Cancer immunotherapy play Juno Therapeutics Inc. (Seattle, Wash.) debuted on Wednesday with $120 million in a series A round co-led by Arch Venture Partners and the Alaska Permanent Fund, through a partnership with Crestline Investors. The company said the round is not milestone-based, but declined to disclose details.
Juno is designing and developing immunotherapies based on chimeric antigen receptor (CAR) and T cell receptor (TCR) technology. Juno's technology is based on research out of the Fred Hutchinson Cancer Research Center, Memorial Sloan-Kettering Cancer Center (MSKCC) and Seattle Children's Research Institute. Prior to Juno, MSKCC was the lone unpartnered academic player with a significant presence in the CAR space (see SciBX: Science-Business eXchange, Oct. 24).
Juno's technology is in multiple Phase I trials. Co-founder and CEO Hans Bishop said there was a complete response rate of 88% in 17 patients with acute lymphoblastic leukemia (ALL) in one undisclosed program. Bishop is former EVP and COO of Dendreon Corp. (NASDAQ:DNDN), which markets prostate cancer immunotherapy Provenge sipuleucel-T.
The Medicines Co. (NASDAQ:MDCO) acquired Rempex Pharmaceuticals Inc. (San Diego, Calif.) for $140 million in cash up front, plus up to $334 million in milestones. Rempex is developing beta lactamase inhibitors and antibiotics for multi-drug-resistant Gram-negative bacteria. The company's Carbavance is an IV combination of RPX7009, a boron-containing beta lactamase inhibitor, and biapenem (RPX2003), a generic carbapenem antibiotic. Next year, the compound is slated to start Phase III testing for complicated urinary tract infections (cUTIs) and serious Gram-negative infections, with data expected in 2016.
The Medicines Co. already has one antibiotic in late-stage development. By year end, the company plans to submit an NDA to FDA for oritavancin -- a semi-synthetic lipoglycopeptide antibiotic -- to treat acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria (see BioCentury, Sept. 17, 2012).
The Medicines Co. also gains Minocin IV, an injectable formulation of minocycline, to treat multi-drug-resistant infections due to Acinetobacter species. Late last year, Rempex acquired from PreCision Dermatology Inc. (Cumberland, R.I.) an NDA for the product, which has "limited commercialization" in the U.S. Rempex is also developing RPX-602, a follow-on version of the product for which an sNDA submission is expected next year.
RBC Capital Markets advised The Medicines Co., and BofA Merrill Lynch advised Rempex. On Wednesday, The Medicines Co. was up $1.15 to $37.70.
Molecular Partners AG (Schlieren, Switzerland) and Roche (SIX:ROG; OTCQX: RHHBY) partnered to generate conjugates of toxic agents from Roche with Molecular Partners' designed ankyrin repeat proteins (DARPins) against a set of undisclosed targets for cancer. Molecular Partners will receive undisclosed research funding and up to CHF55 million ($60.2 million) in upfront and initiation payments. The company is also eligible for over CHF1 billion ($1.1 billion) in milestones, plus tiered royalties. Roche has an undisclosed "limited number of options" to select compounds to develop and commercialize.
Roche has been active in the drug-conjugate space. The pharma's most advanced conjugate is Kadcyla ado-trastuzumab, a humanized mAb against HER2 linked to a DM1 cytotoxic agent from ImmunoGen Inc. (NASDAQ:IMGN) that is approved in the U.S., EU and Japan to treat HER2-positive metastatic breast cancer. In October, Roche said it would invest about CHF190 million ($208.1 million) in a new antibody-drug conjugate (ADC) production facility in Basel.
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said it has approved 15 new therapeutic entity (NTE) programs for development, including four abuse-deterrent opioids, four fixed-dose combinations of antiretrovirals for HIV, a once-daily fixed combination of a prostaglandin agonist and beta blocker for glaucoma and a once-monthly subcutaneous formulation of schizophrenia drug risperidone. The details came in a Wednesday update on Teva's NTE program, which is focused on developing reformulations and novel combinations of approved drugs. Over the next three years, Teva plans to submit applications to FDA for eight of the products under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products.
The NTE program is part of a strategy developed and introduced by former President and CEO Jeremy Levin to put the ailing generics and specialty pharmaceuticals company back on a growth trajectory. Levin abruptly departed from the company in October due to disagreement over an unspecified aspect of implementing the strategy (see BioCentury, Nov. 4).
Separately, Teva disclosed that earlier this year it granted Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) Japanese commercialization rights to glatiramer acetate, which is approved as Copaxone for multiple sclerosis (MS) in 55 countries including the U.S. and those in the EU. Takeda will be responsible for submitting an NDA for the compound in Japan. The companies did not disclose financial terms.
On Wednesday, Teva was off $0.16 to $40.04.
Forest Laboratories Inc. (NYSE:FRX) declined to comment on rumors that it is in talks to be acquired by AstraZeneca plc (LSE:AZN; NYSE:AZN). According to the Financial Times, talks between the companies may already have stalled because of Forest's recent stock spike. The company's shares are up about 30% since early October, including a jump of $5.01 (10%) to $56.32 on Monday after Forest unveiled a restructuring (see BioCentury Extra, Dec. 2).
AstraZeneca could not be reached for comment. Of the banks rumored to be advising the pharma, Goldman Sachs and Evercore Partners declined to comment, while Barclays could not be reached. On Wednesday, Forest was off $0.17 to $56.27.
For trials sponsored by Pfizer Inc. (NYSE:PFE) that start enrolling next year or later, the pharma said trial participants will be able to receive a summary of trial results and to download their own electronic clinical data through the "Blue Button" program developed by the U.S. Department of Veterans' Affairs and HHS. Starting Jan. 1, Pfizer also said qualified researchers can request access to de-identified, patient-level data from Pfizer-sponsored trials of approved or discontinued products two years after trial completion. The pharma said an independent review panel will consider all requests that Pfizer denies or only partially approves and make a final decision.
The pharma will also publish on its website synopses of clinical study reports for trials since 2007 that were submitted to regulatory agencies following approval of a product. Pfizer currently submits trial results for publication in journals within 18 months of study completion and posts summary results to clinicaltrials.gov and other registries.
Cerus Corp. (NASDAQ:CERS) submitted the final module of a PMA for the company's Intercept Blood System for plasma. In March, the company plans to submit the final module for a PMA for the system for platelets. The Intercept Blood System, which uses light-activated molecules to crosslink DNA and RNA to prevent pathogen replication, already has CE Mark approval for platelets and plasma, and Cerus markets the system in Europe to inactivate blood-borne pathogens in donated blood components intended for transfusion.
Cerus was off $0.01 to $6.43 on Wednesday.
Puma Biotechnology Inc. (NYSE:PBYI) said a regimen containing the company's neratinib "graduated" from the open-label I-SPY 2 trial based on having a high probability of success in patients with HER2-positive/hormone receptor-negative breast cancer in a Phase III trial. The company said that as far as it knows, the neratinib-containing regimen is the first to graduate from I-SPY 2, which is designed to rapidly and inexpensively develop data to support small Phase III trials of new neoadjuvant therapies for locally advanced breast cancer or to help companies quickly kill ineffective candidates. The trial involves an adaptive trial design based on Bayesian predictive probability that a regimen will be statistically superior to standard therapy in an equally randomized 300-patient confirmatory trial.
Puma said neratinib is now eligible for the upcoming Phase III I-SPY 3 trial, which is likely to start next year. Puma has exclusive, worldwide rights to develop and commercialize the oral inhibitor of HER1, HER2 and HER4 kinases from Pfizer Inc. (NYSE:PFE). Earlier this year Puma began a Phase III trial of neratinib in third-line breast cancer.
After a compound has been "graduated" as being ready for Phase III testing by the sponsor, or dropped for futility, additional compounds may be added to I-SPY 2, which is evaluating up to 12 compounds. All data from I-SPY 2 will be placed in the public domain.
Puma, which announced the news after market close on Wednesday, was off $0.74 to $46.21 on the day. The company jumped $6.79 (15%) to $53 in early after-hours trading.
The New York City Economic Development Corp. partnered with Celgene Corp. (NASDAQ:CELG), Eli Lilly and Co. (NYSE:LLY) and GE Ventures to invest at least $100 million in early stage life science companies in New York City, with the first investment slated to be announced by mid-2014. The parties will invest at least a combined $50 million for a life sciences fund, while additional VC firms are expected to contribute at least $50 million in matching funds. The Economic Development Corp. is reviewing proposals from eight prospective VC partners, with the first partner to be selected by year end. The initiative is aiming to invest in seed and series A rounds of 15 to 20 companies by 2020.
TWi Pharmaceuticals Holding Inc. (GreTai:4180) raised NT$3.3 billion ($111.5 million) through the sale of 13.3 million shares at NT$248 in an IPO in Taiwan -- the largest IPO for a pharma or biotech in the country, according to the company. The price values TWi at NT$27.9 billion ($943.8 million). In its first day of trading on Tuesday, the company was up NT$82 to NT$330. On Wednesday, TWi was unchanged at NT$330 (see BioCentury Extra, Dec.3 ).
TWi's AC-201, a small molecule that modulates the transcription of IL-1 beta and IL-1RA, is in Phase II testing for Type II diabetes. TWi spun out of generics company Anchen Inc. in 2010. Par Pharmaceutical Cos. Inc. (NYSE:PRX) acquired Anchen in 2011.
Zafgen Inc. (Cambridge, Mass.) raised $35 million in the first tranche of a $45 million series E round from new investors RA Capital Management; Brookside Capital; Venrock; an undisclosed blue chip investor; and a private investor. Existing investor Alta Partners also participated. The remaining $10 million is tied to undisclosed milestones. Last month, Zafgen presented final 12-week data from 122 evaluable patients in a Phase IIa trial evaluating subcutaneous beloranib (ZGN-440) to treat obesity. Beloranib is a subcutaneous formulation of a methionine aminopeptidase 2 (MetAP2) inhibitor (see BioCentury Extra, Nov. 15).
PaxVax Inc. (Menlo Park, Calif.) raised $22 million in a series B round led by existing investor Ignition Growth. Existing investor Ignition Ventures and new investor Blue Haven Initiative also participated. PexVax's PXVX0200, a live attenuated vaccine against Vibrio cholerae, is in Phase III testing to prevent cholera infection.
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