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.

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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 5, 2024 Ichnos Glenmark Innovation (IGI), a global fully-integrated clinical-stage biotech company developing multispecifics in oncology reported that it will present first-time data from its Phase 1 study of ISB 2001 in an oral presentation at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, CA (Press release, Ichnos Sciences, NOV 4, 2024, View Source;utm_medium=rss&utm_campaign=igi-announces-first-presentation-of-data-from-phase-1-study-of-the-trispecific-isb-2001-in-relapsed_refractory-multiple-myeloma-r-rmm-at-upcoming-ash-annual-meeting [SID1234647727]). ISB 2001 is IGI’s first-in-class trispecific antibody targeting BCMA and CD38 on myeloma cells and CD3 on T cells, currently investigated in relapsed/refractory multiple myeloma (r/r MM).

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"Although recent advancements have brought new therapeutic options to multiple myeloma patients, resistance mechanisms continue to limit their efficacy, necessitating multiple lines of treatment for many patients," said Lida Pacaud, M.D., Chief Medical Officer at IGI. "We are encouraged by the early data from our Phase 1 study of ISB 2001, which shows a remarkable response rate and demonstrates potential to address these challenges in heavily pretreated patients."

The oral presentation will detail results from the dose-escalation portion of the study. The abstract features data as of July 2024, including:

An overall response rate (ORR) of 75% (9/12) in efficacy-evaluable patients, including one (1) MRD negative stringent complete response (sCR)
A favorable safety and tolerability profile that showed no dose-limiting toxicities (DLTs), only one adverse event of special interest (AE) above Grade 2, and no treatment discontinuation.
The oral presentation at ASH (Free ASH Whitepaper) will be supplemented with additional data and analyses.

Presentation details:

ISB 2001 Oral Presentation: First results of a Phase 1, First-in-Human, Dose Escalation Study of ISB 2001, a BCMAxCD38xCD3 Targeting Trispecific Antibody in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Presenter: Hang Quach, M.B.B.S, Professor of Haematology, University of Melbourne and Director of Clinical Haematology and Clinical Haematology Research, St. Vincent’s Hospital Melbourne

Session Name: 654. Multiple Myeloma: Pharmacologic Therapies: Into the Future: New Drugs and Combinations in Multiple Myeloma

Date & Time: Monday, December 9, 2024, at 5:45 PM

Room: San Diego Convention Center, Hall B

ISB 1442 Poster Presentation: Dose Escalation of ISB 1442, a Novel CD38 Biparatopic x CD47 Bispecific Antibody, in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Presenter: Binod Dhakal, M.D., M.S., Associate Professor of Medicine, Medical College of Wisconsin, Division of Hematology

Session Name: 654. Multiple Myeloma: Pharmacologic Therapies: Poster II

Presentation Date & Time: Sunday, December 8, 2024, 6:00-8:00 PM

Room: San Diego Convention Center, Halls G-H

About ISB 2001

ISB 2001 is the first trispecific antibody that simultaneously targets BCMA and CD38 on MM cells and CD3 to engage T cells. This first-in-class multispecific was developed using our BEAT (Bispecific Engagement by Antibodies based on the TCR) technology to create a highly specific antibody therapeutic that increases binding to MM cells while minimizing off-target activity. ISB 2001 is currently in a multi-center Phase 1 clinical trial in r/r MM. For more information about the study, visit: View Source

About ISB 1442

ISB 1442 is a first in class biparatopic CD38 x CD47 bispecific antibody based on the BEAT antibody technology with the ability to induce synthetic immunity via multiple effector mechanisms. ISB 1442 is in a Phase 1/2 study to assess safety and efficacy in r/r MM. For more information about the study, visit: View Source

On November 04, 2024 CrossBridge Bio, a biotechnology company pioneering dual-payload antibody-drug conjugates (ADCs) as targeted cancer therapies, reported the closing of a $10 million seed financing led by TMC Venture Fund and CE-Ventures, the corporate venture capital platform of Crescent Enterprises, with participation from Portal Innovations, Alexandria Venture Investments, Linden Lake Labs, and several pre-seed investors (Press release, CrossBridge Bio, NOV 4, 2024, View Source [SID1234647682]).

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Based on breakthrough research from Dr. Kyoji Tsuchikama and Dr. Zhiqiang An of UTHealth Houston, CrossBridge Bio’s dual-payload ADC platform combines both established and novel antibodies with various payload mechanisms of action, to develop a suite of ADC programs designed to offer distinct molecular properties, pharmacological actions, including payload synergy, and safety profiles for a range of cancer indications. The seed capital will fund the development of the company’s lead program, CBB-120, a potential best-in-class TROP-2 dual-payload ADC for the treatment of solid tumors, and accelerate the expansion of its pipeline of novel ADC programs. Additionally, funds will be used to further derisk the company’s proprietary linker technology with dual-payload applications, a critical component of its ADC platform, to improve the safety and efficacy profiles of its current and future drug candidates.

