Chinese Biopharma Innovators Shine at AACR 2024 Late-Breaking Research with Novel Oncology Candidates

▎Edited by the WuXi AppTec content team

——✦Late-Breaking Poster Sessions✦——

HaiHe Biopharma: HH100937, HH102007

Mechanism of Action: SOS1 Inhibitor, PARP1 Inhibitor

Abstract ID: LB031, LB032

Report Time: April 7, 1:30 PM~5:00 PM(All times are local US time, the same below)

HaiHe Biopharma Co., Ltd. has two preclinical research achievements selected for the Late-Breaking Research session of this year's AACR Annual Meeting, one of which introducesA Highly Selective and Active SOS1 Inhibitor HH100937, the study revealed the synergistic efficacy of combining SOS1 inhibitors with KRAS/MAPK targeted therapies; another study introducedA Highly Selective and Active PARP1 InhibitorDiscovery.

Innovent Bio: IBI3001, IBI334, IBI343

Mechanism of Action: ADC, Bispecific Antibody

Abstract Numbers: LB055, LB056, LB057
Report Time: April 7, 1:30 PM~5:00 PM

According to the abstract on the AACR official website, Innovent Bio has three studies selected for this year's Late-Breaking Research.

• The study introduces a potential "first-in-class"Bispecific Antibody-Drug Conjugate (ADC) Targeting B7-H3 and EGFRIBI3001, which is under development for the treatment of various solid tumors.

• This study introduces aNovelAntibody-Dependent Cellular Cytotoxicity (ADCC)Enhanced B7-H3/EGFR Bispecific AntibodyIBI334, which has demonstrated promising efficacy in preclinical studies for solid tumors. In September 2023, IBI334 was approved for clinical trials in China and is intended for the treatment of patients with unresectable, locally advanced or metastatic solid tumors.

• The study introduced aAn ADC therapy targeting Claudin18.2Preclinical Research Status of IBI343 in the Treatment of Solid Tumors

Abbisko: pimicotinib

Mechanism of Action: CSF-1R Inhibitor

Abstract Number: LB077

Report Time: April 7, 1:30 PM ~ 5:00 PM

Pimicotinib (ABSK021) is an orally administered, highly selective, and highly active CSF-1R small molecule inhibitor developed by Abbisko. It is currently undergoing a global multi-center Phase 3 clinical trial for the treatment of tenosynovial giant cell tumor (TGCT). At this year's AACR conference, a preclinical study of pimicotinib was selected for the Late-Breaking Research session, which demonstrated that pimicotinibCan Enhance the Antitumor Effect of KRAS G12C Inhibitors in Preclinical Non-Small Cell Lung Cancer Mouse Models。

Orange Sail Pharmaceuticals: VBC101-F11, VBC103

Mechanism of Action: EGFR/cMet Bispecific ADC, Trop2/Nectin4 Bispecific ADC

Abstract ID: LB043, LB448
Reporting Time: April 7, 1:30 PM ~ 5:00 PM; April 10, 9:00 AM ~ 12:30 PM

Orange Sail Pharmaceuticals Announces That the Company HasTwoTargeted Bispecific ADCThe preclinical study was selected for Late-Breaking Research. One of the studies introducedAn Innovative EGFR/cMet Bispecific ADC ProductVBC101-F11, a product targeting key oncogenic factors in solid tumors. Another study exploredAn Innovative Trop2/Nectin4-Targeted Bispecific ADCProductVBC103The drug is intended for use in bladder urothelial carcinoma, triple-negative breast cancer, etc.VBC103Expected to achieve better tumor selectivity and a wide therapeutic window through new molecular design.

EpimAb Biotherapeutics: EMB-07

Mechanism of Action: T Cell Engager (TCE) Program

Abstract Number: LB126
Report Time: April 8, 9:00AM~12:30PM

EpimAb Biotherapeutics AnnouncesROR1×CD3 T Cell Redirecting Bispecific Antibody EMB-07The research was selected for the Late-Breaking Research session at this year's AACR Annual Meeting. According to a press release from EpimAb Biotherapeutics,The report selected for this session will specially showcase the preclinical study results of EMB-07.. This is an innovative targeted ROR1T Cell Engager (TCE) Program, and is optimized in design for effectiveness, safety, and pharmacokinetic properties. In addition, this report will discuss the differentiation of EMB-07 in terms of in vitro activity compared to other molecules constructed with different mechanisms of action. Currently, EMB-07 is being evaluated in a Phase 1 study for solid tumors and lymphoma.

