The acquisition came at the time when the company was preparing to file for approval of momelotinib in the United States within the next few weeks and in Europe before the end of the year, armed with phase 3 data announced in January. In the MOMENTUM trial, Momelotinib reduced the need for blood transfusions in myelofibrosis patients previously treated with JAK inhibitors and anemic, with 31% of patients transfusion-independent at week 24 compared to 20% in a control group treated with danazol, a steroid used to treat anemia. Momelotinib will further compliment Blenrep (belantamab mafodotin), GSK’s BCMA-targeting antibody-drug combination, which was approved in 2020 as a treatment for Multiple Myeloma, a form of blood cancer.
BriaCell Receives FDA Fast Track Approval for Targeted Breast Cancer Immunotherapy
The FDA has granted Fast Track Designation to BriaCell’s lead candidate, Bria-IMT, an experimental cell-based therapy for the Metastatic Breast Cancer treatment in women. Bria-IMT is a gene-edited, granulocyte-macrophage colony-stimulating factor-secreting breast cancer cell line developed from biopsied grade II tumor tissues. HLA class I and class II antigens are expressed by the cells. The cells are irradiated and administered as an inoculation at four different locations. Bria-IMT is administered as part of a regimen that includes low-dose cyclophosphamide before and after injection at each inoculation site and interferon-alpha-2-beta.
Bria-IMT is now being evaluated in a Phase 1/phase 2A trial in women with recurrent or Metastatic Breast Cancer who have undergone at least one prior line of treatment. Bria-IMT is being evaluated in conjunction with two other investigational therapies: retifanlimab (Incyte), a PD-1 inhibitor, and epacadostat, an immunomodulator.
Patient survival data from this study were initially reported at the San Antonio Breast Cancer Symposium in December 2021, and it was over 12 months (average of 9 prior regimens) compared to 7-10 months in a study of 3rd line Breast Cancer patients (those who failed 2 prior regimens for Metastatic Breast Cancer). Patients who matched Bria-IMTTM at one or more HLA types and those with grade I (well-differentiated) or grade II (moderately differentiated) breast cancer were among those who could benefit from a survival benefit.
The FDA’s fast track designation aids in the expediting of therapy development, review, and potential approval for serious or life-threatening disorders. According to the company, the regulator’s fast track approval for BriaIMT will apply to patients with Metastatic Breast Cancer.
Eli Lilly Announces Updates on Retevmo Phase 2 Clinical Trial
Eli Lilly and Company declared updated data from the Phase 1/2 LIBRETTO-001 trial of Retevmo® in patients suffering from RET fusion-positive non-small cell lung cancer. Retevmo is a selective and potent RET kinase inhibitor that is approved in multiple countries, including the U.S., to treat and cure adults with metastatic rearranged during transfection fusion-positive non-small cell lung cancer and the treatment of adult & pediatric patients 12 years of age and older suffering with advanced/metastatic RET-mutant medullary thyroid cancer who require systemic therapy or developed or metastatic RET fusion-positive thyroid cancer who need systemic therapy and who are radioactive iodine-refractory.
Retevmo is a selective & potent RET kinase inhibitor. Retevmo may affect both tumor and healthy cells, resulting in aftereffects. RET-driver alterations are mutually exclusive from other oncogenic drivers.
The confirmed objective response rate was 61.1% among 247 patients previously treated with platinum chemotherapy and 84.1% among 69 treatment-naïve patients. Twenty-six patients had measurable central nervous system metastases at baseline. Treatment with Retevmo resulted in a CNS objective response rate of 84.6%, with 22 patients having a confirmed best response of complete or partial response.
At a median follow-up of around two years in both the treatments-naïve and platinum-chemotherapy pretreated populations, the median duration of response is estimated at 20.2 and 28.6 months, respectively, and median progression-free survival is expected at 22.0 and 24.9 months, respectively. Of the 26 patients with measurable central nervous system disease, Retevmo treatment resulted in a median intracranial PFS of 19.4 months.
A global, randomized, Phase III trial is currently going on. It will compare the treatment with Retevmo to the current standard therapy in the first-line treatment of advanced/metastatic RET fusion-positive non-small cell lung cancer.
