A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study - IgPro20_3007

Start Date11 Apr 2024

Sponsor / Collaborator

CSL Behring LLC

[+1]

NCT05193552 / RecruitingPhase 4IIT

A Prospective Study of the Utility of Spirometry to Identify and Manage Immunoglobulin Replacement Dosage in Primary Antibody Deficiency in Patients With Potentially Reversible Airway Disease

Although there is evidence in the literature that gammaglobulin replacement therapy can lead to a reduction in the prevalence of pulmonary infection and improved lung function, there is no published study to guide immunologists regarding the use of spirometry in titrating IG therapy to assist in the management of immunodeficiency patients with regards to gammaglobulin replacement therapy.
The investigators propose to study the use of spirometry to identify patients that could potentially benefit from an increase in IGRT. The investigators will identify 22 common variable immune deficiency (CVID) study subjects on stable IGRT replacement therapy equivalent to 0.40 to 0.60 gm/kg per 4 weeks who have evidence of mild to moderate obstruction as assessed by an FEF25-75% between 50% and 80% of predicted. Patients who are on Hizentra will be preferentially recruited. Of these 22, 11 will be identified at random and treated for 6 months at their current dose (control population). The remaining 11 study subjects (treatment group) will have their level of IGRT increased by the equivalent of 0.05 gm/kg in dose per 4 weeks, adjusted for bioavailability as per manufacturer's instructions. On average, rounded up to the nearest gram, this will typically increase their dose of Hizentra by 2 gm per week.

Start Date15 Jan 2024

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT05614128 / RecruitingNot ApplicableIIT

Validation of Cutaneous Nerve Demyelination in Diagnosis and Treatment of CIDP

The goal of this observational study is to learn about chronic inflammatory demyelinating polyneuropathy. The main question the investigators would like to answer is 1) can skin biopsy identify demyelination better than nerve conduction studies (electrical tests of the nerves)? and 2) how do nerves improve after treatment in CIDP? Participants will be asked to undergo skin biopsy of the finger at baseline and at 3 months and 6 months after treatment with IVIG (which is the FDA approved treatment for CIDP).

Start Date28 Feb 2023

Sponsor / Collaborator

Vanderbilt University Medical Center

[+1]

100 Clinical Results associated with Normal Human Immunoglobulin (CSL Behring)

100 Translational Medicine associated with Normal Human Immunoglobulin (CSL Behring)

100 Patents (Medical) associated with Normal Human Immunoglobulin (CSL Behring)

727

Literatures (Medical) associated with Normal Human Immunoglobulin (CSL Behring)

01 Feb 2024·International immunopharmacology

Population pharmacokinetics of immunoglobulin G after intravenous, subcutaneous, or hyaluronidase-facilitated subcutaneous administration in immunoglobulin-naive patients with primary immunodeficiencies

Article

Author: Yel, Leman ; Li, Zhaoyang ; Follman, Kristin ; Freshwater, Ed ; Engler, Frank

Immunoglobulin G (IgG) replacement therapy is the standard of care for patients with primary immunodeficiencies with antibody deficiencies. Intravenous (IVIG), subcutaneous (SCIG), and hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) therapies differ in their pharmacokinetic (PK) profiles, administration routes, and dosing regimens. Information on use of subcutaneous therapy in IgG treatment-naive patients is limited. This study used population pharmacokinetic (popPK) model-based simulations to characterize IgG PKs in IgG-naive patients with varying disease severity across several IVIG, SCIG, and fSCIG dosing regimens. An integrated popPK model, developed and validated using data from eight clinical trials, was utilized to simulate scenarios that varied by therapy, loading regimen, maintenance dose (equivalent to 400, 600, or 800 mg/kg every 4 weeks [Q4W]), and baseline endogenous total IgG concentration (1.5 or 4.0 g/L). Simulations were performed for age groups of 2-<6, 6-<12, 12-<18, and ≥18 years. Steady-state serum trough IgG concentrations (C_min,ss), proportion of patients achieving C_min,ss ≥ 7 g/L, and days taken to reach this threshold were summarized. SCIG provided greater mean C_min,ss values than IVIG and fSCIG for any scenario. Across all therapies, C_min,ss tended to increase with age, dose, and endogenous concentration. Although the findings are model-based and not a summarization of real-world observations, doses ≥ 800 mg/kg Q4W with corresponding loading regimens are likely to be clinically appropriate for achieving target IgG concentrations in treatment-naive patients in a timely manner, especially at low endogenous starting concentrations. Therapy-specific dose adjustment based on baseline endogenous IgG concentration, clinical status, and patient characteristics may be warranted.

