Sangamo Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On May 9, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported financial results and provided corporate updates for the first quarter of 2018 (Press release, Evotec, MAY 9, 2018, View Source;announcements/press-releases/p/evotec-reports-first-quarter-2018-results-and-provides-corporate-update-5682 [SID1234526299]).

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GOOD FINANCIAL PERFORMANCE WITH NEW BUSINESS MIX
Group revenues: 55% increase to € 79.0 m (Q1 2017: € 50.9 m);
EVT Execute revenues of € 78.5 m (Q1 2017: € 48.6 m);
EVT Innovate revenues of € 10.4 m (Q1 2017: € 12.5 m)
Adjusted Group EBITDA up 4% to € 14.0 m (Q1 2017: € 13.4 m);
Adjusted EBITDA for EVT Execute of € 17.2 m (Q1 2017: € 12.4 m);
Adjusted EBITDA for EVT Innovate of € (3.2) m (Q1 2017: € 1.0 m)
Group R&D expenses at € 4.6 m (Q1 2017: € 4.7 m)
Solid liquidity position of € 78.5 m

EVT EXECUTE – HIGH QUALITY AND EFFICIENCY IN R&D
Significant progress within ongoing alliances (e.g. start of third clinical Phase I study in endometriosis with Bayer (after period-end))
Aptuit integration according to plan
Launch of INDiGO solution to accelerate drug candidate delivery; first alliances established (e.g. Petra Pharma, Japanese company Carna Biosciences (after period-end))
New and extended integrated drug discovery and development agreements
Expansion of CRISPR-based technology offering with licence from ERS Genomics (after period-end)

EVT INNOVATE – FOCUS ON ACCELERATING INNOVATION
In Q1 2018, as expected, no noteworthy milestones, but all key projects on track
Continued focus on expansion of iPSC platform and patient-centric approaches
Academic BRIDGE model gaining momentum: First project identified in LAB150 with MaRS Innovation, further three projects identified in LAB282 with Oxford University
Alliance with Sanofi to accelerate infectious disease R&D (close of transaction expected in H1 2018)

CORPORATE
Preparation to convert into European Company (SE)

FINANCIAL GUIDANCE 2018 CONFIRMED
1. GOOD FINANCIAL PERFORMANCE WITH NEW BUSINESS MIX
In the first quarter of 2018, Evotec’s Group revenues grew to € 79.0 m, an increase of 55% compared to the same period of the previous year (Q1 2017: € 50.9 m). This increase resulted primarily from the strong performance in the base business and the Aptuit contribution (€ 25.3 m). Due to the timing of milestones, revenues from milestones, upfronts and licences in Q1 2018 decreased to € 2.7 m (Q1 2017: € 6.2 m). Q1 2017 revenues were driven by significant milestone achievements. The gross margin amounted to 23.4% in the first three months of 2018 (Q1 2017: 37.3%). This margin decrease compared to the prior-year period primarily reflects a new business mix following the most recent acquisition of Aptuit, amortisation, adverse FX effects and the timing of milestones. Gross margin excluding amortisation from M&A would be at 27.3%.

In the first quarter of 2018, Evotec’s R&D expenses amounted to € 4.6 m (Q1 2017: € 4.7 m) and were focused on first-in-class innovation mainly in CNS, metabolic disease, oncology and academic BRIDGE initiatives. Selling, general and administrative (SG&A) expenses increased as expected by 82% in the first quarter of 2018 to € 13.3 m (Q1 2017: € 7.3 m) and are on a similar level as in Q4 2017. This increase mainly results from expenses of Aptuit for three months as well as an increase in headcount in response to Company growth.

Adjusted Group EBITDA in the first quarter of 2018 increased to € 14.0 m (Q1 2017: € 13.4 m). Evotec’s operating result in the first quarter of 2018 amounted to € 6.5 m (Q1 2017: € 9.9 m). The Company’s net result in Q1 2018 amounted to € 3.5 m (Q1 2017: € 7.1 m) and decreased compared to the prior year mainly due to increased amortisation resulting from the purchase price allocations of recent acquisitions, adverse foreign currency effects, milestone timing and the higher share of the loss of associates accounted for using the equity method.

Liquidity, which includes cash and cash equivalents (€ 57.3 m) and investments (€ 21.2 m) amounted to € 78.5 m as of 31 March 2018 (31 December 2017: € 91.2 m). This decrease reflects the repayment of loans, increased capital expenditure, equity investments and bonus payments.

