Form 6-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of November 2021

Commission File Number: 001-39173

 

 

I-MAB

 

 

Suite 802, West Tower, OmniVision, 88 Shangke Road, Pudong District

Shanghai, 201210

People’s Republic of China

(Address of principal executive offices)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F  ☒            Form 40-F  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

 

 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

I-MAB    
By   :    

/s/ John Long

Name   :   John Long
Title   :   Chief Financial Officer

Date: November 12, 2021


Exhibit Index

 

Exhibit 99.1—Press Release dated November 9, 2021
Exhibit 99.2—Press Release dated November 10, 2021
EX-99.1

Exhibit 99.1

 

LOGO

I-Mab and ABL Bio Report Preclinical Data of 4-1BB-targeting Bispecific Antibodies at 2021 SITC

 

   

Preclinical data of TJ-CD4B/ABL111 and TJ-L14B/ABL503 demonstrate targeted safety profile and enhanced anti-tumor activity

 

   

Both studies are undergoing phase 1 clinical trials in the United States

SHANGHAI, China, GAITHERSBURG, MD. and SEONGNAM, South Korea. November 9, 2021 I-Mab (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, and ABL Bio, Inc. (Kosdaq:298380, hereafter “ABL”), a clinical-stage biotech developing bispecific antibody technology for immune-oncology and neurodegenerative diseases, today jointly announced preclinical data of their 4-1BB bispecific antibodies at the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The new data demonstrate the unique mechanisms of action of TJ-CD4B/ABL111 and TJ-L14B/ABL503 which have resulted in localized drug action and reduced systemic toxicity, as well as sustained anti-tumor efficacy.

Stimulation of 4-1BB is a promising therapeutic strategy for improving the current immunotherapy for multiple cancers. TJ-CD4B/ABL111 and TJ-L14B/ABL503, both jointly developed by I-Mab and ABL, are undergoing phase 1 clinical studies in the United States.

“Bispecific antibodies are rapidly recognized for their transformative potential, and our pipeline of highly-differentiated 4-1BB bispecific therapies are key components of our biologics pipeline development strategy,” said Dr. Taylor Guo, Chief Scientific Officer of I-Mab. “Dose-limiting toxicities have hampered clinical development of 4-1BB targeting molecules as a drug class. The studies being presented at SITC suggested that both our bispecific assets could have the ability to overcome this common problem, and we are confident that this differentiation places TJ-CD4B/ABL111 and TJ-L14B/ABL503 at the forefront of 4-1BB bispecific development.”

”The preclinical data from this pair of bispecific molecules prove that our ‘Grabody-T’ platform effectively reduces peripheral toxicity by allowing the activation of T cells only in the tumor microenvironment,” said Dr. Sang Hoon Lee, CEO of ABL Bio. “We look forward to further validating its therapeutic potential in the ongoing clinical studies and as we continue to develop 4-1BB bispecific antibodies in various cancer indications.”

Key data highlights:

TJ-CD4B/ABL111

Poster title (#702): TJ-CD4B (ABL111), a Claudin18.2-targeted 4-1BB tumor engager induces potent tumor-dependent immune response without dose-limiting toxicity in preclinical studies

The preclinical studies confirmed the unique pharmacodynamic data and safety of TJ-CD4B/ABL111 in animal models and cell cultures. Analysis of the data found:

 

   

Potent, anti-tumor activity was observed with the proliferation of immune cells in the tumor microenvironment (TME) as well as an increase in memory T cells in the peripheral blood, suggesting long-term immunity against the tumor.

 

Shanghai (HQ)

Suites 802, 505, 702, West Tower

88 Shangke Road, Pudong New District

Shanghai, China

 

United States

Suite 710, 9801 Washingtonian Blvd

Gaithersburg

Maryland 20878

     

 

www.i-mabbiopharma.com


LOGO

 

   

TJ-CD4B/ABL111 was well tolerated in non-human primates and did not induce a systemic immune response or liver toxicity up to levels of 100mg/kg.