01 Jan 2024·European journal of neurology

Immunomodulatory effects of intravenous and subcutaneous immunoglobulin in chronic inflammatory demyelinating polyneuropathy: An observational study

Article

Author: Wüstenberg, Hauke ; Kohle, Felix ; Svačina, Martin K R ; Meißner, Anika ; Ladwig, Anne ; Sprenger-Svačina, Alina ; Lehmann, Helmar C ; Kofler, David M ; Schneider, Christian ; Pitarokoili, Kalliopi ; Schweitzer, Finja ; Klein, Ines

Abstract:

Background and purpose:

It is not known whether the route of administration affects the mechanisms of action of therapeutic immunoglobulin in chronic inflammatory demyelinating polyneuropathy (CIDP). The aim of this study, therefore, was to compare the immunomodulatory effects of intravenous (IVIg) and subcutaneous immunoglobulin (SCIg) in patients with CIDP and in IVIg‐treated common variable immunodeficiency (CVID) patients.

Methods:

Serum and peripheral blood mononuclear cell samples were obtained from 30 CIDP patients receiving IVIg, 10 CIDP patients receiving SCIg, and 15 patients with CVID receiving IVIg. Samples and clinical data were obtained prior to IVIg/SCIg and at 3 days, 7 days, and, in CIDP patients receiving IVIg, 21 days post‐administration. Serum cytokines were assessed by Luminex‐based multiplex assay and enzyme‐linked immunosorbent assay. Immune cells were characterized by flow cytometry.

Results:

Immune cell profiles of CIDP and CVID patients differed in frequencies of myeloid dendritic cells and cytotoxic natural killer cells. During treatment with IVIg or SCIg in CIDP patients, cellular immunomarkers were largely similar. CIDP patients receiving IVIg had higher macrophage inflammatory protein (MIP)‐1α (p = 0.01), interleukin (IL)‐4 (p = 0.04), and IL‐33 (p = 0.04) levels than SCIg recipients. IVIg treatment more broadly modulated cytokines in CIDP than SCIg treatment.

Conclusions:

Our study demonstrates that the modulation of cellular immunomarkers in CIDP is independent of the application route of therapeutic immunoglobulin. Minor differences were observed between CIDP and CVID patients. In contrast, cytokines were differentially modulated by IVIg and SCIg in CIDP.

01 Jan 2024·Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners

The Experiences of Children with Primary Immunodeficiency Who Receive Immunoglobulin Subcutaneously Instead of Intravenously

Article

Author: Kaleci, Elanur ; Sabetsarvestani, Raheleh ; Köse, Semra ; Geçkil, Emine ; Dönmez, Hatice

BACKGROUND:

Children with primary immunodeficiency disorder have begun receiving subcutaneous immunoglobulin (SCIg) instead of intravenous immunoglobulin (IVIg). So, we aim to explore the experiences of primary immunodeficiency children with regard to receiving SCIg instead of IVIg.

METHOD:

We adopted a phenomenological approach in 2022 in Turkey using semi-structured interviews. We recruited 15 participants using the purposive sampling method.

RESULTS:

The main theme was the sweetness and bitterness of living with SCIg. The first subtheme was sweetness (sense of freedom, having a normal life, saving time, ease of use, and feeling better). The second subtheme was bitterness (worries about taking responsibility for injection, impaired body image due to abdominal edema, and minimal tolerable complications).

