On February 26, 2019 MannKind Corporation (NASDAQ:MNKD) reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Mannkind, FEB 26, 2019, View Source [SID1234533692]).

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Fourth Quarter Results

For the fourth quarter of 2018, total revenues were $16.0 million, reflecting Afrezza net revenue of $5.7 million and collaboration and services revenue of $10.3 million. Afrezza net revenue increased 28% on a GAAP basis compared to $4.5 million for the fourth quarter of 2017. In the fourth quarter of 2017, we recognized a $1.4 million change in estimate to Afrezza net revenue; when this adjustment is excluded, Afrezza net revenue increased 86% (non-GAAP) compared to the fourth quarter of 2017, primarily driven by higher product demand and a more favorable mix of cartridges. Collaborations and services revenue increased $10.2 million primarily attributable to the United Therapeutics licensing and research agreements.

Afrezza cost of goods sold (COGS) was $5.0 million for the fourth quarter of both 2018 and 2017. Afrezza COGS in the fourth quarter of 2018 reflected a one-time charge of $2.0 million related to an amendment fee associated with our insulin supply agreement, offset by lower inventory write-offs in 2018 of $0.8 million and $0.7 million lower spending associated with manufacturing absorption. Afrezza gross profit was $0.7 million for the fourth quarter, the first quarterly gross profit recognized from Afrezza sales. When the one-time charge of $2.0 million related to the amendment fee is excluded, Afrezza gross profit was $2.7 million (non-GAAP) for the fourth quarter.

Research and development (R&D) expenses for the fourth quarter of 2018 were $1.1 million compared to $3.5 million for the fourth quarter of 2017. The decrease of $2.4 million was primarily due to $0.8 million associated with the United Therapeutics research agreement, which was classified as a cost of collaborations and services revenue, and a decrease in spending of $0.8 million related to clinical trials.

Selling, general and administrative (SG&A) expenses were $18.0 million for the fourth quarter of 2018 compared to $23.3 million for the fourth quarter of 2017. The decrease of $5.3 million was primarily due to $5.0 million in selling expenses associated with our first direct-to-consumer television advertising campaign in the fourth quarter of 2017.

Interest expense on notes (facility financing obligation and senior convertible notes) was $0.6 million for the fourth quarter of 2018 compared to $2.1 million for the fourth quarter of 2017. The $1.5 million decrease was primarily due to a reduction in the debt principal balances.

The net loss for the fourth quarter of 2018 was $9.7 million, or $0.06 per share, compared to the $32.8 million net loss in the fourth quarter of 2017, or $0.28 per share. The lower net loss is mainly attributable to an increase in total revenues of $11.5 million and a decrease in total expenses of $9.6 million.

Full Year 2018 Results

For the full year ended December 31, 2018, total revenues were $27.9 million, reflecting Afrezza net revenue of $17.3 million and collaborations and service revenue of $10.6 million. Afrezza net revenue increased 88% compared to $9.2 million for the same period in 2017, primarily reflecting increased product demand and a more favorable mix of cartridges. Collaborations and services revenue increased $10.3 million primarily attributable to the United Therapeutics licensing and research agreements.

Afrezza COGS for the year ended December 31, 2018 was $19.4 million compared to $17.2 million for the year ended December 31, 2017. The increase of $2.2 million was primarily attributable to an increase in costs associated with increased Afrezza sales and a one-time charge of $2.0 million related to an amendment fee associated with our insulin supply agreement, offset by a decrease of $0.8 million in inventory write-offs.

R&D expenses for the year ended December 31, 2018 were $8.7 million compared to $14.1 million for the same period in 2017. This $5.4 million decrease was primarily attributable to lower clinical trials expenses of $2.2 million, a $1.7 million decrease in salary-related expenses and a $0.8 million decrease in research and development supply and services costs.

