Amunix Pharmaceuticals, Inc.

Despite largely exiting oncology, Sanofi continues to reap the benefit of its multiple myeloma treatment Sarclisa. The FDA on Friday approved the anti-CD38 treatment as a first-line option for patients who have been recently diagnosed but are not eligible for an autologous stem cell transplant. The French pharma said it’s the only CD38 blocker that’s been shown to reduce the risk of death when combined with standard of care compared to standard of care alone. That regimen is known as VRd because it’s a combination of Velcade, Revlimid and the corticosteroid dexamethasone. The decision marks the third approval for Sarclisa and the first time it’s been given the green light to treat newly-diagnosed patients. Sarclisa was first approved in March 2020 as a third-line treatment in patients with relapsed or refractory multiple myeloma. “Since first launching in 2020, we have made significant progress towards our ambition of establishing Sarclisa as a best-in-class therapy,” Brian Foard, Sanofi’s head of specialty care, said in a statement. Sanofi’s Phase 3 data found the estimated progression-free survival rate at five years was 63.2% for patients receiving Sarclisa on top of VRd compared to 45.2% for patients who just received the standard of care. Nearly three-quarters of patients who received Sarclisa notched a complete response or better compared to 64.1% of patients who did not. The safety profile in that trial is similar to the already known side effects of Sarclisa and VRd. The most frequent serious adverse event was pneumonia, which occurred in 30% of patients receiving Sarclisa, but more patients dropped out of the VRd-only arm due to side effects than those who received Sarclisa. The treatment is being studied in a handful of other mid-to-late stage studies across six multiple myeloma indications, and Sanofi said it’s assessing a subcutaneous version as well. Sarclisa has fared well on the market so far, earning €227 million ($253 million) in the first half of the year , a 32% increase compared to the same period in 2023. Despite the drug’s early success and continued regulatory nods, Sanofi decided that oncology is no longer a priority when it comes to R&D spending. R&D head Houman Ashrafian said at a company R&D day at the end of last year that the company has “the right to win in oncology, but in a focused way.” A large-scale restructuring of Sanofi’s R&D strategy went into effect earlier this year, with the company winding down some oncology-focused partnerships and early-stage assets. It also sold three T cell engagers acquired from Amunix to Vir Biotechnology in a transaction that closed earlier this month.

Vir Biotechnology’s workforce changes alone are expected to bring in around $50 million of annual cost savings from next year. Vir Biotechnology’s second-quarter earnings report wasn’t short of big news. The company welcomed a trio of clinical-stage T-cell engagers (TCEs) from Sanofi while discarding a quarter of its workforce and a clutch of preclinical vaccine programs.This “strategic restructuring” is designed to push more resources into Vir’s hepatitis program “and focus on the highest near-term value opportunities,” the biotech explained.It means phasing out some preclinical programs like VIR-7229, a next-generation COVID monoclonal antibody that was being developed with funds from the U.S. government, as well as VIR-2981, a neuraminidase-targeting monoclonal antibody against influenza A and B.Also being thrown on the scrap heap is Vir’s T cell-based viral vector platform. The platform produced a preclinical therapeutic cancer vaccine called VIR-1949 as well as a HIV vaccine dubbed VIR-1388 that had made it into a phase 1 trial.  These R&D changes will save $50 million through to the end of 2025, money that Vir plans to reinvest in candidates it licensed from Sanofi today.That deal, announced alongside yesterday’s earnings, sees Vir paying an undisclosed upfront fee and potential milestone payments for three masked TCEs in phase 1. SAR446309 is a dual-masked HER2-targeted TCE, while SAR446329 is a dual-masked PSMA-targeted TCE and SAR446368 is a dual-masked EGFR-targeted TCE.The deal also gives Vir exclusive use of the protease-cleavable masking platform that Sanofi acquired as part of its $1 billion buyout of Amunix Pharmaceuticals in 2021. The platform “can be applied to TCEs, cytokines, and other molecules by exploiting the intrinsically high protease activity of the tumor microenvironment to specifically activate drugs in tumor tissues,” Vir explained in an accompanying release.Alongside these pipeline changes, Vir is waving goodbye to around 140 employees—equivalent to 25% of its workforce. It means the company is set to end the year with about 435 employees—a decrease of around 200 from Vir’s “peak headcount” a year ago, the company explained.“This decision was not taken lightly yet is essential to ensure that our resources are aligned with our evolving strategy and that Vir is positioned for sustainable growth and long-term success,” Vir CEO Marianne De Backer, Ph.D., said in the Aug. 1 earnings report.These workforce changes alone are expected to bring in around $50 million of annual cost savings from next year. Combined with the elimination of 75 positions and the biotech’s small-molecule group back in December, it means the company will have reduced its costs by around $90 million since 2023 and will be able to use a portion of these savings to take on some key personnel tied to the Sanofi deal. Carving off a chunk of its workforce doesn’t come cheap, though, and Vir expects related expenses to land between $11 million and $13 million, primarily from severance payouts.It’s not like Vir was short of cash to begin with, either, having ended June with $1.43 billion in the bank.At the forefront of the restructured Vir will be its hepatitis program. In June, the company shared early data from a phase 2 trial suggesting that its hepatitis D cocktail—comprising tobevibart or elebsiran—may have an edge over Gilead Sciences' bulevirtide.“The positive preliminary SOLSTICE phase 2 study together with the recent FDA IND clearance and fast track designation for tobevibart and elebsiran for the treatment of chronic hepatitis delta infection highlight the encouraging momentum we’re building towards addressing the substantial unmet medical need for patients affected by this life-threatening disease,” De Backer said in yesterday’s release.“In addition, we are taking decisive steps to strategically restructure our organization and prioritize our resources to focus on the highest value near-term opportunities,” she added. “These key strategic decisions will enable us to drive sustainable growth and accelerate patient impact as we advance in our mission of powering the immune system to transform lives.” 

