Array BioPharma announced updated results from the Phase 3 COLUMBUS trial in BRAF-mutant advanced melanoma. The results showed median overall survival was 33.6 months for patients treated with the combination of encorafenib and binimetinib compared to 16.9 months for patients treated with vemurafenib as a monotherapy. The combination reduced the risk of death compared to treatment with vemurafenib alone. The observed efficacy of vemurafenib in the control arm is also consistent with historical data, providing an additional benchmark for validating the patient population and results observed in COLUMBUS. Further, the two-year OS with combination therapy was 58%. These results will be part of an oral presentation at the American Society of Clinical Oncology annual meeting in Chicago, Illinois and have been selected for the “Best of ASCO” program
Monday, June 4, 2018
Retrophin can proceed with Phase 3 of neural pediatric med: panel
Retrophin announced that the independent Data Monitoring Committee for the pivotal Phase 3 FORT Study, which is evaluating fosmetpantotenate for the treatment of pantothenate kinase-associated neurodegeneration, has completed its scheduled clinical safety review required to open enrollment for pediatric patients. Upon review of the available safety and tolerability data of fosmetpantotenate in adult patients with PKAN in the study to date, the DMC recommended that the pivotal trial continue as planned, and supported initiation of enrollment in pediatric patients aged 6 to 17. The FORT Study is a pivotal Phase 3 clinical trial conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration. Under the terms of the SPA agreement, the FORT Study protocol required an initial group of adult patients be treated with fosmetpantotenate to allow a safety assessment by the DMC prior to opening enrollment to pediatric patients aged 6 to 17. The Company anticipates completion of patient enrollment around year-end 2018, and top-line data to become available in the second half of 2019.
#ASCO18: MEI has high response rate for Phase 1 lymphoma med
MEI Pharma announced that data presented at ASCO 2018 from a Phase 1b study of ME-401 demonstrate a 90% objective response rate in patients with relapsed or refractory follicular lymphoma, chronic lymphocytic lymphoma and small lymphocytic lymphoma. Based on the data in this program, MEI anticipates progressing into a single-agent registration study later in 2018 for the treatment of adults with relapsed or refractory follicular lymphoma. ME-401 is a next-generation selective oral inhibitor of PI3K delta. “The clinical evidence we are accumulating from the Phase 1b study of ME-401 is very promising; the data demonstrate a 90% response rate across all patients with relapsed or refractory FL, CLL and SL, and an 86% rate in patients with relapsed or refractory follicular lymphoma,” said Daniel P. Gold, Ph.D., president and CEO of MEI Pharma. “There continues to be a need for effective treatment options among patients with relapsed or refractory follicular lymphoma. We therefore anticipate moving into a single-agent registration study by the end of the year”
Rexahn has Phase 2 data at #ASCO18
Rexahn Pharmaceuticals announced that preliminary data from a Phase 2a clinical trial of RX-5902 in metastatic triple negative breast cancer, or TNBC, and updated data from the Phase 2a trial of RX-3117 in advanced bladder cancer were presented at the American Society of Clinical Oncology, or ASCO, 2018 annual meeting on June 2, 2018.
#ASCO18: Sellas has high year 1 survival rate for Phase 1 ovarian cancer med
SELLAS Life Sciences announces interim Phase 1 data of GPS in combination with nivolumab in patients with WT1+ ovarian cancer in second or third remission after salvage chemotherapy at the 2018 American Society of Clinical Oncology Annual Meeting. The presentation, “A phase I study of concomitant galinpepimut-S, or GPS, in combination with nivolumab in patients with WT1+ ovarian cancer in second or third remission,” is being delivered by Roisin E. O’Cearbhaill, M.D., Gynecologic Medical Oncology Service, Memorial Sloan Kettering Cancer Center, during the “Gynecologic Cancer” session from 1:15 to 4:45 p.m. CT. The primary endpoint of the study is safety and assessment of toxicity, and treatment is continued until disease progression or toxicity. The secondary endpoint is immune response, and the exploratory endpoints include landmark 1-year PFS rate compared to historical controls and correlative analyses between clinical and immune responses. Exploratory efficacy interim data from this open-label Phase 1 investigator-sponsored trial showed that GPS, when combined with a PD-1 inhibitor, demonstrated PFS of 64% at one year in an intent to treat group of 11 evaluable patients with WT1+ ovarian cancer in second or greater remission. Among patients who received at least three doses of GPS in combination with nivolumab, PFS at one year was 70%. With regard to clinical and immune responses: in 11 evaluable patients, the landmark 1-year PFS rate was 64% in the ITT group and 70% in the ten patients who received at least three doses of GPS + nivolumab. Historical rates do not exceed 50% in this disease setting; serum levels of antigen-specific IgG, against both individual WT1 peptides within GPS and the full-length WT1 protein, were induced in 86% of patients; achievement of high titers of WT1-specific IgG post-GPS results from Immunoglobulin M to IgG class switching, the latter being a surrogate marker of induction of activated T-helper cells after vaccination.
