Incyte to present at ASCO meeting in Chicago

Incyte announces abstracts featuring genomic profiling data for ASCO

Incyte Corp. (INCY) announces that multiple abstracts highlighting data from its oncology portfolio will be presented at the upcoming 2019 American Society of Clinical Oncology Annual Meeting, to be held from May 31-June 4, in Chicago, Illinois; and the 24th Congress of the European Hematology Association, to be held June 13-16, in Amsterdam, the Netherlands.

Abstracts accepted for presentation at ASCO feature genomic profiling data from Incyte’s ongoing Phase 2 FIGHT-202 trial evaluating its selective fibroblast growth factor receptor inhibitor, pemigatinib, in patients with cholangiocarcinoma, as well as efficacy and safety data from the Novartis-sponsored GEOMETRY mono-1 trial of capmatinib, the investigational selective MET inhibitor licensed to Novartis (NVS) by Incyte.

Additionally, data to be presented at EHA will showcase the continued study of Incyte’s JAK1/JAK2 inhibitor, #ruxolitinib, in myeloproliferative neoplasms.

“Our presence at ASCO and EHA illustrates Incyte’s ongoing commitment to discovering and developing therapeutic options that address significant unmet medical needs for patients,” said Steven Stein, M.D., Chief Medical Officer, Incyte.

ASCO’s annual meeting is May 31-June 4 in Chicago, Stockwinners

“We are pleased to highlight new data on two investigational medicines – pemigatinib and capmatinib – that were discovered by Incyte scientists and for which we anticipate applications for initial U.S. regulatory approvals later this year, as well as data that furthers our understanding of the treatment of MPNs.”

Incyte Corporation focuses on the discovery, development, and commercialization of various therapeutics in the United States. The company offers JAKAFI, a drug for the treatment of myelofibrosis and polycythemia vera cancers; and Iclusig, a kinase inhibitor to treat chronic myeloid leukemia and philadelphia-chromosome positive acute lymphoblastic leukemia.

Its clinical stage products include ruxolitinib, a drug in Phase III clinical trial for steroid-refractory acute graft-versus-host-diseases (GVHD); and Phase II trial for the treatment of essential thrombocythemia and refractory myelofibrosis.

In addition, the company engages in the development of itacitinib, which is in Phase III clinical trial to treat naïve acute and chronic GVHD, as well as Phase I/II clinical trial in combination with osimertinib for non-small cell lung cancer (NSCLC); and pemigatinib that is in Phase II clinical trial for treating bladder cancer, cholangiocarcinoma, and 8p11 myeloproliferative syndrome, as well as a pivotal program for solid tumors with driver activations of FGF/FGFR.

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Bio-Path Holdings presents positive pancreatic cancer data

Bio-Path Holdings presents BP1003 data at AACR

Bio-Path Holdings presents positive pancreatic cancer data, Stockwinners

Bio-Path Holdings (BPTH) announced that data from pre-clinical studies supporting the potential of BP1003, a liposome-incorporated STAT3 oligodeoxynucleotide inhibitor, for the treatment of pancreatic cancer, non-small cell lung cancer, or NSCLC, and acute myelogenous leukemia, or AML, were presented in a poster at the American Association for Cancer Research, or AACR.

The poster highlights four antisense oligo sequences directed against STAT3 mRNA identified by Bio-Path and manufactured using DNAbilize antisense RNAi nanoparticle technology.

Cell viability tests and western blots were conducted to determine the inhibitory effects of liposome-incorporated STAT3 antisense oligo on NSCLC and AML cells.

An ex vivo live tissue sensitivity assay was performed with a panel of 20 pancreatic ductal adenocarcinoma patient-derived xenografts to study the overall activity of BP1003 alone, and in combination with gemcitabine.

Using previously defined criteria, tissue slice viability inhibition greater than 30% and with a less than 0.05 value was considered to be a response.

For validation of ex vivo results, tumor bearing mice were administered BP1003 and gemcitabine twice a week for 28 days. Tumor volumes were monitored for up to 49 days.

The most potent liposome-incorporated STAT3 antisense sequence in decreasing NSCLC cell viability was selected as the drug candidate BP1003.

Further validation in AML cells demonstrated that BP1003 inhibited cell viability and STAT3 protein expression. In the ex vivo LTSA assay, BP1003 at a dose of 10 microM significantly inhibited the tissue slice viability in 9 out of 18 PDAC PDXs by more than 30%.

The combination of BP1003 and gemcitabine further enhanced ex vivo efficacy of BP1003 in a subset of PDXs.

