iBIO https://ibio.org To promote, connect and engage the life sciences community Wed, 04 Dec 2019 13:07:47 -0600 en-US hourly 1 https://ibio.org/wp-content/uploads/cropped-android-chrome-512x512-32x32.png iBIO https://ibio.org 32 32 CLP Spinout Rounds Third Base with New Treatment for Metastatic Cancers and Fibrosis https://ibio.org/clp-spinout-rounds-third-base-with-new-treatment-for-metastatic-cancers-and-fibrosis/ https://ibio.org/clp-spinout-rounds-third-base-with-new-treatment-for-metastatic-cancers-and-fibrosis/#respond Wed, 04 Dec 2019 13:07:47 +0000 https://ibio.org/?p=4632 Veteran entrepreneurs and cofounders of Actuate Therapeutics, Inc., Daniel Schmitt and Andrew Mazar, PhD, are taking no chances with their lead clinical candidate 9-ING-41, a promising new treatment for advanced and drug-resistant cancers and select inflammatory diseases.

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Today is #GivingTuesday: Send a Girl to STEMgirls CAMP https://ibio.org/today-is-givingtuesday-send-a-girl-to-stemgirls-camp/ https://ibio.org/today-is-givingtuesday-send-a-girl-to-stemgirls-camp/#respond Tue, 03 Dec 2019 12:35:12 +0000 https://ibio.org/?p=4627

This Giving Tuesday please commit to helping girls grades 3-8 discover and embrace their interests, self-confidence and skills in STEM by purchasing our t-shirts.

Every t-shirt we sell helps a girl from an underserved Illinois community attend our STEMgirls Camp (25 shirts = 1 camper), which empowers girls to explore STEM through fun, hands-on STEM and STEAM-centered activities.

Since 2011 our programming has helped over 2,100 girls develop a belief in their own abilities and make connections between the hands-on explorations and future careers in the STEM field. 

There is only a limited time to purchase. This campaign ends the day after Giving Tuesday on December 4, 2019!

Help us send a girl to camp and share online why its important for you that #ThisShirt inspires a future scientist.

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#ThisShirt Sends a Girl to STEMgirls CAMP https://ibio.org/thisshirt-sends-a-girl-to-stemgirls-camp/ https://ibio.org/thisshirt-sends-a-girl-to-stemgirls-camp/#respond Mon, 18 Nov 2019 15:17:57 +0000 https://ibio.org/?p=4588

This Giving Tuesday please commit to helping girls grades 3-8 discover and embrace their interests, self-confidence and skills in STEM by purchasing our t-shirts.

Every t-shirt we sell helps a girl from an underserved Illinois community attend our STEMgirls Camp (25 shirts = 1 camper), which empowers girls to explore STEM through fun, hands-on STEM and STEAM-centered activities.

Since 2011 our programming has helped over 2,100 girls develop a belief in their own abilities and make connections between the hands-on explorations and future careers in the STEM field. 

There is only a limited time to purchase. This campaign ends the day after Giving Tuesday on December 4, 2019!

Help us send a girl to camp and share online why its important for you that #ThisShirt inspires a future scientist.

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Endotronix Announces Positive Data from the SIRONA First-in-Human Trial for the Cordella™ PA Pressure Sensor System https://ibio.org/endotronix-announces-positive-data-from-the-sirona-first-in-human-trial-for-the-cordella-pa-pressure-sensor-system/ https://ibio.org/endotronix-announces-positive-data-from-the-sirona-first-in-human-trial-for-the-cordella-pa-pressure-sensor-system/#respond Mon, 18 Nov 2019 13:58:13 +0000 https://ibio.org/?p=4611 Endotronix, a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), presented positive first-in-human data of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor). Data was presented at the 2019 American Heart Association (AHA) Scientific Sessions in Philadelphia, PA by Prof. Dr. Wilfried Mullens of the Hospital Oost-Limburg in Genk, Belgium.

“Chronic heart failure patients too frequently have cycles of decompensation and hospitalization that negatively impact patient outcomes and drive up treatment costs. Recent data shows that using PA pressure-guided therapy with this population keeps them healthier and out of the hospital,” stated Prof. Dr. Mullens. “The Cordella System is an elegant solution that integrates a PA pressure sensor and a comprehensive patient management platform in one. The straightforward sensor implant provides reliable pressure data, while the patient management platform enables a comprehensive clinical picture of the patient that allows my team to make informed therapy decisions and improve outcomes.”

The 90-day results from the first-in-human trial confirm the device safety and accuracy of pressure measurements in the right pulmonary artery using the implanted Cordella Sensor and handheld patient reader. The study included 15 patients across two European sites: Prof. Dr. Mullens in Belgium and Dr. Faisal Sharif of the National University of Ireland(NUI) in Galway, Ireland.

Highlights include:

  • The primary accuracy endpoint was met with no significant difference in measured mean PA pressure for the Cordella Sensor and the reference catheter at 90 days.
  • The study demonstrated encouraging safety results with zero Device Related System Complications (DSRC) at 90 days.
  • High patient compliance (>98%) with daily remote measurements of vital signs and PA pressure throughout the study.

“The presentation of our first-in-human data at AHA this year is another exciting milestone for the company,” commented Dr. Katrin Leadley, Chief Medical Officer of Endotronix. “This work lays the clinical foundation for our groundbreaking IDE trial, PROACTIVE-HF, which will begin enrollment in the U.S. later this year. Designed to provide the highest level of clinical evidence for PA pressure-guided therapy, PROACTIVE-HF will support U.S. market access of the Cordella Sensor and inform a national coverage decision from the Centers for Medicare & Medicaid Services (CMS).”

The Cordella Sensor is not available for commercial use in any geography and is under clinical investigation in Europe(SIRONA II CE Mark Trial) and the U.S. (PROACTIVE-HF IDE Trial). CAUTION – Investigational Device. Limited by Federal (or United States) Law to Investigational Use. Exclusively for clinical investigations. The Cordella System, without the sensor, is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S.

About the Cordella™ Heart Failure System
The Cordella Heart Failure System (Cordella System) is designed to help patients suffering from chronic heart failure feel better and stay out of the hospital with streamlined care and remote medication titration. The system provides a comprehensive health status of the patient at home with easy-to-use tools to securely collect and share health related data with healthcare providers for trend-based management. The Cordella Sensor seamlessly integrates pulmonary artery (PA) pressure data into the Cordella System. Together, they proactively deliver the information necessary to improve patient care between office visits and support reimbursement for care delivery activities.

About Endotronix
Endotronix, Inc., is a medical technology company focused on advancing the treatment of chronic heart failure. Privately held, the company is backed by world-class medtech investors including Aperture Venture Partners, BioVentures Investors, LSP, Lumira Ventures, OSF Ventures, Seroba Life Sciences, Skydeck LLC, SV Health Investors, Wanxiang Healthcare Investments, and two unnamed corporate strategic investors. Learn more at www.endotronix.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

MEDIA CONTACTS:
Carla Benigni
SPRIG Consulting LLC (847) 951-7430
Carla@sprigconsulting.com

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Actuate Therapeutics Inc. Completes $6.5 Million Series B-3 Financing https://ibio.org/actuate-therapeutics-inc-completes-6-5-million-series-b-3-financing/ https://ibio.org/actuate-therapeutics-inc-completes-6-5-million-series-b-3-financing/#respond Fri, 15 Nov 2019 19:14:57 +0000 https://ibio.org/?p=4609 Actuate Therapeutics, Inc. has raised an additional $6.5M in a Series B-3 financing round led by Bios Partners with Kairos Ventures, DEFTA Partners, and other existing investors participating. This Series B-3 brings total funding for Actuate’s Series B round to over $28.2M.

Actuate is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutic agents for patients with cancer or inflammatory diseases. Actuate will use the proceeds of the financing to initiate a Phase 2 clinical trial in myelofibrosis and expand the company’s ongoing 1801 clinical trial to include an arm for treating patients with a combination of 9-ING-41 with irinotecan.

