On August 31, 2020 Viva Biotech Holdings (the "Company" and, together with its subsidiaries, collectively the "Group" or "Viva Biotech"; stock code: 1873.HK) reported its interim results for the 6 months ended June 30, 2020 (the "Reporting Period") (Press release, Viva Biotech, AUG 31, 2020, View Source [SID1234564198]). As of June 30, 2020, the Group’s revenue amounted to RMB197.6 million, representing a YOY increase of 38.9%. Gross profit was RMB100.1 million, representing a YOY increase of 39.2%. Adjusted net profit was RMB123.7 million, representing a YOY increase of 25.5%. Backlog amount reached approximately RMB493 million, representing a significant YOY increase of approximately 138.2%.

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Facing difficulties induced by the COVID-19 pandemic, the Group proactively implemented containment measures to seek opportunities behind such crisis and accelerate the integration of research and development ("R&D") and production service chain of new drug industry, thereby achieving further synergistic effect between the cash-for-service (CFS) and equity-for service (EFS) models.

Revenue from CFS Surged Successively with Continuously Optimized Customer Structure

During the Reporting Period, both the Company’s backlog amount and number of customers recorded substantial growth. As of June 30, 2020, the Company has provided drug discovery services to an aggregate of over 495 biotechnology and pharmaceutical customers worldwide, delivered over 17,000 protein complex structures and conducted research into more than 1,300 independent drug targets. Revenue from the CFS segment maintained a rapid escalation to RMB154.0 million from RMB105.4 million for the corresponding period last year, representing a YOY growth of 46.1%. Furthermore, total revenue from the top 10 customers increased YOY from RMB64.7 million to RMB82.1 million, while that as a percentage of the Group’s total revenue dropped from 45.5% to 41.5%, indicating a continuously optimized customer structure.

Extensively Explored EFS Opportunities, Proactively Developed Post-Investment Management

As for the EFS segment, the Company extensively explored business opportunities around the globe on an ongoing basis and established long-term cooperation relations and recommendation systems with nearly 60 universities, research transformation centers and investment institutions world-wide. During the Reporting Period, the Company reviewed a total of over 425 projects globally, added 10 start-ups to its portfolio companies, made additional investment in 3 existing portfolio companies and was in negotiation for incubation and investment in 3 new companies. As of June 30, 2020, the Company had a total of 56 portfolio start-ups with a wide range of indications and geographical coverage.

Viva Biotech continuously attracts top ranking scientists from China and overseas to join as business partners. The Company’s business partners have increased to 30, of who have attained remarkable achievements in their academic and drug discovery fields. The Company also actively conducted post-investment management to facilitate incubated companies to advance R&D progress, introduce talents, optimize product pipeline development strategies and coordinate fund-raising resources.

Actively Developed New Technology Platforms, Accelerate the Expansion of Facilities

As of June 30, 2020, the Company’s R&D investment totaled RMB 22.3 million, representing a YOY increase of 42.9%, primarily used for introduction of new technology platforms such as Cryo-EM, Computational Chemistry and HDX-MS. In addition, the Company also proactively mapped out in the antibody macromolecules field and set up CMC process development team so as to expand and satisfy customers’ needs at different R&D stages. To better meet the Company’s requirements arising from rapid business development, in February 2020, the Company acquired the property with a site area of 7,576 square meters located on Faladi Road, Pudong, Shanghai. In April 2020, Viva Biotech New Drug Incubation and Production R&D Center located in Wenjiang of Chengdu with a site area of 33,607 square meters also commenced construction. Furthermore, the Company successfully entered into a bid for the property located in Zhoupu, Pudong, Shanghai, with a gross floor area of approximately 40,000 square meters. It will be developed as Viva Biotech’s Shanghai headquarters. The above facilities will save the Company’s rental expenses and provide stable R&D, manufacturing and operation premise.

