On August 26, 2021 Cardinal Health (NYSE: CAH) and IRE ELiT (the radiopharmaceutical subsidiary of IRE Group) reported that are working to expand patient access to novel radiopharmaceuticals for Positron Emission Tomography (PET) imaging as demand in the United States (U.S.) continues to grow (Press release, Cardinal Health, AUG 26, 2021, View Source [SID1234591440]). Cardinal Health is the preferred U.S. distributor of the IRE ELiT 100 mCi Germanium-68/Gallium-68 radionuclide generator (Ge-68/Ga-68 Galli Eo generator) in support of clinical investigational trials, pre-commercial research and post-approval commercial sales in the U.S. and its territories, including Puerto Rico.

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Designed for the on-site preparation of Ga-68 radiolabeled pharmaceuticals, IRE ELiT modified its Ge-68/Ga-68 Galli Eo generator to double its activity from 50 mCi to 100 mCi. This activity enhancement will enable the Nuclear & Precision Health Solutions business of Cardinal Health to increase preparation of Ga-68 radiolabeled pharmaceuticals, which are approved and under investigation for many cancers.

The new, higher-activity 100 mCi generator provides users with more flexibility by increasing the number of daily elutions and the activity in each elution, ultimately increasing the number of patients that can be served. "As a leading U.S. provider of Ga-68 radiopharmaceuticals, Cardinal Health commends IRE ELiT for their efforts to increase the activity of Ge-68/Ga-68 Galli Eo generators," said Mike Pintek, president of Cardinal Health Nuclear & Precision Health Solutions. "Ultimately, this will allow us to better supply medical providers, and their patients, with current and future novel Ga-68 diagnostics."

"Increasing the activity of our Galli Eo generator is a critical part of our plan to meet the exponential demand for Ga-68 radiolabeled pharmaceuticals in the U.S.," said Erich Kollegger, chief executive officer of IRE ELiT. "Combining the expertise of our R&D department with the experience of our production team, IRE ELiT is prepared to produce and supply Cardinal Health with these high-activity generators."

While the activity of the Ge-68/Ga-68 Galli Eo generator has increased, the footprint of each unit will remain the same to ensure Cardinal Health can seamlessly transition to the new 100 mCi Ge-68/Ga-68 Galli Eo generators without impact to the pharmacy.

Cardinal Health currently has the majority of its more than 130 nuclear pharmacies licensed for Gallium-68 and plans to license them all to expand patient access to PET imaging.

On August 26, 2021 Sesen Bio reported that bladder cancer drug with a Complete Response Letter, the company has withdrawn its Marketing Application Authorization from the European Union (Press release, Sesen Bio, AUG 26, 2021, View Source [SID1234586964]).

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In a filing with the U.S. Securities and Exchange Commission, Sesen Bio said its decision to pull the MAA was based on the FDA’s CRL. The company acknowledged that certain components in the European Medicines Agency review are "interrelated" with some of the elements that forced the FDA to issues the CRL for Viceneum (oportuzumab monatox-qqrs) as a treatment for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Sesen is pausing its plans to pursue approval in Europe until there is more clarity from the FDA on the next steps it must take to win approval.

The company has also requested a Type A meeting with the FDA to discuss those necessary steps. Additionally, Sesen made a curious comment that noted it is "committed to the highest standards of ethics and integrity and continues to believe in the safety and efficacy data of Vicineum."

That comment points back to a STAT News report alleging that Sesen’s entire clinical program for Viceneum was allegedly marked by multiple instances of unethical behavior. According to the report, the company’s clinical program saw "thousands of violations of study rules" and "damning investigator misconduct." It also added that Sesen’s drug had much poorer safety data than was reported.

The news also revealed that the company did not disclose "worrying signs of toxicity" and that it was backed by hundreds of pages of internal documents from Sesen, as well as confirmation by "three people familiar with the matter." Sesen has yet to comment against the allegations raised by the report.

Vicenium, the drug Sesen is hoping to gain approval for, is a recombinant fusion protein. Vicenium targets epithelial cell adhesion molecule (EpCAM) antigens located on the surface of tumor cells. It aims to deliver what has been described as a potent protein payload of Pseudomonas Exotoxin A to the tumor.

When the FDA rejected Vicenium, the regulatory agency recommended that Sesen conduct additional clinical and statistical data analyses. The FDA also recommended addressing issues related to the company’s Chemistry, Manufacturing, and Controls (CMC). In the CRL, the FDA expressed concern about drug substance and drug product manufacturing, cell bank, characterization, resin reuse, reference standards, methods, specifications, stability, and microbiology.

Shares of Sesen Bio are down nearly 2% in premarket trading to $1.05, losing the gains it made on Wednesday. Since the CRL was issued, Sesen’s stock has fallen from a 2021 high of $4.91 per share.

On August 26, 2021 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported the launch of its wholly-owned subsidiary, Skunkworx Bio, Inc. ("Skunkworx"), focused on the development of a drug discovery paradigm to enable rapid drug development (Press release, Heat Biologics, AUG 26, 2021, View Source [SID1234586963]).

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Skunkworx’s unique, highly diverse, proprietary libraries of "Pocket Biologics" are used to identify miniature proteins which bind to critical domains of druggable targets. The Skunkworx approach aims to enable rapid drug discovery and validation of new innovative therapeutics utilizing advanced computational methods and bioinformatics to further enhance target precision. Skunkworx has successfully identified agonists and antagonists for a number of targets and is in the process of progressing several of these assets through preclinical studies.

