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MedNess: Healthcare Business News from the Month of May

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Hello everyone and welcome to MedNess: At the frontier of healthcare news. I am back with the news from healthcare business that had the most impact this month Read below to find out more.

 

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Neurotrope’s Alzheimer’s candidate fails to yield statistically significant results

Earlier this month Neurotrope reported results from its Phase 2 Alzheimer’s study of Bryostatin. The trial involving 147 patients with moderate to severe Alzheimer’s met its primary endpoint in patients that completed the full course of treatment. Bryostatin improved outcomes in cognition and ability to handle daily activities but failed to achieve statistical significance over placebo (FierceBiotech).

Neurotrope is hopeful of its candidate and plans to take the study forward.

MedNess: This is yet another Alzheimer’s candidate that failed in Phase 2 testing. The successful treatment of dementia is an enigma, and most drug candidates fail larger phase 2 trials. No new drug has been approved for Alzheimer’s for more than a decade. Neurotrope’s shares fell by 63% (Biospace)

Moderna Therapeutics reports interim Phase 1 results from mRNA based H10N8 flu vaccine

The private biotech company; Moderna Therapeutics reported positive interim results from phase 1 study of mRNA-1440 vaccine against avian H10N8 flu. The complete data and results were published in the journal Molecular Therapy.

31 subjects were enrolled in the Phase 1 study, and 23 received 100 µg of the vaccine. All participants achieved HAI titers suggesting seroprotection against seasonal flu. No response was achieved in the placebo arm (8 subjects). (FiercePharma)

MedNess: Since the company is still private, the only investment that can be made in Moderna Therapeutics is through venture capital funds. The company’s valuation is $3B, and primary sources of funding are grants and private investments (Investopedia and The Motley Fool).

Sanofi against affordable pricing for Zika vaccine

Sanofi Pasteur, the leader in vaccine manufacture, was under fire by US army officials and Senator Bernie Sanders after refusing the US Army’s plea for affordable US price for a Zika virus vaccine. Sanofi boasts of about $43 million US research grant money. Sanders and lawmakers have been requesting the US Army to reconsider its term of negotiations with Sanofi that could provide the latter an exclusive license to make and sell Zika vaccine in the US. The vaccine is being developed with the American taxpayer funds, thus prompting both the US Army and Sanders to request an affordable price for the American population.

The spokesperson from the Army states that the decision to provide Sanofi an exclusive licensing is still under consideration and the final decision will be made in the summer (STAT).

Corbus Pharma’s anabasum denied BTD for systemic sclerosis; enrolls the last patient for mid stage-study dermatomyositis

Corbus Pharma’s anabasum (Resunab) was previously provided Orphan Drug designation for Fast Track review by the FDA for systemic sclerosis. However, this month Corbus Pharmaceuticals was trying to gain Breakthrough Therapy status for the drug. The plea was rejected by the FDA. The BTD designation entails recurrent meetings with senior personnel and a rolling review of the New Drug Application. Meanwhile, in another phase 2 clinical trial where anabasum is being tested for dermatomyositis, the last patient was enrolled

MedNess: The failure to gain BTD designation by the FDA worried the investors, slipping shares down by 12%. However, with the news of last patient enrollment, the shares moved up by 3%.

The Belgian-Dutch Biotech Argenx draws $115M post-IPO filing

Argenx filed for IPO last month to draw cash from American investors; in order to push its lead candidate ARGX-113, an antibody directed against autoimmune disorders myasthenia gravis and primary immune thrombocytopenia, to phase 3 trials. It also proposed moving its lead cancer candidate ARGX-110 through mid phase studies. The biotech was able to rope in $115M, 50% above its target goal of $75M.

The biotech started their phase 2 studies with ARGX-113 earlier this year, and the results are expected in the first quarter of next year. A 30% drop in the IgG antibody level would be considered clinically significant (Fierce Biotech, Market Watch).

Incyte reports positive results from selective IDO1 enzyme inhibitor, epacadostat in two separate combined trials

Incyte reported first set of positive results from ongoing combined trials; ECHO-202 in combination with Merck (epacadostat+ Keytruda) and ECHO-204 in combination with BMS (epacadostat + Opdivo). The full sets of results will be announced at American Society of Clinical Oncology (ASCO) meeting next month.

The ECHO-202 trial is assessing epacadostat (selective IDO1 enzyme inhibitor) in combination with Merck’s Keytruda (anti-PD1 immunotherapy). The efficacy and safety results from the phase I/II trial showed that epacadostat in combination with Keytruda was well-tolerated in the following cohorts: non-small cell lung cancer, renal cell carcinoma, ovarian cancer, triple-negative breast cancer, bladder cancer, and head and neck squamous cell carcinoma.

