EyesOn AbbVie, Sangamo, and Pfizer

This week we've had EyesOn all the recent Business Development activities in the BioPharma world. We're sharing a few that caught our eye. Check out AbbVie's acquisition of Apogee to strengthen out their I&I portfolio, Sangamo's asset sale, and Pfizer's recent clinical results from one of their Seagen candidates.

Apogee Therapeutics will be acquired by AbbVie for $10.9 billion. Eli Lilly, Regeneron, and Sanofi may face competition from AbbVie’s acquisition of a late-phase eczema treatment candidate.

Zumilokibart, an anti-IL-13 antibody that has wowed analysts and investors in recent phase 2 updates, is Apogee’s top option. Cross-trial comparisons indicate that the therapeutic candidate can reduce injection burden while matching or surpassing the effectiveness of Sanofi and Regeneron’s Dupixent and Lilly’s Ebglyss, both of which target IL-13. In the phase 2 experiment, patients were given zumilokibart every three or six months.

In a note to investors, analysts stated that the transaction is a natural fit with AbbVie’s current portfolio of immunology and inflammation (I&I) products. With Skyrizi and Rinvoq as its main medications, AbbVie’s success in I&I indicates the business has what it takes to fulfil the potential of zumilokibart.

Analysts expect clear synergies with AbbVie’s portfolio for zumilokibart if the business can eventually commercialise the treatment, despite investors debating which long-acting atopic dermatitis competitors may demonstrate the best sustained efficacy, with many turning to Nektar as well.

When phase 2 data was released in March, analysts doubled their peak sales projection to $5.2 billion, confirming Apogee’s position as a possible rival to Ebglyss and Dupixent.

After Apogee released induction results from the second phase 2 trial, the analysts reiterated their prediction last month. Apogee and AbbVie observed comparable rates of complete skin clearance and very minimal disease activity, according to data on Rinvoq.

With a combined revenue of almost $26 billion last year, Skyrizi and Rinvoq are essential to AbbVie’s operations. AbbVie is under pressure due to a number of factors, including the approval of Johnson & Johnson’s oral psoriasis medication Icotyde and the widening of the label for its injectable Tremfya.

Concerns about how AbbVie’s I&I portfolio would be affected by changes in the competitive landscape are growing among analysts. AbbVie cited its highly active dealmaking as proof that it can maintain its competitive edge.

In the upcoming years, the benefits of the Apogee agreement may become more apparent. Apogee stated last month that it anticipates releasing one-year data from the second phase of its zumilokibart study in the first half of 2027. Phase 3 data may be available in 2028. This year, phase 1b data on a different therapeutic candidate that targets OX40L and IL-13 are due. The asset, APG279, is being compared to Dupixent in the phase 1b trial.

Apogee had secured up to $1.3 billion from Blackstone Life Sciences, positioning itself to launch zumilokibart. However, AbbVie convinced the biotech to give up with a cash offer of $135.11 per share. Towards the beginning of June, Apogee’s stock was trading below $80; toward the end of the week, it ended just above $90.

Sangamo, a struggling genomic medicine startup, has had a difficult time lately, with unfulfilled R&D aspirations and a sharp decline in stock price. The company is currently laying off employees, declaring bankruptcy, and disclosing asset sale deals with two major pharmaceutical corporations.

As part of Sangamo’s bankruptcy process, Eli Lilly and Astellas have turned prospective buyers for specific assets, the biotech recently said. As its bankruptcy process begins, Sangamo revealed the interest in its assets and stated that it has received significant baseline proposals.

According to the business, Lilly is in line to acquire Sangamo’s prion disease program ST-506, zinc finger platform, capsid delivery platform, and modular integrase (MINT) platform as part of a recent dealmaking spree.

Astellas, a Japanese pharmaceutical company, plans to acquire Sangamo’s Fabry disease asset, isaralgagene civaparvovec. As of June of last year, Sangamo claimed that data from a phase 1/2 trial will help with an attempt to obtain an expedited approval.