“Myelofibrosis is a therapeutically challenging myeloproliferative neoplasm where we need novel approaches and where recent findings support the potential clinical benefits of anti-fibrotic therapy. 9-ING-41 has demonstrated significant activity in reversing pathologic fibrosis with attendant restoration of normal function in pre-clinical models of fibrotic diseases. In addition, 9-ING-41 has significant anti-neoplastic activity and is without clinically significant adverse events to date,” said Dr. Frank Giles, Actuate’s Chief Medical Officer. “The absence of myelosuppression with 9-ING-41 is particularly important for patients with advanced myelofibrosis for whom we are initiating the international Phase 2 study of 9-ING-41 as a single agent and in combination with ruxolitinib, the current standard of care for treatment of myelofibrosis.”

The 1801 clinical trial was designed as a histology agnostic study with seamless extension from the investigation of single agent therapy to that of six different 9-ING-41-based combinations with standard-of-care chemotherapeutics. The initial combinations were prioritized based on evidence of reversal of resistance to key cytotoxic agents in diverse pre-clinical models. The design has proven to be efficient and highly productive, with over 70 patients enrolled since the start of the study in January.

“Key data from the 1801 study on the pharmacokinetics of, tolerability of, and clinical responses to 9-ING-41 have been very rapidly developed in the context of vigorous accrual by our investigators,” said Dr. Ludimila Cavalcante, Actuate’s Lead, Medical Affairs. “Adding irinotecan as a partner agent to 9-ING-41 will significantly expand the options we can offer patients being treated on the 1801 study, particularly those with advanced gastrointestinal cancers. Data on adults receiving 9-ING-41 combined with irinotecan will also inform the optimal design of our planned studies in children and adolescents with neuroblastoma.”

“We are very pleased with the progress we are making in the clinic with the 1801 study, and the promise of the myelofibrosis and neuroblastoma trials which we expect to initiate early in 2020,” said Daniel Schmitt, President and CEO of Actuate. “We are also pleased with the ongoing support of our investors in the Series B financing, which allows us to continue this important and promising work.”

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Exicure and Allergan Enter Into Collaboration, Option and License Agreement to Discover and Develop SNA-based Treatments for Hair Loss Disorders https://ibio.org/exicure-and-allergan-enter-into-collaboration-option-and-license-agreement-to-discover-and-develop-sna-based-treatments-for-hair-loss-disorders/ https://ibio.org/exicure-and-allergan-enter-into-collaboration-option-and-license-agreement-to-discover-and-develop-sna-based-treatments-for-hair-loss-disorders/#respond Fri, 15 Nov 2019 19:13:20 +0000 https://ibio.org/?p=4607 Exicure to Receive $25 Million Upfront Payment and Up to $725 Million in potential Milestones

CHICAGO & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Exicure, Inc., (NASDAQ:XCUR) a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) technology, today announced that Allergan’s wholly-owned subsidiary, Allergan Pharmaceuticals International Limited, and Exicure, Inc. have entered into a global collaboration agreement to discover and develop novel treatments for hair loss disorders based on Exicure’s proprietary SNA technology.

Under the terms of the agreement, Allergan will receive exclusive access and options to license SNA-based therapeutics arising from two collaboration programs related to the treatment of hair loss disorders. Exicure will receive an upfront payment of $25 million and will conduct discovery and development in two collaboration programs for hair loss disorders. In the event that Allergan exercises an option, Allergan will be responsible for clinical development and commercialization of the licensed products. Exicure will be eligible to receive development and regulatory milestones of up to $97.5 million per program and commercial milestones of up to $265 million per program. Exicure will also be eligible to receive tiered royalties on worldwide net product sales of mid-single digit to mid-teens percentages on worldwide net product sales.

“We are excited to combine our knowledge of nucleic acid therapeutics with Allergan’s deep expertise in medical aesthetics to develop and commercialize innovative treatments for hair loss disorders.” said Dr. David Giljohann, chief executive officer of Exicure. “This collaboration is an exciting opportunity to advance Exicure’s SNA technology in an important new therapeutic area.”

