Archive for the ‘SBIR and Funding’ Category

Apexian Pharmaceuticals is Closing a Series A Round to Initiate Phase 1 Trial

December 4, 2017

Apexian Logo Font

FOR IMMEDIATE RELEASE

Indianapolis, IN – November 29, 2017 – Apexian Pharmaceuticals, an Indiana-based clinical stage biotechnology company developing novel compounds to treat cancer, announced today that they are closing their Series A round. This financing follows previous investments as well as numerous grants and awards by the company since its founding. Proceeds will be used to initiate their phase 1 clinical study for APX3330 a novel first in class oral treatment for patients with cancer.

 

APX3330, the lead molecule for Apexian has a unique dual biological role targeting the APE1/Ref-1 protein.  The APE1 protein is a critical molecular “switch” controlling the activity of cancer regulatory proteins, including transcription factors HIF-1-alpha, STAT3, NF-kappa B, and AP-1. The Investigational New Drug application was issued based on robust non-clinical data and a safety database of over 422 patients in non-cancer studies. In addition, the data identified APE1/Ref-1 protein also plays a critical role in the repair of neuronal DNA that has been damaged through oxidative mechanisms which are common with platinum-containing chemotherapy agents. Apexian has developed robust non-clinical data demonstrating APX3330 prevents and/or reverses such damage and is the basis for pursuing an indication for Chemotherapy Induced Peripheral Neuropathy (CIPN).

 

Elevate Ventures, a venture development organization based in Indiana, committed funding through their Indiana 21st Century Research & Technology Fund, a direct investment vehicle overseen by the Indiana Economic Development Corporation positioned to support early-stage high-growth companies. “Apexian Pharmaceuticals has an impressive body of preclinical work in an exciting new target to treat cancer,” said Elevate Ventures Chief Executive Officer Chris LaMothe. “We look forward to joining other sophisticated investors to see this molecule tested in the clinical setting.”

 

Apexian Pharmaceuticals President and Chief Executive Officer Steve Carchedi commented: “We are very pleased to have an Indiana group, like Elevate Ventures join with others to enable this key data to be generated for our lead molecule. Developing a first-in-class oral molecule to treat pancreatic, colon and other difficult to treat cancers, is at the core of our mission. Cancer patients are truly waiting for novel treatments to attack these deadly diseases.”

 

About Elevate Ventures
Elevate Ventures nurtures and develops emerging and existing high-potential businesses into high-performing, Indiana-based companies. Elevate Ventures accomplishes this by providing access to capital, rigorous business analysis and robust advisory services that connect companies with the right mix of resources businesses need to succeed long-term. To learn more about its team and funds under management, visit www.elevateventures.com.

 

About Apexian Pharmaceuticals

Apexian Pharmaceuticals is a clinical-stage biotechnology company focused on developing safe and effective therapy for patients with high unmet medical needs. Apexian’s lead drug candidate APX3330, is an oral first in class novel inhibitor of the APE1 protein, a critical node in cancer cell signaling. To learn more about Apexian Pharmaceuticals, please visit the company’s website at www.ApexianPharma.com

 

Media Contact:

Email: PR@Apexianpharma.com

Telephone: 844-463-3330 x113

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VisionTech Partners, Pearl Pathways Form Alliance to Fuel Growth in Indiana’s Life Sciences Startup Community

September 27, 2017

For Immediate Release

INDIANAPOLIS, Indiana (August 30, 2017) – – VisionTech Partners, the parent of Indiana’s most active angel investing group, and Pearl Pathways, a provider of life sciences product development services, have joined forces to fuel Indiana’s life sciences startup community, which includes biopharmaceutical, medical device and diagnostics technology.

 

The VisionTech Partners-Pearl Pathways alliance will focus on three essential goals. First, identify the most promising early stage/early growth companies for potential investment by VisionTech’s statewide network of angel investors. Second, connect entrepreneurs with individuals who have already achieved success in the life sciences and are willing to serve as mentors and business advisors. And finally, provide entrepreneurs with access to the highly specialized services required to negotiate the FDA approval process.

