened an expansion cohort combining pivekimab, azacitidine, and venetoclax in unfit relapsed AML.
●Advanced dose escalation in the Phase 1 study of IMGC936 in multiple solid tumor types.
●Submitted the investigational new drug (IND) application for IMGN151.
●Appointed Kristen Harrington-Smith as Chief Commercial Officer, Mimi Huizinga, MD, MPH, FACP as Head of Medical Affairs, and Tracey L. McCain, Esq. to the Board of Directors.
●Announced a global licensing agreement granting Eli Lilly and Company (Lilly) exclusive rights to research, develop, and commercialize ADCs directed to targets selected by Lilly based on ImmunoGen’s novel camptothecin technology.

ANTICIPATED UPCOMING EVENTS

●Present full SORAYA data during the plenary session at the Society of Gynecologic Oncology (SGO) Annual Meeting in March.
●Submit the biologics license application (BLA) to the FDA for mirvetuximab in FRα-high platinum-resistant ovarian cancer in the first quarter of 2022 to support potential accelerated approval and launch.
●Generate top-line data for the confirmatory MIRASOL study in the third quarter of 2022.
●Initiate GLORIOSA, a randomized Phase 3 trial of mirvetuximab in combination with bevacizumab maintenance in FRα-high platinum-sensitive ovarian cancer, in the second quarter of 2022.
●Initiate Trial 0420, a single-arm Phase 2 trial of mirvetuximab in combination with carboplatin followed by mirvetuximab continuation in FRα-low, medium, and high patients with platinum-sensitive ovarian cancer, in the second quarter of 2022.
●Report top-line data from the pivotal CADENZA study of pivekimab in BPDCN in the second half of 2022.
●Initiate expansion cohort combining pivekimab, azacitidine, and venetoclax in frontline AML.
●Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated in 2022.
●Begin enrollment in the Phase 1 study of IMGN151 following submission of chemistry, manufacturing, and controls (CMC) information to the FDA.

FINANCIAL RESULTS

Total revenues were $28.0 million for the quarter ended December 31, 2021 compared to $85.8 million for the quarter ended December 31, 2020, and $69.9 million for the year ended December 31, 2021 compared to $132.3 million for the year ended December 31, 2020. The decrease in both periods was driven by the recognition of a $60.5 million upfront fee received under the Company’s collaboration agreement with Jazz Pharmaceuticals during the quarter and year ended December 31, 2020 and a reduction in non-cash royalty revenue in 2021 due to the completion of the first tranche of payments under the 2015 Kadcyla royalties agreement. Partially offsetting these decreases, during the quarter and year ended December 31, 2021, the Company recognized $14.6 million of the $40.0 million upfront fee previously received pursuant to the Company’s collaboration agreement with Huadong Medicine.

Research and development expenses rose to $49.0 million for the quarter ended December 31, 2021 compared to $39.6 million for the quarter ended December 31, 2020, and $151.1 million for the year ended December 31, 2021 compared to $114.6 million for the year ended December 31, 2020. The increases in both periods were driven by greater clinical trial expenses, personnel and temporary staffing costs, external manufacturing costs, and third-party service fees in support of commercial readiness.

General and administrative expenses were $13.6 million for the quarter ended December 31, 2021 compared to $9.7 million for the quarter ended December 31, 2020, and $43.8 million for the year ended December 31, 2021 compared to $38.6 million for the year ended December 31, 2020. The increases in both periods were

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driven by higher professional fees and personnel expenses, including greater non-cash stock compensation expense.

Net loss for the fourth quarter of 2021 was $(37.2) million, or $(0.17) per diluted share, compared to net income of $31.4 million, or $0.16 per diluted share, for the fourth quarter of 2020. Net loss for the year ended December 31, 2021 was $(139.3) million, or $(0.68) per diluted share, compared to a net loss of $(44.4) million, or $(0.25) per diluted share, for the year ended December 31, 2020.

ImmunoGen had $478.8 million in cash and cash equivalents as of December 31, 2021, compared with $293.9 million as of December 31, 2020, and had $2.1 million of convertible debt outstanding as of December 31, 2020. There was no convertible debt outstanding as of December 31, 2021. Cash used in operations was $169.4 million for the year ended December 31, 2021 compared with $78.6 million for the year ended December 31, 2020, with the prior year benefitting from a $40 million upfront license payment received from Huadong Medicine and lower operating expenses for the year as discussed above. Capital expenditures were $(1.4) million for year ended December 31, 2021, compared with $0.5 million of net proceeds from the sale of equipment in the year ended December 31, 2020.

FINANCIAL GUIDANCE

For 2022, ImmunoGen expects:

●revenues between $75 million and $85 million;
●operating expenses between $285 million and $295 million; and
●cash and cash equivalents at December 31, 2022, to be between $245 million and $255 million.

Given the range in timing for potential approval, revenue guidance does not yet include potential product sales from mirvetuximab.

ImmunoGen expects that its current cash, combined with anticipated product and collaboration revenues, will fund operations into 2024.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 5566069. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.