IGM Biosciences Initiates First-in-Human Clinical Trial of IGM-8444 for the Treatment of Solid Cancers and Non-Hodgkin’s Lymphoma

MOUNTAIN VIEW, Calif., September 30, 2020IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-8444, an IgM antibody targeting the Death Receptor 5 (DR5) protein, in patients with solid cancers and non-Hodgkin’s lymphoma.

The multicenter, open-label Phase 1 clinical trial will evaluate IGM-8444 intravenously administered as a monotherapy and in combination with chemotherapy in patients with relapsed and/or refractory solid cancers and non-Hodgkin’s lymphoma. The key objectives of this trial are to provide an initial assessment of the pharmacokinetics, safety, biomarkers and preliminary efficacy of IGM-8444 both as a single agent and in combination with standard of care chemotherapy. IGM expects to report initial data from this Phase 1 trial in 2021.

“The initiation of this clinical trial is another significant milestone in IGM’s development, as it marks the second program from our proprietary IgM antibody platform to begin clinical development,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “We believe that IgM antibodies have the potential to overcome some of the limitations of current IgG-based medicines and deliver new therapeutic options to patients with cancer and other serious diseases, and we hope to pursue a broad clinical development strategy for IGM-8444, including in combination with other targeted oncology drugs.”

“DR5 IgM antibodies have the capacity for multivalent binding of DR5 and are designed to more efficiently send an apoptotic signal to the cancer cell and enhance in vitro potency in killing cancer cells compared to IgG antibodies with the same binding units,” said Johanna Bendell, M.D., Chief Development Officer, Director, Drug Development Program, Sarah Cannon Research Institute at Tennessee Oncology. “I look forward to working with the IGM team in their pursuit to fully elucidate the potential of this novel therapy.”

About IGM Biosciences, Inc.
Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding, the Company’s IgM technology platform, its IgM antibodies and IGM-8444, statements regarding the Company’s Phase 1 clinical trial of IGM-8444, statements regarding the Company’s development strategy for IGM-8444, 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: potential delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including any future impacts to IGM’s operations, the manufacturing of its product candidates, the progression of its clinical trials, enrollment in its current and future clinical trials and on its collaborations and related efforts; 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 advance product candidates into, and successfully complete, clinical trials on the timelines it projects; the risk that all necessary regulatory approvals cannot be obtained; IGM’s ability to adequately demonstrate sufficient safety and efficacy of its product candidates; IGM’s ability to enroll patients in its ongoing and future clinical trials; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; IGM’s ability to obtain additional capital to finance its operations, if needed; 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; general economic and market conditions; 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 26, 2020, IGM’s Quarterly Report on Form 10-Q filed with the SEC on August 6, 2020 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

AbCellera and IGM Biosciences Announce Multi-Year Antibody Discovery Collaboration

– Multi-year, Multi-target Agreement Intended to Expedite Discovery of Novel IgM Antibodies –

VANCOUVER, British Columbia and MOUNTAIN VIEW, Calif., September 24, 2020 – AbCellera and IGM Biosciences, Inc. (Nasdaq: IGMS), announced today that they have entered into a multi-year, multi-target strategic research collaboration and license agreement to facilitate the discovery and development of novel IgM antibodies. AbCellera will generate panels of antibodies for multiple therapeutic targets identified by IGM using       its full-stack, AI-powered antibody discovery technology, and IGM will have the rights to develop and commercialize the novel antibodies resulting from this collaboration. Financial terms of the collaboration were not disclosed.

“We believe that AbCellera’s technology will assist us in rapidly identifying the best antibodies against a large number of agonist targets, as well as other historically difficult targets, for both oncology and immunology applications,” said Fred Schwarzer, CEO of IGM Biosciences. “Engineered IgM and IgA antibodies may be able to overcome some of the limitations of the current IgG-based therapeutics, and this partnership demonstrates the depth of our commitment to ensuring that the potential of our IgM and IgA technology platform is fully realized in areas of high unmet medical need.”

“We believe partnerships like these, which connect breakthrough science with the teams and technologies needed to move forward quickly, are essential in expediting new therapeutic approaches against complex diseases,” said Carl Hansen, Ph.D., President and CEO of AbCellera. “We look forward to working closely with IGM’s innovative team with the goal of accelerating their discovery efforts against high-value disease targets.”

