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Puma Biotech (PBYI) Inks Agreement for Takeda's Alisertib

Puma Biotechnology PBYI shares were up almost 6% on Sep 20 after the company announced that it is acquiring global development and commercialization rights to Japan-based Takeda’s investigational aurora kinase A inhibitor, alisertib

Per the agreement, Takeda will receive an upfront payment of $7 million from Puma. Takeda is entitled to receive up to $283.73 million in potential regulatory and commercial milestone payments and tiered royalty payments for any net sales of the candidate if approved.

Alisertib is an adenosine triphosphate–competitive and reversible inhibitor of aurora kinase, which has been tested in clinical studies for various patients with metastatic cancers like breast cancer, small cell lung cancer, head and neck cancer, ovarian cancer, peripheral T cell lymphoma (PTCL) and acute myeloid leukemia.

Puma initially plans to focus on developing alisertib to treat patients with metastatic estrogen receptor-positive (ER-positive) HER2-negative breast cancer, triple-negative breast cancer and small cell lung cancer (SCLC).

Shares of Puma have declined 18.1% in the year-to-date period compared with the industry’s fall of 23.8%.

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In 2015, Takeda terminated a phase III study of alitersib in refractory PTCL based on a pre-specified interim analysis. The results indicated that the study is less likely to meet its primary endpoint of superior progression-free survival (PFS) over the standard-of-care treatment. Nevertheless, Takeda continued with the clinical development program of the candidate, testing it in other indications, including breast cancer, SCLC, non-Hodgkin lymphoma (NHL) and a slew of other solid tumor cancers.

Alisertib has previously been tested in a phase II clinical study as a single agent in ER-positive HER2-negative breast cancer and triple-negative breast cancer. Alisertib has also been tested in a phase II study in combination with AstraZeneca’s AZN Faslodex (fulvestrant) in ER-positive HER-2 negative breast cancer.

AstraZeneca’s Faslodex (fulvestrant) is approved as a monotherapy for expanded use in breast cancer in the United States, Europe and many other countries.

Alisertib has also been evaluated in a phase II clinical study in combination with Calgene’s [now a part of Bristol-Myers’ BMY] Abraxane (paclitaxel)against Abraxane (paclitaxel) monotherapy as a treatment for ER-positive HER2-negative breast cancer and triple-negative breast cancer.

Bristol-Myers acquired Calgene Pharmaceuticals in 2019, adding Abraxane (nab-paclitaxel) to its oncology portfolio. Abraxane is currently approved for treating breast cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer.

Alisertib had demonstrated meaningful clinical activity in ER-positive breast cancer patients who have previously been treated with a CDK4/6 inhibitor.Alisertib has also been tested as a treatment for small cell lung cancer as a single agent and in combination with Bristol-Myers’ Abraxane (paclitaxel) in a phase II study.

Alisertib is Puma’s second clinical-stage project.

Puma Biotechnology already markets Nerlynx (neratinib), a drug for HER2-positive breast cancer, in-licensed from Pfizer, which drives most of its revenues.

Moreover, Puma is working on expanding the usage of Nerlynx in multiple breast cancer settings and other types of solid tumor cancers.

Puma Biotechnology, Inc. Price


Puma Biotechnology, Inc. Price
Puma Biotechnology, Inc. Price

Puma Biotechnology, Inc. price | Puma Biotechnology, Inc. Quote


Zacks Rank and Stocks to Consider

Puma Biotechnology currently has a Zacks Rank #3 (Hold).

A better-ranked stock in the same sector is Sesen Bio SESN, flaunting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Sesen Bio’s loss per share estimates for 2022 widened from 31 cents to 43 cents in the past 30 days. The same for 2023 has narrowed from 10 cents to a cent in the same time frame.

Earnings of Sesen Bio missed estimates in all of the trailing four quarters. The average negative earnings surprise for SESN is 89.49%.

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