On August 8, 2018 BioXcel Therapeutics, Inc. ("BTI") (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology, reported financial results for the second quarter ended June 30, 2018, and provided an update on key strategic and operational initiatives (Press release, BioXcel Therapeutics, AUG 8, 2018, View Source [SID1234528608]). During the second quarter, the Company made continued progress in the development of its two lead clinical programs. BXCL501, a proprietary sublingual thin film formulation of dexmedetomidine (Dex), is being developed for the acute treatment of mild to moderate agitation in neurological and psychiatric disorders such as geriatric dementia and schizophrenia/bipolar disorder. BXCL701, a first-in-class oral small-molecule immunomodulator targeting dipeptyl peptidases 8/9 (DPP 8/9) and fibroblast activation protein (FAP) is being developed for treatment emergent neuroendocrine prostate cancer (tNEPC) and pancreatic cancer.

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Second Quarter 2018 and Recent Highlights

Neuroscience Program (BXCL501)-

· Reported positive results from Phase 1b study of intravenously dosed Dex validating clinical development strategy for BXCL501;

·Data supports potential dosing strengths for sublingual thin film formulation of BXCL501, and initiation of Phase 1b PK/PD safety study using IV Dex in mild probable Alzheimer’s (AD) patients;

Company plans to initiate Phase 1b PK/PD safety study using the IV formulation of Dex in schizophrenia patients in the second half of 2018;

·Data from both AD and schizophrenia studies expected during the second half of 2018.

·Initiation of bioavailability study for the sublingual thin film formulation expected in the second half of 2018 following completion of GMP manufacturing and IND approval;

·Formed world-class neuroscience clinical advisory board to support global development of BXCL501 and other neuroscience programs;

·Maintained active dialog with FDA regarding ongoing clinical development of BXCL501.

Immuno-Oncology Program (BXCL701)-

·Company plans to commence single and combination agent open label clinical trials of BXCL701 in the second half of 2018 following completion of GMP manufacturing and IND approval. Preliminary data from these trials will be available throughout 2019.

· Presented encouraging preclinical data on combination therapy of BXCL701, Nektar Therapeutics’ NKTR-214 and an anti-PD1 agent in pancreatic cancer at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting;

Business & Operations-

· Strengthened management team with C-suite and VP-level appointments;

· Formalized the role of Vincent O’Neill MD, as Senior Vice President and Chief Medical Officer;

· Key hires included Vikas Sharma, Ph.D. as Vice President of Business Development to lead the Company’s strategic partnering initiatives, particularly for BTI’s lead immuno-oncology asset, BXCL701; Cedric Burg, Ph.D. as Vice President and Head of Global Clinical Operations and Project Management to lead the development and execution of BTI’s global clinical operations strategy; and Michael DeVivo Ph.D. as Vice President, Neuroscience, to support the Company’s research and development team in advancing current programs and expanding pipeline candidates using the dual strategy of focusing on symptoms-based treatments, and treatments for rare neurological diseases;

· Continued expanding network of partners to leverage capabilities and augment internal drug development teams;

·Continued to build intellectual property portfolio with multiple global patent submissions to protect lead candidates, BXCL501 and BXCL701.

"During the second quarter, we made tremendous progress advancing our lead neuroscience and immuno-oncology programs with positive results from two important studies, as well as further building out our leadership infrastructure," commented Vimal Mehta, President and Chief Executive Officer of BTI.

"We reported positive data from our first-in-human trial of intravenously (IV)-dosed Dex supporting further development of BXCL501, our sublingual formulation of Dex for the acute treatment of agitation. Data from the trial demonstrated that the doses and exposure levels of IV Dex had calming effects on healthy subjects without producing clinically meaningful changes in blood pressure or heart rate. The results from this trial will be valuable in determining the ideal dosing strategy for BXCL501. Based on our ongoing discussions with the FDA regarding development of BXCL501, we expect that proof-of-concept studies in geriatric dementia and schizophrenia/bipolar disease will be initiated in the second half of 2018. We also expect to initiate a bioavalibility study on our proprietary sublingual thin film formulation this year."