Vertically Integrated Industrial Chain to Construct a One-Stop Comprehensive Drug R&D Platform

The Company is speeding up the construction of a comprehensive and one-stop drug service platform, which is designated to provide customers with more comprehensive drug development services. In August 2020, the Company entered into a strategic integration with Zhejiang Langhua Pharmaceutical Co., Ltd., which brought together the synergistic effect of both parties in the R&D, design and manufacturing fields of global pharmaceutical markets, which is of great strategic significance to the Company in terms of vertical integration along the industrial chain and expansion into the CDMO business.

Dr. Cheney Mao, Chairman and Chief Executive Officer of Viva Biotech Holdings said: "Viva Biotech is positioned at the source of early-stage discovery of innovative drugs with technology platform, flow of traffic and talent advantages. Making good use of the traffic flow from CFS and EFS businesses at the source, we will seek strategic collaborations with leading enterprises in each sector along the industrial chain, establish a solid comprehensive R&D and manufacturing system and forge a one-stop platform for new drug discovery, providing customers with the most quality services throughout the full spectrum. Meanwhile, we will continue to strengthen technology advantages, enhance operation efficiency, introduce more talented scientists and technologies, improve capacity of the incubation platforms, strengthen loyalty between existing customers and portfolio companies and proactively conduct industrial integration, in a bid to establish an open and cooperative platform targeting at global biopharmaceutical innovators and build an ecosystem featuring cooperation and mutual benefits."

On August 31, 2020 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, reported that management will participate in the following virtual investor events in September (Press release, NuVasive, AUG 31, 2020, View Source [SID1234564197]):

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Wells Fargo Securities 2020 Virtual Healthcare Conference on Wednesday, September 9, 2020 at 10:00 a.m. ET / 7:00 a.m. PT;
Baird 2020 Virtual Global Healthcare Conference on Thursday, September 10, 2020 at 9:40 a.m. ET / 6:40 a.m. PT; and
Morgan Stanley 18th Annual Virtual Global Healthcare Conference on Monday, September 14, 2020 at 12:00 p.m. ET / 9:00 a.m. PT.
A live webcast of the presentations will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com. A replay of the presentations will remain available on the website for 30 days after the live webcast.

On August 31, 2020 Aptorum Group Limited (NASDAQ: APM, Euronext Paris: APM) ("Aptorum Group"), a biopharmaceutical company focused on the development of novel therapeutics including orphan diseases and oncology indications, reported further positive data from its latest in vivo studies showing significant activity against neuroblastoma tumor reduction when treated with its lead compound SACT-1 in combination with standard of care (SOC) chemotherapy (Press release, Aptorum, AUG 31, 2020, View Source [SID1234564194]). Separately, SACT-1 was also screened for its in vitro activity against over 300 cancer cell lines and showed positive results in a number of cancer types including in particular colorectal cancer, leukemia and lymphoma, etc.

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Our repurposed drug candidate, SACT-1 is undergoing preparation for IND submission and is on track for regulatory application to target to commence phase 1b/2a clinical trials under the US FDA’s 505(b)(2) pathway.

"Neuroblastoma is one of the most prevailing solid tumor cancers in children, representing 8% – 10% of all childhood tumors, accounting for c. 15% of all cancer related deaths in the pediatric population1. For the high-risk patient group, the 5-year survival rate of this condition is around 40-50% as observed by the American Cancer Society2 based on existing treatment. We are delighted to see the progress of our SACT-1, one of our first assets from our SMART-ACT platform. We are extremely excited to observe SACT-1’s significant effect on tumor shrinkage when used in combination with standard of care chemotherapy in our latest in vivo studies. Moreover, we believe that SACT-1 may have potential applications in a number of other cancer types, including non-orphan cancers, which we will be continuing to investigate further for its wider application," said Dr. Clark Cheng, the Chief Medical Officer and Executive Director of the company.

Summary of our in vivo assessment against neuroblastoma and in vitro assessment against other cancers are discussed below.