Revenues from the EVT Execute segment were € 78.5 m in Q1 2018 and significantly increased compared to the prior-year period (Q1 2017: € 48.6 m). This increase is primarily attributable to growth in the base business and a full three months Aptuit contribution. Also included in this amount are € 9.9 m of intersegment revenues (Q1 2017: € 10.3 m). The gross margin for EVT Execute was 20.8% and was affected, against the prior-year period, by amortisation, the new business mix with a different margin expectation in the Aptuit business, adverse FX effects and the timing of milestones. In Q1 2018, the adjusted EBITDA of the EVT Execute segment was very strong at € 17.2 m and significantly improved compared to the prior year (Q1 2017: € 12.4 m).

Revenues from the EVT Innovate segment amounted to € 10.4 m (Q1 2017: € 12.5 m) and consist entirely of third-party revenues. EVT Innovate revenues in Q1 2018 include lower milestone revenues than revenues in the prior-year period. EVT Innovate generated a gross margin of 31.1%, which was affected by adverse FX effects and the timing of milestones. R&D expenses for the EVT Innovate segment were € 5.6 m in Q1 2018 (Q1 2017: € 5.8 m). The EVT Innovate segment reported an adjusted EBITDA of € (3.2) m (Q1 2017: € 1.0 m). Adjusted EBITDA of EVT Innovate in Q1 2017 was driven by significant milestone achievements of € 4.5 m, which were not expected in Q1 2018. All key projects to achieve significant milestones in 2018 are on track.

2. EVT EXECUTE & EVT INNOVATE
EVT EXECUTE – HIGH QUALITY AND EFFICIENCY IN R&D
The first quarter of 2018 saw a strong operational performance by the EVT Execute segment. The Aptuit integration into the Evotec Group is proceeding according to plan. In March 2018, Evotec launched the INDiGO offering, which was part of the strategic rationale behind the Aptuit acquisition. INDiGO is the market-leading integrated drug development solution that accelerates drug candidate delivery from candidate selection through to IND submission. Shortly afterwards, Evotec entered into new INDiGO alliances, e.g. with Petra Pharma and Carna Biosciences (Japan) (after period-end).

Furthermore, Evotec made significant progress within its ongoing alliances. Another promising small molecule was advanced into Phase I for the treatment of endometriosis in Evotec’s strategic Bayer endometriosis alliance (after period-end). Since the beginning of this collaboration, six first-in-class/best-in-class non-hormonal pre-clinical candidates have been generated, three of which have now advanced into Phase I clinical trials.

In addition and amongst other highlights, Evotec entered into new and extended integrated drug discovery and development agreements in the first quarter of 2018 and extended its CRISPR-based technology offering with a licence from ERS Genomics after period-end.

EVT INNOVATE – FOCUS ON ACCELERATING INNOVATION

EVT Innovate also had a very good start into 2018. Evotec continues to place a strong focus on its iPSC platform and the development of patient-centric approaches. The academic BRIDGE model is also gaining momentum. A first project was selected in LAB150 with MaRS Innovation, which was only initiated in September 2017, and three additional projects were selected in LAB282 with Oxford University (initiated in November 2016).

Furthermore, on 08 March 2018, Evotec announced that Evotec and Sanofi entered into exclusive negotiations to accelerate infectious disease research and development through a new open innovation platform led by Evotec. This transaction is expected to close in the first half of 2018, subject to finalisation of definitive agreements and completion of the appropriate social process.

3. CORPORATE
PREPARATION TO CONVERT INTO EUROPEAN COMPANY (SE)
At the end of the first quarter 2018, Evotec announced its preparations for legal conversion of the Company into a European Company (Societas Europaea, SE). The proposal, which has already been approved by the Supervisory Board, will be put to a vote at this year’s Annual General Meeting on 20 June 2018. The conversion reflects the continuing European and international focus of the Evotec Group, which has grown considerably in recent years with subsidiaries in France, Germany, Italy, Switzerland, the United Kingdom and the USA.

4. FINANCIAL GUIDANCE 2018 CONFIRMED

Guidance 2018 Actual 2017
Group revenues More than 30% growth € 257.6 m
Adjusted Group EBITDA1) Improve by approx. 30% compared to 2017 € 58.0 m
R&D expenses Approx. € 20-30 m € 17.6 m
1) EBITDA is defined as earnings before interest, taxes, depreciation, and amortisation of intangibles. Adjusted EBITDA excludes contingent considerations, income from bargain purchase and impairments on goodwill, other intangible and tangible assets as well as the total non-operating result

Webcast/Conference Call

The Company will hold a conference call to discuss the results as well as to provide an update on its performance. Furthermore, the Management Board will present an outlook for the fiscal year 2018. The cnference call will be in English.

