On August 7, 2023 BioCity Biopharma reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for a Phase 1 study of BC3448 (CD3/EGFR Bispecific antibody, BsAb) (Press release, Biocity Biopharmaceutics, AUG 7, 2023, View Source [SID1234633894]). As a result, BioCity Biopharma will initiate a dose escalation/expansion study with BC3448, enrolling patients with advanced solid tumors in the United States.

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BC3448 is a CD3-based BsAb that recruits T cells to tumors cells with high EGFR expression resulting in T cell-driven tumor cell killing. To reduce the possibility of cytokine release syndrome (CRS), a known safety issue associated with CD3-based BsAbs, BC3448 is designed to have differential binding affinities for EGFR and CD3, with a stronger binding affinity for EGFR than that for CD3.

BC3448 is being developed in solid tumors with high EGFR expression, including NSCLC, HNSCC, mCRC, and ESC. In preclinical studies, BC3448 demonstrated antitumor activity in multiple tumor types with high EGFR expression, regardless of mutational status of EGFR, KRAS or BRAF, indicating the potential for BC3448 to be an effective therapy for EGFR-expressing tumors, including those resistant to EGFR-TKI and EGFR mAbs.

Currently, there are few CD3/EGFR BsAb in clinical development globally, making BC3448 one of the leading programs. The Phase I trial of BC3448 conducted in China has completed several dose-escalation cohorts and shown a favorable safety profile. Opening of the US IND by BioCity will accelerate the clinical development of this innovative cancer therapy globally.

On August 7, 2023 XNK Therapeutics reported that it will participate at the SITC (Free SITC Whitepaper) meeting in San Diego in November and present the latest research from the company’s leading preclinical projects in bladder cancer and acute myeloid leukemia (AML) (Press release, XNK Therapeutics, AUG 7, 2023, View Source [SID1234633893]). Two abstracts have been accepted for presentation at the meeting:

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Harnessing the potential of autologous NK cells for immunotherapy of patients with advanced bladder cancer
Feeder-Free Expansion of Autologous Cytotoxic NK Cells for Acute Myeloid Leukemia Treatment
The data have been generated in collaboration with XNK’s external partners, Anders Ullén and Fernanda Costa Svedman at the Department of Oncology-Pathology, Karolinska Institute, Stockholm, Sweden, for the bladder cancer abstract, and Abhishek Maiti and Naval Daver at The University of Texas MD Anderson Cancer Center in Houston, Texas, USA, for the AML abstract.

The yearly SITC (Free SITC Whitepaper) meeting is a multidisciplinary educational and interactive environment focused on improving outcomes for cancer patients by incorporating strategies based on basic and applied cancer immunotherapy. It consists of cutting-edge research presentations by experts in the field.

"We look forward to presenting at this prestigious conference, which both sheds more light on our exciting pipeline and gives us the opportunity to discuss our data with other experts in the field," said Anna-Karin Maltais, CSO of XNK Therapeutics.

On August 7, 2023 Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"), a clinical-stage biotech company focusing on the discovery and development of next generation antibody-drug conjugate ("ADC") therapeutics to treat patients with cancer and autoimmune diseases, reported that the company has expanded its collaboration with BioNTech SE to develop, manufacture and commercialize a third ADC candidate DB-1305 globally, excluding Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region (Press release, DualityBio, AUG 7, 2023, View Source [SID1234633892]). DB-1305 is currently in a Phase 1/2 clinical trial (NCT05438329) for solid tumors. The agreement further builds upon the strategic collaboration the companies announced in April 2023.

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Under the terms of the agreements, DualityBio will receive upfront payments, additional development, regulatory and commercial milestone payments, and single-digit to low-double digit tiered royalties on net sales of DB-1305. BioNTech will hold commercial rights globally (excluding Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region), while DualityBio will retain commercial rights for Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region.

About DB-1305

DB-1305, a third generation Trop2 ADC molecule built from DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates (DITAC) platform, exhibited potent antitumor activity in preclinical tumor models and robust clinical efficacy in NSCLC and other solid tumors.

On August 7, 2023 Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on undruggable targets, reported that Jacobio’s in-house KRAS G12C inhibitor glecirasib was granted breakthrough therapy designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the pancreatic cancer patients with a KRAS G12C mutation who have progressed after frontline standard care treatment (Press release, Jacobio Pharmaceuticals, AUG 7, 2023, View Source [SID1234633891]). This BTD was granted based on the clinical efficacy and safety data from ongoing gleciracib clinical trials. The BTD will expedite the clinical development of glecirasib and accelerate its early access to the patients.