SG&A expenses were $79.7 million for the year ended December 31, 2018 compared to $75.0 million for the same period in 2017. The $4.7 million increase was primarily due to an increase of $2.9 million in headcount-related expenses associated with commercial operations, an increase in spending of $1.7 million in our human resources, accounting, corporate communications, and office support departments, a $1.4 million increase in medical affairs support, a $1.3 million increase in stock-based compensation expense, and a one-time $1.1 million expense to transition corporate support functions from Connecticut to our headquarters in California, which were partially offset by a decrease in selling expenses of $4.7 million associated with our 2017 direct-to-consumer television advertising campaign.

Interest expense on notes (facility financing obligation and senior convertible notes) was $5.1 million for the year ended December 31, 2018 compared to $9.5 million for the same period in 2017. The $4.4 million decrease was primarily due to a reduction in the debt principal balances.

The net loss for the year ended December 31, 2018 was $87.0 million, or $0.60 per share, compared to $117.3 million for the year ended December 31, 2017, or $1.13 per share. The lower net loss is mainly attributable to an increase in Afrezza net revenue of $8.1 million, an increase in collaboration revenue of $10.3 million and a decrease in total expenses of $15.5 million.

"Our fourth quarter and full year 2018 results showed excellent progress in executing against our Afrezza growth plan and recognized for the first time revenues associated with our license and collaboration agreement with United Therapeutics," said Michael Castagna, Chief Executive Officer of MannKind Corporation. "The fourth quarter of last year was the first time we reported gross profit for Afrezza and we ended the year with a strong cash position thanks to the United Therapeutics deal and a public offering of common stock and warrants in December."

Cash and Cash Equivalents

Cash, cash equivalents and restricted cash at December 31, 2018 was $71.7 million compared to $48.4 million at December 31, 2017. The increase was primarily due to the net proceeds of $26.4 million from a second quarter registered direct offering of common stock and warrants and $37.5 million from a fourth quarter public offering of common stock and warrants, partially offset by the net cash used in operating activities of $37.7 million (inclusive of two payments from United Therapeutics totaling $55.0 million).

Non-GAAP Measures

Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a non-GAAP basis. Reported results were prepared in accordance with GAAP whereas non-GAAP measures exclude items described in the reconciliation tables below. Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. To participate in the live call by telephone, please dial (888) 394-8218 or (323) 701-0225 and use the participant passcode: 7809405. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under News & Events.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 7809405#. A replay will also be available on MannKind’s website for 14 days.

On February 26, 2019 OPKO Health, Inc. (NASDAQ: OPK) reported its operating and financial results for the three and twelve months ended December 31, 2018 as well as provide guidance on expected revenues and operating expenses for the first quarter 2019 after the close of the U.S. financial markets on Wednesday, February 27, 2019 (Press release, Opko Health, FEB 26, 2019, View Source [SID1234533691]).

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OPKO’s senior management will provide a business update and discuss its financial results in a live conference call and audio webcast beginning at 4:30 p.m. Eastern time on Wednesday, February 27, 2019.

CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time on Wednesday, February 27, 2019. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN: 866-634-2258
INTERNATIONAL DIAL-IN: 330-863-3454
PASSCODE: 4254518
WEBCAST: View Source
For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 4254518. The replay can be accessed for a period of time on OPKO’s website at View Source.

On February 26, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported financial results for the fourth quarter and full year ended December 31, 2018, and recent operational highlights (Press release, Atara Biotherapeutics, FEB 26, 2019, View Source [SID1234533690]).

