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FDA Turns Down IMMU's Breast Cancer Drug, ZYME/LLY Deal Progresses, ZFGN Abuzz

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Today's Daily Dose brings you news about FDA thumbs down on Immunomedics' breast cancer drug; FDA panel vote on Sanofi/Lexicon's diabetes drug; progress in Zymeworks/ Lilly collaboration; and encouraging data from Zafgen's diabetes trial.

Read on…

The FDA has turned down Immunomedics Inc.'s (IMMU) Biologics License Application seeking accelerated approval of Sacituzumab govitecan due to issues related to Chemistry, Manufacturing and Control matters. No new clinical or preclinical data need to be generated.

Sacituzumab govitecan was proposed for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior treatments.

Triple-negative breast cancer is a type of breast cancer whose cells don't have receptors for the hormones oestrogen and progesterone and protein Her2. It is said to be more aggressive and difficult to treat.

IMMU closed Thursday's trading at $18.09, up 1.46%.

MacroGenics Inc.'s (MGNX) updated data from its phase II clinical trial of margetuximab plus pembrolizumab for patients with advanced HER2+ gastric carcinoma has demonstrated an encouraging profile.

The Objective Response Rate in HER2+ second-line gastric cancer patients was 32.7%, with a Disease Control Rate of 69.1%. The median Progression-Free Survival was 4.7 months. In the subset of these patients who were also PD-L1 positive, objective response rate was 52.2% patients, with a Disease Control Rate of 82.6% and Progression-Free Survival of 4.14 months.

MGNX closed Thursday's trading at $12.54, down 2.26%.

An FDA panel, which assessed Zynquista, an investigational oral treatment as an adjunct therapy to insulin for adults with type 1 diabetes, has voted eight to eight on the question of whether the overall benefits of the drug outweighed the risks to support approval.

Zynquista, developed by Sanofi (SNY) in partnership with Lexicon Pharmaceuticals Inc. (LXRX) is an oral dual inhibitor of SGLT-1 and SGLT-2, proteins that influence how the intestines and kidneys absorb and eliminate sugar (glucose) resulting in improved glucose control and additional clinical benefits.

The final decision of the FDA on Zynquista is expected on March 22, 2019.

The FDA usually follows the panel's recommendations although it is not required to do so. Now, with a split verdict being handed down by the panel, it remains to be seen how the final decision is going to be.

LXRX closed Thursday's trading at $7.70, up 1.32%.

Zymeworks Inc. (ZYME) is all set to receive a milestone payment of US$8.0 million from Eli Lilly and Co. (LLY) under a licensing and collaboration agreement signed in 2014.

The milestone payment is related to Lilly's submission of an IND application for an immuno-oncology bispecific antibody enabled by Zymeworks' proprietary Azymetric platform. This is Lilly's second immune-oncology candidate using Zymeworks' novel Azymetric platform to start clinical trials.

Besides Lilly, Zymeworks has seven other partners, and the total value of remaining potential milestones for all its partnerships is said to exceed US$7.6 billion.

ZYME closed Thursday's trading at $16.13, down 0.98%.

The second cohort of Zafgen Inc.'s (ZFGN) phase II clinical trial of ZGN-1061 in patients with type 2 diabetes has yielded positive results.

According to the Company, the clinical trial met all of its primary objectives at the 1.8 mg dose, which included glycemic control, or change in A1C, and safety and tolerability.

The 12-week data demonstrated that treatment with the 1.8 mg dose of ZGN-1061 produced substantially more improvement in A1C than the 0.9 mg dose. Progressive and notable reduction in body weight also occurred in patients treated with the 1.8 mg dose. The data showed favorable safety and tolerability profile for ZGN-1061, with no treatment-related serious adverse events and no cardiovascular (CV) safety signals observed, added Zafgen.

ZFGN closed Thursday's trading at $4.75, up 0.42%.

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