Dr. Mehta added, "At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 annual meeting, we showcased promising preclinical data on a combination of BXCL701, our oral small molecule immunomodulator, Nektar Therapeutics’ NKTR-214 and an anti-PD1 agent in pancreatic cancer models. The study showed durable anti-tumor response with significant improvement in complete tumor regression and development of anti-cancer immunity. Recently, one component of BXCL701’s dual mechanism of action, DPP 8/9 inhibition, was highlighted in peer reviewed journal, Nature Medicine, providing a key validation of our choice of lead immuno-oncology program and clinical strategy. We are now preparing to initiate clinical studies for BXCL701 in tNEPC and pancreatic cancer in the second half of the year."

Dr. Mehta concluded, "We are well positioned as we enter the third quarter of the year, with a strong cash runway of over $50M to develop our two drug candidates. We have established our leadership team with the appointment of renowned executives who bring international pharma expertise to the company, especially in neuroscience and immuno-oncology. We believe we are well-equipped to build upon the progress we have made in the second quarter of 2018 to achieve our operational and clinical development goals. We remain committed to working towards discovery and development of innovative therapeutic options for neuroscience and immuno-oncology indications, while also creating value for our shareholders.

Second Quarter 2018 Financial Results

BTI reported a net loss of $3.0 million for the second quarter of 2018, compared to a net loss of $0.6 million for the same period in 2017.

Research and development expenses were $1.8 million for the second quarter of 2018, as compared to $0.3 million for the same period in 2017. The increase was primarily due to an expansion of research and development activities , including increased personnel costs, professional fees, clinical trial, and manufacturing costs all, associated with BTI’s two main drug candidates.

General and administrative expenses were $1.5 million for the second quarter of 2018, as compared to $0.2 million for the same period in 2017. The increase was primarily due to additional payroll and payroll-related expenses, professional fees and costs associated with operating as a public company.

As of June 30, 2018, cash and cash equivalents totaled $50.3 million.

On August 8, 2018 Horizon Pharma plc (NASDAQ: HZNP) reported its second-quarter 2018 financial results today (Press release, Horizon Pharma, AUG 8, 2018, View Source [SID1234528580]). Effective with the second quarter of 2018, the Company has realigned its operating structure and is reporting financial results as two separate segments: the orphan and rheumatology segment, its strategic growth business, and the primary care segment. The new operating structure reflects the evolution of the Company’s strategy and vision of transitioning Horizon Pharma to a biopharmaceutical company focused on rare disease medicines.

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"Our orphan and rheumatology segment generated record quarterly net sales, driven by accelerating KRYSTEXXA growth, reflecting the additional investments we are making this year," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. "Our clinical programs continue to advance, with target enrollment now complete in the teprotumumab Phase 3 trial, well ahead of schedule. Additionally, we plan on initiating a new study of KRYSTEXXA to continue exploring a broader clinical profile of this medicine, the only FDA-approved treatment for uncontrolled gout. These advancements support our transformation into a rare disease medicine focused company with a robust pipeline enabling sustainable growth."

Second-Quarter and Recent Company Highlights

Teprotumumab: OPTIC, the teprotumumab Phase 3 clinical trial, has reached its target enrollment of 76 patients, significantly ahead of schedule. The remaining few subjects in screening will be allowed to randomize over the next several weeks.

Teprotumumab is a fully human monoclonal antibody IGF-1R inhibitor being developed for the treatment of thyroid eye disease (TED), in which the muscles and fatty tissue behind the eye become inflamed, which can lead to proptosis, or bulging of the eye, and diplopia, or double vision, as well as quality-of-life issues. In October, data will be presented at the 2018 American Thyroid Association (ATA) meeting from the follow-up period of the Phase 2 clinical trial, during which the Company continued to collect data on study patients off therapy out to 48 weeks to assess durability of response.

New KRYSTEXXA Immunomodulation Study: The Company is planning on initiating a new study of KRYSTEXXA to continue to explore a broader clinical profile of this medicine, the only FDA-approved treatment for uncontrolled gout (chronic gout that is refractory to conventional therapies). The study will evaluate the impact of adding methotrexate to KRYSTEXXA to enhance the patient response rate. Methotrexate is the most common immunomodulator used by rheumatologists. Enrollment is expected to begin in the fourth quarter of 2018.

