On November 8, 2018 Sorrento Therapeutics, Inc. (NASDAQ: SRNE), a clinical-stage immunotherapy biotech company, reported the closing of a debt financing for up to $150 million (Press release, Sorrento Therapeutics, NOV 8, 2018, View Source [SID1234531151]). The financing is being provided by funds and accounts managed by Oaktree Capital Management, L.P. ("Oaktree"), a leading global investment firm. An affiliate of Oaktree is the sole administrative agent and collateral agent for the financing and Morgan Stanley & Co. LLC served as the sole placement agent for the transaction.

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"With this financing, we believe we now have adequate funding for up to the next two years, enabling us to bring several of our key clinical programs in the CAR-T and non-opioid pain management space to FDA approvals and potential commercialization", said Henry Ji, Ph.D., Chairman, President and Chief Executive Officer. "Additionally, with encouraging data readout from our ongoing Anti-CEA trial for liver metastases among pancreatic cancer patients and our recently initiated Anti-CD38 CAR-T trial for multiple myeloma cancer patients, we are optimistic about potential collaborations with strategic partners."

Building off its industry-leading fully human antibody G-MAB library, a wide array of innovative technologies such as the Sofusa lymphatics delivery system, and multi-site multi-modality cGMP facilities, Sorrento continues to expand and advance its robust clinical product pipeline.

The financing is a senior secured five-year term loan, with the first tranche of $100 million already funded and an additional tranche of $50 million available subject to Sorrento’s achievement of certain business milestones in the next nine to twelve months.

On November 8, 2018 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its first quarter ended September 30, 2018 (Press release, MEI Pharma, NOV 8, 2018, View Source [SID1234531199]).

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"Fiscal 2019 is off to a strong start both financially and strategically, with more than $90 million in cash and investments on our balance sheet at the start of the quarter, $10 million additional cash due under the recently executed Japan licensing agreement with Kyowa Hakko Kirin, a new clinical collaboration with BeiGene, and progress in preparations to start the ME-401 Phase 2 study around year-end," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "With the planned start of the ME-401 Phase 2 study, we will have two ongoing clinical trials with the potential to support FDA marketing approval."

Dr. Gold continued: "We are also excited by our continued progress in the other programs across our pipeline, including interim data from the Phase 2 study of pracinostat in MDS, the evaluation of our CDK9 inhibitor, voruciclib, in B-cell malignancies and data from the investigator-initiated study of ME-344 in breast cancer."

Recent Program Highlights and Upcoming Milestones

Upcoming Milestones

MEI will present data from three clinical stage drug development programs at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 1-4, 2018 in San Diego:
Updated results from the Phase 1b study evaluating ME-401 in relapsed/refractory follicular lymphoma (FL) and other indolent B-cell malignancies.
Data from an interim analysis of pracinostat in an ongoing Phase 2 study evaluating patients with high/very high-risk myelodysplastic syndrome (MDS).
Results from a preclinical study demonstrating that voruciclib and venetoclax synergistically induce apoptosis in acute myeloid leukemia (AML) cells in vitro.
MEI plans to initiate the Phase 2 study to support accelerated approval of ME-401 in relapsed or refractory FL around year-end of calendar 2018.
MEI expects to report updates regarding the ongoing voruciclib Phase 1 study at medical meetings in 2019.
MEI expects to report additional data from the investigator-sponsored Phase 1 study evaluating ME-344 at medical meetings in 2019.
Clinical Development Highlights

In October 2018, MEI announced a clinical collaboration to evaluate the safety and efficacy of MEI’s ME-401, an investigational phosphatidylinositol 3-kinase (PI3K) delta inhibitor, in combination with BeiGene’s zanubrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of patients with B-cell malignancies.
In July 2018, the Company discussed with FDA a ME-401 monotherapy accelerated approval strategy in patients with relapsed or refractory FL. Informed by the discussions with the FDA, the Company is advancing ME-401 into a Phase 2, single-agent study for the treatment of adults with relapsed or refractory FL. The Phase 2 study is intended to support accelerated approval and is planned to begin around the end of 2018. Accelerated approval of ME-401 will be subject to FDA review of the improvement provided by ME-401 over other therapies available at the time of the regulatory action.
Corporate Highlights