Additional Details about the Collaboration and Hair Loss Program

One of the most common hair loss disorders and a subject of the collaboration is androgenetic alopecia also known as pattern baldness, affecting approximately 50 million men and 30 million women in the United States. It is estimated that over $3.5 billion a year is spent on treatments, the majority of which are ineffective.

Conference Call Today at 8:30am ET/7:30am CT

Exicure will hold a conference call at 8:30am ET to provide a corporate update and to discuss the strategic collaboration announced today. A live audio only webcast of the conference call can be accessed in the Investors section of the company’s website at www.exicuretx.com. To participate in the conference call, please dial 866-997-1948 or 270-215-9856 five minutes prior to start time. The conference ID is 9849047. An archived version of the webcast will be available on Exicure’s website for 30 days.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.

With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan’s website at www.Allergan.com.

About Exicure

Exicure, Inc. is a clinical-stage biotechnology company developing therapeutics for immuno-oncology, inflammatory diseases and genetic disorders based on our proprietary Spherical Nucleic Acid, or SNA technology. Exicure believes that its proprietary SNA architecture has distinct chemical and biological properties that may provide advantages over other nucleic acid therapeutics and may have therapeutic potential to target diseases not typically addressed with other nucleic acid therapeutics. Exicure’s lead program is in a Phase 1b/2 trial in patients with advanced solid tumors. Exicure is based outside of Chicago, IL and in Cambridge, MA.

For more information, visit Exicure’s website at www.exicuretx.com.

Exicure Forward-Looking Statements

This press release contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning the Company, the Company’s technology, potential therapies, cash requirements and other matters. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “look forward,” and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: unexpected costs, charges or expenses that reduce cash runway; that Exicure’s pre-clinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the cost, timing and results of clinical trials; that many drug candidates that have completed Phase 1 trials do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; regulatory developments; and the ability of Exicure to protect its intellectual property rights. Risks facing the Company and its programs are set forth in the Company’s filings with the SEC. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement (including without limitation its cash runway guidance) or to make any other forward-looking statements, whether as a result of new information, future events or otherwise

 

Investors:
Stern Investor Relations
Kerry Conlin
212-362-1200
kerry.conlin@sternir.com

Media:
MacDougall
Karen Sharma
781-235-3060
ksharma@macbiocom.com

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MedTech Innovator Now Accepting Applications for 2020 Program https://ibio.org/medtech-innovator-now-accepting-applications-for-2020-program/ https://ibio.org/medtech-innovator-now-accepting-applications-for-2020-program/#respond Fri, 15 Nov 2019 19:04:58 +0000 https://ibio.org/?p=4602 Applications are now being accepted for MedTech Innovator 2020. This is a unique opportunity for start-ups and emerging growth medical technology companies to gain access to industry stakeholders such as Baxter, BTG, HOYA, Maxim Ventures, Johnson & Johnson, Olympus, NIPRO, W.L. Gore and RCT Ventures.

The top 50 start-ups selected each receive complimentary registration and are featured in the MedTech Innovator Showcase at The MedTech Conference, taking place October 5-7, 2020 in Toronto. MedTech Innovator will award up to $500,000 in non-dilutive cash prizes and in-kind awards during the 2020 competition.

The grand prize winner will be announced during the MedTech Innovator Finals at The MedTech Conference. The final deadline for applications is Jan. 17, 2020. Early entry is recommended for priority reviews.

Apply Now

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Illinois Needs to Protect Patient’s Access to Sterilized Medical Equipment https://ibio.org/illinois-needs-to-protect-patients-access-to-sterilized-medical-equipment/ https://ibio.org/illinois-needs-to-protect-patients-access-to-sterilized-medical-equipment/#respond Wed, 13 Nov 2019 13:29:43 +0000 https://ibio.org/?p=4586 On November 1, 2019 Crain’s Chicago Business published an op-ed “It’s time for Illinois to protect residents from this cancer-causing agent” by Nancy C. Loeb.

