CP Tianqing’s blockbuster innovative drug Anlotinib Hydrochloride Capsules Approved for Marketing

On May 9, 2018 Chia Tai Tianqing Pharmaceutical Group reported the 1.1-type new drug Anlotinib Hydrochloride Capsules (Focavi) obtained the registration approval document approved by the State Drug Administration (Press release, Jiangsu Chia-tai Tianqing, MAY 9, 2018, View Source [SID1234576212]). This marks the official launch of Anlotinib, an original and innovative drug in the Chinese oncology field that has received much attention. Wang Shanchun, president of CP Tianqing Pharmaceutical Group, said: "We expect that this new national drug will benefit more Chinese patients and even patients around the world after it is launched."

Anlotinib refers to advanced non-small cell lung cancer

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After more than 10 years of hard work, the R&D team of CP Tianqing finally made a breakthrough in the development of oncology drugs. The 1.1-type new drug Anlotinib Hydrochloride Capsules was approved for marketing. This product is a new type of small molecule multi-target tyrosine kinase inhibitor, which can effectively inhibit VEGFR, PDGFR, FGFR, c-Kit and other kinases, and has the dual effects of anti-tumor angiogenesis and inhibiting tumor growth. Clinical trials have confirmed that Focavi is the only effective single-drug oral preparation among the anti-angiogenesis targeted drugs for advanced non-small cell lung cancer, and its adverse reactions are relatively mild, and it is well tolerated by patients. According to analysis by industry experts, Anlotinib is expected to become the standard drug for the third-line treatment of patients with advanced non-small cell lung cancer.

"The listing of Anlotinib is also due to the ongoing reform measures for drug review and approval by the State Food and Drug Administration. As clinical studies have shown that Anlotinib has obvious clinical advantages over existing treatments, after the application That is, it was included in the priority review sequence by the drug review center. It is precisely because of the attention of the drug review department and the review experts working overtime that Anlotinib completed the marketing review and was approved in a short period of time. This will enable the majority of patients to use safe and effective anti-tumor innovative drugs as soon as possible." Wang Shanchun believes that the drug review period coincides with the national drug review and approval policy reform period, and the country’s orientation to encourage R&D and innovation is becoming more and more obvious. The approval of innovative drugs with outstanding clinical value such as Anlotinib has been guaranteed and encouraged. Through the priority review procedure, the Center for Drug Evaluation has provided an effective guarantee for meeting clinical drug needs, reducing drug costs, and promoting public health.

The clinical research results show that Focavi not only has a good therapeutic effect on non-small cell lung cancer, but also on soft tissue sarcoma, ovarian cancer and other cancers. CT Tianqing is actively carrying out multi-center clinical research including the United States. . The results of the Phase 2b clinical study of Anlotinib in the treatment of soft tissue sarcoma were reported orally by ASCO (Free ASCO Whitepaper) this year, and the results of the pathological subgroup of the Phase 3 clinical study for the treatment of non-small cell lung cancer were displayed in the ASCO (Free ASCO Whitepaper) this year, and were written into the "2018 CSCO Lung Cancer Guidelines" . Wang Shanchun said: "It is not easy for China’s original innovative drugs to have won such an honor before they went on the market. This shows the international recognition of Chinese innovative drugs."

Malignant tumors are the unbearable weight of life

There are more than 4 million new cancer patients in China each year, and an average of more than 10,000 people are diagnosed as new patients every day, and the incidence rate is increasing year by year. In particular, lung cancer ranks first in morbidity and mortality among men, and second in morbidity and mortality among women. The five-year survival period of cancer patients is much lower than the average in developed countries.

As an ordinary citizen, once diagnosed with a malignant tumor disease, not only the patient himself will suffer both physical and mental torture, loss of hope of survival, loss of dignity of life, but also a family may be crushed by this, and bear a heavy burden from then on The unbearable spiritual and economic burden. As an enterprise with a social conscience, CP Tianqing is also working hard, hoping to one day conquer the persistent disease of malignant tumors through technological innovation.

In recent years, with the development of traditional chemotherapy, targeted therapy and immunotherapy have successively entered first-line and second-line treatment, and the treatment of advanced non-small cell lung cancer has been greatly improved. However, for Chinese patients who have failed first-line and second-line treatments, the existing third-line treatments are relatively lacking and the choices are confusing, and patients are often in the predicament of no medicines available. In this case, the new small molecule multi-target tyrosine kinase inhibitor anlotinib independently developed by CT Tianqing has finally succeeded, providing an effective new method for the third-line treatment of patients with advanced non-small cell lung cancer in China. treatment method.

