BioSpace BioPharm Exec
Wednesday, December 14, 2016
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So Long 2016 (and Good Riddance?


So Long 2016 (and Good Riddance?

Many of us will be glad to see the end of 2016, a year that was marked by terrorism both domestic and international, a string of celebrity deaths, a new disease scourge (Zika became the new Ebola), and a whole lot of political turmoil that made for some tense Thanksgiving table conversations...More...
The American Society of Hematology—and CAR-T in particular—dominated clinical news this month. Juno's recent woes were amplified by the successes of its rivals—Kite, Novartis, and even come-from-behind Bluebird. So far, however, the market is not impressed by these companies' progress—even Kite, which is filing for approval. But this certainly wasn't the only widely anticipated news. Biogen presented some new data on aducanumab at the 9th Clinical Trials on Alzheimer's Disease (CTAD) conference in San Diego, showing that drug continues to perform well in early studies.

Most significantly, the drug appears to reduce beta amyloid plaque in a dose-dependent manner. That's a critical part of the hypothesis behind aducanumab, but it was also the hypothesis to competing drugs like Lilly's solenazumab. Around the same time Biogen reported its new data, Lilly revealed that solenazumab in fact did not have any appreciable effect on plaque formation. That bolsters hopes for Biogen's approach which, while similar, is using a different mechanism. -KT
Novartis' (NVS) CAR-T Drug Sends 82% of Patients' Blood Cancer into Remission, Eyes 2017 for Marketing
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Investors Sigh With Relief as Biogen's (BIIB) Alzheimer's Drug Delivers in Early-Stage Study
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Celgene (CELG) Decides to Not Move Forward With Phase III Portion of tnAcity
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Kite Pharma (KITE) Presents Results Of Multi-Center Pivotal ZUMA-1 Trial Of Axicabtagene Ciloleucel (KTE-C19) In Aggressive Non-Hodgkin Lymphoma As Late-Breaking Abstract At Annual Meeting Of ASH
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bluebird bio (BLUE), Celgene (CELG)'s Multiple Myeloma CAR-T Drug Shines in Tiny Study
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More Bench To Clinic News
President-elect Trump's plans to reform the FDA haven't taken form yet, but it's certainly possible that there will be more emphasis on approving drugs quickly and doing more post-marketing studies. That probably wouldn't sit well with John Jenkins, longtime director of FDA's Office of New Drugs, who has just announced his retirement. Jenkins hasn't said there is any connection between his decision and looming reform plans, but he was a vocal critic of the recent decision to approve Sarepta's Exondys 51. Novartis, meanwhile, continues to send mixed signals about its CAR-T program. It expects to reach the market with its first product in 2017, yet has also shuttered the independent research unit this summer. While it's hard to say what's going on within the company, the former head of Novartis' Cell and Gene Therapy unit, Usman Azam, sees better opportunities elsewhere. He'll be leading immuno-oncology start-up Tmunity. -KT
So Long, Farewell: Head of Novartis' (NVS) Shuttered CAR-T Unit to Helm Biotech Upstart Tmunity
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FDA's New Drug Boss to Retire in January Ahead of Trump Reform Efforts
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Theranos Cleans House, Gets Rid of Some High-Profile Board Members
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Boehringer to Slash Another 180 Jobs Weeks Before the Holidays
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AstraZeneca (AZN) to Shift an Unknown Number of Jobs to Other Countries in Cost-Cutting Move
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More Career Track News
Spark Therapeutics has been on quite a run since early November, based on rebounding enthusiasm, following some safety concerns, for its hemophilia gene therapy. The concerns came as two patients developed autoimmune responses severe enough to require steroid treatment and that resulted in lower expression of Factor IX. Its latest deal with Selecta takes aim squarely at that issue: Spark believes Selecta's nanoparticle formulation could prevent the formation of neutralizing antibodies. That not only means potentially fewer autoimmune reactions, but also the potential for re-dosing in patients who don't get high enough expression from a single treatment. (The company may have to rethink its ticker symbol, however). -KT
Boston's Acetylon Gets Taken Out By Celgene (CELG), Will Spin Out Startup Regenacy Pharma
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Massachusetts' Selecta (SELB) Wrangles $890M+ R&D Deal Out of Spark Therapeutics (ONCE)
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As Rival Juno (JUNO) Falters, Kite Pharma (KITE) Touts New CAR-T Data and Maps Out BLA Submission Plans
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Valeant's (VRX) $10B Salix (SLXP) Deal With Takeda (TKPYY) Falls Apart
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More Golden Handshakes News

