On April 2, 2020 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [("Merrimack" or the "Company")] reported receipt of $2.25 million in connection with the closing of a transaction in which the Company sold certain assets related to its preclinical nanoliposome programs to Celator Pharmaceuticals, Inc. Merrimack will not receive any further contingent consideration or royalties as a result of this transaction (Press release, Merrimack, APR 2, 2020, View Source [SID1234556110]).

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Under the terms of the agreement for the transaction, Celator, in addition to paying the base purchase price of $2.25 million, reimbursed the Merrimack for certain specified expenses and assumed certain liabilities with respect to the acquired assets. Further, under the agreement, the Company assigned to Celator the previously disclosed intellectual property license agreement among the Company and Ipsen S.A pursuant to which Ipsen granted the Company licenses to certain patents, and Celator also granted the Company an exclusive license to certain specified know-how and patents related to specific nano-liposome projects which remain in the Merrimack portfolio.

Completion of this transaction is a continuation of Merrimack’s strategy of extending its cash runway into 2027 and preserving its ability to capture the potential $450 million of remaining ONIVYDE-related contingent milestone payments resulting from its 2017 asset sale to Ipsen as well as the potential $54.5 million of remaining contingent milestone payments resulting from its 2019 sale of certain programs to Elevation Oncology, Inc. (formerly known as 14ner Oncology, Inc.).

"This asset sale transaction reflects our ongoing strategic focus on both the monetization of our remaining preclinical assets and the further reduction of our operating expenses," said Gary Crocker, Chairman of Merrimack’s Board of Directors. "Ipsen recently publicly announced that ONIVYDE is in Phase 3 clinical trials in two additional indications which we believe could, if successful, support the attainment of certain milestones. The proceeds from the Celator transaction provide an additional operational buffer in the event of any potential unanticipated contingencies, and enhance our ability to focus on our top priority, which is to preserve our ability to collect milestones and to maximize returns to shareholders. As opportunities arise we will continue to look to distribute excess cash not essential to our minimal operations."

On April 2, 2020 Calviri, Inc., a biotech startup spun out of Arizona State University Biodesign Institute, focused on ending deaths from cancer, reported the closing of $2.25 million in seed round funding (Press release, Calviri, APR 2, 2020, View Source [SID1234556111]). The funding is from five private investors including Dr. Jacque Sokolov, a Calviri Board member, and Dr. Mitzi Krockover.

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Calviri was founded based on the discovery that tumors make frequent and recurrent errors in RNA transcription and processing that create highly immunogenic frameshift peptides (FSPs). Calviri has developed a manufacturing process that displays >400,000 FSPs on microchips; this enables patients’ blood to be simply screened for anti-FSP antibodies. This process is the basis for the design of off-the-shelf vaccines for any cancer, as well as diagnostics for the early detection of any cancer. Calviri holds exclusive rights, licensed from Skysong, to the diagnostic technology developed by the Biodesign Center at ASU.

Kathryn Sykes, VP of Research and Product Development, stated, "We will use the funding to demonstrate the strengths of this unique technology. We anticipate demonstrating an accurate predictive diagnostic for response to checkpoint inhibitors and a high sensitivity test for the early detection of breast and colon cancers."

Stephen Albert Johnston, CEO and founder, announced, "This funding is a vote of confidence for our ambitious goals. It comes at a time that will allow Calviri to meet some important valuation inflection milestones for both the diagnostics and vaccines."

On April 2, 2020 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that all three patients of the first dose cohort have been enrolled into the brain cancer clinical trial testing the CXCL12 inhibitor, NOX-A12, and have already received the planned initial treatment (Press release, NOXXON, APR 2, 2020, View Source [SID1234556076]). The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients in a Phase 1/2 clinical trial.

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Once the last patient in the first cohort reaches four-weeks of therapy of NOX-A12 combined with radiotherapy, the independent Data Safety Monitoring Board (DSMB) will determine whether it is safe to proceed from the low to the middle dose level of NOX-A12. Under the approved protocol, it is planned that each patient is treated with NOX-A12 for up to six months.

"The combination of NOX-A12 and radiotherapy has so far been well-tolerated by the patients that participated in this clinical trial. This is a very important first step in the clinical assessment of a new treatment option for these very difficult-to-treat patients with highly aggressive brain cancer," said Dr. Frank Giordano, Chairman of the Department of Radiation Oncology at the University Hospital Bonn.

"Due to the seriousness of the disease we are studying, recruitment into this trial continues in two of our three study centers, despite the challenges that hospital staff face as a result of the COVID-19 pandemic. Provided the next safety analysis after four weeks of treatment confirms the benign safety profile NOX-A12 has shown thus far, the trial will progress so the next patients can receive a higher dose as planned in the protocol," commented Aram Mangasarian, CEO of NOXXON. "Six months of data from the first cohort of patients should be available in October 2020, and from the second and third cohorts in the end of Q1 2021 and mid-2021, respectively. As a measure to ensure the timely completion of the study under the current challenging conditions of the COVID-19 pandemic, we are planning to include additional clinical sites to increase recruitment capacity."

On April 2, 2020 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the first patient has been treated in the Company’s first-in-human Phase 1 clinical trial evaluating FT596, the first cell therapy product candidate engineered with three active anti-tumor modalities, in patients with B-cell malignancies and chronic lymphocytic leukemia (Press release, Fate Therapeutics, APR 2, 2020, View Source [SID1234556096]). FT596 is an off-the-shelf chimeric antigen receptor (CAR) natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a proprietary CD19-targeting CAR, a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, and a unique interleukin-15 receptor fusion (IL-15RF). The hnCD16 Fc receptor enables coincident targeting of additional tumor-associated antigens expressed on cancer cells to overcome antigen escape, and IL-15RF is a potent cytokine complex that promotes survival, proliferation and trans-activation of NK cells and CD8 T cells without the need for systemic cytokine support.

