Bristol Myers Squibb receives FDA approval for immunotherapy combo

Bristol Myers Squibb (BMY) announced that the FDA has given its approval to the combination therapy of Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks. The combination is now authorized to be used a first-line treatment for adult patients with unresectable malignant pleural mesothelioma. It is the first new systemic therapy in more than 15 to be approve in this setting.

The FDA utilized a pre-specified interim analysis from the Phase 3 CheckMate -743 trial for granting this approval. The combination showed superior overall survival with a median OS of 18.1 months over 14.1 months median OS demonstrated by the platinum-based standard of care chemotherapy. These results were collated following 22.1 months of minimum follow-up. At the two-year point, 41 percent of the patients administered combo therapy were alive, while the chemotherapy cohort had 27 percent patients alive.

Opdivo + Yervoy-based combination is already approved for two conditions in thoracic cancers, including as a first-line treatment for metastatic non-small cell lung cancer with specific features. It is also approved in combination with limited chemotherapy for adults with certain types of metastatic or recurrent NSCLC. Overall, it is the seventh indication for the combination.

Adam Lenkowsky of Bristol Myers Squibb said, “With today’s announcement, Opdivo + Yervoy becomes the first new systemic therapy approved in more than 15 years in this setting and may offer these patients a chance for a longer life.”

The combination therapy consists of two immune checkpoint inhibitors featuring a potential synergistic mechanism. Yervoy is believed to help stimulate and proliferate T cells. Opdivo likely helps in discovery of the tumor by existing T cells. The approval for the combination has come less than six weeks after the submission of a new supplemental Biologics License Application. The application was reviews under the FDA’s Real-Time Oncology Review pilot program, aiming to provide safe and effective treatments at the earliest possible time.

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CheckMate -743 is an open-label, multi-center, randomized Phase 3 study. It involved 302 patients who were randomized and were administered cisplatin 75 mg/m2 or carboplatin AUC 5 plus pemetrexed 500 mg/m2 in 3-week cycles for six cycles. The treatment was continued until the disease progressed or reached untenable level of toxicity, or in the case of the combination arm, up to 24 months.

The primary endpoint of the trial pertained to overall survival in all randomized patients. Secondary efficacy outcome measures were progression-free survival, objective response rate and duration of response. These metrics are evaluated using BICR following modified RECIST criteria. For the trial, 23 percent of the patients in the combination therapy arm were permanently discontinued due to adverse reactions, while 52 percent had at least one dose withheld on account of adverse reactions.

Investment Thesis: A blue-chip pharma company, Bristol Myers Squibb is a solid investment candidate for any long-term portfolio. The company has boosted its position through organic growth as well as through strategic acquisitions such as Celgene’s. The stock also provides solid dividend yield, making it ideal for income-generating portfolios.

iBio inks deal with Safi Biosolutions for harnessing FastPharming System

iBio Inc. (IBIO) announced entering into a Master Services Agreement with Safi Biosolutions Inc. The agreement mainly deals with the assessment of iBio’s FastPharming System for expressing key proteins to be used in the bioprocessing of Safi blood cell therapy products. Both the companies will work together to generate cGMP growth factors and cytokines using the FastPharming System.

Under the terms of the agreement, iBio will be responsible for manufacturing ten proteins as per the first Statement of Work. These proteins will be evaluated in the production of Safi’s therapies. Tom Isett, Chairman and CEO of iBio, said, “This opportunity is a natural fit for our new portfolio of Research & Bioprocess products, in which we are developing animal-free solutions for cell culture and 3D-bioprinting applications, amongst others.”

While Safi will have the choice to claim certain proteins as proprietary to its bioprocess, iBio will retain the right to commercialize all other products. iBio has agreed to invest $1.5 million in Safi. The investment will take form a 5% convertible promissory note. The Note comes with a maturity date three years from the date of issuance. The Note will become due in full if it is not converted at or before the three-year term.

Safi Biosolutions is mainly engaged in developing blood cell products and therapeutics, whereas iBio has carved a niche for itself in plant-based biologics manufacturing. Its FastPharming System blends vertical farming, automated hydroponics and glycan engineering technologies. It aims to provide fast delivery of high-quality bioinks, vaccines, monoclonal antibodies and other proteins. Its Glycaneering Development Service comprises an array of glycosylation technologies conducive for producing high-performance recombinant proteins. The company is also working on developing proprietary products for treating fibrotic diseases.

Investment Thesis: iBio is mainly targeted towards investors with a strong risk appetite. The company also has stakes in COVID-19 vaccine segment, and any positive development on that front may provide positive impetus to the stock.

Otonomy reports completing patient recruitment for Otividex trial

Otonomy Inc. (OTIC) announced the completing the patient enrolment for its Phase 3 clinical trial of Otividex in Ménière’s disease. The trial involves 149 participants, randomized to be administered either a single intratympanic injection of OTIVIDEX or placebo. These patients are monitored for three months.

The company stated that the completion of enrolment is a major milestone. Otonomy is looking to report data from the trial in the first quarter of 2021 and seems to be on the right track. David A. Weber, Ph.D., president and CEO of Otonomy, said, “We are grateful to the patients and investigators participating in this trial. We also appreciate the high compliance that continues to be demonstrated by patients in reporting their daily vertigo episodes, which we believe reflects the high disease burden and unmet medical need of Ménière’s disease patients.”

Otonomy already has positive data from AVERTS-2 for the drug candidate. It plans to combine the results with the likely positive data from the Phase 3 clinical trial for supporting its New Drug Application. The company expects the NDA to be filed in the third quarter of 2021.

Otonomy is a biopharmaceutical firm and is mainly invested in developing treatments for neurotology. The company has developed expertise in delivering drugs through the ear. Such application allows for continuous drug delivery from a single local administration. Otonomy is currently working on addressing various conditions such as Ménière’s disease, hearing loss and tinnitus.

Investment Thesis: The stock showed smart recovery from its COVID-19 fall. It is currently trading close to its previous high and may show some correction in the near future. The company has several upcoming catalysts which may provide support to its stock price level.

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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.