On November 4, 2024 Synaffix B.V. ("Synaffix"), a Lonza company (SWX:LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported that it has licensed its ADC technology to BigHat Biosciences, Inc. ("BigHat") (Press release, Synaffix, NOV 4, 2024, View Source [SID1234648078]). BigHat will combine Synaffix technology with its world-class ML antibody design platform for the development of a new ADC pipeline program.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, BigHat will receive target-specific access to Synaffix’s late-clinical stage, site-specific ADC technology platform, which enables the transformation of antibodies into proprietary, best-in-class ADC products. As a result of Lonza’s acquisition of Synaffix in June 2023, BigHat will also gain access to Lonza’s end-to-end ADC offering. This DNA-to-IND offering enables drug developers to seamlessly receive all necessary cGMP/non-cGMP ADC batches leading up to the first clinical trial under a single quality system encompassing all critical development and manufacturing activities, including the production of the antibody, bioconjugation, and drug product filling.

BigHat’s AI/ML-powered antibody design platform, Milliner, integrates a synthetic biology-based high-speed wet lab with state-of-the-art ML technologies into a full-stack antibody discovery and engineering platform, to engineer antibodies with more complex functions and better biophysical properties. This approach reduces the difficulty of designing antibodies and other therapeutic proteins to tackle conditions ranging from chronic illness to life-threatening disease, while also massively speeding up candidate discovery and validation.

The collaboration with Synaffix/Lonza is instrumental to advancing BigHat’s next-gen ADC program, which is at IND-enabling stage and is on track to be BigHat’s first clinical stage program. BigHat’s next-gen ADC was optimized on BigHat’s Milliner platform for maximum payload delivery to tumor cells and optimal drug-like-properties. The incorporation of Synaffix’s GlycoConnect, HydraSpace and toxSYN ADC technologies is intended to further improve the safety and efficacy of Big Hat’s next-gen ADC.

Peter van de Sande, Head of Synaffix, said: "The ADC space continues to develop and evolve, and our collaboration with BigHat exemplifies the continued strength and appeal of our best-in-class ADC technology. We are excited to be at the forefront of next-generation ADC R&D by joining forces with BigHat and its AI/ML-enabled antibody discovery and development platform, BigHat is the ideal partner for Synaffix to collaborate with. We look forward to supporting BigHat with every step in the ADC development and manufacturing process under the Lonza umbrella."

Jean-Christophe Hyvert, President, Biologics, Lonza, added: "We are pleased to announce this collaboration with BigHat for its next-gen ADC molecule, which shows how drug developers can benefit from a fully integrated suite of services across our Biologics division. The Lonza network has continued to adapt to the evolving ADC landscape, including the recent addition of a highly potent vial fill capability at our Stein (CH) facility. This dedicated ADC drug product capacity expansion completes our offer for comprehensive, end-to-end development and manufacturing services for ADCs, simplifying the path from DNA-to-IND and beyond for our customers."

Mark DePristo, CEO at BigHat Biosciences, commented: "BigHat is leveraging our AI-driven antibody design platform, Milliner, to develop advanced biologics that provide safer and more effective treatments for difficult-to-treat cancers. We are excited to combine Synaffix’s conjugation and linker-payload technologies with our custom-designed antibody to create a next-generation ADC for patients with high unmet medical need."

On November 4, 2024 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported financial results for the three and nine months ended September 30, 2024 and provided an update on its corporate progress (Press release, BioNTech, NOV 4, 2024, View Source [SID1234648550]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"BioNTech’s achievements during the period were the successful launch of our variant-adapted COVID-19 vaccines and the progress across our oncology pipeline. In particular, we initiated later-stage trials and shared important updates for our PD-L1 x VEGF-A bispecific antibody candidate BNT327/PM8002 and for our mRNA cancer vaccine portfolio. These successes reinforce the potential of our multi-platform technology approach and inform our strategy to pursue novel proprietary combinations," said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. "We remain focused on advancing our late-stage oncology product candidates towards potential registration. We believe our pipeline and capabilities uniquely position us to execute on our vision of becoming a global multiproduct immunotherapy company."