In the in vivo study, a combination of BP1003 and gemcitabine caused tumor regression during the 28-day drug treatment period.

This anti-cancer activity was maintained for another 21 days, even when drug treatment had ceased.

Preclinical pancreatic cancer models demonstrated that BP1003 successfully penetrated the stroma into pancreatic tumors.

Finally, the results in pancreatic cancer showed that BP1003 inhibited tumor slice viability in nine of 18.

BPTH closed at $19.68, it last traded at $20.61.

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Spark Therapeutics sold for $4.8 billion

Roche acquires Spark Therapeutics for $114.50 per share, a 122% premium

Spark tumbles on hemophilia study , Stockwinners

Roche acquires Spark Therapeutics for $114.50 per share , Stockwinners

Spark Therapeutics (ONCE) announced that it has entered into a definitive merger agreement for Roche (RHHBY) to fully acquire Spark Therapeutics at a price of $114.50 per share in an all-cash transaction.

This corresponds to a total equity value of approximately $4.8B on a fully diluted basis, inclusive of approximately $500M of projected net cash expected at close.

The per share price represents a premium of 122% to Spark’s closing price on Feb. 22, 2019. The merger agreement has been unanimously approved by the boards of both Spark and Roche.

Under the terms of the merger agreement, Roche will commence a tender offer to acquire all outstanding shares of Spark’s common stock, and Spark will file a recommendation statement containing the unanimous recommendation of the Spark board that Spark shareholders tender their shares to Roche.

Spark Therapeutics will continue its operations in Philadelphia as an independent company within the Roche Group.

The closing of the transaction is expected to take place in Q2 of 2019.

Bernstein analyst Vincent #Chen notes that he has long seen Spark Therapeutics (ONCE) as a takeout candidate in gene therapy after the Wall Street Journal reported Roche (RHHBY) is near acquiring the company for close to $5B.

The analyst thinks the deal makes sense as adding hemophilia gene therapy to Hemlibra sets up Roche as a leader in next-gen non-factor hemophilia drugs, CNS gene therapy pipeline is a good fit for Roche’s growing neuroscience franchise, and as it serves as a cornerstone in establishing Roche as a gene therapy leader, to rival the likes of Novartis (NVS).


Credit Suisse analyst Martin Auster notes that the Wall Street Journal recently reported that Roche (RHHBY) is nearing a deal with Spark Therapeutics (ONCE) for $5B.

The analyst believes the transaction value implies the re-emergence of Spark’s hemophilia A gene therapy program with a competitive profile and substantial value assigned to additional pipeline programs, such as SPK-3006 for Pompe, and the technology platform.

Spark’s acquisition would further strengthen the company’s position in the hemophilia space, he contends. Further, Auster argues that the deal may increase M&A interest among other gene therapy names in his coverage universe, which include BioMarin (BMRN), Sarepta (SRPT), Ultragenyx (RARE), PTC (PTC) and Solid Biosciences (SLDB). He sees particularly strong read-through to Sarepta.


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Bristol-Myers comments on Celgene’s purchase

Bristol-Myers sees ‘meaningful financial benefits’ from Celgene transaction.

Bristol-Myers treatment for colorectal cancer approved, Stockwinners

Bristol Meyers Comments on Celgene purchase, Stockwinners

Bristol-Myers Squibb (BMY) said an updated its investor presentation about the Celgene (CELG) transaction.

The company said, “The Celgene transaction is the natural next step in Bristol-Myers Squibb’s proven strategy that has consistently delivered results for over a decade.

Through a disciplined approach to driving innovation, focusing on high-value opportunities and sourcing innovation externally to complement its internal portfolio and pipeline, Bristol-Myers Squibb has generated consistently strong growth and increased its dividend for 10 consecutive years.

The combination with Celgene will create a leading biopharma with increased scale, while maintaining the same agility and a focus on delivering for patients in core disease areas of high-unmet medical need.

The pipeline of the combined company provides significant near-, medium- and long-term opportunities for value creation. Bristol-Myers Squibb is acquiring Celgene’s robust and complementary pipeline at an attractive price.

In addition to six expected near-term product launches representing more than $15B in revenue potential, the combination will greatly increase Bristol-Myers Squibb’s Phase I and II assets, which will provide the next set of registrational opportunities in core therapeutic areas.

With an expanded set of scientific platforms and research capabilities, Bristol-Myers Squibb will be well positioned to discover and develop highly innovative medicines and accelerate these new options to patients through one of the highest-performing commercial organizations in the industry.

Bristol-Myers Squibb is well positioned for 2025 and beyond with continued leadership across Oncology and a diversified portfolio of assets.