In November 2018, MEI announced the execution of a license development and commercialization agreement granting Kyowa Hakko Kirin exclusive rights to develop and commercialize ME-401 in Japan. Under the terms of the agreement, MEI will receive a $10.0 million upfront payment and is eligible to receive up to $87.5M in additional development and commercialization milestones, and royalties on sales.
In July 2018, the Company announced that David M. Urso, J.D., senior vice president of corporate development and general counsel, was promoted to chief operating officer. Mr. Urso is also continuing as the Company’s general counsel and head of corporate development.
Financial Highlights

As of September 30, 2018, MEI had $90.8 million in cash, cash equivalents and short-term investments, with no outstanding debt. Additionally, a $10 million upfront payment is due under the Japan license agreement executed with Kyowa Hakko Kirin.
Research and development expenses were $6.1 million for the quarter ended September 30, 2018, compared to $6.1 million for the same period in 2017. Research and development expenses reflect increased costs for the development of ME-401, offset by a reduction in expenses related to voruciclib, as the prior year amounts included acquisition costs for voruciclib.
General and administrative expenses were $3.4 million for the quarter ended September 30, 2018, compared to $2.5 million for the same period in 2017. The increase primarily relates to professional services expenses, share-based compensation, and general corporate expenses.
The Company recognized revenues of $0.5 million for the quarter ended September 30, 2018, compared to $0.3 million for the same period in 2017. The increase is related to higher levels of research and development activities performed pursuant to the Helsinn license agreement.
Net loss for the quarter ended September 30, 2018, was $14.5 million, or $0.21 per share compared $8.8 million, or $0.24 per share for the same period in 2017. The Company had 71,115,444 shares of common stock outstanding as of September 30, 2018, compared with 36,950,177 shares as of September 30, 2017.
The adjusted net loss, excluding non-cash expenses related to changes in the fair value of the warrants issued in connection with the May 2018 financing (a non-GAAP measure) for the quarter ended September 30, 2018, was $9.6 million, or $0.14 per share.
Cash expenditures for operating activities were $12.8 million for the quarter ended September 30, 2018, compared to $6.6 million for 2017. The increase in cash used for the three months ended September 30, 2018 primarily relates to changes in working capital associated with our clinical development programs, including start-up costs related to the ME-401 Phase 2 accelerated approval study.

On November 8, 2018 Palleon Pharmaceuticals, a leading biotech company focused on developing drugs that target Glyco-Immune Checkpoints to treat cancer, reported that the company will present preclinical data from its EAGLE platform at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting, in Washington, D.C (Press release, Palleon Pharmaceuticals, NOV 8, 2018, View Source [SID1234530957]).

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Palleon’s EAGLE platform enables the development of drugs that inhibit Glyco-Immune Checkpoints by disabling the immunosuppressive function of tumor cell surface glycans. The critical challenge in this area arises from the complexity, heterogeneity and rapidly evolving nature of the tumor glycans. Palleon’s EAGLE platform employs an enzyme/antibody bi-specific construct, which removes terminal sialic acids, the molecules that are responsible for suppressing the immune system, from cancer cell surface glycans in the tumor micro-environment. This enzymatic approach uniquely overcomes tumor glycan heterogeneity and makes tumors vulnerable to both innate and adaptive immune responses.

"Palleon’s EAGLE platform has allowed us to develop a first-in-class therapeutic modality that enhances both the innate and adaptive responses to cancer, which is critical for targeting patients who are resistant to current therapies," said Jim Broderick, M.D., chief executive officer and founder of Palleon. "In addition, the EAGLE platform is robust and adaptable, and it can turn any existing targeted antibody therapy into a potent immuno-oncology agent."

