Pharmaceutical Technology Editors

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted a review of the marketing authorization application (MAA) for EQRx’s sugemalimab, an anti-programmed death-ligand 1 (PD-L1) antibody, in combination with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).

“With the acceptance of this application, we now have two investigational therapies under review with the MHRA in non-small cell lung cancer, which affects about 40,000 people annually in the UK and is a leading cause of cancer death,” said Melanie Nallicheri, president and chief executive officer of EQRx, in a press release. “This significant milestone is a step toward our goal of getting our medicines to patients and delivering on our mission of increasing access to impactful treatments."

The MAA is supported by data from the pivotal Phase III GEMSTONE-302 trial that evaluated treatment with sugemalimab in combination with chemotherapy in patients with metastatic NSCLC.

Sugemalimab was granted the Innovation Passport designation in the UK in 2021 through the Innovative Licensing and Access Pathway (ILAP) from the ILAP partner organizations, including the MHRA.

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The MAA is supported by data from the pivotal Phase III GEMSTONE-302 trial that evaluated treatment with sugemalimab in combination with chemotherapy in patients with metastatic NSCLC.



Marketing Authorization Application Accepted for Sugemalimab in Metastatic Non-small Cell Lung Cancer

FDA announced on Nov. 30, 2022 that bebtelovimab is not currently authorized for emergency use in any region of the United States because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1, according to data included in the 

Commercial distribution of bebtelovimab has been halted by Eli Lilly and its authorized distributers until further notice by FDA. The Administration for Strategic Preparedness and Response (ASPR) has also paused the fulfillment of any pending requests under its 

Bebtelovimab Product Replacement Initiative.

The US government has recommended all product be retained in the event that SARS-CoV-2 variants susceptible to bebtelovimab become more prevalent in the future in the US. These variants are currently circulating at lower prevalence.

FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US. 

FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region

Sosei Heptares announced on Dec. 16, 2022 that it has entered a drug discovery collaboration with Eli Lilly with the goal to discover, develop, and commercialize small molecules that modulate novel G protein-coupled receptor (GPCR) targets associated with diabetes and metabolic diseases.

The agreement will use Sosei Heptares’ StaR technology and structure-based drug design platform and Lilly’s extensive drug development and commercialization expertise as well as its therapeutic area expertise in diabetes and metabolic diseases. Sosei Heptares is eligible to receive $37 million upfront in cash and commercial milestone payments totaling up to $694 million, plus tiered royalties.

“This new agreement with Lilly further reinforces our position as a global partner of choice for GPCR-focused drug discovery targeting major diseases where patients remain in need of new and effective therapies,” said Matt Barnes, head of UK research & development, Sosei Heptares, in a company press release. “We provide a highly attractive approach that is recognized by many of the world’s leading biopharmaceutical companies and are delighted to add Lilly to that list. Lilly is a recognized world leader in diabetes and metabolic diseases, and we look forward to a collaboration that brings together our respective and complementary expertise with the goal of identifying and developing novel candidates to advance in these important areas of unmet need.”

Sosei Heptares and Eli Lilly have entered a multi-target collaboration and license agreement in diabetes and metabolic diseases. 

Sosei Heptares and Eli Lilly Enter Multi-target Collaboration

US-based Discovery Life Sciences (Discovery) has launched its new Proteomic Services Division, which will serve pharmaceutical and biotech companies, government organizations, and non-profit and academic research centers. The company’s innovative offering includes both exploratory and targeted proteomics using the Seer Proteograph Product Suite, SCIEX LC-MS/MS systems, Olink Proximity Extension Assay (PEA), and Luminex xMAP platforms, according to a Dec. 14, 2022 company press release.

Discovery’s proteomic service laboratories are now integrated with the company’s short-and long-read genomic service laboratories and global commercial biorepository of hyper-annotated biospecimens. Meanwhile, as a part of its biomarker services expansion strategy, the company signed a multi-year agreement in January 2022 with Seer, a US-based life science company commercializing a disruptive new platform for proteomics, and SCIEX, a life science analytical technologies company, to form the Proteogenomics Consortium (PGC), a first-of-its-kind, according to a company press release (1), for large-scale plasma proteomic studies. The PGC combines the proprietary technologies and expertise of all three companies. The aim of the consortium is to offer unbiased, high-resolution proteogenomic services to help uncover novel biomarkers that can be mapped back to underlying genetic variations.

“We are very excited to open our doors to researchers and scientists worldwide and provide them access to Discovery’s highly-scaled, multi-omic services to advance their biomarker discovery, clinical development, and large-scale research programs,” said Michael Pisano, Discovery’s executive vice-president of Proteomics, in the company press release. “Our proteomic experts carefully designed, built, and optimized a comprehensive, platform-agnostic suite of leading-edge proteomic and proteo-genomic technologies to support all biomarker strategies, large-scale population studies, and biobank characterization projects.”

“The Proteogenomics Consortium strategically unites these highly advanced plasma proteomic technologies with our … expertise in short-and long-read genomics to add deep, unbiased proteomics data more easily to discovery, translational, and clinical studies, as well as large-scale population research programs,” said Glenn Bilawsky, CEO of Discovery, in the press release. “In addition, the PGC also enables the creation of new diagnostic tools for cancer, neurodegenerative, inflammatory, infectious diseases, and other therapeutic areas.”

1. Discovery Life Sciences, “Seer, Discovery Life Sciences, and SCIEX Announce First-Of-Its-Kind Proteogenomics Consortium for Large-Scale Studies,” Press Release, Jan. 10, 2022.

The launch of Discovery Life Sciences’ new Proteomic Services Division offers a single source for large-scale population studies, biobank characterization, and multi-omic biomarker analysis.

Discovery Life Sciences Now Offers Large-Scale Proteomic Services

GSK and Wave Life Sciences, a US-based clinical-stage genetic medicines company, have entered into a strategic collaboration to advance oligonucleotide therapeutics focusing on novel genetic targets. Oligonucleotides are short strands of DNA or RNA that can reduce, restore, or modulate RNA through several different mechanisms. The collaboration includes Wave’s preclinical RNA editing program that targets alpha-1 antitrypsin deficiency (AATD), WVE-006.

According to a Dec. 13, 2022 company press release, the collaboration comprises two main components: a discovery collaboration and a late-phase development collaboration. In the discovery collaboration component, GSK can advance up to eight programs and Wave can advance up to three programs. In addition to these programs, GSK receives the exclusive global license for Wave’s preclinical program WVE-006. The discovery collaboration has an initial four-year research term and combines GSK’s insights from human genetics and its global development and commercial capabilities with Wave’s proprietary discovery and drug development platform, PRISM.

The second component of the collaboration involves bepirovirsen, an investigational antisense oligonucleotide for the potential treatment of chronic hepatitis B infection, and GSK4532990, a small interfering RNA (siRNA) oligonucleotide. Bepirovirsen is now entering Phase III trials, and GSK4532990 is moving toward Phase II trials for non-alcoholic steatohepatitis (NASH).

Under the agreement, Wave will receive an upfront payment of $170 million, including a cash payment of $120 million and a $50 million equity investment. Additionally, for the WVE-006 program, Wave is eligible to receive up to $225 million in development and launch milestone payments as well as up to $300 million in sales-related milestone payments. The company is also eligible to receive tiered sales royalties. After Wave completes the first-in-patient study, development and commercialization responsibilities will transfer to GSK.

Furthermore, for each of GSK’s eight collaboration programs, Wave will be eligible to receive up to $130 million–$175 million in development and launch milestones and $200 million in sales-related milestones as well as tiered sales royalties. Wave will be responsible for leading all preclinical research for GSK and Wave programs up to investigational new drug (IND)-enabling studies. Meanwhile, GSK collaboration programs will transfer to GSK for IND-enabling studies, clinical development, and commercialization.

“Oligonucleotide therapeutics are becoming a mainstream modality, and this collaboration will enable us to use our leading position in human genetics and genomics to advance novel oligonucleotide therapies. Pairing GSK's genetic expertise with the best-in-class PRISM platform enables us to accelerate drug discovery for newly-identified targets, by matching target to modality. The addition of WVE-006 complements more advanced, clinical-phase oligonucleotides in our pipeline, including bepirovirsen for chronic hepatitis B and GSK4532990 for [NASH],” said Tony Wood, president and chief scientific officer, GSK, in the press release.

“For the past decade, Wave has been building a unique oligonucleotide platform that combines novel chemistry with the means to optimally address disease biology through multiple therapeutic modalities. In 2022, we started to deliver on the promise of our platform with the first data showing translation in the clinic for our next-generation stereopure PN-chemistry containing candidates. Now, with our GSK collaboration, we are excited to leverage their expertise in genetics to continue building a differentiated oligonucleotide pipeline, with a focus on our … RNA editing and upregulation capability,” said Paul Bolno, president and CEO, Wave Life Sciences, in the release.

GSK and Wave Life Sciences have entered into a collaboration to drive drug discovery and development for novel genetic targets.

GSK and Wave Life Sciences to Collaborate on Oligonucleotide Therapeutics

AbCellera and Rallybio, a US-based clinical-stage biotechnology company, have entered into a strategic alliance to discover, develop, and commercialize novel antibody-based therapeutics targeting rare diseases. The partnership is a multi-year, multi-target collaboration that will combine AbCellera’s antibody discovery engine with Rallybio’s clinical and commercial expertise in rare diseases. Together, the companies plan to identify optimal clinical candidates and ultimately deliver therapies to patients, according to a Dec. 1, 2022 company press release.

Under the agreement, AbCellera and Rallybio will co-develop up to five rare disease therapeutic targets chosen together by both companies. The collaboration will also allow Rallybio to add product candidates to its existing pipeline. Meanwhile, AbCellera will have the option to conduct process development and clinical manufacturing activities. The first program out of the collaboration will focus on addressing the significant unmet therapeutic needs of patients with rare metabolic diseases.

“It’s clear that we need to accelerate drug development for rare diseases to address the enormous unmet medical need for these patients,” said Carl Hansen, founder and CEO of AbCellera, in the release. “Rallybio’s team has decades of experience in sourcing, identifying, and evaluating therapeutic targets. By bringing together Rallybio’s deep expertise in rare diseases with AbCellera’s integrated technology for delivering clinical leads … this partnership creates a unique advantage that we believe will deliver new and transformative medicines to patients.”

“AbCellera’s clinically validated discovery engine will strengthen our efforts in identifying novel rare disease candidates to add to our existing pipeline,” said Martin Mackay, CEO, Rallybio, in the release. “We are excited to establish this partnership and look forward to working closely with our colleagues at AbCellera as we build novel medicines together.”

AbCellera and Rallybio are teaming up to discover, develop, and commercialize novel antibody-based therapeutics for rare diseases.