A lot seems happening this week in the biotech sector. Key highlights include Alexion’s ALXN announcement to acquire biotech company Syntimmune while Regeneron REGN obtained an FDA approval for its skin cancer drug.  The FDA also approved a label expansion of Amgen’s AMGN multiple myeloma drug.

Recap of the Week’s Top Stories:

Alexion to Acquire Biotech Syntimmune: Alexion Pharmaceuticals, Inc. announced that it will purchase a clinical-stage biotechnology company, Syntimmune, for $1.2 billion. To this end, the company will make an upfront payment of $400 million along with potential milestone payments of $800 million. The transaction is expected to close during the fourth quarter of 2018.

Syntimmune develops antibody therapeutics, targeting the neonatal Fc receptor (FcRn). The buyout will add a mid-stage candidate, SYNT001, to Alexion’s pipeline. SYNT001 is a humanized monoclonal antibody that inhibits the interaction of FcRn with Immunoglobulin G (IgG) and IgG immune complexes.  It is currently being evaluated in phase Ib/IIa studies on patients with warm autoimmune hemolytic anemia (WAIHA) and on those with pemphigus vulgaris (PV) or pemphigus foliaceus (PF).

The candidate has demonstrated proof of mechanism, showing a rapid IgG reduction in early clinical studies. Of late, Alexion has been quite active on the M&A front.  Earlier in 2018, the company bought Sweden-based Wilson Therapeutics at a value of $855 million. The acquisition will further diversify Alexion’s rare diseases pipeline.

Regeneron/Sanofi Get FDA Nod for Libtayo: Regeneron Pharmaceuticals, Inc. and partner Sanofi SNY announced that the FDA has approved Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC, who are not eligible for curative surgery or curative radiation.  The candidate was reviewed by the FDA under priority review. Libtayo, a fully-human monoclonal antibody, targets the immune checkpoint receptor PD-1 (programmed cell death protein-1).

Per the companies, this is the first and the only treatment, specifically approved and available for advanced CSCC in the United States. The FDA’s decision came much earlier than the scheduled date of Oct 28.

Cemiplimab is under review in the EU. Libtayo will be sold in the United States at a list price or wholesale acquisition cost of $9,100 per three-week treatment cycle. Moreover, cemiplimab is being studied as a monotherapy as well as in combination with other therapies to address a wide range of cancers including non-small cell lung cancer, advanced basal cell carcinoma, cervical cancer and lymphomas.

Gilead Collaborates With HiFiBiO Therapeutics: Gilead Sciences, Inc. GILD announced that it has entered into a research collaboration and license agreement with HiFiBiO Therapeutics to develop technology supporting the discovery of neoantigen-reactive T cell receptors (TCRs) for the potential treatment of various cancers including solid tumors.

Both companies will adapt HiFiBiO’s proprietary single cell technology platform to create a high throughput approach for in-depth screening of TCR repertoires from patient samples to identify shared antigen and neoantigen TCRs for use in adoptive cellular therapies. Per the terms of the agreement, HiFiBiO will receive a $10-million upfront payment along with significant milestones.

In exchange, Kite Pharma (Gilead’s subsidiary) will have an exclusive option to license HiFiBiO’s platform for screening T cell repertoires and identifying TCRs pertaining to its use in TCR engineered T cell therapies with a corresponding payment to HiFiBiO.

FDA Expands Label of Amgen’s Kyrpolis:  Amgen announced that the FDA has approved its supplemental New Drug Application (sNDA) to expand its multiple myeloma drug Kyprolis’ label. As a result, the same was expanded to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients suffering relapsed or refractory multiple myeloma.

The approval was based on positive data from a phase III study, A.R.R.O.W. The application was granted a priority review. The FDA reviewed the application under its Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot programs. Kyprolis is approved in combination with dexamethasone or with Revlimid plus dexamethasone for treating patients with relapsed or refractory multiple myeloma, who have received one to three lines of therapy in the United States.

Amgen carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Geron Plunges on Termination Deal With Janssen: Shares of Geron Corporation GERN plunged significantly after the company’s partner Janssen, a subsidiary of Johnson & Johnson, terminated the joint collaboration and license agreement related to developing Geron’s pipeline candidate, imetelstat.

The effective date of the deal’s termination was Sep 28, 2018. Consequently, Geron regains global rights to imetelstat program. Janssen’s decision was part of its strategic evaluation and prioritization of assets in its portfolio. However, the loss of partnership deal will adversely impact the imetelstat’s development program.

Performance

Medical – Biomedical and Genetics Industry 5YR % Return

 

Medical – Biomedical and Genetics Industry 5YR % Return

The NASDAQ Biotechnology index gained 0.16% over the last five trading sessions. Among major biotech stocks, the Alexion stock has increased 5.34% in the last five trading sessions. Over the past six months, shares of Biogen have rallied 29.42%. (See the last biotech stock roundup here: Biotech Stock Roundup: ALXN Soliris Successful, Respite For Sarepta, AMRN Soars).

 

What’s Next in Biotech?

Stay tuned for regulatory updates and pipeline development news.

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