 

VisionTech Partners Executive Director Ben Pidgeon said both companies are eager to leverage their respective strengths through the alliance, which will formally launch Thursday, August 31, at VisionTech Angels’ “Pitch Night” in Indianapolis, featuring two life sciences startups.

 

“VisionTech Partners is extremely committed to growing Indiana’s life sciences industry and we’ve proven ourselves to be a valuable contributor to this effort as a source of financial and human capital. Of the 24 portfolio companies our angel network has invested in, 10 are in the life sciences and healthcare space; it’s definitely a sweet spot,” said Pidgeon.

 

“The alliance with Pearl Pathways will not only ensure a high quality deal flow, it will also help us make better investment decisions. Most of these companies must secure FDA approval in order to commercialize their drug, device or diagnostic tool. Pearl Pathways will, in effect, be VisionTech Partners’ resident expert on all things FDA,” he added.

 

Based in Indianapolis, Pearl Pathways is a life science product development services company that provides clinical research, regulatory, quality compliance, and independent review board services to life sciences companies. Among Pearl Pathways’ clientele are five of the top 20 medical device companies and six of the top 11 pharmaceutical companies in the world.

 

The balance of their business, said President and CEO Diana Caldwell, is startup companies with pre-commercialization technology that need access to early stage or “seed” funding provided by groups like VisionTech Partners.

 

“VisionTech Partners is unique in the angel investing space. Yes, they are a source of capital, but more importantly, they have deep experience and success in the life sciences industry. They also have a chapter composed entirely of physicians. These are the people who are around medical technology on a daily basis and have knowledge and insight few investors have. Partnering with VisionTech will not only open doors for our clients, startup companies across Indiana will benefit from the combined talents and resources of our two companies,” Caldwell said.

 

About VisionTech Partners I VisionTech Angels

Founded in 2008, VisionTech Partners is a privately held company focused on linking investors to high-potential early-stage companies. Headquartered in Indianapolis, among the nation’s most vibrant innovation regions, VisionTech is where inventors, entrepreneurs, investors, universities, and strategic partners convene to share, fund, and launch novel technologies. VisionTech Angels has chapters in Bloomington, Fort Wayne, Indianapolis, Lafayette, and an Affinity chapter, AngelBom.

 

About Pearl Pathways.

Founded in 2010, Pearl Pathways is a comprehensive life science product development consulting services company with expertise in regulatory, quality compliance, and clinical trial services including an AAHRPP accredited commercial IRB, Pearl IRB. Pearl Pathways works with clients’ clinical teams, in-house regulatory experts, the quality compliance specialists, quality auditors, and the senior leadership team to get life saving diagnostics and therapeutics on the market sooner.

Contact: Melanie Lux, mlux@luxandassociates.com, 803.331.4794

Contact: Waylon Wright, wwright@pearlpathways.com, 317.602.5479

National Cancer Institute selects Apexian Pharmaceuticals to participate in the Small Business Innovation Research (SBIR) Initiative program

September 26, 2017

 Apexian Logo Font

FOR IMMEDIATE RELEASE

 

National Cancer Institute selects Apexian Pharmaceuticals to participate in the Small Business Innovation Research (SBIR) Initiative program

 

Indianapolis, IN – September 25, 2017 –Apexian Pharmaceuticals is pleased to announce that the National Cancer Institute (NCI) has selected the company to participate in its highly competitive Small Business Innovation Research (SBIR) Investor Initiatives program, that encourages domestic small businesses to engage in Research and Development (R&D) that has the potential for commercialization. Through a competitive awards-based program, SBIR enables small businesses to explore their technological potential and provides the incentive to profit from its commercialization. As part of this program, Apexian Pharmaceuticals was selected to present at the BioNetwork Partnering Summit, being held in Laguna Niguel, California on October 23-25 2017. This work was supported by NCI SBIR grant 11196090.  Apexian’s Chief Medical Officer, Dr. Rich Messmann, will be speaking about the development of the company’s lead molecule APX3330, and its effect upon APE1/Ref 1, a dual function protein that is a critical signaling node in cancer cells that also facilitates repair of oxidative damage to DNA.

