LSK BioPharma and Jiangsu Hengrui Medicine Announce Enrollment of The First Patient in a Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Rivoceranib (Apatinib)

On June 30, 2019 LSK BioPharma (or "LSKB"), a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd. (SHA:600276, or "Hengrui"), one of the largest and most innovative fully-integrated biopharmaceutical companies based in China, reported the first patient has been enrolled in a pivotal global phase 3 clinical study of PD-1 antibody camrelizumab (SHR-1210) plus rivoceranib (commonly known as apatinib) versus sorafenib as a first-line therapy in subjects with advanced hepatocellular carcinoma (HCC) (Press release, LSK BioPharma, JUN 30, 2019, View Source [SID1234537337]). Rivoceranib, a selective VEGFR-2 inhibitor commonly known as apatinib, was approved in 3rd line gastric cancer in China in December 2014. Camrelizumab is a humanized anti-PD-1 monoclonal antibody which recently received the approval in China for classic Hodgkin’s Lymphoma (cHL).

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"We are excited to study the potential synergies of rivoceranib with immunotherapy and demonstrate the benefits to HCC patients in a first line setting," said Dr. Steve Norton, Vice President of Drug Development at LSKB.

Hengrui has been conducting an open-label, single arm multicenter phase 2 study (NCT03463876) to evaluate the efficacy and safety of the combination of camrelizumab and apatinib in patients with advanced HCC in China, where Hengrui has received approval of apatinib monotherapy for advanced gastric cancer. At ASCO (Free ASCO Whitepaper) 2018, it was reported that the objective response rate (ORR) and disease control rate (DCR) were 50.0% and 85.7%, respectively, among 14 evaluated advanced HCC patients treated by camrelizumab in combination with apatinib in an open-label, phase 1 study in China (Xu et al., NCT02942329). In addition, camrelizumab and apatinib combination therapy is also being evaluated by Hengrui for multiple indications including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and gastric cancer (GC) in China.

Based upon earlier studies, it is hypothesized that the combination of rivoceranib and camrelizumab may enhance the immune system, aiding the fight against cancer. In addition to the known anti-angiogenic effects of rivoceranib, it may also enhance camrelizumab’s anti-tumor activity by normalizing tumor vasculature and reversing the tumor suppressive immune microenvironment.

About Rivoceranib (Apatinib)

Rivoceranib, also known as apatinib or Aitan (brand name) in China, is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib is investigational outside of China including in the United States; and safety and efficacy have not been established. It acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis.

Hengrui, who owns the China rights to rivoceranib, received the approval from China National Medical Products Administration (NMPA, formerly known as CFDA) in 2014 to market the drug under the brand name Aitan in China for advanced gastric cancer. LSKB, which holds the global rights (ex-China), has completed enrollment of a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib (apatinib) is currently listed in 264 clinical studies on www.clinicaltrials.gov with over 20,000 patients enrolled or planned to be enrolled in trials targeting numerous cancers including GC, colorectal cancer (CRC), HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to improve outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.

Rivoceranib was developed by Advenchen Laboratories in Southern California under the designation YN968D1. The compound was exclusively licensed to Hengrui in China (2005) and LSKB (2007) for rest of the world.

About Camrelizumab (SHR-1210)

Camrelizumab (SHR-1210) is an investigational humanized monoclonal antibody recognizing the programmed death-1 (PD-1) receptor. Camrelizumab functions as an immune checkpoint inhibitor by specifically blocking the interaction between PD-1 and PD-L1 and reversing the immunosuppressive signal of PD-1 on the T cell. Approximately 72 clinical studies on camrelizumab in multiple indications including lung cancer, liver cancer, gastric cancer, esophageal cancer, nasopharyngeal carcinoma, lymphoma, melanoma and other advanced solid tumors are being conducted in China and Australia as monotherapy or in combination with other therapeutic agents. A marketing application for camrelizumab for relapsed/refractory classic Hodgkin’s Lymphoma was submitted by Hengrui to China NMPA, which was accepted in April 2018, and is currently under review.