Yiming Angke: IMM5605

Mechanism of Action: Bispecific Antibody Targeting CD38 and CD47

Abstract Number: LB129
Report Time: April 8, 9:00AM~12:30PM

Preclinical Development of IMM5605 Project for the Treatment of Hematologic Malignancies by Yiming Angke Biomedical Technology(Shanghai) Co., Ltd.ResearchData Selected for Late-Breaking Research. According to publicly available information from Yiming Angke Biomedical Technology(Shanghai) Co., Ltd., IMM5605 isBispecific Antibody Targeting CD38 and CD47Preclinical in vitro data show that the product can effectively kill CD38-positive hematological tumor cells through mechanisms of action such as antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and induction of apoptosis. In vivo data also demonstrate relatively strong tumor inhibition effects.

Genor Biopharma: Trispecific T Cell Engager Targeting BCMA and GPRC5D

Abstract Number: LB128
Report Time: April 8, 9:00AM~12:30PM

Genor BiopharmaSelectedThis AACR ConferenceLate-Breaking ResearchIs aTrispecific T Cell Engagers Targeting BCMA and GPRC5D for the Treatment of Multiple MyelomaResearch.

Hinova Pharma: HP518, HP568, HP537, HP560, HP567, HC-4955

Mechanism of Action: Proteolysis-Targeting Chimeras,p300/CBP inhibitor,BET Inhibitor, PI3Kα Inhibitor

Abstract Numbers: LB178, LB179, LB157, LB159, LB175, LB177
Report Time: April 8, 1:30 PM~5:00 PM

Hinova Pharma Announces Six Preclinical Studies Selected for Late-Breaking Research at the 2024 AACR Annual Meeting

• The study introducesAn oral PROTAC drug targeting the androgen receptor (AR), HP518,and its research status in treating AR-positive triple-negative breast cancer. In November 2023, the application for HP518 to treat metastatic castration-resistant prostate cancer (mCRPC) has been approved for clinical trials in China.

• This study introduces a potentially highly efficientOral PROTAC Targeting Estrogen Receptor (ER)Research Status of HP568 in the Treatment of Breast Cancer

• The study introduces a potentially effectiveSelective p300/CBP InhibitorHP537, a drug under development for the treatment of hematologic malignancies.

• This study introduces aNovel BET InhibitorHP560, intended for development in the treatment of myelofibrosis. Studies show that BET proteins are associated with the occurrence of diseases such as pulmonary fibrosis, myelofibrosis, and malignant hematological tumors. BET inhibitors can be used for the prevention and treatment of various diseases.

• The study introduces a potentially highly efficient, brain-penetrant,H1047R Selective PI3Kα InhibitorHP567, a drug under development for the treatment of carriersH1047RMutated Tumor.

• The study introduces a novelAR-V7-Targeted Protein Degradation Chimeric DrugHC-4955, a drug under development for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Public data shows that AR splice variant 7 (AR-V7) is a clinically common splice variant, expressed in 75% of mCRPC patients.

GenFleet Therapeutics: GFH547

Mechanism of Action: Pan-RAS (on) Inhibitor

Abstract Number: LB165
Report Time: April 8th, 1:30PM~5:00PM

GenFleet Therapeutics' GFH547 Project Selected for Late-Breaking Research. This is aOrally Bioavailable Cyclophilin A-Targeting Pan-RAS(on) Inhibitor with Broad-Spectrum Antitumor ActivityIn the field of new drug development, using chaperone proteins to form a pocket that binds to RAS proteins, thereby developing RAS inhibitors, is a potential approach. Studies have shown that when the activated KRAS protein binds with the chaperone protein cyclophilin A, it can form a pocket that can be targeted by small molecule drugs.

TransThera: tinengotinib

Mechanism of Action: FGFR Inhibitor

Abstract Number: LB162
Report Time: April 8, 1:30PM~5:00PM

Tinengotinib (TT-00420) is a fibroblast growth factor receptor (FGFR) targeted small molecule kinase inhibitor developed by TransThera, which exerts its anti-tumor effects by targeting tumor cells and improving the tumor microenvironment. The product has initiated global multi-center pivotal Phase 3 clinical trials for cholangiocarcinoma in China, the United States, South Korea, Europe, and other regions. At this year's AACR conference, tinengotinibTreatment with actionableFGFR1-3Patients with advanced solid tumors harboring mutationsThe research was selected for Late-Breaking Research.

XZenith Biopharm: XZP-7797, XZP-6924

Mechanism of Action: PARP1 Inhibitor, USP1 Inhibitor

Abstract Numbers: LB268, LB269
Report Time: April 9, 9:00AM~12:30PM

XZenith Biopharm has two studies selected for the Late-Breaking Research at this year's AACR Annual Meeting: one of the studies introduces an effective, selective, brain-penetrant...PARP1 InhibitorXZP-7797; Another study introduced an effective and highly selectiveUSP1 InhibitorXZP-6924, which has the potential to enhance efficacy and overcome PARP inhibitor resistance.

