On September 30, 2021 United Therapeutics Corporation (Nasdaq: UTHR) reported it has officially converted to a public benefit corporation (PBC) (Press release, United Therapeutics, SEP 30, 2021, View Source [SID1234590565]). The conversion follows shareholder approval of the company’s proposal to amend its charter at today’s Special Meeting of Shareholders. This is the first PBC conversion of a public biotech or pharmaceutical company.

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United Therapeutics’ conversion to a PBC aligns its legal charter with its longstanding practices of improving patients’ health, enhancing employee engagement, attracting top talent, promoting healthy communities, and addressing important sustainability priorities through its use of green-building technologies, while simultaneously delivering strong shareholder returns. The company has a proven track record of value creation, along with six years of experience operating its Lung Biotechnology PBC subsidiary (the first ever PBC subsidiary of a publicly-traded biopharmaceutical company), so it understands this corporate form well. This PBC conversion initiative was led by the Nominating and Governance Committee of United Therapeutics’ Board of Directors.

"We are inspired by our shareholders who recognize that caring for our patients, planet, employees, communities, and other stakeholders enhances our ability to generate strong shareholder returns," said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. "Becoming a PBC aligns United Therapeutics’ corporate structure with our foundational DNA and gives us a strong platform to advance our objectives of developing novel pharmaceutical therapies and finding a cure for end-stage organ diseases by creating an unlimited supply of transplantable organs."

United Therapeutics has been proud to receive support from key partners and employees throughout this process, and our stakeholders have shared the following statements as the company operates in its new form as a PBC:

"My interest in United Therapeutics stems from its clear, passionate care for the patients and communities it serves and an unrelenting mission to find a cure for pulmonary arterial hypertension (PAH). A close relative of mine was diagnosed with PAH, and Martine’s deep interest in the mission was inspiring both personally and professionally," said Manju Lal, a Senior Cardiopulmonary Specialist at United Therapeutics. "United Therapeutics values its people and I am proud to be a part of the family, for the past 14 years and counting!"

Robert C. Bourge, M.D., Professor of Medicine, Radiology, and Surgery and Senior Vice Chair, Department of Medicine at The University of Alabama at Birmingham, said, "Having worked with United Therapeutics since its inception, I am not surprised by this evolution. United Therapeutics has always prioritized patients’ wellbeing, and its commitment to expanding the therapies available to patients living with pulmonary hypertension and advancing the future of organ transplants will continue to drive its success. I am honored to have been part of the growth and development of United Therapeutics."

John Hoeppner, Head of U.S. Stewardship and Sustainable Investing for Legal & General Investment Management America, added, "As a manager that values responsible financial sustainability as well as leadership and creativity, we applaud UT being willing to explore the potential that becoming a PBC may hold."

A PBC is a for-profit corporation that, while creating value for shareholders, must also consider the best interests of those materially affected by the company’s conduct and the specific public benefit that it chooses to adopt in its charter. PBCs are intended to produce public benefits and to operate in a responsible and sustainable manner.

On September 30, 2021 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that it has dosed the first patient in it’s OPTIMIZE-1 phase II study, which aims to further assess the efficacy and safety profile of Alligator’s CD40 agonist, Mitazalimab, in combination with standard-of-care chemotherapy, mFOLFIRINOX, for the treatment of first-line metastatic pancreatic cancer (Press release, Alligator Bioscience, SEP 30, 2021, View Source [SID1234590564]). OPTIMIZE-1 is an open-label, multicenter study that will enroll up to 67 patients at clinical sites in Belgium and France. The company is expecting an interim safety readout in Q1 2022 and an interim efficacy readout in Q4 2022.

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With more than 150,000 cases annually, pancreatic cancer is the third leading cause of cancer related deaths in the European Union and is the second leading cause of cancer related deaths in the US. Current treatment options for pancreatic cancer are extremely limited with a 5-year survival rate of less than 10%.

"This is a big step forward for Alligator. Mitazalimab has previously reported positive clinical data from Phase I studies, displaying a manageable safety profile, proof-of-mechanism as well as early signs of efficacy, thus paving the way for this Phase II study. OPTIMIZE-1 reinforces our commitment to developing tumor-directed immuno-oncology antibody drugs," said Søren Bregenholt, CEO of Alligator Bioscience. "The commencement of dosing in the Phase II study of Mitazalimab with patients diagnosed with pancreatic cancer is an important step forward for our best-in-class antibodies as combination therapy for the treatment of metastasized cancers."

"The OPTIMIZE-1 study, providing the opportunity to combine an innovative immunotherapy treatment to the standard-of-care highly active Folfirinox chemotherapy for patients with metastatic pancreatic cancer patients, is very welcome and we are excited to have enrolled our first patient," comments Dr. Ivan Borbath, Professor at Cliniques Universitaires Saint-Luc, Brussels, Belgium. Dr. Borbath joins a network of sites in Belgium and France eager to further assess Mitazalimab’s safety and efficacy profile in combination with chemotherapy in this difficult to treat cancer.