New Uncontrolled Gout and KRYSTEXXA Data Presented at EULAR: In June, the Company participated in the 2018 Annual European Congress of Rheumatology (EULAR) in Amsterdam, where new insights on both gout and KRYSTEXXA were presented. One presentation highlighted a 27 percent increase in U.S. emergency department visits between 2006 and 2014 for people living with gout, suggesting a sizeable and growing population of gout patients who are uncontrolled and not well managed. Several KRYSTEXXA data analyses underscored the complex nature of uncontrolled gout, the potential systemic effects of elevated serum uric acid (sUA) levels and the need to manage uncontrolled gout aggressively. These presentations support the Company’s continued efforts to increase awareness and understanding of uncontrolled gout and the benefits of KRYSTEXXA.

R&D Leadership: The Company made several important leadership additions to its research and development (R&D) organization to expand its capabilities, partner with the business development team in identifying and evaluating development-stage opportunities and lead the orphan and rheumatology therapeutic areas’ clinical development strategies.

Intellectual Property Update: The Company received two new patents from the U.S. Patent and Trademark Office during the quarter that cover RAVICTI, with two additional patents scheduled to be issued in August, resulting in five new patents in an 18-month period. In addition, the Company settled litigation in June with Lupin relating to RAVICTI. Lupin’s license to enter the market with a generic version of RAVICTI would begin on July 1, 2026.

Best Workplace Awards: Great Place to Work and FORTUNE Magazine selected Horizon Pharma as the Number One place to work on FORTUNE’s "Best Workplaces in Health Care & Biopharma" list. The Company has also been awarded a 2018 "Best Places to Work in Chicago" designation by Crain’s Chicago Business, as well as named to its "10 Best Places to Work for Women" list. In addition, in July, the Company was recognized by PEOPLE and Great Place to Work as one of the 2018 "50 Companies That Care," a list that spotlights companies with 1,000 or more employees that have succeeded in business while also demonstrating respect, compassion and concern for their communities, their employees and the environment.

Research and Development Programs

Orphan Candidates and Programs:

Teprotumumab: Teprotumumab is the Company’s fully human monoclonal antibody IGF-1R inhibitor in development for the treatment of TED. The pivotal Phase 3 confirmatory study is evaluating teprotumumab for the treatment of moderate-to-severe active TED, which has no FDA-approved treatments. The Company estimates peak annual U.S. net sales of more than $750 million for teprotumumab, assuming FDA approval.

Rheumatology Pipeline Candidates and Programs:

KRYSTEXXA Immunomodulation Studies: The evaluation of the use of immunomodulation therapies to enhance the response rate to KRYSTEXXA is being studied in two investigator-initiated trials, as well as a new trial being initiated by the Company. The three trials are evaluating different immunomodulators, all of which are used by rheumatologists.

Methotrexate to Increase Response Rates in Patients with Uncontrolled GOut Receiving KRYSTEXXA (MIRROR): a Horizon Pharma-sponsored multicenter, efficacy and safety study for methotrexate co-administered with KRYSTEXXA to evaluate the impact of methotrexate weekly for one month prior to dosing with KRYSTEXXA and then throughout the 24 weeks of treatment with KRYSTEXXA. Enrollment is expected to begin in the fourth quarter of 2018.

REduCing Immunogenicity to PegloticasE (RECIPE): a double-blind, placebo-controlled trial for mycophenolate mofetil (MMF) co-administered with KRYSTEXXA to evaluate the impact of MMF daily for two weeks prior to dosing with KRYSTEXXA, followed by a 12-week course of KRYSTEXXA every two weeks along with daily doses of MMF,followed by dosing of KRYSTEXXA alone every two weeks for 12 weeks.

Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect (TRIPLE) is an exploratory, open-label adaptive trial with multiple patient cohorts, including one evaluating the impact of adding daily doses of azathioprine for a two-week run-in period, followed by KRYSTEXXA every two weeks for a total of 13 doses, along with daily doses of azathioprine.

Next-generation Biologic Programs for Uncontrolled Gout: The Company is pursuing two development programs for next-generation biologics for uncontrolled gout, HZN-003 and PASylated uricase technology to support and sustain the Company’s market leadership in uncontrolled gout. The programs are exploring the use of optimized uricase technology as well as optimized PEGylation and PASylation technology.

Second-Quarter Financial Results

Note: For additional detail and reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures, please refer to the tables at the end of this release.

Net Sales: Second-quarter 2018 net sales were $302.8 million, an increase of 4.6 percent, driven by continued strong growth of the Company’s orphan and rheumatology medicines. Year-over-year growth would have been 6.3 percent, excluding second-quarter 2017 net sales of $4.5 million for PROCYSBI and QUINSAIR in the Europe, the Middle East and Africa (EMEA) regions, which were divested on June 23, 2017.