Merck Pneumococcal Vaccine Gets USFDA Breakthrough Therapy Designation
Merck announced today that V116, an investigational 21-valent pneumococcal conjugate vaccine, has recently earned Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pneumococcal pneumonia and invasive pneumococcal disease caused by Streptococcus pneumoniae serotypes in adults of age 18 years and older. Phase III clinical trials for V116 are to be initiated later this year.
This decision was informed by data from a two-part randomized, comparator-controlled, double-blind Phase I/II study, V116-001, that checked the safety, tolerability, and immunogenicity of a single dose of V116 in pneumococcal vaccine-naïve adults 18-49 years of age and 50 years of age and older.
V116 is designed to address the strains of disease-causing pneumococcal bacteria that are most prevalent in adults, reflecting our population-specific approach to developing pneumococcal conjugate vaccines. V116 targets serotypes that account for about 85% of all invasive pneumococcal disease in individuals aged 65 years and older in the United States as per the data recorded in 2019, and it comprises eight serotypes which are not covered by currently licensed vaccines,” said Dr. Eliav Barr (senior V.P., head of global clinical development and chief medical officer, Merck Research Laboratories). “We are looking forward to discussing the ongoing development of this investigational vaccine, including the approach for Phase III studies, with the FDA and other regulatory agencies,” he added.
The Breakthrough Therapy Designation is an FDA program designed to accelerate the development & review of products intended for life-threatening diseases. To qualify for this position, preliminary clinical evidence must indicate that the product may improve over currently available options on atleast one clinically significant endpoint.
FDA Approves Third Bevacizumab Biosimilar
In a regulatory decision, the FDA approves Alymsys (bevacizumab-maly), a biosimilar of bevacizumab manufactured by mAbxience for Amneal Pharmaceuticals, Inc. It is the third bevacizumab biosimilar authorized in the US and the second of three US biosimilars that the company hopes to have approved this year. Amneal got permission for filgrastim-ayow (Releuko) earlier this year, which references Neupogen. The FDA is currently reviewing the company’s pegfilgrastim biosimilar referencing Neulasta.
Bevacizumab-maly is a vascular endothelial growth factor inhibitor that is used to treat:
- Metastatic colorectal cancer in conjunction with intravenous fluorouracil-based chemotherapy for first- or second-line treatment
- mCRC in combination with fluoropyrimidine/irinotecan– or fluoropyrimidine/oxaliplatin–based chemotherapy for patients who have progressed on a frontline bevacizumab product–containing regimen.
- First-line treatment for Non-Squamous Non-Small Cell Lung Cancer with carboplatin and paclitaxel.
- Adults with recurrent Glioblastoma
- Metastatic Renal Cell Cancer in conjunction with interferon alfa
- Cervical Cancer that is persistent, recurring, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan
- Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer combined with paclitaxel
Previously, the FDA approved ABP-215 (bevacizumab-awwb; Mvasi), a bevacizumab biosimilar developed by Amgen and Allergan that was intended for the treatment of Colorectal, Lung, Brain, Kidney, and Cervical Cancers in adult patients, in September 2017. In June 2019, the FDA approved PF-06439535 (bevacizumab-bvzr; Zirabev) as a bevacizumab biosimilar for the treatment of patients with Metastatic Colon or Rectum Carcinoma, unresectable advanced, metastatic, or recurrent NSCLC, advanced and/or metastatic RCC, and persistent recurrent or metastatic cervix carcinoma.
Halozyme Signs Agreement to Acquire Antares Pharma for $960 million
Halozyme Therapeutics Inc. offered to acquire Antares Pharma Inc. for $960 million in cash, or $5.60 per share, in a deal that will enhance its focus on drug delivery. The acquisition has been authorized unanimously by the boards of directors of Halozyme and Antares and is expected to be completed in the first half of this year, subject to all clearances and conditions.
Antares is a specialized pharmaceutical company founded in Exton that develops, produces, and commercializes therapeutic solutions employing sophisticated drug delivery methods such as autoinjectors. Sumatriptan, a Migraine Headache Therapy delivered by prefilled syringe auto-injectors, is one of its products, which it distributes through its distribution partner Teva Pharmaceuticals. Additionally, the FDA recently authorized Antares’ Tlando, an oral Testosterone Replacement Therapy. Halozyme, a biopharmaceutical business created in 1998, invented the patented Enhanze technology, which allows intravenously given biologics and small molecule drugs to be delivered subcutaneously, reducing hours-long treatments to a matter of minutes. Roche, Baxalta, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, and Alexion are among the pharmaceutical and biotechnology companies that have been licensed by Halozyme to use its Enhanze technology.
