Roswell Park’s Dr. Pawel Kalinski to Lead $14.5M NCI-Funded Immunotherapy Effort

On March 31 2020 A team led by Pawel Kalinski, MD, PhD, of Roswell Park Comprehensive Cancer Center reported that it has earned a five-year, $14.54 million award from the National Cancer Institute (NCI) to expand a promising immunotherapy platform. Funded through the NCI’s Program Project Grant program, this prestigious five-year grant will fund five clinical trials, all focused on a strategy for making some of the most common immunotherapies work for more cancer patients (Press release, OmniSeq, MAR 31, 2020, View Source [SID1234556463]).

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"Our goal with this project is to convert cancers that are traditionally checkpoint-resistant into treatable, ‘hot’ tumors so that more patients will be able to benefit from some of the most commonly prescribed immunotherapies," says Dr. Kalinski, who is Vice Chair for Translational Research, the Rustum Family Professor for Molecular Therapeutics and Translational Research and Director of Cancer Vaccine and Dendritic Cell Therapies at Roswell Park.

"This five-year National Cancer Institute grant continues a long tradition of groundbreaking immunotherapy research at Roswell Park Comprehensive Cancer Center," says Congressman Brian Higgins. "The research the clinicians at Roswell are conducting represents the next generation of transformational care for cancer patients."

"Cancer touches every family in one way or another," says Congressman Tom Reed. "We are pleased to see this critical grant funding delivered to right here in our backyard to promote innovative breakthroughs for cancer treatment. We will continue to be a constant advocate for Roswell Park in the halls of Congress."

Currently, depending on their cancer type and the genetic characteristics of their tumors, only about 20% of cancer patients are good candidates for a newer class of treatments called checkpoint inhibitors — drugs such as pembrolizumab (Keytruda), nivolumab (Opdivo) and ipilimumab (Yervoy). Even among those patients who are likely to respond initially to treatment with a checkpoint inhibitor, 60% to 70% are likely to have their cancers recur or progress.

"Dr. Kalinski and colleagues have built a compelling case in support of their out-of-the-box approach to cancer immunotherapy," says Kunle Odunsi, MD, PhD, FRCOG, FACOG, Deputy Director and Executive Director of the Center for Immunotherapy at Roswell Park Comprehensive Cancer Center. "All of us in the field will be eagerly following this elegant work, which involves combinations that would uniquely harness previously untapped properties of the human immune system, and accompanied by innovative translational science that should yield greater understanding of immune responses to solid tumors."

Dr. Kalinski has spent the last 15 years developing a unique approach to cancer immunotherapy, or cancer treatment strategies that engage the immune system — first as a faculty member at University of Pittsburgh Medical Center (UPMC), and more recently at Roswell Park.

The NCI grant, which involves partners from both UPMC and The Tisch Cancer Institute at Mount Sinai, will enable five new phase II or phase IIA clinical trials to assess the efficacy of this multipronged approach — two studies in patients with metastatic colorectal cancer, one in patients with checkpoint-resistant advanced melanoma and two in advanced ovarian cancer. Three of the five studies will be conducted at Roswell Park, with the two ovarian cancer studies to be led at UPMC’s Hillman Cancer Center, with participation from Roswell Park.

Chemokines are a type of signaling protein with the ability to control the movements and growth of many immune cells, including cancer-fighting cells called cytotoxic T lymphocytes (CTLs). Together, the trials will explore three complementary strategies for targeting chemokines to alter the tumor microenvironment, or cells surrounding cancer cells, to promote the attraction and activation of CTLs, the key antitumor immune cells.

"Based on our earlier studies both in the lab and in early-phase clinical trials, we have evidence that we can selectively promote entry of antitumor killer cells into tumor microenvironments and reduce local accumulation of suppressive cells in order to sensitize ‘cold’ tumors to immune checkpoint-inhibition therapy," notes Dr. Kalinski.