AbCellera sources, searches, decodes and analyzes natural immune responses to identify antibodies for next-generation therapeutics. A modern operating system for antibody discovery, the platform integrates patented and proprietary technologies to advance the development of existing and new biological modalities, from monoclonal, multi-specific, and single-domain antibodies, to bioconjugates, gene-encoded biologics, and cell therapies. IGM’s proprietary platform expands upon the inherent characteristics of IgM and IgA antibodies and is designed to enable the rapid development of engineered therapeutic antibodies. IGM’s technology allows it to create IgM and IgA antibodies with higher affinity and avidity than naturally occurring IgM and IgA antibodies, and is designed to overcome the historical difficulties in recombinantly expressing and manufacturing IgM and IgA antibodies.

About AbCellera Biologics Inc.
AbCellera is a privately held technology company with an antibody discovery platform that searches and analyzes natural immune systems to find antibodies that can be used to prevent and treat disease. AbCellera’s technology, which combines high-throughput microfluidics, hyper-scale data science, machine learning, bioinformatics, and genomics, identifies new drugs and aims to reduce the time it takes to bring treatments to the clinic. AbCellera’s partners include leading biotechnology companies, global health organizations, and many of the top 10 biopharmaceutical companies. For more information, visit www.abcellera.com.

About IGM Biosciences, Inc.
Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

IGM Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding, the collaboration with AbCellera; the nature and scope of such collaboration; the capabilities of the Company’s technology, its IgM and IgA technology platform and AbCellera’s technology, both generally and specifically with respect to discovery, development, and manufacture of antibodies; the potential safety and efficacy of such antibodies; and statements by IGM’s CEO and AbCellera’s President and CEO. 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: termination of the collaboration arrangement; IGM’s ability to demonstrate the safety and efficacy of any antibodies developed in connection with the collaboration; IGM’s ability to successfully manufacture such antibodies; IGM’s ability to successfully and timely advance any antibodies through preclinical studies and clinical trials; the risk that all necessary regulatory approvals cannot be obtained; the risk that the potential benefits of the collaboration and these efforts do not outweigh their costs; potential delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic on the collaboration and related efforts; 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 obtain additional capital to finance its operations, if needed; 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; general economic and market conditions; 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 26, 2020, IGM’s Quarterly Report on Form 10-Q filed with the SEC on August 6, 2020 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.

AbCellera Contacts:

Media
Jessica Yingling, Ph.D.
media@abcellera.com
+1.236.521.6774

Business Development
Kevin Heyries, Ph.D.
bd@abcellera.com
+1.604.559.9005

IGM Biosciences Contact:

Argot Partners
David Pitts
igmbio@argotpartners.com
+1.212.600.1902

IGM Biosciences to Present at Four Upcoming Investor Conferences

MOUNTAIN VIEW, Calif., September 2, 2020 – IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced that Fred Schwarzer, Chief Executive Officer, will present at four upcoming investor conferences:

  • Baird 2020 Global Healthcare Conference on Wednesday, September 9 at 3:10 p.m. ET.
  • H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday, September 16 at 1:00 p.m. ET.
  • 2020 Cantor Global Virtual Healthcare Conference on Thursday, September 17 at 4:40 p.m. ET.
  • Morgan Stanley 18th Annual Global Healthcare Conference on Friday, September 18 at 11:45 a.m. ET.

A live webcast of the events 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 webcasts will be archived on the Company’s website for 90 days following the event.

About IGM Biosciences, Inc.
Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Contact:
Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com

IGM Biosciences Announces Second Quarter 2020 Financial Results and Provides Corporate Update

– IND for IGM-8444 for treatment of patients with solid cancers cleared by FDA –

– Kathy Miller, Ph.D., appointed Vice President, Antibody Discovery –

– Phase I clinical trial of IGM-2323 continues –

MOUNTAIN VIEW, Calif., August 6, 2020IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the second quarter ended June 30, 2020 and provided an update on recent developments.

“We continue to make steady progress advancing our pipeline of engineered IgM antibodies,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “Today, we are pleased to announce that the FDA has cleared our Investigational New Drug (IND) application for IGM-8444, our anti-Death Receptor 5 IgM antibody, which we believe may prove to be helpful in treating a broad range of solid and hematologic malignancies. Later this year, we look forward to beginning our Phase 1 trial of IGM-8444 in solid cancers and to sharing our initial clinical data from our Phase 1 trial of IGM-2323 in relapsed/refractory NHL.” 