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"We are pleased to have worked with the Masonic Cancer Center, University of Minnesota to treat the first patient with FT596," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "The COVID-19 pandemic presents unprecedented challenges for clinical trial conduct worldwide, and we anticipate there will be delays across our studies. We are committed to the health and safety of our employees and partners, and have implemented a remote work program to the greatest extent possible while continuing certain activities that can only be completed on-site. We are also working closely with our clinical sites and principal investigators so that we are well positioned to accelerate clinical trial execution when pressures on the health system ease."

In response to the global COVID-19 pandemic, the Company is providing a business update on the conduct of its operations.

The Company has taken steps in line with guidance from the U.S. Centers for Disease Control and Prevention (CDC) and the State of California to protect the health and safety of its employees and the community. In particular, the Company has implemented a work from home policy, and restricted on-site activities to certain manufacturing, laboratory and related support activities. The Company is continuing to assess the impact of COVID-19 pandemic to best mitigate risk and continue the operations of its business.
The Company is working closely with its clinical sites, physician partners and the patient community to monitor the potential impact of the evolving COVID-19 pandemic. The Company remains committed to its clinical programs and development plans, but expects that the timelines of its ongoing clinical trials will be impacted including by potential delays or disruptions in patient enrollment and site initiation.
The Company continues to engage the U.S. Food and Drug Administration (FDA), and remains on-track to submit Investigational New Drug applications to the FDA for FT538, the Company’s off-the-shelf, iPSC-derived NK cell product candidate for multiple myeloma, and for FT819, the Company’s first off-the-shelf, iPSC-derived CAR T-cell product candidate for B-cell malignancies, in the second quarter of 2020.
About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

About FT596
FT596 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology, which contains a NKG2D transmembrane domain, a 2B4 co-stimulatory domain and a CD3-zeta signaling domain, that targets B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that promotes enhanced NK cell activity. In preclinical studies of FT596, the Company has demonstrated that dual activation of the CAR19 and hnCD16 targeting receptors, in combination with IL-15RF signaling, convey synergistic anti-tumor activity. Increased degranulation and cytokine release were observed upon dual receptor activation in lymphoma cancer cells as compared to activation of each receptor alone, indicating that multi-antigen engagement may elicit a deeper and more durable response. Additionally, in a humanized mouse model of lymphoma, FT596 in combination with the anti-CD20 monoclonal antibody rituximab showed enhanced killing of tumor cells in vivo as compared to rituximab alone. FT596 is being investigated in an open-label Phase 1 clinical trial as a monotherapy, and in combination with rituximab, for the treatment of advanced B-cell lymphoma and in combination with obinutuzumab for the treatment of chronic lymphocytic leukemia (NCT04245722).

On April 2, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported the completion of its acquisition of the core assets of Icagen’s North Carolina operations (Press release, Ligand, APR 2, 2020, View Source [SID1234556112]). As previously announced, the purchase price was $15 million in cash, and Icagen is entitled to receive additional cash payments based on certain revenue achievements.

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"We are very pleased to add the Icagen technologies, partnerships and this profitable business to Ligand," said John Higgins, Chief Executive Officer of Ligand. "We all know how extremely challenging the current business environment is, and I want to commend the teams on both sides who worked together to get this deal done. It’s a fantastic acquisition that will enable Ligand to expand its services to current partners and drive new collaborations. We expect the Icagen ion channel capabilities will have particular synergy with our Vernalis and OmniAb antibody discovery platforms. We welcome our new Icagen colleagues to Ligand."

Higgins continued, "While we adjust to conducting business during the pandemic, Ligand’s balance sheet remains very strong, and we continue to generate positive cash flow. We have a successful track record of acquiring innovative companies, and subsequently growing revenue, increasing our partner portfolio, and leveraging technology and customer synergies. Given our significant financial resources and talented operating team, we are well positioned to pursue acquisitions and new opportunities to expand our business."

The acquisition of Icagen brings Ligand the following:

Technology Platform. Icagen’s extensive biological capability focused on ion channels, transporters and x-ray fluorescence, along with a strong track record in novel drug discovery from screening to lead optimization. Ion channels are key components in a wide variety of biological processes that involve rapid changes in cells and have broad therapeutic applicability including cancer, metabolic disease, pain, neurological diseases, infectious diseases and others.
Roche Collaboration to develop and commercialize therapies for neurological diseases. The collaboration provides research funding, potential milestone payments of up to $274 million and tiered royalty payments should a drug be commercialized.
Cystic Fibrosis Foundation (CFF) Collaboration to discover therapeutics to treat patients with cystic fibrosis caused by specific genetic mutations. The CFF collaboration allows for up to $11 million in research funding, milestone payments of up to $59 million and tiered royalties on sales, should a product be commercialized.
Proprietary Service Unit to Drive New Collaborations and Revenue, including a 32-person R&D team based in Raleigh, N.C., now known as Icagen, a Ligand Company, focused on drug discovery of ion channels and transporters. Icagen provides Ligand with an East Coast operation to efficiently serve partners and brings a portfolio of current or recent/active collaboration agreements with over 30 biopharma companies plus an ongoing business development pipeline.
Novel, Unpartnered Programs that include six preclinical-stage assets applicable to a range of therapy areas including diabetes, Parkinson’s disease, pain and other disorders.