Financial Review for Third Quarter and Nine Months of 2024

in millions €, except per share data Third Quarter 2024 Third Quarter 2023 Nine Months
2024 Nine Months
2023
Revenues 1,244.8 895.3 1,561.1 2,340.0
Net profit / (loss) 198.1 160.6 (924.8) 472.4
Diluted earnings / (loss) per share 0.81 0.66 (3.83) 1.94
Revenues reported were €1,244.8 million for the three months ended September 30, 2024, compared to €895.3 million for the comparative prior year period. For the nine months ended September 30, 2024, revenues were €1,561.1 million, compared to €2,340.0 million for the comparative prior year period. The higher revenues in the third quarter of 2024 as compared to the comparative prior year period can be largely attributed to the earlier approvals received for its variant-adapted COVID-19 vaccines as compared to last year.

Cost of sales were €178.9 million for the three months ended September 30, 2024, compared to €161.8 million for the comparative prior year period. For the nine months ended September 30, 2024, cost of sales were €297.8 million, compared to €420.7 million for the comparative prior year period.

Research and development ("R&D") expenses were €550.3 million for the three months ended September 30, 2024, compared to €497.9 million for the comparative prior year period. For the nine months ended September 30, 2024, R&D expenses were €1,642.4 million, compared to €1,205.3 million for the comparative prior year period. R&D expenses were mainly influenced by progressing clinical studies for the Company’s late-stage oncology pipeline candidates.

Sales, general and administrative ("SG&A") expenses2, in total, amounted to €150.5 million for the three months ended September 30, 2024, compared to €153.5 million for the comparative prior year period. For the nine months ended September 30, 2024, SG&A expenses were €466.9 million, compared to €415.4 million for the comparative prior year period. SG&A expenses were mainly influenced by personnel expenses.

Other operating result amounted to negative €354.6 million during the three months ended September 30, 2024, compared to negative €9.0 million for the comparative prior year period. For the nine months ended September 30, 2024, other operating result amounted to negative €616.9 million compared to negative €134.4 million for the prior year period. Other operating result was primarily influenced by provisions for contractual disputes.

Income taxes were realized with an amount of €39.4 million in tax income for the three months ended September 30, 2024, compared to €66.8 million in accrued tax expenses for the comparative prior year period. For the nine months ended September 30, 2024, income taxes were realized with an amount of €54.1 million in tax income for the nine months ended September 30, 2024, compared to €50.5 million of accrued tax expenses for the comparative prior year period.

Net profit was €198.1 million for the three months ended September 30, 2024, compared to €160.6 million net profit for the comparative prior year period. For the nine months ended September 30, 2024, net loss was €924.8 million, compared to a net profit of €472.4 million for the comparative prior year period.

Cash and cash equivalents plus security investments as of September 30, 2024, reached €17,839.8 million, comprising €9,624.6 million in cash and cash equivalents, €7,078.0 million in current security investments and €1,137.2 million in non-current security investments.

Diluted earnings per share was €0.81 for the three months ended September 30, 2024, compared to €0.66 for the comparative prior year period. For the nine months ended September 30, 2024, loss per share was €3.83, compared to diluted earnings per share of €1.94 for the comparative prior year period.

Shares outstanding as of September 30, 2024, were 239,739,752, excluding 8,812,448 shares held in treasury.

"We successfully launched our variant-adapted COVID-19 vaccines upon receipt of earlier approvals as compared to last year. This drove our strong revenues in the third quarter," said Jens Holstein, CFO of BioNTech. "Our cost discipline in combination with our financial position allow us to continue to focus on those assets that we believe offer a fast path to market and the highest potential to generate value for patients and shareholders."

2024 Financial Year Guidance3

The Company expects its revenues for the full 2024 financial year to be at the low end of the guidance range provided in its outlook:

Total revenues for the 2024 financial year low end of €2.5 billion – €3.1 billion
The range reflects certain assumptions and expectations, including, but not limited to: COVID-19 vaccine uptake and price levels, including seasonal variations; inventory write-downs and other charges by BioNTech’s collaboration partner Pfizer Inc. ("Pfizer") that negatively influence BioNTech’s revenues; anticipated revenues from a pandemic preparedness contract with the German government; and revenues from the BioNTech Group service businesses, namely InstaDeep Ltd ("InstaDeep"), JPT Peptide Technologies GmbH, and BioNTech Innovative Manufacturing Services GmbH. Generally, the Company continues to remain largely dependent on revenues generated in its collaboration partner’s territories in 2024.