IGM-8444 

  • Investigational New Drug (IND) application for IGM-8444 cleared by the U.S. Food and Drug Administration (FDA). IGM today announced that the FDA has cleared the Company to proceed to conduct clinical trials pursuant to its IND for IGM-8444, an IgM antibody targeting the Death Receptor 5 (DR5) protein, which may prove to be useful for the treatment of patients with solid and hematologic malignancies. The proposed multicenter, open-label Phase 1 clinical trial will evaluate IGM-8444 intravenously administered as a monotherapy and in combination with chemotherapy in patients with relapsed and/or refractory solid cancers. The key objectives of this Phase 1 clinical trial are to provide an initial assessment of pharmacokinetics, safety, biomarkers and preliminary efficacy of IGM-8444 both as a single agent and in combination with standard of care chemotherapy.

Corporate Updates 

  • Kathy Miller, Ph.D., appointed as Vice President, Antibody Discovery. IGM today announced the appointment of Kathy Miller, Ph.D., as Vice President, Antibody Discovery. Prior to joining IGM, Dr. Miller served as Vice President, Biotherapeutics at Five Prime Therapeutics from 2015-2020. She has also served in various scientific and leadership roles at Novartis Institutes for Biomedical Research, and at Merck Research Laboratories at the former DNAX/Schering Plough site. Dr. Miller received a B.S. and a Ph.D. in Molecular Genetics from The Ohio State University and conducted post-doctoral research at Genentech.
  • Phase I Clinical Trial of IGM-2323. IGM is continuing the dose escalation portion of its Phase I clinical trial evaluating IGM-2323 in patients with relapsed/refractory NHL, the first-in-human application of IGM’s engineered IgM antibody technology. IGM continues to expect to present initial data from this clinical trial in the fourth quarter of 2020. 

Second Quarter 2020 Financial Results 

  • Cash and Investments: Cash and investments as of June 30, 2020 were $203.1 million, compared to $236.6 million as of December 31, 2019.
  • Research and Development (R&D) Expenses: For the second quarter of 2020, R&D expenses were $15.0 million, compared to $8.3 million for the same period in 2019.
  • General and Administrative (G&A) Expenses: For the second quarter of 2020, G&A expenses were $4.4 million, compared to $2.2 million for the same period in 2019.
  • Net Loss: For the second quarter of 2020, net loss was $18.8 million, or a loss of $0.62 per share, compared with a net loss of $10.7 million, or a loss of $19.08 per share, for the same period in 2019.
  • Shares Outstanding: Weighted-average shares outstanding for the second quarter of 2020 were 30.6 million, compared to 0.6 million for the same period in 2019.

2020 Financial Guidance

IGM reiterates its previously issued financial guidance which consisted of non-GAAP operating expenses for 2020 of approximately $75 – $85 million, excluding estimated non-cash stock-based compensation expense of approximately $8 million. Including non-cash stock-based compensation expense, IGM estimates GAAP operating expenses for 2020 of $83 – $93 million. IGM also expects to end 2020 with a balance of over $140 million in cash and investments.

About IGM Biosciences, Inc.

Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding, the Company’s IgM technology platform, statements regarding the Company’s Phase 1 clinical trial of IGM-8444, including the commencement of that clinical trial, and the Company’s Phase I trial of IGM-2323, including the timing of reporting initial data from that clinical trial, the Company’s future financial and operating performance, including its guidance for the full year 2020 and year end 2020 cash and investments balance,  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: potential delays and disruption resulting from the COVID-19  pandemic and governmental responses to the pandemic, including any future impacts to IGM’s operations, the manufacturing of its product candidates, the progression of its current clinical trials,  enrollment in its current and future clinical trials and on the collaboration and related efforts; 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 advance product candidates into, and successfully complete, clinical trials on the timelines it projects; IGM’s ability to adequately demonstrate sufficient safety and efficacy of its product candidates; IGM’s ability to enroll patients in its ongoing and future clinical trials; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; IGM’s ability to accurately forecast future financial results in the current environment; IGM’s ability to obtain additional capital to finance its operations, if needed; 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; general economic and market conditions; 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 26, 2020, IGM’s Quarterly Report on Form 10-Q filed with the SEC on August 6, 2020 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 to Present at the 2020 Wedbush PacGrow Healthcare Virtual Conference

MOUNTAIN VIEW, Calif., August 4, 2020IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced that Fred Schwarzer, Chief Executive Officer, will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11 at 1:45 p.m. ET.

A live webcast of the presentation 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.
Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Contact:

Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com