Matt Seavey, Ph.D., Skunkworx’s Executive Director of Scientific Operations, commented, "Our unique process flips the paradigm of drug discovery, as it enables us to rapidly identify novel drug targets to determine if a target is druggable. By utilizing this approach, we have been able to identify lead targets and already have several promising programs underway."

Jeff Wolf, Chief Executive Officer of Heat, commented, "We are extremely proud to launch Skunkworx, an innovative platform to accelerate the path from discovery to preclinical development. Skunkworx augments Heat’s emerging drug development ecosystem designed to efficiently move new biologic programs from discovery into the clinic. New programs will be discovered through Skunkworx, developed at Heat and manufactured at Scorpion Biological Services, Heat’s wholly owned manufacturing subsidiary. This integrated platform is focused on driving innovation by rapidly accelerating the drug development process. We look forward to working with Skunkworx to advance a wide repertoire of drugs across a wide variety of indications, including biosecurity applications, an area of growing importance."

On August 26, 2021 Celdara Medical, LLC (Celdara), The New Hampshire Academy of Science (NHAS), and Crossroads Academy reported the opening of the Fanger Center (Press release, Celdara Medical, AUG 26, 2021, View Source [SID1234586956]). The Fanger Center is an adaptable, cutting-edge facility that functions dually as the Crossroads Academy middle school by day and a New Hampshire Academy of Sciences STEM lab outside of school hours, enabling afterschool, holiday, and summer use. This unique collaboration makes the Fanger Center accessible to STEM-interested middle- and high-school students across the region through NHAS Programs, which include need-based financial aid. Constructed on the Crossroads Academy campus in Lyme, NH, the purpose-built facility was supported by Celdara and named after Dr. Michael Fanger, who co-founded Celdara Medical in 2008 with Dr. Jake Reder. The new facility, designed for chemistry, biology, mathematics, engineering, and computer science, is available to students across New Hampshire and Vermont. An outdoor ribbon cutting ceremony was held today for students and teachers to celebrate the start of the school year in the new space.

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"The NHAS has a mission to further the work of scientists and future scientists in New Hampshire by providing a forum for scientific discussion, interaction, and collaboration," notes NHAS Executive Director, Dr. Peter Faletra. "The Fanger Center provides an expanded space for students from all our communities to engage in authentic scientific research with teachers and STEM professionals through an apprenticeship model. NHAS intends to be a main hub for STEM opportunities in the states of NH and VT, with The Fanger Center serving as its flagship STEM research Center. Accessibility is core to our efforts; it is our goal to ensure that motivated students can attend, independent of their financial means."

Crossroads Head of School, Mr. Dan Morrissey, adds: "At Crossroads Academy, our faculty set children on learning journeys in every field of discovery, teaching them that knowledge and virtue – strong minds and kind hearts – can change the world. Like Dr. Fanger, our community is eager to create a better future and is continually exploring ways to do so. The inauguration of the Fanger Center on our 30th Anniversary represents our continued investment in thought leadership and innovation. We are thrilled that the region’s middle and high school students will have the opportunity to engage in high quality curricular and extra-curricular science and engineering research through our unique partnership with NHAS."

The Fanger Center is a replicable and scalable model for schools worldwide and builds upon the success of the current NHAS STEM lab. In addition to regional STEM outreach programs, teacher training and authentic research experiences for students, the existing NHAS STEM lab has resulted in over 100 students from 15 regional schools publishing their research with the American Junior Academy of Science and presenting their work at the annual meetings of the American Association for the Advancement for Science (AAAS). The Fanger Center expands the existing 1,200 square feet of biology lab space to include an additional 2,500 square feet of lab space, in addition to offices, conference spaces, and future-ready maker spaces, all focused on the physical sciences, computer science and engineering.

"Mike and I founded Celdara to transform the work of leading scientists into products and services that can help humanity. Mike gave immeasurably to the field of scientific education, as a mentor, entrepreneur, and academician. Increasing equitable access to educational opportunities and investing in STEM leaders of the future is a wonderful way to honor Mike’s legacy. Some of the next generation of leading scientists, mathematicians, and engineers will find their inspiration here," said Jake Reder, co-founder and CEO of Celdara Medical.

In 1981, Dr. Fanger joined Dartmouth Medical School’s Immunology Program, creating a world-renowned Department of Microbiology and Immunology, for which he served as Chairperson for a decade. As an entrepreneur, Dr. Fanger cofounded the pioneering biotechnology company Medarex, generating technology which created nearly half of the human antibodies approved to date. Two Medarex medicines ignited the immunoncology revolution, providing hope for previously incurable patients and saving thousands of lives. In 2018, Drs. Jim Allison and Tasuku Honjo received the Nobel Prize in Medicine for their pioneering work that led to these world changing Medarex drugs.

"Mike’s impact in the biotech industry is the stuff of legend, but for the many of us that he inspired, his teaching, counselling, advising, mentoring and friendship may be even more impactful. These virtues are a big part of why we are honoring his legacy with this Center. My hope is that every student who passes through these doors will learn something about Mike and realize that they too can be great by doing good," said Reder.

On August 26, 2021 Compugen Ltd. (NASDAQ: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported that management will present at the Morgan Stanley 19th Annual Global Healthcare Conference (virtual), on Thursday, September 9, 2021 at 11:00 am ET (Press release, Compugen, AUG 26, 2021, View Source [SID1234586949]).

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A live webcast of the presentation will be available on the Investor Relations section of Compugen’s website at www.cgen.com. A replay will be available following the live event.