The combined company will have a broad, balanced and earlier life-cycle marketed portfolio with a significantly higher number of opportunities across multiple diseases to drive the growth of Bristol-Myers Squibb in the second half of the decade. These opportunities will support financial strength for continued investment and innovation.

The Celgene transaction is expected to generate meaningful financial benefits for all stockholders.

With more than $45B of expected free cash flow generation over the first three full years post-closing, the combination will enable rapid debt reduction to de-lever the balance sheet and strengthen Bristol-Myers Squibb’s credit profile.

Bristol-Myers Squibb expects to realize run-rate cost synergies of approximately $2.5B by 2022 from the combination, and the combined company is expected to grow revenue and EPS every year through 2025.”

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Novartis receives positive CHMP opinion for Kymriah

Novartis receives positive CHMP opinion for Kymriah

Novartis receives positive CHMP opinion for Kymriah, Stockwinners
Novartis receives positive CHMP opinion for Kymriah, Stockwinners

Novartis (NVS) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending approval of Kymriah – a novel one-time treatment that uses a patient’s own T cells to fight cancer.

The positive opinion includes two B-cell malignancies: B-cell acute lymphoblastic leukemia that is refractory, in relapse post-transplant or in second or later relapse in patients up to 25 years of age; and diffuse large B-cell lymphoma that is relapsed or refractory after two or more lines of systemic therapy in adults.

If approved by the European Commission, Kymriah will be the first CAR-T cell therapy available in the European Union for both DLBCL and B-cell ALL.

Both B-cell ALL and DLBCL are aggressive malignancies with significant treatment gaps for patients.

In Europe, ALL accounts for approximately 80% of leukemia cases among children, and for those patients who relapse, the outlook is poor. This low survival rate is in spite of patients having to undergo multiple treatments, including chemotherapy, radiation, targeted therapy or stem cell transplant, and further highlights the need for new treatment options.

DLBCL is the most common form of non-Hodgkin lymphoma, accounting for up to 40% of all cases globally.

For patients who relapse or don’t respond to initial therapy, there are limited treatment options that provide durable responses, and survival rates are low for the majority of patients due to ineligibility for autologous stem cell transplant or because salvage chemotherapy or ASCT have failed.

The positive CHMP opinion is based on two pivotal Novartis-sponsored global, multi-center, Phase II trials, ELIANA and JULIET, which included patients from Europe, the US, Australia, Canada and Japan. The collaboration of Novartis and the University of Pennsylvania has led to historic milestones in CAR-T cell therapy since 2012, including the initiation of the first global CAR-T trials, the PRIME designation granted by the EMA for Kymriah in pediatric patients with r/r B-cell ALL, and the approval of Kymriah in two distinct indications by the US Food and Drug Administration.

ELIANA is the first pediatric global CAR-T cell therapy registration trial, treating patients in 25 centers in the US, Canada, Australia, Japan and the EU, including: Austria, Belgium, France, Germany, Italy, Norway and Spain. JULIET is the first multi-center global registration study for Kymriah in adult patients with r/r DLBCL.

JULIET is also the largest global study evaluating a CAR-T cell therapy in patients with DLBCL, enrolling patients from 27 sites in 10 countries across the US, Canada, Australia, Japan and the EU, including: Austria, France, Germany, Italy, Norway and the Netherlands.

The Novartis CAR-T cell manufacturing platform includes cryopreservation, the process of freezing patients’ harvested cells in order to preserve them, which provides physicians with the flexibility to decide when to initiate both the harvesting of patients’ cells and the infusion of Kymriah, based on each patient’s condition, and allows for this individualized treatment approach on a global scale.

The European Commission will now review the CHMP recommendation to deliver its final decision, applicable to all 28 EU member states, plus Iceland, Liechtenstein and Norway.

NVS closed at $73.00, it last traded at $75.50.


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Biotech stocks to watch in January

Ten biotech names to watch in January 

Biogen says BAN2401 did not meet primary endpoint. Stockwinners.com

In a research note to investors, Jefferies analyst Michael #Yee identified what he sees as ten potential disclosures or announcements that could come in the next two weeks to start 2018.

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Among the names that may see stock-moving events as the new year begins are Celgene (CELG), Biogen (BIIB) and Vertex (VRTX).

TURNING THE PAGE TO 2018

Jefferies’ Yee told investors that “turning the page to 2018 and into a January conference,” he is modestly optimistic that large-cap biotech picks up a bit given the recent pullback, tax reform and low investor expectations.