 

   

Activation of immune pathways by TJ-CD4B/ABL111 was demonstrated by a pro-inflammatory profile and increased gamma interferon-regulated gene expression in primary human CD8+ T cells co-cultured with CLDN18.2 expressing cells.

TJ-L14B/ABL503

Poster title (#892): ABL503 (TJ-L14B), PD-L1x4-1BB bispecific antibody induces superior anti-tumor activity by PD-L1-dependent 4-1BB activation with the increase of 4-1BB+CD8+ T cells in tumor microenvironment

The preclinical study data confirms the unique mechanism of action of TJ-L14B/ABL503 and its potential to treat resistance to PD-L1 therapies. Analysis of the data found:

 

   

PD-L1-dependent stimulation of the 4-1BB signaling pathway was demonstrated in 4-1BB bioassays with PD-L1 expressing tumor cells

 

   

More potent 4-1BB activation by TJ-L14B/ABL503 was observed at higher PD-L1 expression confirming the requirement of PD-L1 on both tumor and immune cells for optimal activity. Cytokine release assays have also demonstrated minimal peripheral toxicity with TJ-L14B/ABL503

 

   

The in vivo efficacy of TJ-L14B/ABL503 was demonstrated in animal models with tumors expressing different levels of PD-L1. TJ-L14B/ABL503 showed anti-tumor efficacy across the PD-L1 levels. In particular, TJ-L14B/ABL503 demonstrated superior anti-tumor efficacy than atezolizumab in tumors with low PD-L1 expression

 

   

In vitro tumor-killing activity of TJ-L14B/ABL503 was superior compared to atezolizumab when tested in organoid system, even in organoids from atezolizumab non-responders

 

   

Pharmacodynamic changes in TILs and blood were evaluated in animal models. An increase in 4-1BB+ cells, CD8+ T cells, and effector memory T cells was observed in the TME and blood, indicating a strong and long-lasting anti-tumor immune response

 

   

Treatment with TJ-L14B/ABL503 increased MIG/CXCL9, MIP-1b/CCL4, and s4-1BB in the serum, and can potentially be used as pharmacodynamic markers in clinical trials

###

About TJ-CD4B/ABL111

TJ-CD4B, also known as ABL111, is a Claudin 18.2 and 4-1BB bispecific antibody capable of binding to tumor cells expressing Claudin 18.2, i.e., gastric cancer and pancreatic cancer cells, and stimulating intra-tumoral T cells by the 4-1BB arm designed to be activated only upon tumor engagement while silent elsewhere. TJ-CD4B/ABL111 effectively maintains a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both Claudin 18.2 antibody and 4-1BB antibody while it avoids or minimizes liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. Being developed under collaboration between I-Mab and ABL, TJ-CD4B/ABL111 is currently being investigated in a phase 1 clinical study in the U.S.

About TJ-L14B/ABL503

Being developed jointly with ABL, TJ-L14B/ABL503 is a differentiated PD-L1-based bispecific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon tumor engagement. Using ABL’s “Grabody-T” bispecific antibody platform technology, TJ-L14B/ABL503 stimulates 4-1BB activation only in the presence of PD-L1 expressing tumor cells to minimize the risk of off-tumor toxicity. Preclinical studies have demonstrated that the bispecific antibody shows better anti-tumor activity than equimolar doses of single agents alone or in combination. Phase 1 study in currently being conducted in the U.S.

 

Shanghai (HQ)

Suites 802, 505, 702, West Tower

88 Shangke Road, Pudong New District

Shanghai, China

 

United States

Suite 710, 9801 Washingtonian Blvd

Gaithersburg

Maryland 20878

     

 

www.i-mabbiopharma.com


LOGO

 

About I-Mab

I-Mab (Nasdaq: IMAB) is an innovation-driven global biopharma company focused on the discovery, development and commercialization of novel and highly differentiated biologics for immuno-oncology and autoimmune diseases. The Company’s mission is to bring transformational medicines to patients around the world through innovation. I-Mab’s globally competitive pipeline of more than 15 clinical and preclinical-stage drug candidates is driven by its internal discovery and global partnerships for in-licensing, based on the Company’s Fast-to-Proof-of-Concept and Fast-to-Market development strategies. The Company is progressing from a clinical-stage biotech company into a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, a world-class GMP manufacturing facility, and commercial capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou, Guangzhou, Lishui and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter , and WeChat.