The clinical trials will employ a chemokine-modulating regimen targeting three separate pathways of immune response — the toll-like receptor-3, type-1 interferon and prostaglandin networks — as well as specialized dendritic-cell therapeutic vaccines.

The team will also work to assess the immunologic and clinical efficacy of this new therapeutic strategy; identify the biomarkers of response; and develop optimized treatment combinations for many patients with hard-to-treat ovarian and colorectal tumors. The program will also address the pressing challenge of determining the best treatment for patients with melanoma whose tumors recur or persist despite treatment with immunotherapy.

OmniSeq Inc. will conduct advanced molecular diagnostic testing on participating patients’ tumor cells as part of the studies. AIM ImmunoTech Inc. has agreed to provide rintatolimod (brand name Ampligen), the chemokine-modulating agent to be incorporated into these studies.

The clinical trials are not yet underway. Dr. Kalinski and team expect to open all five studies by year-end 2021. When active and open to accrual, the studies will be listed on both and

Entry into a Material Definitive Agreement

On March 31, 2020, Bellicum Pharmaceuticals, Inc. (the "Company") reported that it has entered into a Second Amendment to Loan and Security Agreement (the "Amendment") with Oxford Finance LLC (the "Collateral Agent") and the lenders listed on Schedule 1.1 to the Loan Agreement (as defined below) or otherwise party thereto from time to time (the "Lenders"), effective as of March 31, 2020, related to the Company’s Loan and Security Agreement, dated as of December 21, 2017, as amended on December 24, 2019 (the "Loan Agreement"), by and among the Company, the Collateral Agent and the Lenders, in connection with the proposed sale of certain assets of the Company pursuant to the previously announced asset purchase agreement, dated as of January 21, 2020 (the "Asset Purchase Agreement"), by and between the Company and The University of Texas M.D. Anderson Cancer Center (Filing, 8-K, Bellicum Pharmaceuticals, MAR 31, 2020, View Source [SID1234556144]). Pursuant to the Amendment, the Loan Agreement was amended to, among other things: (i) provide for the Collateral Agent’s and the Lenders’ consent to the Company’s consummation of such asset sale pursuant to the Asset Purchase Agreement, provided such sale occurs on or prior to June 30, 2020; (ii) if such asset sale occurs on or prior to June 30, 2020, extend the interest-only period through as late as July 31, 2021; (iii) if the proposed asset sale closes on or prior to June 30, 2020, provide for a partial repayment to the Lenders of a significant percentage of the proceeds of the asset sale that varies in accordance with the timing of closing and the associated amortization schedule, a portion of which will be applied as partial payment of the Final Payment Percentage (as defined in the Loan Agreement); and (v) grants the Lenders and the Collateral Agent a security interest in the Company’s intellectual property as of the date of the Amendment, in each case as set forth in the Amendment. In the event the proposed asset sale does not close on or prior to June 30, 2020, the Amendment provides that the Company, the Collateral Agent and the Lenders shall renegotiate the foregoing terms.

The foregoing description of the Amendment is only a summary and is qualified in its entirety by reference to the Amendment. The Company intends to file a copy of the Amendment as an exhibit to its Quarterly Report on Form 10-Q for its fiscal quarter ending March 31, 2020.

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Junshi Biosciences Approved for Shanghai STAR IPO, a Dual Listing with Hong Kong

On March 31, 2020 Shanghai Junshi Biosciences reported it has been approved to list on the Shanghai STAR Exchange. In late 2018, Junshi completed a $394 million IPO in Hong Kong, and the company’s shares have climbed about 50% in the 15 months since then (Press release, Shanghai Junshi Bioscience, MAR 31, 2020, View Source [SID1234556060]). Just after the Hong Kong IPO, Junshi was approved to market Tuoyi, the first China-developed anti-PD-1 drug as a second-line treatment for melanoma. It is the first domestic PD-1 approved in China. Tuoyi produced $110 million in revenues during 2019.

