The BioWorld Cancer index, which includes 21 representative companies developing therapies targeting various cancers, entered the new year on a high note, after posting a 22.5% gain for the year. Unfortunately, the group hit a speed bump and the index took a beating in January, dropping almost 9% as a result. However, it didn’t take long for the index to recover those gains and then some as, so far this month, it has pushed 10.6% higher, driven by impressive performances of index members Adaptimmune plc and Aduro Biotech Inc. (See BioWorld Cancer index 2020, below.)
Both companies struggled in 2019, seeing their share values drop dramatically. Now they appear to be on the comeback trail after posting positive news.
Adaptimmune reported at the J.P. Morgan Healthcare Conference last month two confirmed partial responses (PRs) – one in a patient with liver cancer and one in a patient with melanoma. There were also two unconfirmed PRs – one in a patient with gastroesophageal junction cancer and one in a patient with head and neck cancer. Those data, the company said, further confirm the potential of its Specific Peptide Enhanced Affinity Receptor (SPEAR) T-cell therapies cell platform for patients with multiple solid tumors.
The company also reported forging an alliance worth up to $897.5 million with Astellas Pharma Inc. to co-develop and co-commercialize stem cell-based allogeneic CAR T and T-cell receptor (TCR) cell therapies. In addition to the up-front payment, Oxford, U.K.-based Adaptimmune could receive up to $73.75 million in development milestones for up to three products it co-develops with Astellas. Alternatively, it could earn up to $147.5 million in per-product development milestones and up to $110 million in total sales milestones should it fail to opt in and Astellas opted to develop the products independently.
The co-development deal covers up to three targets but excludes any targets that Adaptimmune is already working on in-house or with partners, although there is scope to move existing unpartnered programs into the alliance. On the strength of those announcements, the company’s shares (NASDAQ:ADAP) received a welcome boost and closed January up 225% (235% YTD).
The company also took advantage of its increasing share value and raised net proceeds of $78.1 million from an underwritten public offering of its American depositary shares.
This month, Aduro, of Berkeley, Calif., which is focused on developing therapies targeting the immune system cGAS-STING (stimulator of interferon genes) and APRIL (A Proliferation-Inducing Ligand) pathways for the treatment of cancer, autoimmune and inflammatory diseases, said it earned a $10 million development milestone payment under its worldwide licensing agreement with Merck & Co. Inc., following the start of a phase II trial of MK-5890, an anti-CD27 agonist, in non-small-cell lung cancer (NSCLC). The study is designed to assess the efficacy and safety of Keytruda (pembrolizumab) in combination with MK-5890 in patients with advanced squamous or nonsquamous NSCLC that have been previously treated with anti-PD-L1 therapy. The study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol.
The company said it is also restructuring in order to further extend its operating capital and align personnel toward executing its clinical development strategy. The plan is to reduce the current workforce by 51 employees (approximately 59%) across the organization, minimize its corporate facilities footprint and shut down the Aduro Biotech Europe headquarters in Oss, the Netherlands, by the end of the third quarter. The company’s shares (NASDAQ:ADRO) have increased 186% year to date.
Also pushing 42% higher this year, and continuing its successful 2019 performance, is New York-based TG Therapeutics Inc. (NASDAQ:TGTX). In January, it reported it had initiated a rolling submission of an NDA to the FDA requesting accelerated approval of umbralisib, the company’s oral, once-daily, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma and follicular lymphoma. It expects to complete the submission in the first half of this year.
Menlo Park, Calif.-based Forty Seven Inc., which moved the needle big time last year, with its shares (NASDAQ:FTSV) vaulting a whopping 150%, has carried that momentum into 2020, with the share value up 14%. The immuno-oncology-focused company said its expected milestones for this year include advancing magrolimab in registration-enabling programs for the treatment of patients with untreated, higher-risk myelodysplastic syndrome (MDS) and heavily pretreated, relapsed or refractory diffuse large B-cell lymphoma. In MDS, it plans to initiate a phase III ENHANCE trial evaluating the combination of magrolimab and azacitidine compared to azacitidine alone in patients with untreated, higher risk-MDS in the second quarter.
In a research note, Wainwright analyst Swayampakula Ramakanth said that following discussions with company management, “we believe the company has a sound strategy to secure U.S. approval for its lead product, magrolimab (5F9), for the treatment of myelodysplastic syndrome in the U.S. in 2022.”