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Amgen Adaptive Partner In COVID19 Neutralizing Antibody RD Effort Cover Image

Amgen Inc. and Adaptive Biotechnologies Corp. have been working on diagnostics for hematologic cancer therapies, and now aim develop neutralizing antibody medicines that could prevent or treat patients infected with the COVID-19 virus. They announced the collaboration on April 2, saying they would begin work immediately under a memorandum of understanding while a collaboration and licensing agreement is finalized.

Using genetic insights that Amgen subsidiary deCode genetics EHF has derived from hundreds of patients who contracted and recovered from the novel coronavirus, Adaptive will employ its high-throughput immune medicine platform to screen the genetic diversity of B-cell receptors in patients who have recovered from the virus. Adaptive president Julie Rubinstein said the biotech company anticipates delivering packages of antibodies for candidate identification to Amgen within two months, hoping that part of the process takes no longer than six months at the longest.

“We believe that it’ll take us a couple of months end to end to discover and hand over to Amgen antibody packages that it can use to engineer products,” Rubinstein told Scrip. “We believe unfortunately that the virus is going to be around for a while and may go through some ups and downs, so having a long-term, durable solution is going to be necessary as we head into another unknown year.”

Several research efforts are looking into the potential of neutralizing antibodies to address the virus, Rubinstein added, but Amgen and Adaptive hope that the familiarity from their long-term partnerships, the speed and accuracy of Adaptive’s platform technology and Amgen’s expertise in antibody engineering and manufacturing will differentiate their work from other efforts.

Neutralizing antibodies defend a patient’s healthy cells by interfering with a virus’s biological functioning. Adaptive and Amgen – along with other research teams – believe nABs that specifically target SARS-CoV-2 could offer utility in COVID-19 because so far it appears to be a slow-mutating virus.

“COVID-19 is a disease that is so widespread and very few people have immunity toward it, and yet the disease itself mutates pretty slowly,” Rubinstein noted. “The combination of all of those factors lends itself really well to having antibodies that come from survivors that can be used off-the-shelf to treat as many people as possible to give them that immunity. The hope is that these therapeutics can work for all of the strains, which is different than a virus or pathogen that mutates very quickly. That is not a great environment for a neutralizing antibody.”

Narrowing Down Antibodies To Those Neutralizing COVID-19

Adaptive’s screening is expected to identify tens of thousands of naturally occurring antibodies from COVID-19 infection survivors that will then yield some that specifically can neutralize SARS-CoV-2. Amgen will be responsible for selecting, developing and manufacturing the resulting antibody therapies.

Amgen said it is unable to estimate the timing until a candidate antibody enters clinical development or other milestones are reached further down the line. “We can’t speculate on timing,” the company said in an emailed statement. “Our team is focused on accelerating progress as quickly as possible, and we’ll provide updates as progress happens. We will be able to address definitive steps leading to discussions with local health authorities in the near future.”

“We see our efforts as complementary and additive to others in the industry,” Amgen added. “This is a race to find the best therapies that work.”

The partnership’s goal is to produce a prophylaxis against the virus and/or a therapy for patients infected by it. Rubinstein said it is too early to know which of these uses might be more important, but the companies hope to come up with one product that might be able to both prevent and treat the virus.

“It doesn’t change the work we need to do from an R&D perspective at all. We really believe it could be used in both instances equally importantly,” the exec said.

Amgen and Adaptive’s previous collaborations have focused specifically on monitoring minimal residual disease (MRD) in patients with hematologic cancers. [See Deal] A complementary diagnostic based on Adaptive’s clonoSEQ assay enabled Amgen to expand the label for Blincyto (blinatumomab) to include MRD-positive acute lymphoblastic leukemia (ALL) patients. (Also see "FDA Grants Blincyto Accelerated Approval Based On MRD Response Endpoint" - Pink Sheet, 30 Mar, 2018.)

Amgen Inc. and Adaptive Biotechnologies Corp. have been working on diagnostics for hematologic cancer therapies, and now aim develop neutralizing antibody medicines that could prevent or treat patients infected with the COVID-19 virus. They announced the collaboration on April 2, saying they would begin work immediately under a memorandum of understanding while a collaboration and licensing agreement is finalized.

Using genetic insights that Amgen subsidiary deCode genetics EHF has derived from hundreds of patients who contracted and recovered from the novel coronavirus, Adaptive will employ its high-throughput immune medicine platform to screen the genetic diversity of B-cell receptors in patients who have recovered from the virus. Adaptive president Julie Rubinstein said the biotech company anticipates delivering packages of antibodies for candidate identification to Amgen within two months, hoping that part of the process takes no longer than six months at the longest.

“We believe that it’ll take us a couple of months end to end to discover and hand over to Amgen antibody packages that it can use to engineer products,” Rubinstein told Scrip. “We believe unfortunately that the virus is going to be around for a while and may go through some ups and downs, so having a long-term, durable solution is going to be necessary as we head into another unknown year.”

Several research efforts are looking into the potential of neutralizing antibodies to address the virus, Rubinstein added, but Amgen and Adaptive hope that the familiarity from their long-term partnerships, the speed and accuracy of Adaptive’s platform technology and Amgen’s expertise in antibody engineering and manufacturing will differentiate their work from other efforts.

Neutralizing antibodies defend a patient’s healthy cells by interfering with a virus’s biological functioning. Adaptive and Amgen – along with other research teams – believe nABs that specifically target SARS-CoV-2 could offer utility in COVID-19 because so far it appears to be a slow-mutating virus.

“COVID-19 is a disease that is so widespread and very few people have immunity toward it, and yet the disease itself mutates pretty slowly,” Rubinstein noted. “The combination of all of those factors lends itself really well to having antibodies that come from survivors that can be used off-the-shelf to treat as many people as possible to give them that immunity. The hope is that these therapeutics can work for all of the strains, which is different than a virus or pathogen that mutates very quickly. That is not a great environment for a neutralizing antibody.”

Narrowing Down Antibodies To Those Neutralizing COVID-19

Adaptive’s screening is expected to identify tens of thousands of naturally occurring antibodies from COVID-19 infection survivors that will then yield some that specifically can neutralize SARS-CoV-2. Amgen will be responsible for selecting, developing and manufacturing the resulting antibody therapies.

Amgen said it is unable to estimate the timing until a candidate antibody enters clinical development or other milestones are reached further down the line. “We can’t speculate on timing,” the company said in an emailed statement. “Our team is focused on accelerating progress as quickly as possible, and we’ll provide updates as progress happens. We will be able to address definitive steps leading to discussions with local health authorities in the near future.”

“We see our efforts as complementary and additive to others in the industry,” Amgen added. “This is a race to find the best therapies that work.”

The partnership’s goal is to produce a prophylaxis against the virus and/or a therapy for patients infected by it. Rubinstein said it is too early to know which of these uses might be more important, but the companies hope to come up with one product that might be able to both prevent and treat the virus.

“It doesn’t change the work we need to do from an R&D perspective at all. We really believe it could be used in both instances equally importantly,” the exec said.

Amgen and Adaptive’s previous collaborations have focused specifically on monitoring minimal residual disease (MRD) in patients with hematologic cancers. [See Deal] A complementary diagnostic based on Adaptive’s clonoSEQ assay enabled Amgen to expand the label for Blincyto (blinatumomab) to include MRD-positive acute lymphoblastic leukemia (ALL) patients. (Also see "FDA Grants Blincyto Accelerated Approval Based On MRD Response Endpoint" - Pink Sheet, 30 Mar, 2018.)

 

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