About ABL Bio

ABL Bio, Inc. (Kosdaq: 298380) is a clinical-stage South Korean biotechnology company developing antibody therapeutics for immuno-oncology and neurodegenerative diseases. With internal R&D and global partnerships, ABL has developed multiple BsAb platforms, such as “Grabody-T,” “Grabody-I” and “Grabody-B” and built an innovative pipeline of multiple clinical and pre-clinical stage drug candidates. In the oncology area, ABL has developed Grabody-T, a modular 4-1BB engaging platform that has demonstrated superior efficacy and safety. In the neurodegenerative disorder space, ABL has developed Grabody-B platform, which is designed to maximize blood-brain barrier (BBB) penetration. Grabody-B is applicable to various CNS targets across a plethora of neurological disorders, potentially providing a breakthrough to address the high unmet medical needs in neurodegeneration. For more information, please visit www.ablbio.com

I-Mab Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the TJ-CD4B and TJ-L14B pre-clinical studies, the potential implications of clinical data for patients, and I-Mab’s advancement of, and anticipated clinical development, regulatory milestones, and commercialization of TJ-CD4B and TJ-L14B. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab’s drug candidates; I-Mab’s ability to achieve commercial success for its drug candidates, if approved; I-Mab’s ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab’s reliance on third parties to conduct drug development, manufacturing and other services; I-Mab’s limited operating history and I-Mab’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company’s clinical development, commercial and other operations, as well as those risks more fully discussed in the “Risk Factors” section in I-Mab’s most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab’s subsequent filings with the US Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

 

Shanghai (HQ)

Suites 802, 505, 702, West Tower

88 Shangke Road, Pudong New District

Shanghai, China

 

United States

Suite 710, 9801 Washingtonian Blvd

Gaithersburg

Maryland 20878

     

 

www.i-mabbiopharma.com


LOGO

 

ABL Forward Looking Statements

Statements in this press release contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform act of 1995. Words such as “will,” “could,” “hope,” “expect,” “plan” and similar expressions that are based on ABL’s current expectations and assumptions are subject to risks and uncertainties that are difficult to predict. The risks and uncertainties include but are not limited to, potential delays in clinical trial recruitment and participation; ABL and I-Mab’s ability to demonstrate the safety and efficacy of ABL-111 and ABL-503; adverse results in the clinical development process; changes in expected or existing competition; changes in the biopharmaceutical landscape; ABL’s ability to obtain and maintain protection of intellectual property for its technology and drugs; ABL’s reliance on third parties to conduct drug development; the company’s financial position; future decisions by the FDA or other regulatory authorities; volatile global economic conditions; and the impact of the global COVID-19 pandemic. The reader is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to ABL and the company assumes no obligation to provide public updates to these forward-looking statements that are only as of the date of this press release, even if new information is available in the future.

I-Mab Contacts

 

John Long

Chief Financial Officer

john.long@i-mabbiopharma.com

+86 21 6057 8000

  

Gigi Feng

Chief Communications Officer

gigi.feng@i-mabbiopharma.com

+86 21 6057 8000

Investor Inquiries

 

The Piacente Group, Inc.

