TScan and Novartis partner to develop cancer therapies

Pharmaceutical Technology | April 16, 2020

Biopharmaceutical firm TScan Therapeutics has signed an agreement with Novartis to discover and develop therapies for the treatment of cancer. The companies aim to work on TCR-engineered T-cell therapies for solid tumours. TScan’s platform will identify cancer antigens that could be targeted by TCR-based treatments. As part of the deal, TScan will find and characterise TCRs while Novartis will hold an option to licence and develop TCRs for up to three new targets. Furthermore, Novartis will have rights of first negotiation for more targets and TCRs resulting from the alliance. TScan may develop TCRs that act on targets not licensed by Novartis. TScan Therapeutics president and CEO David Southwell said: “As one of the only companies able to efficiently discover novel cancer antigens that can be targeted with TCR-based therapies, we are delighted to be collaborating with Novartis to develop important TCR treatments.

Spotlight

By reforming harmful supranational regulations, Thomas Pogge is developing a complement to the patent system to stimulate pharmaceutical innovations that would be accessible, without delay, to poor and affluent patients alike around the world.

Spotlight

By reforming harmful supranational regulations, Thomas Pogge is developing a complement to the patent system to stimulate pharmaceutical innovations that would be accessible, without delay, to poor and affluent patients alike around the world.

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PHARMA TECH

Gannex Received U.S. FDA Fast Track Designation for Its NASH Drug Candidate ASC42,an FXR Agonist

Gannex | December 14, 2020

Gannex, an entirely claimed organization of Ascletis Pharma Inc. (HKEX:1672) and completely committed to the R&D and commercialization of new medications in the field of NASH, reported today that it got Fast Track assignment from the U.S. Food and Drug Administration (FDA) for its non-alcoholic steatohepatitis (NASH) drug applicant ASC42. The U.S. FDA's Fast Track advancement program is intended to encourage the turn of events and speed up the survey of medications that have capacity to treat genuine or perilous infections or conditions and exhibit the possibility to address neglected clinical necessities with extra clinical advantages to patients. There are no FDA affirmed drugs for NASH sign yet. This Fast Track assignment speaks to FDA's acknowledgment of ASC42's potential in tending to these neglected clinical requirements for NASH patients. Gannex got the investigational new medication application (IND) endorsement for ASC42 from the U.S. FDA in October this year. ASC42 is an in-house developed,novel non-steroidal, specific, intense Farnesoid X Receptor (FXR) agonist with top tier potential. In two NASH creature models, ASC42 showed critical enhancements in liver steatosis, aggravation and fibrosis. The oral tablet plan of ASC42 has been created with the in-house restrictive innovation and is steady at room temperature. "We are excited that the FDA allowed Fast Track assignment for our FXR agonist ASC42 which is found and created by our in-house skilled R&D group," said Dr. Jinzi J. Wu, "This basic acknowledgment by FDA will quicken worldwide advancement of ASC42, a potential top tier FXR agonist."

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PHARMACY MARKET

Arrowhead Pharmaceuticals Initiates Phase 1/2 Study of ARO-C3 for Treatment of Complement Mediated Diseases

Arrowhead Pharmaceuticals Inc. | February 19, 2022

Arrowhead Pharmaceuticals Inc. announced that it has dosed the first subjects in AROC3-1001, a Phase 1/2 clinical study of ARO-C3, the company’s investigational RNA interference (RNAi) therapeutic designed to reduce production of complement component 3 (C3) as a potential therapy for various complement mediated diseases. “We believe a C3 targeted drug has the potential to address multiple complement mediated and complement associated diseases, where significant unmet medical need exists. These include IgA nephropathy, C3 glomerulopathy, paroxysmal nocturnal hemoglobinuria, and additional renal and hematologic diseases that we intend to evaluate in the future. ARO-C3 has progressed rapidly, and our preclinical data have been very encouraging. We are eager to continue this progress as we evaluate ARO-C3 in clinical studies.” James Hamilton, M.D., MBA, senior vice president of discovery and translational medicine at Arrowhead AROC3-1001 is a Phase 1/2, placebo controlled, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-C3 in up to 24 adult healthy volunteers, up to 24 adult patients with paroxysmal nocturnal hemoglobinuria (PNH), and up to 14 adult patients with complement-mediated renal disease. In Part 1 in healthy volunteers, four cohorts with four escalating dose levels of ARO-C3 will be evaluated. Each cohort will enroll 6 eligible subjects who will be randomized to receive a single subcutaneous injection of ARO-C3 (n=4) or placebo (n=2). In Part 2, eligible subjects with PNH or complement-mediated renal disease will be enrolled to receive open-label ARO-C3 on day 1 and day 85 at one of two dose levels to be determined in Part 1. The primary objective of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of ARO-C3 in normal healthy volunteers and to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of ARO-C3 in subjects with PNH and in subjects with complement-mediated renal disease. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

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BUSINESS INSIGHTS

Astorg to Acquire Global Medical Communications and Market Access Platform OPEN Health From Amulet Capital Partners

Astorg and Amulet Capital Partners | June 01, 2022

Astorg and Amulet Capital Partners announce that they have signed a binding agreement whereby Astorg will acquire OPEN Health, a leading global provider of scientific communications and market access services to the pharmaceutical industry. Established in 2011 and headquartered in London, UK, OPEN Health is a key partner to its customers in helping them develop strategies for evidence generation and data communication by leveraging their extensive scientific knowledge and relentless focus on quality. Together, this approach consistently delivers best-in-class scientific communications, health economics and outcomes research (HEOR) and market access services to an ever-increasing audience. OPEN Health has more than 1,000 employees in 15 locations and six countries, across North America, Europe and Asia. OPEN Health serves over 170 life sciences customers, including 48 of the top 50 pharmaceutical companies. OPEN Health’s existing management team, led by CEO Rob Barker, will continue to lead the organization, building on a strong track-record of organic growth and strategic acquisitions. "We are excited to build on the momentum across our business and to continue executing with our new partners at Astorg on a shared long-term vision to bring deep scientific solutions that support our clients in driving positive health outcomes. We are grateful for the strong partnership of the Amulet team over the last three and a half years and for all that we have accomplished in expanding our industry-leading capabilities across disciplines. We continue to be very well positioned to drive innovation and growth, and we look forward to embarking on this next chapter for OPEN Health." Rob Barker, CEO, OPEN Health Building on OPEN Health’s leading service offerings, Astorg will invest in the development of the business across its main existing offerings, and beyond, to continue delivering best-in-class scientific content to OPEN Health’s customer base and help them harness the full value of their most important assets. "OPEN Health is a very impressive company. We have been following the development of the medical affairs space for a long time as the function evolved from a supportive to a central role and identified OPEN Health as a global leader in the making. We have been impressed with its outstanding reputation and the trust it benefits from its customer base,” said Judith Charpentier, Partner and Head of Healthcare, Astorg. “We look forward to supporting Rob and the OPEN Health management team in continuing to build a global leading scientific focused medical affairs platform, expanding the platform through both organic initiatives and additional strategic acquisitions,” said Olivier Lieven, Director, Astorg. Ramsey Frank, President and Managing Partner of Amulet, said, “OPEN Health was built around Amulet’s investment thesis in medical affairs: the current generation of drugs is fundamentally different from prior generations, and these therapies need to be brought to market with the support of high science communications and data analytics. 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