On March 3, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies, reported INB-600, its potentially breakthrough next generation γδ T cell-based TCE platform. It is designed to address one of the biggest shortcomings of current existing γδ TCEs – insufficient numbers of γδ T cell effector cells to drive real clinical impact (Press release, In8bio, MAR 3, 2025, View Source [SID1234650830]). This groundbreaking platform leverages γδ T cells’ unique properties targeting applications in both oncology and autoimmune indications with potentially greater safety and tolerability than current CAR-T and TCE approaches.

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The platform’s first candidate, INB-619, targets CD19, a key marker broadly found on B cells, which play a central role in leukemias, lymphomas, and autoimmune diseases. In preclinical models, INB-619 demonstrated:

Rapid and sustained B-cell depletion – target cells were eradicated as γδ T cells continued expanding up to 450-fold with continued proliferation until the target cells were undetectable.
Simultaneous expansion and activation of both major γδ T cell subsets (Vδ1+ and Vδ2+) leverages both the rapid antigen presenting properties of Vδ2+ T cells and the longer-term resistance against exhaustion and tissue residence properties of Vδ1+ T cells, potentially resulting in deeper B cell depletion.
Lower cytokine (IL-6) secretion, potentially reducing the risk of dangerous side effects such as CRS and ICANs, two of the most severe side effects limiting CAR-T and traditional CD3-TCE adoption in autoimmune indications.
William Ho, Chief Executive Officer and co-founder of IN8bio, commented, "As the industry rapidly chased immunology and inflammation (I&I) indications, we saw a major unmet need for a therapy that provides deep B cell depletion, ease of delivery with no required lymphodepletion, and improved overall safety and tolerability. Most γδ TCEs have failed because they can’t engage the limited number of effector cells to eliminate their targets. Our INB-600 platform is working to change the equation by not only targeting B cells, but also by actively expanding the γδ T cell immune army needed for deep, lasting B cell depletion. By leveraging our expertise in γδ T cell biology, we have worked to develop a breakthrough technology that combines exceptional preclinical potency, while broadly expanding immune surveillance and potentially avoiding the dangerous side effects of existing approaches. We believe this platform could have significant applications across oncology as well as autoimmune diseases."

TCEs are a class of bispecific antibody therapies that work by binding both a target cell and a T cell, bringing them into close proximity so the T cell can efficiently attack and destroy its target. Traditional TCEs, such as those targeting CD3 – have demonstrated strong target killing abilities but often have severe limitations, including the potential to drive T cells to exhaustion and induce severe toxicities such as CRS and ICANs. γδ T cells naturally secrete lower levels of inflammatory cytokines such as IL-6, which suggests substantially less risk of CRS, which may translate to improved safety and tolerability in future clinical applications. Notably, to date, IN8bio has not observed any CRS or neurotoxicities in any of its on-going γδ T cell clinical programs.

IN8bio plans to evaluate INB-619 in preclinical studies and seek potential partners to support future IND-enabling trials. We remain focused on to pushing the boundaries of next generation γδ cell-based immunotherapies as it pursues its mission of Cancer Zero – a future where cancer is fully eliminated.

Webcast details
TD Cowen 45th Annual Health Care Conference
Date/Time: Monday, March 3, 2025, at 10:30 a.m. ET.
Webcast link: https://wsw.com/webcast/cowen177/inab/1991262

A live webcast and replay will also be available under "Events and Presentations" in the News & Presentations section of the IN8bio website at View Source

On March 3, 2025 Callio Therapeutics, a biotechnology company focused on realizing the promise of multi-payload antibody-drug conjugates (ADCs) to improve cancer therapy, reported its launch with the closing of a $187.0 million Series A financing round (Press release, Callio Therapeutics, MAR 3, 2025, View Source [SID1234650850]). This financing was led by Frazier Life Sciences with significant participation from Jeito Capital alongside other life sciences investors, including Novo Holdings A/S, Omega Funds, ClavystBio, Platanus, Norwest, Pureos Bioventures, SEEDS Capital and EDBI. The newly formed company, with headquarters in Seattle and Singapore, intends to use the proceeds from the Series A financing to achieve clinical proof-of-concept for its HER2-targeted dual-payload ADC and a second undisclosed ADC program.

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In conjunction with the financing, Callio Therapeutics has entered into an exclusive worldwide license agreement with Hummingbird Bioscience for its multi-payload ADC platform in oncology, and associated intellectual property and pipeline assets, in exchange for equity, potential milestone payments and royalties.