Conference call details

Date: Wednesday, 09 May 2018

Time: 02.00 pm CEST (01.00 pm BST/08.00 am EDT)

From Germany: +49 69 22 22 29 043
From France: +33 170 750 705
From Italy: +39 023 601 3806
From UK: +44 20 3009 2452
From USA: +1 855 402 7766
Access Code: 37969784#

A simultaneous slide presentation for participants dialling in via phone is available at http://www.audio-webcast.com/, password: evotec0518.

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our home page www.evotec.com shortly before the event.

A replay of the conference call will be available for 24 hours and can be accessed in Europe by dialling +49 69 22 22 33 985 (Germany) or +44 20 3426 2807 (UK) and in the USA by dialling +1 866 535 8030. The access code is 654573#. The on-demand version of the webcast will be available on our website: View Source

On May 9, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported recent business highlights and financial results for the first quarter of 2018 (Press release, BeiGene, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348272 [SID1234526360]).

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"We continue to make great progress launching new clinical trials on a global scale for patients with a wide variety of cancers, where we believe our investigational treatments can have a profound impact," said John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene. "We have now enrolled more than 2,300 patients worldwide in more than 30 clinical trials of our investigational agents as of the end of March 2018 and remain on target for our first NDA filings in China later this year."

"Given the significantly reformed regulatory environment in China, as well as important additions to our senior leadership team highlighted by the appointment of Dr. Xiaobin Wu as our General Manager of China and President of BeiGene, Ltd., we are excited about our China and global prospects," continued Mr. Oyler.

Recent Business Highlights

Clinical Programs:

Zanubrutinib (BGB-3111), an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK)

Completed enrollment in the Phase 2 pivotal trial in China in patients with Waldenström macroglobulinemia (WM).
Tislelizumab (BGB-A317), an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1

Initiated the following trials:

• Global Phase 2 trial in patients with relapsed or refractory mature T- and natural killer (NK)-cell lymphomas; and

• Global Phase 2 trial in patients with previously treated hepatocellular carcinoma (HCC or liver cancer), under collaboration with Celgene Corporation for solid tumors.
Pamiparib (BGB-290), an investigational small molecule PARP inhibitor

Presented preliminary Phase 1 clinical data in Chinese patients with ovarian or triple-negative breast cancer at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago.
Commercial Products:

Continued to expand potential patient access to ABRAXANE (nanoparticle albumin-bound paclitaxel) in China by obtaining inclusion in the provincial reimbursement drug list in Jiangsu and critical illness insurance in Zhejiang; and

Launched a first-line indication of REVLIMID (lenalidomide) in China following its regulatory approval by the China Food and Drug Administration (CFDA) for the treatment of multiple myeloma (MM) in combination with dexamethasone in adult patients with previously untreated MM who are not eligible for transplant.
Corporate Development:

Appointed J. Samuel Su, former Vice Chairman of the Board of Directors of Yum! Brands, Inc. and Chairman and CEO of its China division, to the BeiGene Board of Directors;

Appointed Dr. Xiaobin Wu to the position of General Manager of China and President of BeiGene, Ltd.;

Appointed Yifei Zhu to the position of China Co-Commercial Head, Sales and Market Access; and

Appointed Dr. Guillaume Vignon to the position of Senior Vice President, Business Development.
Expected Upcoming Milestones in 2018

Zanubrutinib

Present updated Phase 1 clinical data in patients with WM and pooled safety analysis in patients with hematologic malignancies at the 2018 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in Stockholm, Sweden, June 14-17;

Present other updated Phase 1 data and China pivotal trial data;

Submit first new drug application (NDA) in China for mantle cell lymphoma;

Complete enrollment in the global Phase 3 trial for WM in Q3 2018; and

Initiate a global head-to-head Phase 3 trial versus ibrutinib in relapsed/refractory chronic lymphocytic leukemia.
Tislelizumab

Present updated Phase 1 data and China pivotal trial data;
Submit first NDA in China for Hodgkin’s lymphoma;

Complete enrollment in the Phase 2 pivotal trial in China for urothelial carcinoma; and
Initiate additional pivotal trials.