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Fosun Pharma Announces 2019 Annual Results

On March 31 2020 Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma"; Stock Code: 600196.SH, 02196.HK), a leading healthcare group in China, reported its annual results for the year 2019 ("the reporting period") (Press release, Fosun, MAR 31, 2020, View Source [SID1234556058]).

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During the reporting period:

The revenue increased by 14.72% as compared to 2018 to RMB 28,585 million;
The net profit amounted to RMB 3,744 million, representing a respective increase of 23.96%;
The net profit attributable to shareholders of the listed company amounted to RMB 3,322 million, representing a respective increase of 22.66%.
The cash flow from operating activities continued to rise. Net cash flow from operating activities amounted to RMB 3,222 million, representing an increase of 9.23% as compared to 2018.
Wu Yifang, President and CEO of Fosun Pharma, expressed that "2019 marks a crucial period for the pharmaceutical industry to experience comprehensive transformation. On the basis of properly carrying out the existing business and industrial upgrade, Fosun Pharma is firmly committed to the path of innovation and international development. Focusing on unmet medical needs, it continuously improved its product competitiveness and brand strength, persistently enhanced its capability of innovation, integration and international development, and conducted efficient operations, thereby maintaining the balanced growth of its principal businesses. We believe that our efforts in innovation will help Fosun Pharma realize its innovation transformation. The steady international-oriented development will make us more competitive internationally in terms of operation standards and market expansion."

Revenue for core products grew steadily and deeply cultivated the whole-industry chain of healthcare industry

The business areas of Fosun Pharma cover the whole-industry chain of pharmaceutical and healthcare. Its business development is based on China while Fosun Pharma actively conducts global layouts. In 2019, the core business of Fosun Pharma, pharmaceutical manufacturing and R&D segment, maintained stable growth and recorded segment operating revenue of RMB 21,766 million, an increase by 16.51% as compared to 2018.

After years of professional operations, Fosun Pharma owns several advantageous products in the metabolism and alimentary system, anti-tumor therapeutic area, anti-infection therapeutic area, the central nervous system, cardiovascular system, blood system and other areas. In 2019, Rituximab injection (Han Li Kang) was launched as the first biosimilar that was independently developed in PRC. The number of preparation products of Fosun Pharma with annual sales revenue of over RMB100 million rose to 35, among which ten products reported annual sales revenue of over RMB500 million. The sales growth volume of core products, febuxostat tablets (You Li Tong), pitavastatin calcium tablets (Bang Zhi) and enoxaparin sodium injection recorded growth of 105%, 113% and 57%, respectively.

By virtue of endogenous operations and epitaxial M&A, the medical devices and medical diagnosis segment achieved favorable growth and recorded operating income of RMB 3,736 million in 2019, an increase of 2.66% over 2018, 28.5% YoY increase on the same basis. The existing medical devices and products of Fosun Pharma, including medical laser equipment for aesthetic treatments, high-end medical emergency ambulance and surgical robots, ranked top in the segmented industry and market. In particular. Da Vinci surgical robotic system, created by the joint venture Intuitive Fosun, is the world’s only minimally invasive endoscopic surgery robot product licensed by both FDA and China National Medical Products Administration. It recorded a rapid increase in its installation and number of surgeries performed, with 60 Da Vinci surgical robotic system installed and over 40,000 surgeries performed in Chinese Mainland and Hong Kong SAR in 2019. A rapid increase in sales recorded in HPV diagnostic reagent and genetic testing reagent for Thalassemias.