"We are delighted to be launching Callio Therapeutics with the support of Frazier Life Sciences and this syndicate of investors. Multi-payload ADCs have the potential to enable the targeted delivery of rational drug combinations to cancer cells, and may provide significantly enhanced efficacy," said Piers Ingram, PhD, co-founder and Chief Executive Officer of Callio Therapeutics. "This new generation of ADC therapies may meaningfully improve outcomes for patients."

Leadership Team

The founding Callio Therapeutics management team comprises individuals with extensive experience from leading biotechnology and biopharmaceutical companies including ProfoundBio, Silverback Therapeutics, SeaGen, Medarex, Hummingbird Bioscience and Genentech:

Piers Ingram, PhD, Chief Executive Officer
Jerome Boyd-Kirkup, PhD, Chief Scientific Officer
Naomi Hunder, MD, Chief Medical Officer
Angèle Maki, PhD, Chief Business Officer
"The multi-payload ADCs being developed at Callio Therapeutics have the potential to address large unmet medical needs by overcoming many of the limitations of existing ADCs," said Adam Simpson, Executive Board Chair of Callio Therapeutics and Venture Partner at Frazier Life Sciences. "With the expertise of the Callio Therapeutics team, together with access to the innovative multi-payload ADC technology, we believe that Callio Therapeutics will be the first company to show the clinical benefit of this exciting new multi-payload ADC approach and is well positioned to transform cancer therapy."

On March 3, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported a regulatory update on its planned US clinical trial following its Type D meeting with the United States Food and Drug Administration (FDA) (Press release, Amplia Therapeutics, MAR 3, 2025, View Source [SID1234650784]).

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The Company has previously disclosed plans for a clinical trial in the US of its best-in-class FAK inhibitor narmafotinib, in combination with the chemotherapy regime FOLFIRINOX, in advanced pancreatic cancer patients. FOLFIRINOX, which is a mixture of four different drugs, is the preferred first-line treatment option for advanced pancreatic cancer in the US. The Company has previously reported1 that narmafotinib enhances the activity of FOLFIRINOX in preclinical models of pancreatic cancer.

A Type D meeting is an opportunity for a company to seek feedback from the FDA for specific questions regarding clinical development activities. The Company sought the FDA’s feedback regarding modifications to the clinical trial protocol previously submitted as part of the Investigational New Drug application cleared by the FDA in January 20242 . Specifically, the Company was seeking commentary regarding changes to the dose-escalation and dose-optimization phase of the study and concerning removal of a pharmacokinetic assessment of FOLFIRINOX in the trial. In the written response received by the Company, the FDA noted that the proposed changes ‘appear reasonable’ clearing the way for the Company to finalise the study protocol and initiate the final stages of trial planning prior to commencing the study.

Amplia CEO and MD Dr Chris Burns commented: "We are grateful for the thoughtful input from the FDA regarding the modifications to our clinical trial protocol. These changes will allow the Company to progress the trial in a more time-efficient and capital-efficient manner, and we are now in the final planning stages to start the trial in the coming months."

Dr Burns continued: "Positive data from this clinical study, combined with promising data from the current ACCENT trial – where narmafotinib is combined with gemcitabine and Abraxane – will position narmafotinib as the preferred drug to combine with the two main chemotherapy regimes used for the treatment of pancreatic cancer across the globe."

On March 3, 2025 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the quarter and year ended December 31, 2024 (Press release, Emergent BioSolutions, MAR 3, 2025, View Source [SID1234650833]).

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"As we close out 2024, I’m proud to share we delivered favorable full-year financial results driven by our core products, all the while, completing a series of strategic stabilization actions to strengthen our financial position ahead of plan," said Joe Papa, president and chief executive officer of Emergent. "This strong foundation enables Emergent to focus on profitable revenue growth and cash generation as we move forward with turnaround activities, a critical phase in our multi-year transformation plan. Our results and progress are a testament to the hard work and dedication of our entire team, and we believe Emergent’s future will be defined by the durability of our business, opportunities for new markets and innovation, and a steadfast commitment to protecting and saving lives."

FINANCIAL HIGHLIGHTS(1)
Q4 2024 vs. Q4 2023
($ in millions, except per share amounts) Q4 2024 Q4 2023 % Change
Total Revenues $ 194.7 $ 276.6 (30) %
Net Loss $ (31.3) $ (49.5) 37 %
Net Loss per Diluted Share $ (0.58) $ (0.95) 39 %
Adjusted Net Income (Loss)(2)
$ 2.6 $ (40.0) 107 %
Adjusted Net Income (Loss) per Diluted Share(2)
$ 0.05 $ (0.77) 106 %
Adjusted EBITDA(2)
$ 21.0 $ 3.4 518 %
Total Segment Gross Margin %(2)
29 % 25 %
Total Segment Adjusted Gross Margin %(2)
40 % 32 %