DISCUSSION:

The results show these children had more sweet experiences than bitter ones. Being flexible in choosing a method, teaching patients to apply it correctly, and providing enough time to cope are as reasons for this.

News (Medical) associated with Normal Human Immunoglobulin (CSL Behring)

08 May 2024

·www.globenewswire.com

IGM Biosciences Announces First Quarter 2024 Financial Results and Provides Corporate Update

- Enrollment target exceeded in aplitabart randomized colorectal cancer clinical trial - - Enrollment completed in first dose cohort in imvotamab rheumatoid arthritis clinical trial - MOUNTAIN VIEW, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fiscal quarter ended March 31, 2024 and provided an update on recent developments. “We are pleased to have exceeded our enrollment target of 110 patients in our randomized study of 3 mg/kg of aplitabart plus FOLFIRI and bevacizumab in second line colorectal cancer,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “While we are still scheduling first doses for a few patients, we expect that final enrollment in this clinical trial will exceed 120 patients. We are also pleased that we have completed enrollment in the first dose cohort of our clinical trial of imvotamab in severe rheumatoid arthritis.” Pipeline Updates Aplitabart (DR5 agonist) Clinical development of aplitabart advances. Enrollment target exceeded in ongoing randomized colorectal cancer clinical trial. The Company has exceeded its target of enrolling 110 patients in its randomized clinical trial of 3 mg/kg of aplitabart, a death receptor 5 agonist, plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer. Patients have been enrolled across multiple clinical trial sites in the United States, Asia and Europe. This randomized trial is designed to assess the benefit of 3 mg/kg of aplitabart when administered in combination with FOLFIRI and bevacizumab compared to the current standard of care treatment of FOLFIRI and bevacizumab, with a primary endpoint of progression-free survival (PFS). The release of data from this randomized clinical trial will be dependent upon the timing of PFS events in both the control and the experimental arms of this study. Based on its assumptions as to the timing of PFS events, the Company expects to be able to release top-line PFS results from this study by the end of the first quarter of 2025. Enrollment target met in 10 mg/kg dose single arm colorectal cancer clinical trial. The Company has also met its target of enrolling 20 patients in its single arm clinical study of 10 mg/kg of aplitabart in combination with FOLFIRI and bevacizumab in the treatment of later line colorectal cancer patients. Imvotamab (CD20 x CD3) Clinical development of imvotamab in autoimmune diseases advances. Enrollment completed in first dose cohort of imvotamab in rheumatoid arthritis. The Company has completed enrollment in the first dose cohort of its placebo-controlled clinical study testing imvotamab in severe rheumatoid arthritis. In this first dose cohort, the Company treated six patients with imvotamab and two patients with a placebo. The Company plans to enroll two additional dose cohorts, each consisting of six patients treated with imvotamab and two patients treated with a placebo. The doses of imvotamab received in the second dose cohort are planned to be higher than those received in the first dose cohort, and the doses of imvotamab received in the third dose cohort are planned to be higher than those received in the second dose cohort. This clinical study is now being expanded to include international clinical trial sites, in addition to sites in the United States.Enrollment continues in first dose cohort of imvotamab in severe systemic lupus erythematosus. The Company also continues to enroll patients in the first dose cohort of its single arm, open-label clinical study testing imvotamab in severe systemic lupus erythematosus (SLE). All six patients treated in the first SLE dose cohort will receive imvotamab. The Company also plans to enroll two additional dose cohorts, each consisting of six patients treated with imvotamab. The doses of imvotamab received in the second dose cohort are planned to be higher than those received in the first dose cohort, and the doses of imvotamab received in the third dose cohort are planned to be higher than those received in the second dose cohort.Enrollment to begin in myositis. The Company is currently initiating a clinical trial of imvotamab in idiopathic inflammatory myopathies (myositis). The Company expects to begin recruiting patients for this clinical trial in the current quarter. IGM-2644 (CD38 x CD3) Clinical development of IGM-2644 in autoimmune diseases to be initiated. The Company continues to make plans to begin clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the treatment of autoimmune diseases. First Quarter 2024 Financial Results Cash and Investments: Cash and investments as of March 31, 2024 were $293.8 million, compared to $337.7 million as of December 31, 2023.Collaboration Revenue: For the first quarter of 2024 and 2023, collaboration revenues were $0.5 million in each quarter.Research and Development (R&D) Expenses: For the first quarter of 2024, R&D expenses were $43.8 million, compared to $50.9 million for the first quarter of 2023.General and Administrative (G&A) Expenses: For the first quarter of 2024, G&A expenses were $10.5 million, compared to $13.0 million for the first quarter of 2023.Net Loss: For the first quarter of 2024, net loss was $49.8 million, or a loss of $0.83 per share, compared to a net loss of $59.3 million, or a loss of $1.33 per share, for the first quarter of 2023. 