Athenex Announces Strategic Global Initiatives to Expand Clinical Operations

On June 28, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, reported that the Company has strategically expanded its presence in Europe and Latin America to grow its global clinical research and development capacity (Press release, Athenex, JUN 28, 2019, View Source [SID1234573890]). The Company believes these initiatives have the potential to enhance Athenex’s capacity to conduct global clinical studies and support its regional marketing decision process. They are part of the Company’s strategy to build on its current strong presence in U.S. and Asia, and help maximize the global potential of its pipeline.

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Athenex’s oncology-focused pipeline currently has nine clinical candidates, including two drug candidates in Phase III development. In line with the Company’s goal to expand its capability and bandwidth to optimize global development and commercialization of its pipeline products, Athenex has been evaluating operational opportunities in Europe and Latin America.

As part of Athenex’s strategy to establish operations in Europe, the second largest healthcare market in the world, the Company has formed a subsidiary in the United Kingdom and established offices in Manchester. The Company is currently conducting clinical studies in the United Kingdom and intends to continue expanding its research and development capabilities in the region.

In Latin America, Athenex recently entered into a definitive agreement to acquire certain assets of CIDAL Limited in exchange for shares of Athenex common stock, subject to customary closing conditions. CIDAL is a contract research organization with headquarters in Guatemala and operations in various countries in Latin America. CIDAL has provided important CRO services and support to Athenex, including for its Phase III study of oral paclitaxel and encequidar for metastatic breast cancer. The asset purchase is expected to strengthen Athenex’s clinical research and operations capabilities and support the Company’s clinical development worldwide.

"These initiatives represent an important step in our ongoing strategic efforts to expand our clinical research and operations for global development, with the potential for increased clinical research efficiencies and cost-effectiveness" said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "Our office in Manchester will enable us to evaluate the best strategy for Europe, an important market for Athenex. We have been engaging with many experienced pharma/biotech specialists who are already contributing to our research programs and look forward to working more closely with these talents. We are also delighted to extend our operations in Latin America through CIDAL, which we believe will increase our bandwidth for clinical research and regulatory development. We believe having a stronger presence in these territories will position us well to evaluate new R&D and commercialization opportunities in Europe and Latin America."

CARRICK THERAPEUTICS ANNOUNCES PLAN TO ESTABLISH US OPERATIONS AND APPOINTMENT OF TIM PEARSON AS CEO

On June 28, 2019 Carrick Therapeutics, a biopharmaceutical company focusing on the innovative research and development of transformative oncology medicines, has reported that it plans to establish business operations in Boston, Massachusetts, and the transition of leadership from Elaine Sullivan, based in Dublin, to Tim Pearson, based in Boston, Massachusetts (Press release, Carrick Therapeutics, JUN 28, 2019, View Sourcecarrick-therapeutics-announces-plan-establish-us-operations-appointment-tim-pearson-ceo/" target="_blank" title="View Sourcecarrick-therapeutics-announces-plan-establish-us-operations-appointment-tim-pearson-ceo/" rel="nofollow">View Source [SID1234537569]).

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"The board of directors has made the decision to expand company operations in Boston to access U.S. capital markets and the tremendous talent pool to support the expected growth of Carrick. With this transition, we will continue operations in Dublin and the UK, while adding new capabilities in Boston," said Dr. George Golumbeski, Chairman of the Board. "We are thankful for all that Elaine has done in taking Carrick from inception to a company with multiple clinical assets in such a short period of time, and I am delighted that we will continue to have Elaine drive the company forward as Executive Entrepreneur and Advisor to the Board of Directors."

"As a founder of Carrick and CEO since 2016, I am very proud of the accomplishments of our team and the creation of a multi-asset portfolio of clinical-stage drugs targeting critical pathways that drive aggressive and resistant cancers," said Elaine Sullivan. "It is now time for a new phase of growth fuelled by new funding and talent. I am excited about my new role and look forward to supporting the future success of the company and the board of directors as Carrick expands."