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"2018 was a year of pipeline expansion and strong operational execution for Atara as we advanced our T-cell immunotherapy programs across all three of our major value drivers: tab-cel, multiple sclerosis and next-generation CAR T," said Isaac Ciechanover M.D., Chief Executive Officer and President of Atara Biotherapeutics. "Notably, we successfully executed on our strategy to build a leading next-generation and off-the-shelf, allogeneic CAR T portfolio. Our collaborations with academic leaders leverage technologies at the forefront of CAR T innovation for hematologic malignancies and solid tumors. We also opened a state-of-the-art T-cell operations and manufacturing facility and expanded our R&D, operational and commercial leadership. I am extremely gratified with where the Company is today and wish to acknowledge the many extraordinary contributions by Atara employees that enabled us to reach this point. I anticipate 2019 to be another pivotal year with multiple clinical and regulatory milestones, moving Atara closer to realizing our mission of transforming the lives of patients with serious medical conditions."

Atara continues to progress tab-cel (tabelecleucel) Phase 3 studies for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disease (EBV+ PTLD) and anticipates initial tab-cel Phase 3 results to be available to the company in the first half of 2019.

Discussions with the European Medicines Agency (EMA) and U.S. Food & Drug Administration (FDA) regarding the development of tab-cel are ongoing and Atara’s intention is to align on a global regulatory strategy for patients with EBV+ PTLD. Outcomes of these discussions are expected in the first half of 2019.

Atara plans to submit a tab-cel EU conditional marketing authorization (CMA) application in the second half of 2019. To ensure the integrity of the ongoing, open-label tab-cel Phase 3 studies, the Company anticipates disclosing initial top-line EBV+ PTLD results in the second half of 2019 following submission of the EMA CMA application.

Atara expects initial safety results from the ongoing off-the-shelf, allogeneic ATA188 Phase 1 study in patients with progressive multiple sclerosis (MS) in the first half of 2019. Additional safety and efficacy results from this study are expected in the second half of 2019.

The Company is also rapidly advancing its next-generation chimeric antigen receptor T-cell (CAR T) pipeline across multiple therapeutic areas and expects results to be presented at upcoming scientific conferences.

Recent Highlights and Anticipated Upcoming Milestones

Tab-cel (tabelecleucel)

Two Phase 3 clinical studies are ongoing (MATCH and ALLELE) to evaluate tab-cel for patients with EBV+ PTLD who have failed rituximab following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
Expanded MATCH and ALLELE study sites, with 30 sites available for enrollment in the United States and Australia, and with additional sites expected to open in the United States and other geographies.
ATA188 & ATA190 for Multiple Sclerosis (MS)

A Phase 1 clinical study of off-the-shelf, allogeneic ATA188 in patients with progressive MS is ongoing across clinical sites in the United States and Australia.
Atara also plans to initiate a randomized autologous ATA190 study in progressive MS patients in the second half of 2019.
Next-Generation CAR T Development Pipeline

Licensed worldwide rights to a mesothelin-targeted chimeric antigen receptor T-cell (CAR T) immunotherapy for solid tumors from Memorial Sloan Kettering Cancer Center (MSK).
Development with MSK will focus on a next-generation, mesothelin-targeted CAR T using novel 1XX CAR signaling domain and PD-1 dominant negative receptor (DNR) checkpoint inhibition technologies for patients with mesothelin-associated solid tumors.
Expect clinical and preclinical results supporting Atara’s next-generation CAR T programs to be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 to be held March 29 to April 3 in Atlanta, Georgia.
First IND submission for Atara’s next-generation CAR T program expected in the fourth quarter of 2019 or first quarter of 2020.
Other Pipeline

Conducting IND-enabling manufacturing process development for ATA621, targeting both JC and BK viruses for patients with progressive multifocal leukoencephalopathy (PML).
Corporate

Atara’s Board of Directors is currently conducting a search for a new Chief Executive Officer following Dr. Ciechanover’s transition plan announced in January. Dr. Ciechanover will remain in his role as President and CEO until the earlier of the appointment of his successor or June 30, 2019.
Fourth Quarter and Full Year 2018 Financial Results