Sunday, June 3, 2018
Cantor Fitzgerald Taps Spinal Stocks: 4 Top Picks
Spine stocks were steadied with supportive coverage from the Street this week.
The Ratings
Cantor Fitzgerald analysts Craig Bijou and Jordan Abrams initiated coverage on:
- Globus Medical Inc GMED 0.72% with an Overweight rating and $65 price target;
- K2M Group Holdings Inc KTWO 0.72% with an Overweight rating and $28 price target;
- Orthofix International NV OFIX 1.35% with an Overweight rating and $62 price target; and
- SeaSpine Holdings Corp SPNE 0.59% with an Overweight rating and $16 price target.
They also initiated on Mazor Robotics Ltd – ADR MZOR 0.55% and NuVasive, Inc. NUVA 0.18% with Neutral ratings and respective targets of $57 and $54.
The Thesis
The analysts consider the spine segment — a $9-billion global opportunity — to be the largest orthopedic market and one of the biggest medical device end markets.
“While the spine market has faced a bevy of headwinds and challenges over the last 18 months that [have] suppressed growth, we believe that spine is still an important and relevant market,” Bijou and Abrams said in a note.
In the near-term, the analysts said they expect the Overweight-rated stocks to secure sales and seize share through their differentiated technology, appeal to surgeons and emphasis on growing niches around the spine.
Biotech week ahead: #ASCO18 dominates
A few FDA approvals and the impending 2018 American Society of Clinical Oncology annual meeting gave some impetus to the biotech space in the week ending June 1.
The FDA greenlighted Pfizer Inc. (NYSE: PFE)’s sNDA for Xeljanz, while TherapeuticsMD Inc(NASDAQ: TXMD) finally secured a FDA nod for its vaginal pain medication Imvexxy.
The iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) has been higher for the week.
Here are a few catalytic events biotech investors should watch in the unfolding week:
Medical, Health Care And Biotech Conferences
- 2018 American Society of Clinical Oncology Annual Meeting: June 1-5, McCormick Place, Chicago.
- Jefferies 2018 Global Healthcare Conference: June 5-8 in New York City.
- American Society for Microbiology 2018 meeting: June 7-11 in Atlanta.
Clinical Trial Outcomes
- Cidara Therapeutics Inc (NASDAQ: CDTX) is due to present Phase 2 data for its candidemia treatment rezafungin IV at the ASM meeting at 11 a.m. on Friday, June 8. The data from Cidara’s STRIVE study released in March showed that the study met the primary objectives.
ASCO Presentations Pick Up Steam
Sunday, June 3
- Merck & Co., Inc. (NYSE: MRK) is presenting the following:
- Phase 3 data from KEYNOTE-042 study for non-small cell lung cancer, or NSCLC.
- Phase 2 data for a Keytruda and chemo combo for first-line non-squamous NSCLC.
- Data for Keytruda and carboplatin-paclitaxel or nab-paclitaxel from the KEYNOTE-407 study evaluating the combo for squamous NSCLC.
- Data for MK-3475-189 from the KEYNOTE-180 study that evaluated the pipeline candidate for treating first-line metastatic non-squamous NSCLC.
- Celgene Corporation (NASDAQ: CELG): Updated Phase 1 data for Lico-cel in B cell non-Hodgkin lymphoma
- Novartis AG (ADR) (NYSE: NVS): Phase 3 data for LEE011 from MONALEESA-3 study that evaluated for breast cancer in post-menopausal women.
- TESARO Inc (NASDAQ: TSRO): Phase 1 data for niraparib-keytruda combo for treating triple-negative breast cancer or ovarian cancer.
- Calithera Biosciences Inc (NASDAQ: CALA): Phase 1/2 data for CB-839 and panitumumab for treating colorectal cancer.
- MacroGenics Inc (NASDAQ: MGNX): Phase 2 data for margetuximab in combination with Keytruda to treat gastric cancer.
- Incyte Corporation (NASDAQ: INCY): Phase 1 data for DPX-survivac vaccine therapy and epacadostat for recurrent ovarian cancer.
- ARMO Biosciences Inc (NASDAQ: ARMO): Phase 1b data for AM0010 in solid tumors
- Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY) is presenting the following:
- Phase 3 data for venclexta for treating relapsed or refractory chronic lymphocytic leukemia.
- Updated Phase 3 data for alecensa for treating ALK-positive metastatic NSCLC.
- Pfizer is presenting the following:
- Phase 3 data for ibrance from the PALOMA-3 study in breast cancer patients.
- Phase 2 data for ibrance in treating head and neck squamous cell carcinoma.
