Almirall has signed a licensing agreement with EpimAb Biotherapeutics to utilise the latter’s Fabs-In-Tandem Immunoglobulin (FIT-Ig) platform to develop up to three bispecific antibody targets. EpimAb is eligible for up to $210m (¥1.53bn) in milestone-based payments and net sale royalties. Almirall will hold exclusive global commercialisation rights over the therapies developed during the course of the partnership, based on a 12 October press release. EpimAb’s FIT-Ig platform rearranges the DNA sequences of two monoclonal antibodies to generate bispecific antibodies. “While we have made significant progress in utilizing our platform technology to develop a differentiated portfolio of bispecific antibodies in oncology, the potential of our platform in other areas such as immunology remains untapped,” said EpimAb’s CEOChengbin Wu in the press release. “We believe Almirall is the partner of choice for this endeavour and look forward to exploring the use of our novel bispecific platform to offer additional treatment options for ...
Amid a global expansion spree at WuXi Biologics, the company’s immunization-focused subsidiary has christened its inaugural CDMO site in China. Tuesday, WuXi Vaccines launched its first standalone vaccines contract manufacturing facility in Suzhou. With the plant, the company adds drug substance and drug product capacity for projects in various stages of development. WuXi Vaccines is a contract development and manufacturing organization that helps its partners tackle clinical- and commercial-stage vaccine projects across a range of modalities, including protein-, virus- and mRNA-based shots. The new site’s drug substance production area houses two cell culture lines and one purification line, teeing up drug substance production scales ranging from 50 liters to 1,000 liters, according to a release. WuXi Vaccines says it will also maintain 2,000 liters of reserve capacity at the facility. Meanwhile, the drug product facility is equipped with an automatic vial washing, sterilizing, filling and capping line, which can support ...
By Tristan Manalac Pictured: Illustration of a blood clot in a blood vessel/iStock, libre de droit Anthos Therapeutics is ending the Phase II AZALEA-TIMI 71 study ahead of schedule after its investigational monoclonal antibody abelacimab demonstrated an “overwhelming reduction” in bleeding compared to Bayer and Johnson & Johnson’s Xarelto (rivaroxaban), the company announced Monday. Patients treated with abelacimab saw a sharp reduction in the composite endpoint of major and clinically relevant non-major bleeding events compared with counterparts given rivaroxaban, the current standard-of-care oral anticoagulant. The Massachusetts-based biopharma did not provide specific data in Monday’s announcement but said that the Data Monitoring Committee stopped the study early following these data. Anthos will share the full results and analysis of the trial in an upcoming medical meeting. Due to the “overwhelming reduction in bleeding” reported in AZALEA-TIMI 71, abelacimab may represent a “paradigm shift” in atrial fibrillation care particularly in the prevention ...
Johnson & Johnson’s plan to expand decade-old pulmonary hypertension med Opsumit has hit a snag.J&J’s Janssen has decided to stop a phase 3 trial for a 75-mg dose of macitentan in patients with chronic thromboembolic pulmonary hypertension (CTEPH). The company pulled the plug after an independent data monitoring committee performed an interim analysis and figured the trial wouldn’t succeed. Macitentan, given at 10 mg daily, won approval in 2013 under the brand name Opsumit for treating pulmonary arterial hypertension (PAH). PAH and CTEPH are slightly different diseases, but both feature abnormally high blood pressure in the arteries of the lungs. The results from the high-dose trial, dubbed MACiTEPH, won’t affect the marketed product, J&J said. Separately, J&J is trying to show that the higher dose works better than the FDA-approved 10-mg version in PAH. That study, coded UNISUS, remains ongoing with an estimated primary completion date next month, according to ...
Eight years after an initial FDA approval in heavily pretreated colorectal cancer, Taiho Oncology’s Lonsurf has won another green light in the same indication but as part of a more powerful regimen. Instead of a single-agent regimen, the FDA on Wednesday cleared Lonsurf to be used alongside bevacizumab for previously treated metastatic colorectal cancer. Patients who have tried an anti-VEGF inhibitor such as bevacizumab—originally developed by Roche as Avastin—may also qualify for this new combo. The Lonsurf-bevacizumab cocktail proved to be more efficacious than Taiho’s drug alone. Compared with Lonsurf monotherapy, the new combination significantly reduced the risk of death by 39% in a group of patients who had previously received a maximum of two prior chemotherapy regimens and an anti-VEGF agent, plus, in some cases, an anti-EGFR therapy such as Eli Lilly’s Erbitux. In that phase 3 trial, patients who received the combo lived a median 10.8 months, while ...