Vir expects to save approximately $100m from its “strategic restructuring”, which will be reinvested into the Sanofi-licensed programmes. Image Credit: izzuanroslan / Shutterstock. Vir Biotechnology has signed a licensing agreement with Sanofi for three clinical-stage masked T-cell engagers (TCE) for cancer treatment. The US-based company has also started strategic restructuring, which includes a workforce reduction of approximately 25% and the discontinuation of its influenza and Covid-19 programmes . Vir will also phase out its T cell-based viral vector platform . The company expects to save approximately $50m each from staff cuts and pipeline reprioritisation, which will be reinvested into the Sanofi-licensed programmes. Vir reported $1.43bn in cash reserves at the end of Q2. The Sanofi-licensed TCE candidates include SAR446309, a dual inhibitor of HER2 and CD3; SAR446329, a dual-masked PSMA and CD3 TCE; and SAR446368, a dual-masked EGFR and CD3 TCE. The TCE candidates were developed using the protease-cleavable masking platform, which Sanofi acquired from Amunix Pharmaceuticals . Both SAR446309 and SAR446329 are being evaluated in Phase I trials in patients with metastatic treatment-resistant HER2-positive tumours and metastatic castration-resistant prostate cancer, respectively. Data from both trials is expected in H2 2025. The Phase I trial for SAR446368 in patients with EGFR-expressing tumours is expected to start enrolment by Q1 2025. See Also: Casgevy: Launch sequence and price analysis of the first marketed CRISPR therapy FibroGen axes 75% of staff after lead cancer therapy fails in Phase III trials Although Vir did not disclose the financials of the licensing deal, it stated that Sanofi would receive an upfront payment, milestone-based payments, and royalties on net sales. Vir’s lead programme is chronic hepatitis delta combination treatment of tobevibart, an investigational monoclonal antibody; and elebsiran, an investigational small interfering ribonucleic acid therapy. The combination therapy is being developed in partnership with Alnylam Pharmaceuticals . The tobevibart and elebsiran combination treatment received fast track designation and investigational new drug clearance from the US Food and Drug Administration in June. The same month, the companies reported positive preliminary data from a Phase II SOLSTICE trial (NCT05461170) showing that the combination treatment of tobevibart and elebsiran achieved high rates of virologic response at weeks 12 and 24. Additional data from the study is expected in Q4 this year. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy