Latest news with #MountLaurel
National Post
20-05-2025
- Business
- National Post
CCM Biosciences Announces Presentation of Data on its First-In-Class AML Drug Program at ASCO 2025
Article content Company's AML drug program is focused on both newly diagnosed and relapsed/refractory FLT3-positive AML, overcoming major forms of resistance to FDA-approved FLT3 inhibitors, and outperforms other investigational inhibitors in a wide range of drug resistance models. Article content Article content MOUNT LAUREL, N.J. — CCM Biosciences, a diversified pharmaceutical discovery and development company, today announced the upcoming presentation of its next-generation FLT3 inhibitor drug program for acute myeloid leukemia (AML) at the 2025 Annual Conference of the American Society of Clinical Oncology (ASCO), taking place May 30 to June 3 in Chicago. Acute Myeloid Leukemia (AML) is the most severe form of leukemia with few treatment options, and a malignancy frequently driven by mutations in the FMS-like tyrosine kinase 3 (FLT3) gene. The FLT3 internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations, particularly D835 and F691, appear in approximately 30% of AML patients, often leading to poor prognosis and resistance to existing therapies. Gilteritinib (Xospata ®; Astellas Pharma, peak annual sales projection: $1.5 billion) and Quizartinib (Vanflyta ®; Daiichi Sankyo) are two FDA-approved FLT3 inhibitors, with the former approved only for relapsed/refractory AML and the latter approved only for newly diagnosed AML. Quizartinib does not target TKD resistance mutations, whereas Gilteritinib's efficacy on FLT3-ITD-D835 mutations is limited and it is not effective against the FLT3-ITD-F691 gatekeeper mutation, both of which are very common. Crenolanib (AROG/Pfizer) is an FLT3 inhibitor whose NDA submitted to the FDA does not address the indications above, whose NDA was previously rejected by the FDA, and which binds to FLT3 mutants less tightly than Gilteritinib. Consequently, there is a critical need for next-generation FLT3 inhibitors that can address all of these mutations. Article content At ASCO 2025, CCM Biosciences' presentation 'Novel, Potent and Selective Inhibitors Targeting FLT3 for AML Therapy' in the Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant session (Abstract #: 6542, will report novel FLT3 inhibitors have been identified that can both target FLT3-ITD and potentially overcome mutational resistance to FDA-approved FLT3 inhibitors. These agents are significantly more effective than Gilteritinib and have significant potential clinical applications. Article content CCM Biosciences' novel, orally bioavailable FLT3 inhibitors (CCM-405 and CCM-445) are the first drug candidates to overcome both FLT3-ITD juxtamembrane domain and tyrosine kinase domain (TKD) mutational drug resistance (including D835Y, F691L), significantly outperforming the aforementioned current-generation inhibitors both in the absence and presence of resistance mutations. Other reported investigational drug candidates capable of addressing FLT3-ITD resistance mutations either have poor pharmacokinetics, significant off-target binding, or both. Article content CCM Biosciences is advancing clinical candidates from its FLT3 inhibitor program to investigational new drug (IND) filing this year for entry into clinical trials for both newly diagnosed FLT3-positive AML and relapsed/refractory FLT3-positive AML. Multiple failures in AML clinical trials from competitors in 2024 present an attractive landscape for clinical trials of these drug candidates. Article content The company is actively partnering with biotechnology and pharmaceutical companies for co-development rights in selected countries. CCM Biosciences, a sister company of the global chemical and pharmaceutical services company PMC Group, Inc., is also a Featured Exhibitor at ASCO 2025 — — and will be showcasing both its drug programs and the state-of-the-art platforms used to discover and develop them. Article content About CCM Biosciences CCM Biosciences is a diversified biotechnology company dedicated to discovering and developing novel drugs, including small molecules, gene therapies, biologics, and nanomedicines within multiple corporate subsidiaries. CCM's patented drug discovery platforms were developed at Chakrabarti Advanced Technology, a privately funded R&D institute founded in 2010 with scientists in the US, France and India and with publications in leading scientific journals including PNAS, Nucleic Acids Research, Physical Review, American Chemical Society journals, Biophysical Society journals, and Nature Publishing Group journals. These platforms are complemented by the contract research, development, and manufacturing organizations (CRDMO) at PMC Group, the sister company of CCM Biosciences and a global chemical and pharmaceutical company with ~$1 billion in annual revenue. Article content Article content Article content Article content Article content Article content