ZAIMING

Abstract Number: LB271
Report Time: April 9, 9:00AM~12:30PM

ZAIMING has 1 study selected for Late-Breaking Research. The study shows that in relation to Olaparib (PARP Inhibitor）In sensitive and drug-resistant modelsSimultaneous Inhibition of USP1 and PARP Demonstrates Synergistic Antitumor Effects。USP1 is considered a treatment for carryingHRDA Promising Synthetic Lethal Target for Mutant Tumors.PreviouslyZAIMINGIndependently DevelopedUSP1 Small Molecule InhibitorSIM0501 has been approved for clinical trials in China and the United States.SIM0501 is expected to overcome the resistance issue of PARP inhibitors and may produce a synergistic effect with PARP inhibitors.。

Fangde Menda: ThisCART Universal CAR-T Platform Technology

Abstract Number: LB341
Report Time: April 9th, 1:30PM~5:00PM

Suzhou Fangde Menda New Drug Development Co., Ltd. A project about itsNovel Allogeneic Technology PlatformThisCARTClinical Validation and Mechanism Insights Research Selected for Late-Breaking Research。Fangde MendaFocusing on the development of breakthrough tumor immunotherapy cell drugs as its main goal. According to the official website of Suzhou Fangde Menda New Drug Development Co., Ltd., the company's ThisCART universal CAR-T platform technology employs a membrane protein intracellular retention technique, which not only avoids the off-target risks associated with gene editing but also aligns almost completely with the manufacturing process of autologous CAR-T. Using a single viral vector, it can simultaneously achieve CAR expression and the elimination of GvHD.

Huahui Health, Protheragen Bio: ADC Targeting CD98

Abstract Number: LB425
Report Time: April 10, 9:00AM~12:30PM

A preclinical study led by Huahui Health, Provention Bio, and the Beijing Life Science Institute was selected for this Late-Breaking Research. The study showsAn ADC Targeting CD98 in the Tumor Microenvironment Demonstrates Potent Antitumor Activity Across Multiple Cancers, and has good pharmacokinetics and safety. Public data shows that CD98 is a tumor-associated antigen highly expressed in various hematologic and solid tumors, and is considered a potential target for the development of new cancer drugs.

Kygent Therapeutics：KY-001

Abstract Number: LB428
Report Time: April 10, 9:00AM~12:30PM

Kygent Therapeutics' Research on KY-001 Selected for Late-Breaking Research.KY-001Is aDirect Inhibitor of TEAD-YAP Protein-Protein Interaction for the Treatment of Advanced Solid Tumors with Abnormal Hippo Signaling PathwayAccording to literature reports, Hippo is a classical signaling pathway that can dramatically regulate organ size. Its mutation leads to tissue overgrowth, and the phenotype observed in fruit flies evokes the image of a "hippo," hence the name Hippo. This signaling pathway also plays a crucial role in the rampant growth of tumors.YAP and TEAD are two important transcription factors in the Hippo signaling pathway, and the interaction between YAP and TEAD is a key regulatory step in the Hippo signaling pathway.。

——✦Late-Breaking Minisymposium✦——

Leman Biotech: CD19 CAR-T

Mechanism of Action: CAR-T Therapy

Abstract Number: LB236
Report Time: April 8, 3:50 PM~4:50PM

According to the AACR official website, a total of 9 studies have been selected for the Late-Breaking Minisymposium (oral presentations of breakthrough research) this year.Leman Biotech's metabolically enhanced CD19-targeted CAR-T therapy is one of them.According to the press release from Leman Bio, the product has been selected for an investigator-initiated clinical study (IIT).Aimed to evaluate its efficacy and safety in treating relapsed or refractory CD19+ B-cell hematologic malignancies at ultra-low doses.Currently, the IIT clinical study of metabolism-enhanced CD19 CAR-T cells has consecutively completed the enrollment and treatment of 20 patients, all achieving complete remission (CR).

In addition to the aforementioned research, several other studies have also been selected for this year's AACR Annual Meeting.Late-Breaking Research and Other Sessions, limited by the length of this article, we will not introduce them one by one. The AACR Annual Meeting is one of the most influential cancer science conferences in the world, gathering the latest research achievements in the field of oncology every year.。We will also continue to track this year's AACR conference and share more cutting-edge developments in the field of cancer research with everyone.

References:

[1]LBMS01 - Minisymposium: Late-Breaking Research. From https://www.abstractsonline.com/pp8/#!/20272/session/609

[2]Late-Breaking Poster Session. From https://www.abstractsonline.com/pp8/#!/20272/sessions/@sessiontype=Late-Breaking%20Poster%20Session/1

[3] Official press releases and public materials from various companies