Alternatively, data from the ECHO-204 trial evaluating the safety and efficacy of epacadostat, in combination with Bristol-Myers Squibb’s PD-1 inhibitor Opdivo showed the combination was well tolerated in melanoma, head and neck squamous cell carcinoma, ovarian cancer, and colorectal cancer (Incyte.com).

MedNess: Following the positive results, Incyte’s shares gained 2.3%, rose by 6% by mid-day which rose by 8% towards the end of the day (Thursday, May 18, 2017) with the overall increase of 14.10% by the end of the week (Zacks, Investor Place, The Street, and CNN Money).

About the Author:  

Imit Kaur is a freelance medical writer, editor, and an active science blogger. She pursued her Ph.D. in Pharmaceutics and Pharmaceutical Chemistry from the University of Utah. She is experienced in the field of oncology, hematology, pharmacology, nanotechnology and drug development.

Follow Imit on LinkedIn (Imit Kaur) or Twitter (@imit_kaur)

 

 

MedNess- Immuno Oncology, Precision Medicine and more….

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Picture Illustration: Ipsa Jain

CAR-T therapy- a step closer to precision medicine?

Kite Pharma’s CAR-T candidate axicabtagene ciloleucel (previously referred to as KTE-C19) might be the first gene therapy to gain approval from FDA. The candidate therapy attained primary endpoints in a major study. The study encompassed patients with chemorefractory aggressive B-cell non-Hodgkin lymphoma. The study showed that out of 101 patients enrolled in ZUMA-1 trial, 82% had their cancer shrunk at least by half after six months. In addition, 41% had partial response while 36% of patients went on complete remission. The therapy comes with its own share of risks. 3 patients in the study died and 2 of the deaths were attributed to the treatment.

CAR-T therapy, one of the most controversial treatments involving gene therapy, utilizes reengineered patient’s T cells. These T cells (immune system’s killer cells) are filtered from patients blood and altered in the lab and injected back intravenously making it a “living drug”.

Novartis and Juno Therapeutics are also in the race for CAR-T therapy. However, Juno Therapeutics announced the discontinuation of their experimental product early this month. This is because thirteen percent of patient deaths were reported, majorly due to cerebral edema and brain swelling. Kite Pharma’s CART-T cell product is safer in this regard. Kite Pharma’s axicabtagene ciloleucel was granted Breakthrough Therapy Designation status for diffuse large B cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma by the FDA and by the Food Priority Medicines (PRIME) regulatory support for DLBCL in the EU.

MedNess: Although Kite Pharma has not presented formal results of the trial and is expected to present their report at the annual conference of American Association of Cancer Research in April this year, the reports of axicabtegene ciloleucel meeting primary endpoints raised the stock prices by 13% of this California-based biopharmaceutical company. Kite Pharma’s CAR-T product might be first in line to gain approval from FDA by the end of this year leaving behind the products from its competitors. Therefore, stocks of Kite Pharma hold a lucrative future. However, a lot can change in further studies and it all comes down to safety and efficacy of the final product (FiercePharma, STAT).

Barclays analyst’s stern advice to Gilead Sciences

Geoff Meacham, Barclays senior analyst apparently lost patience with Gilead Sciences, urging it to “do something”. He sent an open letter to the management prompting the company to either make an acquisition or take strict measures to improve sales and profit growth. Meacham suggested measures including Gilead’s orphan drugs diversification, cost cutting in Hep-C business due to declining market, HIV franchise clarification and/ or in-licensing deals in order to gain trust of its investors (Seekingalpha)

MedNess: Gilead Sciences sales and profit growth have eroded as its hepatitis C franchise has declined, the shares have slipped by 1% and profits have declined in each of the past five quarters.

Scott Gottlieb to lead FDA under Trump administration

Scott Gottlieb who has served as a practicing physician, clinical assistant professor at New York University and health information technology adviser for the department of Health and Human Services, has been selected as Trump’s nominee to lead FDA. The president’s selection is expected to yield support from biopharma industry. Gottlieb, if confirmed, is likely to hasten the drug approval process that might have earned him Trump’s support. He was a former deputy commissioner for medical and scientific affairs at the FDA under George W. Bush (FiercePharma).

Earlier this month, Club SciWri initiated a new section on Science and Policy, emphasizing on the involvement of scientists in the healthcare policy decisions. Gottlieb’s nomination to lead FDA will serve as a perfect example, underscoring the relevance of this sensitive subject.