Company board member Paul Thurk, of ARCH Venture Partners, said: "With this transition, we are excited to add the leadership of Tim Pearson as CEO with 20 years of experience building successful biotechnology companies and oncology drug development, previously leading significant functions with TESARO and MedImmune."

Tim Pearson commented: "Now is an exciting time to be joining Carrick as the pipeline develops and provides more robust evidence of the benefits to targeting CDK7 and Folate Receptor Alpha. I am honored to join such a talented management team and exceptional collaborators in the mission of transforming cancer treatments and the lives of cancer patients. I look forward to working with the board and leading Carrick in the years ahead."

Mr. Pearson brings a track record of growing biotech companies from R&D stage through commercialization, along with significant fund raising and strategic business development. He most recently held the position of Executive Vice President and Chief Financial Officer for TESARO, a public oncology-focused biopharmaceutical company acquired by GSK in January of 2019. Prior to that, he was Chief Financial Officer at Catalyst Health Solutions, a publicly held pharmacy benefit manager with over $5 billion in revenues until the company was acquired by SXC Health Solutions in 2012. Prior to Catalyst Health Solutions, Mr. Pearson spent 13 years at MedImmune, now a division of AstraZeneca, most recently as division CFO. Mr. Pearson also sits on the board of directors of GlycoMimetics (NASDAQ: GLYC) and Ra Pharmaceuticals (NASDAQ: RARX).

Carrick is privately held with headquarters in Dublin and operations in the U.K. The company raised $95 million in a series A financing during 2016. Carrick is focused on oncology therapeutics and currently has two significant programs in clinical studies, as well as a number of pre-clinical candidates. CT7001 is an oral CDK7 inhibitor that is progressing through phase one studies. CT900 has shown clinical proof-of-concept in platinum-resistant ovarian cancer. For further information, please visit: View Source

SORRENTO THERAPEUTICS ANNOUNCES PRICING OF UNDERWRITTEN PUBLIC OFFERING OF COMMON STOCK AND
WARRANTS

On June 28, 2019 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), a clinical stage, antibody-centric biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases, reported the pricing of its public offering of 8,333,334 shares of its common stock, Series A warrants to purchase up to an aggregate of 8,333,334 shares of its common stock, Series B warrants to purchase up to an aggregate of 8,333,334 shares of its common stock and Series C warrants to purchase up to an aggregate of 8,333,334 shares of its common stock, at a price to the public of $3.00 per share and accompanying Series A, Series B and Series C warrant (Press release, Sorrento Therapeutics, JUN 28, 2019, View Source [SID1234537336]). The Series A warrants will be exercisable commencing six months from the date of issuance, will expire on the 10-year anniversary of the date of issuance and will have an exercise price of $3.75 per share, subject to certain adjustments. The Series B warrants will be exercisable commencing on the date of issuance, will expire on the date that is nine months from the date of issuance and will have an exercise price of $3.00 per share, subject to certain adjustments. The Series C warrants will be exercisable six months from the date of issuance and only to the extent and in proportion to a holder of the Series C warrants exercising its corresponding Series B warrants, will expire on the 10-year anniversary of the date of issuance and will have an exercise price of $3.75 per share, subject to certain adjustments. Gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $25.0 million. Sorrento currently intends to use the net proceeds from the offering for the continued clinical development of its RTX, CEA CAR-T and CD38 CAR-T programs and general research and development, working capital and general corporate purposes. In addition, Sorrento has granted the underwriters a 30-day option to purchase up to 1,250,000 additional shares of its common stock and/or 1,250,000 warrant combinations, which consists of 1,250,000 Series A warrants, 1,250,000 Series B warrants and 1,250,000 Series C warrants. The offering is expected to close on or about July 2 2019, subject to satisfaction of customary closing conditions.

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JMP Securities and H.C. Wainwright & Co. are acting as joint book-running managers for the offering.

The public offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-221443) previously filed with the Securities and Exchange Commission (the "SEC") on November 9, 2017, amended on December 1, 2017 and declared effective by the SEC on December 6, 2017. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from JMP Securities LLC, 600 Montgomery Street, Suite 1100, San Francisco, California 94111, Attention: Prospectus Department, by calling (415) 835-8985 or by e-mail at [email protected] or H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or by e-mail at [email protected]

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Replimune Reports Fourth Fiscal Quarter and Year 2019 Financial Results and Provides UpdateCorporate

On June 28, 2019 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported financial results for its fourth fiscal quarter and year ended March 31, 2019, and provided an update on its business (Press release, Replimune, JUN 28, 2019, View Source [SID1234537335]).

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"This past fiscal year has been incredibly productive for Replimune, with the advancement of several important clinical programs and a successful IPO that provides us with a solid financial foundation to continue to develop our portfolio of therapies," said Robert Coffin, Ph.D., co-founder, President and CEO of Replimune. "We are continuing to make significant strides as we work towards delivering on the promise of our oncolytic immuno-gene therapies. Importantly, we expect to initiate our randomized controlled registration-directed Phase 2 clinical trial in cutaneous squamous cell carcinoma (CSCC) in the near term, and to advance our second product candidate into the clinic with the initiation of a Phase 1 trial of RP2 later this year. The Phase 2 part of our clinical trial of RP1 in combination with nivolumab in four solid tumor types has also initiated, and we expect to be sharing the first set of clinical data from the Phase 1 part of the clinical trial in the fourth quarter of 2019."

Recent Business Highlights and Upcoming Events

RP1 – Initiated the Phase 2 part of the Phase 1/2 clinical trial of RP1 in combination with nivolumab. In the Phase 2 part of the clinical trial, RP1 in combination with nivolumab is being tested in four 30-patient cohorts of patients with melanoma, non-melanoma skin cancers (NMSC), metastatic bladder cancer and microsatellite instability-high (MSI-H) tumors. Enrollment in the United States and the United Kingdom is now open in the melanoma, NMSC and bladder cancer cohorts, and enrollment in the MSI-H cohort will open as soon as a protocol-required MSI-H patient is evaluable from Phase 1. The patients enrolled into the melanoma cohort will either be treatment naïve or have received one prior systemic therapy, including anti-PD1 and/or anti-CTLA-4 therapy, and the patients enrolled into the other three cohorts will all be naïve to anti-PD1 therapy. Efficacy and biomarker data will be evaluated within each tumor-type cohort.
RP1 – Data from the Phase 1 part of the Phase 1/2 clinical trial of RP1 alone and in combination with nivolumab is expected to be reported at a medical conference in the fourth quarter of 2019. The Phase 1 part of this ongoing clinical trial tested single-agent RP1 by direct injection into a single superficial or nodal tumor and by imaging-guided injection into a single visceral tumor in patients with advanced heavily pre-treated cancers who have failed available therapy, with the goal of defining the recommended Phase 2 dose. Following determination of the recommended Phase 2 dose, an expansion group of advanced cancer patients, who have failed available therapy, then received RP1 at the recommended Phase 2 dose in combination with nivolumab at standard clinical doses. This clinical trial is being conducted under a clinical trial supply agreement with Bristol Myers Squibb (BMS) for the supply of nivolumab.
RP1 – Opening of the Phase 2 clinical trial of RP1 in combination with cemiplimab is expected in the near term. The registration directed randomized controlled Phase 2 clinical trial will enroll approximately 240 patients with CSCC, comparing treatment with cemiplimab alone to treatment with cemiplimab in combination with RP1, under the Company’s collaboration with Regeneron. Cemiplimab is Regeneron’s anti-PD1 therapy that was approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally recurrent and metastatic CSCC.
RP 2 – Phase 1 clinical trial of RP2 as a single agent and in combination with nivolumab anti-PD1 therapy anticipated to initiate in the third quarter of 2019.RP2 is a further armed oncolytic immuno-gene therapy that, in addition to expressing GALV-GP-R- and GM-CSF, also expresses a genetically encoded anti-CTLA-4 antibody intended to block the inhibition of the initiation of immune response caused by CTLA-4. RP2 is intended to be used primarily in combination with anti-PD1 or anti-PD-L1 therapy. Because of the need to address questions from regulatory authorities regarding certain Chemistry, Manufacturing, and Controls aspects of RP2, this clinical trial is expected to initiate one quarter later than originally anticipated. As with the clinical trial with RP1 in combination with nivolumab, this clinical trial will be conducted under a clinical trial supply agreement with BMS for the supply of nivolumab.
RP3 – Phase 1 clinical trial of RP3 as a single agent and in combination with anti-PD1 therapy to initiate in 2020.RP3 is a further armed oncolytic immuno-gene therapy which expresses two immune co-stimulatory activating ligands in addition to the GALV-GP R- fusogenic protein and anti-CTLA-4. Following the assessment of a number of co-stimulatory pathways, which, like anti-CTLA-4, are expected to be primarily active at the site and time of anti-tumor immune response initiation, the selected immune co-stimulatory pathway activating proteins are CD40L and 4-1BBL. CD40L activates CD40, resulting in the broad activation of both innate and adaptive immunity, and 4-1BBL activates 4-1BB (CD137) to promote the expansion of cellular and memory immune responses.
Presented posters at ASCO (Free ASCO Whitepaper) and AACR (Free AACR Whitepaper). At the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Replimune presented a "trials in progress" poster on the Company’s Phase 1/2 clinical trial of RP1 alone and in combination with nivolumab. A poster describing preclinical data relating to Replimune’s Immulytic platform and entitled "Development & characterization of a new oncolytic immunotherapy platform based on herpes simplex virus type 1" was presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in March 2019. Both posters are available on the Company’s website.
Build out of Replimune’s manufacturing facility to support late-stage development and commercialization is on track and expected to be operational in the first half of 2020. In July 2018, Replimune signed a lease for a 63,000-square-foot facility in Framingham, MA where the Company intends to establish world-class multi-product manufacturing capabilities for its Immulytic product candidates. The capacity of this facility is expected to be sufficient to support full commercialization of the Company’s product candidates. The facility is expected to be operational in the first half of 2020.
Financial Highlights