The revenue from the Healthcare services segment amounted to recorded operating income of RMB 3,040 million, representing an increase of an increase of 18.61% as compared to 2018. Fosun Pharma always adheres to the guideline of "Valuing Discipline Development and Offering Quality Medical Services" for medical services. Fosun Pharma had completed a strategic deployment of healthcare services in specialty and general hospitals with the Pearl River Delta Greater Bay Area, Yangtze River Delta and Huaihai Economic Zone being the regional focus for healthcare services. As of the end of 2019, over 10 medical institutions controlled by the Group, with a total of 4,328 authorized beds available for the public. In addition, Fosun Pharma proactively developed new medical services and products based on the Internet and constructed a service network from communities to hospitals. During the reporting period, Foshan Chancheng Hospital obtained the first internet hospital license within the Guangdong Province private hospital system.

Boost investment in innovation and R&D to build an international R&D platform

Fosun Pharma regarded innovation and R&D as the core-driving factor of development and continued to enhance its R&D expenditures. In 2019, the R&D expenses amounted to RMB 3,463 million, representing an increase of 38.15% as compared to 2018; the R&D expenses reached RMB 2,041 million, up by 37.97%. Specifically, R&D investment in the pharmaceutical manufacturing business was RMB 3,131 million, up by 39.12% and accounting for 14.38% among the revenue of the pharmaceutical manufacturing segment.

Fosun Pharma continuously optimized its pharmaceutical R&D system of "Combination of integrates biosimilars and innovative drugs", conducted layouts in China, the US, India and other places, developed efficient small-molecule innovative drugs platform, high-value generic drugs platform, biologics platform and cell-therapy platform, and has formed a globally interactive R&D system as well as strong R&D capability.

As of the end of the reporting period, Fosun Pharma had 264 pipeline innovative drugs, generic drugs, biosimilars and consistency evaluation projects of generic drugs (including 19 small molecular innovative drugs, 12 biopharmaceutical innovative drugs, 21 biosimilars, 133 generic drugs of international standards, 49 consistency evaluation projects, 2 traditional Chinese medicine drugs, 28 external projects (including 8 imported innovative drugs and 20 generic drugs were introduced)).

In 2019, Fosun Pharma focused on increasing its R&D investment in small molecular innovative drugs and monoclonal antibody biopharmaceutical innovative drugs and biosimilars, and CAR-T cell drugs, and systematically carried forward the introduction and registration of drug approvals and the consistency evaluation of generic drugs.

As of the end of 2019, Fosun Pharma has obtained approval for clinical trial in Mainland China on 9 small molecule innovative products (including 1 improved new drug) and 9 indications; as well as approval for overseas clinical trials for 3 small molecule innovative drugs and 3 indications. In particular, ORIN1001 had launched phase I clinical trials in the U.S. and recognized by the U.S. Food and Drug Admistration (”U.S. FDA”) under the Fast Track Development Program. In 2019, rituximab injection (Han Li Kang), the first domestic biosimilar, was approved for sales in Chinese Mainland; 2 monoclonal antibody biosimilars (Trastuzumab for injection and Adalimumab solution injection) were accepted for new drug application and included in the priority review procedure in Chinese Mainland; and 12 monoclonal antibody products and 8 combination therapies had launched more than 20 clinical trials worldwide;Axicabtagene Ciloleucel (code FKC876, i.e. anti-human CD19 CAR-T cell injection) of Fosun Kite, a joint venture, completed the bridging clinical trial of the Product for the treatment of adult patients with relapsed and refractory large B-cell lymphoma in Chinese Mainland and commenced clinical trials in Chinese Mainland and was granted priority review status for the launch and registration of drugs in March 2020.

Persist with international development for greater global competitiveness

In addition to constant innovation, Fosun Pharma furthered its international development strategy, with the proportion of overseas revenue rising to 23.17%. Revenue of an equivalent of RMB 6,622 million was recorded in other countries or regions, representing an increase of 12.12% as compared to 2018. Particularly, the core enterprise Gland Pharma’s net profit increased by 52.2% year-on year during the Reporting Period. During the reporting period, totally 15 generic drug products were approved by the US FDA for sales in the market. As of the announcement date, Gland Pharma for a total of 2 imported products for registration and marketing authorization, and applications for import registration and clinical trials for 4 products.