2024 Financial Guidance The Company expects full year 2024 GAAP operating expenses of $210 million to $220 million including estimated non-cash stock-based compensation expense of approximately $40 million. As a result of the refocusing of the Sanofi collaboration announced in April 2024, the Company expects to recognize full year collaboration revenue of approximately $63 million, of which $62 million is expected to be recognized in the second quarter of 2024. This collaboration revenue relates to accounting recognition of the upfront $150 million payment received from Sanofi in 2022 and will not impact the Company’s cash balance or runway. The Company expects to end 2024 with a balance of approximately $180 million in cash and investments and for the balance to enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2026. About IGM Biosciences, Inc. IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer and autoimmune and inflammatory diseases. IGM’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. IGM also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against immunology and inflammation targets. For more information, please visit www.igmbio.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements. Such forward-looking statements are not based on historical fact and include, but are not limited to: the potential of, and expectations regarding, IGM’s technology platform and its IgM antibodies and product candidates, including aplitabart, imvotamab, and IGM-2644; IGM’s plans and expectations regarding its clinical development efforts and activities; statements regarding the clinical development of aplitabart, imvotamab, and IGM-2644, including the timing of clinical trial initiation, expected patient enrollment, expected dosing, expected expansion to international clinical trial sites, and the timing of the release of data; IGM’s expectations regarding its financial position and projected cash runway; expected impact of the refocusing of the Sanofi collaboration on the Company’s recognition of revenue; and statements by IGM’s Chief Executive Officer. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to demonstrate the safety and efficacy of its product candidates; IGM’s ability to successfully and timely advance its product candidates through clinical trials; IGM’s ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary, initial or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; the potential impact of continuing or worsening supply chain constraints; the risk that all necessary regulatory approvals cannot be obtained; the potential market for IGM’s product candidates, and the progress and success of alternative therapeutics currently available or in development; IGM’s ability to obtain additional capital to finance its operations; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; any potential delays or disruptions resulting from catastrophic events, including epidemics or other outbreaks of infectious disease; general economic and market conditions, including inflation; uncertainties related to IGM’s ability to realize the contemplated benefits of its pipeline prioritization efforts and related reduction in force; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (SEC), including IGM’s Quarterly Report on Form 10-Q filed with the SEC on May 8, 2024 and in IGM’s future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law. Contact:Argot PartnersDavid Pitts212-600-1902igmbio@argotpartners.com IGM Biosciences, Inc.Selected Statement of Operations Data(unaudited)(in thousands, except share and per share data) Three Months Ended March 31, 2024 2023 Collaboration revenue$497 $522 Operating expenses: Research and development(1) 43,815 50,894 General and administrative(1) 10,538 13,002 Total operating expenses 54,353 63,896 Loss from operations (53,856) (63,374) Other income (expense): Interest income 4,040 4,172 Other expense — (20)Total other income (expense) 4,040 4,152 Loss before income tax expense (49,816) (59,222)Income tax expense — (87)Net loss$(49,816) $(59,309) Net loss per share, basic and diluted$(0.83) $(1.33)Weighted-average common shares outstanding, basic and diluted 60,114,409 44,466,764 (1)Amounts include stock-based compensation expense as follows: Research and development$4,362 $6,439 General and administrative 3,560 4,608 Total stock-based compensation expense$7,922 $11,047 IGM Biosciences, Inc.Selected Balance Sheet Data(unaudited)(in thousands) March 31, December 31, 2024 2023 Cash and investments$293,768 $337,677 Total assets 376,132 423,411 Accounts payable 3,995 1,326 Accrued liabilities 23,652 31,544 Deferred revenue 146,304 146,801 Total liabilities 214,879 220,177 Accumulated deficit (871,058) (821,242)Total stockholders' equity 161,253 203,234