2024 Financial Year Expenses and Capex

The Company has reduced its previous guidance for expected SG&A expenses and capital expenditures for operating activities for the 2024 financial year:

Guidance March 2024 Guidance November 2024
R&D expenses4 €2,400 million – €2,600 million €2,400 million – €2,600 million
SG&A expenses €700 million – €800 million €600 million – €700 million
Capital expenditures for operating activities €400 million – €500 million €300 million – €400 million
The full interim unaudited condensed consolidated financial statements can be found in BioNTech’s Report on Form 6-K for the period ended September 30, 2024, filed today with the United States Securities and Exchange Commission ("SEC") and available at View Source

On November 4, 2024 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that overcome tumor immune evasion and drug resistance, reported it has identified serum CEACAM1 as an additional new potential blood biomarker that may help determine which metastatic pancreatic ductal adenocarcinoma (PDAC) patients are most likely to benefit from treatment with CM24 (Press release, Purple Biotech, NOV 4, 2024, View Source [SID1234647668]). CM24 is a humanized monoclonal antibody that blocks CEACAM1 binding thereby inhibits its activity. CEACAM1 is overexpressed on certain tumor cells, immune cells, and neutrophils extracellular traps (NETs).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

PDAC patients who had pretreatment serum CEACAM1 levels between 6K and 15K pg/mL demonstrated the best outcomes following treatment with CM24 and nivolumab in combination with irinotecan/fluoropyrimidine based chemotherapy compared to chemotherapy control, with respect to both progression free survival (PFS) (median = 4.6 months, hazard ratio [HR] < 0.1, P = 0.003) and overall survival (OS) with an 79% reduction in risk of death (HR = 0.21, P = 0.04). The median OS improved from 3.6 months with chemotherapy alone to 8.7 months with the combination.

Purple Biotech’s randomized Phase 2 study of CM24 in the second line treatment of PDAC has previously identified multiple potential biomarkers including another serum-based marker, myeloperoxidase (MPO), and tumor markers.

"As we look ahead to topline Phase 2 results before the end of the year and anticipate advancing CM24 into further clinical development, the identification of an additional serum biomarker for patient selection is a critical advantage for our future CM24 study and more importantly, potentially for cancer patients in need of better outcomes, particularly for pancreatic cancer," said Gil Efron, Purple Biotech CEO.

On November 4, 2024 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported it will prioritize future development activity for SC291, the company’s CD19-directed allogeneic CAR T cell therapy, in B-cell mediated autoimmune diseases (AID) (Press release, Sana Biotechnology, NOV 4, 2024, View Source [SID1234647669]). The company will suspend development of both SC291 in oncology and of SC379, its glial progenitor cell program, as it seeks partnerships for these programs. Sana will increase its investment in its type 1 diabetes program with the cash savings from these changes.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Early clinical data with our hypoimmune platform (HIP) suggest HIP-modified cells evade immune detection, giving us confidence in the potential of the platform across multiple therapeutic areas. At the same time, we need to ensure that we are directing our investments into the areas where we believe we can have the greatest impact for patients," said Steve Harr, Sana’s President and Chief Executive Officer. "Greater focus on type 1 diabetes, SC291 in AID, and SC262 in refractory blood cancers will enhance our ability to present robust clinical data over the next twelve to eighteen months. This modified strategy will also help us reduce our cash burn but comes with the necessity of parting with some talented and valued colleagues. We thank them for their contributions toward building Sana and thank the patients who have been treated in the SC291 oncology study."

With these changes, Sana extends its expected cash runway into 2026. Payments related to ongoing activities combined with the reduction in force may increase the 2024 operating cash burn above prior guidance of less than $200 million.

