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Stemline Therapeutics Highlights Recent Clinical and Regulatory Developments and Details Upcoming Milestones following its Annual Shareholder Meeting

On July 8, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported its annual shareholder meeting, highlights recent clinical and regulatory developments, and details other upcoming events (Press release, Stemline Therapeutics, JUL 8, 2019, View Source [SID1234537418]).

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ELZONRIS clinical data were presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois and the 24thCongress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Amsterdam, Netherlands. Presentations highlighted updated results from ongoing Phase 2 clinical trials in chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), as well as final results of the pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN). In addition, ELZONRIS preclinical results in systemic sclerosis, an autoimmune disorder in which CD123+ plasmacytoid dendritic cells (pDCs) play a role in disease pathogenesis, were presented at the Annual European Congress of Rheumatology (EULAR) in Madrid, Spain.

As previously announced, an additional single-arm cohort of patients with previously-treated CMML, Stage 3, will be added to the currently enrolling trial. In the first part of Stage 3 (Stage 3a), enrichment strategies and certain efficacy endpoints (including spleen size reduction) will be assessed for inclusion in the confirmatory cohort (Stage 3b), that will aim to provide the primary evidence of efficacy to support potential registration. We expect to open enrollment of the new cohort in 4Q19.

Stemline continues to build out a European commercial infrastructure in advance of potential approval by the European Medicines Agency (EMA). A scientific advisory group meeting is planned for September, and the ELZONRIS marketing authorization application (MAA) review will proceed on a standard timeline. We expect an opinion by the Committee for Medicinal Products for Human Use (CHMP) later this year. If successful, Stemline is targeting a commercial launch in Europe in 1Q20.

In an ongoing market expansion effort, corporate and investigator-sponsored clinical trials with ELZONRIS in additional indications are ongoing in myelofibrosis (MF) and acute myeloid leukemia (AML) and others are planned to roll out later this year and next.

Stemline continues to advance its clinical-stage assets, including SL-801 (a reversible inhibitor of XPO1). XPO1 is a clinically validated target in oncology, and the FDA recently approved an XPO1 inhibitor in patients with relapsed/refractory multiple myeloma. Stemline is also developing its preclinical assets SL-1001 (RET kinase inhibitor) and SL-901 (kinase inhibitor).

Stemline will provide further details on commercial and clinical progress during its second quarter financial results teleconference in early August. Call-in details will be provided in advance of the call.
About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

Coherus BioSciences Announces Unaudited Second Quarter 2019 UDENYCA® Net Sales of $79 Million to $84 Million

On July 8, 2019 Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), reported that UDENYCA preliminary unaudited net sales for the quarter that ended June 30, 2019 are expected to be in the range of $79.0 million to $84.0 million (Press release, Coherus Biosciences, JUL 8, 2019, View Source [SID1234537417]).

Coherus will not disclose topline gross sales, discounts, or gross-to-net data until these data are reported in its Form 10-Q for the quarter ended June 30, 2019.

As announced, Coherus will provide additional financial updates and business highlights on August 1, 2019 at 4:30 p.m. Eastern Time.

Regeneron to Report Second Quarter 2019 Financial and Operating Results and Host Conference Call and Webcast on August 6, 2019

On July 8, 2019 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its second quarter 2019 financial and operating results on Tuesday, August 6, 2019, before the U.S. financial markets open (Press release, Regeneron, JUL 8, 2019, https://www.prnewswire.com/news-releases/regeneron-to-report-second-quarter-2019-financial-and-operating-results-and-host-conference-call-and-webcast-on-august-6-2019-300879907.html [SID1234537414]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

Conference Call Information
To access this call, dial (800) 708-4540 (U.S.) or (847) 619-6397 (International). A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website and will be available for 30 days.

AIVITA Biomedical Announces New Clinical Data in Ongoing Phase 2 Brain Cancer Trial

On July 8, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported new clinical data from its ongoing glioblastoma Phase 2 clinical trial, investigating AIVITA’s platform immunotherapy targeting cancer stem cells (Press release, AIVITA Biomedical, JUL 8, 2019, View Source [SID1234537413]). Blood plasma biomarker analyses have identified predictive markers of efficacy in seven of eight treated subjects, a sample that represents 15% of the total clinical trial size.

The findings were made by analyzing data collected from AIVITA’s ongoing Phase 2 clinical study in glioblastoma and data collected from completed Phase 2 clinical trials in melanoma which had demonstrated 72% 2-year survival, and 54% 5-year survival. In both the current and past trials, blood was collected from subjects at one week after dose administration. Principal component analysis, an advanced statistical tool used in making predictive models, was performed to analyze the immune responses in all patients from both trials. The majority of glioblastoma patients had the same cytotoxic and immunoglobulin responses that were associated with survival in the previous melanoma trials.