Emilie Wu

E-mail: emilie@thepiacentegroup.com

Office line: +86 21 6039 8363

 

Shanghai (HQ)

Suites 802, 505, 702, West Tower

88 Shangke Road, Pudong New District

Shanghai, China

 

United States

Suite 710, 9801 Washingtonian Blvd

Gaithersburg

Maryland 20878

     

 

www.i-mabbiopharma.com

EX-99.2

Exhibit 99.2

 

LOGO

I-Mab and Jumpcan Announce Strategic Commercial Partnership on

Eftansomatropin Alfa

 

   

The partnership brings together the strengths of an innovative global biotech and a domestic leading pharmaceutical company specialized in and committed to pediatric medicines to accelerate the commercialization of eftansomatropin alfa

 

   

Jumpcan will pay I-Mab for a total of up to RMB 2.016 billion (approximately $315 million), including the upfront payment of RMB 224 million (approximately $35 million); this partnership deal represents one of the largest regarding China biopharma market

 

   

The partnership marks another critical milestone for I-Mab’s transformation towards commercialization and bringing this transformative treatment option for patients in need

SHANGHAI, China and GAITHERSBURG, MD. November 10, 2021 – I-Mab (the “Company”) (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, announced today that it has entered into a strategic collaboration agreement with Jumpcan Pharmaceutical Group (“Jumpcan”), a leading China pharmaceutical company specialized in and committed to pediatric medicines, for the development, manufacturing and commercialization of I-Mab’s highly differentiated long-acting recombinant human growth hormone, eftansomatropin alfa (TJ101) in mainland China.

Jumpcan is listed among the China Top 100 pharmaceutical companies. With a focus in pediatric medicines, it has more than 3,500 medical representatives and retail specialists, covering over 23,000 tiered hospitals in 30 provinces and cities across the country. Jumpcan’s revenue for full year 2020 and nine month ended September 30, 2021 reached RMB 6.2 billion and RMB 5.4 billion, respectively, with the pediatric segment accounting for 60% of the total.

The partnership brings together I-Mab’s leadership in drug innovation and manufacturing with Jumpcan’s commercial leadership in pediatric medicines in China with proven capabilities in market access and retail channels. The deal creates a strong foundation for the future development and commercialization of eftansomatropin alfa and marks another significant milestone in I-Mab’s commercial transformation following the announcement of its strategic collaboration with Sinopharm in October.

Under the collaboration agreement, I-Mab will continue to lead the ongoing registrational Phase 3 clinical trial of eftansomatropin alfa in pediatric growth hormone deficiency (PGHD). The two companies will share costs of manufacturing tech transfer, process optimization and new formulation development. I-Mab will be the marketing authorization holder (MAH) of the product and supply the product at agreed cost to Jumpcan. Jumpcan will be responsible for commercializing the product and developing new indications in collaboration with I-Mab in mainland China. I-Mab will provide clinical, manufacturing and academic support.

According to the terms of the collaboration agreement, Jumpcan will make an upfront payment of RMB 224 million to I-Mab and, upon achievement of development, registration and sales milestones, certain milestone payments of up to RMB 1.792 billion, making the non-royalty payments a total of up to RMB 2.016 billion. In addition, I-Mab and Jumpcan will share profits generated from commercialization of the product in mainland China on a 50/50 basis, pursuant to which I-Mab will be entitled to receive tiered low double-digit royalties on net sales.

 

Shanghai (HQ)

Suites 802, 505, 702, West Tower

88 Shangke Road, Pudong New District

Shanghai, China

  

United States

Suite 710, 9801 Washingtonian Blvd Gaithersburg

Maryland 20878

     

 

www.i-mabbiopharma.com


LOGO

 

“Jumpcan is a leading player in pediatric therapeutics across China with a strong sales force covering more than 23,000 tiered hospitals in 30 provinces and cities,” said Dr. Jingwu Zang, Founder, Chairman and Director of I-Mab. “The strategic collaboration with Jumpcan is crucial for I-Mab as I believe the broad coverage and deep commercial experience of Jumpcan will accelerate the pre-launch and commercial launch readiness of eftansomatropin alfa to bring this differentiated therapy quickly to market and improve the lives of pediatric patients.”