Pamiparib

Present updated Phase 1 data;

Initiate a global Phase 3 trial in gastric cancer in Q2 or Q3 2018; and
Initiate a Phase 3 trial in China as maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer.
Commercial Products

Continue to expand provincial reimbursement for ABRAXANE in China.
First Quarter 2018 Financial Results

Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $1,481.48 million as of March 31, 2018, compared to $837.52 million as of December 31, 2017. The increase was primarily due to net proceeds of $757.59 million raised in a public offering in January 2018. Cash, cash equivalents, restricted cash and short-term investments include approximately $131.04 million held by our 95%-owned joint venture, BeiGene Biologics, to build a commercial biologics facility under construction in Guangzhou, China. Restricted cash of $17.46 million relates to BeiGene Guangzhou Factory’s secured deposits that are held in designated bank accounts for the issuance of a letter of credit.

Cash used in operations for the quarter ended March 31, 2018 was $104.50 million, compared to $35.71 million for the same period in 2017. The increase was primarily attributable to higher operating expenses in support of our clinical programs and organizational growth. Capital expenditures for the quarter ended March 31, 2018 were $9.70 million, compared to $7.39 million for the same period in 2017. The increase was primarily attributable to the construction of our manufacturing facilities in Guangzhou.

Revenues for the three months ended March 31, 2018 were $32.54 million, compared to nil in the same period in 2017, attributable to product and collaboration revenue under our collaboration with Celgene.

Product revenue from sales of ABRAXANE, REVLIMID and VIDAZA in China totaled $23.25 million for the first quarter 2018.

Collaboration revenue totaled $9.29 million for the first quarter 2018, reflecting $7.55 million that was recognized as research and development reimbursement revenue from Celgene and $1.74 million of deferred upfront fees from Celgene recognized in the first quarter of 2018. In addition, unbilled receivables of $23.86 million on the balance sheet reflect research and development reimbursement under the Celgene collaboration for expenses incurred through the first quarter of 2018.
Expenses for the quarter ended March 31, 2018 were $143.35 million, compared to $51.54 million in the same period 2017, consisting primarily of the following:

Cost of sales for the first quarter were $4.55 million, compared to nil in the first quarter of 2017. Cost of sales relates to the cost of acquiring ABRAXANE, REVLIMID and VIDAZA for distribution in China.

R&D Expenses for the three months ended March 31, 2018 were $109.70, compared to $42.77 million in the same period in 2017. The increase in R&D expenses was primarily attributable to increased spending on our ongoing late-stage clinical trials and increased employee compensation expense as a result of increased headcount to support our clinical programs. Also contributing to the increase was the up-front license fee of $10 million paid to Mirati Therapeutics for the license of sitravatinib in Asia (excluding Japan), Australia and New Zealand. R&D-associated share-based compensation expense was $12.05 million for the three months ended March 31, 2018, compared to $4.53 million for the same period in 2017, due to increased headcount and a higher share price.

SG&A Expenses for the three months ended March 31, 2018 were $28.92 million, compared to $8.77 million in the same period in 2017. The increase in SG&A expenses was primarily attributable to increased headcount, including employees transferred from Celgene China in connection with the license agreement for Celgene’s commercial products in China, as well as higher professional service fees and costs to support our growing operations. SG&A-associated share-based compensation expense was $5.34 million for the three months ended March 31, 2018, compared to $1.46 million for the same period in 2017, due to increased headcount and a higher share price.

Net Loss for the first quarter of 2018 was $105.12 million, or $2.03 per American Depositary Share (ADS), compared to a net loss of $50.62 million, or $1.27 per ADS in the same period in 2017.

On May 9, 2018 MannKind Corporation(NASDAQ:MNKD) reported financial results for the first quarter ended March 31, 2018 (Press release, Mannkind, MAY 9, 2018, View Source [SID1234526376]).

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"We started 2018 with solid growth of 184% in quarterly Afrezza sales year-over-year, which reflects our progression as a fully-integrated commercial enterprise and our focused promotional efforts," said Michael Castagna, Chief Executive Officer of MannKind Corporation. "We look forward to new scientific data releases at the American Diabetes Association scientific meeting in June to help clinicians better understand the unique benefits of this innovative product."

For the first quarter of 2018, Afrezza net revenue was $3.4 million compared to $1.2 million for the first quarter of 2017, an increase of $2.2 million or 184%. On January 1, 2018, the Company adopted ASC 606, the new revenue recognition standard, under which it recognizes revenue as it sells product to wholesale distributors. Previously, it recognized sales on the basis of a model that estimated the sale of Afrezza to patients. As of January 1 2018, it reduced $3.4 million in previously deferred revenue (that reflected inventory in sales channels) to zero and also made a corresponding decrease to accumulated deficit. A comparison of the condensed consolidated financial statements with and without the adoption of ASC 606 can be found in the Notes to Condensed Consolidated Financial Statements in the form 10-Q for the quarter ended March 31, 2018. Total revenue for the first quarter of 2018 was $3.4 million compared to $3.0 million for the first quarter of 2017, an increase of $0.4 million or 15%. This increase was primarily due to the increased net revenue from Afrezza, partially offset by the sale of bulk insulin of $1.7 million in the first quarter of 2017.

