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Biocytogen’s Subsidiary Eucure Biopharma and Chipscreen Biosciences’ Holding Subsidiary Chipscreen NewWay Biosciences Enter into Greater China License Agreement for Bispecific Antibody YH008

On February 27, 2023 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) reported that its wholly owned subsidiary, Eucure (Beijing) Biopharma Co., Ltd. ("Eucure Biopharma"), has reached an exclusive licensing agreement with Chipscreen NewWay Biosciences ("Chipscreen NewWay"), a holding subsidiary of Shenzhen Chipscreen Biosciences Co., Ltd. ("Chipscreen Biosciences", SSE: 688321) for the clinical development and commercialization of bispecific antibody YH008 in Greater China (including Mainland China, Hong Kong, Macau and Taiwan) (Press release, Biocytogen, FEB 27, 2023, View Source [SID1234627780]). Eucure Biopharma retains YH008’s global rights to develop and commercialize YH008 outside Greater China. Under the agreement, Chipscreen NewWay will pay Eucure Biopharma an upfront payment of 40 million RMB, a potential development milestone payment of up to 360 million RMB, a potential sales milestone payment of up to 196 million RMB, as well as tiered royalties on net sales.

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YH008 is Biocytogen’s independently developed proprietary bispecific antibody for tumor immunotherapy. The IND application for a phase I study of YH008 was cleared by the US FDA and accepted by the Chinese NMPA.

"Chipscreen Biosciences and Chipscreen NewWay have extensive experience in clinical drug development and commercialization," said Dr. Yuelei Shen, President and CEO of Biocytogen. "With this agreement in place, we will work together to accelerate YH008’s entry into the market to benefit patients."

"Biocytogen’s YH008 has unique mechanisms and outstanding preclinical results," said Dr. Xianping Lu, CEO and President of Chipscreen Biosciences. "This licensing agreement will expand Chipscreen NewWay’s pipeline in the field of antibody drugs and immuno-oncology. I look forward to these fruitful collaborations."

"The unique mechanism of action of YH008 bring together the synergies of immune activation and immunosuppressive blockade, and can reduce toxic side effects and increase safety," said Dr. Bin Liu, Head of the Center of Antibody Early R&D at Chipscreen NewWay. "The clinical potential of YH008 is worth looking forward to and it is a good addition to the products under development of Chipscreen NewWay. Chipscreen NewWay will rapidly advance the clinical stage research and development of YH008."

About YH008

YH008 is a bispecific antibody that exerts antagonistic and agonistic activities. In vitro and in vivo studies indicate that YH008 can conditionally activate the immune pathway in the tumor microenvironment where certain tumor specific T cells are enriched to avoid systemic non-specific activation. Additionally, YH008 was engineered with an Fc-silent IgG1 isotype to avoid Fc-receptor-mediated non-specific immune activation. YH008 demonstrated superior anti-tumor activity when compared to parental monoclonal antibodies (mAbs) or combination therapy in syngeneic models. In vivo pharmacodynamic studies indicate that YH008 can activate tumor-infiltrating DCs and T cells. In addition, both in vivo studies and GLP toxicology studies indicate improved safety of YH008 compared with benchmark mAbs.

China Performs First Cancer Patient Treatments in the Xiamen Humanity Hospital Using Novel Accelerator-based Radiation Oncology Therapy (BNCT)

On February 27, 2023 Neuboron Medical Group (NMG), a leading global Accelerator-based Boron Neutron Capture Therapy (AB-BNCT) total solution provider reported that the first AB-BNCT cancer research center in China, Xiamen Humanity Hospital (XHH) BNCT Center has successfully performed 14 irradiations on 12 patients for its first Investigator Initiated Trial (IIT) aimed to evaluate the safety and efficacy of BNCT in the treatment of advanced refractory malignant tumors (Press release, Neuboron Medtech, FEB 27, 2023, View Source [SID1234627779]). With this milestone, China has become the second country to master and utilize accelerator BNCT technology.

The clinical protocol relied on a full suite of NeuPex AB-BNCT device system and NeuMANTA Treatment Planning system, boron-containing drug BPA and PET imaging drug F-BPA supplied from Neuboron. NeuPex is a highly integrated and sophisticated medical system that consists of a Beam Shaping Assembly, Accelerator, Patient Positioning System, Dose Monitoring System, QC/QA System, Medical User Control system and Interlocks, etc. Benefiting from Neuboron’s unique beam control technology, the NeuPex system under the proton condition of 18.4 kW/2.3 MeV/8 mA (the highest efficiency of AB-BNCT system in clinical use worldwide) has already met the clinical criteria. The accelerator for the NeuPex system is manufactured by Neuboron’s partner TAE Life Sciences.

