On September 14, 2022 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported that TST003, its first-in-class, high affinity humanized monoclonal antibody targeting Gremlin1, has received IND clearance from U.S. Food and Drug Administration (FDA) (Press release, Transcenta, SEP 14, 2022, View Source [SID1234619568]).

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Gremlin1, a member of the TGF-β super family, is highly expressed by stromal cells in diverse human carcinomas, such as esophageal cancer, pancreatic cancer, gastric cancer, colon cancer, lung cancer, breast cancer and prostate cancer and is associated with tumorigenesis, contributing to the proliferation, migration, invasion and metastasis of cancer cells. TST003 has displayed significant anti-tumor activities both in vitro and in vivo in preclinical studies. TST003 has the potential to become a novel cancer treatment, either as monotherapy or in combination with immune checkpoint inhibitor and/or other anti-tumor agents.

In May 2022, Nature Cancer published the study results by Transcenta and Shanghai Jiao Tong University scientists on the potential application of the its first-in-class Gremlin1 targeting antibody in the treatment of androgen receptor-negative/low prostate cancer. The study results revealed that Gremlin1 protein can promote lineage plasticity and drive castration resistance in prostate cancer. Gremlin1-specific antibodies can effectively control tumor growth in androgen receptor-negative/low prostate cancer. The study also demonstrated a synergistic activity between the anti-Gremlin1 antibody and enzalutamide against patient-derived castration-resistant prostate cancer models in vitro and in vivo.

"Targeting Gremlin1 with our antibody TST003 has the potential to be transformative in the treatment of high unmet need cancer indications, such as castration resistant prostate cancer. We look forward to initiating our first time in human clinical study which is designed to address key questions to optimize TST003 clinical development plan." said Dr. Caroline Germa, Transcenta’s Executive Vice President, Global Medicine Development and Chief Medical Officer.

About TST003

TST003 is a potentially first-in-class antibody drug candidate around the world targeting a novel immune regulatory protein produced by tumor-associated fibroblasts or tumor cells with mesenchymal phenotype. In preclinical studies, TST003 has demonstrated anti-tumor activities either as a single agent or in combination with targeted agent in "target-expressing" patient-derived xenografts (PDX) tumor model. In addition, TST003 displayed anti-tumor activities as a single agent and enhanced the anti-tumor activity of checkpoint inhibitor in multiple syngeneic tumor models.

On September 14, 2022 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the management team will participate in and attend one-on-one meetings at three investor conferences in September 2022 as follows (Press release, Gracell Biotechnologies, SEP 14, 2022, View Source [SID1234619566]):

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Citi Hong Kong China Corporate Day – Virtual
One-on-one meetings: Tuesday, September 20, 2022 – Wednesday, September 21, 2022

Cantor Oncology, Hematology & HemeOnc Conference
Panel Presentation: Wednesday, September 28 at 4:15 p.m. ET
One-on-one meetings: Wednesday, September 28, 2022
Location: New York, NY

Jefferies Cell & Genetic Medicine Summit
Fireside Chat: Friday, September 30 at 2:00 p.m. ET
One-on-one meetings: Friday, September 30, 2022
Location: New York, NY

A webcast of the fireside chat will be available on the News and Events section of Gracell’s investor website. A replay of the webcast will be available for 30 days following the event.

On September 14, 2022 IDEAYA Biosciences, Inc. ( Nasdaq: IDYA) reported the pricing of an underwritten public offering of 7,619,048 shares of its common stock at a public offering price of $10.50 per share, before underwriting discounts and commissions (Press release, Ideaya Biosciences, SEP 14, 2022, View Source [SID1234619565]). In addition, IDEAYA has granted the underwriters a 30-day option to purchase up to an additional 1,142,857 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by IDEAYA, are expected to be approximately $80.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about September 19, 2022, subject to the satisfaction of customary closing conditions.

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J.P. Morgan, Jefferies, Citigroup and Guggenheim Securities are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

The securities described above are being offered by IDEAYA pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the U.S. Securities and Exchange Commission, or the SEC. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, copies of which may be obtained, when available, by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at [email protected]; Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; or Guggenheim Securities, by mail at Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, or by telephone at (212) 518-5548 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On September 14, 2022 Qurient Co. Ltd. (KRX: 115180), a clinical-stage biotech company based in Korea, reported that the company has entered into a clinical collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ., USA), for clinical study of Q901, a selective CDK7 inhibitor in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) (Press release, Qurient Therapeutics, SEP 14, 2022, View Source [SID1234619564]).

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Under this agreement, Qurient will conduct a phase 1/2 study in the U.S. to evaluate safety and efficacy of Q901 in combination with KEYTRUDA for the treatment of selected advanced solid tumors.