Cash, cash equivalents and short-term investments as of December 31, 2018 totaled $309.6 million, which we believe will be sufficient to fund planned operations to mid-2020. The balance excludes the impact of one-time license fees of $12.5 million paid in the first quarter of 2019 for worldwide rights to the next-generation allogeneic CAR T program targeting mesothelin.
The Company reported net losses of $80.0 million, or $1.75 per share, and $230.7 million, or $5.27 per share, for the fourth quarter and fiscal year 2018, respectively, as compared to $35.3 million, or $1.15 per share, and $119.5 million, or $4.00 per share, for the same periods in 2017.
Total operating expenses include total non-cash expenses of $11.0 million and $37.5 million for the fourth quarter and fiscal year 2018, respectively, as compared to $6.4 million and $24.1 for the same periods in 2017.
Research and development expenses were $62.3 million and $167.5 million for the fourth quarter and fiscal year 2018, respectively, as compared to $24.8 million and $81.2 million for the same periods in 2017. The increases in the fourth quarter and fiscal year 2018 were due to costs associated with the Company’s continuing expansion of research and development activities, including:
clinical study, manufacturing and outside service costs related to the two Phase 3 clinical studies of tab-cel in patients with EBV+ PTLD and the Phase 1 clinical study of allogeneic ATA188 in patients with progressive MS;
one-time license fees of $12.5 million incurred in the fourth quarter of 2018 for exclusive rights to a next-generation allogeneic CAR T program targeting mesothelin from MSK;
higher employee-related and overhead costs from increased headcount and operations, and
an increase in facilities and information technology expenses that are allocated to our research and development function.
Research and development expenses include $5.2 million and $16.2 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2018, respectively, as compared to $2.5 million and $8.8 million for the same periods in 2017.
General and administrative expenses were $19.6 million and $69.7 million for the fourth quarter and fiscal year 2018, respectively, as compared to $11.0 million and $40.3 million for the same periods in 2017. The increases in the fourth quarter and fiscal year 2018 were primarily due to increases in professional services costs and employee-related costs driven by increased headcount to support the Company’s expanding operations.
General and administrative expenses include $4.3 million and $17.6 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2018, respectively, as compared to $3.6 million and $14.3 million for the same periods in 2017.

On February 26, 2019 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported financial results and provided a business update for the fourth quarter and full year ended December 31, 2018 (Press release, Blueprint Medicines, FEB 26, 2019, View Source [SID1234533689]).

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Print

"Following a year of remarkable clinical progress across our portfolio in 2018, we are focused on executing our ‘2020 Blueprint’ vision to transform Blueprint Medicines into a fully-integrated global precision therapy company," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "The cornerstone of this effort is our planned NDA submission for avapritinib for patients with PDGFRA Exon 18 mutant GIST and fourth-line GIST in the second quarter. As we work to bring this new therapy to GIST patients who currently have no approved treatment options, we are also partnering with treating physicians, the patient community and testing companies to evolve the GIST treatment paradigm toward precision medicine, with the shared goals of maximizing patient outcomes, enabling efficient clinical trials and delivering value to the healthcare system."

Fourth Quarter 2018 Highlights and Recent Progress:

Avapritinib: Gastrointestinal stromal tumors (GIST):

Locked the registration database and reported top-line results from the Phase 1 NAVIGATOR trial of avapritinib in patients with PDGFRA Exon 18 mutant GIST and fourth-line GIST in preparation for the planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second quarter of 2019. Read the top-line data here.
Presented updated data from the Phase 1 NAVIGATOR trial across treatment lines at the Connective Tissue Oncology Society 2018 Annual Meeting in November 2018 and disclosed plans to conduct the registration-enabling Phase 3 COMPASS-2L precision medicine trial of avapritinib in second-line GIST. Read the full data here.
Under Blueprint Medicines’ collaboration with CStone Pharmaceuticals, announced the China National Medical Products Administration (NMPA) cleared an Investigational New Drug (IND) application for the ongoing Phase 3 VOYAGER trial of avapritinib in third-line GIST.
Avapritinib: Systemic mastocytosis (SM):

