- Sierra lays the groundwork for collaboration with Tesaro.
- Amgen gets a new nod from the CHMP for its neutropenia drug.
- Midatech shows early favor from European regulators in liver cancer.
Note: Subscribers to Avisol Capital Partners Total Pharma Tracker got an early look at this publication.
Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.
Sierra lays the groundwork for collaboration with Tesaro
Therapy: Niraparib and SRA737
Disease: Prostate cancer
News: SRRA announced that it has signed a clinical supply agreement with Janssen to get access to the PARP inhibitor niraparib, made by TSRO. SRRA intends to combine niraparib with its Chk1 inhibitor SRA737 for treatment of metastatic castration-resistant prostate cancer. Combination studies will be conducted on the basis of preclinical findings showing synergistic activity between SRA737 and PARP inhibitors.
Looking forward: We have not yet seen the supporting evidence for combining PARP and Chk1 inhibition. However, SRRA is scheduled to present these findings at this year's AACR meeting, which will take place in mid-April. Until then, it is up to us to speculate on what this move might mean for SRRA and TSRO if the combination proves active. It is probably no accident that TSRO and SRRA are now tied together in clinical development, as opposed to other PARP inhibitor developers.
Overall, this may be a positive move for both companies, but we need to see further supporting evidence.
Amgen gets a new nod from the CHMP for its neutropenia drug
Company: Amgen (AMGN)
News: The EMA's CHMP offered a positive opinion on a label modification for pegfilgrastim to include the Neulasta Onpro Kit, which will allow for careful delivery of the drug in a more convenient method for patients. This will mean that patients would not have to return to their infusion center in the days following chemotherapy in order to receive supportive care for neutropenia.
Looking forward: A bit lacking in the pop that other label expansions might have, this is nevertheless an important step in helping AMGN maintain market position for its version of pegfilgrastim, especially as the threat of competition from biosimilars looms large.
Overall, I think this is a very positive development for a market that is on the forefront of biosimilar movements.
Midatech shows early favor from European regulators in liver cancer
Company: Midatech Pharma (MTP) [LON:MTPH]
Disease: Hepatocellular carcinoma
News: MTPH announced that the EMA has granted orphan drug designation to its nanoparticle-based chemotherapy formulation called MTD119. Currently, the company is conducting pilot studies investigating the toxicology of this agent, with completion anticipated in the first half of 2018. The company provided further guidance that it expects to submit an IND to the US FDA in the second half of 2018 at the earliest.
Looking forward: Interesting development for a tiny biotech newcomer, although it's very tough to say at this point how well a nanoparticle-based chemotherapy might improve on the current standard of care. Liver cancer, in particular, has had a long, long history of failure of therapeutic development. There are no systemic chemotherapy options approved for liver cancer, so I'll need to see more in the way of data before I'd possibly become a believer in this approach.
This is cool science and a positive step forward for MTPH, but I personally would wait until I can learn more about this treatment approach.
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