Poster #037, titled "A New Immunomodulatory Strategy of Inhibiting Glyco-Immune Checkpoints Using EAGLE Technology" will be on display in Hall E. Presentation hours are Friday, November 9 from 12:45 – 2:15 p.m. and 6:30 – 8:00 p.m. ET. Li Peng, Ph.D., vice president, biotherapeutics discovery at Palleon, will make an oral presentation on Sunday, November 11 at 9:25 a.m. ET during SITC (Free SITC Whitepaper)’s Next Generation Bispecifics and Antibody-Like Molecules session.

Additionally, Poster #676, from Palleon’s Scientific Advisory Board member, Heinz Läubli, titled, "Targeting the Sialoglycan/Siglec Pathway in Combination with Checkpoint Inhibitors for Cancer Immunotherapy" will be on display in Hall E. Presentation hours are Saturday, November 10 from 12:20 – 1:50 p.m. and 7:00 – 8:30 p.m.

About Glyco-Immune Checkpoints
Cancer uses multiple pathways to evade the immune system, and Glyco-Immune Checkpoints are a significant and under-appreciated axis of immunosuppression in cancer. Tumors exploit Glyco-Immune Checkpoints through the alteration of glycans on the surface of their cells, impairing both innate and adaptive immune cells and resulting in a broad, comprehensive suppression of the anti-tumor immune response. Glyco-Immune Checkpoints had been overlooked relative to other anti-cancer strategies due to the complexity of glycoscience, and, until recently, the lack of scientific tools to demonstrate its relevance to immuno-oncology. Palleon has assembled the technologies needed to overcome these barriers and make drug development in this field possible.

On November 8, 2018 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported its two poster presentations by its licensee NantCell, Inc. at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, taking place November 7-11, 2018 in Washington, DC (Press release, CytRx, NOV 8, 2018, View Source [SID1234530976]). The abstracts describe early safety and efficacy data from the Phase 1b portion of Phase 1b/2 clinical trials evaluating NantCell’s high-affinity natural killer (haNK) cell therapy in combination with anti-cancer agents, including aldoxorubicin, in patients with third-line or greater triple negative breast cancer (TNBC), fourth-line or greater head and neck squamous cell carcinoma (HNSCC) or recurrent metastatic pancreatic cancer.

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Preliminary Phase 1b Results in TNBC and HNSCC

In this Phase 1b, single-arm, open-label trial, treatment was administered in 3-week cycles of low-dose chemotherapy (aldoxorubicin, cyclophosphamide, cisplatin, nab-paclitaxel, 5-FU/L), antiangiogenic therapy (bevacizumab), engineered allogeneic high affinity CD-16 NK-92 cells (haNK), IL-15RαFc (N803), adenoviral vector-based CEA, MUC1, Brachyury, HER2 vaccine, yeast vector-based RAS, Brachyury and CEA vaccine, and an IgG1 PD-L1 inhibitor, avelumab plus cetuximab. All patients in both trials received aldoxorubicin. The primary endpoint is incidence of treatment-related adverse events (AEs). Secondary endpoints include overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).

The abstract includes data from three patients with third-line or greater TNBC and two patients with fourth-line or greater HNSCC. All treatment was completed in the outpatient setting, with no immune-related AEs. Four hematologic dose limiting toxicities (DLTs) were observed and managed with a planned dose reduction of cisplatin. Of the three patients with TNBC, two (67%) experienced a partial response (PR). Of the two patients with HNSCC, both (100%) experienced objective tumor response (100% and 47% decrease, respectively). Overall, four out of the five TNBC and HNSCC patients (80%) had confirmed overall responses, including one patient (20%) with fifth-line metastatic disease who demonstrated a complete response (CR). All responding patients are still undergoing therapy. These preliminary data suggest that the NANT Cancer Vaccine (NCV), comprised of low-dose chemo-radiation combined with innate and adaptive immunotherapy, can be administered safely in an outpatient setting without any observed increase in immune-related AEs.

Preliminary Phase 1b Results in Metastatic Pancreatic Cancer

In this Phase 1b, single-arm, open-label trial, treatment was administered in 3-week cycles of low-dose chemotherapy (aldoxorubicin, cyclophosphamide, oxaliplatin, nab-paclitaxel, 5-FU/L), antiangiogenic therapy (bevacizumab), engineered allogeneic high affinity CD-16 NK-92 cells (haNK), IL-15RαFc (N-803), adenoviral vector-based CEA vaccine, yeast vector-based RAS vaccine, and an IgG1 PDL1 inhibitor, avelumab. All metastatic pancreatic cancer patients received aldoxorubicin. The primary endpoint is incidence of treatment-related AEs. Secondary endpoints include ORR, DCR, PFS, and OS.

The abstract includes data from ten patients with third-line or greater metastatic pancreatic cancer. All treatment was safely administered in the outpatient setting. AEs were primarily hematologic which were managed by appropriate planned chemo dose reductions. No DLTs have occurred and no haNK-related AEs have occurred to date. Of the ten evaluable patients, nine have achieved stable disease (SD) for ≥ 8 weeks for a DCR of 90%. Median PFS was 5.8 months (95% confidence interval: 3.3 – 8.8) and OS was 9.5 months (95% CI: 5.0 – upper limit not yet reached) with patients continuing treatment. One patient demonstrated resolution of a metastatic lung tumor within 8 weeks of initiating NCV therapy. These preliminary results suggest that the NCV treatment regimen was well tolerated and support the safety and tolerability of the regimen. These preliminary efficacy results are encouraging and the overall survival of 9.5 months currently exceeds all standards of care for patients at this advanced stage of disease.

Eric Curtis, CytRx’s President and Chief Operating Officer, stated, "The data presented by NantCell at SITC (Free SITC Whitepaper)’s 33rd Annual Meeting are optimistic. We are pleased to see that these NCV regimens including aldoxorubicin are well tolerated and support the overall thesis being investigated. These data may ultimately lead to more combinations of aldoxorubicin with cutting edge therapies being studied in tumor types with high unmet needs. We look forward to seeing more data as these clinical trials progress."

"In the oncology marketplace, we have seen clear treatment trends by Big Pharma and recent regulatory approvals moving toward combining the category of potential Centurion drug candidates such as LADR 7, 8, 9 and 10 with immunotherapy."

Aldoxorubicin is a rationally-engineered cytotoxic which employs a linker bound to albumin to deliver doxorubicin directly into the tumor. CytRx out-licensed global development, manufacturing, and commercialization rights for aldoxorubicin to NantCell, Inc., a private subsidiary of NantWorks, LLC, in July 2017.

These data were highlighted at SITC (Free SITC Whitepaper)’s 33rd Annual Meeting in a presentation titled, "First in Human Data in Advanced Solid Tumors of NANT Cancer Vaccine: A Novel Temporospatial Orchestration of the Innate (NK) & Adaptive Immune System to Induce Antigen Cascade & Immunogenic Cell Death" which took place on Wednesday, November 7, 2018 from 5:45-6:00pm ET.

About the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)

The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is the world’s leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Established in 1984, SITC (Free SITC Whitepaper), a 501(c)(3) not-for-profit organization, serves scientists, clinicians, academicians, patients, patient advocates, government representatives and industry leaders from around the world. Currently, SITC (Free SITC Whitepaper) has more than 2,000 members who represent 22 medical specialties in 42 countries around the world. Through emphasis on high-caliber scientific meetings; dedication to education and outreach activities; focus on initiatives of major importance in the field; and commitment to collaborations with like-minded domestic and international organizations, government and regulatory agencies, associations and patient advocacy groups, SITC (Free SITC Whitepaper) brings together all aspects of the cancer immunology and immunotherapy community. Through educational programs that foster scientific exchange and collaboration, SITC (Free SITC Whitepaper) aims to one day make the word "cure" a reality for cancer patients everywhere.

On November 8, 2018 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Credit Suisse 27th Annual Healthcare Conference on Tuesday, November 13, 2018 (Press release, Eli Lilly, NOV 8, 2018, View Source [SID1234531002]). Enrique Conterno, senior vice president of Lilly and president of Lilly Diabetes and Lilly USA, will participate in a fireside chat at 3:40 p.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.