Sangamo stated that almost all of its assets would be for sale during the bankruptcy process. According to the biotech, additional assets not included in the agreements between Lilly and Astellas include Sangamo’s ST-503 for chronic neuropathic pain, giroctocogene fitelparvovec for haemophilia A and its cell treatment, and regulatory T cell (Treg) assets.

According to the company, the troubled biotech is also laying off about 51 employees, or almost 40% of its whole workforce. 77 workers will be left to manage the assets that will be acquired by Lilly and Astellas.

Sangamo has been dealing with declining cash reserves for years, despite having prominent agreements with multiple companies. About eighteen months ago, Sangamo lost a significant partner when Pfizer withdrew from a haemophilia A gene therapy partnership.

Over a five-year period, Sangamo’s stock has fallen by 99%, indicating that investors have moved on and its options have decreased. The business feels that this procedure offers a clear framework for pursuing value-maximizing transactions after a thorough analysis of all available options.

Pfizer’s high-stakes wager on antibody-drug conjugates (ADCs) has seen a setback. Following its $43 billion acquisition of Seagen, the pharmaceutical company revealed last week that sigvotatug vedotin, the first novel ADC to read out key data, had failed a phase 3 lung cancer trial.

The phase 3 SigVie-002 trial, also known as Be6A Lung-01, missed its primary aim because the putative first-in-class ADC did not substantially enhance overall survival (OS) when compared with docetaxel treatment in patients with previously treated nonsquamous NSCLC.

Pfizer’s chief oncology officer stated that the readout, along with additional phase 1 data, supports the company’s confidence in the potential of the sigvotatug vedotin program, which includes an ongoing phase 3 trial in combination with pembrolizumab in first-line advanced NSCLC. However, it also shows a stronger trend for OS and progression-free survival in a subgroup of patients who received only one prior line of therapy.

Integrin beta-6 (IB6), which is expressed in over 90% of NSCKC tumours, is the target of sigvotatug vedotin. According to Pfizer, an exploratory study of the SigVie-002 trial revealed no conclusive link between patient response and IB6 expression.

In the meantime, patients with first-line NSCLC who have high levels of PD-L1 expression are being evaluated for the combination of sigvotatug vedotin and Merck & Co.’s Keytruda in the phase 3 Be6A Lung-02 trial, which the firm mentioned when discussing its ongoing confidence in the program.

According to Pfizer’s principal investigator, sigvotatug vedotin’s capacity to cause immunogenic cell death offers a compelling case for combination methods with immunotherapy, especially in earlier treatment settings where immunological competence is better retained.

The most recent trial failure raises doubts about Pfizer’s capacity to develop ADCs outside of Seagen’s current commercial offers. Pfizer has consistently reduced efforts around its RemeGen-partnered HER2 ADC disitamab vedotin since the acquisition, discontinuing a B7-H4 ADC a year ago.

The New York pharmaceutical company eliminated PF-08046037, which employs a TLR7 agonist as an immunostimulatory payload rather than a cytotoxic payload, and pruned PF-08046031, an ADC that targets CD228, earlier this year.

Pfizer claims to be actively developing next-generation ADCs with a range of variations, such as new targets, antibody structures, and innovative payloads. In contrast to the MMAE payload utilised in sigvotatug vedonin, Pfizer is testing an additional IB6 candidate using Topol 1.

Additionally, the business is investigating potential combinations of sigvotatug vedotin, such as with its recently acquired PD-1xVEGF bispecific antibody, PF-08634404, which is another exciting area in first-line NSCLC therapeutic development.

Pfizer also stated that fetrastobart vedotin (PF-08046054), a PD-L1-directed ADC, is undergoing a phase 3 trial in NSCLC patients who have already received treatment.

In a roadmap released following the acquisition of Seagen, the company shared that it hopes to develop at least eight successful cancer medications by 2030.

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