Year to Date ("YTD") 2024 vs. YTD 2023
($ in millions, except per share amounts) YTD 2024 YTD 2023 % Change
Total Revenues $ 1,043.6 $ 1,049.3 (1) %
Net Loss $ (190.6) $ (760.5) 75 %
Net Loss per Diluted Share $ (3.60) $ (14.85) 76 %
Adjusted Net Loss(2)
$ (12.1) $ (319.0) 96 %
Adjusted Net Loss per Diluted Share(2)
$ (0.23) $ (6.23) 96 %
Adjusted EBITDA(2)
$ 183.1 $ (22.3) 921 %
Total Segment Gross Margin %(2)
26 % 25 %
Total Segment Adjusted Gross Margin %(2)
45 % 33 %

1

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SELECT 2024 FULL YEAR BUSINESS UPDATES
•Appointed industry leader Joseph C. Papa as President, CEO and Director
•Appointed Dr. Simon Lowry as Chief Medical Officer and Head of Research and Development
•Received approximately $550 million of Medical Countermeasure Contract Modification Awards
•Awarded procurement contract valued up to $235.8 million to supply BioThrax (Anthrax Vaccine Adsorbed) to the U.S. Department of Defense
•FDA approved sBLA for expansion of the indication for ACAM2000 to include prevention of mpox disease in individuals determined to be at high risk

•Repaid $168 million of debt and extended maturities to 2029 with new $250 million secured term loan and $100 million asset-backed revolving credit facility
•Completed $117 million of targeted asset divestitures and streamlined manufacturing footprint
•Resolved legacy legal disputes including receipt of $50 million settlement payment from Janssen
•Received $30 million in development milestone payments from Bavarian Nordic as part of the sale of the Travel Health Business
•Returned to strong, positive operating cash flow
FOURTH QUARTER 2024 FINANCIAL PERFORMANCE(1)
Revenues
The Company uses the following categories in discussing product/service level revenues:
•NARCAN — comprises contributions from NARCAN Nasal Spray
•Anthrax MCM — comprises contributions from CYFENDUS, previously known as AV7909, BioThrax, Anthrasil and Raxibacumab
•Smallpox MCM — comprises contributions from ACAM2000, VIGIV CNJ-016 and TEMBEXA
•Other Products — comprises contributions from BAT and RSDL
•Bioservices — comprises service and lease revenues from the Bioservices business
($ in millions) Q4 2024 Q4 2023 % Change
Product sales, net:(3)
NARCAN
$ 65.1 $ 111.0 (41) %
Anthrax MCM 32.5 111.6 (71) %
Smallpox MCM 76.5 11.5 565 %
Other Products 7.8 15.0 (48) %
Total Product sales, net $ 181.9 $ 249.1 (27) %
Bioservices:
Services $ 6.8 $ 20.6 (67) %
Leases 0.6 0.2 200 %
Total Bioservices revenues $ 7.4 $ 20.8 (64) %
Contracts and grants $ 5.4 $ 6.7 (19) %
Total revenues $ 194.7 $ 276.6 (30) %

2

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Product Sales, net
NARCAN
For Q4 2024, revenues from NARCAN (naloxone HCl) Nasal Spray decreased $45.9 million, or 41%, as compared with Q4 2023. The decrease was primarily driven by lower sales of over-the-counter ("OTC") NARCAN, coupled with lower revenues for Canadian retail sales.
Anthrax MCM
For Q4 2024, revenues from Anthrax MCM products decreased $79.1 million, or 71%, as compared with Q4 2023. The decrease reflects the impact of timing of sales related to CYFENDUS, Anthrasil, and BioThrax. Anthrax vaccine product sales are primarily made under annual purchase options exercised by the U.S. government (the "USG"). Fluctuations in revenues result from the timing of USG purchases and the exercise of annual purchase options, the availability of governmental funding and the Company’s delivery of orders that follow.
Smallpox MCM
For Q4 2024, revenues from Smallpox MCM products increased $65.0 million, or 565%, as compared with Q4 2023. The increase was primarily due higher ACAM2000 sales to non-U.S. customers and timing of USG purchases of VIGIV CNJ-016. Fluctuations in revenues result from the timing of USG purchases and the exercise of annual purchase options in existing procurement contracts, the availability of governmental funding and Company delivery of orders that follow.
Other Products
For Q4 2024, revenues from Other Product sales decreased $7.2 million, or 48%, as compared with Q4 2023. The decrease was due to lower sales of RSDL, which was sold to SERB during the third quarter of 2024, and lower product sales of BAT, due to timing of deliveries.
Bioservices Revenues
Services
For Q4 2024, revenues from Bioservices services decreased $13.8 million, or 67%, as compared with Q4 2023. The decrease was primarily attributable to the sale of the Camden facility to Bora Pharmaceuticals Injectables Inc., a subsidiary of Bora Pharmaceuticals Co., Ltd ("Bora"), during the third quarter of 2024, coupled with lower revenue from the Company’s Bayview facility as a result of the prior year resolution of a customer’s outstanding obligation, partially offset by higher production from the Company’s Winnipeg facility.
Leases
For Q4 2024, revenues from Bioservices leases increased $0.4 million, or 200%, as compared with Q4 2023. The increase was attributable to an increase in lease revenue associated with SERB at our Winnipeg facility.
Contracts and Grants
For Q4 2024, revenues from contracts and grants decreased $1.3 million, or 19%, as compared with Q4 2023. The decrease was primarily attributable to the wind-down of various development initiatives.

