Merck-partnered Janux seeks $100M IPO on preclinical promise of bispecific pipeline

On May 21, 2021 Janux Therapeutics reported that it has filed to raise up to $100 million in an IPO (Press release, Janux Therapeutics, MAY 21, 2021, View Source [SID1234580465]). The Merck-partnered biotech wants the money to take a clutch of T-cell engager drug candidates into phase 1 clinical trials.

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San Diego-based Janux has raised $201 million from investors including Avalon Ventures and RA Capital since setting up shop in 2017. Using the money, Janux has established a preclinical pipeline based on its TRACTr platform. The platform is designed to overcome the limitations of existing T-cell engagers and, in doing so, realize the potential of the modality in solid tumors.

Now, with candidates against PSMA, EGFR and TROP2 going through IND-enabling studies on route to clinical development, Janux is turning to public investors to finance the next stage of its evolution.

Using the IPO haul, Janux plans to submit four INDs, starting in the first half of next year. The PSMA candidate is leading the way, trailed by the EGFR and TROP2 assets and an early-stage PD-L1xCD28 costimulatory bispecific.

The areas of focus put Janux up against bigger companies with more advanced assets. Regeneron, for example, took a PSMA bispecific into the clinic in 2019. Bayer, in collaboration with Amgen, moved a candidate into human testing back in 2012, although Janux sees the difficulties that program ran into as evidence of the differentiation of its asset. Amgen now has a different PSMA drug in the clinic.

Janux is asking public investors to back it on the strength of early-stage evidence. The IPO paperwork features the findings of an initial proof-of-technology study that showed its EGFR prospect did not lead to cytokine release syndrome in nonhuman primates and drove tumor shrinkage in a mouse model. Janux has preclinical data on its other candidates, too.

In addition to the early evidence, Janux has the validation of its investor syndicate and Merck, which teamed up with the biotech late last year to work on TRACTr candidates against two cancer targets.

The Merck collaboration, which is currently Janux’s sole source of revenue, generated $380,000 for the biotech over the first three months of the year. Merck paid $8 million upfront to kick off work on the first collaboration and will pay the same amount when the second target is selected.

Janux could ultimately receive almost $500 million in success-based fees per target, but the payments are heavily backloaded, with $350 million tied to sales milestones. The development and regulatory milestones are worth up to $142.5 million per target.

Arvinas to Present at the UBS Global Healthcare Virtual Conference

On May 20, 2021 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that John Houston, Ph.D., President and Chief Executive Officer and Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the UBS Global Healthcare Virtual Conference on Tuesday, May 25 at 10:00 a.m. ET (Press release, Arvinas, MAY 20, 2021, View Source [SID1234580350]).

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A live audio webcast of the presentation will be available here and on Arvinas’ website at www.arvinas.com. A replay of the webcast will be archived on Arvinas’ website for 30 days following the presentation.

Invitae to Present at the William Blair 41st Annual Growth Stock Conference

On May 20, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that members of its management team will present at the William Blair 41st Annual Growth Stock Conference on Thursday, June 3, 2021 at 3:20 p.m. Central / 4:20 p.m. Eastern / 1:20 p.m. Pacific (Press release, Invitae, MAY 20, 2021, View Source [SID1234580366]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

The live webcast of the fireside chat may be accessed by visiting the investors section of the company website at ir.invitae.com. A replay of the webcast will be available shortly after the conclusion of the fireside chat.

Crescendo Biologics announces initiation of Phase 1 study of CB307 in patients with advanced, PSMA-positive solid tumours

On May 20, 2021 Crescendo Biologics Ltd (Crescendo), a clinical stage immuno-oncology company developing novel, targeted T cell enhancing therapeutics, reported that the first patient has entered the POTENTIA trial, a Phase 1, open-label, monotherapy study of CB307, the most advanced Humabody in Crescendo’s portfolio of T cell enhancers (Press release, Crescendo Biologics, MAY 20, 2021, View Source [SID1234580383]).

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CB307 is a unique, half-life extended Humabody targeting prostate-specific membrane antigen (PSMA) and the potent co-stimulatory molecule CD137 (4-1BB). Monospecific monoclonal antibodies against CD137 have been shown to enhance T cell activity in clinical studies as a cancer therapy, and CB307 is designed to enable potent, conditional and tumour-specific T cell activation whilst avoiding systemic toxicity.

The POTENTIA trial is a Phase 1, multi-centre, non-randomised study of CB307 in patients with advanced and/or metastatic PSMA-positive solid tumours. The study is designed to recruit up to 50 patients across dose escalation and expansion cohorts. The primary endpoint of the trial is to assess the safety and tolerability of CB307 and to determine the maximum tolerated dose.

Additional endpoints include initial evaluation of clinical efficacy, and the trial also includes a comprehensive panel of pharmacokinetic and other translational endpoints. Initial data from the dose escalation part of the trial are expected to be presented at a medical conference in 2022.

More information about the POTENTIA trial can be found on clinicaltrials.gov via NCT04839991 and in the poster recently presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2021.

Dr Kenji Hashimoto, Chief Medical Officer of Crescendo Biologics, said: "Recent clinical data have provided important validation for both PSMA and CD137 as therapeutic targets. We are therefore delighted to have initiated the CB307 clinical programme with our investigators. CB307 is a unique immuno-oncology therapy which we believe has potential to bring significant benefit to people suffering from hard-to-treat cancers."

Theodora Harold, Chief Executive Officer of Crescendo Biologics, added: "The initiation of the POTENTIA trial is an important milestone for Crescendo as it marks the beginning of clinical development of the first product candidate in our proprietary pipeline of T cell enhancing Humabody therapeutics. We have reached this point thanks to the dedication and focus of the Crescendo team, and we look forward to applying the data emerging from this trial to guide future clinical programmes."

ImmunoGen Announces Webcast of Presentation at Upcoming Jefferies Virtual Healthcare Conference

On May 20, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Susan Altschuller, Chief Financial Officer, and Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming Jefferies Virtual Healthcare Conference. The presentation is scheduled for June 2, 2021 at 9:30am ET (Press release, ImmunoGen, MAY 20, 2021, View Source [SID1234580399]).

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A webcast of the presentation will be accessible through the Investors and Media section of the Company’s website on www.immunogen.com. Following the live webcast, a replay will be available at the same location.