"We are thrilled to have the support of such experienced investors who share our vision of bringing transformative cancer therapies to patients in need," said Michael Torres, Ph.D., CEO of CrossBridge Bio. "Our dual-payload ADC technology is designed to deliver synergistic therapeutic effects using highly stable linkers that ensure payload release only within the targeted cancer cells, thereby maximizing their therapeutic effectiveness while minimizing the liabilities associated with uptake in unintended tissues, as seen with many of today’s cancer treatments. With these funds, the seasoned team we have built at CrossBridge will advance CBB-120, the first development candidate in our portfolio, into preclinical non-GLP toxicology studies and lay the groundwork for its future clinical development."

As part of this financing, both William McKeon, President and CEO of the Texas Medical Center (TMC), and Damir Illich, Ph.D. Manager, Life Sciences of CE-Ventures, will join CrossBridge Bio’s board of directors, bringing extensive experience in healthcare and life sciences to support the company’s strategic growth.

"We are proud to back CrossBridge Bio in their mission to develop the next generation of cancer therapies," said Mr. McKeon. "Their dual-payload ADCs are designed to deliver targeted drug release within cancer cells with greater stability, precision, and control. These breakthrough advancements have the potential to change patients’ lives worldwide and we look forward to helping drive their development."

"CrossBridge Bio’s innovative platform and ambitious pipeline have positioned the company as a new leader in the ADC drug discovery and development arena," said Dr. Illich. "We are excited to support their efforts to translate their platform innovations into therapies that meaningfully impact patients’ lives, starting with CBB-120."

On November 4, 2024 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported financial results for the quarter that ended September 30, 2024 (Press release, Tempus, NOV 4, 2024, View Source [SID1234647681]). The company also announced that it has entered into an agreement to acquire Ambry Genetics, a leader in genetic testing that aims to improve health by understanding the relationship between genetics and disease.

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Revenue increased 33.0% year-over-year to $180.9 million in the third quarter of 2024
Data and services revenue growth accelerated to 64.4% year-over-year
Genomics unit growth accelerated to 23.9% annually with rising average revenue per clinical test
Net Loss of $(75.8 million), which included $22.2 million of stock compensation expense and related employer payroll taxes
Adjusted EBITDA improved $14.4 million year over year to $(21.8 million)
Expect full year 2024 revenue of ~$700 million, which represents ~32% annual growth
For additional information on the quarter, including a letter from our CEO and CFO, please visit our investors relations site at investors.tempus.com.

"The overall business performed well in the quarter, as demonstrated by accelerating volume growth in our genomics business and accelerating revenue growth in our data and services business, specifically within Insights," said Eric Lefkofsky, Founder and CEO of Tempus. "We’re also excited to announce the pending acquisition of Ambry Genetics, which broadens our testing portfolio, expands our disease coverage, and enhances the types of products we can offer to our biotech and pharmaceutical partners. In addition, Ambry is uniquely positioned given that its revenues are currently growing at north of 25% a year and it generates meaningful EBITDA and cash flow."Genomics revenue of $116.4 million in the third quarter of 2024, an increase of $19.6 million or 20.3% over the third quarter of 2023, with 23.9% unit growth.
Data and services revenue of $64.5 million in the third quarter of 2024, an increase of $25.3 million or 64.4% over the third quarter of 2023.
Non-GAAP Genomics gross margin was 49.3% in the third quarter of 2024, compared to 51.9% in the third quarter of 2023, largely related to one-time cash payments in 2023.

Non-GAAP Data and services gross margin was 78.3% in the third quarter of 2024, compared to 60.5% in the third quarter of 2023, led by Insights, or data licensing revenue, which grew 86.6% year over year.
Net Loss of $(75.8 million), which included $22.2 million of stock compensation and related employer payroll taxes compared to net loss of $(552.2 million) in the second quarter of 2024, including $493.1 million of stock compensation and related employer taxes and net loss of $(53.4 million) in the third quarter of 2023.
Adjusted EBITDA $(21.8 million) in the third quarter of 2024, compared to $(31.2 million) in the second quarter of 2024, and $(36.2 million) in the third quarter of 2023.
Ending cash and marketable securities were $466.3 million.
Additional Operating Highlights

Announced a multi-year first of its kind collaboration with BioNTech to leverage Tempus’ TCR dataset in support of BioNTech’s next-generation oncology pipeline.
Announced a 3 year extension with Merck EMD at the culmination of our last 3 year strategic agreement.
Initiated a collaboration with OneOncology to bring more biomarker-driven trials to patients in the community setting at scale.
Initiated the beta launch of our patient-facing app, Olivia, an AI-enabled personal health locker that empowers individuals to holistically organize, store, and manage their own health data through our generative AI healthcare concierge.

Ambry Genetics Acquisition

Tempus reported that it has entered into an agreement to acquire Ambry Genetics, a leader in genetic testing. Under the terms of the agreement, Tempus will pay $375 million in cash and $225 million in shares at closing, of which $100 million will be subject to a lock-up agreement until one year post-transaction close. The deal is expected to be financed in part through a $300 million increase in short and long term debt provided by Ares, Tempus’ current lender. Ambry expects to generate >$300 million in revenue in calendar year 2024 and EBITDA of >$40 million. For more information on Ambry and its impact, see Tempus’ latest investor deck.

Ambry is a leader in hereditary cancer screening and currently serves as Tempus’ main reference lab in this category. The acquisition will provide Tempus with expanded testing capabilities for inherited cancer risk. These services are becoming more and more important for healthcare professionals navigating critical medical decisions with cancer patients and their relatives.

In addition to expanding and enhancing the company’s hereditary screening portfolio, the acquisition of Ambry will complement Tempus’ strategy of using data to advance clinical and scientific innovation. Ambry’s extensive product offerings will also allow Tempus to expand into new disease categories, including pediatrics, rare disease, immunology, women’s reproductive health, and cardiology.

Financial Outlook and Guidance

Tempus continues to expect full year 2024 revenue of approximately $700 million, which represents approximately 32% year-over-year growth and approximately $(105 million) in adjusted EBITDA, an improvement of approximately $50 million over 2023.

Webcast and Conference Call Information

A conference call and webcast will begin today, November 4, 2024 after market close at 4:30 p.m. Eastern Time. Interested parties may access details at:

Conference ID: 7177136
Domestic Dial-in Number: (800) 715-9871
International Dial-in Number: (646) 307-1963
Live Webcast: View Source

The webcast may be accessed on the company’s investor relations website at investors.tempus.com. For those unable to listen to the live webcast, a recording will be made available on the company’s website after the event and will be accessible for one year. Visit the investor relations website to find the company’s latest deck, and commentary on the quarter by Eric Lefkofsky, Founder and CEO and Jim Rogers, CFO, which will be discussed on the conference call and webcast.

On November 4, 2024 AbCellera (Nasdaq: ABCL) reported financial results for the third quarter of 2024 (Press release, AbCellera, NOV 4, 2024, View Source [SID1234647680]). All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

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"Through the third quarter we continued to execute on our key priorities of advancing our internal pipeline and building capabilities to support clinical trials activities in 2025 and beyond," said Carl Hansen, Ph.D., founder and CEO of AbCellera. "Notably, we completed the consolidation into our new headquarters in Vancouver, Canada, which marks a significant milestone towards completing our platform and infrastructure investments."

Q3 2024 Business Summary

Expanded existing collaboration with Eli Lilly and Company to discover therapeutic antibodies for programs in immunology, cardiovascular disease, and neuroscience.
Reported the start of two additional partner-initiated programs with downstreams to reach a cumulative total of 95 partner-initiated program starts with downstreams.
Maintained a cumulative total of 14 molecules advanced to the clinic.
Key Business Metrics

Cumulative Metrics

September 30, 2023

September 30, 2024

Change %

Partner-initiated program starts with downstreams

84

95

13%

Molecules in the clinic

10

14

40%

AbCellera started discovery on an additional two partner-initiated programs with downstreams to reach a cumulative total of 95 partner-initiated program starts with downstreams in Q3 2024 (up from 84 on September 30, 2023). AbCellera’s partners have advanced a cumulative total of 14 molecules into the clinic (up from 10 on September 30, 2023).

Discussion of Q3 2024 Financial Results

Revenue – Total revenue was $6.5 million, compared to $6.6 million in Q3 2023. In both periods, the majority of revenues were research fees generated by our partnerships.
Research & Development (R&D) Expenses – R&D expenses were $41.0 million, compared to $37.9 million in Q3 2023, reflecting underlying continued growth in program execution, platform development, and investments in internal programs.
Sales & Marketing (S&M) Expenses – S&M expenses were $3.1 million, compared to $3.5 million in Q3 2023.
General & Administrative (G&A) Expenses – G&A expenses were $19.1 million, compared to $14.4 million in Q3 2023.
Net Loss – Net loss of $51.1 million, or $(0.17) per share on a basic and diluted basis, compared to net loss of $28.6 million, or $(0.10) per share on a basic and diluted basis in Q3 2023.
Liquidity – $670.4 million of total cash, cash equivalents, and marketable securities and with approximately $205 million in available non-dilutive government funding to execute on AbCellera’s strategy, bringing total available liquidity to over $875 million.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.