CP Tianqing has a rich product line in the anti-tumor field

The listing of Anlotinib can be said to be a milestone event in the development history of CP Tianqing. The drug is Chia Tai Tianqing’s first innovative small molecule drug in accordance with international R&D procedures and standards, and it is also the company’s most invested anti-cancer drug so far. The successful listing of Anlotinib marks a solid step forward by CP Tianqing from "combination of imitation and innovation" to "combination of innovation and imitation". It is also a major breakthrough in the oncology field of the company based on the "focus on liver disease" strategy. .

Chia Tai Tianqing Pharmaceutical Group is an innovative pharmaceutical group enterprise integrating scientific research, production and sales. It is a well-known liver health drug research and development and production base in China. It is a national key high-tech enterprise and a national Torch Plan Lianyungang new pharmaceutical industry base. The backbone enterprise ranks 16th among the top 100 enterprises in China’s pharmaceutical industry. Chia Tai Tianqing currently invests more than 10% of its sales revenue every year. It has more than 1,000 R&D personnel and more than 180 products under research, including more than 40 innovative drugs and more than 20 biological drugs.

It is reported that in addition to the field of strong liver diseases, CP Tianqing has also formed a unique product line in the field of anti-tumor. Hematological tumor products Decitabine, Imatinib, and Dasatinib are the first imitation products in China. In the next three years, CP Tianqing will launch more products in the oncology field, such as bortezomib, bendamustine, lenalidomide, azacitidine, etc., to improve drug accessibility and quality of life for cancer patients.

Idera Pharmaceuticals Reports First Quarter 2018 Financial Results and Provides Corporate Update

On May 9, 2018 Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ:IDRA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel nucleic acid-based therapeutics for oncology and rare diseases, reported its financial and operational results for the first quarter ended March 31, 2018 (Press release, Idera Pharmaceuticals, MAY 9, 2018, View Source [SID1234526315]).

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"Our company continues to make significant progress advancing our two lead TLR modulating clinical development candidates, tilsotolimod and IMO-8400," stated Vincent Milano, Idera’s chief executive officer. Milano continued, "As we now advance through the second quarter, we are continuing to enroll patients in the ILLUMINATE oncology trials, with the next planned data from ILLUMINATE-204 in PD-1 refractory metastatic melanoma to be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting and completion of enrollment expected by year end. For IMO-8400, we plan to report top-line data from our Phase 2 trial in dermatomyositis in June. As it pertains to our nucleic acid chemistry research group, we completed our data analysis for IDRA-008 which has led us to a decision to not advance that program into the clinic."

"In January of this year, we announced our proposed merger with BioCryst Pharmaceuticals, Inc. that we believe will build greater and more sustainable value for the benefit of stockholders as well as patients with rare diseases beyond what we could achieve alone. The Idera Board determined this combination was compelling from both a strategic and financial perspective following a careful evaluation of a range of strategies to enhance long-term stockholder value. The transaction will create a leading rare disease company with a robust pipeline including two promising Phase 3 rare disease programs and combines synergistic discovery engines that will not only expand the number of rare diseases we can target but create meaningful opportunities for differentiation in the market through joint small molecule and oligo treatments. Importantly, joining with BioCryst will also enable us to achieve cost synergies and increase our financial strength and flexibility. Subject to shareholder approval, we expect to close the transaction in the third quarter," Milano expressed.

Clinical Development Program Updates:
TLR Modulation Technology Development Candidates

ILLUMINATE (tilsotolimod) Clinical Development

ILLUMINATE 301 – Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with PD-1 refractory metastatic melanoma:

Trial initiated in Q1 2018;
Approximately 80 sites planned for trial participation across 12 countries;
Planned enrollment of approximately 300 patients with Overall Response Rate ("ORR") and Overall Survival as primary endpoints; and
U.S. Food and Drug Administration granted Fast Track Designation for tilsotolimod in combination with ipilimumab for treatment of PD-1 refractory metastatic melanoma in fourth quarter of 2017.
ILLUMINATE 204 – Phase 1/2 trial of intratumoral tilsotolimod in combination with ipilimumab or pembrolizumab in patients with PD-1 refractory metastatic melanoma:

Ipilimumab Combination Arm – Phase 2 Expansion Ongoing at RP2D of 8mg

Enrollment (60 patients) completion expected by year end 2018;
5 of the first 10 evaluable patients at the 8 mg dose of tilsotolimod were responders (50% ORR);
Additional data from the Phase 2 expansion of ILLUMINATE-204 selected for presentation at upcoming ASCO (Free ASCO Whitepaper) meeting in Chicago, IL.
Melanoma/Skin Cancers poster discussion session on June 4, 2018 at 4:45 PM CT; and
Investor/Analyst Event featuring lead ILLUMINATE-204 investigator, Adi Diab, MD from the University of Texas, MD Anderson Cancer Center to be held at 6:30 PM CT, also on June 4, 2018. As a convenience to those unable to attend, this event will be webcast.
Pembrolizumab Combination Arm – Phase 1 Dose Escalation Ongoing

Enrollment into the last dosing cohort (32 mg) ongoing;
The previously reported partial response (PR) in 1 of the first 6 patients in the 16 mg cohort of intratumoral tilsotolimod in combination with pembrolizumab has evolved into a confirmed complete response (CR).
ILLUMINATE 101 – Phase 1b trial of intratumoral tilsotolimod monotherapy in patients with refractory solid tumors:

Completed enrollment in first two cohorts (11 patients treated with 8 mg dose of tilsotolimod, 8 patients treated with 16 mg dose of tilsotolimod);
Two patients in cohort 1 (8 mg) continue in follow-up; 2 patients in cohort 2 (16 mg) continue tilsotolimod monotherapy and two patients continue in follow-up; and
6 of 8 planned patients for cohort 3 (23 mg) enrolled.
(IMO-8400) Development Activities

PIONEER-211 – Randomized placebo controlled Phase 2 trial of IMO-8400 in adult patients with dermatomyositis:

Enrollment concluded during Q3 2017 (30 patients); and
Topline phase 2 trial data expected in June 2018.
Nucleic Acid Chemistry Research Group

We are developing our nucleic acid chemistry technology to "turn off" the mRNA associated with disease causing genes. Our focus is on creating candidates targeted to specific genes to treat cancer and rare diseases.
We had selected IDRA-008 as our first nucleic acid chemistry research program candidate. IDRA-008 targets the Apolipoprotein C-III (APOC-III) gene and was being developed for the treatment of Familial Chylomicronemia Syndrome (FCS) and Familial Partial Lipodystrophy (FPL) which had available pre-clinical animal models and well-known clinical endpoints.
During the first quarter of 2018, we completed our pre-clinical analysis for IDRA-008 and based upon the outcome of pre-clinical pharmacology studies, including a comparative pharmacology study with the competitive development asset volanesorsen, and IND-enabling safety evaluation, we made a data-driven decision to not advance IDRA-008 into clinical development.
We are currently conducting analysis throughout our research portfolio to identify other candidates for future clinical development based on our nucleic acid technology expertise and potential strategic commercial opportunity.
Financial Results
First Quarter Results
Net loss applicable to common stockholders for the three months ended March 31, 2018 was $20.1 million, or $0.10 per basic and diluted share, compared to net loss applicable to common stockholders of $15.1 million, or $0.10 per basic and diluted share, for the same period in 2017. Revenue in each of the three months ended March 31, 2018 and 2017 was nominal. Research and development expenses for the three months ended March 31, 2018 totaled $13.6 million compared to $11.5 million for the same period in 2017. General and administrative expense for the three months ended March 31, 2018 totaled $7.0 million compared to $4.1 million for the same period in 2017.

During the three months ended March 31, 2018, holders of warrants, including Baker Brothers, exercised warrants to purchase shares of the Idera’s common stock which generated $9.6 million in cash proceeds. As of March 31, 2018, our cash and cash equivalents totaled $107.5 million compared to $112.6 million as of December 31, 2017. We currently anticipate that, based on our current operating plan and without taking into account the transaction with BioCryst Pharmaceuticals, Inc. ("BioCryst"), our existing cash, cash equivalents and investments will fund our operations into the third quarter of 2019.

Corporate Updates:

On January 22, 2018, BioCryst and Idera jointly announced the signing of a definitive merger agreement to create a company focused on the development and commercialization of medicines to serve patients suffering from rare diseases. The combined company will be renamed upon closing, and will be led by Vincent Milano, the current chief executive officer of Idera. Jon Stonehouse, the current chief executive officer of BioCryst, will serve as a member of the Board of Directors. The transaction is subject to approval by the stockholders of both companies, as well as the satisfaction of customary closing conditions. The transaction is expected to be completed by the end of the third quarter of 2018.