He reiterated that the big biotech names are working toward a much bigger 2018 product cycle and late-stage data read out period.

Celgene tumbles

Thinking outside of the box, the analyst pointed out that the key upside “wild-card” is whether “big consolidation” actually occurs in the large caps based on pharmaceutical companies buying pharma or “big biotech” companies.

STOCK-MOVING ANNOUNCEMENTS

Other than surprise M&A deals that could swing sentiment in biotech, Jefferies’ Yee sees the potential for at least ten stock-moving announcements within his coverage going into a major industry conference in two weeks.

The analyst told investors that #Celgene is likely to pre-announce results for its fourth quarter and provide new 2018 guidance, though investors should assume that outlook could be conservative.

#Biogen could also disclose color around Spinraza patient numbers and update on aducanumab Alzheimer’s enrollment, he contended.

Yee argued that #Vertex could pre-announce on its fourth quarter but may not provide 2018 Cystic Fibrosis guidance until its ‘661 combo is approved in February. The company could also disclose Phase 3 triple plans and update on Phase 2 data.

Regarding #Alnylam Pharmaceuticals (ALNY), the analyst highlighted the company may discuss the path forward for ALN-TTRsc02, update on the ALN-GO1 phase 1 program, or announce a new program in the near-term.

#AveXis (AVXS) may provide FDA meeting updates and next steps post recent regulatory discussions; Intercept Pharmaceuticals (ICPT) may pre-announce fourth quarter Ocaliva sales or announced the initiation of a Phase 3 cirrhosis study, or give color on upcoming FDA label change; and Assembly Biosciences (ASMB) could announce Phase 1b HBV data on viral knockdown, he contended.

stockwinners.com ICPT

Lastly, Yee pointed out that Axovant Sciences (AXON) may report Phase 2B data for intepiridine in dementia with Lewy bodies and nelotansersin in visual hallucinations, while Acorda Therapeutics (ACOR) is likely to pre-announce 2017 Ampyra net sales and provide 2018 financial guidance, and FibroGen (FGEN) could disclose HRCT imaging IPF data or Phase 2 pancreatic cancer data for pamrevlumab.


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Celgene’s Revlimid fails in lymphoma patients

Celgene’s Revlimid in follicular lymphoma shows no superiority vs. standard

Celgene tumbles
Celgene’s Revlimid fails in lymphoma patients

Celgene (CELG) and the Lymphoma Academic Research Organisation reported results from a phase III, randomized, open-label, international clinical study evaluating Revlimid plus rituximab – R2 – followed by R2 maintenance compared to the standard of care with rituximab plus chemotherapy followed by rituximab maintenance in patients with previously untreated follicular lymphoma.

The R2 treatment arm did not achieve superiority in the co-primary endpoints of complete response or unconfirmed complete response at 120 weeks and progression-free survival during the pre-planned analysis. Neither arm was superior for either of the co-primary endpoints.

The safety findings were consistent with the known profiles of the regimens investigated. Additional analyses are ongoing and planned.

ANALYST  REACTION

Piper cuts Celgene target to $100 on second Revlimid failure in lymphoma – Piper Jaffray analyst Christopher Raymond lowered his price target for Celgene to $100 from $109 after the Phase 3 Relevance trial evaluating Revlimid plus Rituximab in front line follicular lymphoma failed to show superior efficacy versus standard-of-care.

This is the second Revlimid failure in lymphoma following last year’s disappointment in diffuse large B-cell lymphoma,

#Raymond tells investors in a research note. This latest failure could have a near-term negative impact on Revlimid’s revenue trajectory since a “decent chunk” of off-label use in the U.S. likely stems from lymphoma, the analyst contends. He sees a “new element of uncertainty” and keeps a Neutral rating on Celgene.

Jefferies analyst Michael Yee says the failed Phase III Relevance study announced tonight by Celgene is irrelevant. The study had somewhat low expectations and it also makes Revlimid “less big,” which isn’t necessarily a bad problem, Yee tells investors in a research note.

The analyst says his thesis on the stock is unchanged and keeps a Buy rating on Celgene with a $125 price target.

The stock in after-hours trading is down 4% to $103.76. It has a 52-week trading range of $94.55 – $147.17.

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Genentech and AbbVie report positive Leukemia data

Genentech says Venclexta, Rituxan reduces risk of disease progression or death in Leukemia patients

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Venclexta is being developed by AbbVie (ABBV) and Genentech

Genentech, a member of the Roche Group (RHHBY), announced the first results from the pivotal Phase III MURANO study evaluating Venclexta plus Rituxan compared to bendamustine plus Rituxan for the treatment of people with relapsed or refractory chronic lymphocytic leukemia.