- Other companies due to present data June 3 include:
- Immunomedics, Inc. (NASDAQ: IMMU)
- Epizyme Inc (NASDAQ: EPZM)
- Exelixis, Inc. (NASDAQ: EXEL)
- NewLink Genetics Corp (NASDAQ: NLNK)
- AbbVie Inc (NYSE: ABBV)
- Syndax Pharmaceuticals Inc (NASDAQ: SNDX)
- Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI)
- Seattle Genetics, Inc. (NASDAQ: SGEN)
- FibroGen Inc (NASDAQ: FGEN)
- Tyme Technologies Inc (NASDAQ: TYME)
- Five Prime Therapeutics Inc (NASDAQ: FPRX)
- Zai Lab Ltd (NASDAQ: ZLAB)
Monday, June 4
- Roche is presenting:
- Phase 3 data for tecentriq and cb and pac/nab-pac from the Impower 131 study that evaluated for squamous NSCLC.
- Phase 3 data for tecentriq from the Impower 150 study in patients with non-squamous NSCLC.
- Infinera Corp. (NASDAQ: INFN): Phase 1 study of IPI-549 and opdivo for treating solid tumors.
- Agenus Inc (NASDAQ: AGEN): A Phase 1/2 study of AGEN2034 in cervical cancer and Phase 1 data for AGEN1884 in solid cancers.
- Acceleron Pharma Inc (NASDAQ: XLRN): Phase 2 study of luspatercept for myelodysplastic syndromes.
- Nektar Therapeutics (NASDAQ: NKTR): Phase 1/2 data for NKTR-214 and tecentriq in solid tumors.
- Eli Lilly And Co (NYSE: LLY): Phase 3 data from the REACH-2 study that evaluated its ramucirumab for hepatocellular carcinoma.
- ImmunoGen, Inc. (NASDAQ: IMGN): Phase 1/2 data for mirvetuximab soravtansine in the FORWARD II study that evaluated it in ovarian cancer and relapsed endometrial cancer.
- Bristol-Myers Squibb Co (NYSE: BMY) is presenting:
- Phase 3 data of CM-227 (opdivo-yervoy combo) for first-line NSCLC.
- Phase 2 data for opdivo and rubraca in castration-resistant prostate cancer, along withClovis Oncology Inc (NASDAQ: CLVS).
- AstraZeneca plc (ADR) (NYSE: AZN) – Phase 2 data for lyparza and Keytruda for castration-resistant prostate cancer.
- Regeneron Pharmaceuticals Inc (NASDAQ: REGN) & Sanofi SA (ADR) (NYSE: SNY): Phase 1 data for cemiplimab in NSCLC
- Celgene and Acceleron: Phase 2 data for luspatercept in myelofibrosis.
- Pfizer: Phase 3 data on dacomitinib for treating NSCLC.
Other companies due to present data on June 4 include:
- Stemline Therapeutics Inc (NASDAQ: STML)
- Verastem Inc (NASDAQ: VSTM)
- CytomX Therapeutics Inc (NASDAQ: CTMX)
- OncoSec Medical Inc (NASDAQ: ONCS)
- Corcept Therapeutics Incorporated (NASDAQ: CORT)
- Protalix Biotherapeutics Inc (NYSE: PLX)
- MEI Pharma Inc (NASDAQ: MEIP)
- Portola Pharmaceuticals Inc (NASDAQ: PTLA)
- Agios Pharmaceuticals Inc (NASDAQ: AGIO)
- Molecular Templates Inc (NASDAQ: MTEM)
- Mersana Therapeutics Inc (NASDAQ: MRSN)
- Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP)
- Calithera Biosciences
- Miragen Therapeutics Inc (NASDAQ: MGEN)
- AbbVie Inc
- Dynavax Technologies Corporation (NASDAQ: DVAX)
- ZIOPHARM Oncology Inc. (NASDAQ: ZIOP)
- Tesaro
- TG Therapeutics Inc common stock (NASDAQ: TGTX)
- Sellas Life Sciences Group Inc (NASDAQ: SLS)
- Merrimack Pharmaceuticals Inc (NASDAQ: MACK)
- Idera Pharmaceuticals Inc (NASDAQ: IDRA)
Earnings
Thursday, June 7
- Advaxis, Inc. (NASDAQ: ADXS)
IPO Calendar
MeiraGTx Holdings, a gene therapy company that focuses on disorders of the eye and salivary gland, is set offer 5 million shares at an estimated price range of $14-$16.
The company seeks to list its shares on the Nasdaq under the ticker symbol MGTX.
Quiet Period Expirations
Evelo Biosciences Inc (NASDAQ: EVLO) listed its shares on the Nasdaq on May 8, with the stock closing its debut session at its offer price of $16. The stock is currently trading at a discount to the offer price.
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