Amsterdam’s Synaffix BV has expanded a deal focusing on its antibody-drug conjugate (ADC) linker tech with U.S. cancer biotech Mersana Therapeutics Inc., with the revised contract potentially paying out more than $1 billion. Synaffix is hoping to ride a wave of interest in ADC technology, which is finally coming of age more than two decades after the first drug of this type was approved. With 11 FDA-approved ADCs on the market, companies such as Seagen Inc. and Daiichi Sankyo Co. Ltd. have proved that the technology can produce viable drugs with blockbuster-level sales potential. 

Phase III data with ADC in ovarian cancer sends Immunogen stock upward

Shares of Immunogen Inc. (NASDAQ:IMGN) shares were trading midday at $6.55, up $1.80, or almost 38% after the company disclosed top-line data from the pivotal phase III trial called Soraya, testing the antibody-drug conjugate mirvetuximab soravtansine as a monotherapy in patients with folate receptor alpha-high platinum-resistant ovarian cancer who have been treated with Avastin (bevacizumab, Roche Holding AG). Soraya enrolled 106 patients with a median of three prior lines of therapy (a range of one to four); 51% had three prior lines of therapy and 48% had one to two lines. All subjects had been treated with Avastin; 48% had received a PARP inhibitor. As of the data cutoff on Nov. 16, the median follow-up time was 8.1 months, and mirvetuximab turned up an overall response rate of 32.4% (95% CI: 23.6%, 42.2%), including five complete responses.

FDA eying patient population for molnupiravir, adcom looking at MOA and data

The FDA seems posed to grant an emergency use authorization for molnupiravir, an oral antiviral drug intended to keep mild COVID-19 infections from becoming severe in adults at high risk of severe disease. In a presentation before the agency’s Antimicrobial Drugs Advisory Committee Nov. 30, FDA officials focused not so much on whether the Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s drug should be authorized but on defining the population that could most benefit from it despite potential risks. However, at least a few committee members voiced concern about possible changes the drug could induce in the SARS-CoV-2 virus responsible for COVID-19. Since the drug’s mechanism of action is to induce mutagenicity, the sponsor has an obligation to determine the likelihood of an escape mutant, said James Hildreth, president and CEO of Meharry Medical College. Even if the probability is low, that possibility could be globally devastating should it occur, he added. Other members dug into late data showing the drug may not be as effective as interim results indicated.

Demand for COVID-19 rapid tests may spike for use with FDA-approved therapies

While the FDA’s reaction to the results of the Nov. 30 advisory hearing for the COVID-19 therapy molnupiravir is difficult to predict, demand for rapid antigen tests may jump considerably when this or any such product is approved. That increased demand could crunch supplies of these tests due to the convergence of any such approvals, the upcoming holiday season and the 2021-22 flu season, a convergence that could hamper efforts to roll out these new therapies.

Alphamab’s subcutaneous PD-1 drug envafolimab wins conditional approval in China  

Alphamab Oncology Co. Ltd. has won conditional marketing approval from China’s NMPA for KN-035 (envafolimab), the world’s first PD-1/PD-L1 antibody to be administered by subcutaneous injection. The drug was cleared for use in treating adult patients with advanced solid tumors who have unresectable or metastatic advanced microsatellite instability-high phenotype/mismatch-repair deficiency. That includes patients with advanced colorectal cancer who have experienced disease progression after previous therapy with fluorouracil, oxaliplatin and irinotecan. It also covers other patients with advanced solid tumors who have experienced disease progression after previous therapy and have no satisfactory treatment alternatives.

Fennec’s CRL: A familiar problem reappears  

Fennec Inc. received the complete response letter (CRL) it had expected from the FDA, sidelining U.S. development of Pedmark, a formulation of sodium thiosulfate for preventing ototoxicity associated with cisplatin chemotherapy in pediatric patients older than 1 month to those 18 years of age with localized, non-metastatic, solid tumors. According to Fennec, the CRL noted manufacturing deficiencies that need to be resolved before the NDA is approved. The Research Triangle Park, N.C.-based company said it will ask for a type A meeting to discuss the issues. It’s a familiar story for Fennec as it received a CRL from the FDA citing manufacturing deficiencies in August 2020.

Shionogi licenses out COVID-19 treatment to Ildong

Ildong Pharmaceutical Co. Ltd. inked a partnership with Shionogi & Co. Ltd. to co-develop S-217622, the latter’s orally administered 3CL protease inhibitor treating COVID-19, and has obtained an IND for a phase II/III trial in South Korea to enroll more than 200 patients who are asymptomatic or suffering from mild to moderate COVID-19. While Seoul-based Ildong conducts the trial in South Korea, Osaka, Japan-based Shionogi will be responsible for clinical trials in countries including Japan and Singapore.

Kadimastem signals Nasdaq listing, lands $3.2M from Ilex Medical

Ilex Medical Inc. has injected $3.2 million into cell therapy company Kadimastem Ltd., as it prepares to list on Nasdaq. As part of the investment, Ilex was granted a total of 1.4 million options (60% coverage) in two series, at exercise prices of $2.20 and $2.70 per share (up to 100% from the share price at the transaction). If exercised, it would increase the total investment to $6.7 million. Ness Ziona, Israel-based Kadimastem is undergoing clinical programs for its stem cell-based technology. The company’s lead product, Astro Rx, is an astrocyte cell therapy for the treatment of amyotrophic lateral sclerosis, and it has a second product in development – Islet Rx – for treatment of insulin-dependent diabetes.

SEC provides guidance on executive compensation

The U.S. SEC released guidance Nov. 29 that could impact how drug and medical device companies shape, and report, their executive compensation packages when it comes to "spring-loaded awards.” Such awards are share-based compensation arrangements where a company grants stock options or other awards shortly before it announces market-moving information such as an earnings release with better-than-expected results or a significant transaction. “Nonroutine spring-loaded grants merit particular scrutiny by those responsible for compensation and financial reporting governance at public companies,” according to the SEC.

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