Complix to Present Progress on its Pipeline of Cell Penetrating Alphabodies Acting on Intracellular Cancer Targets at BioEquity Europe 2018

On May 9, 2018 Complix, a biopharmaceutical company developing Cell Penetrating Alphabodies (CPABs) to target intracellular disease targets, reported that its Chief Executive Officer, Dr Mark Vaeck, will be presenting the Company´s progress at the 19th Annual BioEquity Europe in Ghent Belgium, May 14-16 (Press release, Complix, MAY 9, 2018, View Source [SID1234526365]).

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In his presentation Dr Vaeck will give insight into Complix’ recent achievements in expanding its pipeline of CPABs acting on important but intractable cancer targets.

The presentation will take place on Wednesday May 16th at 10.40h CET.

For more information on BioEquity Europe 2018, please click here.

Neurocrine Biosciences to Present at the Bank of America Merrill Lynch 2018 Healthcare Conference

On May 9, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will present at the Bank of America Merrill Lynch 2018 Healthcare Conference at 8:40 a.m. PT (11:40 a.m. ET) on Tuesday, May 15, 2018, in Las Vegas, Nevada. Kevin Gorman, CEO of Neurocrine Biosciences, will present at the conference (Press release, Neurocrine Biosciences, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348202 [SID1234526381]).

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at View Source A replay of the presentation will be available on the website approximately one hour after the conclusion of the event and will be archived for one month.

XOMA Reports First Quarter 2018 Financial Results

On May 9, 2018 XOMA Corporation (Nasdaq: XOMA), a pioneer in the discovery, development and licensing of therapeutic antibodies, reported its first quarter 2018 financial results (Press release, Xoma, MAY 9, 2018, View Source [SID1234526401]).

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"Our efforts in the first quarter were dedicated to identifying, assessing and analyzing out-license and asset acquisition opportunities. These included potential partnering conversations regarding our novel IL-2 antibody program, as well as discussions with companies seeking to monetize future potential milestone and royalty revenue streams," stated Jim Neal, Chief Executive Officer at XOMA. "While the number of opportunities continues to expand, we are focused on identifying a narrower set of high quality potential transactions. With a cash runway that spans multiple years and additional access to capital from our credit facility, we remain intensely focused on allowing our fully-funded programs to mature in the hands of our partners while expanding and diversifying our portfolio of potential future revenue streams to drive both near- and long-term value."

Financial Results

XOMA recorded total revenues of $0.5 million for the first quarter of 2018, compared to $0.3 million for the first quarter of 2017.

Research and development (R&D) expenses were $0.4 million for the first quarter of 2018, compared to $4.0 million for the first quarter of 2017. The decrease in R&D expenses was due primarily to reductions of $1.0 million in clinical trial costs, $0.8 million in consulting costs, $0.6 million in the allocation of facilities costs, $0.3 million in salaries and related expenses, $0.3 million in stock-based compensation, and $0.3 million in external manufacturing costs. The significant reduction in R&D spending year-over-year is a result of the execution of the Company’s royalty-aggregator business model that is designed to leverage its extensive portfolio of partnered programs and licensed technologies.

General and administrative (G&A) expenses were $5.2 million for the three months ended March 31, 2018 and 2017, respectively. The minimal change in G&A expenses for the three months ended March 31, 2018 was due primarily to decreases of $0.8 million in consulting services, $0.3 million in legal and audit fees, and $0.2 million in information technology costs, partially offset by increases of $0.7 million in stock compensation cost and $0.6 million in the allocation of facilities costs due to a greater proportion of general and administrative personnel after the Company’s restructuring activities.

Net loss for the first quarter of 2018 was $3.8 million. Net loss for the first quarter of 2017 was $16.3 million and included non-recurring and restructuring charges totaling $7.6 million.

On March 31, 2018, XOMA had cash and cash equivalents of $42.0 million. The Company ended December 31, 2017, with cash and cash equivalents of $43.5 million. The Company’s current cash and cash equivalents are expected to be sufficient to fund its operations for multiple years.

In May 2018, the Company announced a flexible $20 million credit facility with Silicon Valley Bank. The credit facility is available to XOMA through March 2019 and may be extended to March 2020 upon certain conditions. The credit facility includes the opportunity to increase the borrowing capacity to an aggregate amount of $40 million.