Top Jobs
• Genetown (Waltham, Massachusetts)

AstraZeneca
Chief Scientist, ImmunoOncology-GHP
An important component of this role will be developing and maintaining an interface between the AZ group and the biologics IO efforts at MedImmune

• Biotech Bay (Palo Alto, California)

BioInspire Technologies
VP, Manufacturing Operations
Responsibilities: Will Oversee the process development of a novel manufacturing process of a drug/device product from R&D stage to clinical and commercial production.

• Biotech Bay (South San Francisco, California)

Catalyst Biosciences
Director of Project Management
Will be responsible for ensuring that cross functional program activities are aligned and integrated. The role contributes to both the short term tactical and longer term strategic success of the company.

• LoneStarBio (Austin, Texas)

Molecular Templates
Director of Operations
Will direct and conduct efforts related to expression and purification of novel protein-based therapeutics with minimal supervision. Prior experience with protein expression, purification, and/or engineering is required.

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There have been lots of interesting start-ups formed in the past couple years, but TCR2 certainly has the advantage of timeliness: Its immuno-oncology platform is a next-generation approach to overcoming current problems with engineering T cells to attack cancers, particularly solid tumors. Cerevance is essentially a spin-off of Takeda's CNS operations. Axial Biotherapeutics is a new stab at the intriguing area of microbiome R&D. It is taking a unique spin, focusing on the role of gut microbes in brain development and CNS disorders, particularly autism and Parkinson's. -KT
Cambridge Biotech TCR2 Therapeutics Launches From Stealth Mode With $44.5M
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Google Ventures Ex-Boss Raising $230M to Start Healthcare Venture Capital Fund
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Cerevance Launches With $36M and 25 Former Takeda (TKPYY) Employees on Its Roster
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New Boston Biotech Axial Biotech Launches With $19.15M and Will be Helmed by AbbVie (ABBV)-GlaxoSmithKline (GSK) Vet
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Bayer (BAY), Versant Ventures Launch BlueRock Therapeutics With $225M to Focus on Stem Cell R&D
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More Money Talk News

There has been some overheated rhetoric about Trump's pick for HHS secretary, Rep. Tom Price (R-Ga.) trying to abolish Medicare. That's not going to happen. But for Obamacare, it doesn't look so good. What's less clear is how he'll view NIH's role in forwarding research; he is at least on record as having supported increased funding for nanotech R&D. For what it's worth, he's also staunchly anti-abortion, against marijuana legalization, against regulating tobacco as a drug, and—interestingly—against having Medicare part D directly negotiate on drug prices (at least back in 2007). -KT
Emails Reveal Theranos Never Saw it Coming, Predicted Revenue of Nearly $2B for 2016
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Read Trump's Lips: These Words Sent Biotech Stocks Reeling
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Trump Names Rep. Tom Price as Next HHS Secretary
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Pfizer (PFE) Fined a Record $107M for Ramping Up Epilepsy Drug Price by as Much as 2,600%
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Peter Thiel Touts Ally for Top Job at the FDA or a Role at HHS
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More Legal Briefs News
This year was never going to match the 45 novel drug approvals from 2015, but it has been a remarkable slowdown. FDA has green-lighted just 19XX new chemical entities this year. And quite a few of the drugs approved represent either small markets or follow-on products for existing categories. But if Kite and Novartis have their way, 2017 will see the first approval of an entirely new category of therapeutic. -KT
Kite Pharma (KITE) Initiates Rolling Submission Of U.S. BLA For KTE-C19, Its Investigational Anti-CD19 CAR-T Therapy, For The Treatment Of Patients With Relapsed/Refractory Aggressive B-Cell NHL
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Repros Therapeutics (RPRX) Release: FDA Advisory Committee Discusses Clinical Trial Designs for Obesity-Related Hypogonadism
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More Rockville Files News

Karl Thiel is an analyst for The Motley Fool and a longtime follower of the biotech industry. He lives in Austin, Texas.

You may contact Karl Thiel at news@biospace.com.

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