On September 1, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported multiple presentations of data evaluating its first VDC candidate, belzupacap sarotalocan (AU-011), for the first-line treatment of patients with early-stage choroidal melanoma [indeterminate lesions and small choroidal melanoma (IL/CM)] (Press release, Aura Biosciences, SEP 1, 2022, View Source [SID1234618914]). The presentations include interim safety data from the ongoing Phase 2 trial using suprachoroidal (SC) administration, final safety and efficacy data from the Phase 1b/2 trial using intravitreal (IVT) administration, and preclinical results that highlight belzupacap sarotalocan’s targeted cytotoxicity towards tumor cells derived from the most common cancer types known to metastasize to the choroid, supporting its potential use for the treatment of choroidal metastases, a key second ocular oncology indication. The presentation also includes preclinical data that supports the activity of belzupacap sarotalocan as a single agent as well as in combination with checkpoint inhibitors, highlighting the possibility to treat not only primary tumors in the eye but potentially distant metastases by an abscopal effect. The results will be presented at the 22nd EURETINA Congress, being held September 1-4, 2022, in Hamburg, Germany.

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"We are excited to present for the first time in Europe the final safety and efficacy data from the Phase 1b/2 trial evaluating IVT administration of belzupacap sarotalocan for the treatment of early-stage choroidal melanoma, along with interim safety data from the ongoing Phase 2 trial using SC administration. In Europe, early-stage choroidal melanoma is a high unmet medical need with no approved therapies. We continue to progress with our Phase 2 SC trial, and we plan to finalize a decision on the route of administration and initiate our pivotal program in Q4 of this year," said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura Biosciences. "Preclinical data that will be presented at EURETINA provides further evidence that belzupacap sarotalocan has shown anti-tumor activity across multiple tumor types that are known to metastasize to the choroid, supporting clinical development in this second ocular oncology indication. We look forward to submitting the IND in choroidal metastases in the second half of this year."

"I am encouraged by the interim safety data observed in the Phase 2 suprachoroidal study to date. These results further support belzupacap sarotalocan’s potential as a vision-preserving first line treatment option for patients with suspicious pigmented choroidal lesions whose only option is radiotherapy, which usually causes severe and irreversible vision loss. Preliminary data from the dose-escalation phase of the Phase 2 SC trial have shown minimal inflammation with most adverse events of intraocular inflammation reported as Grade 1 across all treatment regimens," said Dr. Martine Jager, Professor of Ophthalmology at Leiden University. "Additional preclinical data from a research collaboration with the University of Leiden (Netherlands) highlights the possibility of using belzupacap sarotalocan in combination with immune checkpoint inhibitors to treat not only the primary lesions in the choroid but also potentially treat distant lesions by an abscopal effect."

Details for EURETINA 2022 presentations:

Title: Clinical Evaluation of AU-011, a First-in-Class Targeted Therapy for Choroidal Melanoma, with Intravitreal or Suprachoroidal Route of Administration
Presenter: Martine Jager, Professor of Ophthalmology at Leiden University
Session: Miscellaneous Free Paper Session
Date/Time: Friday, September 2, 2022 from 17:14-17:20 CEST

Title: New treatment of melanocytic lesions – AU011
Presenter: Martine Jager, Professor of Ophthalmology at Leiden University
Session: Tumors
Date/Time: Saturday, September 3, 2022 from 8:52-9:02 CEST

The presentations will be available on the "Scientific Presentations" section of "VDC Platform" page of the Aura Biosciences website on Saturday, September 3, 2022.

On September 1, 2022 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) reported the company’s official listing on the Main Board of the Stock Exchange of Hong Kong (Press release, Biocytogen, SEP 1, 2022, View Source [SID1234618913]). Government representatives, shareholders, agencies, collaborative partners, and employee representatives attended the listing ceremony . In total, 21.76 million shares were offered globally with a price of HK$ 25.22 per share. The net proceeds from the Global Offering will be approximately HK$ 471.1 million.

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Since its establishment in 2009, Biocytogen has established a series of genetically modified animal and cell models using advanced proprietary technologies, including target humanized mice and severely immunodeficient mice. The company harnesses these specialized models to provide preclinical pharmacology evaluation services for global pharmaceutical/biotech companies. These products and services greatly accelerate the research and development of novel drugs.

Biocytogen’s proprietary size-unlimited, precise chromosome engineering (SUPCE) technology, which was developed over a period of 6 years, was applied to generate a series of fully human antibody mice (RenMiceTM), including RenMabTM and RenLite. The company has developed 5 core antibody development platforms using RenMiceTM, including a fully human monoclonal antibody discovery platform, bispecific antibody discovery platform, bispecific ADC platform, GPCR antibody platform and TCR-mimic antibody platform, which form the core competitiveness of Biocytogen’s antibody drug discovery capability. The company’s RenMiceTM-based "Project Integrum", a large-scale antibody discovery and development program launched in 2020, involves deriving knockout RenMiceTM, target verification and antibody discovery for 1000+ potential antibody-druggable targets. With these 5 antibody platforms, Biocytogen plans to continuously produce novel antibody drug molecules that can be licensed or co-developed with global pharmaceutical/biotech companies. Over the past two years, the company has generated 1000+ target gene knock-out RenMiceTM, with 300+ targets undergoing antibody screening, 240+ targets with hits molecules identified, and PCCs obtained for nearly 20 targets. Biocytogen strives to become the headstream of novel antibody drugs.

