Therapeutic Class

Biocon: One eye on biologics IPO to support blossoming biosimilars

Managing director Kiran Mazumdar-Shaw has told Indian news outlets Biocon could spin-out its biologics division to raise funds for further biosimilar development. Biocon is Indian’s largest pharmaceutical firm with a portfolio of small molecule and branded formulation products. But the Indian drugmaker has also begun to make its mark on the international biosimilars market with commercialization partner Mylan launching various products in both the US and European markets. Ogivri became the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved…

CDMO Masthercell boosting capacity and adding 150 jobs at Belgium plant

Months after doubling capacity at the Gosselies site, Orgenesis has announced further plans to expand its CDMO Masthercell too feed the demand for cell and gene therapies. Late last year, contract development and manufacturing organization (CDMO) Masthercell unveiled a wing with five cleanrooms at its site in Gosselies, Belgium, which it said effectively doubled its cell therapy production capacity. Four months on and the firm’s parent company Orgenesis has announced another expansion at the site having signed a lease on…

Manufacturing is the differentiator for CAR-T success, says Allogene

Allogene has tweaked the manufacturing process for its allogeneic CAR-T candidate ALLO-501 to produce more robust and consistent product. Since raising $324 million (€283 million) in an initial public offering (IPO) last October, Allogene Therapeutics has announced plans to build a 118,000 square foot cell therapy manufacturing facility in Newark, California and reported its first fourth quarter financials. In the call discussing the latter, the firm’s CEO David Chang told stakeholders that success for chimeric antigen receptor (CAR) T-cell therapies…

Breaking the Big 4: How Takeda is taking on vaccines

While vaccines will continue to be dominated by GSK, Merck, Pfizer, and Sanofi, manufacturing and collaborations can help to unblock this consolidated industry says recent entrant Takeda. Rahul Singhyi, COO of Takeda vaccines, told delegates at the BPI West event in Santa Clara, California that vaccines used to be viewed as “the backwaters of the pharma industry, largely considered part of corporate social responsibility,” but that has changed over the past 20 years due to innovations and approvals in disease…

Shanghai center aims to accelerate cell and gene therapy development

The ATLATL-MACS Center will support biotech firms in the burgeoning cell and gene therapy space and will include access to Miltenyi automated CAR-T preparation instruments. Having spent a year under construction, ATLATL-MACS Center opened this week. The center is a collaboration between ATLATL Innovation Cluster (AIC) – a Chinese innovation support firm offering lab space as a service – and cell and gene therapy vendor Miltenyi Biotec aimed at supporting the growing research in innovative and personalized medicines. ATLATL and…

Lonza’s POC CAR-T tech: Out with the cleanroom, in with the Cocoon

Lonza will provide its point-of-care (POC) Cocoon cell therapy platform to the Sheba Medical Center in Israel to provide automated and closed CAR-T manufacturing. The collaboration between Sheba and Swiss contract development and manufacturing organization (CDMO) Lonza aims to confirm the benefits of using the Cocoon system to make autologous cell therapies in a POC environment. “The partnership with Sheba will test the Cocoon in the clinical setting,” Eytan Abraham, head of Personalized Medicine at Lonza Pharma Biotech, told Bioprocess…

Moderna begins making mRNA cancer vaccine from MA plant

Moderna has successfully transferred personalized cancer vaccine capabilities to its recently opened production facility in Norwood, Massachusetts. In July 2018, Moderna Therapeutics opened a 200,000 square foot clinical development manufacturing plant in Norwood, Massachusetts to support its pipeline of messenger RNA (mRNA) therapies. “Since the site opening, we have successfully manufactured clinical grade mRNA and then moved to formulation and went to filling and finally labeling of our vials,” Stéphane Bancel, Moderna’s CEO told stakeholders during his firm’ recent Q4…

Biosimilar… but different: FDA tweaking nonproprietary name guidance

The US FDA has proposed changes to its nonproprietary naming guidance to remove the proposed controversial four-letter suffix from older biologics. In 2017, the US Food and Drug Administration (FDA) published guidance to include a random four-letter suffix to the international nonproprietary names (INN) of all biological products. The ruling essentially distinguished a biosimilar from its reference product, so Amgen’s reference product Neupogen, for example, is known as ‘filgrastim-jcwp,’ while Sandoz’s biosimilar version Zarxio – the first biosimilar approved and…

Precision Bio $100m IPO to support allo CAR-T build-out

Precision Bio hopes the initial public offering (IPO) will advance its off-the-shelf CAR-T candidates, based on its ARCUS genome editing platform. North Carolina-based Precision Bio has applied for a listing on the Nasdaq exchange. According to its Form S-1 filed with the SEC, the firm will use the anticipated $100 million (€88 million) raised in the IPO to advance and expand its clinical and preclinical development programs. This includes plans to complete a Phase I/IIa clinical trial for its CD19…

Xenetic buying Scripps-developed XCART technology

The currently marketed CAR-T therapies cannot discriminate between healthy and malignant B-cells says Xenetic Biosciences, which is buying a technology to enhance the safety and efficacy of such products. The XCART technology platform, developed by the Scripps Research Institute in collaboration with the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, will be used by Xenetic Biosciences to develop cell-based therapeutics for the treatment of B-cell Non-Hodgkin lymphomas. The two chimeric antigen receptor (CAR) T-cell products on the market – Kymriah (tisagenlecleucel) and…