Nanjing, China (Press Release) – IASO Biotherapeutics (IASO BIO), a clin­i­cal stage bio­technology com­pany ad­vanc­ing the devel­op­ment of inno­va­tive ther­a­pies for cancer, and Innovent Biologics, Inc. (Innovent) (HKEX:01801), a world-class bio­pharma­ceu­tical com­pany that de­vel­ops and com­mer­cial­izes high quality med­i­cines, an­nounced to­day that IASO BIO has re­ceived National Medical Products Admin­istra­tion (NMPA) ap­prov­al for an Inves­ti­ga­tional New Drug Appli­ca­tion (IND) for CT103A – an inno­va­tive ther­apy for the treat­ment of re­lapsed re­frac­tory mul­ti­ple myeloma (rr/mm) patients. IASO Bio and Innovent will start a Phase Ib/II study to con­firm the R2PD and move to phase II shortly after, with ap­prov­al antic­i­pated in 2021.

Multiple myeloma is a deadly blood cancer that often infiltrates the bone mar­row causing anemia, kidney failure, immune problems and bone fractures. With a global annual in­ci­dence rate of 2/100,000 persons, it is one of the most commonly diag­nosed blood cancers, sec­ond only to non-Hodgkin lym­phoma.

Hu Guang, Ph.D., Director of R&D at IASO BIO, commented that: "This is an im­por­tant mile­stone that allows us to con­tinue with CT103A’s clin­i­cal devel­op­ment for the treat­ment of rr/mm. We’re a young com­pany, and this is a big step for­ward in achieving our objectives to de­vel­op and bring to mar­ket the most ad­vanced ther­a­pies for treating patients more ef­fec­tively.”

News of the IND ap­prov­al coincided with the latest pre­sen­ta­tion of CT103A clin­i­cal results at the 17th Annual Inter­na­tional Myeloma Workshop, Boston, Sep­tem­ber 12-15 (Abstract #440).

This annual event is devoted to fostering scientific and clin­i­cal ex­change on the latest break­­throughs in mul­ti­ple myeloma and related plasma cell disorders.

In an IIT study conducted by Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, re­searchers pre­sented compelling results for ef­fi­cacy and persistence of a ther­apy that may provide patients, having re­lapsed from a prior CAR-T, an op­tion for CAR-T re­treat­ment.

In general, the treat­ment was well tolerated, with dosage levels ranging from 1X106, 3X106 and 6X106 CAR-T/kg.

CRS oc­curred in 17/18 patients (Grade 1&2- 66.6% (12), Grade 3- 22.2% (4), Grade 4- 5.6% (1)), but was generally man­ageable with no neurotoxicity.

At even the lowest dosage level (1 x106 cells/kg), CT103A remains ef­fec­tive with an im­proved safety profile. For re­sponse, 7/8 evaluable patients achieved VGPR or better. With respect to safety, only 1/8 evaluable patients ex­peri­enced CRS at > grade 2.

About CT103A

CT103A is an inno­va­tive ther­apy co-developed by IASO BIO and Innovent Biologics, Inc. Previous stud­ies in­di­cated patients with re­lapsed / re­frac­tory mul­ti­ple myeloma (RRMM) who re­ceived high-dose BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the dis­ease progresses, the re-infusion of CAR-T cells is not ef­fec­tive. To solve this dilemma, CT103A has been devel­oped, a lentiviral vector con­taining a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3z activation domains. Based on strict selection and screen­ing, uti­liz­ing a pro­pri­e­tary in-house optimization plat­form, the con­struct of the CT103A CAR-T is potent and persistent.

About Nanjing IASO Biotherapeutics

Founded in March 2017, IASO BIO is a clin­i­cal stage bio­technology com­pany ad­vanc­ing the devel­op­ment of inno­va­tive cell ther­a­pies for cancer. IASO BIO is ded­i­cated to curing cancer using engi­neered au­tol­o­gous/allogenic T cell ther­a­pies de­signed to en­hance the immune sys­tem's ability to recog­nize and eradicate cancer cells.

Currently, IASO BIO is devel­op­ing over 10 high-potential, high-end bio­pharma­ceu­tical prod­ucts, uti­liz­ing a fully-human scFv sequence targeting hema­to­logical, solid and virus asso­ci­ated tumors. Addi­tion­al devel­op­ment efforts in­clude unique TCR-like CAR-T cell ther­apy prod­ucts for indi­ca­tions such as gastric cancer, nasopharyngeal carcinoma and viral in­fec­tion related solid tumors.

IASO BIO has devel­oped broad ca­pa­bil­i­ty in­clud­ing; a pro­pri­e­tary phage library（>1x1011）support­ing the devel­op­ment of CAR-T prod­ucts, anti­body drugs and intracellular targets, a screen­ing sys­tem using high-through­put CAR-T analysis techniques and large scale data mining to obtain Best-in-class CAR-T drug can­di­dates, in-house plasmid, lentivirus and CAR-T pro­duc­tion tech­nology plat­forms meeting the re­quire­ments for IND sub­missions and clin­i­cal re­search. For more in­for­ma­tion, please visit: www.iasobio.com

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action,” Innovent’s mis­sion is to de­vel­op and com­mer­cial­ize high quality bio­pharma­ceu­tical prod­ucts that are affordable to ordinary people. Established in 2011, Innovent is com­mit­ted to devel­op­ing, manu­fac­tur­ing and com­mer­cial­iz­ing high quality inno­va­tive med­i­cines for the treat­ment of on­col­ogy, metabolic disorders, and other major dis­eases. On Octo­ber 31, 2018, Innovent was listed on the Main Board of the Stock Ex­change of Hong Kong Limited with the stock code: 01801.HK.

Since it was founded, Innovent has devel­oped a fully-integrated plat­form which in­cludes R&D, CMC (Chemistry, Manufacturing, and Controls), clin­i­cal devel­op­ment and com­mer­cial­iza­tion capabilities. Leveraging the plat­form, the com­pany has built a robust pipe­line of 21 inno­va­tive assets in the fields of on­col­ogy, metabolic dis­eases and other major thera­peutic areas. Sixteen have entered into clin­i­cal devel­op­ment, four have entered Phase 3 clin­i­cal trials, three mono­clonal anti­bodies have their New Drug Appli­ca­tion (NDA) under review and three of them have been granted with priority review status, and one, Tyvyt® (sintilimab in­jec­tion), is now approved for re­lapsed or re­frac­tory classical Hodgkin’s lym­phoma (r/r cHL).

Innovent has built an inter­na­tional team of ad­vanced talents in high-end bio­logical drug devel­op­ment and com­mer­cial­iza­tion, in­clud­ing many overseas experts. The com­pany has also entered into stra­te­gic col­lab­o­rations with Eli Lilly and Com­pany, Adimab, Incyte, Hanmi and other inter­na­tional pharma­ceu­tical com­pa­nies. Innovent strives to work with all relevant parties to help ad­vance China’s bio­pharma­ceu­tical industry, im­prove drug avail­a­bil­ity to ordinary people and en­hance the quality of the patients’ lives. For more in­for­ma­tion, please visit：www.innoventbio.com.

Source: IASO Biotherapeutics.