On November 8, 2018 Zepsyre (lurbinectedin), from PharmaMar (MSE:PHM), reported noteworthy clinical activity in patients with metastatic breast cancer that have mutations in the BRCA 1 and/or BRCA 2 genes (Press release, PharmaMar, NOV 8, 2018, View Source [SID1234531166]). This is the conclusion contained in the "The Lancet Oncology" and the "Journal of Clinical Oncology", in their September and November issues, respectively; both having published the positive results of PharmaMar’s phase II trial.

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This trial intended to assess the clinical activity of lurbinectedin in patients affected by metastatic breast cancer in BRCA 1 and/or BRCA 2 gene mutations. It is important to highlight that in the patients with BRCA2 mutations, the confirmed overall response rate (ORR) was observed to be 61%, the median progression-free survival (PFS) was observed to be 5.9 months and the median overall survival (OS) was observed to be 26.6 months.

In the prior, untreated PARP population, the confirmed ORR was 72%, this being the highest reported figure in this tumor setting so far. The 54 breast cancer patients with mutations in the BRCA 1 and/or BRCA 2 genes
included in the trial were recruited from 11 research centers in the United States and Spain.

"Lurbinectedin is a selective inhibitor of active transcription of protein-coding genes," explained by Judith Balmaña (Vall d’Hebron Institute of Oncology) in The Lancet Oncology. "In this phase II trial, it showed a notable efficacy in patients with metastatic breast cancer and a germline BRCA1/2 mutation."

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On November 8, 2018 Myovant Sciences (NYSE: MYOV), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of women’s health and endocrine diseases, reported corporate updates and reported financial results for the second fiscal quarter ended September 30, 2018 (Press release, Myovant Sciences, NOV 8, 2018, http://investors.myovant.com/news-releases/2018/11-08-2018-210604964 [SID1234531182]).

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"We continue to make significant progress in advancing our Phase 3 clinical trials and have achieved several important milestones," said Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "We completed patient enrollment in both our Phase 3 LIBERTY 1 trial evaluating relugolix in combination with estradiol and a progestin in women with heavy menstrual bleeding associated with uterine fibroids and our Phase 3 HERO trial evaluating relugolix monotherapy in treating men with advanced prostate cancer. Screening has also been completed for our Phase 3 LIBERTY 2 trial. We remain on track to announce top-line safety and efficacy data for relugolix in 2019 in three distinct indications, each with wholly owned North American and European rights."

Recent Business Highlights and Upcoming Milestones

Relugolix Phase 3 Clinical Programs

Completed enrollment in the Phase 3 LIBERTY 1 trial and completed patient screening for the Phase 3 LIBERTY 2 trial. Both trials are evaluating relugolix in combination with estradiol and a progestin in women with heavy menstrual bleeding associated with uterine fibroids. Top-line safety and efficacy data from the LIBERTY 1 trial are expected in the second quarter of 2019, and data from the LIBERTY 2 trial are expected in the third quarter of 2019, with a New Drug Application (NDA) filing expected in the fourth quarter of 2019.
Continued enrolling patients in the Phase 3 SPIRIT 1 and SPIRIT 2 trials, which are evaluating relugolix in women with pain associated with endometriosis. Top-line results are expected in 2019.
Completed patient enrollment in the pivotal Phase 3 HERO trial, which is evaluating the safety and efficacy of relugolix monotherapy for the treatment of men with advanced prostate cancer. Top-line safety and efficacy data are expected in the fourth quarter of 2019, with a NDA filing expected in early 2020.
MVT-602 Clinical Program

Presented data at the American Society for Reproductive Medicine (ASRM) Annual Congress from a Phase 1 trial of MVT-602, a novel oligopeptide kisspeptin-1 receptor agonist in development as a potential treatment for female infertility in women as part of assisted reproduction.
Completed enrollment in a Phase 2a clinical trial in approximately 70 fertile women undergoing a controlled ovarian stimulation. Top-line results are expected in the first half of 2019.
Corporate