Gross Profit: Under U.S. GAAP in the second quarter of 2018, the gross profit ratio was 67.0 percent compared to 55.0 percent in the second quarter of 2017. The non-GAAP gross profit ratio in the second quarter of 2018 was 90.2 percent compared to 90.6 percent in the second quarter of 2017.

Operating Expenses: R&D expenses were 8.0 percent of net sales and selling, general and administrative (SG&A) expenses were 58.3 percent of net sales. Non-GAAP R&D expenses were 6.7 percent of net sales, and non-GAAP SG&A expenses were 45.0 percent of net sales.

Income Tax Rate: The income tax rate in the second quarter of 2018 on a GAAP basis was negative 13.7 percent and on a non-GAAP basis was 12.0 percent.

Net (Loss) Income: On a GAAP basis in the second quarter of 2018, net loss was $32.8 million.Second-quarter 2018 non-GAAP net income was $80.5 million.

Adjusted EBITDA: Second-quarter 2018 adjusted EBITDA was $116.8 million.

Earnings (Loss) per Share: On a GAAP basis in the second quarter of 2018, diluted loss per share was $0.20; in the second quarter of 2017, diluted loss per share was $1.29. Non-GAAP diluted earnings per share in the second quarter of 2018 and 2017 were $0.48 and $0.41, respectively. Weighted average shares outstanding used for calculating GAAP diluted loss per share and non-GAAP diluted earnings per share in the second quarter of 2018 were 165.5 million and 169.4 million, respectively.

Second-Quarter Segment Results

The Company has realigned its structure to operate its strategic growth business, orphan and rheumatology, separately from its primary care business. The new structure allows the Company to more efficiently allocate its resources to address unmet treatment needs for patients with rare diseases. As a result of the realignment, effective with the second-quarter of 2018, the Company is reporting its financial results as two separate segments: the orphan and rheumatology segment and the primary care segment, reporting net sales and operating income for each segment. Historical segment net sales and operating income for 2017 are provided in the accompanying financial schedules.

Management uses net sales and segment operating income to evaluate the performance of the Company’s two segments. While segment operating income contains certain adjustments to the directly comparable GAAP figures in the Company’s consolidated financial results, it is considered to be prepared in accordance with GAAP for purposes of presenting the Company’s segment operating results.

Orphan and Rheumatology Segment

On June 23, 2017, Horizon Pharma completed the divestiture of a European subsidiary that owned the marketing rights to PROCYSBI and QUINSAIR in Europe, the Middle East and Africa (EMEA) to Chiesi Farmaceutici S.p.A. Horizon Pharma retains marketing rights for the two medicines in the United States, Canada, Latin America and Asia. Second-quarter and year-to-date 2017 net sales of PROCYSBI and QUINSAIR in EMEA were $4.5 million and $9.5 million, respectively.

Second-quarter 2018 net sales of the orphan and rheumatology segment were $201.7 million, an increase of 17.2 percent over the prior year’s quarter, driven by continued strong KRYSTEXXA growth, as well as growth of RAVICTI and PROCYSBI. Excluding the second-quarter 2017 EMEA net sales of $4.5 million for PROCYSBI and QUINSAIR that were divested in June 2017, orphan and rheumatology segment year-over-year net sales growth would have been 20.4 percent.

In line with the Company’s expectations, second-quarter 2018 orphan and rheumatology segment operating income was $70.6 million, or 35 percent of orphan and rheumatology net sales. The Company is investing significantly in the commercial expansion of KRYSTEXXA in 2018, which is expected to continue to drive future net sales growth and margin expansion over time.

Second-quarter 2018 net sales of the primary care segment were $101.1 million.

In line with the Company’s expectations, second-quarter 2018 operating income for the primary care segment was $45.9 million, or 45 percent of primary care net sales.

Cash Flow Statement and Balance Sheet Highlights

On a GAAP basis in the second quarter of 2018, operating cash flow was $61.8 million. Non-GAAP operating cash flow was $75.2 million.

The Company had cash and cash equivalents of $710.2 million as of June 30, 2018.