License out/inFinancial StatementClinical ResultPhase 1

10 Apr 2024

·www.globenewswire.com

IGM Biosciences to Present at the Stifel 2024 Virtual Targeted Oncology Forum

MOUNTAIN VIEW, Calif., April 10, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced that Fred Schwarzer, Chief Executive Officer, will participate in a fireside chat at the Stifel 2024 Virtual Targeted Oncology Forum on Wednesday, April 17, 2024, at 12:00 p.m. EDT. A live webcast of the event will be available on the “Events and Presentations” page in the “Investors” section of the Company’s website at https://investor.igmbio.com/news-and-events/events-and-presentations. A replay of the webcast will be archived on the Company’s website for 90 days following the presentation. About IGM Biosciences, Inc.IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer and autoimmune and inflammatory diseases. IGM’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. IGM also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets. For more information, please visit www.igmbio.com. Contact:Argot PartnersDavid Pitts212-600-1902igmbio@argotpartners.com

07 Mar 2024

·www.biospace.com

IGM Biosciences Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

MOUNTAIN VIEW, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc., (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on recent developments. “We made significant progress during 2023 in the clinical development of our two lead product candidates in therapeutic areas that we believe have the greatest potential to produce significant near-term value,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “Enrollment in our randomized clinical trial of aplitabart plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer continues to be encouraging, and we expect to expeditiously complete our target enrollment of 110 patients. If the control arm of this randomized study demonstrates the expected median progression free survival of approximately six months, we will be able to begin evaluating the benefit of aplitabart in enhancing progression free survival by the end of this year." Mr. Schwarzer continued, “We also initiated two Phase 1b clinical trials of imvotamab in severe systemic lupus erythematosus and in severe rheumatoid arthritis. We are encouraged by the initial level of investigator and patient interest that we have seen in these clinical trials, and we are optimistic that we will be able to generate meaningful initial clinical data by the end of 2024.” Pipeline Updates Aplitabart (DR5 agonist) Clinical development of aplitabart advances. Enrollment ongoing in randomized colorectal cancer clinical trial. The Company continues to enroll patients in a randomized clinical trial of aplitabart, a death receptor 5 agonist, plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer. In addition to clinical trial sites in the United States, this study includes multiple clinical trial sites in Asia and Europe. This randomized trial is designed to assess the additional benefit of 3 mg/kg of aplitabart when administered in combination with the current standard of care treatment arm of FOLFIRI and bevacizumab, with a primary endpoint of progression-free survival (PFS). Evaluating 10 mg/kg dose in single arm colorectal cancer clinical trial. The Company also continues to evaluate a dose of 10 mg/kg of aplitabart in combination with FOLFIRI and bevacizumab in the treatment of later line colorectal cancer patients in its single arm combination clinical trial. The Company expects to complete enrollment of patients in this 10 mg/kg single arm combination dose cohort in the first half of 2024. Imvotamab (CD20 x CD3) Clinical development of imvotamab in autoimmune diseases advances. The Company currently has two Phase 1b clinical trials underway for imvotamab, an IgM-based CD20 x CD3 bispecific T cell engaging antibody: one in severe systemic lupus erythematosus (SLE) and one in severe rheumatoid arthritis (RA). These clinical trials are being expanded to include multiple U.S. and international clinical trial sites. The Company also received clearance in late 2023 from the FDA of its IND application for the use of imvotamab in treating idiopathic inflammatory myopathies (myositis), and the Company is currently making preparations to initiate this clinical trial. IGM-2644 (CD38 x CD3) Clinical development of IGM-2644 in autoimmune diseases to be initiated. The Company is currently making plans to begin clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the treatment of autoimmune diseases. Fourth Quarter and Full Year 2023 Financial Results Cash and Investments: Cash and investments as of December 31, 2023 were $337.7 million, compared to $427.2 million as of December 31, 2022. Collaboration Revenue: For the fourth quarter and year ended 2023, collaboration revenues were $0.7 million and $2.1 million, respectively, compared to $0.4 million and $1.1 million for the fourth quarter and year ended 2022, respectively. Research and Development (R&D) Expenses: For the fourth quarter and year ended 2023, R&D expenses were $54.2 million and $215.5 million, respectively, compared to $45.0 million and $179.3 million for the fourth quarter and year ended 2022, respectively. General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2023, G&A expenses were $11.6 million and $50.1 million, respectively, compared to $11.6 million and $49.7 million for the fourth quarter and year ended 2022, respectively. Net Loss: For the fourth quarter of 2023, net loss was $60.7 million, or a loss of $1.01 per share, compared to a net loss of $52.6 million, or a loss of $1.19 per share, for the fourth quarter of 2022. For the year ended 2023, net loss was $246.4 million, or a loss of $4.71 per share, compared to a net loss of $221.1 million, or a loss of $5.32 per share, for the year ended 2022. 