Mitazalimab, a best-in-class second generation CD40 agonist IgG1-wt human antibody and "Universal" combination partner with standard-of-care such as chemotherapy or checkpoint inhibitors, is Alligator’s most advanced drug candidate for immunotherapy and is designed for the treatment of metastatic cancers, including pancreatic cancer.

On September 30, 2021 GeoVax Labs Inc. shares were up 12% to $4.68 after the company said reported that it entered into an assignment and license agreement with PNP Therapeutics Inc., granting GeoVax exclusive rights to develop and commercialize Gedeptin, a novel patented product for the treatment of solid tumors (Press release, Southern Research Institute, SEP 30, 2021, View Source [SID1234590563]).

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The biotechnology company said the license provides exclusive worldwide rights to key intellectual property, including Gedeptin patents, know-how, regulatory filings, clinical materials and trademarks.

The patent portfolio covering Gedeptin was originally licensed from the University of Alabama at Birmingham and Southern Research Institute by PNP. Under the License, GeoVax will become the successor to PNP under its license agreement with UAB/SRI.

Detailed financial terms of the transaction weren’t disclosed, but include a combination of upfront payments, milestone fees, and royalties on net sales.

A Phase 1/2 trial, evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma, with tumors accessible for injection and no curable treatment options, is currently enrolling. The initial stage of the study is being funded by the U.S. Food and Drug Administration pursuant to its Orphan Products Clinical Trials Grants Program. The FDA also has granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities.

On September 30, 2021 Vernalis, a fully owned subsidiary of HitGen Inc., and Servier reported the achievement of a research milestone in one of their oncology drug discovery collaborations, triggering an undisclosed milestone payment to Vernalis (Press release, Vernalis, SEP 30, 2021, View Source;utm_medium=rss&utm_campaign=vernalis-a-fully-owned-subsidiary-of-hitgen-inc-and-servier-achieve-a-milestone-in-their-oncology-drug-discovery-collaboration [SID1234590562]).

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Vernalis and Servier’s partnership has been running successfully since 2007 with a number of collaborations on different therapeutic targets. This particular collaboration was established in January 2017 in which Vernalis’ proprietary fragment and structure-based drug discovery platform is combined with the oncology expertise at Servier on a challenging protein target which is implicated in many different cancers. This milestone recognizes success in achieving a particular research milestone. The financial terms of the agreement are not disclosed.

"The milestone further validates our fragment and structure-based drug discovery platform and the strength and success of our relationship with Servier. We look forward to working together to develop exciting new cancer treatment opportunities to add to the already disclosed successes with Bcl-2 and Mcl-1", commented James Murray, Research Director at Vernalis.

"This research milestone is the result of highly interactive joint efforts between chemists, biochemists and biologists from both companies and hopefully will lead to new treatments for cancer patients," commented Frederic Colland, Head of Hard-to-treat Cancer research program at Servier. "This research program is in line with Servier’s strategy, which has made oncology one of its foremost priorities to respond the growing needs for therapeutic solutions."

Under the current agreement, Vernalis receives fees for work undertaken as well as research and development milestones and potentially royalties on sales.

On September 30, 2021 Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, reported that research in the Proceedings of the National Academy of Sciences describing the structural basis for isoform-specific inhibition of human CTPS1 (CTP synthase 1) (Press release, Nimbus Therapeutics, SEP 30, 2021, View Source [SID1234590561]). Selective inhibition of CTPS1 is a promising approach for the treatment of autoimmune and other T cell-driven diseases, but little is known about the mechanisms underlying selective versus non-selective inhibition.

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Nimbus scientists, in partnership with researchers from the University of Washington and Schrödinger, used cryo-electron microscopy (cryo-EM) to characterize the activity of CTPS inhibitors in binding to, inhibiting and distinguishing between CTPS1 and its isoform CTPS2. The cryo-EM research was funded by Nimbus and led by professor Justin Kollman at the University of Washington.

"We’re proud to have conducted this impactful research in partnership with our valued colleagues at University of Washington and Schrödinger, further building on Nimbus’ long history of fruitful academic collaborations," said Peter Tummino, Ph.D., Chief Scientific Officer at Nimbus. "The insights we have published will be instrumental in our efforts to develop selective inhibitors of CTPS1 that can potentially offer a powerful new means of treating autoimmune diseases and T cell-driven cancers."

"A defining feature of Nimbus’ structure-based drug discovery approach is our use of leading-edge computational technology, including cryo-EM, to characterize drug targets in unprecedented detail," said Scott Edmondson, Ph.D., Senior Vice President and Head of Chemistry at Nimbus. "The discoveries made in this research, together with Nimbus’ expertise in computational chemistry, molecular sciences and disease biology, will inform our ongoing development of highly selective small-molecule CTPS1 inhibitors."

The paper, entitled "Structural basis for isoform-specific inhibition of human CTPS1," published online in the Proceedings of the National Academy of Sciences this week: View Source