Cost of goods sold for the first quarter of 2018 was $4.0 million compared to $2.5 million for the first quarter of 2017, an increase $1.5 million or 57%. This increase was primarily the result of higher Afrezza sales compared to the same period in the prior year together with inventory write-offs of $0.6 million in the quarter ended March 31, 2018. There were no inventory write-offs in the same period of the prior year.

Research and development (R&D) expenses for the first quarter of 2018 were $2.6 million compared to $3.1 million for the first quarter of 2017, a decrease of $0.5 million or 16%. This decrease reflected a $1.1 million reallocation of salary and salary-related expenses from R&D in 2017 to selling, general and administrative expenses (SG&A) in 2018) associated with personnel who were engaged in R&D activities in 2017 and transitioned to providing medical affairs and pharmacovigilance support to Afrezza commercial activities in 2018. The decrease in R&D expenses in the first quart of 2018 was offset by increased outside contract research organization spending on clinical trials of $0.5 million.

SG&A expenses were $20.6 million for the first quarter of 2018 compared to $15.4 million for the first quarter of 2017. The $5.2 million or 34% increase was primarily due to $5.7 million in headcount-related expenses from additional field force and G&A support functions (inclusive of the $1.1 million reallocation from R&D). In addition, there was a charge of $0.8 million in the first quarter 2018 for costs related to transitioning corporate support functions from Danbury, CT to Westlake Village, CA to create a more efficient back-office operation. Partially offsetting these increases were a $0.5 million decrease in spending on outside sales efforts that were transitioned in-house, $0.6 million lower consulting costs, and $0.2 million due to lower facility costs.

The net loss for the first quarter of 2018 was $30.4 million, or $0.25 per share compared to a $16.3 million net loss in the first quarter of 2017 or $0.17 per share. In addition to the variances described above which impacted the net loss in 2017, there was a favorable change due to a non-cash gain recognized in the first quarter of 2017 for the decrease in the fair value of warrant liability of $6.6 million which did not have a corresponding first quarter 2018 amount as the warrants were exchanged for shares and cancelled in October 2017.

Cash, cash equivalents and restricted cash at March 31, 2018 decreased to $27.2 million compared to $48.4 million at December 31, 2017, primarily due to net cash used in operating activities of $21.7 million in the first quarter 2018 offset by $0.5 million of net proceeds from the at-the-market equity offering facility. Subsequent to the quarter end in early April, the Company raised $26.3 million of net proceeds from a registered direct offering of 14 million shares of common stock and warrants at a purchase price of $2.00 per share and accompanying warrant exercisable at $2.38 per share.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. To participate in the live call by telephone, please dial (800) 289-0438 toll-free or (323)794-2423 toll/international and use the conference passcode: 3321662. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at www.mannkindcorp.com.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 toll free or (412) 317-6671 toll/international and use the replay passcode: 3321662. A replay will also be available on MannKind’s website for 14 days.

On May 9, 2018 SELLAS Life Sciences Group Inc. (Nasdaq:SLS) ("SELLAS"), a clinical-stage biopharmaceutical company focused on novel cancer immunotherapies for a broad range of cancer indications, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its novel drug candidate, galinpepimut-S (GPS), for the treatment of multiple myeloma (MM) (Press release, Sellas Life Sciences, MAY 9, 2018, View Source [SID1234526392]). GPS is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types.

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"We are delighted to receive this orphan drug designation as it underscores the great need for innovative, effective treatments for this rare cancer, and recognizes the potential benefits that GPS may provide for patients with MM," said Angelos Stergiou, MD, ScD h.c., President & Chief Executive Officer of SELLAS. "Receiving orphan drug designation for the treatment of MM is a significant regulatory milestone in the development of GPS. We have reported median progression-free survival (PFS) of 23.6 months in the high-risk MM disease setting, compared to historically inferior outcomes in such a patient cohort of around 12 months, and GPS stimulated time-dependent and robust CD4+ T cell or CD8+ T cell immune responses as well as multifunctional cross-epitope T cell reactivity."

GPS has also received orphan drug designation for the treatment of acute myeloid leukemia (AML) and malignant plural mesothelioma (MPM). SELLAS has Phase 3 clinical trials planned for GPS in both AML and MPM and is developing GPS as a potential treatment for a broad range of other cancer indications, including multiple myeloma.

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.