National Post
20-05-2025
- Business
- National Post
CCM Biosciences Announces Presentation of Data on its First-In-Class NSCLC Drug Program at ASCO 2025
Article content Company's NSCLC drug program is focused on overcoming both mutational and non-mutational resistance to 3 rd -generation EGFR inhibitors and outperforms other investigational 4 th -generation inhibitors in a wide range of drug resistance models. Article content Article content MOUNT LAUREL, N.J. — CCM Biosciences, a diversified pharmaceutical discovery and development company, today announced the upcoming presentation of its 4th-generation EGFR inhibitor drug program for non-small cell lung cancer (NSCLC) at the 2025 Annual Conference of the American Society of Clinical Oncology (ASCO), taking place May 30 to June 3 in Chicago. Article content NSCLC, which accounts for 80% of lung cancer, is the most common cause of cancer death worldwide. Epidermal growth factor receptor (EGFR)-activating mutations (Del19 or L858R) are major oncogenic drivers of NSCLC. EGFR-positive NSCLC accounts for approximately 30% of all diagnosed cases of NSCLC (a similar market size to PD-L1-positive NSCLC, which is addressed by the world's top-selling drug, Keytruda®). The current standard of care for EGFR-positive NSCLC is comprised of 3 rd -generation inhibitors, most notably Osimertinib (Tagrisso®), whose annual sales exceed $6 billion. Most patients treated by tyrosine kinase inhibitors (TKIs) will eventually develop resistance mutations including the T790M gatekeeper mutation. Osimertinib, a 3rd-generation covalent TKI, is efficacious against the T790M resistance mutation and prevents its onset if administered as first line therapy. However, treatment with Osimertinib inevitably induces additional mutations, especially the C797S mutation, as well as various off-target resistance mechanisms. To date, there are no approved therapies capable of overcoming mutational or non-mutational resistance to 3rd-generation TKIs. As such, there is an urgent unmet medical need to develop next-generation EGFR inhibitors that overcome these forms of resistance. While billions of dollars have been invested over the last several years on the development of 4 th -generation EGFR inhibitors that overcome tumor resistance to 3 rd -generation inhibitors, due to the diversity of resistance mechanisms, these inhibitors have failed to progress beyond early-stage clinical trials. Article content At ASCO 2025, CCM Biosciences' presentation 'Novel, potent and selective fourth-generation inhibitors targeting EGFR for NSCLC therapy' in the Lung Cancer – Non-small cell – Metastatic session (Abstract #: 8622, will report novel 4 th -generation, orally bioavailable EGFR inhibitors (CCM-205, CCM-245 and CCM-308) that can overcome both on-target and off-target resistance in lung cancer models, significantly outperforming the aforementioned 4 th -generation inhibitors in the face of resistance to 3 rd -generation inhibitors, and have significant potential clinical applications. In addition to their potent activity as monotherapies, CCM-205 and CCM-245 are highly efficacious in combination with 3 rd -generation EGFR inhibitors as well as anti-EGFR antibodies, neither of which can maintain or regress tumor volume in the presence of resistance as monotherapies. Article content CCM Biosciences is advancing clinical candidates from its EGFR inhibitor program to investigational new drug (IND) filing this year for entry to clinical trials. The company is actively partnering with biotechnology and pharmaceutical companies for co-development rights in selected countries. CCM Biosciences, a sister company of the global chemical and pharmaceutical services company PMC Group, Inc., is also a Featured Exhibitor at ASCO 2025 — — and will be showcasing both its drug programs and the state-of-the-art platforms used to discover and develop them. Article content CCM Biosciences is a