With gene-edited animal and cell models serving as the foundation, Biocytogen has developed an innovative evidence-based in vivo drug efficacy and safety screening process. These preclinical discovery and pharmacology platforms have supported the establishment of 10+ preclinical and clinical pipelines, including monoclonal antibodies, bispecific antibodies and bispecific ADCs; 3 products have been out-licensed and/or entered co-development. The company’s leading products, YH003 (CD40 mAb) and YH001 (CTLA-4 mAb), are currently in phase II multi-regional clinical trials and global drug development, with their phase I studies showing excellent safety profiles and promising preliminary anti-tumor activities.

Biocytogen has developed over 2500 innovative animal models since 2013 and these models have been sold to more than 20 countries around the world. In the future, 1000+ innovative models are expected to be successfully developed and put into the market. Biocytogen has completed more than 500 preclinical antibody drug evaluation projects for more than 200 biopharmaceutical companies, including many of the top 10 global biopharmaceutical companies. The company has licensed the RenMiceTM platform to 14 companies, including Merck Healthcare KGaA, BeiGene, Xencor and Innovent; 32 projects have initiated. Additionally, the company has reached 24 preclinical antibody co-development or license agreements with 15 companies, including Merck Healthcare KGaA, RemeGen, China Resources Biopharm, Nanjing Chia-Tai Tianqing Pharmaceutical Company (NJCTTQ) and LiberoThera. The company is also collaborating with partners such as Remgen, TRACON and Gene Quantum to co-develop preclinical and clinical antibody drug pipelines.

When picturing the future of Biocytogen, Dr. Yuelei Shen, Founder, Chairman and CEO, said: "Biocytogen’s fast growth and development is impossible without the efforts of all employees, the strong support of local government, shareholders, and global collaborators. Listing on the Hong Kong Stock Exchange is the recognition of our company’s past achievements and the trust for our company’s future growth from the capital market. We believe that with the help of the HKEX listing, Biocytogen will further strengthen innovative research and development, continue to produce high-quality products and services, and persist in flexible and mutually beneficial business collaboration models. As a biotechnology company rooted in China with a global view, we strive to further accelerate the globalization of the company’s business and give back to our shareholders, employees, and society with excellent achievements and financial return."

On September 1, 2022 Avacta Group plc (AIM: AVCT), a clinical stage oncology drug company and developer of powerful diagnostics based on its innovative Affimer and pre|CISION platforms, reported that the first-in-human Phase I trial (ALS-6000-101) of AVA6000 Pro-doxorubicin will advance to the fourth dose cohort of patients following a positive review of the safety and tolerability data from the dosing of the third cohort (Press release, Avacta, SEP 1, 2022, View Source [SID1234618912]).

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Avacta’s Safety Data Monitoring Committee (SDMC), comprised of clinicians currently recruiting patients, has completed its review of the safety data from the third cohort dosed with AVA6000 at 160mg/m2 in the ongoing Phase I trial. Following this review, the SDMC has recommended that the clinical trial continues as planned and escalates to the next dose of AVA6000 at 200mg/m2.

AVA6000 is a novel form of doxorubicin that has been modified with Avacta’s pre|CISION FAP-activated delivery platform to improve its safety and therapeutic index. AVA6000 has been designed to limit cell penetration of the drug, and therefore its cell killing effect, until it is specifically activated by fibroblast activation protein α (FAP) which is in high concentration in many solid tumours compared with healthy tissues. The resulting reduced exposure of healthy tissues to active doxorubicin has the potential to significantly increase its therapeutic index by reducing the incidence of adverse effects, including cardiotoxicity and myelosuppression. Anthracyclines such as doxorubicin, a generic chemotherapeutic agent, with a market size that is expected to grow to $1.38bn by 20241, are widely used as part of standard of care in several tumour types, but its use is limited by cumulative dose toxicity associated with cardiomyopathy.

Dr Alastair Smith, Chief Executive Officer of Avacta, commented: "We are very much encouraged by this recommendation from the SDMC to move onto the fourth dose cohort in our ongoing ALS-6000-101 Phase 1 dose escalation study. This very positive progress reflects the safety profile and tolerability demonstrated in patients enrolled in the study to date."

On September 1, 2022 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported that John Butler, Chief Executive Officer, will present virtually at the H.C. Wainwright 24th Annual Global Investment Conference (Press release, Akebia, SEP 1, 2022, View Source/news-releases/news-release-details/akebia-therapeutics-present-virtually-hc-wainwright-24th-annual" target="_blank" title="View Source/news-releases/news-release-details/akebia-therapeutics-present-virtually-hc-wainwright-24th-annual" rel="nofollow">View Source [SID1234618911]). The hybrid conference will take place September 12–14, 2022.

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The presentation will be available on-demand beginning September 12, 2022 through the Investors section of Akebia’s website at View Source for approximately 90 days.

On September 1, 2022 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported that Dr. Helen Torley, president and chief executive officer, is scheduled to present and host investor meetings at the 2022 Wells Fargo Healthcare Conference being held in Boston, MA on September 7-9, 2022 (Press release, Halozyme, SEP 1, 2022, View Source [SID1234618910]).

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A live audio webcast of the presentation will be available in the Investor Relations section of the Company’s website. Replays of the audio webcast will be available for 90 days following the conference.