AbbVie, J&J’s Imbruvica comes up short in non-Hodgkin lymphoma trial

With eight FDA-approved indications since 2013, Johnson & Johnson and AbbVie’s Imbruvica hasn’t run into many stumbling blocks. But it has hit one in non-Hodgkin lymphoma.

On Wednesday, the drugmakers said adding Imbruvica to the standard-of-care chemo regimen didn’t improve event-free survival in previously untreated diffuse large B-cell lymphoma patients. For now, the companies are staying tight-lipped on details of the flop, which will be presented at an upcoming medical meeting and published in a medical journal.

As AbbVie and J&J were quick to note, though, “clinically meaningful improvements were observed in a patient sub-population that warrant further analysis.” They also pointed out that the study targeted patients with a subtype of DLBCL that typically sees “poorer treatment outcomes”—and DLBCL, the most common type of NHL in adults, is itself already an aggressive form.

“The nature of research is such that some studies succeed and others do not. We continue to believe that ibrutinib has great untapped potential as a cancer treatment alone or in combination,” Thorsten Graef, M.D., Ph.D., head of clinical development at AbbVie’s Pharmacyclics, said in a statement.

Since winning its first-ever FDA go-ahead, Imbruvica has gone on to grab nods across six different diseases—five of them in B-cell blood cancers, including high-cost chronic lymphocytic leukemia. Imbruvica “has continued to expand its position as the clear market share leader across all lines of therapy in CLL,” AbbVie CEO Richard Gonzalez said on the company’s first-quarter earnings call in April, and that leadership helped the drug rake in $762 million for the period.

With new competition on the scene, though, AbbVie and J&J are working to branch out. Last Halloween, AstraZeneca’s Calquence hit the scene in previously treated mantle cell lymphoma, with plans to eventually threaten Imbruvica’s share in CLL as well.

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Trump reportedly told Pfizer CEO price boost complicated drug plan

U.S. President Donald Trump spoke with Pfizer CEO Ian Read to say that the company’s July 1 price increases had complicated the administrations drug pricing plans, prompting the drug maker to defer its planned hikes, Reuters reports, citing a source familiar with the matter. Pfizer said Tuesday it was deferring its drug price hikes for no more than six months following Read’s phone call with the president, the report notes. U.S. Health and Human Services secretary Alex Azar called the Pfizer CEO previously, but Read asked to speak directly with Trump, the report says, citing the source.

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Biocept Dates and Terms of Rights Offering

Biocept, Inc. (NASDAQ: BIOC) (“Biocept”), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, today provided an informational update to stockholders regarding its proposed rights offering and the expected key dates and terms relative to the offering. Stockholders are advised to ensure they complete their open market purchases of Biocept’s common stock by Thursday, July 19, 2018 to be considered a stockholder of record on Monday, July 23, 2018. Holders of the Company’s warrants issued February 13, 2015, May 4, 2016, October 19, 2016, March 31, 2017, August 9, 2017 and January 30, 2018 are also entitled to participate in the rights offering on the same terms as the stockholders. Stockholders, warrant holders or interested parties are advised to direct all questions and informational requests to the contacts listed below.

Under the proposed rights offering, Biocept will distribute one non-transferable subscription right for each share of common stock and each warrant (on an as-if-converted-to-common-stock basis) held on the record date. Each right will entitle the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of Series A Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into shares of Biocept’s common stock at a conversion price of $4.53 per share) and 220 warrants to purchase Biocept’s common stock with an exercise price of $4.53 per share. The warrants will be exercisable for 5 years after the date of issuance.

The subscription rights are non-transferable and may only be exercised during the anticipated subscription period of Tuesday, July 24, 2018 through 5:00 PM ET on Wednesday, August 8, 2018, unless extended by Biocept.

The expected calendar for the rights offering is as follows:

• Thursday, July 19, 2018: Ownership Day — in order to be considered a stockholder of record on Monday, July 23, 2018, shares should be acquired by this date.
• Monday, July 23, 2018: Record Date
• Tuesday, July 24, 2018: Distribution Date; Subscription Period Begins
• Wednesday, August 8, 2018: Subscription Period Ends 5:00 PM ET (unless extended at Biocept’s sole discretion)

Holders who exercise their subscription rights in full will be entitled, if available, to subscribe for additional units that are not purchased by other stockholders, on a pro rata basis and subject to ownership limitations.

Biocept has engaged Maxim Group LLC and Dawson James Securities, Inc. as co-dealer-managers in the offering.

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Lancet Paper on Robust Immune Response to J&J Preventive HIV Vaccine

Johnson & Johnson today announced that The Lancet has published key early-stage data regarding a mosaic-based, investigational HIV-1 vaccine in development at its Janssen Pharmaceutical Companies.