2024 Financial Guidance The Company expects full year 2024 GAAP operating expenses of $210 million to $220 million, including estimated non-cash stock-based compensation expense of approximately $40 million, and full year collaboration revenue of approximately $3 million related to the Sanofi agreement. The Company expects to end 2024 with a balance of approximately $180 million in cash and investments, and for the balance to enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2026. About IGM Biosciences, Inc. IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer and autoimmune and inflammatory diseases. IGM’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. IGM also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets. For more information, please visit . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements. Such forward-looking statements are not based on historical fact and include, but are not limited to: the potential of, and expectations regarding, IGM’s technology platform and its IgM antibodies and product candidates, including aplitabart, imvotamab, and IGM-2644; IGM’s plans and expectations regarding its clinical development efforts and activities; statements regarding the clinical development of aplitabart, imvotamab, and IGM-2644, including the timing of clinical trial initiation and patient enrollment; IGM’s expectations regarding its financial position and guidance, including non-cash stock-based compensation expense, collaboration revenue, ending 2024 cash and investments and projected cash runway; and statements by IGM’s Chief Executive Officer. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to demonstrate the safety and efficacy of its product candidates; IGM’s ability to successfully and timely advance its product candidates through clinical trials; IGM’s ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary, initial or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of collaborations with third parties; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; the potential impact of continuing or worsening supply chain constraints; the risk that all necessary regulatory approvals cannot be obtained; the potential market for IGM’s product candidates, and the progress and success of alternative therapeutics currently available or in development; IGM’s ability to obtain additional capital to finance its operations; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; any potential delays or disruptions resulting from catastrophic events, including epidemics or other outbreaks of infectious disease; general economic and market conditions, including inflation; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (SEC), including IGM’s Annual Report on Form 10-K filed with the SEC on March 7, 2024 and in IGM’s future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law. Contact Argot Partners David Pitts 212-600-1902 igmbio@argotpartners.com IGM Biosciences, Inc. Selected Statement of Operations Data (in thousands, except share and per share data) Three Months Ended Twelve Months Ended December 31, December 31, 2023 2022 2023 2022 Collaboration revenue $ 651 $ 372 $ 2,130 $ 1,069 Operating expenses: Research and development (1) 54,190 45,018 215,519 179,289 General and administrative (1) 11,580 11,618 50,072 49,736 Total operating expenses 65,770 56,636 265,591 229,025 Loss from operations (65,119 ) (56,264 ) (263,461 ) (227,956 ) Other income (expense) Interest income 4,666 3,746 17,743 7,035 Other expense — (58 ) (20 ) (181 ) Total other income (expense) 4,666 3,688 17,723 6,854 Loss before income tax expense (60,453 ) (52,576 ) (245,738 ) (221,102 ) Income tax expense (242 ) — (678 ) — Net Loss $ (60,695 ) $ (52,576 ) $ (246,416 ) $ (221,102 ) Net loss per share, basic and diluted $ (1.01 ) $ (1.19 ) $ (4.71 ) $ (5.32 ) Weighted-average common shares outstanding, basic and diluted 59,829,077 44,241,491 52,311,958 41,543,954 (!)Amounts include stock-based compensation expense as follows: Research and development $ 5,421 $ 6,582 $ 27,499 $ 25,620 General and administrative 3,816 4,527 19,048 19,090 Total stock-based compensation expense $ 9,237 $ 11,109 $ 46,547 $ 44,710 IGM Biosciences, Inc. Selected Balance Sheet Data (in thousands) December 31, 2023 2022 Cash and investments $ 337,677 $ 427,162 Total assets 423,411 513,499 Accounts payable 1,326 2,512 Accrued liabilities 31,544 33,621 Deferred revenue 146,801 148,931 Total liabilities 220,177 226,236 Accumulated deficit (821,242 ) (574,826 ) Total stockholders' equity 203,234 287,263

