On February 20, 2025 Myris Therapeutics emerged from stealth reported its strategic focus (Press release, Myris Therapeutics, FEB 20, 2025, View Source [SID1234650430]). Myris, formerly known as BioHybrid Solutions, has built on its history in enzyme bioconjugate development to emerge as a new Antibody Drug Conjugate (ADC) therapeutics company focused on the discovery and development of ultra-high Drug Antibody Ratio (DAR) ADCs. The first public release of Myris’ ADC capabilities will be presented at AACR (Free AACR Whitepaper) in Chicago, April 25-30, 2025.

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Myris Therapeutics has a novel pipeline of ultra-high DAR ADC oncology medicines, developed using the company’s deep expertise in polymer chemistry and cancer biologics. Myris’ technology enables the development of ADCs with DAR50-300, meaning Myris can put 50-300 copies of the drug payload per antibody which is 10-100x higher than current standards. "This dramatically expands the range of possible payloads and precision therapy opportunities. Moreover, there are many clinically-validated small molecules that have previously not been amenable to use in ADCs because of their pharmacology or therapeutic index," said Laura Benjamin, PhD, CEO of Myris Therapeutics. "We are advancing promising clinical candidates by utilizing innovative, yet proven, antibodies and payloads. Our emerging preclinical data suggest that we will see the expected improvement in efficacy and tolerability that the field so desperately needs."

Laura Benjamin, PhD, joined Myris’ Board in 2023 and stepped in as CEO in 2024 to lead the company’s shift to oncology. Prior to Myris, Laura was the CEO at OncXerna, where she raised >$100 million USD to advance clinical development of two oncology programs. Earlier positions included VP/CSO in oncology at Eli Lilly, Associate Professor in Pathology at Harvard Medical School, and Co-director of the Center for Vascular Biology at the Beth Israel Deaconess Medical School. Laura received her BA in Biology from Barnard College, Columbia University and her PhD in Molecular Biology from the University of Pennsylvania.

Myris Therapeutic’s predecessor company, BioHybrid Solutions, was founded to use sophisticated polymer chemistry to improve the druggability of therapeutic enzymes. The polymer technology remains central to Myris’ ultra-high DAR ADC capabilities and the company’s founders continue to play a leading role in Myris. Co-founder Krzysztof Matyjaszewski, PhD, from CMU is one of the leading figures in polymer chemistry world-wide and is a Director of Myris and active scientific advisor, co-founder Tonia Simakova, PhD, leads discovery research at Myris, and co-founder Alan Russell, PhD, currently VP of Large Molecule Discovery and Research Data Science at Amgen, is Chair of Myris’ Scientific Advisory Board. The company’s legacy programs are partnered and continue to advance rapidly towards the clinic. Pipeline success has allowed Myris to develop the technical capabilities needed to support the shift in focus to ultra-high DAR ADCs. Most notably, the lead program has been fully funded by the Department of Defense and has led to the successful nomination of a development candidate.

Under Laura Benjamin’s leadership, the team has been expanded to support the successful development of the ADC pipeline. Key advisors include biotech veteran Patrick Zweidler-McKay, MD, an experienced oncologist with over 11 years at MD Anderson, who spent 8 years developing ADCs at Immunogen before its acquisition by AbbVie, and decorated oncologist Pasi Janne, MD, currently Director for the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute and Professor of Medicine at Harvard. In addition, the internal team has been strengthened by the addition of Becky Wolfe, a proven business and program leader in biopharma, as COO; Jeffrey S. Humphrey, MD, a seasoned industry oncologist, as CMO; and Bryant McLaughlin, PhD, an accomplished CMC scientist, as Head of CMC.

On February 20, 2025 Harbour BioMed (HKEX: 02142, the "Company"), a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immunology and oncology, and Insilico Medicine ("Insilico"), a clinical stage generative artificial intelligence (AI)-driven biotechnology company, reported a strategic collaboration to accelerate the discovery and development of innovative therapeutic antibodies, leveraging their respective technological strengths in antibody discovery and artificial intelligence (Press release, Harbour BioMed, FEB 20, 2025, View Source [SID1234650433]).

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Under the collaboration agreement, the parties will combine Harbour BioMed’s industry-leading technology platform, proprietary dataset and extensive expertise in antibody development with Insilico’s advanced capabilities in designing integrated AI-driven drug discovery and development platforms to jointly develop the next-generation AI-powered antibody application. Additionally, the two companies will collaborate on early-stage drug discovery programs targeting novel, specific antibodies, leveraging Insilico’s AI expertise and Harbour BioMed’s wet lab capabilities. These efforts aim to deliver innovative therapeutic solutions for the unmet medical needs of immunology, oncology, and neuroscience.