“I-Mab is a true pioneer in R&D innovation with a globally competitive innovative pipeline. Eftansomatropin alfa is a safe and efficacious weekly therapy equivalent to daily rhGH therapy. We are excited to establish this strategic collaboration with I-Mab to accelerate the commercialization of this novel product. We regard this collaboration as an important turning point for Jumpcan to further strengthen our commitment to the pediatric therapeutic area.” said Mr. Fei Cao, Chairman of Jumpcan.

PGHD is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland. A decrease in growth hormone can affect numerous physiological processes, including short stature and other physical traits as well as psychological disorders. In China there are more than 3.4 million children with growth hormone deficiency. Most recombinant human growth hormone (rhGH) available in China requires daily injections, which often hampers patient compliance and can adversely affect the clinical outcomes.

###

About Eftansomatropin alfa (TJ101)

Eftansomatropin alfa (TJ101) is a potential highly differentiated long-acting recombinant human growth hormone being developed as a more convenient and effective therapy for growth hormone deficiency (GHD). Like endogenous growth hormone, eftansomatropin alfa stimulates the production of insulin-like growth factor 1 (IGF-1) in the liver, which has growth-stimulating effects on a variety of tissues, including osteoblast and chondrocyte activities that stimulate bone growth. IGF-1 is a reliable pharmacodynamic marker and the key mediator of growth-promoting activity of eftansomatropin alfa. Eftansomatropin alfa is based on Genexine’s patented hyFc® technology. The hyFc part consists of a portion of human immunoglobulin D (“IgD”) and G4 (“IgG4”). The former contains a flexible hinge, and the latter is responsible for half-life extension through neonatal Fc receptor (“FcRn”)-mediated recycling. Eftansomatropin alfa is currently in Phase 3 clinical study. Because of its unique molecular features, eftansomatropin alfa may have advantages over the conventional pegylated rhGH drugs and daily injections. In the previous clinical trials, including a Phase 2 study in Europe, eftansomatropin alfa demonstrated its safety and clinical efficacy of weekly or biweekly regimens as compared to that of the daily injected rhGH (Genotropin).

 

Shanghai (HQ)

Suites 802, 505, 702, West Tower

88 Shangke Road, Pudong New District

Shanghai, China

  

United States

Suite 710, 9801 Washingtonian Blvd Gaithersburg

Maryland 20878

     

 

www.i-mabbiopharma.com


LOGO

 

About I-Mab

I-Mab (Nasdaq: IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon, commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company’s mission is to bring transformational medicines to patients around the world through innovation. I-Mab’s innovative pipeline of close to 20 clinical and pre-clinical stage drug candidates is driven by the Company’s Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transition from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facilities and commercial capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou, Guangzhou, Lishui and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the eftansomatropin alfa (TJ101) clinical trials, the potential implications of clinical data for patients, and I-Mab’s advancement of, and anticipated clinical development, regulatory milestones and commercialization of eftansomatropin alfa (TJ101). Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab’s drug candidates; I-Mab’s ability to achieve commercial success for its drug candidates, if approved; I-Mab’s ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab’s reliance on third parties to conduct drug development, manufacturing and other services; I-Mab’s limited operating history and I-Mab’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company’s clinical development, commercial and other operations, as well as those risks more fully discussed in the “Risk Factors” section in I-Mab’s most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab’s subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

I-Mab Contacts

 

John Long

Chief Financial Officer

john.long@i-mabbiopharma.com

+86 21 6057 8000

  

Gigi Feng

Chief Communications Officer

gigi.feng@i-mabbiopharma.com

+86 21 6057 8000

Investor Inquiries

 

The Piacente Group, Inc.

Emilie Wu

E-mail: emilie@thepiacentegroup.com

Office line: +86 21 6039 8363

 

Shanghai (HQ)

Suites 802, 505, 702, West Tower

88 Shangke Road, Pudong New District

Shanghai, China

  

United States

Suite 710, 9801 Washingtonian Blvd Gaithersburg

Maryland 20878

     

 

www.i-mabbiopharma.com