BMS appoints Thomas Lynch as its new Chief Scientific Officer

BMS has been in news for quite a while now and that too for all the wrong reasons. Amongst the turmoil and speculations of its buyout, BMS appointed Thomas Lynch as its new Chief Scientific Officer (CSO) while the former CSO Francis Cuff made the exit this Wednesday. Thomas Lynch, an oncologist, was a former board member of BMS. With the new appointment, hopes are high on the Opdivo front as well. Recently, Opdivo fell short in a major clinical trial when tested on previously untreated lung cancer patients. Opdivo is PD-L1 checkpoint inhibitor and therefore its efficacy is expected to be better in patients with higher levels of this biomarker. However, BMS lost its non-small cell lung cancer lead to rival Merck’s Keytruda that succeeded in patients with a PD-L1 score of 50% or more. Also, earlier this year, BMS decided to not to seek accelerated approval for their Opdivo-plus-Yervoy combination in lung cancer. These two events combined with new checkpoint inhibitors expected from Roche, AstraZeneca, Merck and Pfizer have put BMS’s shares down. However, analysts suggest, BMS share might still be a great bargain if the drug succeeds in other arms of the trial, testing Opdivo as a monotherapy in first-line lung cancer. The company also awaits readouts from Phase 2 and Phase 3 studies evaluating Opdivo and Yervoy in other types of cancer (FiercePharma, The Motley Fool).

 

MedNess- At the frontier of Medicine, Pharmaceutical and Healthcare Business

in Poli-Scie/SciBiz/Uncategorized by

Hello and welcome to the biweekly roundup of Healthcare business top stories. Please follow us on Twitter and LinkedIn

MedNess 

BMS’s injectable Opdivo approved by FDA for bladder cancer

FDA approved intravenous use of Opdivo (nivolumab), a PD-1 checkpoint inhibitor for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have not benefitted from platinum-containing chemotherapy or in cases where the disease progressed within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy. Last year, FDA approved Roche’s Tecentriq, a checkpoint inhibitor, for the treatement of bladder cancer.

From the business standpoint, this was much awaited good news for BMS as the Opdivo did not make the cut as first line monotherapy study in non small cell lung cancer (NSCLC) in 2016. However, Merck’s Keytruda gained FDA approval soon after Opdivo failed in NSCLC study (Fierce Pharma).

 

The battle of patents: bad news for Teva Pharmaceuticals

Genric drug maker giant: Teva Pharmaceuticals lost the patent challenge in U.S. District Court, safeguarding their star drug Copaxone against generic competition. Copaxone, approved in 1996, became the most prescribed drug for the treatment of multiple sclerosis. The patents protecting Copaxone against generic competition expired two years ago for 20mg dose. Novartis and Momenta launched their 20 mg alternative (Glatopa) in 2015. To recuperate, Teva launched a 40 mg formulation of Copaxone. However, this week, U.S. District Court invalidated Teva’s last and fourth key patent protecting 40 mg Copaxone from generic drug competition. Teva lost other 3 patents last year (Madison.com).

Trump pledges to bring drug costs down

Pharmaceutical industries were told by Trump that the drugs should be manufactured in the USA and the foreign countries buying US manufactured drugs should pay “fair share”. These changes in addition to “better innovation” will help bringing prices down for the US patients (CNBC).

MedNess from MedPol: Amgen CEO Robert Bradway announced that soon nearly 1600 jobs will be added. Bank of America Merrill Lynch predicted that Trump’s policies could help Amgen recover their stocks by 23% in the next 12 months (CNBC)

MedPol

US President’s executive order on immigration: the aftermaths

This is not a political blog, but the executive order has a very significant impact on the scientific, medical and healthcare community. In the following paragraphs, I will brief you with the sectors that have been affected.

  • NRMP issues the statement for the upcoming Match

Nearly 260 people from seven nations affected by travel ban, applied through National Resident Matching Program (NRMP) for medical residency in the USA (Association of American Medical Colleges, AAMC). Both the applicants and the hospital programs are concerned and affected by the travel ban. However, NRMP has urged the programs and the applicants to be discrete in their decisions that are in the interest of healthcare. The official statement issued by NRMP on their website states, “The medical education community must support all international medical graduates and their families during these difficult times. As for the current Match cycle, NRMP encourages applicants and programs to make the best decisions they can under current circumstances. For its part, NRMP will be liberal in granting waivers to applicants and programs if they cannot meet their respective Match obligations because of the effects of the Executive Order” (NRMP.org).

  • Dark times for the US hospitals and patients from seven nations affected by travel ban

Ill patients scheduled for treatment at the USA’s premier healthcare centers, John Hopkins Medicine and Cleveland Clinic are uncertain of their treatment options. Hopkins is taking a step ahead by either urging the patients to postpone their travel or sending their staff abroad for their treatment (STAT News)

We wrap up our biweekly MedNess and MedPol news section. Have a great weekend!

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