In the Phase 1/2a APPROACH study, based on the data generated, the mosaic vaccine was safe and well tolerated and elicited a robust HIV antibody response in all healthy volunteers receiving active vaccine. Additionally in a parallel study in non-human primates (NHPs), the most immunogenic mosaic regimen in humans demonstrated similar immune responses in NHPs and afforded 67% protection against an HIV-like virus.

The Lancet paper provides the first detailed analysis of topline results presented by Janssen at the 9th IAS Conference on HIV Science (IAS 2017) in July 2017, and supports the recent advancement of the mosaic vaccine into its first large-scale efficacy study.

‘These are promising but still early-stage results. At 52 weeks, we observed that the mosaic HIV vaccine induced robust and comparable immune responses to HIV in humans and in nonhuman primates, and the vaccine protected against infection with an HIV-like virus in nonhuman primates,’ said Professor Dan Barouch, Harvard Medical School, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and a lead author of The Lancet paper.

Janssen’s investigational mosaic-based vaccine regimen contains immunogens created using genes from different viral subtypes responsible for HIV infections worldwide.

‘The progress made in the last thirty years in the fight against HIV is remarkable, yet HIV still persists as a global health threat affecting millions,’ said Paul Stoffels, MD, Executive Vice President, Chief Scientific Officer, Johnson & Johnson. ‘The genetic diversity inherent in HIV brings many challenges, but we are committed to developing a ‘global vaccine’ effective against the multiple strains of the virus. Our quest is to develop a vaccine that would put an end to the worldwide pandemic for good.’

In addition to the results reported in The Lancet, the first long-term immunological data from the APPROACH study will be presented in an oral presentation at the 22nd International AIDS Conference (AIDS 2018) on Tuesday, July 24, 2018 in Amsterdam, The Netherlands. This presentation has also been selected for inclusion in the official press program of the conference.

Based on results from APPROACH and other early-stage studies, in November 2017Janssen and its global partners initiated the first efficacy study for a mosaic-based vaccine regimen. The Phase 2b trial, HVTN 705/HPX2008 (also known as ‘Imbokodo’), aims to enroll 2,600 young women aged 18-35 in five sub-Saharan African countries to see whether the vaccine is safe and able to reduce HIV infection in this at-risk population. Participants are now enrolling at clinical research sites in South Africa, Zimbabwe and Malawi. The study has been cleared to start in Zambia, and regulatory approval is pending in Mozambique. Results from Imbokodo are expected in 2021.

Although great progress has been made in the fight against AIDS, a safe and effective vaccine will likely be required to truly end the HIV pandemic. In 2016, nearly 37 million people were living with HIV globally, 1.8 million people were newly infected with HIV, and 1 million people died of AIDS.[i]

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Dr Reddy’s, UCB to co-promote, distribute epilepsy treatment in India

Dr. Reddy’s Laboratories Limited (BSE: 500124, NSE: DRREDDY, NYSE: RDY) and UCB, a biopharmaceutical company, announced today that they have entered into a distribution and co-promotion agreement for Briviact, a brand of brivaracetam.

The agreement grants Dr. Reddy’s the exclusive right to distribute Briviact in India.

Briviact (brivaracetam) is approved as an adjunctive therapy for the treatment of partial-onset seizures in epilepsy patients who are 16 years of age and older.

M. V. Ramana, CEO – Branded Markets (India and Emerging Markets), Dr. Reddy’s said, ‘In our endeavor to make innovative medicines accessible to patients in India, we are excited to partner with UCB India for Briviact, a novel treatment for epilepsy that will make a difference to the lives of patients living with epilepsy.’

‘We know that as many as one third of people with epilepsy are currently uncontrolled on their existing medicines.’ Explained Max Bricchi, Head of International Markets, UCB Neurology Patient Value Unit. ‘This partnership is another important step towards us providing value together to patients by making Briviact available as an additional treatment choice for epilepsy.’

Epilepsy is the second most common neurological condition and as per a recent study, an estimate of 70 million people suffer from it worldwide. There are over 12 million people suffering from epilepsy in India, which contributes to nearly one-sixth of the global burden.

https://bit.ly/2L5to4e

Arbutus Presents Corporate Update on Key Milestones

Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, today announced updates on several key milestones in advance of the companys presentation at Roivant Pipeline Day in New York City this afternoon. Those updates are as follows:

AB-506 (Capsid Inhibitor) and AB-452 (RNA Destabilizer) Studies on Track to Support All-Oral Combination Study in 2019The first subject has been dosed in a clinical trial of AB-506, Arbutus second-generation capsid inhibitor. The healthy volunteer portion of an innovative Phase 1 study design will be followed by dosing cohorts of HBV patients. The initiation of dosing in HBV patients is expected later this year. Topline results are expected by Q2 2019.