 

In extensive preclinical testing, much of it conducted by Dr. Mark Kelley, Apexian’s Chief Scientific Officer, and Associate Director of Basic Science Research at the Indiana University Simon Cancer Center, and as summarized in a recent Nature Precision Oncology article (Shah et al. 2017 npj Precision Oncology), APX3330 provided robust anti-cancer effect by inhibiting the activation of cancer regulatory proteins, including transcription factors HIF-1-alpha, AP-1, NF-kappa B, and STAT3, as well as an ability to prevent and reverse the oxidative damage -called chemotherapy induced peripheral neuropathy or CIPN- caused by platinum-containing chemotherapy agents such as oxaliplatin and cisplatin.  The U.S. Food and Drug Administration has issued an Investigational New Drug license to Apexian to commence human testing of APX3330 and accrual into the initial study will begin in the near future. Details of the trial, including contact information on participating centers, will be found at www.clinicaltrials.gov.

 

Steve Carchedi, President and Chief Executive Officer of Apexian Pharmaceuticals, commented:  “We are very honored by the NCI’s decision and excited to tell the Apexian story at the BioNetwork event. Cancer patients need additional safe and effective therapy, and the prospect that APX3330 not only provides anti-cancer effect, but may also prevent or reverse the debilitating effects of CIPN could fundamentally change the manner in which certain cancers are treated. We are looking forward to initiating our clinical study in an area with such high unmet need.”

 

About Apexian Pharmaceuticals

Apexian Pharmaceuticals is a clinical-stage biotechnology company focused on developing safe and effective therapy for patients with high unmet medical needs.  Apexian’s lead drug candidate is named APX3330. To learn more about Apexian Pharmaceuticals, please visit the company’s website at http://www.ApexianPharma.com

 

Media Contact:

Email: PR@Apexianpharma.com

Telephone: 844-463-3330 x113

New ShareVault White Paper: What’s the role of Non-Immuno Oncology in an Immuno Oncology World?

August 10, 2017

“New ShareVault White Paper:  ” What’s the role of Non-Immuno Oncology in an Immuno Oncology World?”

This white paper discusses the role of non-immuno-oncology therapies for cancer in a world where immuno-oncology is playing a greater role.

 

The clinical success of checkpoint inhibitors has made Immuno-Oncology an amazingly “hot” area for pharmaceutical and biotech deal making.  With checkpoint antibodies seen as backbones for combination therapy in cancer, many in Oncology are asking:

• What is the role of non-IO in an IO world and can you partner a non-IO opportunity?

• Is there still room for new anticancer agents that are not working in IO models?

• Are drug candidates evaluated with the assumption that everything will eventually be used in combination with IO agents?  Or are there indications or mechanisms for which IO will never be important?  Should I pursue combinations with IO?

• What kinds of mechanisms are attractive in non-IO?  What data and models will big pharma want to see?   Do I need to run experiments with their molecule?  Are there certain tumor types that are particularly attractive?

• Is it too late to try to compete in the crowded space of combination with PD1 antibodies?  What other IO agents are likely to backbones of oncology franchises?

• What will make my non-IO drug candidate compelling for partners and investors?

Download the white paper at this link.

Pitch at INX3 – $100,000 prize

May 19, 2017

Pitch at INX3. The grand prize is $100,000 in cash and services.

INX3 is a five-day conference in Indianapolis that focuses on entrepreneurship, startups, and venture capital. You can find more here: http://www.inx3.org/

In order to pitch at INX3, you need to qualify at one of the regional pitch qualification events (Bloomington).   This event is being organized by Pat East (Hannapin Marketing), The City of Bloomington, and the BEDC.

