From L-R: Luigi Naldini, Genenta CEO Pierluigi Paracchi and Genenta CMO Carlo Russo
After years of developing its gene therapy for cancer on the outskirts of biotech, Genenta has landed on Nasdaq as the first Italian biotech on the American exchange.
Genenta’s IPO is small compared to what you usually see these days, but the $36 million — or $40 million if all options are exercised — in gross proceeds will allow Pierluigi Paracchi’s crew to take its current proof-of-concept trial to fruition and pave the way to Phase II, fund long-term monitoring of patients, pay for preclinical research and manufacturing, while leaving enough money to run the actual Phase II trial slated to start in 2023 (the business development and admin team also gets some).
With backing from both existing shareholders and new investors, Genenta ended up pricing the upsized offering of 2.4 million shares at $11.50 per share.
The pitch revolved around its lead candidate, Temferon, which gets its name, in part, from the specific class of tumor-associated myeloid cells that make up the drug.
Scientific co-founder Luigi Naldini — a scientist with an impressive background in gene therapy and the former president of the European Society of Gene and Cell Therapy — first characterized this group of cells, dubbed Tie2-expressing monocytes or TEMs for short, in 2005.
The other part of Temferon refers to the key concept of adding interferon to TEMs. Specifically, the scientists engineer the TEMs in a way that they would release IFN-α inside tumors, unleashing a powerful attack on cancer while avoiding the toxicity that made systemic IFN-α dosage a bad idea.
CMO Carlo Russo, the last in the trio of execs running Genenta, is leading the clinical team as they first test the therapy in glioblastoma multiforme — with the last patient expected to be treated in Q3 2022. Long-term monitoring is expected to run through 2029. Once they determine the dose, Genenta expects to enroll around 30 patients in a Phase II study set to take place from early 2023 to late 2025.
Meanwhile, Naldini will oversee preclinical work to see if Temferon may work against other cancers and develop a second-generation switchable version, as well as explore additional payloads and combos.
Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.
Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).
Crowd gathering at the Westin St. Francis for JPM in 2019 (Endpoints News)
Well, see you in January 2023.
In a surprise about-face, #JPM22 will now be fully virtual after organizers of the popular biotech conference decided to pull the plug on a live event in San Francisco given fears over the Omicron variant and a growing chorus of drugmakers opting out.
The move is no big surprise after reports swirled about some of the industry’s biggest players nixing plans to attend live and pressuring the bank to reconsider the annual meet at the Westin St. Francis. STAT reported Tuesday that Moderna and Amgen, among other large drugmakers, had already pulled out.
The FDA on Wednesday not only approved the first generic versions of the decades-old diabetes insipidus treatment vasopressin, but also simultaneously offered a particularly damning rebuke of a citizen petition attempting to block the generic, while promising to pass along the matter to the Federal Trade Commission.
The response could prove troublesome for the sponsor of the brand name version of the drug, Endo’s Par Sterile Products, which brought in more than $780 million in 2020 for its brand name version of the drug Vasostrict.
Robert Califf (Graeme Sloan/Sipa via AP Images)
As Rob Califf likely makes his return as FDA commissioner next month, his confirmation hearing yesterday offered a peek into some of the larger obstacles he’s going to face in the coming months and years.
The pandemic isn’t going away anytime soon with Omicron, and some vaccines and therapeutics may need to be tweaked or pulled from the market entirely as they prove to be ineffective against the new variant. The FDA, meanwhile, needs to get back on even footing with some longer-term direction.
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Alice Zhang, founder and CEO of Verge Genomics
Just a few months after California AI and genomics player Verge Genomics partnered with Eli Lilly in a $700 million-plus biobucks deal for 4 neurological programs, the biotech has finished raising its next financing round — netting $98 million in equity funding with Lilly jumping on board as a new investor.
The South San Francisco-based, neuroscience-focused company announced the completion of the Series B this morning, which was led by BlackRock-managed funds and supported by some new big-name investors such as Eli Lilly, Merck’s Global Health Innovation Fund and Vulcan Capital. Some existing investors joined in as well, including ALS Investment Fund and Tao Capital Partners.
For the first time, Biogen released details Thursday on how it intends to prove that its by turns celebrated and maligned drug Aduhelm can actually slow the decline of patients with Alzheimer’s, as required by the FDA.
The biotech said it will launch a global 1,300-person trial next May that will randomize early-stage Alzheimer’s patients to receive either Aduhelm or placebo. It will probably take about four years for the trial to generate results, the company said, pushing a final answer to 2026.
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A nurse administers a COVID-19 booster shot to Joe Rigdon at a vaccination site in Eastmonte Park, Altamonte Springs. (Photo by Paul Hennessy/SOPA Images/LightRocket via Getty Images)
When Laura Burns went to get her first Covid-19 shot last January, no one had warned her that the vaccines might not work for her.
Burns, the recipient of a double-lung transplant in 2016, knew to be careful about the medicines she took. She consulted with her transplant team when the Pfizer and Moderna shots were authorized and only signed up after being told the vaccines would likely be safe for her, which they were.
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Jay Bradner, President, Novartis Institutes for BioMedical Research
John Carroll: Well, hello everybody. This is John Carroll. I’m the editor of Endpoints News, the editor and founder of Endpoints News. I’m here with Jay Bradner, the president of the Novartis Institutes for BioMedical Research. Jay, we’re going to be talking about ASH in just a second, but you’ve just recently celebrated your sixth anniversary as president of NIBR. And I’m curious, it’s such a significant amount of time for anybody to spend in one career phase. And looking back over the last six years, is everything fundamentally different about the research process and the translational arena that you’re in?
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Thomas Lingelbach, Valneva CEO
Two weeks ago, Valneva pushed back against a study that found its candidate, VLA2001, was the only one out of seven tested vaccines that didn’t significantly boost protection when given to volunteers who had two doses of the Pfizer/BioNTech mRNA shot.
Valneva said the participants had been given booster doses after a shorter interval than usual — and vaccines made from inactivated viruses, such as its candidate, typically require a longer period of time to be effective.
https://endpts.com/italian-cancer-gene-therapy-biotech-makes-history-with-modest-nasdaq-ipo/
