Oncology

Animal models, long the basis of academic research and preclinical drug discovery, continue to play an important role in advancing our understanding of basic pharmacology and bringing critical therapies to those in need. However, animal models have some natural drawbacks (e.g., not being humans) that hamper their ability to fully predict the interaction of new…

Eli Lilly (NYSE:LLY) has announced that it has approved Verzenio (abemaciclib) for certain patients with HR+ HER2– high-risk early breast cancer. The drug will become the first inhibitor of cyclin-dependent kinase 4 and 6 (CDK4/6) to hit the U.S. market. “Over time, the collective results of the Verzenio clinical development program have demonstrated a differentiated…

Today, the allogeneic CAR-T company Allogene Therapeutics (NSDQ:ALLO) saw its stock dip to the lowest level since its IPO in 2018. The company announced that FDA had placed a hold on its AlloCAR T clinical trials after the identification of a chromosomal abnormality in a patient enrolled in its ALPHA2 study (NCT04416984). That trial was…

Merck (NYSE:MRK) has agreed to acquire the biopharma Acceleron Pharma (NSDQ:XLRN) for $180 per share in cash, bringing the purchase price to roughly $11.5 billion. The companies expect the deal to close in the fourth quarter of 2021. Cambridge, Massachusetts–based Acceleron specializes in developing drugs that aim to balance transforming growth factor (TGF)-beta, which plays…

FDA has approved a new indication for Lilly‘s (NYSE:LLY) Erbitux (cetuximab injection) in combination with Pfizer’s Braftovi (encorafenib) to treat adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation confirmed with an FDA-approved test. The indication covers previously-treated patients. Erbitux is currently the only FDA-approved antibody that targets the epidermal growth factor receptor…

Oncology-focused Ayala Pharmaceuticals (NASDAQ: AYLA) has published two positive case studies of adults with desmoid tumors treated with gamma secretase inhibitor AL101 in Current Oncology. Desmoid tumors are noncancerous and most often appear in the abdomen, arms or legs. They can also occur in the head and neck, chest and other areas of the body.…

Merck & Co. (NSDQ:MRNA) scientists have explored fighting cancer by way of the STING (stimulator of interferon genes)-controlled innate immune pathway. Now, the company has published research in Advanced Therapeutics detailing a preclinical study with its partner Vesselon Inc. that reported impressive pharmacokinetics results related to MSA-1, a STING agonist. The researchers found that low…

Bristol Myers Squibb (NYSE: BMY) has won priority review for its Biologics License Application for the fixed-dose combination of the checkpoint inhibitors relatlimab and nivolumab to treat patients 12 and older who weigh at least 40 kg (88 pounds) with unresectable or metastatic melanoma. Relatlimab would be a novel lymphocyte-activation gene 3 (LAG-3) blocking antibody.…

Boehringer Ingelheim announced today that it acquired Abexxa Biologics, a developer of precision medicines for treating cancer. Acquiring Abexxa, which utilizes a new approach in immuno-oncology and oncology research, offers Boehringer Ingelheim access to the company’s expertise in targeting cancer-specific proteins located inside the cell instead of those expressed on the cell membrane, according to…

The FDA has granted accelerated approval to the first-in-class antibody-drug conjugate Tivdak (tisotumab vedotin-tftv) from Genmab and Seagen to treat adults with recurrent or metastatic cervical cancer. Specifically, the approval covers cancer with disease progression on or after chemotherapy. The drug targets protein tissue factor (TF), which is abnormally expressed in cervical cancer. Historically, physicians…

Ivy Brain Tumor Center and its partner Sonalasense have announced positive initial results in a first-in-human Phase 0/1 clinical trial involving recurrent glioblastoma patients. Sonalasense has developed a sonodynamic therapy (SDT) that pairs low-intensity ultrasound with chemotherapeutic agents known as sonosensitizers. The therapy is noninvasive. Data from the trial indicate that SDT swiftly causes targeted…

Minorities tend to participate in clinical trials at far lower rates than their real-world demographics and prevalence of the disease, according to the American Society of Clinical Oncology. In addition, minorities often have worse outcomes for certain cancers than the broader public. Just one example: the mortality rate for Black women with breast cancer is 40% higher than…

Immunotherapy-specialist Hookipa Pharma (NSDQ:HOOK) has announced a clinical collaboration and supply agreement with Merck (NYSE:MRK). Hookipa will test its immunotherapeutic HB-200 in conjunction with Merck’s blockbuster anti-PD-1 therapy, Keytruda (pembrolizumab), as first-line treatment for patients with advanced head and neck squamous cell carcinoma (HNSCC). Last year, Merck raked in $14.5 billion in sales revenue from Keytruda.…