The addition of commercial products and Antares’ current auto injector technology will expedite Halozyme’s strategy to deliver long-term revenue growth and value generation. Halozyme intends to expand on Antares’ capabilities and core platform technology to produce further long-term income possibilities, with additional intellectual property protections in place for the latter’s technology beyond 2030. “The addition of Antares, particularly with its best-in-class auto-injector platform and speciality commercial business, augments Halozyme’s strategy, further strengthens our position as a leading drug delivery company, and extends our strategy to include specialty products,” said Halozyme president and CEO Dr Helen Torley.
NICE Recommends Merck’s Tepmetko for Lung Cancer
On April 14, 2022, Merck announced that National Institute for Health and Care Excellence (NICE) has recommended the Tepmetko (tepotinib) for the treatment of adult patients with advanced non-small-cell lung cancer (NSCLC) in the UK. Tepotinib is the first and only oral MET inhibitor to be recommended for the treatment of adult patients with advanced NSCLC harbouring METex14 skipping alterations for use on the NHS in England, Wales, and Northern Ireland. NICE based its recommendation on clinical and real-world data indicating that Tepmetko might prolong life in patients with METex14 skipping NSCLC.
Phase II VISION study assessing tepotinib as a monotherapy to treat advanced or metastatic NSCLC with METex14 skipping alterations has supported the NICE appraisal. Previously, the NHS could not provide targeted treatments for patients with the specific form of NSCLC with METex14 skipping-gene alterations. Instead, patients with the genetic biomarker were given the same treatment as other NSCLC patients.
Under Project Orbis, the tepotinib has been recommended for routine use across the NHS in England. Project Orbis aims to review and approve promising cancer drugs helping patients access treatments faster. Till NICE final guidance is published, interim funding via the Cancer Drugs Fund will reimburse tepotinib in England.
In the UK, the list price of Tepmetko for 60 tablets of 250 mg each is around $3,500. Two 225 mg tablets once daily are suggested to the patients until disease progression or unacceptable toxicity. The discounted price for NHS coverage was not disclosed.
NSCLC accounts for nearly 85% of all lung cancers. It is observed that NSCLC metastasizes to other organs slower in comparison to SCLC, and microscopically, SCLC is composed of much smaller cells. As per Cancer Research UK, in the UK, there are around 48,500 new lung cancer cases every year which is almost equal to 130 cases every day (2016-2018). Additionally, it is observed that Lung cancer is the 3rd most common cancer in the UK, accounting for 13% of all new cancer cases (2016-2018).
FDA Lifts Partial Clinical Hold on Gilead’s Magrolimab for MDS and AML
On April 11, 2022, Gilead Sciences announced that the US FDA has lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine. After the review of the safety data from the trial, the FDA removed the partial clinical hold. With this decision, the Gilead can now resume enrollment in the U.S. for the studies investigating magrolimab in combination with azacitidine.
Magrolimab is a potential, a first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with the recognition of CD47 by the SIRPα receptor on macrophages, with the goal of blocking the “don’t eat me” signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being designed to target hematologic cancers, including myelodysplastic syndrome (MDS), as well as solid tumor malignancies. Additionally, Gilead is looking forward to work with the FDA regarding the remaining partial clinical hold affecting studies evaluating magrolimab in diffuse large B-cell lymphoma and multiple myeloma. Gilead plans to re-open enrollment in the magrolimab studies placed on a voluntary hold outside of the U.S.
In January 2022, due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions between study arms, the FDA placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine. Due to which the Gilead had to paused the screening and enrollment of new study participants for investigating the combination of magrolimab with azacitidine.
In 2020, the FDA granted Breakthrough Therapy designation to the Magrolimab for the treatment of newly diagnosed myelodysplastic syndrome. Earlier, in July 2019, Ono entered into a license agreement with Forty-Seven to exclusively develop, manufacture, and commercialize 5F9 (magrolimab), their monoclonal antibody against CD47, in Japan, South Korea, Taiwan, and ASEAN countries. Inc. In April 2020, Gilead acquired Forty Seven for $4.9 Billion.