Neuroblastoma In Vivo Assessment

Based on the initial 22 day data of a recent study we conducted in a xenograft mouse model of neuroblastoma, SACT-1 was orally administered daily at 60mg/kg in combination of SOC chemotherapy brought a statistically significant tumor shrinkage (unpaired student’s t-test, p<0.01) from Day 15 to Day 22, compared to the control group which received SOC only. Indeed, the combination reduced the tumor size by up to 54.2% in the first 22 days compared with the control (SOC only). SACT-1 appears to be effective in accelerating the effect of the SOC in early time points (from Day 1 – 7 vs control). This further supports our earlier in vitro observation that SACT-1 promotes tumor DNA damage and tumor cell death.

Other Cancer Types In Vitro Assessment

In addition, SACT-1 was also screened for in vitro activity in a panel of over 300 cancer cell lines. Similar to our previous findings against neuroblastoma cell lines, SACT-1 exhibits similar anti-tumor efficacy across one or more other major cancer types, including but not limited to colorectal cancer, leukemia and lymphoma cell lines. As a result, in addition to treating neuroblastoma, SACT-1 may have potential applications in the treatment of other cancers. Based on this discovery, the company plans to carry out further in vivo studies to study the efficacy of SACT-1 over other types of cancers to maximize the potential of SACT-1.

About SACT-1

As part of Aptorum Group’s SMART-ACT platform, SACT-1 was discovered from our SMART-ACT platform focused on orphan and unmet diseases. SACT-1 is a repurposed drug targeted for the treatment of neuroblastoma (and potentially other cancer types) especially in combination with SOC chemotherapy. SACT-1’s mechanism has been demonstrated in vitro to enhance DNA damage and tumor cell death.

On August 31, 2020 Arrakis Therapeutics, a biopharmaceutical company pioneering the discovery of a new class of small molecule medicines that directly target RNA, reported the publication of data demonstrating the capabilities of its proprietary PEARL-seq technology for the systematic identification of binding sites in RNA molecules, as an advanced research method to facilitate the discovery of RNA-targeted small molecule (rSM) medicines (Press release, Arrakis Therapeutics, AUG 31, 2020, View Source [SID1234564193]). The research was published online in the American Chemical Society’s peer-reviewed journal, ACS Chemical Biology, in an article titled "PEARL-seq: A Photoaffinity Platform for the Analysis of Small Molecule-RNA Interactions." PEARL-seq, which stands for Photoaffinity Evaluation of RNA Ligation-sequencing, is one of the chemical biology components of Arrakis’ proprietary end-to-end platform for discovery of rSM medicines.

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"PEARL-seq represents our innovative approach to establish target engagement, identify binding sites on the RNA, and learn about selectivity across the transcriptome," said Jennifer C. Petter, Ph.D., Founder and Chief Scientific Officer of Arrakis. "As part of Arrakis’ mission to drug RNA, we are building and refining the tools needed to discover and design rSMs against important RNA targets involved in disease."

The published study describes the development of PEARL-seq, which utilizes photoaffinity labeling of RNA in combination with next-generation sequencing and a dedicated bioinformatic analysis pipeline. Overall, the published work demonstrates the ability of the PEARL-seq platform to identify ligand binding sites within a model aptamer RNA as well as to identify potential off-target binding interactions. These data, combined with conventional RNA structure probing methods, can be used to generate and refine two- and three-dimensional structures of RNA-small molecule complexes, thereby facilitating the rational design of rSM therapeutics.

Key findings of the study include:

PEARL-seq enabled the identification of ligand binding sites as well as selectivity across RNAs in a single experiment.
The research showed that photoaffinity labels could be tethered to rSMs without disrupting the binding interactions between the rSM and the RNA. Upon activation with UV light, the rSM irreversibly crosslinks to the RNA, enabling mapping of the interaction by sequencing analysis.
The research further integrated RNA binding site characterization with transcriptome-wide sequencing to assess small molecule selectivity across the transcriptome.
Beyond binding site identification for directing RNA-targeted medicines, the results were integrated with multiple chemical probing data streams to support better informed two- and three-dimensional RNA structural predictions.
The researchers demonstrated the use of a DNA-encoded library screen to identify a novel small-molecule ligand to an aptamer RNA and used PEARL-seq to confirm a shared binding site with the original ligand.
"In this publication, we demonstrate the power of PEARL-seq to drive the rational design of rSMs," said Herschel Mukherjee, a chemist at Arrakis and a co-author of the publication. "Consistent with our platform-based approach, we combined photoaffinity labeling of RNA with refined sequencing and bioinformatics pipelines to develop a highly sensitive method for studying small molecule-RNA interactions."

"It was exciting to be a part of this close collaboration among the biology, chemistry and computational teams at Arrakis, along with external partners," added Craig Blain, a senior scientist and co-author of the publication. "‘Thriving as a team is an important part of how we work at Arrakis and has helped us build the PEARL-seq platform, a critical part of our mission to drug RNA."

Arrakis’ Platform for Developing rSM Medicines

Arrakis has developed a proprietary drug discovery platform for the systematic discovery and design of RNA-targeted small molecules (rSMs), by identifying small molecules that bind to and modulate RNA to predictably impact disease-related biology. The comprehensive drug discovery toolkit integrates leading‐edge RNA bioinformatics and chemical biology tools, RNA‐specific chemical and biological assays, and RNA-directed medicinal chemistry. By leveraging the best existing tools with Arrakis’ exclusive technologies, we can, for the first time on an industrial scale, identify small molecules that modulate RNA function and predictably impact important biology in disease processes.

On August 31, 2020 Shattuck Labs, Inc. ("Shattuck"), an innovative clinical-stage biotechnology company advancing its proprietary Agonist Redirected Checkpoint (ARC) platform to develop an entirely new class of biologic medicine for the treatment of cancer and autoimmune disease, reported initiation of a Phase 1 clinical trial of its compound SL-172154 (SIRPα-Fc-CD40L), a bi-functional fusion protein that simultaneously blocks the CD47/SIRPα checkpoint and activates the tumor necrosis factor (TNF) costimulatory receptor CD40 (Press release, Shattuck Labs, AUG 31, 2020, View Source [SID1234564192]).

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"SL-172154 is our lead wholly owned product candidate and a potentially best-in-class CD47 checkpoint inhibitor, a recently clinically validated target for cancer immunotherapy," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "In preclinical studies, SL-172154 demonstrated superior anti-tumor activity as compared to either CD47- or CD40-targeted antibodies, either alone or in combination. Based on its ability to simultaneously block the CD47/SIRPα checkpoint and activate the CD40 costimulatory receptor, we believe SL-172154 offers a promising approach to treating patients with ovarian cancer and a range of other cancer types."

The Phase 1 clinical trial is a multicenter, open-label, dose-escalation study. The study will evaluate the safety, tolerability, pharmacokinetics, anti-tumor, and pharmacodynamic effects of SL-172154. Initial clinical data from the trial are expected in the second half of 2021. In addition, Shattuck plans to evaluate SL-172154 in combination with other therapeutic agents in specific cancers.

"CD47/SIRPα checkpoint blocking therapeutics have emerged as promising immuno-oncology therapies. We are incredibly excited to have now initiated this clinical trial evaluating SL-172154 in patients with ovarian cancer, where there remains a high unmet need for effective new therapies," said Lini Pandite, M.D., Chief Medical Officer of Shattuck.

About SL-172154

SL-172154 is a bi-functional fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint and activate the TNF costimulatory receptor CD40. In preclinical studies, SL-172154 demonstrated the ability to bridge the innate and adaptive immune response by simultaneously blocking the CD47 macrophage "don’t eat me" signal and agonizing CD40 to induce a T cell-mediated immune response, or "eat me" signal.