"Since joining Sana, I have actively engaged with the team to understand both Sana and competitor data and believe it is the right time to prioritize where we believe we have the most differentiated therapeutic candidates and the highest probability of success for patients," said Dhaval Patel, M.D., Ph.D., Chief Scientific Officer of Sana. "Type 1 diabetes is a significant unmet need, and we are optimistic that our program is novel and has the potential to offer patients meaningful benefit. The decision to prioritize SC291 in B-cell mediated autoimmune diseases is based on early clinical data with this drug in both oncology and autoimmune diseases, which show that therapy with SC291 can predictably lead to the deep B cell depletion that appears to drive an immune "reset" and significant clinical benefit in patients with B-cell mediated autoimmune diseases such as lupus. We look forward to generating and sharing more data from across our portfolio."

Select Program Review

UP421 (HIP-modified primary pancreatic islet cells) in type 1 diabetes: The investigator-sponsored trial exploring the potential of HIP modifications to allogeneic primary islet cells to enable immune evasion and overcome transplant rejection in type 1 diabetes is active; Sana expects to share proof of concept data in 2024 and/or 2025.

SC291 (HIP-modified CD19-directed allogeneic CAR T) in autoimmune diseases: Sana continues enrollment in the Phase 1 GLEAM trial for SC291 for the treatment of B-cell mediated autoimmune diseases and expects to share clinical data in 2024 and/or 2025.

SC262 (HIP-modified CD22-directed allogeneic CAR T) in oncology: Sana continues enrollment in the Phase 1 VIVID study for patients with refractory B-cell malignancies who have failed a previous CD19-directed CAR T therapy and expects to share data in 2025.

SC451 (HIP-modified stem cell-derived pancreatic islet cells) in type 1 diabetes: Sana continues preclinical development of this HIP-modified, stem-cell derived therapy for patients with type 1 diabetes.

SG299 (in vivo CAR T with CD8-targeted fusogen delivery of a CD19-directed CAR): Sana is continuing its preclinical development of this program, with potential in both B-cell mediated autoimmune diseases and oncology.

SC291 (HIP-modified CD19-directed allogeneic CAR T) in oncology: Given alternative opportunities within its pipeline as well as increased competition within blood cancers and uncertainty about the best path to regulatory and commercial success, Sana is halting enrollment and further internal investment in the Phase 1 ARDENT trial. It is actively seeking a licensing partner to support advancement.

SC379 (stem-cell derived glial progenitor cells) in various CNS diseases: Sana will actively seek a partner or opportunity to spin out this program into a new company.

On November 4, 2024 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that the company will have five presentations at the 15th Annual World ADC Conference, taking place in San Diego, November 4-6, 2024 (Press release, Sutro Biopharma, NOV 4, 2024, View Source;utm_medium=rss&utm_campaign=sutro-biopharma-demonstrates-meaningful-adc-innovation-with-five-presentations-at-the-15th-annual-world-adc-conference [SID1234647670]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentation Details:
Development of Dual-Payload Antibody Drug Conjugates
Presenter: Daniel Calarese, Ph.D.
Date/Time: November 4, 2024, 2:00pm PT
Showcasing Clinical Update & Learnings for Luvelta Targeting Folate Receptor
Presenter: Hanspeter Gerber, Ph.D.
Date/Time: November 5, 2024, 11:30am PT
Characterizing ADC Safety & Activity in Preclinical Development of STRO-004
Presenter: Alice Yam, Ph.D.
Date/Time: November 5, 2024, 2:00pm PT
Leveraging Cell-Free Protein Synthesis for Site- Specific Conjugation to Enhance ADC Therapeutic Index
Presenter: Gang Yin, Ph.D.
Date/Time: November 5, 2024, 2:30pm PT
Optimizing High DAR & Dual Payload ADCs: Discovery of Hydrophilic β-glu Cleavable Linker Payloads for Superior Efficacy and Safety
Presenter: Krishna Bajjuri, Ph.D.
Date/Time: November 6, 2024, 3:00pm PT

Following the event, the content will be made available in the Clinical/Scientific Presentation and Publication Highlights section of Sutro Biopharma’s website at www.sutrobio.com.