This clinical research was launched on Oct. 9, 2022, after being validated by a large number of animal preclinical studies and approved by Xiamen Humanity Hospital’s Institutional Review Board (IRB). These twelve patients were diagnosed with recurrent head and neck, high-grade glioma, and melanoma cancers with traditional cancer therapies exhausted.

After a 3-month follow-up, the first 4 patients showed satisfactory safety and superior tumor control performance. All of them showed tumor regression. The 12 patients will have remained follow-up observation accordingly. The clinical study preliminarily not only verifies the safety of the combined treatment of neutron radiation and BPA drug, but also demonstrated good clinical treatment value.

"The completion of our first-in-human clinical study at this stage demonstrates great efficacy and safety using novel in-hospital accelerator-based BNCT," said Prof Yuan-Hao Liu, Ph.D., CEO and CSO of Neuboron Medical Group. "This milestone marks a great potential to treat recurrent, advanced, and refractory cancer." "We are very excited to have witnessed this binary radiotherapy expanding our patient’s lives and will continue to work tirelessly on our end to bring our one-stop BNCT total solution to the global market as quickly as possible," emphasized Prof. Dr. Liu.

About BNCT

Boron Neutron Capture Therapy (BNCT) is a targeted radiation oncology therapy in that neutron beams destroy only boron compound-bearing tumors without destroying neighboring healthy tissue. BNCT has significant advantages of delivering highly effective and very cell-centralized radiation therapy in treating patients with recurrent, invasive, and local-regional metastases refractory tumors with a relatively low impact on the patient’s quality of life. To date, approximately 2,000 patients have been treated with BNCT at research sites worldwide.

Cantex Receives FDA "Study May Proceed" Letter for Phase 2 Clinical Trial of Azeliragon for the Treatment of Unmethylated Glioblastoma

On February 27, 2023 Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions, reported that the U.S. Food and Drug Administration (FDA) reviewed Cantex’s Investigational New Drug application and issued a "Study May Proceed" letter for Cantex’s Phase 2 clinical trial to assess the safety and therapeutic effect of azeliragon in patients with newly diagnosed unmethylated glioblastoma treated with standard of care radiation therapy (Press release, Cantex, FEB 27, 2023, View Source [SID1234627778]). Azeliragon was recently granted FDA Orphan Drug Designation for the treatment of glioblastoma.

"We are very pleased to have received this favorable response from the FDA enabling Cantex to initiate a Phase 2 clinical trial of azeliragon for the treatment of glioblastoma," commented Stephen G. Marcus, M.D., Chief Executive Officer of Cantex. "Today’s news significantly advances Cantex’s azeliragon development program. We look forward to soon commencing enrollment in this trial given the urgent need for novel therapies that can better address this devastating disease."

Glioblastoma is the most common primary brain cancer, with approximately 13,000 cases diagnosed in the U.S. per year. It is a highly malignant brain tumor for which current therapeutic options provide a limited life extension benefit. The median survival after a glioblastoma diagnosis is 15-18 months and 5-year survival is less than 10%. Given this prognosis, new treatments of glioblastoma are urgently needed.

Azeliragon is an orally administered small molecule, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the glioblastoma microenvironment. By preventing interaction of RAGE with these ligands, azeliragon may inhibit glioblastoma and overcome its resistance to effective treatment. Cantex is also developing azeliragon for the treatment of other major cancers not adequately addressed by current treatments where RAGE has been implicated in disease progression and in complications of cancer treatment.

Dr. Marcus continued: "The Phase 2 trial of azeliragon in glioblastoma is one of several promising clinical programs we continue to advance with azeliragon to treat cancer and other diseases where RAGE is implicated. Additional azeliragon indications include pancreatic cancer, breast cancer, and cancers such as lung cancer and breast cancer that have metastasized to the brain. These programs highlight the versatility of azeliragon and our commitment to develop new treatment options for these cancers. We expect significant progress on these clinical trials during 2023 and 2024."

About Azeliragon
Azeliragon, previously known as TTP488, is an orally active, small molecule, antagonist of the receptor for advanced glycation end products (RAGE) licensed by Cantex from vTv Therapeutics Inc. (NASDAQ:VTVT). vTv Therapeutics discovered azeliragon and carried out phase 3 clinical trials for Alzheimer’s disease. Although these trials did not demonstrate efficacy in Alzheimer’s disease, clinical safety data from these trials, involving over 2000 patients dosed for periods up to 18 months, indicate that azeliragon is very well tolerated. A broad range of evidence suggests that RAGE—ligand interactions play a critical role in cancer and its complications as well as in a range of inflammatory diseases.