Presented updated data from the Phase 1 EXPLORER trial at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2018. Read the full data here.
Initiated patient dosing in two registration-enabling trials: the Phase 2 PATHFINDER trial in advanced SM and the Phase 2 PIONEER trial in indolent and smoldering SM.
BLU-667: RET-altered solid tumors:

Today announced the FDA has granted Breakthrough Therapy Designation to BLU-667 for the treatment of RET-mutation-positive medullary thyroid cancer (MTC) that requires systemic treatment and for which there are no acceptable alternative treatments.
BLU-554: Hepatocellular carcinoma (HCC):

Under Blueprint Medicines’ collaboration with CStone Pharmaceuticals, announced the China NMPA cleared an IND application for the ongoing Phase 1 trial of BLU-554 as a monotherapy in advanced HCC.
BLU-782: Fibrodysplasia ossificans progressiva (FOP):

Initiated participant dosing in a Phase 1 trial of BLU-782 in healthy volunteers in the first quarter of 2019.
Today announced the FDA has granted Fast Track Designation to BLU-782 for the treatment of FOP.
Corporate:

Announced "2020 Blueprint," a two-year global business strategy under which Blueprint Medicines expects to have two marketed products, four pending marketing applications in the United States or Europe, six clinical-stage therapeutic candidates and eight research programs by the end of 2020.
Announced the promotion of Michael Landsittel to Chief Financial Officer and the promotion of Kate Haviland to Chief Operating Officer in February 2019.
Key Upcoming Milestones:

The company expects to achieve the following milestones by the end of the second quarter of 2019.

Submit an NDA for avapritinib for PDGFRA Exon 18 mutant GIST and fourth-line GIST.
Present the registration dataset for avapritinib in PDGFRA Exon 18 mutant GIST and fourth-line GIST.
Present updated data from the Phase 1 EXPLORER trial of avapritinib in advanced SM.
Present updated data from the Phase 1 ARROW trial of BLU-667 in RET-altered cancers.
Complete enrollment of previously treated NSCLC and MTC patient cohorts in the Phase 1 ARROW trial of BLU-667.
Fourth Quarter and Year End 2018 Financial Results:

Cash Position: As of December 31, 2018, cash, cash equivalents and investments were $494.0 million, as compared to $673.4 million as of December 31, 2017. This decrease was primarily related to cash used in operating activities, partially offset by the $40.0 million upfront payment received in connection with entering into the collaboration with CStone Pharmaceuticals and the $10.0 million milestone payment achieved under the Roche collaboration in June 2018.
Collaboration Revenues: Collaboration revenues were $1.0 million for the fourth quarter of 2018 and $44.5 million for the year ended December 31, 2018, as compared to $1.6 million for the fourth quarter of 2017 and $21.4 million for the year ended December 31, 2017. This increase for the year was primarily due to revenue recognized under the collaboration agreement with CStone Pharmaceuticals, partially offset by the termination of the Alexion agreement in 2017.
R&D Expenses: Research and development expenses were $70.5 million for the fourth quarter of 2018 and $243.6 million for the year ended December 31, 2018, as compared to $43.6 million for the fourth quarter of 2017 and $144.7 million for the year ended December 31, 2017. This increase was primarily due to increased clinical and manufacturing expenses driven by Blueprint Medicines’ lead development candidates and increased personnel-related expenses. Research and development expenses included $4.9 million in stock-based compensation expenses for the fourth quarter of 2018 and $17.0 million in stock-based compensation expenses for the year ended December 31, 2018.
G&A Expenses: General and administrative expenses were $13.6 million for the fourth quarter of 2018 and $47.9 million for the year ended December 31, 2018, as compared to $8.1 million for the fourth quarter of 2018 and $28.0 million for the year ended December 31, 2017. This increase was primarily due to increased personnel-related expenses and increased professional fees, including pre-commercial planning activities. General and administrative expenses included $3.9 million in stock-based compensation expenses for the fourth quarter of 2018 and $13.5 million in stock-based compensation expenses for the year ended December 31, 2018.
Net Loss: Net loss was $80.3 million for the fourth quarter of 2018 and $236.6 million for the year ended December 31, 2018, or a net loss per share of $1.83 and $5.39, respectively, as compared to a net loss of $49.0 million for the fourth quarter of 2017 and $148.1 million for the year ended December 31, 2017, or a net loss per share of $1.23 and $3.92, respectively.
Financial Guidance:

Based on its current plans, Blueprint Medicines expects that its existing cash, cash equivalents and investments, excluding any potential option fees and milestone payments under its existing collaborations with Roche and CStone Pharmaceuticals, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2020.

Conference Call Information:

Blueprint Medicines will host a live conference call and webcast at 8:30 a.m. ET today to discuss fourth quarter and full year 2018 financial results and recent business activities. The conference call may be accessed by dialing (855) 728-4793 (domestic) or (503) 343-6666 (international) and referring to conference ID 26735762. A webcast of the conference call will be available in the Investors section of the Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

On February 26, 2019 Alkermes plc (Nasdaq: ALKS) reported the initiation of ARTISTRY-2, a new clinical study of ALKS 4230 administered subcutaneously as monotherapy and in combination with the PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with advanced solid tumors (Press release, Alkermes, FEB 26, 2019, View Source;p=irol-newsArticle&ID=2388952 [SID1234533688]). The study will explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules. ALKS 4230 is a novel, engineered fusion protein designed to selectively activate tumor-killing immune cells while avoiding the expansion of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex. Pembrolizumab is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.

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ARTISTRY-2, a phase 1/2 study, will be conducted in two stages: dose-escalation followed by dose-expansion. The dose-escalation stage is designed to evaluate the safety and tolerability of ascending doses of ALKS 4230 administered subcutaneously once-weekly and once-every-three-weeks as both lead-in monotherapy and in combination with pembrolizumab. Following identification of the optimal dose and recommended dosing schedule, the dose-expansion stage of the study will evaluate ALKS 4230 administered subcutaneously in combination with pembrolizumab in patients with advanced solid tumors. The dose-expansion stage will evaluate overall response rate, duration of response, non-progression rate at specific time points and overall survival.

"The initiation of our clinical subcutaneous dosing study represents an important milestone for the ALKS 4230 program as we explore new regimens that may offer patients a more convenient alternative to daily IV dosing that is complementary to checkpoint inhibitor regimens," said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. "Based on the emerging profile of ALKS 4230, we’ve rapidly expanded our clinical development program in recent months to evaluate combination therapy, potential efficacy in new tumor types and dosing optionality. The expansion of this program reflects our belief in the significant potential of ALKS 4230 and our recognition of the urgent and persistent need that exists for patients with cancer."

Data presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting demonstrated that subcutaneous administration of ALKS 4230 in non-clinical models achieved similar total systemic exposure of ALKS 4230 compared to intravenous (IV) administration, yet with less frequent dosing and a lower Cmax, leading to similar expansion of total CD8+ T cell and natural killer (NK) cell populations. These data support further clinical evaluation of subcutaneous administration of ALKS 4230 as an alternative to IV dosing.

About ALKS 4230
ALKS 4230 is a novel, engineered fusion protein designed to selectively activate tumor-killing immune cells while avoiding the expansion of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Program
ARTISTRY is an Alkermes-sponsored clinical program evaluating ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase 1 study in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. ARTISTRY-1 has three distinct stages: an ongoing monotherapy dose-escalation stage, a planned monotherapy dose-expansion stage and an ongoing combination therapy stage with pembrolizumab. ARTISTRY-2 is the second clinical study to initiate in the ARTISTRY clinical development program for ALKS 4230.