Step 1: Apply via this form: https://hanapinmarketing.formstack.com/forms/bloomington_pitch_qualification_for_inx3

Step 2: Hannapin will schedule a 10-minute introduction phone call. The purpose is both informational and for screening purposes.

Step 3: Hannapin will email invited applicants the rubric the judges will use. These criteria are set by INX3 and will be the same criteria in other regional pitch qualifications.

Step 4: Invited startups will pitch in the Bloomington finals at the Dimension Mill on Thursday, June 8 at 5:30 pm. You’ll receive feedback and be notified that night whether you advance to INX3.

You can find more info on the conference here: http://www.inx3.org/ (do *not* apply via the form here, apply via https://hanapinmarketing.formstack.com/forms/bloomington_pitch_qualification_for_inx3 or by emailing me directly at pat.east@cofoundventures.com.)

FAST BioMedical Raises $8 Million as part of Series A2 Financing Round

May 3, 2017

Carmel, Indiana – May 3, 2017 – FAST BioMedical, Inc. today announced it has secured $8 million of additional financing.  $5 million comes from a Series A2 Financing led by one new investor, F&M Investment Office.  This financing augments $3 million of grant funding received as a competing renewal award from the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health.  The proceeds will primarily be used to advance clinical trials of the company’s technology as well as to hire additional talent and advance the company’s global patent portfolio.

“This financing is an important and validating step to continue our progress,” said Joe Muldoon, FAST BioMedical Chief Executive Officer.  “We have already begun adding talent to the team, and are excited about their ability to immediately add value”

“FAST BioMedical has enormous potential to serve large unmet medical needs with its innovative technology,” said Mr. McClure, President of F&M Investment Office.  “We are delighted to partner with them, and see great promise in the ability to favorably impact critical patient care. ”

About FAST BioMedical

FAST BioMedical is a private, clinical-stage medical technology company in Carmel, Indiana.  The company’s globally patented first-in-class technologies directly measure blood volume and kidney function in a clinically viable way.  This has the potential for profound impact on care of congestive heart failure, major surgery, sepsis, critical care, and kidney disease patients.   The company has been financially supported by the NIH, Elevate Ventures, the Indiana 21st Century Fund, Rose-Hulman Ventures, BioCrossroads, Indiana University Medical Group, The Purdue Foundry Fund, Ellipsis Ventures, StepStone Partners, and private family office investors. The FDA has determined the company’s technology met the requirements for an Expedited Review.

These products are investigational and not yet approved for human use.

For more information, please visit www.FASTBioMedical.com

Deadlines to Apply for NCATS Funding Opportunities are Coming Up September 6!

August 21, 2016

This is a reminder that the National Center for Advancing Translational Sciences (NCATS) has several open Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) program funding opportunities designed to help advance and commercialize translational research technologies. NCATS encourages applications in these four research areas of interest: drug discovery and development, diagnostics and devices, bioinformatics and information technology, and clinical research.

 

All opportunities below have an application deadline of Sept. 6, 2016, 5 p.m. local time.

 

2016 Omnibus Solicitation

Small businesses, research and technology transfer organizations are eligible to apply for the 2016 Omnibus Solicitation. Applications may address any stage of translation, from target validation through pre-clinical and clinical evaluation to intervention, implementation and dissemination. Review NCATS’ research priorities to determine its areas of interest.

Other Funding Opportunities

SBIR Direct Phase II

Small businesses that have accomplished the objectives of a Phase I SBIR grant through non-SBIR funds are able to apply for SBIR direct-to-Phase II funding. Applicants must demonstrate the scientific and technical merit and feasibility of the prototype stage of developing a biomedical technology that has commercial potential.

  • PAR-15-288: Direct Phase II SBIR Grants to Support Extended Development, Hardening, and Dissemination of Technologies in Biomedical Computing, Informatics, and Big Data Science
  • PAR-14-088: Direct Phase II SBIR Grants to Support Biomedical Technology Development

 

SBIR Technology Transfer

This funding opportunity encourages SBIR grant applications from small business concerns for projects to transfer technology out of the NIH intramural research labs into the private sector.