diversified biotechnology company dedicated to discovering and developing novel drugs, including small molecules, gene therapies, biologics, and nanomedicines within multiple corporate subsidiaries. CCM's patented drug discovery platforms were developed at Chakrabarti Advanced Technology, a privately funded R&D institute founded in 2010 with scientists in the US, France and India and with publications in leading scientific journals including PNAS, Nucleic Acids Research, Physical Review, American Chemical Society journals, Biophysical Society journals and Nature Publishing Group journals. These platforms are complemented by the contract research, development, and manufacturing organizations (CRDMO) at PMC Group, the sister company of CCM Biosciences and a global chemical and pharmaceutical company with ~$1 billion in annual revenue, enabling fully integrated drug discovery and development. Article content Article content Article content Article content Article content Article content
Yahoo
10-02-2025
- Business
- Yahoo
Which North Jersey towns met affordable housing deadline? Which are fighting? See the list
After a Jan. 31 deadline, almost 80% of New Jersey municipalities have signed on to participate in the fourth round of a state-mandated order to build more affordable housing. At the same time, a small but growing consortium of towns has vowed to keep fighting, despite two recent court setbacks in their challenge to the law enacted last year. As of Thursday, 440 of the state's 564 municipalities had adopted resolutions to declare their compliance with the housing mandate, according to the Fair Share Housing Center, a nonprofit that advocates, and sometimes litigates, on behalf of the program. 'It's encouraging that the vast majority of municipalities are moving forward with creating homes under the new law,' Adam Gordon, executive director of Fair Share housing, said in a release after the deadline. 'In the midst of a deep housing crisis, New Jersey's new affordable housing law creates a win-win situation by giving municipal leaders tools to plan in the best way for their communities." The mandate, born of a decades-long series of court rulings known as the Mount Laurel doctrine, has fueled a wave of construction in what is already the nation's most densely populated state. The coalition challenging the process recently added three more municipalities, expanding to 28 total. They filed a new lawsuit on Feb. 3. Under the law adopted last year, all New Jersey towns had until the end of January to declare whether they would accept the 10-year affordable housing goals announced in October by the Department of Community Affairs. Their other option was to challenge the numbers by presenting their own goal calculation to the state's new Affordable Housing Dispute Resolution Program. Towns that failed to meet the Jan. 31 deadline may still be working on their strategy. They may already have agreed to separate goals in settlements with the Fair Share Housing Center. Or they may have decided to take their chances in a court battle, as Edison did when it objected to the state's proposal that it could accommodate 727 new homes. Collectively, the Community Affairs goals could require the construction of 85,000 more affordable housing units over the next decade, along with the renovation of 65,000 existing residences. Towns are not required to build their own housing, although some, like Madison, have approved municipal projects to create all-affordable dwellings to meet their Mount Laurel obligations. Most municipalities, however, choose to set their master plans and local zoning to entice private developers to construct the required units. Towns that do not accommodate developers willing to commit a small percentage (an often negotiable number, up to 20%) of their inventory to be sold at "affordable" rates can be hauled into courts. Through so-called "builder's remedy" lawsuits, judges can award broad leverage to developers to build whatever they wish and sell or rent at market rates if they include an affordable-housing component. Any interested party can file a challenge to the municipal calculations before the end of February. The Dispute Resolution Center must issue a decision no later than March 31. Towns have until June 30 to adopt what are known as housing elements and fair share plans, including proposed drafts of zoning and other measures. As of Thursday, North Jersey towns that adopted resolutions