The regulatory filing for AB-452, Arbutus novel and proprietary RNA destabilizer, is on track for submission in Q3, with subject dosing to follow in Q4. Study completion is expected by Q3 2019. AB-452 was discovered under the leadership of Arbutus Chief Scientific Officer Dr. Michael J. Sofia, the Lasker Award-winning inventor of sofosbuvir (SOVALDI). Pending completion of the monotherapy studies for AB-506 and AB-452, Arbutus expects to begin an all-oral combination study in 2H 2019.

The initiation of our first-in-human study with our next-generation capsid inhibitor is a crucial milestone for Arbutus because of the important role that a potent capsid inhibitor could play in an all-oral therapeutic regimen, said Dr. Sofia. We are especially excited about advancing our first-in-class RNA destabilizer into a clinical study, setting up for an important all-oral combination study in 2019. We have worked carefully over the past two years to ensure that we are advancing our best and most potent candidates into the clinic.

ARB-1467 Interim Results Expected in Q4Arbutus also announced that interim 6-week results from Arbutus ongoing clinical study of ARB-1467 in combination with tenofovir and PEG-IFN are expected in Q4. ARB-1467 is Arbutus first-generation HBV-RNAi agent. The result of this study will inform small molecule clinical combination studies planned for 2H 2019.

Patisiran Data and PDUFA Date Set for August 11, 2018Pivotal study results from Alnylams APOLLO Phase 3 trial of patisiran have been published in The New England Journal of Medicine (NEJM). Patisiran is currently under Priority Review as a Breakthrough Therapy with the U.S. Food and Drug Administration (FDA). The FDA has set a PDUFA date of August 11, 2018. Successful approval will trigger a royalty entitlement to Arbutus for the proprietary LNP technology licensed by Arbutus to Alnylam for patisiran.

Genevant Enters Transformative Partnership with BioNTechGenevant, a recently-launched new company jointly owned by Arbutus and Roivant Sciences,announced today that it has entered into a strategic partnership with BioNTech AG, an industry leader in mRNA therapy development. BioNTech and Genevant will develop five mRNA products for rare diseases with high unmet medical need under a 50/50 co-development and co-commercialization collaboration. Genevant and BioNTech have also agreed a series of exclusive licenses covering the application of Genevants proprietary delivery technology to five oncology targets, for which Genevant is eligible to receive significant commercial milestones. This partnership advances Genevants goal of having 5-10 programs in the clinic by 2020 across RNAi, mRNA, and gene editing modalities and positions Genevant as a leader in the development of RNA-based therapeutics.

This is an exciting time for Arbutus with many pivotal catalysts in the months ahead as we continue our mission of delivering a curative treatment regimen for HBV, said Dr. Mark J. Murray, Arbutus President and Chief Executive Officer. I am especially excited about our opportunity to enter all-oral studies in 2019, laying the groundwork for a potentially similar paradigm shift in treatment as we saw in HCV over the past decade. I am also proud of the work we have done to enable the development of additional therapies at Alnylam and at Genevant while retaining significant economic upside for Arbutus.

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Achillion starts Phase 1 for immune-condition med

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a clinical-stage pharmaceutical company focused on developing small molecule inhibitors of factor D in the complement alternative pathway (AP), today announced that the Company had begun dosing healthy volunteer subjects in a first-in-human phase 1 trial of ACH-5548, an oral small-molecule complement factor D inhibitor. ACH-5548 is the third clinical compound discovered and developed by Achillion from its complement factor D platform.

ACH-5548, like the second compound from Achillions factor D portfolio, ACH-5228, is structurally designed to achieve significant improvements in potency and pharmacokinetic properties over first-generation ACH-4471. In pre-clinical studies, both ACH-5228 and ACH-5548 demonstrate multiple-fold increased potency with pharmacokinetic profiles that offer potential for less frequent dosing than ACH-4471.

The advancement of ACH-5548 into the clinic is an important milestone for Achillion as we continue to broaden our clinical stage factor D portfolio. Clinical data generated to date demonstrate that factor D inhibition represents a novel, first-in-class approach to developing potential treatments for patients suffering from alternative pathway-mediated diseases, commented Joe Truitt, President and Chief Executive Officer of Achillion. As we continue our transition to a late-stage clinical and commercial company in our global phase 2 clinical programs with ACH-4471 in both PNH and C3G, we also continue to advance next generation compounds in an effort to bring new treatments to patients. We believe this expanded portfolio of three clinical stage factor D inhibitors will provide important strategic optionality for Achillion.

https://bit.ly/2KNx66l