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Glecirasib’s pivotal study for pancreatic cancer was approved by CDE in July 2023, which became the first global pancreatic cancer KRAS G12C registrational clinical study. The pivotal clinical trial will evaluate the efficacy and safety of single agent glecirasib in KRAS G12C-mutated locally advanced or metastatic pancreatic cancer patients who have progressed on frontline standard care treatment. This is a multi-center, single-arm, open-label study. Pancreatic cancer is a highly aggressive malignancy and with a limited effective treatment currently. The five-year overall survival rate is only 5%.

Pancreatic cancer is glecirasib’s second BTD indication in China. In December 2022, gleciracib was granted BTD for the second line setting and beyond of advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation.

About CDE’s Breakthrough Therapy Designation

CDE’s Breakthrough Therapy Designation (BTD) is designed to expedite the clinical development of innovative drugs presenting significant clinical advantages. A breakthrough therapy must provide effective treatment for a seriously debilitating or life-threatening condition that has no effective therapy or demonstrate substantial improvement over available therapies. According to the CDE, the breakthrough therapy designation provides opportunities for more intensive CDE guidance and discussion with respect to clinical trials and development strategy, and for priority review later.

About Glecirasib

Glecirasib is a KRAS G12C inhibitor developed by Jacobio. A number of Phase I/II clinical trials of glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. This includes a pivotal clinical trial in NSCLC in China; a monotherapy study for STK11 co-mutated NSCLC in the front-line setting, and combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with Cetuximab in colorectal cancer.

On August 7, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that first patient has been dosed in a Phase I study of the Company’s investigational therapy TLX101 (4-L-[131I] iodo-phenylalanine, or 131I-IPA) in combination with post-surgical standard of care treatment in patients with newly diagnosed glioblastoma, the most common and aggressive form of primary brain cancer (Press release, Telix Pharmaceuticals, AUG 7, 2023, View Source [SID1234633890]).

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IPAX-2 (ClinicalTrials.gov Identifier: NCT05450744) is a Phase I dose escalation study to confirm safety profile of TLX101 in combination with external beam radiation therapy (EBRT) and temozolomide in front-line glioblastoma. Twelve patients are expected to be recruited to evaluate whether the observed safety and drug interaction profile remains suitable in this setting before progressing to a proof-of-concept Phase II study.

IPAX-2 is being conducted at six sites across Australia, New Zealand and Europe. The study will build on data generated in IPAX-1 (ClinicalTrials.gov Identifier NCT03849105), which reported final results in September 2022.[1] The IPAX-1 study met its primary objective demonstrating safety and tolerability profile of intravenous 131I-IPA administered concurrently with second line EBRT. The study also delivered encouraging preliminary therapeutic effect, demonstrating a median overall survival of 13 months from the initiation of treatment in the recurring setting, or 23 months from initial diagnosis.

Professor Josef Pichler, Kepler University Hospital, Austria and Principal Investigator in the IPAX-2 study said, "Promising efficacy data observed in IPAX-1 clearly warrants further investigation in an earlier setting. We are therefore pleased to be exploring Telix’s glioblastoma therapy candidate in newly diagnosed patients, to accelerate development in this underserved disease area with few effective treatment options."

Dr. Colin Hayward, Telix Chief Medical Officer added, "Commencing this study supports Telix’s goal to expedite new radiopharmaceutical therapies in areas of unmet need. With IPAX-2, we are taking the development of TLX101 into front-line glioblastoma for the first time, and excited to see the potential impact of targeted radiation in patients after initial surgery."

Telix’s investigational positron emission tomography (PET) agent TLX101-CDx (18F-FET) will be used for imaging in the study to identify participants with over-expressed LAT-1 as suitable candidates for 131I-IPA therapy, and to provide baseline and follow up information on tumour response and progression.

In parallel to IPAX-2, TLX101 is being further investigated in the recurrent setting in the investigator-initiated Phase II IPAX-Linz study, which dosed a first patient in November 2022[2] and has now exceeded 70% of the patient enrolment target.

About TLX101

TLX101 (4-L-[131I] iodo-phenylalanine, or 131I-IPA) is one of Telix’s lead therapeutic clinical programs and has been granted orphan drug designation in the United States and Europe for glioblastoma therapy. TLX101 targets a membrane transport protein called L-type amino acid transporter 1 (LAT-1) that is typically highly expressed in glioblastoma. TLX101 is a novel approach that is readily able to pass through the blood-brain barrier, the normal protective barrier that prevents many potential drug candidates entering the brain.

About TLX101-CDx (18F-FET)

18F-FET has been widely used in clinical research settings while recently, new practice guidelines have been developed for the imaging of gliomas using PET with radiolabelled amino acids, of which 18F-FET is a key enabling radiopharmaceutical.[3] 18F-FET targets the amino acid transport system L (LAT) and is therefore highly suitable for use as a complementary diagnostic agent to TLX101. Telix is preparing to file a new drug application for TLX101-CDx with the United States Food and Drug Administration (FDA) during 2023, in preparation for U.S. commercial launch in 2024, pending regulatory approval.