Phase 1Financial StatementPhase 2IND

100 Deals associated with Normal Human Immunoglobulin (CSL Behring)

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Secondary immunodeficiencies	EU	CSL Behring GmbH	14 Apr 2011
Secondary immunodeficiencies	IS	CSL Behring GmbH	14 Apr 2011
Secondary immunodeficiencies	LI	CSL Behring GmbH	14 Apr 2011
Secondary immunodeficiencies	NO	CSL Behring GmbH	14 Apr 2011
Acquired Immunodeficiency Syndrome	EU	CSL Behring GmbH	24 Apr 2008
Acquired Immunodeficiency Syndrome	IS	CSL Behring GmbH	24 Apr 2008
Acquired Immunodeficiency Syndrome	LI	CSL Behring GmbH	24 Apr 2008
Acquired Immunodeficiency Syndrome	NO	CSL Behring GmbH	24 Apr 2008
Agammaglobulinemia	EU	CSL Behring GmbH	24 Apr 2008
Agammaglobulinemia	IS	CSL Behring GmbH	24 Apr 2008
Agammaglobulinemia	LI	CSL Behring GmbH	24 Apr 2008
Agammaglobulinemia	NO	CSL Behring GmbH	24 Apr 2008
Bacterial Infections	EU	CSL Behring GmbH	24 Apr 2008
Bacterial Infections	IS	CSL Behring GmbH	24 Apr 2008
Bacterial Infections	LI	CSL Behring GmbH	24 Apr 2008
Bacterial Infections	NO	CSL Behring GmbH	24 Apr 2008
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	US	CSL Behring AG	26 Jul 2007
Primary Immunodeficiency Diseases	US	CSL Behring AG	27 Jul 2000
Purpura, Thrombocytopenic, Idiopathic	US	CSL Behring AG	27 Jul 2000

