Feliza Mirasol is the science editor for 

Feliza Mirasol

PeptiDream, a public Kanagawa, Japan-based biopharmaceutical company, has entered into a new multi-target collaboration and license agreement with Genentech, a member of the Roche Group, in which the companies will work to discover and develop novel macrocyclic peptide-radioisotope (peptide-RI) drug conjugates.

Under the agreement, PeptiDream will utilize its proprietary Peptide Discovery Platform System (PDPS) technology to discover, optimize, and develop macrocyclic peptide candidates. The candidates will be used as peptide-RI drug conjugates against targets of interest to Genentech. PeptiDream will lead early preclinical development, and Genentech will take over further development and commercialization of any peptide-RI drug conjugate products that result from the collaboration. However, PeptiDream will retain the right to develop and commercialize such peptide-RI drug conjugate products in Japan, according to a Sept. 20, 2023 company press release.

According to the transaction terms, PeptiDream will receive an upfront payment of $40 million from Genentech. PeptiDream will be eligible for potentially up to $1 billion in payments based on certain development, regulatory, and commercial milestones. PeptiDream is also eligible to receive tiered royalties on net sales (ex-Japan) of products arising from the collaboration.

This new collaboration and license agreement follows a long-term partnership between the companies that started out as a multi-target collaboration and license agreement in December 2015, after which Genentech licensed PeptiDream’s PDPS technology in 2016. The companies initially expanded that original collaboration in 2018.

“We are extremely excited to announce this new collaboration with Genentech for the discovery and development of peptide-RI drug conjugates. Combining this expertise with Genentech’s powerful clinical development and commercialization capabilities, we hope to bring innovative first-in-class peptide radiopharmaceuticals to patients worldwide,” said Patrick C. Reid, president and CEO, PeptiDream, in the press release.

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Under a new pact, Genentech and PeptiDream will collaborate to discover and develop novel peptide-radioisotope drug conjugates.

Genentech Forms Collaboration with PeptiDream for Peptide-Radioisotope Drug Conjugates

On Sept. 21, 2023, the Novo Nordisk Foundation announced that it is investing up to DKK 950 million (€127 million, US$136 million) into a new cell therapy manufacturing facility in Lyngby, Denmark. The facility, which will be known as the Cellerator, will be located on the Technical University of Denmark (DTU) campus and will be used for the final development steps and upscaling of cell therapies for human testing. According to a company press release, the Cellerator will be a limited liability company and will be fully owned and funded by the Novo Nordisk Foundation. It will operate as an independent philanthropic initiative.

The facility will serve public, private, national, and international clients from academia, biotech, and the pharmaceutical industry. Construction is expected to begin in the summer of 2024, and the facility will be operational in 2027.

The establishment of the new facility is intended to fill a critical gap in the Danish cell therapy market. Having this facility on the DTU campus will help translate breakthroughs in cell therapy research into real-world treatments for diseases such as chronic heart failure, Parkinson’s disease, kidney disease, type 1 diabetes, and several forms of cancer, according to the press release. The Cellerator will further develop cell therapies that have already been tested successfully in animals and will manufacture these therapies consistently and at-scale for early clinical trials.

The facility will support several cell therapy types, including those derived from embryonic stem cells, from induced pluripotent stem cells, and from adult stem cells. The range of services it will provide include process development, good manufacturing practice manufacturing, product release, and regulatory support. In addition, the facility will have built-in flexibility to respond to changing demands for therapy types and services.

“We’ve seen major advances in the laboratory in recent years, but many promising cell therapy candidates face difficulties reaching clinical trials, partly because we can’t currently develop cell therapy products in large, consistent quantities here in Denmark. I’m thrilled to be heading an initiative that will change this and provide hope to people living with chronic diseases,” said Thomas H.R. Carlsen, CEO of the Novo Nordisk Foundation Cellerator, in the press release.

“The location of the Novo Nordisk Foundation Cellerator at DTU allows for significant synergies with our research, education, and innovation in health tech and biotechnology, which is happening in close collaboration with start-ups and companies. The Cellerator will provide our researchers and students with a unique opportunity to translate cell technologies into cell therapy treatments,” said Anders Bjarklev, president of DTU, in the release.

The Novo Nordisk Foundation will invest up to DKK 950 million (€127 million, US$136 million) in a new cell therapy manufacturing facility in Lyngby, Denmark.

Novo Nordisk Foundation to Establish New Cell Therapy Manufacturing Facility in Denmark

On Sept. 20, 2023, Orionis Biosciences, a privately held US-based life sciences company with an integrated drug discovery and chemical biology platform, announced that it has entered into a multi-year collaboration with Genentech, a member of the Roche Group, under which the companies will discover novel small-molecule therapeutics for challenging disease targets, including oncology and neurodegeneration.

Under the agreement, Orionis will discover and optimize molecular glues using its Allo-Glue platform. The molecular glues will be used for Genentech’s designated targets. For its part, Genentech will take care of subsequent later-stage preclinical, clinical development, regulatory filing, and commercialization of such small molecules discovered through the collaboration. Orionis will get an upfront payment of $47 million and will also be eligible to receive development milestone payments, including commercial and net sales milestone payments, that may exceed $2 billion. The company can also receive a tiered royalty upon sale of collaboration products.

Orionis’s Allo-Glue platform works by using multiple unique approaches to discover drug-like small molecules against disease targets, particularly targets that have remained elusive to traditional discovery approaches. The platform is built on the integration of a suite of proprietary chemical biology technologies, including biological assays, computational analyses, chemical libraries, and automated processes. The platform allows for high throughput discovery, rational design, and optimization of small molecules that promote or induce interactions of proteins in living cells. Such molecules include molecular glues which have been shown to promote interactions that lead to either target degradation (via a ligase) or modulation of target function (via either direct or allosteric mechanisms), according to a company press release.

“Molecular glues represent one of the most exciting recent developments in small-molecule drug discovery. We are thrilled to collaborate with Genentech, a company long known for its world-class science and trailblazing medicines, to make use of technological innovations that we have systematically evolved over the past years to unlock novel target space with such drug modalities,” said Nikolai Kley, co-founder and CEO of Orionis Biosciences, in the press release. “We could not be more excited about the potential for this pioneering collaboration to lead to impactful new treatment paradigms.”

“Molecular glue degraders are an exciting modality to target disease-related proteins that have proven challenging with more traditional treatment modalities,” said James Sabry, global head, Roche Pharma Partnering, in the press release. “For patients with unmet needs, this offers a new therapeutic approach to modulate major disease drivers. This collaboration enables us to apply the concept of targeted protein degradation to discover and develop medicines for patients with serious and life-threatening diseases.”

Under the collaboration, Orionis will receive $47 million upfront to leverage its Allo-Glue platform to discover small-molecule monovalent glues.

Genentech Partners with Orionis Biosciences to Discover and Develop Molecular Glue Class Medicines

On Sept. 15, 2023, CPHI Barcelona announced the finalists for the 2023 CPHI Pharma Awards. The awards ceremony will be held on Oct. 24, 2023, the opening day of CPHI Barcelona, the world’s largest pharma event, at the Fiera Barcelona.

According to an event press release, the shortlist of finalists was narrowed down from more than 180 entries across 12 categories that cover innovations across the full pharmaceutical supply chain. The finalists featured include many of the pharma industry’s biggest names and breakthrough companies.

The 2023 awards mark the 20th anniversary of the CPHI Pharma Awards, which began in 2004. These awards have traditionally celebrated pharma’s brightest individuals and companies, and winners have been selected for their contributions to driving the industry forward through people, products, and performance. This year’s edition has introduced three new categories to reflect the wave of current innovation that has engulfed the industry, according to the press release.

The 2023 finalists include companies that led by example in sustainable manufacturing and manufacturers and innovators that developed new technologies to advance drug discovery, development, and manufacturing, as well as honoring transformational digital solutions of the future and philanthropic initiatives. The “CEO of the Year” category will celebrate this year’s most exemplary leader.

Each entry was extensively evaluated by an expert panel comprising individuals who collectively bring decades of expertise from big pharma, consultancy, regulatory, market intelligence, and academia.

The 2023 shortlist of finalists is as follows.

Aurorium: Detergent-free membrane protein solubilization agents

CurifyLabs Oy:The MiniLab: 3D printing personalized medicines service platform for pharmacies

 digital tools for reduction of clinical studies & product development timelines

KBI Biopharma: PUREcoli (part of PUREplatform solution)

Kepler Healthcare PVT Ltd.: Bi-folate syrup

Single Use Support: RoSS.PADL–homogenizing solution

SK pharmteco: “A modular platform for rapid and flexible Continuous Manufacturing of APIs under cGMP [current good manufacturing practice].”

Cromaoak: Multifrequency liquid chromatography

IOL Chemicals and Pharmaceuticals Limited: Sitagliptin phosphate monohydrate

Merck: ChetoSensar novel solubilization technology for hydrophobic antibody drug conjugates

Snapdragon Chemistry, a Cambrex company: Axial Chirality in the Sotorasib Drug Substance: Leveraging a High-Temperature Thermal Racemization to Recycle the Classical Resolution Waste Stream

Symbio Generrics India Pvt Ltd.: EcoPrimeAPI: Revolutionizing sustainability, scalability, and commercialization through green chemistry development in API.

Accord Healthcare Ltd.: Working Together to Make it Better; Driving Healthcare Equity

Eurolab (Pty) Ltd.: Eurolab (Pty) Ltd – Health Equity Initiatives

Zentiva: Supplying Ibuflam Suspension 40 mg/mL to the German market in crisis situation

Lambda Therapeutic Research Ltd.: Bindi Chudgar

Adalvo: Drug delivery & device Innovation for: fentanyl; dalbavancin RTU (ready to use); lisdexamfetamine oral solution; pregabalin; rosuvastatin/candesartan; ambrisentan/tadalafil

Amaterasu Lifesciences LLP: SiDMI–single dose anti-malaria injection

ApiJEct Systems: ApiJect prefilled injector

Lonza: Capsugel Enprotect enteric drug delivery

Medicsen: Sonophoresis Smartpatch for needle-free drug delivery

West Pharmaceutical Services: The FluroTec 5–10mL Cartridge Plunger, the 13mm NovaPure Ready to Use Stopper & the Flip-Off CCS Seal combined offering to support large volume injection.

Adalvo: Lisdexamfetamine oral solution, nitrofurantoin, dalbavancin RTU (ready to use); fentanyl; rosuvastatin/candesartan; ambrisentan/tadalafil; semaglutide

Halewood Laboratories PVT Ltd.: ORS with postbiotic with zinc

Kepler Healthcare Pvt Ltd.: Bi-folate syrup

Lubrizol Life Science Health: Apisolex Polymer

MedPharm: MedSpray Patch-in-Can Aerosol Technology

Nanoform: Nanoform’s nanoamorphous to nanocrystalline platform

ProBiotix Health Plc: CholBiome CH–cholesterol-reducing food supplement

Thermo Fisher Scientific: Development of an orally delivered large-molecule biologic for clinical trials

Zentiva: Daruph–dasatinib, company’s first value-added medicine, which is a lifesaving oncology treatment indicated to cure chronic myeloid leukemia and acute lymphoblastic leukemia.

Dr. Reddy's Laboratories Ltd.: Dr. Reddy’s digital journey to keep medicines affordable

FabRx: FabRx's M3DIMAKER pharmaceutical 3D printer series

Honeywell Process Solutions: Honeywell Manufacturing Excellence platform

Hovione: iSDX–a fully automated, scale representative laboratorial spray dryer

Nanoform: Globally unique high-potency nanoparticle GMP production site

Piramal Pharma Solutions: Throughput Improvement in peptide API manufacturing

SmartSkin Technologies: SmartSkin pressure and seal tightness drones.

Bilcare Limited: Elite PVC-free compact barrier coldform blister

IMA S.p.A.: Croma, continuous tablet coater

Körber Pharma Packaging Materials: Rapid test made out of cardboard

Rotor Print: Recyclable blister: PET 100%

Syntegon Technology GmbH: Versynta microBatch.

DDReg Pharma Pvt. Ltd.: Technology-enabled regulatory services through Vitalic

Eurolab (Pty) Ltd.: Eurolabs Exemplary Regulatory and Compliance Practices in Expanding Access to Affordable Oncology Products in Africa

Famar: Famar Integrated System of Flash Audits: Innovation in auditing

Lambda Therapeutic Research Ltd.: Enhancing Compliance & Data Generation in Clinical Trials through Advanced Software Solutions and EDC Platform

Loftware: Loftware Spectrum for Medical Device

Mitsubishi Chemical Group: The LSG (Life Science Grade) Portfolio—A thermoplastic stock shapes product portfolio for bioprocessing and medical applications.

Bionter: Bionter EVE the particle counter

Cellexus International Ltd.: The CellMaker

Congruence Medical Solutions, LLC: High Dose Autoinjector with Injection Pause

Dr. Ferrer Biopharma: GentleMist Technology

IamFluidics B.V.: Revolutionizing microencapsulation with in-air microfluidics technology for next-generation sustainable healthcare solutions

ACI Group: SCM software tool for pharma distribution

Catalent: Case management services for cell/gene therapies

Cipla: Digital innovation at cipla global supply chain

Thermo Fisher Scientific: mySupply Platform.

The finalists for this year’s CPHI Barcelona Pharma Awards span 12 categories with awards ranging from accelerating innovations through to improved sustainability and best start-up initiative.

Pharma Award Finalists for CPHI Barcelona Have Been Announced

On Sept. 18, 2023, Sandoz announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has given a positive opinion on the company’s biosimilar trastuzumab (150 mg, for intravenous use), a monoclonal antibody for treating human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, the same indications for which the reference biologic is approved in Europe. The biosimilar trastuzumab was developed by EirGenix, a Taiwan-based biopharmaceutical company.

Under an April 2019 licensing agreement (1), EirGenix will maintain responsibility for the development and manufacturing of the biosimilar trastuzumab, while Sandoz holds the rights to commercialize the product once approval is gained in respective markets.

Breast and gastric cancers have significant impact in Europe, with more than 355,000 women each year diagnosed with breast cancer. With 92,000 deaths per year, breast cancer is the number one cause of cancer death among women, according to a company press release. Gastric cancer, meanwhile, is the sixth most common cancer type and ranks the fourth most common cause of cancer-related deaths in Europe, with 107,000 deaths annually, according to the release. HER2 protein overexpression (or HER2 gene amplification) is detected in up to 20% of breast cancers and up to 30% of gastric cancers that are diagnosed. The overexpression of this protein leads to uncontrolled growth and division of cells, and HER2 cancers are known to be particularly aggressive cancer types that respond well to targeted treatment, according to the press release.

The regulatory submission package for Sandoz’ biosimilar trastuzumab comprised comprehensive analytical, preclinical, and clinical data and included evidence that was derived from extensive analytical characterization. Data also included results from a Phase I pharmacokinetic/pharmacodynamic study and a confirmatory Phase III study. The results showed that both studies met their respective primary endpoints, which confirms that the biosimilar matches the reference biologic in terms of both pharmacokinetics and efficacy, safety, and immunogenicity.

“Breast and gastric cancers are among the most frequently occurring in Europe and, combined, are responsible for nearly 200,000 deaths annually. Biosimilars have enormous potential to improve cancer care by substantially increasing access to these critical medicines,” said Pierre Bourdage, chief commercial officer, Sandoz, in the release.

1. EirGenix, Eirgenix Signs Trastuzumab Biosimilar License Agreement with Novartis Sandoz. Press Release, April 30, 2019.

The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

EMA Committee Issues Positive Opinion on Sandoz’ Biosimilar Trastuzumab

The opening of a new solutions center in Bengaluru, India, by Illumina, a US-based company specializing in DNA sequencing and array-based technologies, in August 2023 not only expands Illumina’s capabilities in genomics, but also expands access to genomics in that country.

The new center houses a fully equipped laboratory with the latest next-generation sequencing and array technologies. It is also fully resourced with field applications and service engineers that can offer broad genomics capabilities. The center will also provide training and education to increase technical expertise and access to genomics locally.

The new center is a permanent facility on the ground in Bengaluru for Illumina, which has spent the past 16 years working in partnership with Premas Life Sciences, an India-based contract research organization and provider of niche technologies in genomics, cell biology, and biopharma. With the help of the new solutions center, Illumina will continue collaborative work with Premas to grow the genomics market in India, according to an Aug. 17, 2023 company press release.

"Expanding Illumina's presence in India allows the company to collaborate and be part of a vibrant biotech ecosystem with skilled labor, strong research and development resources, and supportive government policies," said Gretchen Weightman, senior vice-president, Asia Pacific, Middle East & Africa, Illumina, in the company press release. "In our 25th anniversary year, it's a very exciting time to be growing our physical presence in India to drive access and the further adoption of genomics to transform human health, particularly in oncology and infectious disease."

Illumina’s business in India is led by Abhishek Gupta, country manager, and, according to Weightman in the press release, "Abhishek brings vast knowledge and experience to Illumina India, and we look forward to supporting him and the team as they collaborate with and support our customers." said Weightman.

The new solutions center also presents the opportunity to pursue equitable access and more diverse data in India. "Democratizing genomics and making it available to the many and not just the few will take a collaborative approach. We must better reflect diversity in genomic data and drive awareness for, access to, and adoption of genomic technologies, through partnership," Weightman said in the release.

Illumina’s new solutions center in Bengaluru, India, will expand access to genomics in the country.