Sanofi (NSDQ:SNY) announced today that it has completed the purchase of its mRNA partner Translate Bio. The previously announced deal, according to Sanofi, accelerates the French pharma giant’s efforts to develop transformative vaccines and therapies using mRNA technology. The deal comes during a year in which mRNA-based Moderna (NSDQ:MRNA) and Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccines are…

AB Science today touted results from a study of masitinib in combination with docetaxel in treating prostate cancer. Paris-based AB Science presented the data at the 2021 American Urological Association (AUA) annual meeting, according to a news release. Masitinib in combination with docetaxel as a first-line treatment of metastatic castrate refractory prostate cancer (mCRPC) eligible…

AstraZeneca (LON: AZN) announced that Imfinzi (durvalumab) together with tremelimumab and platinum-based chemotherapy improved overall survival by 23% and progression-free survival by 28% compared to chemotherapy alone in patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). The data came from a Phase 3 trial known as POSEIDON. Imfinzi and tremelimumab are immune checkpoint…

A multi-year partnership between Janssen Research & Development (NYSE: JNJ) and ConcertAI (Cambridge, Mass.) will focus on using real-world data and AI for oncology applications involving multiple cancer types. ConcertAI will work “almost an extension of [Janssen’s] R&D development process,” said Jeff Elton, CEO of the company. The two companies’ teams will work closely together…

Roche (OTCQX:RHHBY) has voluntarily withdrawn its application for FDA accelerated approval for the monoclonal antibody Tecentriq (atezolizumab) in combination with chemotherapy to treat unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) with tumors expressing programmed death-ligand 1 (PD-L1). Earlier this month, Roche won priority review for Tecentriq for people with non-small cell lung cancer…

Biopharma iBio, Inc. (NYSEA:IBIO) has entered into a definitive global exclusive license agreement with RubrYc Therapeutics for RTX-003, an immunotherapy candidate targeting regulatory T cells. In addition, the deal includes an option for iBio to license additional antibodies designed with RubrYc’s antibody discovery platform based on machine learning and computational biology. iBio made an upfront $5 million…

The U.S. Court of Appeals for the Federal Circuit tossed a $1.2 billion fine against Gilead Sciences after invalidating portions of a Memorial Sloan Kettering Cancer Center patent licensed to a Bristol Myers Squibb subsidiary. The patent was the basis for the previous ruling against Foster City, Calif.–based Gilead, which related to patent infringement claims…

Focused on antibody-based cancer therapies, Zymeworks (NYSE:ZYME) believes bi- and multi-specific antibodies offer significant potential in oncology. Such therapies could provide new biological avenues for cancer treatment and extend immunotherapy to patients with few options. The FDA has approved three bispecific antibodies, and more than one hundred others are in development across the industry. Zymeworks…

Novartis (NYSE:NVS) has announced that the FDA has granted priority review for its application for allosteric inhibitor asciminib (ABL001) in chronic myeloid leukemia (CML). The drug targets the ABL myristoyl pocket (STAMP). The priority review status could trim four months off the review time, dropping the review period to eight months from 12 months under a…

Novartis (SWX:NOVN) has announced that the genetically modified autologous T cell immunotherapy Kymriah (tisagenlecleucel) failed to meet the primary endpoint in its Phase 3 BELINDA trial. That endpoint involved event-free survival for people with aggressive B-cell non-Hodgkin lymphoma compared to standard of care. To qualify for the study, patients needed to have primary refractory disease…

Theratechnologies (NSDQ:THTX) announced that the peer-reviewed journal Cancer Science had published its preclinical research related to TH1902, a peptide linked to the chemotherapeutic agent docetaxel. The research tested the investigational drug as a sortilin-positive triple-negative breast cancer (TNBC) treatment. TNBC lacks the expression or amplification of targetable biomarker. The prognosis for this cancer subgroup tends…

Gilead (NSDQ:GILD) subsidiary Kite will collaborate with Appia Bio (Culver City, Calif.) to develop engineered allogeneic cell therapies from hematopoietic stem cells (HSCs) for cancer patients.  To that end, they have entered into a collaboration and license agreement to develop HSC-derived cell therapies for hematological malignancies.  Under the agreement, Appia Bio will lead preclinical and…