to accept the state numbers or propose their own included: BERGEN: Allendale, Alpine, Bergenfield, Bogota, Carlstadt, Cliffside Park, Closter, Cresskill, Demarest, Dumont, Elmwood Park, East Rutherford, Edgewater, Emerson, Englewood, Englewood Cliffs, Fair Lawn, Fairview, Fort Lee, Franklin Lakes, Garfield, Glen Rock, Hackensack, Montvale, New Milford, North Arlington, Northvale, Norwood, Oakland, Old Tappan, Oradell, Palisades Park, Paramus, Park Ridge, Ramsey, Ridgefield, Ridgefield Park, Ridgewood, River Edge, River Vale, Rochelle Park, Rockleigh, Rutherford, Saddle Brook, Saddle River, South Hackensack, Teaneck, Tenafly, Teterboro, Upper Saddle River, Waldwick, Wallington, Washington, Westwood, Woodcliff Lake, Wood-Ridge, Wyckoff. ESSEX: Belleville, Bloomfield, Caldwell, Fairfield, Cedar Grove, Essex Fells, Glen Ridge, Livingston, Maplewood, Millburn, Montclair, North Caldwell, Roseland, South Orange, Verona, West Caldwell, West Orange. MORRIS: Boonton, Boonton Township, Butler, Chatham, Chatham Township, Chester, Chester Township, Denville, Dover, East Hanover, Florham Park, Hanover, Harding, Jefferson Township, Kinnelon, Lincoln Park, Long Hill Township, Madison, Mendham, Mendham Township, Mine Hill, Montville, Morris Plains, Morris Township, Morristown, Mount Arlington, Mount Olive, Mountain Lakes, Netcong, Parsippany, Pequannock, Randolph, Riverdale, Rockaway, Rockaway Township, Roxbury, Victory Gardens, Washington Township, Wharton. PASSAIC: Bloomingdale, Clifton, Hawthorne, Little Falls, North Haledon, Pompton Lakes, Ringwood, Totowa, Wanaque, Wayne, West Milford, Woodland Park. SUSSEX: Andover, Branchville, Byram, Frankford, Franklin, Fredon, Green, Hampton, Hardyston, Hopatcong, Lafayette, Montague, Newton, Ogdensburg, Sparta, Stanhope, Stillwater, Vernon, Wantage. The original consortium of nine towns that filed a lawsuit in September to suspend implementation of the program has grown to 28. "The law imposes new affirmative obligations upon municipalities that exceed any remedy ever imposed under the Mount Laurel doctrine," said one of the legal claims filed by the towns, which call themselves Local Leaders for Responsible Planning. Most are in North Jersey, where densely populated communities worry about the increased traffic, utility consumption and school enrollment that the new units would require. "High-density housing may seem like a solution, but it raises serious concerns about our infrastructure and budget," Parsippany Mayor James Barberio said at a 2024 town hall presentation on the issue attended by several mayors. "It seems like the state wants us to sacrifice quality for quantity." Parsippany, Little Falls and Warren are the latest towns to join the lawsuits. The other plaintiffs are: Bergen County: Allendale, Closter, Franklin Lakes, Hillsdale, Montvale, Norwood, Old Tappan, Oradell, Washington Township, Westwood and Wyckoff. Morris County: Denville, East Hanover, Florham Park, Hanover, Mendham, Montville and Wharton. Passaic County: Totowa. Essex County: Cedar Grove and Millburn. Hunterdon County: West Amwell. Monmouth County: Wall and Holmdel. Salem County: Mannington. More: Paramus agrees to build 1,000 affordable housing units over next decade Despite two recent denials of their claims by a state Superior Court judge in Mercer County, the consortium filed a new suit last Monday in yet another attempt to pause the process. The second complaint names New Jersey, the Affordable Housing Dispute Resolution Program and Glenn Grant, New Jersey's acting director of the New Jersey Administrative Office of the Courts, as defendants. The plaintiff towns allege that the court process has denied them due process and violated their civil rights. The Mount Laurel court rulings required municipalities to provide their "fair share" of housing for low- and moderate-income families. Gov. Phil Murphy and state legislators enshrined that goal in a law passed last year that sought to smooth enforcement of those obligations. 'We face a somewhat perfect storm of low housing inventory and escalating pricing, which leaves thousands of working families all across our state with no viable options,' said Sen. Troy Singleton, D-Burlington, a sponsor of the 2024 bill. 'Without securing the most basic human needs — a place to live — the other policies we pass cannot be as effective.' This article originally appeared on Morristown Daily Record: Which NJ towns met affordable housing mandate deadline?
