JPM2021, Day 3: Sanofi, Jazz Pharma, Replimune and More
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Although the 2021 virtual J.P. Morgan Healthcare Conference is winding down, news continues to roll out of the meeting with announcements of deals, partnerships, pipeline goals and regulatory updates. Here’s a look at some of the stories that emerged from the conference on Wednesday.
Sanofi – After announcing its intention to spin-off its active pharmaceutical ingredients division last year, the French pharma giant has finally given a name to the new company, EUROAPI. In its announcement, Sanofi said EUROAPI will represent the “made in Europe” API state-of-the-art industrial capabilities and technologies. The new entity is expected to have approximately €1 billion in expected sales by 2022 and will rank in the top spot in small molecules API, and in the number two position on the global API market behind Lonza, the company said.
EUROPAI will combine Sanofi’s API commercial and development activities with six of its European API production sites: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France).
“Addressing recent increasing medicine shortages that critically impact patient care, EUROAPI will ensure additional API supply capacities for Europe and beyond, and help balancing the industry’s heavy reliance on API sourced from other regions,” Sanofi announced.
Jazz – Jazz Pharma Chief Executive Officer Bruce Cozzad said his company is well-positioned for sustainable growth in 2021. Cozzad said he expects new product sales to drive nearly 50% of the company’s revenue by 2022. This includes new product launches for Sunosi, Zepzelca, Xywav for cataplexy or excessive daytime sleepiness associated with narcolepsy, and the experimental assets, JZP-458 and JZP-258, or Xywav, for idiopathic hypersomnia. In addition to those five assets expected to be key revenue drivers, Cozzad said targeted investments made by Jazz Pharma are designed to fuel growth through 2025 and beyond. During the presentation, Cozzad reaffirmed the company’s revenue guidance for 2020. The company anticipates revenue of approximately $2.3 billion for the year, he said. The company’s neuroscience assets drove the lion’s share of revenue.
Replimune – Massachusetts-based Replimune outlines its goals for the coming year during a presentation at the conference. The company has three products in clinical trials, and recently announced dosing of the first patient in the newest Phase I trial of its asset, RP3 in patients with advanced solid tumors. RP3 is the company’s third product candidate, which in addition to GALV-GP R- and anti-CTLA-4 also expresses CD40L and 4-1BBL. The Phase I clinical trial is designed to evaluate
The company is also conducting an overall analysis of the solid tumor space to define the clinical development pathway for RP3 and RP2, an enhanced potency oncolytic immunotherapy which expresses an anti-CTLA-4 molecule, which is currently being tested as a combination therapy with Bristol Myers Squibb’s Opdivo. The analysis is being conducted from the perspective Replimmune’s two candidates are intended to target less immune responsive tumor types.
UroGen – UroGen Pharma announced a three-year collaboration with the University of Texas MD Anderson Cancer Center to advance combinatorial intravesical immunotherapy, which is delivered directly into the bladder, for the treatment of high-grade non-muscle invasive bladder cancer (HG-NMIBC). UroGen’s approach involves the local delivery of potent immunomodulators including its own UGN-201, a TLR 7/8 agonist and UGN-301, an anti-CTLA-4 antibody. UGN-301, an immune checkpoint inhibitor, is delivered using UroGen’s proprietary RTGel platform to increase dwell time, which has been shown to significantly improve the effectiveness of intravesical therapy. UroGen’s investigational candidates, UGN-201 and UGN-301, are being developed to ablate tumors by non-surgical means in the treatment of HG-NMIBC.
Precigen – Maryland’s Precigen provided updates on its clinical pipeline Wednesday. During the presentation, Precigen introduced the company's vision for a new UltraCAR-T library approach that is aimed to transform the personalized cell therapy landscape for cancer patients. Precigen's goal is to develop and validate a library of non-viral plasmids to target tumor-associated antigens. Precigen is working to empower cancer centers to deliver personalized, autologous UltraCAR-T treatment with overnight manufacturing to any cancer patient. Based on the patient's cancer indication and biomarker profile, one or more non-viral plasmids would be selected from the library to build a personalized UltraCAR-T treatment. Precigen believes that the combination of the advanced UltraVector DNA construction platform and the ease of overnight manufacturing gives this library approach a proprietary advantage over traditional T-cell therapies.
In addition to its library approach, Precigen provided preliminary data for the ongoing Phase I/II study of the first-in-class PRGN-2009 AdenoVerse immunotherapy to treat HPV-positive (HPV+) solid tumors. The Phase I study is evaluating safety and response of PRGN-2009 alone (Arm A) and in combination with bintrafusp alfa, an investigational bifunctional fusion protein, (Arm B) in patients with HPV-associated cancers.
Actinium – Actinium Pharmaceuticals and Astellas Pharma forged a research collaboration to develop novel targeted radiotherapies. For its part, Actinium will use its Antibody Warhead Enabling (AWE) technology platform to develop and characterize selected Astellas targeting agents labeled with the potent alpha-emitting radioisotope Actinium-225 (Ac-225).