As of June 30, 2018, the total principal amount of debt outstanding was $1.993 billion, which consists of $818 million in senior secured term loans due 2024; $300 million senior notes due 2024; $475 million senior notes due 2023; and $400 million exchangeable senior notes due 2022. As of June 30, 2018, net debt was $1.283 billion.

Full-Year 2018 Guidance

The Company continues to expect full-year 2018 net sales in a range of $1.170 billion to $1.200 billion. The Company increased its full-year 2018 adjusted EBITDA guidance to a range of $400 million to $420 million, from $390 million to $415 million. The Company continues to project full-year 2018 net sales growth for KRYSTEXXA of more than 65 percent.

Webcast

At 8 a.m. EDT / 1 p.m. IST today, the Company will host a live webcast to review its financial and operating results and provide a general business update. The live webcast and a replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.

On August 8, 2018 Context Therapeutics, a clinical stage biopharmaceutical company dedicated to the treatment of hormone driven cancers, reported it has signed multiple research collaborations to further understand the role of progesterone receptor (PR) signaling and its blockade to overcome resistance mechanisms underlying metastatic breast cancer (mBCa) (Press release, Context Therapeutics, AUG 8, 2018, View Source [SID1234528579]). These collaborations are with key leaders in the progesterone and breast cancer fields and include Dr. Carol Lange, PhD at University of Minnesota and Dr. Suzanne Fuqua, PhD at Baylor College of Medicine, both of whom also serve as Scientific Advisory Board members at Context. Additional academic collaborations include the laboratories of Dr. Sarat Chandarlapaty, MD, PhD at Memorial Sloan Kettering Cancer Center, Dr. Geoffrey Greene, PhD at University of Chicago and Dr. Seema Khan, MD at Northwestern University.

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Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer related death in women. Approximately 155,0002 women in the United States have mBCa and the median overall survival in this setting is three years. Three primary mBCa subtypes exist: hormone receptor positive (HR+) that express estrogen receptor (ER) and/or progesterone receptor (70-80% of patients); human epidermal growth factor receptor 2 (HER2)-positive (10-15%); and triple negative (10-17%). For patients with HR+ mBCa, antiestrogen blockade is the backbone therapy across first (1L) and second (2L) treatment lines. Unfortunately, current treatments in 1L and 2L are not curative and only delay progression to chemotherapy. Therefore, there is a critical need for targeting additional mechanisms alone or in combination with antiestrogens to enhance therapeutic response and provide these patients with better outcomes.

Progesterone, a major mitogen in the adult human mammary epithelium, is also a key driver of breast cancer cell proliferation. Context Therapeutics is pursuing an innovative approach to the treatment of advanced breast cancer by blocking both ER and PR, the primary drivers of HR+ mBCa disease progression, through the combination of Apristor, a unique PR full antagonist, with the antiestrogen Falsodex (fulvestrant). Apristor has established efficacy as an antitumor agent in this setting, as well as in multiple preclinical breast cancer models and exhibits additive/synergistic effects with antiestrogens, providing a strong rationale for this combination.

A Phase 2 clinical trial in advanced breast cancer patients with Apristor in combination with Fulvestrant in 2L therapy is planned for early 2019. The randomized, double-blind, placebo-controlled study will be powered to show efficacy with Apristor added to the standard of care (Fulvestrant) versus the standard of care alone.

The research at the above academic centers will focus on expanding the understanding of mechanisms underlying resistance in breast cancer and novel therapeutic combinations that could be useful in treating advanced breast cancer with Apristor.

Under the terms of the collaborations, Context will provide Apristor and collaborate with the research groups. While it is well known that Apristor is a unique PR antagonist8 that inhibits both ligand-dependent and growth factor induced PR activities, access to the drug for basic research purposes has been historically limited. Context is providing the compound to key interested academic partners with the aim of advancing breast cancer research and understanding the role of PR signaling in mammary tumors and other indications.

About Progesterone Receptor Antagonism

Context is developing Apristor, a first-in-class orally-bioavailable progesterone receptor (PR) antagonist for PR+ breast cancer. Up to 60% of breast cancer patients are believed to be PR+. Apristor is an investigational medicine that has completed Phase 1 development and will be further evaluated in an upcoming randomized, placebo-controlled Phase 2 trial in second-line metastatic breast cancer patients who are PR+ and have failed prior antiestrogen therapeutic with or without the addition of a Cdk4/6 inhibitor.

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."