  • PA-15-354: SBIR Technology Transfer (R43/R44)

 

Platform Delivery Technologies for Nucleic Acid Therapeutics

This funding opportunity is designed to incentivize small businesses to generate new technologies and products for delivering nucleic acids into cells and tissues for the purpose of treatment or prevention of human disease.

  • PA-14-307: Platform Delivery Technologies for Nucleic Acid Therapeutics (R43/R44)
  • PA-14-308: Platform Delivery Technologies for Nucleic Acid Therapeutics (R41/R42)

 

Development of Appropriate Pediatric Formulations and Drug Delivery Systems

Applications must address different and complementary research needs for the development of appropriate pediatric drug formulations in different age groups.

  • PAR-13-345: Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R43)
  • PAR-13-346: Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R41)

 

Learn more about current funding opportunities for small business at NCATS Small Business, including eligibility requirements and research priorities. Need help? Contact NCATS SBIR and STTR to discuss your project idea.

 

Connect with NCATS! Like us on Facebook and follow us on Twitter. Use #NCATSsbir and join the online conversation.

 

***

NCATS’ SBIR and STTR programs are engines of innovation for developing and commercializing tools, technologies and intervention platforms to support the creation of new therapeutics and diagnostics. SBIR and STTR are government set-aside programs for domestic small businesses to engage in research and development that has the potential for commercialization and public benefit.

NCI FY2017 Contract Topics Now Available

August 3, 2016

FY2017 Contract Topics Now Available!

The National Cancer Institute Small Business Innovation Research (NCI SBIR) Development Center funding opportunities come in two large categories: grants and contracts. Contracts are legally binding agreement for the direct use or benefit of the Government, and involve deliverables at the end. This year, there are 15 contract topics in high priority research areas ranging from therapeutics to digital health. See below or visit our website to find out more about this year’s topics. Proposals are due by October 21, 2016, 5:00 PM EDT.  Please direct all questions regarding contracts to the NCI Office of Acquisitions (ncioasbir@mail.nih.gov).

INFORMATION

SOLICITATION      TOPICS      SUBMIT PROPOSAL      QUESTIONS


PRE-PROPOSAL WEBINAR

August 24, 2016, 2:00 PM EDT

REGISTER

The session will cover:
PHS2017-1 Solicitation
Contract Topics per IC
Electronic Contract Proposal Submission (eCPS) Website


For more information about the NCI SBIR & STTR Programs, please visit the website.

The SBIR & STTR Programs are NCI’s engine of innovation for developing and commercializing novel technologies and products to prevent, diagnose, and treat cancer. The SBIR & STTR Programs are government set-aside programs for domestic small businesses to engage in research and development that has the potential for commercialization and public benefit.

Sign up to receive updates about SBIR & STTR funding opportunities at sbir.cancer.gov.

 

NCI SBIR/STTR Webinar & Great Funding Opportunity by JLABS!

July 8, 2016

The National Cancer Institute Small Business Innovation Research (NCI SBIR) Development Center will be participating in the Women in Biotech webinar on Tuesday, July 14, 2016. NCI SBIR Program Staff Kory Hallett, Ph.D. will be speaking at the webinar about NCI SBIR/STTR funding opportunities and application tips. Register today for this free webinar and get in-depth information about SBIR and STTR programs.

In addition to the webinar, we would like to share with you a great funding opportunity that could help fuel your cancer research. The JLABS QuickFire Challenge will award up to $500,000 in a research grant and entrance to JLABS. We hope you find the contest useful for advancing your cancer research. Detailed information about the webinar and the QuickFire Challenge can be found below.

If you have any questions about the webinar or the NCI SBIR/STTR programs, please send us an email at ncisbir@mail.nih.gov.

