AbbVie (NYSE:ABBV) and Janssen Pharmaceutical (NYSE:JNJ) have revealed their intent to voluntarily withdraw the accelerated approvals for Imbruvica (ibrutinib) for patients with mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) in the U.S. Ibrutinib is a selective Bruton’s tyrosine kinase (BTK). The main reasons for the move relate to FDA’s request for additional studies…
BioTheryX’s Prodegy platform takes center stage in cancer research partnership with Incyte
BioTheryX, a privately-held company, and Incyte (Nasdaq:INCY) have formed a research collaboration and license agreement. Their focus is on discovering and developing molecular glue targeted protein degraders for oncology targets. Several other privately-held companies also focus on protein degradation. Examples include Kymera Therapeutics (Cambridge, Massachusetts), Arvinas (New Haven, Connecticut), Nurix Therapeutics (San Francisco), Cullgen (San…
The new National Cancer Plan launches with goal of cutting cancer death rate by half in 25 years
Today, the U.S. Department of Health and Human Services (HHS) debuted the National Cancer Plan with an ambitious albeit vague quest to “end cancer as we know it.” Specifically, the initiative will serves as a guideline to support President Biden’s Cancer Moonshot objectives, which aims to reduce the cancer mortality rate by 50% over a…
Dostarlimab shows promise in improving endometrial cancer treatment outcomes
Endometrial cancer, a common gynecological malignancy, leaves considerable unmet needs for patients with advanced or recurrent disease. GSK‘s (NYSE:GSK) Jemperli (dostarlimab), a PD-1 receptor antagonist, brings hope to the numerous women diagnosed with this cancer each year. As the first immunotherapy approved for patients with deficient mismatch repair (dMMR) endometrial cancer, dostarlimab has the potential…
This RNA sensor could trigger cells to turn on a synthetic gene
Engineers at MIT designed a new way to trigger cells that could lead to targeted therapies for cancer and other diseases. Using an RNA sensor for the trigger, the researchers ensure that synthetic genes activate only in specific cells. They demonstrated that the sensor could accurately identify cells expressing a mutated version of the p53…
AbbVie’s partnership with Dare to Dream Project focuses on pediatric leukemia
AbbVie Oncology (NYSE:ABBV) recently joined the Dare to Dream Project, an initiative of the Leukemia & Lymphoma Society (LLS) focused on improving the treatment of cancer patients. The initiative is designed to accelerate the development of novel treatments for pediatric blood cancers. In the interview, Pooja Hingorani, the medical director of oncology early development at AbbVie,…
Pfizer’s elranatamab wins priority review from FDA for multiple myeloma
FDA has granted priority review to Pfizer’s (NYSE:PFE) bispecific antibody elranatamab for patients with relapsed or refractory multiple myeloma (RRMM). Also known as PF-06863135, the immunotherapy won breakthrough therapy designation from the FDA for RRMM in November 2022. The FDA has also accepted elranatamab’s Biologics License Application (BLA) while the European Medicines Agency (EMA) has…
Exploring the future of mRNA therapy: Where are we now?
Interest in mRNA therapy has exploded in recent years following the development of mRNA-based COVID-19 vaccines, but can the platform live up to the initial hype that surrounded it? More companies have announced clinical trial data from mRNA trials for conditions ranging from cardiovascular disease to cancer. mRNA, or messenger RNA, is a type of…
FDA approves Jemperli to treat dMMR-related endometrial cancer
FDA has approved Jemperli from GSK (NYSE:GSK) for adult patients with mismatch repair-deficient or advanced endometrial carcinoma (dMMR). GSK predicts Jemperli will generate peak sales of $1.4 billion to $2.8 million. The drug is indicated for adults with dMMR-related or advanced endometrial carcinoma who have progressed after a previous platinum-containing regimen. This drug is not…
Ymmunobio gets ownership rights to NPTXR antibodies
The biotech Ymmunobio has acquired ownership rights to neuronal pentraxin receptor (NPTXR) antibodies, which could promise in treating several gastrointestinal cancers. Basel, Switzerland–based Ymmunobio reached an agreement with Nagoya University in Japan in 2022 to transfer rights to the antibodies. Professor Mitsuro Kanda of Nagoya University invented the antibodies. A 2020 article published in Molecular…
Federated learning pact between Penn Medicine and Intel boosted glioblastoma detection capabilities
A research alliance between Penn Medicine and Intel aggregated data from 6,314 glioblastoma (GBM) patients at 71 sites across six continents over three years. The study made use of federated learning – a distributed machine learning (ML) approach – to facilitate the identification of malignant brain tumors without compromising patient privacy. The research led to…
Genentech on how Lunsumio could shift the treatment landscape for R/R FL
In late 2022, the FDA approved Genentech‘s Lunsumio (mosunetuzumab-axgb), a bispecific antibody for relapsed or refractory follicular lymphoma (R/R FL) patients who have received at least two prior systemic therapies. We recently caught up with Ginna Laport, VP, global head of lymphoma/CLL development franchise at Genentech, to learn more about how the drug could change the…
Why the immunotherapy startup 3T Biosciences is working with Boehringer Ingelheim
At the dawn of 2023, 3T Biosciences and Boehringer Ingelheim (BI) revealed a strategic collaboration and licensing agreement focused on the discovery and development of next-generation cancer therapies focused on high unmet patient needs. The alliance unites 3T Biosciences’ 3T-TRACE (T-Cell Receptor Antigen and Cross-Reactivity Engine) discovery platform and Boehringer Ingelheim‘s focus on cancer cell-directed…