Appointed Kim Sablich, formerly Vice President of Primary Care Marketing in the United States for GlaxoSmithKline (GSK), as Chief Commercial Officer, and Jeff Nornhold, formerly Senior Vice President of Technical Operations for Impax Laboratories (now Amneal Pharmaceuticals, Inc.), as Senior Vice President of Pharmaceutical Operations & Development.
Appointed industry veterans Myrtle Potter, Mark Guinan and Frank Torti, M.D., to the company’s Board of Directors, and Ms. Potter to Chairman of the Board.
Raised aggregate net proceeds of approximately $74.4 million from the issuance and sale of 3,533,399 common shares in an underwritten secondary public equity offering.
Second Fiscal Quarter 2018 Financial Summary

Research and development (R&D) expenses for the quarter ended September 30, 2018, were $53.8 million compared to $24.2 million for the comparable period in 2017. The increase for the quarter primarily reflects the progress of Myovant’s ongoing Phase 3 clinical trials of relugolix, which were initiated in 2017, as well as additional personnel-related expenses and MVT-602 clinical trial expenses.

General and administrative (G&A) expenses for the quarter ended September 30, 2018, were $10.3 million compared to $6.1 million for the comparable period in 2017. The increase for the quarter primarily reflects increases in personnel-related expenses, professional service fees, and other administrative expenses to support Myovant’s headcount growth and expanding operations.

Interest expense for the quarter ended September 30, 2018, was $1.6 million compared to no interest expense in the comparable prior year period. Interest expense for the quarter consisted of interest expense related to financing agreements with NovaQuest Pharma Opportunities Fund IV L.P. and Hercules Capital, Inc., as well as the associated non-cash amortization of debt discount and issuance costs.

Net loss for the quarter ended September 30, 2018, was $65.8 million, compared to $29.9 million for the comparable period in 2017. On a per common share basis, net loss was $0.99 and $0.50 for the quarters ended September 30, 2018, and 2017, respectively. The increases in the net loss and net loss per common share for the quarter were driven primarily by the increase in costs outlined above.

Capital resources: Cash and committed funding totaled $246.3 million at September 30, 2018, consisting of $154.3 million in cash and $92.0 million in remaining financing commitments available from NovaQuest under the NovaQuest Securities Purchase Agreement and the NovaQuest Equity Purchase Agreement. An additional $40.6 million of capacity remains available under the "at-the-market" equity offering program that Myovant initiated in April 2018.

About Relugolix

Relugolix is an oral, once-daily, small molecule that acts as a gonadotropin-releasing hormone, or GnRH, receptor antagonist. More than 2,150 study participants have received treatment with relugolix in Phase 1, Phase 2 and Phase 3 clinical trials. In completed trials, relugolix was generally well tolerated and suppressed estrogen and progesterone levels in women and testosterone levels in men. Common side effects observed were consistent with suppression of these hormones.

In the ongoing Phase 3 LIBERTY clinical trials in women with heavy menstrual bleeding associated with uterine fibroids and the ongoing Phase 3 SPIRIT clinical trials in women with pain associated with endometriosis, relugolix is undergoing evaluation in combination with estradiol and norethindrone acetate, a progestin, and as monotherapy. Myovant is studying whether the combination decreases estradiol levels to the range required to treat signs and symptoms of endometriosis and uterine fibroids while minimizing the side effects associated with low estrogen levels, which include bone mineral density loss and hot flashes. The ongoing Phase 3 HERO study is evaluating relugolix monotherapy in men with advanced prostate cancer.

About MVT-602

MVT-602 is an oligopeptide kisspeptin-1 receptor agonist. Kisspeptin, the ligand, is a naturally-occurring peptide that stimulates GnRH release and is required for puberty and maintenance of normal reproductive function, including production of sperm, follicular maturation and ovulation, and production of estrogen and progesterone in women and testosterone in men.

A Phase 2a clinical trial in healthy female volunteers is under way to characterize the dose-response curve in the controlled ovarian stimulation setting prior to studying MVT-602 in infertile women seeking pregnancy.

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.