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Dermatomyositis	Phase 3	US	CSL Behring LLC	21 Oct 2019
Dermatomyositis	Phase 3	JP	CSL Behring LLC	21 Oct 2019
Dermatomyositis	Phase 3	AR	CSL Behring LLC	21 Oct 2019
Dermatomyositis	Phase 3	BE	CSL Behring LLC	21 Oct 2019
Dermatomyositis	Phase 3	FR	CSL Behring LLC	21 Oct 2019
Dermatomyositis	Phase 3	DE	CSL Behring LLC	21 Oct 2019
Dermatomyositis	Phase 3	HU	CSL Behring LLC	21 Oct 2019
Dermatomyositis	Phase 3	IT	CSL Behring LLC	21 Oct 2019
Dermatomyositis	Phase 3	MX	CSL Behring LLC	21 Oct 2019
Dermatomyositis	Phase 3	PL	CSL Behring LLC	21 Oct 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04137224 (CTgov)	Phase 2	Scleroderma, Diffuse	27	IgPro20 (Sequence A: IgPro20)	ocbtggtlse(bneozthgcu) = lgvylzmjsq pptsncgqzs (xdwqzxjhrc, sdorynxiea - uqaxagwteg) View more	-	05 Feb 2024
NCT04137224 (CTgov)	Phase 2	Scleroderma, Diffuse	27	IgPro20 (Sequence B: IgPro20)	ocbtggtlse(bneozthgcu) = zmxvhyrghc pptsncgqzs (xdwqzxjhrc, xvluqbzmgi - qofvftcmzh) View more	-	05 Feb 2024
AAAAI2023	Not Applicable	Primary Immunodeficiency Diseases	57	IGSC 16.5%	xonsqycyjl(tvsulatsch) = 44 bacterial RTIs were reported in 29 patients (rate of 0.77 infections/patient/year), with 1 serious iqqevxawge (smtfejipih )	-	01 Feb 2023
EHA2021	Not Applicable	Chronic Lymphocytic Leukemia	10	Subcutaneous Immunoglobulins	kbjrdysqhc(xljninhznj) = jscgrjytef somftkrsgp (jxlwropttp )	-	09 Jun 2021
NCT04044690 (Pubmed \| Rheumatology (Oxford)) Manual	Phase 3	Myositis First line	20	Privigen	ukvucodhgx(qgsbshnypl) = ponxaewotb ndcfbswrya (oeafvfapto ) View more	Positive	06 Apr 2021
NCT03593902 (CTgov)	Phase 2/3	Scleroderma, Systemic	9	Autologous Stem Cells+Mesna+Methylprednisolone+Fludarabine+CYCLOPHOSPHAMIDE+rATG+G-CSF+IVIg+Rituximab	snzzwneyvp(taghytermw) = qwnkblvncw ygoufvpkhw (objscsbclw, fbxcgqzrmp - gmgwhsfvxz) View more	-	12 Aug 2020
AAAAI2020	Not Applicable	Primary Immunodeficiency Diseases	33	IGSC 16.5%	fxvvtpabzn(dmxkogseit) = A total of 22/33 (67%) patients reported local-site reactions (rate 0.60/infusion), with injection pain and swelling most common. Systemic reactions were reported in 20/33 (61%) of patients (0.47/infusion), with headache and fatigue most common. Incidence of reactions was highest with the first infusion. Therapy was discontinued in one per patient request tfmosqntcb (jwbiupldjb ) View more	-	01 Feb 2020
NCT03033745 (HILO Study, AAAAI2020)	Phase 4	Primary Immunodeficiency Diseases	16	Manual IgPro20 push infusions at high flow rate	uihqipzwki(yhvczrfsnv) = hjsxewkwcs qayosejftu (bqatpfqwze )	-	01 Feb 2020
NCT02100969 (CTgov)	Phase 2	Myasthenia Gravis	23	HIZENTRA ®	rmjpjuzmtv(nifixchtsc) = hyohgrfimw vjvoktbciv (xxlvhcworm, ytkqckozoi - ssesmcvmha)	-	13 Dec 2019
EASL2019	Not Applicable	Decompensated cirrhosis of liver serum albumin \| MELD score \| ACLF	79	Human albumin solution (HAS)	lwgceovyej(gnykvejwwx) = agbmbsnsrv chbvqxyhvc (jlsbdlviug ) View more	Negative	12 Apr 2019
PATH Study (AAN2019)	Not Applicable	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Maintenance	172	Placebo	wdbmnndecg(fuqsyhqakc) = xmedizbmja bunkcdjalx (bxquytwxju )	-	09 Apr 2019
PATH Study (AAN2019)	Not Applicable		172	0.2 g/kg SCIG	wdbmnndecg(fuqsyhqakc) = brezbhovfv bunkcdjalx (bxquytwxju )	-	09 Apr 2019

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Normal Human Immunoglobulin (CSL Behring)

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation