On August 8, 2018 TOT BIOPHARM Company Limited ("TOT BIOPHARM"), headquartered in Suzhou Industrial Park, China, reported the completion of a Series B financing round, raising US$102 million in capital (Press release, Tot Biopharm, AUG 8, 2018, View Source [SID1234528578]). The financing round was supported by China Universal (Cayman) GP Limited and several renowned domestic and foreign investors, as well as investors who had participated in earlier rounds, including Center Laboratories Group, Vivo Capital, Chengwei Capital, Yuanta Financial Holdings Group and Cathay Capital. TOT BIOPHARM focuses on the R&D, manufacturing and marketing of high-end anti-tumor drugs. The company now has over 10 drugs in the R&D stage, including three biologics and three small molecules, which have received investigational new drug application (IND) approvals, as well as one antibody-drug conjugate (ADC), which is expected to receive approval soon. All project pipelines are meeting their milestones and all products on the roadmap are expected to reach the market according to their planned timelines.

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TOT BIOPHARM general manager Gloria Huang said, "With the completion of this round, we are very pleased to see that our achievements to date as well as what we foresee for the future have been recognized by several renowned domestic and foreign investors and continue to receive the support of our existing shareholders. The financing will allow us to accelerate development of our key pipelines. TOT BIOPHARM is taking advantage of the high-speed growth opportunities in China’s oncology market. In the future, we will also utilize the existing advantages of our established platforms to expand multi-perspective partnerships and cooperation at different levels, so that the benefits of resource integration will be maximized."

Vivo Capital, a major shareholder of TOT BIOPHARM, has partnered with the Series B investment team spanning several projects across multiple sectors. Existing shareholders and several renowned investors participated in the Series B round, fully demonstrating that investors have confidence in TOT BIOPHARM’s current achievements and future prospects. As a hi-tech company with the advantage of having built an integrated product R&D, manufacturing and marketing platform in the Chinese anti-tumor drug market, TOT BIOPHARM has been at the forefront of technological innovations and expansion into international markets for many years, and, as a result of having held steadfast to this approach, has achieved solid and steady progress. The firm has entered into strategic partnerships with several top-tier companies in the global anti-tumor sector. The completion of the Series B round will serve to accelerate the R&D of new products as well as the commercialization of existing ones, greatly improving TOT BIOPHARM’s competitive power and value."

TOT BIOPHARM recently announced results of the Phase I clinical trial (double-blind, head-to-head pharmacokinetics and safety comparisons) of Bevacizumab biosimilar, TAB008, at ASCO (Free ASCO Whitepaper) 2018, demonstrating that both in pharmacokinetics and safety indicators, TAB008 shows high similarity to Avastin. TAB008 is now in Phase III clinic trial, and, in terms of progress, TOT BIOPHARM is among the top three firms in China competing to get the drug on market. The financing will further accelerate the progress of TAB008’s Phase III study, as well as other R&D programs. The IND application for TAA013, an ADC, submitted by TOT BIOPHARM, is currently in the review process. With the higher threshold for manufacturing ADCs, the number of companies in China that can produce such drugs is quite limited. However, TOT BIOPHARM has its own manufacturing technologies and capability. The firm is in the process of ramping up production of its third-generation innovative oncolytic virus drug TVP211. Combined with its domestically leading BSL-2 certified virus manufacturing plant, TOT BIOPHARM plans to further accelerate the development program, taking a leadership position in this promising technology sector.

The construction of TOT BIOPHARM’s second-phase project – the monoclonal antibody R&D and manufacturing base was completed and put into operation in May 2018. The base, with a planned cell culture scale of up to 16,000L, was built in full compliance with international standards. Plans call for the establishment of three preparation production lines, responsible for the filling of drugs with different specifications. The facility also plans to successively launch a pre-filled preparation line, a lyophilized preparation line and a Grade OEL-5 plant for the mass production of ADC. The facility also has the flexibility to expand production capacities and adjust the layout of the production areas. Combining the existing 500L pilot plant, the facility is prepared to meet all demands for biologic drugs, from upstream R&D, pilot manufacturing, and clinical trial drugs to commercial production.

The completion of the financing is a major milestone in TOT BIOPHARM’s efforts to accelerate commercialization of product pipelines. Together with the international standards-compliant monoclonal antibody R&D and manufacturing base, TOT BIOPHARM will open its platforms for collaboration, making it the most distinctive company and the best strategic partner in the high-end oncology field.

On August 8, 2018 EdiGene Inc., which develops genome editing technologies into novel therapeutics for a broad range of diseases and into creative solutions to advance drug discovery, reported the successful completion of approximately $15 Million in a Series pre-B financing (Press release, EdiGene, AUG 8, 2018, View Source [SID1234528577]).

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The financing is led by new investor Lilly Asia Ventures (LAV). New investor HuagaiCapital participated in this round. Series A lead investor IDG Capital, Series A investor WI Harper Group and other insiders also participated in this round.

"This investment will allow us to continue advancing ourpromising portfolio of therapeutic programs based on gene-editing technologies," said Dr. Dong Wei, CEO of EdiGene, "In addition, we will continue to further develop our proprietary High Throughput Genome Screening platforms into a comprehensive solution for our partners in key areas such as drug sensitivity, drug resistance and synthetic lethality."

"We are excited to invest in EdiGene," said Dr. Fei Chen, Managing Partner of Lilly Asia Ventures, "Gene editing is bringing evolutional breakthrough to drug discovery and potential clinical therapeutics, and we are pleased to collaborate with EdiGene team and to support EdiGene’s growth in the global market."

"This new round of financing led by Lilly Asia Ventures with participation of new and existing investors further validates the progress we have made and the potential of our platforms," said Dr. Wensheng Wei, founder of EdiGene. "Now we arewell positioned to further advance our pipeline and get one step closer to help patients with our technologies. We look forward to working with Lilly Asia Ventures and other investors for the years to come."

On August 8, 2018 CBT Pharmaceuticals (CBT), a U.S. and China-based innovative biopharmaceutical company committed to becoming a leader in the discovery and development of oncology combination therapies, reported the receipt of ethics approval from the Bellberry Human Research Ethics Committee (HREC) in Australia for its planned APOLLO-1 clinical trial (Press release, CBT Pharmaceuticals, AUG 8, 2018, View Source [SID1234528576]). HREC is an independent ethics review board compliant with strict national Health and Medical Research Council (NHMRC) guidelines for clinical trials.

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"Ethics approval is an essential element of the process to initiate a clinical trial in Australia as we prepare to launch our first combination study with our proprietary c-Met inhibitor and anti PD-1 immunotherapies," stated Sanjeev Redkar, PhD, President and Chief Executive Officer. "We are thrilled to partner with the world-leading oncologists and hepatologists in Australia who are highly experienced clinical trial investigators and share our commitment to the development of new combination approaches to treat cancer patients."

APOLLO-1 is a Phase 1/2 open label, multi-center dose escalation and expansion study of combination immunotherapy in locally advanced or metastatic disease: CBT-101 (c-Met inhibitor) with CBT-501 (anti-PD-1) in hepatocellular carcinoma (HCC), or CBT-101 and nivolumab in renal cell carcinoma (RCC). CBT-101 is CBT’s c-Met inhibitor targeting the epithelial to mesenchymal transition (EMT) pathway, and CBT-501 is CBT’s IgG4 humanized monoclonal antibody against the Programmable Death-1 (PD-1) membrane receptor on immune cells. Nivolumab (OPDIVO; Bristol-Myers Squibb Company) is approved for advanced kidney cancer. CBT-101 will be administered concomitantly with the PD-1 cancer immunotherapy.

"Our c-Met inhibitor may improve responses to cancer immunotherapy in settings beyond c-MET-dependent tumors by eliminating resistance in the tumor microenvironment, reactivating T-cells to kill the tumor, and sustaining that T-cell response. We look forward to initiating the trial in the next few weeks," added Tillman Pearce, MD, Chief Medical Officer.

About CBT-501 (genolimzumab Injection)

CBT-501 is a novel IgG4 humanized monoclonal antibody against the Programmable Death-1 (PD-1) membrane receptor on immune cells. It has a comparable efficacy profile in in vitro and in vivo studies to the marketed anti-PD-1 antibodies, nivolumab and pembrolizumab, and has a favorable profile with very low antibody-dependent cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) activity. In China, CBT-501 is referred to as GB226 where it is being developed by CBT partner Genor BioPharma Co. Ltd. Visit clinicaltrials.gov for additional information on the ongoing clinical trials: NCT03053466, NCT03374007, and NCT03502629.

CBT-101 Oral Capsule

CBT-101 is a novel, small molecule drug that targets the epithelial to mesenchymal transition (EMT) pathway that is dysregulated in several tumors. It is a specific inhibitor of the c-Met receptor. CBT-101 has demonstrated tumor inhibitory effect in a variety of human primary c-Met amplified gastric, hepatic, pancreatic and lung cancer xenograft animal models with c-Met fusions, mutations or amplifications. In China, CBT-101 is referred to as PLB1001 where it is being developed by CBT partner Beijing Pearl Biotechnology Co. Ltd. Visit clinicaltrials.gov for additional information on the ongoing clinical trials: NCT03175224, NCT02896231, and NCT02978261.

On August 8, 2018 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported its financial results for the second quarter ended June 30, 2018 and provided an update on its programs (Press release, Synlogic, AUG 8, 2018, View Source [SID1234528561]).

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"Synlogic’s recent progress, including initiation of two clinical trials and multiple presentations of preclinical data, highlight the potential of Synthetic Biotic medicines across a range of diseases," said Aoife Brennan, M.B., B.Ch., Synlogic’s interim president and chief executive officer and chief medical officer. "In the second half of 2018, we look to continue this momentum as we advance our clinical pipeline, with data expected from phase 1/2 clinical trials of our two lead programs, SYNB1020 in patients with hyperammonemia due to cirrhosis and SYNB1618 in healthy volunteers. In addition, we look forward to advancing our first immuno-oncology program into IND-enabling studies for the treatment of cancer."

Recent Highlights
Pipeline

Presentation of preclinical data highlighting potential of Synthetic Biotic medicines in immuno-oncology (IO) at the annual meeting of the Federation of Clinical Immunology Societies (FOCIS 2018), including the platform’s broad capabilities to generate candidates that secrete or consume immunologically relevant compounds for the potential treatment of cancer and inflammation. Data presented in two sessions demonstrate that intratumorally injected E. coli Nissle was able to colonize and persist in the tumor, and that multiple functions can be engineered into a single bacterial strain. These properties support the continued development of Synthetic Biotic immunotherapies for the treatment of solid tumors, particularly "cold" tumors that may be resistant to current immunotherapies due to their lack of infiltrating immune cells or a highly immunosuppressive tumor microenvironment. Synlogic plans to advance its first immuno-oncology program into IND-enabling studies in the fourth quarter of 2018.
Presentation of preclinical data supporting continued development of SYNB1618 for the treatment of Phenylketonuria (PKU) in a plenary session at the annual meeting of the American Society for Microbiology (ASM Microbe 2018). The data demonstrate, in a mouse model of PKU and healthy non-human primates, that orally administered SYNB1618 can result in significant decreases in blood phenylalanine levels and dose-responsive pharmacokinetics. Synlogic is currently evaluating SYNB1618 in a Phase 1/2a clinical trial for the management of PKU and expects to report interim data from healthy volunteers before the end of 2018 and full data that includes cohorts of patients with PKU in 2019.
Presentation of new preclinical data highlighting beneficial activity of SYNB1020 in animal model of liver disease at Digestive Disease Week (DDW 2018). The data demonstrate that, in addition to lowering systemic levels of ammonia, administration of SYNB1020 resulted in reduced indicators of liver damage, providing additional support for its continued development for the potential treatment of liver disease. SYNB1020 is currently being evaluated in a Phase 1b/2a clinical trial in patients with elevated ammonia due to cirrhosis, with topline data expected at the end of 2018.
Corporate

Strengthened balance sheet: As of June 30, 2018, Synlogic had cash, cash equivalents, and short-term investments of $143.2 million which includes $28.9 million in net proceeds generated by a registered direct offering completed in April 2018.
Addition to Russell 3000 Index following its annual reconstitution, providing Synlogic increased visibility and exposure to institutional investors.
Second Quarter 2018 Financial Results
For the three months ended June 30, 2018, Synlogic reported a consolidated net loss of $14.6 million, or $0.59 per share, compared to a consolidated net loss of $9.4 million, or $4.70 per share, for the corresponding period in 2017.

Research and development expenses were $10.9 million for the three months ended June 30, 2018 compared to $8.5 million for the corresponding period in 2017. The increase was primarily due to an increase in expenses associated with Synlogic’s SYNB1618 program including its ongoing Phase 1/2a clinical trial, an increase in compensation and other employee-related expenses associated with increased headcount, partially offset by one-time equity-based and patent-related charges of $2.1 million associated with Synlogic’s MIT-BU license agreement.

General and administrative expenses for the three months ended June 30, 2018 were $4.7 million compared to $3.0 million for the corresponding period in 2017. The increase was primarily due to an increase of $1.2 million in compensation costs associated with the separation of Synlogic’s former chief executive officer, as well as compensation and other employee-related expenses associated with increased headcount.

Revenues were $0.3 million for the three months ended June 30, 2018, compared to $2.1 million for the corresponding period in 2017. Revenue for both periods was associated with Synlogic’s collaboration with AbbVie to develop Synthetic Biotic medicines for the treatment of irritable bowel disease (IBD). The decrease in revenue was primarily the result of a milestone achieved and recognized during the three months ended June 30, 2017.

Six-months Results
For the six months ended June 30, 2018, the consolidated net loss was $25.8 million, or $1.14 per share, compared to a consolidated net loss of $16.8 million, or $9.20 per share, for the corresponding period in 2017.

Total operating expenses were $27.6 million for the six months ended June 30, 2018, compared to $19.1 million for the corresponding period in 2017. The increase in operating expenses was primarily due to compensation-related expenses associated with increased headcount, increased external costs associated with development of Synlogic’s Synthetic Biotic programs including process and formulation development, pre-clinical and clinical studies as well as increased general and administrative expenses as a consequence of becoming a public company.

On August 8, 2018 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported a business update and financial results for the second quarter ended June 30, 2018 (Press release, Leap Therapeutics, AUG 8, 2018, View Source [SID1234528560]).

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"Over the past few months, we have seen patients in the studies of both of our antibody programs experience clinical responses in combination with checkpoint inhibitors, including in patients who would not be expected to respond to checkpoint inhibitors alone. We look forward to continuing to read out data throughout the second half of 2018 from these ongoing clinical trials, including from our study evaluating DKN-01 in combination with KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer at the European Society for Molecular Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting in October," commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. "In addition, we recently announced a TRX518 collaboration with Pfizer and EMD Serono to add to our existing DKN-01 collaborations with Merck and Roche."

Recent Highlights

Since the end of the first quarter, we have made substantial progress with the development of our product candidates:

· Presented clinical results from our study evaluating DKN-01 in combination with KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer.

· Combination has been well tolerated with no dose limiting toxicity.

· In the high-dose DKN-01 cohort of dose escalation, two of four evaluable patients naïve to anti-PD-1/PD-L1 therapy have had a partial response, with two other evaluable patients having a best response of stable disease.

· Both of the responding patients have a tumor phenotype which is typically less responsive to anti-PD-1 therapy.

· Currently enrolling expansion cohorts in patients who are naïve to anti-PD-1/PD-L1 therapy and patients who are refractory to anti-PD-1/PD-L1 therapy.

· The treatment-naïve cohort has passed the Simon Stage 2 threshold.

· Enrollment of the full study is expected during the first quarter of 2019.

· Additional data from this study will be presented at the ESMO (Free ESMO Whitepaper) 2018 Annual Meeting in October.

· Announced a collaboration agreement with Pfizer and Merck KGaA, Darmstadt, Germany to evaluate TRX518 in combination with BAVENCIO (avelumab) and cyclophosphamide chemotherapy.

· Under the terms of the collaboration, we will be conducting a Phase I/II clinical trial in advanced solid tumors including expansion populations in patients with relapsed/refractory ovarian, breast, and prostate cancers.

· The study is expected to begin enrolling patients in the first quarter of 2019.

· Presented initial data from our clinical trial evaluating TRX518 in combination with gemcitabine chemotherapy or in combination with KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab).

· The first two patients treated with the higher dose of TRX518 in combination with KEYTRUDA have experienced clinical benefit after the end of two cycles of therapy.

· Esophageal squamous cell carcinoma patient demonstrated a partial response with a 36% reduction in tumor volume.

· Ocular melanoma patient experienced stable disease with a 23% reduction in tumor volume.

· Seven patients have been treated with the lower dose of TRX518 in combination with OPDIVO.

· Urothelial carcinoma patient who had progressed while on KEYTRUDA has had a partial response with a 39% reduction in tumor volume after the end of two cycles.

· Four other patients experienced progressive disease, one patient was non-evaluable, and one patient has not yet had any on treatment disease evaluation.

·Enrollment continues in the dose escalation phase for both the KEYTRUDA and OPDIVO combinations and in the dose expansion phase for the gemcitabine combination.

Selected Second Quarter 2018 Financial Results

Net loss was $7.4 million for the second quarter of 2018, compared to $6.9 million for the same period in 2017.

Research and development expenses were $4.2 million for the second quarter 2018, compared to $4.9 million for same period in 2017. The decrease of $0.7 million was primarily due to a decrease of $0.4 million in manufacturing costs related to clinical trial material, a decrease of $0.2 million in clinical trial costs and a decrease of $0.2 million in consulting fees associated with research and development activities. These decreases were partially offset by an increase of $0.1 million in stock based compensation expense.

General and administrative expenses were $2.6 million for the second quarter 2018, compared to $2.1 million for the same period in 2017. The increase of $0.5 million in general and administrative expenses was primarily due to a $0.4 million increase in legal, audit and consulting fees associated with corporate and business development activities and an increase of $0.1 million of stock based compensation expense.

Cash, cash equivalents and marketable securities totaled $30.5 million at June 30, 2018. Research and development incentive receivables totaled $1.8 million. The Company believes that its current cash and cash equivalents and the anticipated receipt of the research and development incentive receivable will be sufficient to fund the Company’s operating expenses into the fourth quarter of 2019.