FogPharma’s lead program is a peptide that blocks a difficult-to-drug pathway inside of cells. The new financing will go toward an ongoing Phase 1/2 study in advanced solid tumors and support development of pipeline programs for other elusive cancer targets. By FRANK VINLUAN FogPharma has reached early clinical development with a therapeutic candidate that takes a novel approach to treatment of solid tumors. The company now has $145 million to continue the drug’s clinical development and advance more programs in its pipeline. Cambridge, Massachusetts-based FogPharma discovers and develops peptides capable of entering cells to address targets that drive disease. Such targets haven’t been drugged before due to the difficulty of getting a drug to act within a cell. FogPharma says its peptide drugs, which it calls Helicon therapeutics, can get inside a cell to modulate protein-protein interactions as well as protein-DNA interactions. FogPharma’s lead program is FOG-001, a Helicon therapeutic ...
Don Tracy, Associate Editor New label marks the first Bruton’s tyrosine kinase inhibitor to be approved with an oral suspension formulation. The FDA has approved an addendum to the Imbruvica (ibrutinib) label to include an oral suspension formulation across the drug’s indications. Johnson & Johnson (J&J), in partnership with Pharmacyclics LLC, an AbbVie Company, announced that the new formulation is approved to treat patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD) following the failure of one or more lines of systemic therapy. This option is designed for patients who have difficulty swallowing pills, part of J&J’s ongoing efforts to provide multiple patient-friendly treatment options, the company stated in a press release.1 “As the most comprehensively studied therapy in its class, Imbruvica has helped change the standard of care for adults living with certain blood cancers and cGVHD. Nearly 300,000 ...
Davy James The FDA granted Allecra with a five-year marketing exclusivity extension for Exblifep (cefepime/enmetazobactam) through the Generating Antibiotic Incentives Now Act. The FDA has approved Allecra Therapeutics’ Exblifep (cefepime/enmetazobactam) for the treatment of complicated urinary tract infections (cUTIs), including the kidney infection pyelonephritis, in patients aged 18 years and older.1 The FDA also granted Allecra with a five-year marketing exclusivity extension for the β-lactam/β-lactamase inhibitor combination through the Generating Antibiotic Incentives Now Act (GAIN Act), which is legislation that incentivizes the development of new anti-infective treatments. “Receiving FDA approval is a tremendous achievement for Allecra and a testament to the hard work and dedication of a small, yet highly focused team of individuals. I extend my sincere congratulations to my colleagues Omar Lahlou and Patrick Velicitat for their leadership and oversight throughout this whole process,” Iain Buchanan, supervisory board member of Allecra Therapeutics, said in a press release. “As ...
Individuals with Jewish ancestry are six times more likely to carry a genetic fault The NHS has announced the launch of a new BRCA gene testing programme to identify cancer risk early in individuals with Jewish ancestry. People with Jewish ancestry are about six times more likely to carry a genetic fault, which can increase the risk of developing some cancers, than the general population. Across the next two years, the national NHS Jewish BRCA Testing Programme plans to identify thousands more people carrying faults in the BRCA genes so they can seek early access to surveillance and prevention services. In alignment with the health services drive to catch tumours earlier, when they are easier to treat, anyone over the age of 18 years with Jewish ancestry will be eligible to receive a simple genetic saliva test to look for the presence of BRCA1 or BRCA2 faults. BRCA1 and BRCA2 ...
The Senate Health, Education, Labor, and Pensions (HELP) Committee grilled the CEOs of major pharmaceutical companies on what chairman Senator Bernie Sanders labelled “the outrageously high cost of prescription drugs” in the US. Despite intense interrogation, the CEOs made no solid commitments to improve drug prices in the US. The February 8 hearing allowed US senators to question the CEOs of Merck & Co (MSD), Bristol Myers Squibb (BMS) and Johnson & Johnson (J&J) about their drug prices in the US and potential solutions to target high costs. Sanders highlighted price discrepancies between the US and other countries, pointing out that the list price for MSD’s Keytruda (pembrolizumab) is approximately $191,000 in the US, but $112,000 in Canada. On the issue of differential pricing in different countries, BMS CEO Chris Boerner said that the lower prices in countries such as Canada reduced access to essential medications. He said that patients ...
