Archive for the ‘blood cancer’ Category
Dec
12
Posted under
Blog,
blood cancer,
chronic lymphocytic leukemia,
Companies,
Diagnostics,
Funding,
leukemia,
Medical Devices,
Medical Supply,
PCI-32765,
Pharmaceuticals,
Pharmacyclics,
Startups,
Universities,
Videos by John Carroll
Anyone looking for a solid reason why J&J's Janssen would pay $150 million upfront to partner on Pharmacyclics' experimental blood cancer drug need look no further than the leukemia data the biotech had to offer analysts over the weekend.
Pharmacyclics ($PCYC) reported on Sunday that the 10-month follow-up data on its low-dose formulation of PCI-32765, a Btk inhibitor, looks better than the six-month data it's gathered in a small Phase Ib/II study. A total of 70% of the 61 chronic lymphocytic leukemia patients in the trial demonstrated a significant response, compared to 48% at the six-month mark. Progression-free survival hit 90% at six months,
All of the patients had failed at least two standard therapies for leukemia. The response rate in the high-dose group hit 44%. Lead author Dr. John Byrd of Ohio State called the data "phenomenal."
"In the 15 years I've been practicing as a CLL-specific specialist, this is by far the most phenomenally active drug for refractory CLL patients in terms of response and durability and tolerability," Byrd told HemOnc Today. "Eighty-six percent of people receiving this drug are progression free at 1 year. Given the durability and the potential that patients can stay on therapy for an extended period of time without adverse events, it's likely this is going a paradigm-shifting drug."
J&J ($JNJ) presumably agreed with that upbeat assessment. On Friday Janssen committed an old-fashioned blockbuster upfront to buy into the program, demonstrating once again that the Big Pharma company is willing to dig down into its very deep pockets to jump into a late-stage program that has been significantly de-risked. J&J will now help orchestrate a range of Phase III studies for the treatment.
- here's the Reuters story
- get the article from HemOnc Today
Related Articles:
Updated: J&J locks in blood cancer compound in $975M pact
Pharmacyclics snares $39.5M development deal
Dec
12
Posted under
Blog,
blood cancer,
chronic lymphocytic leukemia,
Companies,
Diagnostics,
Funding,
leukemia,
Medical Devices,
Medical Supply,
PCI-32765,
Pharmaceuticals,
Pharmacyclics,
Startups,
Universities,
Videos by John Carroll
Anyone looking for a solid reason why J&J's Janssen would pay $150 million upfront to partner on Pharmacyclics' experimental blood cancer drug need look no further than the leukemia data the biotech had to offer analysts over the weekend.
Pharmacyclics ($PCYC) reported on Sunday that the 10-month follow-up data on its low-dose formulation of PCI-32765, a Btk inhibitor, looks better than the six-month data it's gathered in a small Phase Ib/II study. A total of 70% of the 61 chronic lymphocytic leukemia patients in the trial demonstrated a significant response, compared to 48% at the six-month mark. Progression-free survival hit 90% at six months,
All of the patients had failed at least two standard therapies for leukemia. The response rate in the high-dose group hit 44%. Lead author Dr. John Byrd of Ohio State called the data "phenomenal."
"In the 15 years I've been practicing as a CLL-specific specialist, this is by far the most phenomenally active drug for refractory CLL patients in terms of response and durability and tolerability," Byrd told HemOnc Today. "Eighty-six percent of people receiving this drug are progression free at 1 year. Given the durability and the potential that patients can stay on therapy for an extended period of time without adverse events, it's likely this is going a paradigm-shifting drug."
J&J ($JNJ) presumably agreed with that upbeat assessment. On Friday Janssen committed an old-fashioned blockbuster upfront to buy into the program, demonstrating once again that the Big Pharma company is willing to dig down into its very deep pockets to jump into a late-stage program that has been significantly de-risked. J&J will now help orchestrate a range of Phase III studies for the treatment.
- here's the Reuters story
- get the article from HemOnc Today
Related Articles:
Updated: J&J locks in blood cancer compound in $975M pact
Pharmacyclics snares $39.5M development deal
Dec
09
Posted under
Blog,
blood cancer,
Companies,
Diagnostics,
Funding,
Janssen,
Medical Devices,
Medical Supply,
PCI-32765,
Pharmaceuticals,
Pharmacyclics,
Startups,
Universities,
Videos by Ryan McBride
A unit of Johnson & Johnson ($JNJ) has made big bet on the future of developer Pharmacyclics' ($PCYC) experimental compound in midstage testing for blood cancers, shelling out $150 million in upfront money to seal the deal and promising up to $825 million in milestone payments.