Ms. Loeb’s misleading op-ed included a number of  misstatements on the use of Ethylene Oxide (EO) for medical device sterilization that need to be corrected.

In her op-ed, Ms. Loeb states “there are several other methods for sterilizing medical equipment”, and provides a link to a FDA Sterilization Guidance document. But this claim and the link to the FDA is misleading. The FDA clearly addresses the possibility of alternative sterilization methods in an October 25th statement from FDA Acting Commissioner Norman Sharpless:

“It’s important to note at this time there are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices. In short: this method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices.”

In addition, the concern about trace ethylene oxide from these plants is misguided and unsupported by science. EO sterilization plants go above and beyond federal law, using the best available technology to destroy and abate EO emissions. Toxicologists confirm that the air around these plants poses no threat to public health whatsoever.

This summer Governor Pritzker signed into law the most restrictive limits on Ethylene Oxide emissions, requiring companies to install the most advanced pollution control equipment available.

Despite passing this legislation, Illinois lawmakers are considering additional legislation (HB 3888 and SB 0557) that could effectively close the remaining EO sterilization facilities in Metro-Chicago which may quickly lead to real harm for Illinois patients and patients throughout the Midwest.

The FDA’s October 25th statement alerts the public and policy makers about the FDA’s growing concerns about the future availability of sterile medical devices and impending medal devise shortages related to the closure of facilities in Illinois and Georgia.

Without adequate availability of EO sterilization facilities, the FDA anticipates national shortages of surgical kits used in emergency and routine procedures along with other critical devices including feeding tubes used in neonatal intensive care units, drug-elating cardiac stents, catheters, shunts and other implantable devices. This statement and the potential impact of passing legislation that could close these facilities was not included in Ms. Loeb’s op-ed.

Illinois already passed legislation this year to address emissions from EO sterilization facilities and the chemical is fundamentally safe at very low levels of exposure which occur every day from a variety of other sources.

Additional legislation is not needed, and it could pose a real threat to Hospitals and patients in Illinois.

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Headed to #JPM20? iBIO Members get free access to BIO’s 1X1 Partnering System and Discounted Meeting Space https://ibio.org/headed-to-jpm20-ibio-members-get-free-access-to-bios-1x1-partnering-system-and-discounted-meeting-space/ https://ibio.org/headed-to-jpm20-ibio-members-get-free-access-to-bios-1x1-partnering-system-and-discounted-meeting-space/#respond Tue, 12 Nov 2019 14:53:06 +0000 https://ibio.org/?p=4583 Real estate in San Francisco is expensive, and its next to impossible January 13th – 16th during the JP Morgan Healthcare Conference.

iBIO Members can connect with companies, investors, in-licensors and others using BIO’s partnering system, which is available to you regardless of whether you are attending any particular conference during JPM week. IBIO Members can schedule meetings in your own meeting space or in public space for free. You can also schedule meetings in BIO’s prime meeting space at the San Francisco Marriott Marquis (4th & Mission) at competitive rates using BIO’s partnering system.

CLICK HERE TO PARTICIPATE

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Cyclopure Named to C&EN’s 10 Start-UPS to Watch https://ibio.org/cyclopure-named-to-cens-10-start-ups-to-watch/ https://ibio.org/cyclopure-named-to-cens-10-start-ups-to-watch/#respond Mon, 11 Nov 2019 13:07:20 +0000 https://ibio.org/?p=4579 Cyclopure based out of the Illinois Science + Technology Park in Skokie, Illinois was named in C&EN’s annual list of startups to watch.

CycloPure is a materials science company and a leader in water purification technologies.  The company’s line of DEXSORB adsorbents are based on breakthrough technology that converts renewable, corn-based cyclodextrins into highly adsorbent materials engineered to safely strip away hundreds of micropollutants, including perfluorinated compounds (PFOA and PFOS), pesticides, and pharmaceutical compounds from drinking water.

In September Cyclopure announced a $1 million SBIR Phase II grant.

Click here to read C&EN’s 10 Star-ups to Watch

 

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