Hemogenyx has received the all-clear from the US Food and Drug Administration (FDA) to begin a Phase I clinical trial of its acute myeloid leukaemia (AML) chimeric antigen receptor (CAR) T-therapy in the US. In June 2023, the US FDA placed a clinical hold on the trial for HEMO-CAR-T, requesting additional information from Hemogenyx after a splicing deficiency during manufacture of the lentivirus used to produce CAR-T cells. Hemogenyx produced a plan, supported by laboratory tests to address FDA’s concerns in August 2023, which was accepted the following month. In January, the London, UK-based biopharma issued a complete response to the agency to lift the hold. Hemogenyx’s stock price has increased by 62% following the announcement of the lifting of the hold today (9 February) since the market close yesterday. CAR-T therapies have been hitting the headlines recently after the FDA launched an investigation into the incidence of potentially associated ...
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to Johnson & Johnson’s (J&J) nipocalimab for alloimmunised pregnant people at increased risk of increased severe haemolytic disease of the foetus and newborn (HDFN), which can cause life-threatening anaemia. This investigational therapy is the only one in the clinics for the condition, which occurs when the blood types of the pregnant individual and the foetus are incompatible. Nipocalimab is a fully human, aglycosylated, effectorless, monoclonal antibody designed to hinder the neonatal fragment crystallisable receptor (FcRn) and reduce levels of circulating immunoglobulin G antibodies. The regulator granted BTD based on findings from the proof-of-concept, open-label Phase II UNITY clinical trial of the therapy. The multicentre, international, non-blinded trial assessed nipocalimab’s efficacy, safety, pharmacodynamics and pharmacokinetics. The study met this primary endpoint with 54% of pregnant subjects. A small number of severe adverse events were reported in the study. ...
Hemogenyx has received the all-clear from the US Food and Drug Administration (FDA) to begin a Phase I clinical trial of its acute myeloid leukaemia (AML) chimeric antigen receptor (CAR) T-therapy in the US. In June 2023, the US FDA placed a clinical hold on the trial for HEMO-CAR-T, requesting additional information from Hemogenyx after a splicing deficiency during manufacture of the lentivirus used to produce CAR-T cells. Hemogenyx produced a plan, supported by laboratory tests to address FDA’s concerns in August 2023, which was accepted the following month. In January, the London, UK-based biopharma issued a complete response to the agency to lift the hold. Hemogenyx’s stock price has increased by 62% following the announcement of the lifting of the hold today (9 February) since the market close yesterday.CAR-T therapies have been hitting the headlines recently after the FDA launched an investigation into the incidence of potentially associated secondary ...
Stalicla announced the successful closing of a $17.4m Series B funding round as deal-making interest stirs in the central nervous system disorder space. “In the current environment, we see this [financing round] as a huge success, but we’re targeting a much larger round in Q3 2024 with the involvement of large venture capital funds,” says Stalicla CEO Lynn Durham in an exclusive interview with Pharmaceutical Technology. Stalicla aims to use the extra funds to launch a Phase III substance use disorder (SUD) study for its STP7 mGluR5 Negative Allosteric Modulator (mGluR5 NAM) platform in 2025. The US National Institute on Drug Abuse and the National Institutes of Health are supporting Stalicla’s development of STP7.Stalicla acquired the therapy through an in-licensing agreement with Novartis in January 2023. In this deal, the Swiss company acquired the worldwide rights for studies using the STP7 platform for SUD, neurodevelopmental disorders, and other indications in ...
Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting to discuss applications for Bristol Myers Squibb’s Abecma and Johnson & Johnson’s Carvykti. The FDA will convene its Oncologic Drugs Advisory Committee (ODAC) for a full-day meeting March 15 to review the applications for BMS and 2seventy bio’s Abecma and J&J and Legend Biotech’s Carvykti in earlier treatment of multiple myeloma, a government filing shows. External experts invited by the FDA will review clinical data from Carvykti’s CARTITUDE-4 trial and Abecma’s KarMMa-3 study. In both cases, overall survival data will be the focus of the discussions. The meeting is expected to carry a lot of weight in the oncology community. For one, industry watchers are trying to take the FDA’s pulse around the benefit-risk profile of CAR-T cell therapies amid an investigation into a new safety signal ...
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