While the pact may be a small piece of the pipeline puzzle at the healthcare giant J&J, it's a significant step forward for Sunnyvale, CA-based Pharmacyclics, which has no products on the market and failed to get FDA approval of a previous cancer drug. Pharmacyclics now has a deep-pocketed development partner to advance PCI-32765, a Bruton's tyrosine kinase (Btk) inhibitor that targets the BCR signaling pathway linked to the growth and spread of certain types of blood cancers. The developer is keeping for itself rights to the drug for inflammation and immune-mediated ailments.
The drug has made it as far as Phase II testing, making the sizable $150 million down payment from J&J's Janssen Biotech worth noticing, as many upfront payments for midstage assets haven't been so rich. Pharmacyclics is now trialing the small molecule drug in non-Hodgkin's lymphoma, chronic lymphocytic leukemia and multiple myeloma. With its big partner on board, the developer will pay for 40% of development costs of the program and J&J will handle the rest. Bloomberg reports that the companies will split worldwide profits from potential sales of the drug right down the middle.
Some investors apparently weren't thrilled with the terms of the deal for Pharmacyclics, sending the company's shares down by more than 15% as of 12:50 pm ET on Friday.
"The agreement with Pharmacyclics is an opportunity to bring a new form of oral therapy to patients with B-cell malignancies," said Dr. William Hait, global therapeutic head of oncology for Janssen, in a statement. "PCI-32765 is an innovative compound, with broad applicability and the potential to help a large number of patients with B-cell malignancies."
For Pharmacyclics, PCI-32765 gives the company another chance for FDA approval after the agency shot down an application for a market green light on a previous cancer therapy, Xcytrin, with a refuse to file letter in 2007. Now that J&J is backing PCI-32765's development, there's likely to be some extra attention on the program's midstage data that are to be presented at the upcoming American Society of Hematology meeting.
- here's Pharmacyclics' release
- see J&J's release
- and Bloomberg's report
Related Articles:
Pharmacyclics snares $39.5M development deal
Janssen inks $800M discovery deal for Molecular Partners' small protein tech
Nov
29
Posted under
Blog,
blood cancer,
Companies,
Diagnostics,
Funding,
Infinity Pharmaceuticals,
Medical Devices,
Medical Supply,
Mundipharma International,
Pharmaceuticals,
Startups,
Universities,
Videos by Ryan McBride
Infinity Pharmaceuticals ($INFI) has some new wiggle room in its budget to develop its PI3K inhibitor intended to combat blood cancers and inflammation. Mundipharma International, Infinity's partner on the drug, agreed to pump more than $50 million into the program and other candidates in 2013, building on the alliance formed between the two companies in 2008, Infinity said Tuesday.
The Cambridge, MA-based developer's PI3K inhibitor, IPI-145, is in two Phase I clinical trials, including one to test the safety and tolerance in healthy volunteers and a second that will enable the company to gauge the activity of the drug in patients with advanced hematologic cancers. Mundipharma, headquartered in Cambridge, U.K., initially committed $75 million to Infinity when the two companies formed the alliance in 2008, Mass High Tech reported.
Infinity reported Tuesday that IPI-145 is the only inhibitor of the PI3K-delta and gamma enzymes in clinical development, and data from the Phase I studies of the drug are expected in 2012.
"Since our alliance began in 2008, Infinity has advanced and expanded its portfolio of innovative product candidates," Antony Mattessich, regional director of Europe at Mundipharma, said in a statement. "Infinity's productivity and track record in achieving its development objectives make the company an ideal partner, and we look forward to an ongoing collaboration which we hope will yield multiple best-in-class treatments that address significant unmet medical needs."
Separate from the R&D funding, Infinity has taken a $50 million line of credit from Mundipharma and said Tuesday that it has drawn the full amount of the credit line.
- here's the release
- see MHT's coverage
Related Articles:
Infinity gets $75M for cancer partnership
Infinity halts late-stage cancer trial, shares plunge
Infinity inks $488M pact on Intellikine's PI3K portfolio