Gracell Biotechnologies to Report Fourth Quarter 2022 Financials on Monday, March 13, 2023

On February 27, 2023 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that it plans to release unaudited financial results for the fourth quarter ended December 31, 2022 and provide an update on recent developments prior to the open of the U.S. financial markets on Monday, March 13, 2023 (Press release, Gracell Biotechnologies, FEB 27, 2023, View Source [SID1234627777]). The management team will host a live audio webcast and conference call at 8:00 am Eastern Time.

Conference call and webcast details:

Monday, March 13, 2023 @ 8:00 a.m. ET
Investor domestic dial-in: (800) 715-9871
Investor international dial-in: (646) 307-1963
Conference ID: 5617240

Live webcast link: View Source

A replay of the webcast will be available on ir.gracellbio.com shortly after the conclusion of the event for 90 days.

Telix 2022 Full Year Results: Revenue up 20x in first year of commercial sales, underpins transition to cash flow positive

On February 27, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported its financial results for the financial year ended 31 December 2022 (Press release, Telix Pharmaceuticals, FEB 27, 2023, View Source [SID1234627776]). All figures are in AU$ unless otherwise stated.

2022 HIGHLIGHTS

Total Group revenue $160.1M (2021: $7.6M) commercial launch of Illuccix drives 20x increase in revenue
Highly positive top-line data from Phase III ZIRCON trial of investigational kidney cancer imaging agent TLX250-CDx paves way to commence regulatory filing process for a second imaging agent for the urology field
Advancement across the core therapy pipeline programs, including:
– Patient dosing in ProstACT SELECT and TARGET prostate cancer therapy trials
– Manufacturing scale-up to facilitate commencement of the ProstACT GLOBAL trial in international sites in 2023
– Patients dosed in STARLITE-2 study of therapy candidate TLX250 in patients with advanced clear cell renal cell carcinoma (ccRCC) in combination with immunotherapy
– Final data from IPAX-1, a Phase I/II trial of TLX101, an investigational therapy in patients with recurrent glioblastoma multiforme (GBM), confirmed the study met its primary objectives and demonstrated encouraging preliminary efficacy data
Build out of the radioisotope production facility in Brussels South progressing, on-track to commence operations in 2023
Net loss after tax $104.1M (2021: $80.5M), reflecting a period of investment to scale-up commercial and clinical activities
Adjusted earnings before tax, interest, depreciation and amortisation (Adjusted EBITDA) $(67.8)M (2021: $(76.1)M)
Gross margin (62%) has steadily improved since launch, reflecting efficiency gains in manufacturing of commercial products and scale benefits
Improvement in cash balance and net cash utilisation:
– Cash and cash equivalents of $116.3M as at 31 December 2022 (2021: $22.0M)
– Improved cash balance reflects $175.0M capital raise undertaken in January 2022, cash generation from sales of Illuccix and improved operating expenditure control
– Customer receipts generated cash of $124.1M (2021: $4.2M), reflecting the commencement of commercial sales
Dr Christian Behrenbruch, Group Chief Executive Officer and Managing Director commented on the result:

"This year Telix has demonstrated it can effectively identify, develop and commercialise assets. This included the delivery of a complex Phase III trial and scale-up of the business to support the highly successful launch of our first commercial product, Illuccix. These achievements, along with a continued focus on expenditure control, have seen us finish 2022 in a strong financial position with a healthy cash balance and a growing revenue stream. Our commitment to financial stewardship is enabling us to invest our earnings to fund the late-stage programs in our pipeline, while transitioning to cash flow positive. Ultimately this will deliver further benefits to patients and shareholders.

"Along with the launch of Illuccix, the positive readout of our Phase III ZIRCON study of our kidney cancer imaging agent, TLX250-CDx was a major highlight of 2022. We look forward to building on this strong foundation in 2023 as we prepare regulatory filings for two imaging agents for kidney and brain cancer and continue to advance the late-stage therapy programs in prostate, kidney and brain cancer."

Further details on the Company’s results can be found in the Company’s Appendix 4E, investor presentation slides and 2022 Annual Report lodged with the ASX and also available on the Company’s website.

Investor Call

An investor conference call / webcast will be held on Tuesday 28 February 2023 at 9.00am AEDT (Monday 27 February 2023 at 5.00pm EST).

Participants may register for the call at the following link: View Source