It was a busy week for the biotech sector. While leading biotech Celgene Corporation (CELG - Free Report) obtained EC approval for label expansion of its drugs, ImmunoGen (IMGN - Free Report) crashed on the outcome of a meeting with the FDA. However, Adverum (ADVM - Free Report) gained on the news of removal of clinical hold on its study.
Recap of the Week’s Top Stories:
Label Expansion of Celgene’s Revlimid, Imnovid Approved in Europe: Celgene announced that the European Commission (EC) has approved the label expansion of IMiD medications, leading oncology drug Revlimid (lenalidomide) and Imnovid. The EC approved Revlimid in combination with Velcade and dexamethasone (RVd) for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. The approval for RVd was supported by data from SWOG S0777, a phase III trial evaluating the triplet combination, RVd, in adult patients with previously untreated multiple myeloma.
The commission also approved Imnovid in combination with Velcade and dexamethasone (PVd) for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. The approval of PVd was supported by data from OPTIMISMM study, which evaluated the regimen in patients who were previously treated with Revlimid.
An approval was in the cards as the CHMP had recommended approval of the same last month. The new triplet regimens should improve outcomes for both newly diagnosed patients as well as those who have relapsed or become refractory to first-line therapy.
Celgene currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
FDA Recommends New Study for ImmunoGen Lead Drug: Shares of ImmunoGen declined after the FDA recommended a new study on lead candidate — mirvetuximab soravtansine. The agency has advised the company to conduct a phase III study to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with high folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer. ImmunoGen requested the meeting to discuss the results of the phase III FORWARD I trial and a potential path for registration of mirvetuximab as monotherapy.
The agency concluded that the data, assessing the secondary endpoints from the study, could not be used to support an application for accelerated approval and the company needs to conduct an additional trial. An additional study will involve extra costs. The company had approximately $270 million on the balance sheet at the end of the first quarter.
FDA Lifts Hold on Adverum Study: The FDA lifted the clinical hold on the second cohort of phase I trial on lead candidate, ADVM-022. The hold was lifted as the independent data monitoring committee (DMC) unanimously voted to proceed with dose escalation per protocol, following their review of the safety data from the first cohort. No patient in the first cohort has experienced a serious adverse event (SAE), with the first patient completing the 24-week (6 month) assessment.
The phase I study, OPTIC, is evaluating the candidate for age-related macular degeneration (wet AMD). As a result, the study can now evaluate a higher dose of 2 x 10^12 vg/eye, which is three times the dose of 6 x 10^11 vg/eye evaluated in the first cohort. However, Adverum will begin dosing in the second cohort with a lower dose of 2 x 10^11 vg/eye, which is three times lesser than the dosage in the first cohort based on the robust preliminary anatomical response observed to date. The dosing of patients in the second cohort will start next month.
Vertex Enters Into a Collaboration With Kymera: Vertex Pharmaceuticals (VRTX - Free Report) entered into a four-year strategic agreement with Kymera Therapeutics to advance small molecule protein degraders against multiple targets. The collaboration will leverage Kymera’s expertise in targeted protein degradation and its proprietary Pegasus drug discovery platform to accelerate the development of first-in-class drugs for serious diseases.
Kymera will conduct research activities in multiple targets under the collaboration while Vertex has the option to exclusively license molecules against the designated target. Kymera is also eligible to receive more than $1 billion in potential payments based upon the successful achievement of specified research, development, regulatory, and commercial milestones for up to six programs optioned as part of the collaboration. Moreover, Vertex will pay tiered royalties on future net sales on any products that result from this collaboration.
Biogen Urges Shareholders to Reject Tender Offer: Biogen (BIIB - Free Report) announced that it has received a notice of an unsolicited mini-tender offer by TRC Capital Corporation to purchase up to 500,000 shares of Biogen’s common stock at a price of $216.25 per share in cash. However, the company does not endorse TRC Capital’s unsolicited mini-tender offer and had urged shareholders not to accept the offer.
The NASDAQ Biotechnology index has gained 1.4% in the past five trading sessions. Among the major biotech giants, Celgene gained 2.2% in the period. Over the past six months, shares of Celgene have surged 42.5% whereas Biogen stock has lost 26.2%. (See the last biotech stock roundup here: Biotech Stock Roundup: FDA Nod for REGN's Eylea in DR, Tie-Ups & Other Updates).
What's Next in Biotech?
Stay tuned for pipeline development news.
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