Today’s Daily Dose brings you news about NantKwest teaming up with ImmunityBio to accelerate the development of vaccines and therapeutics for COVID-19; Mersana’s promising data in ovarian cancer and non-small cell lung adenocarcinoma trial; Arcus’ 10-year partnership with Gilead; Ironwood’s disappointing results from a phase II study of MD-7246 in the treatment of abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D); and PhaseBio’s COVID-19 drug candidate that is all set to enter a pivotal clinical trial by the end of June.
1. Arcus Inks 10-year Partnership With Gilead
Gilead Sciences Inc. (GILD) and Arcus Biosciences Inc. (RCUS) have entered into a 10-year partnership to co-develop and co-commercialize current and future therapeutic product candidates in Arcus’ pipeline.
Arcus’ drug candidates include Zimberelimab, which is evaluated as monotherapy and as combination regimen for cancers, AB928, which is under phase Ib and phase II trials in multiple tumor types; AB154, under a phase II study in non-small cell lung cancer and AB680 in a phase I trial in pancreatic ductal adenocarcinoma, among others.
Under the terms of the agreement, Gilead will gain access to Arcus’ investigational immuno-oncology products Zimberelimab, AB154, AB928, and AB680 as well as the future investigational products. In turn, Arcus will receive a $175 million upfront payment and a $200 million equity investment from Gilead, and up to $1.225 billion in opt-in and milestone payments with respect to its current clinical product candidates.
In other news, Arcus Biosciences on Wednesday announced that it has commenced an underwritten public offering of its common stock.
RCUS was trading around $9 when we had alerted readers to it on January 27, 2020.
Stock To Watch: Arcus Biosciences (RCUS)
The stock closed Wednesday’s trading at $27.05, down 19.35%.
2. BioCryst Announces Stock Offering
BioCryst Pharmaceuticals Inc. (BCRX) has offered to sell $100 million of its common stock and pre-funded warrants to purchase shares of its common stock in an underwritten public offering.
The Company’s lead asset is Berotralstat, an oral, once-daily therapy for the prevention of hereditary angioedema (HAE) attacks, and it is under review by the FDA – with a decision date set for December 3, 2020. This compound is also under review in Japan and the European Union.
BioCryst is slated to present new Berotralstat data at the European Academy of Allergy and Clinical Immunology Digital Congress on June 6.
BCRX closed Wednesday’s trading at $5.03, down 3.17%. In after-hours, the stock fell another 4.07% and was at $4.83.
3. Ironwood Throws In The Towel On IBS-D Drug Candidate
Ironwood Pharmaceuticals Inc. (IRWD) and its partner Allergan plc (AGN) has decided to discontinue the development of MD-7246 in the treatment of abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D) due to disappointing results from a phase II study.
The phase II trial of MD-7246 did not achieve statistically significant improvements in abdominal pain relative to placebo.
IRWD closed Wednesday’s trading at $10.65, down 8.97%.
4. Amivas’ Gain Is La Jolla’s Loss
Shares of La Jolla Pharmaceutical Company (LJPC) took a beating on Wednesday, following the FDA approval of Amivas LLC’s IV Artesunate product for severe malaria.
La Jolla is also developing a drug for severe malaria that goes by the name LJPC-0118 and the active ingredient used in this compound is also Artesunate.
Amivas had previously been granted Orphan Drug designation for its IV Artesunate product, and now that the drug has been approved, La Jolla will not be able to get approval for its drug candidate LJPC-0118 in the indication of severe malaria for the next 7 years.
According to FDA regulations, an Orphan drug has 7 Years of marketing exclusivity from approval.
La Jolla had filed a New Drug Application with the FDA for LJPC-0118 for the treatment of severe malaria in the second half of 2019.
LJPC closed Wednesday’s trading at $5.03, down 26.35%.
5. Mersana Hits A High As Investors Cheer Trial Data
Shares of Mersana Therapeutics Inc. (MRSN) hit a new 52-week high on Wednesday, thanks to encouraging data from a phase I trial of XMT-1536 in patients with ovarian cancer and non-small cell lung adenocarcinoma.
