AmideBio Awarded SBIR Phase II Grant to Further Development of its Novel Glucagons for the Treatment of Hyperinsulinism

Monday, September 30, 2019

BOULDER, CO, September 30, 2019 – AmideBio, LLC, a privately held biopharmaceutical company, announced today that it has received $1.56M in funding through a Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The goal of this two-year grant is to enable an Investigational New Drug (IND) filing with the FDA of a clinical candidate for the long term treatment of congenital hyperinsulinism. Several promising glucagon analogs were identified during the Phase 1 SBIR, and the Phase II grant will enable the final selection of a clinical candidate and preparation of an IND.

Congenital hyperinsulinism is a rare disease that affects newborns and results in persistent hypoglycemia which can lead to serious neurological complications inluding seizures and brain damage. Dr. Diva D. De León-Crutchlow, MD, MSCE, Chief of the Division of Endocrinology and Diabetes and Director of the Congenital Hyperinsulinism Center at Children's Hospital of Philadelphia (CHOP) will serve as a co-principal investigator on the grant. She is a recognized leader in the treatment of hyperinsulinism and in her role of co-PI, will provide the in vivo preclinical testing necessary for the program to progress to an IND stage.

“We are honored to receive this Phase II SBIR grant from the NIH. It is an acknowledgement of the success of our development under the Phase I SBIR and will allow us to complete our preclinical testing and produce sufficient therapeutic material to move forward with an IND,” said Pawel Fludzinski, CEO and President of AmideBio. “We are delighted to be able to continue to collaborate with Dr. Diva D. De LeónCrutchlow at CHOP who is a world leader in the treatment of CHI and brings significant expertise in the evaluation of potential drug candidates for this tragic disease.”

A solution-stable glucagon may also have potential benefits in the treatment of emergency hypoglycemia, for patients suffering from hypoglycemia after bariatric surgery and in an artificial pancreas for Type 1 and Type 2 diabetes treatment.

About AmideBio:
AmideBio has a pipeline of novel biotherapeutics generated by leveraging its knowhow to drive intelligent design of drug candidates targeting metabolic diseases. Its proprietary Cap-Clip™ technology delivers high-purity and difficult-to-manufacture BioPure™ peptides of any length with unprecedented purity for the pharmaceutical and biotech industry.

Dr. Pawel Fludzinski
CEO & President
T: (505) 469-8466
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Weekly Policy Update: CBSA Submits Comment Letter to CMS Advocating for Patient Access to Timely Precision Diagnostic Information

Friday, September 27, 2019

In July the Centers for Medicare and Medicaid Services (CMS) issued the CY 2020 Hospital Outpatient Prospective Payment System (HOPPS) Proposed Rule, which included concerning proposed revisions to the current Laboratory Date of Service (DOS) policy. After engaging our members about the potential impact of these changes, CBSA submitted a comment letter to CMS this week expressing that if finalized, the proposed revisions would significantly limit patient access to clinically important diagnostic testing information.  

GREFFEX, Inc. Awarded $18.7 Million Contract with NIH to Develop a Plug-and-Play Technology Platform to Expedite Production of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Friday, September 27, 2019

GREFFEX, Inc. (Aurora, CO), a Fitzsimons Innovation Community company, is a transformative leader in genetic engineering. The company was recently awarded an $18.7 million contract with the National Institute of Health's (NIH) National Institute for Allergy and Infectious Diseases to develop and exploit its GreVac vaccine platform and expedite the production of vaccine candidates for biodefense and emerging infectious diseases. Through the support of the NIH contract, GREFFEX expects to advance the development of two of its influenza vaccines through clinical trials.