On March 3, 2025 Biond Biologics Ltd. ("Biond" or the "Company"), a private clinical-stage biopharmaceutical company developing novel therapies for cancer, reported that it would regain full rights to BND-22 (SAR444881) from Sanofi (Press release, Biond Biologics, MAR 3, 2025, View Source [SID1234650851]). Sanofi is returning the rights of BND-22 as part of their broader R&D prioritization to focus on programs that support the company’s strategy. Biond and Sanofi, are working together to complete full transfer of the BND-22 program to Biond.

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In January 2021, Biond entered into an exclusive worldwide license agreement with Sanofi for the development and commercialization of BND-22. As part of the agreement, Biond collaborated with Sanofi to initiate a first-in-human Phase 1 study (BND-22-001, NCT04717375), designed to evaluate the safety and tolerability of BND-22, both as a monotherapy and in combination with the approved cancer therapies cetuximab and pembrolizumab. The Phase 1 dose-escalation study was successfully completed and demonstrated a favorable safety profile across all patient groups. More specifically, data showed that BND-22 was well-tolerated and exhibited anti-tumor activity in heavily pretreated patients. Consistent with preclinical findings, a dose-dependent upregulation of activation markers was observed in monocytes and ILT2-expressing T and natural killer (NK) cell subsets. Notably, several confirmed clinical responses to both monotherapy and combination therapies regimens, were reported during the dose-escalation phase. These findings highlight the potential of BND-22 to address critical unmet needs in oncology.

Building on these encouraging results, Sanofi initiated enrollment for a Phase 2 dose-optimization and expansion study (BND-22-001, NCT04717375). The study was designed to evaluate BND-22 as monotherapy for patients with cholangiocarcinoma and in combination with cetuximab for patients with non-small cell lung cancer (NSCLC) or colorectal cancer (CRC). For more information about the trial, please visit View Source (Trial Identifier: NCT04717375).

"As part of the agreement between Biond and Sanofi, Biond will regain full rights to BND-22, including access to the clinical data generated by Sanofi," said Dr. Tehila Ben Moshe, Biond’s CEO and co-founder. "Sanofi has been an outstanding partner, and together, we have made remarkable progress in advancing the clinical development of BND-22. We remain committed to the continued development of BND-22 program, whether independently or in partnership with strategic collaborators".

"We are encouraged by the data demonstrated so far for BND-22 in the dose-escalation and dose-expansion study", said Dr. Natalia Ashtamker, Biond’s VP of Clinical Development. "We intend to continue treating patients who are benefiting from BND-22 treatment in the BND-22-001 study and are looking forward to the initiation of a Phase 2 biomarker study of BND-22 in combination with anti-PD-1 therapy".

About BND-22

BND-22 is a humanized IgG4 antagonist antibody targeting the ILT2 receptor, developed for the treatment of solid tumors. ILT2 is an inhibitory immuno-modulating receptor expressed on both innate and adaptive immune cells. It binds to major histocompatibility complex (MHC) class I molecules, including HLA-G, an immunosuppressive protein expressed by various tumor types.

Preclinical studies have demonstrated that BND-22 exerts broad anti-tumor effects by disrupting ILT2-mediated "do not eat me" signals in macrophages and activating NK and CD8+ lymphocytes.

BND-22-001, a Phase 1/2 multicenter, open-label, dose-escalation, dose-expansion and dose optimization study enrolled patients with advanced solid tumors known to express HLA-G. The study included evaluations of BND-22 as monotherapy in cholangiocarcinoma and in combination with cetuximab in patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Additionally, a future Phase 2 biomarker trial will explore BND-22 in combination with an anti-PD-1 agent in NSCLC, CRC and ovarian cancers.