"We are pleased to collaborate with MSD to evaluate Q901 in combination with KEYTRUDA for advanced solid tumors where limited treatment options are currently available. Q901 shows very effective tumor growth inhibition through cell cycle regulation and triggers genomic instability, which may set synthetic lethality for anti-PD-1 therapy. The Q901 and anti-PD-1 antibody combination showed beneficial effect in preclinical models, and we expect the same clinical benefits," said Kiyean Nam, Ph.D., CEO of Qurient. "The clinical collaboration with MSD on Q901-KEYTRUDA combination follows on clinical collaboration on Q702-KEYTRUDA combination agreement announced in November 2021, and they are important milestones for patients who have had few treatment options, and Qurient’s two lead oncology assets."

Terms of the collaboration were not disclosed.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme, LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Q901

Q901 is a highly selective cyclin dependent kinase 7 (CDK7) inhibitor that only inhibits CDK7 in the human kinome. CDK7 is a master regulator of cell cycle checkpoints and an essential component of transcription machinery. Selective inhibition of CDK7 by Q901 specifically kills cancer cells with aberrant cell division cycle or transcriptional regulation. In animal studies, Q901 exerts tumor growth inhibition in a number of murine cell-derived and patient-derived xenograft models, including breast, ovarian, prostate, pancreatic, small-cell lung, and colorectal cancers. Qurient licensed the CDK7 inhibitor program at the discovery research stage from Lead Discovery Center (LDC) and the Max-Planck Society and further optimized the program, completed the IND-enabling studies, and received FDA clearance of investigational new drug (IND) application.

On September 14, 2022 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) reported a strategic collaboration with Guangzhou FineImmune Biotechnology Co., LTD. ("FineImmune") to co-develop cell-based therapeutic drugs targeting intracellular tumor-associated antigens (Press release, Biocytogen, SEP 14, 2022, View Source [SID1234619563]). Biocytogen will use its proprietary TCR-mimic antibody platform to discover fully human antibody sequences that will be further developed using FineImmune’s unique cell therapy platform.

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Biocytogen’s TCR-mimic antibody development platform utilizes its proprietary fully human antibody RenMice (RenMab and RenLite mice) that have been further engineered to express a human leukocyte antigen (HLA) gene. Antibodies against intracellular tumor-associated antigens are subjected to advanced high-throughput antibody screening technologies to discover antibodies with high specificity and affinity.

"Most tumor antigens are intracellular, and our TCR-mimic platform provides a solution for developing antibodies against these valuable targets," said Dr. Yuelei Shen, Founder, Chairman and CEO of Biocytogen. "TCR-mimic antibodies generated by our TCR-mimic platform have potentials to be developed into multiple drug modalities such as T cell engagers, bispecific/multispecific antibodies and CAR-T therapies. We are pleased to collaborate with FineImmune to explore the application of our antibodies in the field of cell therapies."

FineImmune is a pioneering T cell therapy company, and has solved multiple critical barriers in the microenvironment of solid tumors by using multiple proprietary technology platforms, such as GSOP for T-cell engineering, HAP for TCR identification, CMP for personalized TCR-T cell production and in vivo T-cell delivery platform (TDP). FineImmune’s product pipelines include TCR-T, CAR-T, TAL, TIL, etc. The company developed the first personalized neoantigen-specific TCR-T cell therapy, which is in phase I clinical trial now. In addition, FineImmune possesses technologies for the precision prediction of the efficacy and side effects of immunotherapy, enabling healthcare professionals to provide effective and safe immunotherapy to patients with common malignant tumors.

"T cells play an important role in treating cancers. Biocytogen’s advanced TCR-mimic platform makes it possible for us to develop T cell therapies against crucial but low-expressed intracellular tumor antigens," said Dr. Penghui Zhou, Founder and Chief Technology Officer of FineImmune. "We focus on providing efficient and safe immunotherapy using advanced technologies. This collaboration will promote the development of new cell therapeutic drugs and the expansion of the potential of immunotherapy to benefit patients."

About the TCR-Mimic Platform

Biocytogen’s T Cell Receptor (TCR)-Mimic platform utilizes HLA-expressing fully human antibody mice (HLA/RenMice) to generate antibodies to intracellular tumor-associated antigens when immunized with MHC-antigen-peptide complexes. Subsequently, Biocytogen’s high-throughput antibody screening platform aims to swiftly identify TCR-mimic antibodies with higher specificity and affinity than endogenous TCRs derived from patients. Currently, antibody sequences against multiple intracellular targets have been obtained, and their efficacies have been verified in vitro and in vivo. Fully human antibody sequences obtained from the TCR-mimic platform can empower the development of T cell engagers, bispecific/multispecific antibodies, and CAR-T therapies.