Teneobio and its next-gen cancer work acquired by Amgen 

Amgen has penned a major new buyout deal to boost its oncology pipeline further. The biopharma is putting USD 900 million down upfront, with USD 1.6 billion in biobucks on the table to buy Teneobio and its suite of bispecific and multispecific antibody technologies focused on cancer and other disease targets.

The deal adds TNB-585, a phase 1 bispecific T cell-engager zeroed in at metastatic castrate-resistant prostate cancer (mCRPC), and several preclinical oncology pipeline assets with the potential for near-term IND filings. 

TNB-585 complements Amgen’s existing prostate cancer portfolio, including acapatamab (formerly AMG 160), a half-life extended, PSMA-targeted BiTE; and AMG 509, a STEAP1 x CD3 T cell-recruiting XmAb 2+1 immune therapy, which is both in phase 1.

The acquisition of Teneobio will bolster their ability to develop innovative medicines to treat patients with serious illnesses and to bring to market best-in-class products, particularly concerning multispecific and bispecific medicines directed against targets in a broad range of diseases across their core therapeutic areas, as said by David M. Reese, M.D., executive vice president of research and development at Amgen.

Signifier raises USD 35 Million to accelerate commercialization of eXciteOSA therapy

Signifier Medical Technologies now has about 35 million other things to add to its mission to build devices to enhance sleep-disordered breathing.

The London-based company recently closed its Series D funding round, which brought in USD 35 million from lead investors Segulah Medical Acceleration, Angelus Venture Fund I, Pioneer Healthcare Partners, and Alan Howard, the co-founder of European hedge fund platform Brevan Howard Asset Management.

Following close behind the FDA’s nod of Signifier’s flagship device for treating mild cases of sleep apnea and excessive snoring, the financing will mainly be utilized to back the commercialization of the eXciteOSA system.

Signifier will also fund further studies of the device to bolster the evidence of its treatment capabilities. It will continue to develop the eXciteOSA’s accompanying digital management platforms for both patients and physicians.

Roger Gunnarsson, the Managing Partner at Segulah Medical Acceleration, said in a statement that they are very thrilled about the prospects for eXciteOSA as a revolutionary daytime therapy to treat Obstructive sleep apnea (OSA). With around 25% of the global adult population suffering from sleep-disordered breathing, they believe that eXciteOSA will become the first-line therapy for these patients.

The eXciteOSA system centers on a handheld device, which is placed on the tongue for 20-minute sessions during the day. It emits low-intensity electrical impulses via four electrodes to trigger and strengthen the tongue and pharyngeal muscles.

Biogen-Ionis’ experimental drug meets primary goal in Alzheimer’s trial

Biogen and Ionis Pharmaceuticals have demonstrated that their experimental drug, BIIB080 (IONIS-MAPT), fulfilled the primary goal of safety and tolerability in the Phase Ib multiple ascending doses (MAD) clinical trials in mild Alzheimer’s disease patients.

An antisense treatment, BIIB080 potentially aims at microtubule-linked protein tau (MAPT) messenger RNA (mRNA) and impedes tau protein production. The placebo-controlled, two-part Phase Ib trial enrolled patients aged 50 to 74 years with confirmed amyloid positivity.

The first part was a MAD study that comprised 46 subjects, while the second open-label long-term extension part is underway. Subjects were enrolled into four ascending dose arms and randomized in a 3:1 ratio to get various intrathecal (IT) bolus administrations of BIIB080 or placebo.

Top-line data from the trial demonstrated that BIIB080 proffered a substantial time and dose-reliant decline in tau protein in cerebrospinal fluid (CSF) over a treatment period of three months and lasting decreases during the six months after treatment.

Subjects receiving low, medium, and high BIIB080 doses every four weeks had a mean reduction of 30%, 40%, and 49%, respectively, in the total-tau concentration in CSF eight weeks after the last dose the drug. The group receiving the treatment every 12 weeks had a 42% mean reduction in the total-tau concentration.

AbbVie hits go on USD 1 Billion re-upped Calico deal as Google’s life science spin-out continues I-O, Neuropush

AbbVie penned an early-stage deal seven years ago, with Google/Alphabet’s life sciences division Calico: the pair are penning a second extension for that collaboration.

This deal first saw pen hit paperback in 2014 and focused on age-related diseases, comprising neurodegeneration and cancer. Back in 2018, the pair inked their first extension to the collab, putting in an extra USD 1 billion to keep it going.

Another USD 1 billion (divided into halves) goes into the pot, and another extension, bringing the deal another three years from 2022, now up to 2025. Under the terms, Calico is responsible for research and early development until that date and will push the collab projects into phase 2a through to the next decade.

AbbVie, for its part, said it would continue to support Calico in its early R&D efforts and, when those midstage tests are done, it has an option to manage late-stage development and the sales side.

Since the deal got underway in 2014, in Calico’s early days after being formed by Google, researchers have developed more than two dozen early-stage programs in oncology and neuroscience. They have also discovered the underlying biology of aging.

Calico was by Alphabet and Calico CEO Arthur Levinson, Ph.D., who previously led Roche’s Genentech as chairman and CEO. With an R&D facility in the San Francisco Bay Area, the company remains relatively secretive, though this AbbVie deal has become one of its more public deals.

Details on the pipeline are still very thin. However, it proffered a crumb of information for its lead immuno-oncology target, which is currently in phase 1 studies and includes two Protein tyrosine phosphatase non-receptor type 2 (PTPN2) inhibitors, which act at multiple steps in the cancer immunity cycle.