"The data indicate that all mechanistic pathways with anti-tumoral effects are being activated in the surviving melanoma patients and seven out of eight of the treated glioblastoma patients, in particular the cytotoxic Th1-Th17 response and an immunoglobulin Th2 response," said Dr. Gabriel Nistor, AIVITA’s Chief Science Officer. "It just makes sense; this is how the immune system fights cancer."

The findings add to AIVITA’s understanding of the mechanism of action behind its next-generation cancer stem cell targeting immunotherapy and could offer physicians an early indication of how patients will respond to treatment.

"Predictive markers of efficacy, an outstanding patient recruitment rate and a manufacturing success rate of over 95%; this is shaping up to be a highly successful clinical trial in a field that desperately needs a win," said Dr. Hans S. Keirstead, AIVITA’s Chief Executive Officer.

AIVITA is currently conducting three clinical studies investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN skincare line to support the treatment of women with ovarian cancer.

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous cancer stem cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the cancer stem cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s cancer stem cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

For additional information about AIVITA’s AV-MEL-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03743298

Targovax Announces Encouraging Results From Part 1 of the ONCOS-102 and Keytruda Combination Trial in Anti-PD1 Refractory Melanoma

On July 8, 2019 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that clinical responses were observed in 3 out of 9 patients in part 1 of the ONCOS-102 and Keytruda combination trial in anti-PD1 checkpoint inhibitor (CPI) refractory advanced melanoma, corresponding to an overall response rate (ORR) of 33% (Press release, Targovax, JUL 8, 2019, View Source [SID1234537412]).

In this trial, ONCOS-102 immune activation is being tested in patients with advanced, unresectable melanoma who have had disease progression on treatment with anti-PD1 CPI. This is a particularly challenging patient population, with few treatment alternatives available. The nine patients in part 1 of the trial were given three intra-tumoral ONCOS-102 injections during the first week, followed by re-challenge with the anti-PD1 CPI Keytruda. The primary and secondary endpoints of the trial are to assess safety, immune activation and clinical responses of ONCOS-102 and Keytruda combination treatment. The main scientific aim is to test the hypothesis that ONCOS-102 can immune activate anti-PD1 resistant patients to respond to re-challenge with an anti-PD1 CPI.

Part 1 safety data shows that the sequential ONCOS-102 and Keytruda treatment regimen is well tolerated. The efficacy is also very encouraging, with three of nine patients demonstrating a clinical response (33% ORR); one patient had a complete response (CR) and two patients had partial responses (PR) according to RECIST1.1 and irRECIST assessment criteria. Although the patient number is small, these results compare favorably to reports from other explorative immunotherapy trials in this hard-to-treat population. Importantly, the data also confirms the hypothesis that ONCOS-102 is able to immune activate treatment resistant tumors to respond to re-challenge with an anti-PD-1 CPI.

ONCOS-102 was also seen to induce profound innate and adaptive immune activation. By week three, prior to starting Keytruda treatment, systemic increases in pro-inflammatory cytokines were observed in all nine patients (IL-6, TNFα and/or IFNγ), demonstrating potent systemic immune activation in response to the intra-tumoral ONCOS-102 injections. At the tumor level, increased infiltration of CD8+ T-cells were found in eight out of nine patients and the relative level of activated CD8+ T-cells (GrzB+) increased in all nine patients. Examples of increased T-cell infiltration into lesions not injected with ONCOS-102 were also observed. In addition, T-cells recognizing specific tumor antigens were found in circulation in four patients (MAGE-A1 and/or NY-ESO-1). These data suggest that the initial innate immune activation is translated into systemic anti-tumor immune responses.

Part 2 of the trial is currently enrolling patients, where safety and efficacy of a more intensive treatment regimen of twelve ONCOS-102 injections will be evaluated. The trial is running at Memorial Sloan Kettering Cancer Centre in New York, Fox Chase Cancer Centre, Philadelphia, and the University of Maryland, Baltimore.

Dr. Alexander Shoushtari, Principal Investigator, Memorial Sloan Kettering Cancer Centre, New York said: "It is encouraging to see clinical responses in this hard-to-treat population of advanced melanoma. Earlier this year, we decided to expand the trial to test a more intensified schedule of ONCOS-102, and it will be interesting to see whether this regimen can generate more and deeper clinical responses."

Dr. Magnus Jäderberg, CMO of Targovax, said: "We are very pleased to confirm our hypothesis that ONCOS-102 has the potential to immune activate checkpoint inhibitor resistant patients to respond to PD-1 blockade with Keytruda. It is promising to see this level of clinical responses after only three ONCOS-102 injections, including a complete response, which is rare in this heavily pre-treated patient population. Based on our experience so far, we speculate that patients will benefit from receiving more ONCOS-102 injections over a longer period of time and we will follow with interest the effect of the intensified dosing regimen in the second patient cohort of the trial."

CONTACT:

For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47-922-61-624
Email: [email protected]

Media and IR enquires:
Andreas Tinglum – Corporate Communications (Norway)
Phone: +47-9300-1773
Email: [email protected]

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