Securing SBIR and STTR Funding: Support for Women
Entrepreneurs and Researchers in Biotech

Thursday, July 14, 2016, 1:00 – 2:00 p.m. ET | 10:00 – 11:00 a.m. PT

Register Today

Speakers:

  • Kory Hallett, Ph.D., Program Staff, AAAS Science & Technology Policy Fellow, NCI, NIH
  • Cartier Esham, Ph.D., Executive Vice President, Emerging Companies, Biotechnology Innovation Organization (BIO)
  • Lili M. Portilla, M.P.A., Director, Strategic Alliances, NCATS, NIH
  • Stephanie Fertig, M.B.A. Director, NINDS Small Business Programs, NIH

The webinar will feature:

  • An overview of SBIR and STTR programs and funding opportunities
  • Examples and case studies of women founders of bio- and healthcare-technology early-stage businesses

Tips and tools for applying for funding, and resources available for women entrepreneurs and researchers from socially and economically disadvantaged backgrounds

 

JLABS QuickFire Challenge

[APPLY HERE]

Johnson & Johnson Innovation and Janssen Pharmaceuticals, Inc. aim to improve the health and wellness of people around the world. To that end, there is a passionate and engaged workforce across the consumer, medical device and pharmaceutical units who are interested in finding and deploying comprehensive, end to end, integrated solutions which take into account the world in which we live today. Johnson & Johnson Innovation and Janssen Pharmaceuticals, Inc. are bringing together the consumer, medical device and pharmaceutical sectors to award a prize or a series of prizes to the person or team(s) who submits the best idea, technology, or solution that will address a critical health need for the world’s population. Please check out the areas of interest, with an emphasis on lung cancer and metabolism.

Solutions will be evaluated based on their ability to meet the following criteria:

  • Address a particular cohort with a critical unmet medical need in strategic areas of interest, such as lung cancer and metabolic diseases.
  • Integrate a novel approach that combines pharmaceutical, devices and/or consumer health solutions.
  • Address part or all of the spectrum of prevention, interception and cure.
  • Outline how the award would help them reach a critical milestone within the time frame of a single year and provide a full “time-to-market” plan for their solution.

The deadline to apply is August 31, 2016, and winners will be announced by the end of the year.

Thomas Medical Receives Indy Chamber GoGlobal Grant to Support Export Growth

June 3, 2016

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[Indianapolis] — Thomas Medical has been awarded one of the Indy Chamber’s first GoGlobal grants, a new program in partnership with JPMorgan Chase to recognize and support the efforts of local employers to begin or expand exporting activity. To earn the competitive grant, Thomas Medical shared specific, practical plans to increase international sales over the next year.

“Thomas Medical is thrilled to be awarded a GoGlobal Grant from the Indy Chamber,” said Ben Ovenden, Sales Manager for Thomas Medical. “The incremental expenses associated with export growth can be prohibitive for smaller companies, so reaping the benefits of exporting, such as job growth, can seem daunting. Support like the Indy Chamber’s Global Indy Initiative goes a long way to keeping local companies on the global market.”

 
The grant announcement was made at the Indy Chamber’s 2016 World Trade Day, an annual event highlighting the impact of global trade and investment in the Indianapolis region. Exports and foreign investment support more than 100,000 local jobs, with Indianapolis companies selling nearly $15 billion in goods and services outside the U.S. last year.

 
“Indy ranks 23rd out of the 100 largest metro areas in total exports, but the successful exporters in our community are far outnumbered by companies who aren’t taking advantage of global opportunities,” said Michael Huber, president and CEO of the Indy Chamber. “With the support of JPMorgan Chase, the GoGlobal grant program will help businesses explore new markets and find new customers around the world – and inspire others to follow suit.”

 

Thomas Medical will use the grant funds to participate in the annual meeting of the European Society of Human Reproduction and Embryology (ESHRE), July 3-6 in Helsinki, Finland.

 
The GoGlobal Grant awards are part of the Indy Chamber’s Global Indy initiative, which exists to encourage the Indy metro’s companies to engage in global opportunities through export support and facilitating foreign direct investment activity.

 
For more information about the GoGlobal Grant awards, visit IndyChamber.com/GoGlobalGrant.