By centering on the unsatisfied healthcare needs, Fosun Pharma connected excellent scientist teams, leading technology and high-value products across the globe through permitted introduction, deep incubation, risk investment and other diversified and multi-tiered cooperation modes, so as to promote the global development, transformation and implementation of innovative technology and products.

In 2019, in order to further enrich the product lines, Fosun Pharma engaged in cooperation with ReNeuron Limited, a global leader in cell therapy, and imported cell therapy products targeting post-stroke disability and retinitis pigmentosa to advance the development of the stem cell platform. Fosun Pharma was authorized by MimiVax LLC to exclusively develop and commercialize SurVaxM, an immunotherapy product targeting recurrent glioblastoma. In addition, Fosun Pharma has accelerated the clinical trials and launch of permitted imported drugs Avatrombopag tablets and Tenapanor tablets. In terms of international expansion, Fosun Pharma not only established subsidiaries and developed its operating capability in mature markets such as the US and Europe, but developed markets and production capacity through self-development and M&A in emerging markets such as Africa and India. As at the end of 2019, Fosun Pharma has built a marketing team consisting of nearly 5,300 people, including nearly 1,000 overseas pharmaceutical, medical equipment marketing team. In oversea market, artemisinin-based antimalarial products are highly recognized in the African market.

ESSA Pharma Submits IND for EPI-7386 for Prostate Cancer and Provides Business Update

On March 31, 2020 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX, TSX-V: EPI), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate its lead clinical candidate, EPI-7386, in a Phase 1 clinical study for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, ESSA, MAR 31, 2020, View Source [SID1234556057]).

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"We believe that EPI-7386 has the potential to be an important new therapy for men with prostate cancer. All of the preclinical data accumulated to date leads us to believe that it will be an active agent with a good PK profile," commented David R. Parkinson, MD, CEO of ESSA. "We remain focused on conducting a clinical trial of this unique inhibitor of the N-terminal domain of the androgen receptor in adult male patients with mCRPC resistant to standard of care treatments. We are pleased that we were able to file the IND as planned. This is a significant milestone for the Company and we look forward to beginning clinical testing of EPI-7386 in patients as soon as possible."

The Company also provided a business update as the COVID-19 situation rapidly evolves. To date, the global coronavirus outbreak has not had a material impact on the Company’s business operations. At present, ESSA does not anticipate changes to planned achievement of key clinical milestones in calendar year 2020, but is continuing to monitor the situation.

Business Updates:

We remain on track to commence the monotherapy clinical study of EPI-7386 in mCRPC patients resistant to standard of care treatments in Q2 2020.

Enrollment will be approximately 18 patients at multiple US and Canadian medical institutions in a standard 3+3 trial design with up to 10 additional patients enrolled in the dose expansion cohort.

Clinical sites are being finalized and we are preparing for clinical trial initiation. We are working with our contract research organization ("CRO") to prepare for clinical trial initiation, despite the current limitations on travel. We will also augment our trial risk management plan including mitigation strategies to deal with clinical trial sites that may be impacted by the COVID-19 situation. This plan will incorporate the latest FDA guidance regarding clinical trial conduct during the COVID-19 pandemic.

Although our in-person lab activities are affected by COVID-19, we have conducted extensive gene expression studies demonstrating differentiation of our N-terminal domain (NTD) inhibition mechanism from ligand binding domain (LBD) inhibition by anti-androgens as well as the unique quantitative and qualitative effects of the combination of NTD and LBD androgen receptor inhibition. The full analysis of these results will be presented at a future scientific meeting.

The Company ended December 31, 2019 with $45.9 million cash, which we believe provides operating funds through fiscal year end 2022 (September 30) and will allow ESSA to complete the Phase 1 monotherapy dose-escalation study, an expansion phase to that study, and a combination study of EPI-7386 with currently utilized antiandrogens in metastatic prostate cancer patients with earlier stages of the disease.