Weekly Policy Update: House Speaker Nancy Pelosi Releases Proposal on Prescription Drug Pricing

Monday, September 23, 2019

On September 19, House Speaker Nancy Pelosi released a long-anticipated proposal intended to reduce prescription drug prices. H.R. 3, the Lower Drug Costs Now Act of 2019, includes the following provisions:

  • Allows Medicare to negotiate prescription drug prices for 25 – 250 brand-named drugs per year. The price cap negotiated by Medicare would be no more than 1.2 times the volume-weighted average price of six other countries and would also apply to the commercial insurance market. If a manufacturer refuses to negotiate with Medicare or leaves the negotiation before agreeing to a “maximum fair price,” they will be assessed an escalating excise tax levied on their annual gross sales – starting at 65% and increasing by 10% every quarter the manufacturer is out of compliance, until they reach 95%.
  • Imposes an inflation rebate on all drugs in Medicare Part B and Part D. This means if a manufacturer raises the price of a drug above the rate of inflation since 2016, they can either lower the price or pay the entire price over inflation in the form of a rebate back to the U.S. Treasury.
  • Creates a cap on the costs for prescription drugs for Medicare Part D beneficiaries by setting an annual out-of-pocket limit of $2,000.
  • Restructures the liability in the coverage phases of Medicare Part D. Manufacturers would be required to pay 10% of the cost in the initial coverage phase and 30% of the costs in the catastrophic coverage phase.

Over the past few months, CBSA has expressed opposition to a number of these provisions that we’ve seen included in other legislative proposals, including allowing government negotiation in Medicare and imposing inflation rebates in Medicare Part B and D. Such proposals would destabilize the market- based system that determines the value of medicines and deter investment in life sciences innovation.

We will continue coordinate with members and industry partners to voice our strong concerns about these proposals and educate lawmakers about how these policies will limit patient access and stifle medical innovation.

A legislative hearing on the bill is set for Wednesday, September 25 in the House Energy and Commerce Committee’s Subcommittee on Health. More information can be found here.

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Boulder Based Edgewise Therapeutics Closes $50 Million Series B Financing

Tuesday, September 17, 2019


Weekly Policy Update: Zimmer Biomet Spine Hosts Congressman Ed Perlmutter at Westminster Facility

Friday, September 13, 2019

At the end of August, Congressman Ed Perlmutter (CO-07) visited Zimmer Biomet Spine in Westminster to tour the medical education training facilities, biomechanics labs, and manufacturing area. Following the tour, the Congressman joined Zimmer Biomet staff for a discussion about products and markets, legislative priorities, and other issues of common interest.

Denver Business Journal Highlights Colorado’s Life Sciences Ecosystem and Our Leadership In Gene Editing

Monday, September 09, 2019

Gene editing is becoming an increasingly common remedy for a variety of ailments, and Boulder area bioscience companies are leading those advancements. Building on research and technology originating at University of Colorado Boulder, several front range companies are employing CRISPR to create new breakthroughs.  

Nymbl Science Releases Their August Update

Monday, September 09, 2019

Below please find an overview of our progress for the month of August:

  • We continue to move forward towards closing out our round. We have about $235k remaining with 4 angel pitches lined up in the next two weeks.
  • We are excited to announce 3 new senior living customers and 2 successful implementations where greater than 25% of residents are actively participating.
  • We remain on track for 3 Medicare Advantage plan launches on January 1.
  • We have seen a doubling of the average number of weekly users across our Senior Living accounts. One new account has 61 weekly participants.

Two asks this time, both focused on sales talent:

  • Introductions to any sales people who have enterprise/mid-market SaaS experience and would be interested in working with Nymbl, either on a short term contract basis or as a full-time hire.
  • Introductions to anyone willing to advise us on enterprise SaaS sales.
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SomaLogic launches its first SomaSignal™ tests in select medical practices

Wednesday, September 04, 2019

Novel tests based on large-scale protein measurements will first offer personal and precise information about an individual’s cardiometabolic health status and trajectory  

2019 Rocky Mountain Life Science Investor and Partnering Conference Opens in Vail

Wednesday, September 04, 2019

Colorado BioScience Association connects health innovators to investors during biennial event