The results showed that a fixed duration of treatment with Venclexta plus Rituxan significantly reduced the risk of disease progression or death by 83% compared with BR.

No new safety signals were observed. Venclexta is being developed by AbbVie (ABBV) and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.

Data from the MURANO study will be submitted to global health authorities, including the U.S. Food and Drug Administration, which has granted Breakthrough Therapy Designation for Venclexta in combination with Rituxan for the treatment of relapsed or refractory CLL based on promising results from the Phase Ib M13-365 study.

Venclexta was granted accelerated approval by the FDA in April 2016 for the treatment of people with CLL with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy.

The MURANO study is part of the company’s commitment in the United States to convert the current accelerated approval of Venclexta to a full approval.

MURANO is a Phase III open-label, international, multicenter, randomized study evaluating the efficacy and safety of Venclexta in combination with Rituxan compared to bendamustine in combination with Rituxan.

All treatments were of fixed duration. The study included 389 patients with relapsed or refractory chronic lymphocytic leukemia who had been previously treated with at least one, but not more than three, lines of therapy.

Patients were randomly assigned in a 1:1 ratio to receive either Venclexta plus Rituxan or BR.

The primary endpoint of the study is investigator-assessed progression-free survival. Secondary endpoints include PFS assessed by independent review committee, overall response rate, complete response rate, overall survival, minimal residual disease status, duration of response, event-free survival and time to next CLL treatment.

RHHBY closed at $30.26. ABBV closed at $96.47.


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Juno Therapeutics and Celgene higher on lymphoma data

Juno Therapeutics, Celgene report additional data from TRANSCEND study

Juno Therapeutics (JUNO) and Celgene Corporation (CELG) released additional data from the TRANSCEND study of JCAR017 in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.

Celgene tumbles following Phase III failure of GED-003. See Stockwinners.com for stocks to buy, stocks to watch, stocks to trade

TRANSCEND is an open-label, multicenter Phase 1 study to determine the safety, pharmacokinetics, and antitumor activity of JCAR017 in adult patients with relapsed or refractory diffuse large B cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma Grade 3B, and mantle cell lymphoma.

As with previous readouts, the TRANSCEND data were presented for both the core and full groups.

The core group includes 29 patients who received dose level two, 34 patients who received dose level one, and 4 patients who received dose level one twice, approximately 14 days apart.

The core group includes patients with DLBCL who are ECOG Performance Status 0-1. These patients represent a high-risk patient population, with approximately 90% of treated patients having one or more predictors of poor survival, including double or triple hit lymphoma, being chemorefractory to front-line or subsequent therapies, never reaching a complete remission with prior treatments, or never having undergone an autologous transplant.

Enrollment of the pivotal cohort is ongoing with the core group at DL2. The full analysis group represents evaluable r/r patients in the DLBCL cohort, which includes an additional 24 patients with poor performance status or with niche subtypes of aggressive NHL.

In both analysis groups all efficacy data are based on at least one month of follow-up with a 28-day restaging scan and all safety evaluable data are based on having received JCAR017 with at least one month of follow-up. Product was available for 98% of patients apheresed in the DLBCL cohort.

Topline data from the presentation as of the October 9 data cutoff date included: Responses in core group: At DL2, the data showed a 3 month overall response rate of 74% and a 3 month complete response rate of 68%. Of patients that have reached 6 months of follow-up, 50% were in CR.

Across doses, 80% of patients with CR at 3 months stayed in CR at 6 months, and 92% of patients in response at 6 months remain in response as of data cutoff.

Across doses, median duration of response was 9.2 months and median durability of CR was not reached. Tolerability in core group:1% experienced severe cytokine release syndrome and 15% experienced severe neurotoxicity. 36% had any grade CRS and 21% had any grade NT. 58% had no CRS or NT of any grade.

At dose level 1, 3% experienced severe CRS and 21% experienced severe NT. At dose level 2, 0% experienced severe CRS and 7% experienced severe NT. 13% received tocilizumab and 18% received corticosteroids. Tolerability across doses in full group:1% experienced severe CRS and 12% experienced severe NT. 35% had any grade CRS and 19% had any grade NT. 60% had no CRS or NT of any grade.

The most common treatment-emergent adverse events other than CRS and NT that occurred at greater than or equal to 25% included neutropenia, anemia, fatigue, thrombocytopenia, nausea, and diarrhea. The most common TEAEs were similar between core and full groups.

CELG closed at $106.09. JUNO closed at $58.65


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