Replimune reported a net loss of $6.6 million for the fiscal fourth quarter, ended March 31, 2019, and a net loss of $30.8 million for the fiscal year ended March 31, 2019, as compared to a net loss of $7.1 million and net loss of $19.7 million for the comparable periods in the prior fiscal year, respectively. The increase in net losses for both periods were primarily due to an increase in research and development expenses and administrative costs associated with our operations.

Research and development expenses were $5.4 million for the fiscal fourth quarter of 2019, and $22.2 million for the year ended March 31, 2019, as compared to $4.5 million and $13.5 million for the comparable periods in the prior fiscal year, respectively. The increase in research and development expenses was primarily driven by additional costs related to Replimune’s preclinical and clinical development activities for its pipeline, as well as increased salary and related benefits costs due to the increase in employee headcount from 44 on March 31, 2018 to 67 on March 31, 2019.

General and administrative expenses were $2.4 million for the fiscal fourth quarter of 2019, and $8.8 million for the year ended March 31, 2019, as compared to $2.5 million and $5.7 million for the comparable periods in the prior fiscal year, respectively. The increase in general and administrative expenses was primarily due to the increase in employee headcount and the impact of stock-based compensation in 2019.

Replimune ended the fiscal year with $134.8 million in cash and cash equivalents and short-term investments, compared with $141.8 million as of December 31, 2018 and $61.6 million as of March 31, 2018. The year-on-year increase reflects net proceeds received of $103.3 million (net of deferred offering costs of $9.9 million) in connection with the Company’s IPO in July 2018.

Based on its current operating plan, Replimune expects that its current cash and cash equivalents and short-term investments will enable it to fund its operating expenses and capital expenditure requirements into the second half of calendar 2021.