In the ongoing expansion portion of the phase I study, of the 20 platinum-resistant ovarian cancer patients that were evaluable for response, 2 (10%) achieved confirmed complete responses and 5 (25%) achieved confirmed partial responses for an objective response rate (ORR) of 35%. Additionally, 8 (40%) patients achieved stable disease and the disease control rate was 80%.
As for non-small cell lung adenocarcinoma, four out of seven patients were evaluable for response, and 2 (50%) patients had achieved stable disease as best response, according to the Company.
The Company looks forward to reporting more mature data in the second half of the year and continuing to advance XMT-1536 for both platinum-resistant ovarian cancer and NSCLC adenocarcinoma patients.
We had alerted our readers to MRSN on February 18, 2020, when it was trading around $8.
Stock Alert: Mersana (MRSN) Working To Make 2020 A Transformational Year?
The stock closed Wednesday’s trading at $18.19, up 69.05%.
6. NantKwest And ImmunityBio Team Up In Fight Against COVID-19
NantKwest Inc. (NK) has teamed up with ImmunityBio, a privately-held immunotherapy company, for the joint development, manufacture and marketing of vaccines and therapeutics for COVID-19.
ImmunityBio’s COVID-19 human adenovirus vaccine (hAd5) candidate is the first vaccine designed to deliver both Spike (S) and Nucleocapsid (N) DNA, offering the potential for patients to develop a long-lasting immunity to the virus, according to the Company.
Large-scale manufacturing facilities have been enabled at NantKwest, with hopes of producing a high-volume Ad5 vaccine later this year.
In addition to the vaccine, ImmunityBio’s therapeutic candidate N-803 has been given FDA clearance to be tested in a phase Ib trial that is expected to begin in Los Angeles area hospitals in June 2020. This trial will enroll 30 subjects who have tested positive for SARS-CoV-2 and have confirmed mild-to-moderate COVID-19 symptoms.
NantKwest will be evaluating bone marrow-derived mesenchymal stem cells for severe and critically ill COVID-19 patients on ventilator support. A phase Ib study evaluating the safety and efficacy of BM-Allo.MSC versus current supporting care in treating patients with severe disease requiring ventilator support is expected to begin in early June 2020 in the Los Angeles area.
NantKwest and ImmunityBio will share equally all costs relating to developing, manufacturing, and marketing of the product candidates globally, and the global net profits from the collaboration products will be split 60%/40% in favor of the company contributing the product on which the sales are based.
NK closed Wednesday’s trading at $7.58, up 39.08%.
7. PhaseBio Pharma Jumps On The COVID-19 Drug Bandwagon
PhaseBio Pharmaceuticals Inc. (PHAS) has been given the go-ahead by the FDA to initiate a pivotal clinical trial of PB1046 as a treatment for hospitalized COVID-19 patients who are at high risk for rapid clinical deterioration and acute respiratory distress syndrome.
The trial, dubbed VANGARD, which is designed to enroll 210 patients at roughly 20 sites nationwide, will start dosing patients by the end of June. The primary endpoint will measure days alive and free of respiratory failure.
PhaseBio expects trial results to be available late in the fourth quarter of 2020.
PHAS closed Wednesday’s trading at $4.42, down 1.56%. In after-hours, the stock jumped 82.13% to $8.05.
8. Stocks That Moved On No News
1. Verrica Pharmaceuticals Inc. (VRCA): closed Wednesday’s trading at $13.86, up 15.21%.
2. Tivity Health Inc. (TVTY): closed Wednesday’s trading at $11.29, up 14.62%.
3. Coherus BioSciences Inc. (CHRS) : closed Wednesday’s trading at $19.15, up 12.91%.
4. Arcturus Therapeutics Ltd. (ARCT) : closed Wednesday’s trading at $38.56, down 28.99%.
5. Harpoon Therapeutics Inc. (HARP): closed Wednesday’s trading at $21.69, down 12.26%.
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