Pictured: Illustration of a liver with tumors/iStock, libre de droit A pre-specified primary analysis of the Phase III CARES 310 trial showed that Elevar Therapeutics’ cancer candidate rivoceranib, when combined with fellow investigational drug camrelizumab, significantly improved survival in patients with unresectable hepatocellular carcinoma, the company announced Monday. Patients who received the drug combination saw a 48% reduction in the risk of death or disease progression, an effect that was significantly better as compared with Bayer’s Nexavar (sorafenib), the standard first-line treatment for unresectable hepatocellular carcinoma (uHCC). At the interim analysis, overall survival was also significantly longer in the rivoceranib-camrelizumab group versus Nexavar. Results of CARES 310 showed that “camrelizumab plus rivoceranib demonstrate significant promise as a potentially improved therapy for advanced hepatocellular carcinoma,” Elevar CEO Saeho Chong said in a statement. The study’s findings were published Monday in the medical journal The Lancet. CARES 310 is a randomized, ...
NASDAQ-listed Bicycle Therapeutics has announced that $200m worth of shares will be available at a price of $21.25 each. The company, which has offices in the UK and US, expects the underwritten public offering to close around 17 July. On 13 July, more than 12 times the volume of shares were traded on the exchange, compared to the previous day. The underwriters will also have the option to purchase a further $30m of shares in a 30-day period. The company has recently signed two lucrative deals with Novartis and Bayer for the use of its peptide technology to develop radio-conjugates. In March, Novartis paid an upfront sum of $50m, and a possible $1.7bn in milestone payments. Bayer then followed suit in May, with a $45m upfront deal, with a possibility of a further $1.7bn. Both partnerships involve undisclosed oncology targets. The company reported net losses of ...
Clinical-stage biotech Recursion continues to go from strength to strength. After its recent acquisition of Cyclica and Valence, the company announced a partnership with—and $50 million investment from—NVIDIA on Wednesday. Under the agreement, the tech giant is giving Recursion a $50 million private investment in public equity. The two companies are looking to accelerate the development of Recursion’s AI foundation models to help the biopharma industry create improved patient therapies more quickly. “With our powerful dataset and NVIDIA’s accelerated computing capabilities, we intend to create groundbreaking foundation models in biology and chemistry at a scale unlike anything that has ever been released in the biological space,” Recursion CEO Chris Gibson said in a statement. Recursion has built a massive biological and chemical database via its Recursion OS, which exceeds 23 petabytes and has three trillion searchable compound and gene relationships. The company has been training machine-learning algorithms on this dataset to tackle the complex ...
The FDA turned down the closely watched eye med because of manufacturing problems the agency spotted at a third-party drug filler, Regeneron said in a release. The FDA didn’t flag any issues with the med’s efficacy and safety or its labeling and drug substance manufacturing and didn’t request additional clinical data, the company said. In a race against Roche’s Vabysmo, Regeneron and its partner Bayer’s application for the 8 mg Eylea (aflibercept) version was accepted in February, hoping for approval in wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. Despite the hurdle, Regeneron remains “committed to working closely with the FDA and the third-party filler” to introduce the high-dose drug, the company said. A Regeneron spokesperson declined to comment on the identity of the filler or where it’s located. Elsewhere, the FDA recently published a Form 483 against an Eli Lilly plant in Indianapolis after an inspection in ...
An Astellas Pharma drug that treats hot flashes and night sweats from menopause is now approved by the FDA, a regulatory decision that makes the therapy the first one that hits a particular central nervous system target to ease the symptoms of this change in life. The Friday approval of the drug, fezolinetant, covers the treatment of moderate-to-severe vasomotor symptoms caused by menopause. Tokyo-based Astellas will market the once-a-day pill under the brand name Veozah. In an email, the company said the new drug will carry a wholesale price of $550 for a 30-day supply. Astellas expects Veozah will become available within three weeks. Menopause brings a decline in the production of estrogen and progesterone. The resulting hormonal imbalance can affect the way the body regulates body temperature, leading to hot flashes, the sudden and intense feelings of warmth. While hormone therapy is standard treatment for such vasomotor symptoms, ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.