Harbour BioMed has built a strong foundation in antibody discovery and development, underpinned by its advanced technology platform, proprietary dataset, and deep expertise. The Company’s proprietary Harbour Mice platform enables the generation of fully human monoclonal antibodies in both conventional (H2L2) and heavy chain-only (HCAb) formats, eliminating the need for additional engineering or humanization. The HCAb technology, in particular, produces unique, fully human heavy chain-only antibodies that are approximately half the size of conventional IgGs, offering significant advantages for next-generation antibody therapies. With a clinically validated and globally recognized platform, Harbour BioMed has applied its technology in more than 250 drug discovery programs across various therapeutic areas, establishing itself as a leader in the field of biotherapeutics.

Insilico has previously showcased the capability of its proprietary AI platform to significantly reduce cost and improve efficiency in the early stages of small molecule drug discovery and development. Since 2021, the company has established a wholly-owned pipeline of 30 assets powered by its Pharma.AI platform, 10 of which have received IND clearance, setting a benchmark for AI-driven drug discovery and development. In July 2024, Insilico introduced Generative Biologics, an AI-powered tool for de novo protein engineering, designed to accelerate the development of next-generation biologics. Moving forward, the company plans to leverage real-world case studies to further refine and advance the application through ongoing enhancements and iterative improvements.

"We are excited to collaborate with Insilico, a pioneer and leading advocate in AI-driven drug discovery and development, to integrate AI technologies with our industry-leading technology platform and proven expertise in antibody discovery and development," said Jingsong Wang, MD, PhD, Founder, Chairman, and CEO of Harbour BioMed. "By combining our validated Harbour Mice platform with advanced generative AI approaches, we aim to further streamline antibody discovery, enhance candidate selection, and ultimately bring innovative therapies to patients more efficiently."

"By combining advanced machine learning models with biological expertise, AI platforms are transforming antibody discovery and engineering – enabling the prediction of antibody structures, identification of binding sites, and design of candidates with enhanced specificity, efficacy, and safety," said Feng Ren, PhD, Co-CEO and Chief Scientific Officer of Insilico Medicine. "High-quality dataset and wet-lab validation are critical components in this process, and we are thrilled to collaborate with Harbour BioMed who excel in these areas. Together, we aim to build the next generation AI-driven antibody platforms and deliver breakthrough antibody therapies to address critical healthcare needs."

On February 20, 2025 Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) reported its financial results for the year ended 31 December 2024 (Press release, Telix Pharmaceuticals, FEB 20, 2025, View Source [SID1234650432]). All figures are in AU$ unless stated otherwise.

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FY2024 highlights

Total revenue, driven primarily from sales of Illuccix of $783.2 million, up by 56%1 from $502.5 million in 2023, beating full year guidance2.
Second year of profitable growth, delivered in a period of investment, including:
R&D investment of $194.6 million, in line with guidance, with a focus on late-stage assets.
Expanded global supply chain and product delivery infrastructure, including acquisitions of ARTMS, Inc. and IsoTherapeutics Group, LLC, and expansion of Telix Manufacturing Solutions’ Brussels South facility, resulting in an incremental increase of $15.8 million in manufacturing and distribution investment.
Adjusted EBITDA of $99.3 million, up by 70%, demonstrating strong underlying growth3.
Telix continued to deliver on its growth strategy. The Company’s key achievements, aligned to its strategic pillars:
Grow precision medicine: Prepared for launch of three new products TLX007-CDx (Gozellix), TLX101-CDx (Pixclara) and TLX250-CDx (Zircaix)4 in 2025 while continuing to increase sales and market share for Illuccix.
Deliver late-stage therapeutics: Expanded ProstACT GLOBAL Phase 3 prostate cancer therapy trial recruitment in the U.S. and continued to advance therapeutic trials for the brain and kidney cancer programs.
Build next generation pipeline: Delivered clinical proof-of-concept for first alpha therapy candidate in prostate cancer (TLX592) and added depth to urology franchise with acquisition of FAP5-targeting theranostic.
Expand global delivery infrastructure: Completed acquisitions of ARTMS, IsoTherapeutics and RLS (USA), Inc. (RLS)6 and expanded Brussels South facility, in preparation to commence GMP7 production in 2025.
For a full list of operational achievements, please refer to the Telix 2024 Annual Report.

1. All comparisons to Full Year 2023 results.

2. Previously stated guidance of AU$745 million to AU$776 million (US$490 million to US$510 million).

3. Adjusted EBITDA excludes one-off expenses related to both the Company’s U.S. capital markets activity ($9.1 million) and strategic acquisitions ($8.2 million).

4. Launch and brand names subject to regulatory approval.

5. Fibroblast activation protein. Transaction subject to customary closing conditions.

6. RLS acquisition completed 27 January 2025, subsequent to year end. Refer to ASX disclosure.

7. Good manufacturing practice.

Summary Group financial results

Full Year 2024

Full Year 2023

AU$M

AU$M

% change

Revenue

783.2

502.5

56 %

Cost of sales

(273.6)

(188.2)

45 %

Gross profit

509.6

314.3

62 %

Research and development (R&D)

(194.6)

(128.5)

51 %

Selling and marketing

(85.5)

(50.1)

71 %

Manufacturing and distribution

(25.7)

(9.9)

160 %

General and administration

(129.8)

(74.2)

75 %

Other gains/(losses) (net)

8.1

(35.9)

*

Operating profit

82.1

15.7

423 %

Profit after tax

49.9

5.2

860 %

Adjusted EBITDA1

99.3

58.4

70 %

Cash from operating activities

43.0

23.9

80 %

1. Earnings before interest, tax, depreciation and amortization.

Commentary

Group CEO, Dr. Christian Behrenbruch, commented on the result:

"2024 has been an extraordinary year for Telix. We generated strong financial growth while investing for the future. The Precision Medicine business is poised for step-change growth with three commercial product launches planned for this year in the U.S. and the European rollout of Illuccix. We have a deep therapeutic pipeline with multiple assets moving into pivotal trials, and we are building out the infrastructure to ensure we can deliver our products to patients around the world. We see 2025 as a year of significant growth and evolution for Telix in terms of international business, multiple product launches and the integration of key infrastructure that will further deliver on our mission to ensure global patient access."

Further details on the Company’s results can be found in the Appendix 4E, investor presentation, and 2024 Annual Report lodged with the ASX and also available on the Company’s website.

Guidance

Telix provides FY2025 revenue guidance of $1.18 billion to $1.23 billion (US$770 million to US$800 million1). This guidance includes revenue from Illuccix (in jurisdictions with a marketing authorization)2 and 11 months of revenue from RLS (and excluding RLS revenue generated from Illuccix). Guidance does not reflect revenue for products that have not yet received a marketing authorization (for example, Gozellix, Pixclara and Zircaix3).

Telix has also provided R&D expenditure guidance, expecting an increased investment range of 20% to 25% compared to FY2024.

lnvestor call

An investor webcast will be held at 9.00am AEDT on Friday 21 February 2025 (5.00pm EST, Thursday 20 February 2025).

Participants can register for the webcast and find audio call details at the following link: View Source diamondpass/10044775-kmnuu.html

On February 20, 2025 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) , a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported that its CEO will join the Cancer Progress Panel discussion on February 27th at 1:10 pm CET at the 18th Annual European Life Sciences CEO Forum, which will include HealthTech topics such as AI, convergence, and diagnostics (Press release, TC Biopharm, FEB 20, 2025, View Source [SID1234650431]).

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The forum will take place on the 26th – 27th of February 2025 at the Hilton Zurich Airport Hotel. The main programme for the 18th Annual ELSF will feature more than 12 hours of high-level keynotes and panel discussions.

Additionally, there will be a global company showcase of 50+ presentations by established public, private, emerging, and seed companies, offering innovative solutions and seeking investment and partnering opportunities. For more information about the 18th Annual European Life Sciences CEO Forum.

On February 20, 2025 Bantam Pharmaceutical, a drug discovery and development company targeting selective modulation of mitochondrial dynamics in cancer, reported the activation of its first clinical trial site at The University of Texas MD Anderson Cancer Center for its Phase 1 study evaluating BTM-3566 in relapsed/refractory mature B-cell lymphomas (Press release, Bantam Pharmaceutical, FEB 20, 2025, View Source [SID1234650429]). BTM-3566 is a first-in-class, small molecule cancer therapeutic which targets mitochondrial homeostasis via the ATF4-Integrated Stress Response (ISR) pathway to treat aggressive tumors.

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"We are pleased to activate our first clinical site at MD Anderson Cancer Center, a world-renowned institution known for its leadership in cancer research and treatment," said Michael Stocum, President & CEO of Bantam Pharmaceutical. "This represents a major milestone for our company as we transition from discovery into clinical development. Through its novel mechanism of action, BTM-3566 has the potential to deliver the tumor-killing potency of chemotherapy with the precision and selectivity of targeted therapies. We are excited to partner with MD Anderson and believe this collaboration reflects our shared commitment to advancing medical research and improving patient outcomes."

The Phase 1 clinical trial is a multicenter, open-label, dose-escalation and -expansion study. The study will evaluate the safety, tolerability, pharmacokinetics, anti-tumor, and pharmacodynamic effects of BTM-3566. Initial clinical data from the trial are expected in the second half of 2025.

Bantam remains dedicated to addressing the need for new treatments targeting aggressive tumors and looks forward to expanding the clinical trial to additional North American sites in the coming months.

For more information about the trial, visit ClinicalTrials.gov and search NCT number NCT06792734.

About BTM-3566

BTM-3566 is a novel, orally available small molecule designed to target a wide range of cancers, including both hematologic and solid tumors. Its initial clinical focus is on mature B-cell lymphomas, such as mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL). In preclinical studies, BTM-3566 demonstrated potent anti-cancer activity, driving significant tumor regression – and in many cases, complete tumor elimination – in tumor models resistant to standard treatments, including CAR-T cell therapy. BTM-3566 works by disrupting the mitochondrial function in tumor cells, triggering their natural cell death process (apoptosis). With its unique mechanism of action and strong preclinical data, Bantam also plans to expand clinical development into solid tumors, broadening its potential impact for patients with limited treatment options.