BMO Capital analyst Do Kim raised his price target on Ionis Pharmaceuticals (IONS) to $96 and kept his outperform rating after including the risk-adjusted royalties for HTT-Rx in his model as part of the update on its partnership with Roche (RHHBY) disclosed last month. The analyst notes that the stock price has started to reflect the company’s Huntington’s disease opportunity based on the “potential for an accelerated path with Phase 2 data” and believes that his HTT-Rx projections could prove to be “conservative”.
Monday, April 22, 2019
Orgenesis to fund Columbia University cellular vaccination product platform
Orgenesis announced that it has entered into an agreement with Columbia University, by which it will fund research to develop a cellular vaccination product platform, which it has licensed from Columbia University, for pancreatic, hepatic and cholangiocarcinoma cancers. Orgenesis will receive exclusive license on the technology developed at Columbia University under the research agreement. This patented dual-vaccine design utilizes whole cancer cells as a source of antigens and the patient’s dendritic cells and macrophages to present the cancer antigens to the immune system. It differs from similar approaches, which use dendritic cells pulsed with individual tumor-associated antigens or peptides. When individual tumor antigens are selected for targeting cancer cells it leaves a possibility that cancer cells will mutate and thus evade the immune system response. Conversely, targeting the entire repertoire of tumor cell antigens leaves little or no possibility for cancer cells to escape the immune system response.
Lilly and Avidity Biosciences Announce Licensing and Research Collaboration
Eli Lilly and Company (NYSE: LLY) and Avidity Biosciences, Inc. today announced a global licensing and research collaboration focused on the discovery, development and commercialization of potential new medicines in immunology and other select indications.
The companies will utilize Avidity’s technology platform to progress new therapeutic approaches toward clinical development and commercialization. Avidity’s platform seeks to combine the tissue selectivity of monoclonal antibodies and the precision of oligonucleotide-based therapeutics to potentially overcome barriers to the delivery of oligonucleotides and target genetic drivers of disease.
“We are excited to expand our oligonucleotide research and development efforts through this strategic collaboration with Avidity,” said Andrew C. Adams, Ph.D., chief scientific officer for RNA therapeutics at Lilly. “Their expertise in studying the combination of monoclonal antibodies and oligonucleotide-based therapies represent a promising avenue of research toward development of new RNA-based medicines.”
“This collaboration with Lilly provides an exceptional opportunity to leverage Avidity’s proprietary AOC platform in order to generate new therapeutic targets in disease areas that have been challenging to pursue using oligonucleotide-based approaches,” said Kent Hawryluk, Avidity’s chief business officer. “Lilly’s extensive research, development, regulatory, and commercial capabilities make them an ideal partner, and we look forward to a long and productive relationship.”
Under the terms of the agreement, Avidity will receive an upfront payment of $20 million, as well as an investment of $15 million. Avidity is also eligible to receive up to approximately $405 million per target for development, regulatory and commercialization milestones, as well as tiered royalties ranging from the mid-single to low-double digits on product sales.
This transaction is subject to clearance under customary closing conditions. The transaction will be reflected in Lilly’s reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly’s 2019 non-GAAP earnings per share guidance as a result of this transaction.
FDA OKs Merck KEYTRUDA Combo as 1st-Line for Advanced Renal Cell Carcinoma
Approval Based on Results of KEYNOTE-426, Where KEYTRUDA in Combination With Axitinib Reduced the Risk of Death by Nearly Half Compared to Sunitinib
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The approval is based on findings from the pivotal Phase 3 KEYNOTE-426 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA in combination with axitinib (KEYTRUDA-axitinib combination) compared to sunitinib. Consistent results were observed across pre-specified subgroups, IMDC risk categories and PD-L1 tumor expression status. For the main efficacy outcome measures of OS and PFS, the KEYTRUDA-axitinib combination reduced the risk of death by 47% compared to sunitinib (HR=0.53 [95% CI, 0.38-0.74]; p<0.0001); for PFS, the KEYTRUDA-axitinib combination showed a reduction in the risk of progression of disease or death of 31% compared to sunitinib (HR=0.69 [95% CI, 0.57-0.84]; p=0.0001). The ORR, an additional efficacy outcome measure, was 59% for patients who received the KEYTRUDA-axitinib combination (95% CI, 54-64) and 36% for those who received sunitinib (95% CI, 31-40) (p<0.0001). This is the first indication for KEYTRUDA in advanced RCC, the most common type of kidney cancer, and the first anti-PD-1 therapy FDA-approved as part of a combination regimen that significantly improved OS, PFS, and ORR versus sunitinib in patients with advanced RCC.
CMS Sets Code for Eagle Pharma BELRAPZO
Eagle’s bendamustine 500mL hydrochloride injectable will be sold as BELRAPZO beginning June 3, 2019
Eagle Pharmaceuticals, Inc. (“Eagle” or the “Company”) (Nasdaq:EGRX) today announced that the Centers for Medicare & Medicaid Services (CMS) has established a unique, product-specific billing code, or J-code (J9036), for BELRAPZO™ (bendamustine 500mL hydrochloride injection). The J-code will become effective on July 1, 2019. Eagle’s bendamustine 500mL hydrochloride injectable will be sold as BELRAPZO beginning June 3, 2019. “We launched our 500mL bendamustine hydrochloride injection, to address the need in the market for our unique formulation at a lower price point. The new J-code provides reimbursement coding clarity to outpatient facilities and physicians that will administer BELRAPZO, facilitating access for patients, and Medicare, Medicaid and commercial insurance reimbursement,” said Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals. About BELRAPZO Indications BELRAPZO is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established. BELRAPZO is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
BTIG raises price targets on Editas Medicine, CRISPR Therapeutics
BTIG analyst Amanda Murphy raised her price target on Buy-rated Editas Medicine (EDIT) to $33 from $30 and CRISPR Therapeutics (CRSP) to $49 from $43 as part of her first installment of a broader research note analyzing hiring trends in the gene therapy space. The analyst notes that the latter is “aggressively adding process development/CMC/Tech capabilities in cell therapy, including late stage process development resources”, which may suggest that the company is “farther along” in the development of CTX110. Murphy also observes that Editas Medicine appears to be “shifting focus to engineered stem cell therapy while still investing in allo CAR-T and potentially new in vivo indications and delivery vectors.”
Gritstone Oncology announces potential clinical acceleration for SLATE study
Gritstone Oncology announced that following feedback from the FDA the SLATE Phase 1 clinical study may be accelerated by up to six months from the company’s prior expectations by leveraging pre-clinical data generated for the original GRANITE investigational new drug, or IND, application. Based on the similarities in the two investigational therapies, the common patient populations and the consistency in manufacturing that has led to comparable drug products, the FDA has in principle agreed to accept previously conducted GRANITE IND-enabling toxicology studies in support of the SLATE IND, which brings the anticipated IND filing date closer. The Phase 1 study will evaluate SLATE in combination with immune checkpoint blockade for the treatment of patients with advanced solid tumors, including metastatic lung cancer, pancreatic cancer and colorectal cancer. There will also be a cohort of patients with other solid tumor types who possess appropriate mutation/HLA combinations. Clinical acceleration is also enabled by early identification of eligible patients using a screening protocol which is currently running at multiple trial sites. The company expects to present preliminary data from the first part of both the SLATE and GRANITE Phase 1 trials in Q4.
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