Drug Discovery & Development’s top stories of 2022
After the majority of pharmaceutical companies released their earnings reports for 2022, we released our annual Pharma 50 feature detailing how the pharma landscape has evolved. Four of the five most popular pieces of content on Drug Discovery & Development were part of the Pharma 50 feature. In the past year, Pfizer (NYSE:PFE) cemented its…
FDA approves bispecific antibody from Genentech
The FDA has approved Genentech‘s Lunsumio (mosunetuzumab-axgb), a novel bispecific antibody for relapsed or refractory follicular lymphoma (R/R FL). The indication covers R/R FL patients who have received at least two prior systemic therapies. Patients with the cancer subtype have had limited treatment options and significant morbidity and mortality. The approval of Lunsumio is the…
At ASH, Genentech showcases expanded hematology portfolio that includes bispecific antibodies
At ASH 2022, Roche (SWX: ROG) subsidiary Genentech presented new data demonstrating the potential of glofitamab and mosunetuzumab, its investigational CD20xCD3 T-cell engaging bispecific antibodies, as fixed-duration, off-the-shelf treatment options for two types of non-Hodgkin’s lymphoma (NHL) – large B-cell lymphoma (LBCL) and follicular lymphoma (FL), respectively. “The new data demonstrated durable and impressive patient…
Gilead and Arcus share positive data from Phase 2 ARC-7 study of zimberelimab
Gilead Sciences (Nasdaq: GILD) and Arcus Biosciences (NYSE:RCUS) are touting positive results from the fourth interim analysis of the randomized, open-label Phase 2 ARC-7 study in patients with first-line metastatic non-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology (ASCO). Patients in the arms who received the investigational Fc-silent anti-TIGIT monoclonal antibody…
GSK’s Jemperli fares well in interim analysis of endometrial cancer trial
GSK (LSE/NYSE:GSK) has shared positive headline results from a planned interim analysis of Part 1 of a Phase 3 study of adults with primary advanced or recurrent endometrial cancer. In the study, patients in the Jemperli (dostarlimab) arm also received chemotherapy (carboplatin-paclitaxel) followed by Jemperli alone. The study tested the treatment regimen against chemotherapy with…
BioNTech to partner with Polish STING agonist firm Ryvu Therapeutics
The mRNA-focused biotech BioNTech (Nasdaq:BNTX) has partnered with Ryvu Therapeutics (Warsaw Stock Exchange:RVU), which specializes in novel small molecule therapies for emerging oncology targets. In the deal, Mainz, Germany–based BioNTech will have an exclusive global license to commercialize Ryvu’s stimulator of interferon genes (STING) agonist portfolio. The companies will also partner to develop small molecule…
Why GSK is pulling multiple myeloma drug Blenrep from U.S. market
FDA has requested that GSK plc (LSE/NYSE:GSK) withdraw the relapsed and refractory multiple myeloma drug Blenrep (belantamab mandolin-blmf) from the U.S. market. GSK announced in a statement that it has initiated the process. On November 7, the company announced that the drug did not meet its primary endpoint of progression-free survival (PFS) in the Phase 3 DREAMM-3…
AstraZeneca wins positive CHMP opinion for Imfinzi for unresectable or metastatic biliary tract cancer
Cambridge, UK–based AstraZeneca (Nasdaq:AZN) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended a new marketing authorization of Imfinzi (durvalumab). The recommendation specifically refers to the first-line treatment of adults with unresectable or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine with cisplatin).…
FDA grants breakthrough therapy designation to Pfizer’s elranatamab for multiple myeloma
The investigational bispecfic antibody elranatamab has won breakthrough therapy designation from the FDA for relapsed or refractory multiple myeloma (RRMM). Also known as PF-06863135, erlanatamab is a B-cell maturation antigen (BCMA)-targeted T-cell redirecting immunotherapy. BCMA is highly expressed on the surface of multiple myeloma (MM) cells. Elranatamab is also designed to target the CD3 receptor…
Click chemistry company Shasqi has a link to the Nobel Prize in Chemistry
The Royal Swedish Academy of Sciences recently awarded the 2022 Nobel Prize in Chemistry to three individuals for the development of click chemistry and bioorthogonal chemistry. Among them was Carolyn Bertozzi, a scientific advisor to Shasqi (San Francisco). The oncology company has developed a novel platform to localize and activate cancer ‘protodrugs’ at a tumor…
And the most innovative biotechnology and pharma products are…
The Galien Foundation has selected Regeneron’s (Nasdaq:REGN) Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the best biotechnology product of 2022 and Amgen’s (Nasdaq:AMGN) Lumakras as the best pharmaceutical agent. The organization announced the news last week as part of the Prix Galien USA 2022 awards series in a ceremony in New York City. The antibody cocktail Inmazeb…
GSK shares positive headline results from Phase 2 study of dostarlimab with chemotherapy in non-small cell lung cancer
GSK (LSE/NYSE:GSK) said that the PERLA Phase 2 study of dostarlimab met its endpoint of objective response rate in non-small cell lung cancer patients. The study used Response Evaluation Criteria in Solid Tumors (RECIST) criteria to compare dostarlimab against Merck’s Keytruda (pembrolizumab) in patients with metastatic non-squamous non-small cell lung cancer who also received chemotherapy.…