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Actithera Raises $75.5M in Oversubscribed Series A Financing to Redefine Precision Radioligand Therapy

On July 9, 2025 Actithera, a radiopharmaceutical biotech company translating medicinal chemistry insights into next-generation radioligand therapies (RLTs), reported the close of an oversubscribed $75.5 million Series A financing round (Press release, Actithera, JUL 9, 2025, View Source [SID1234654293]). The financing will support the advancement of Actithera’s lead FAP asset into clinical development in multiple indications, while also enabling the continued development of its proprietary RLT discovery platform and preclinical pipeline.

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The round was co-led by founding investor M Ventures and new lead investors Hadean Ventures, Sofinnova Partners, and 4BIO Capital, with additional participation from Bioqube Ventures, Innovestor’s Life Science Fund, Investinor, Surveyor Capital (a Citadel company), and second founding investor, Arkin Bio Ventures II.

The Company’s discovery platform combines rational drug design with radiochemistry to create novel small molecule radioligands that overcome current limitations in radiopharmaceutical development. Its three-pillar platform includes first-in-class covalent targeting strategies, designed to optimize tumor residence time, while ensuring rapid systemic clearance – improving precision, safety, and efficacy. Two additional proprietary approaches further support compound differentiation and improve tumor residence time and selectivity. This platform was validated through Actithera’s work on FAP, a high-value theranostic target known for being difficult to drug with molecules that maintain prolonged tumor residency. These efforts have resulted in a FAP-directed RLT development candidate with best-in-class potential due to its optimal pharmacokinetic profile and tumor specificity.

Dr. Andreas Goutopoulos, founder and CEO, brings over 25 years of pharmaceutical and biotech industry experience, including a track record of more than a dozen development candidates. His background includes over a decade of discovery leadership at EMD Serono, where he led medicinal chemistry. In his role as Entrepreneur-in-Residence (EIR) at M Ventures, he led the scientific efforts of and supported a number of oncology small molecule biotechs. At Actithera, he is pioneering a chemistry-driven, precision approach to RLTs by integrating novel covalent-targeting chemistries, rational drug design principles and an isotope-agnostic philosophy.

"We set out to bring structure-based and kinetics-driven thinking from small molecule drug design into the world of radiopharmaceuticals," said Dr. Andreas Goutopoulos. "This oversubscribed Series A, backed by a truly global and experienced investor syndicate, is strong validation of our approach. We engineer our radioconjugates for extended retention within tumors, making them ideally suited for longer-lived radionuclides and ultimately delivering more convenient dosing schedules and enhanced efficacy and safety for patients."

Karl Naegler, incoming Board member and Partner at Sofinnova Partners, noted: "Actithera is applying Big Pharma discipline to an emerging field with enormous potential. Its radioligand therapies represent a meaningful shift in oncology, with the opportunity to redefine the therapeutic index. We’re excited to support that vision."

Roger Franklin, incoming Board member and Partner at Hadean Ventures, added: "Actithera stands out as one of the most thoughtfully constructed radiopharma platforms we’ve seen, combining smart molecular design with a deep understanding of tumor biology and clinical need. The team’s work to align pharmacokinetics with therapeutic effect could transform how patients experience and benefit from radioligand therapies."

Therese Liechtenstein, incoming Board member and Investment Director at 4BIO Capital, added: "We are honored to support Actithera, whose molecules address key challenges in the nascent radioligand therapies space; a large therapeutic window through high tumor retention and low systemic exposure, applied to a lead program that has significant pan-tumor therapeutic potential."

Hakan Goker, current Chairman of Actithera, and Managing Director at M Ventures, said: "We are excited to see Actithera evolve from the one-person ideation we seeded with Andreas and Arkin to the transatlantic company it has become today. The innovative chemistry platform built and the first-in-class approach on FAP have the potential for a large impact in the RLT field and a significant benefit for patients. We welcome the new investor group and Board members to the company aligned with this bold vision of building the next generation of RLTs."

As part of the Series A financing, Roger Franklin, Partner at Hadean Ventures, Karl Naegler, Partner at Sofinnova Partners, Therese Liechtenstein, Investment Director at 4BIO Capital, and Debbie Dumont, Managing Partner at Bioqube Ventures will join the Actithera Board of Directors, including Noga Yerushalmi, Investment Director at M Ventures, who is currently on the Board.

CStone Pharmaceuticals and Istituto Gentili Enter into Exclusive Strategic Collaboration for Sugemalimab in Western Europe and the UK

On July 8, 2025 CStone Pharmaceuticals (stock code: 2616.HK), an innovation-driven biopharmaceutical company focused on the research and development of oncology drugs, reported an exclusive strategic collaboration with Istituto Gentili ("Gentili"), a biopharmaceutical company focused on oncology with a century-long history in the European market, for the commercialization of sugemalimab in Western Europe and the United Kingdom (Press release, CStone Pharmaceauticals, JUL 8, 2025, View Source [SID1234656252]).

Under the terms of the agreement, Gentili will obtain exclusive commercialization rights for sugemalimab in 23 countries, including 18 EEA countries (Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Malta, the Netherlands, Norway, Portugal, Spain and Sweden), as well as the United Kingdom, Andorra, Monaco, San Marino and the Vatican.

CStone Pharmaceuticals will receive an upfront payment, regulatory and sales milestone payments from Gentili, with the total transaction value reaching up to US$192.5 million . By supplying Gentili, CStone will also receive approximately 50% of net sales of sugemalimab in the licensed territory . Gentili will be responsible for regulatory and commercial activities for sugemalimab in these territories.

Dr. Jianxin Yang, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, said: "Sugemalimab is the first PD-L1 monoclonal antibody approved in the EU and UK for the first-line combination treatment of stage IV non-small cell lung cancer (NSCLC) in all patients (regardless of histological type or PD-L1 expression level) in combination with chemotherapy. Our new indication application for stage III NSCLC has also been accepted by the European Medicines Agency (EMA). If approved, sugemalimab will become the second PD-(L)1 antibody for this indication in Europe.

With its deep expertise in oncology, mature commercialization system, and patient-centric innovation, Gentili is an ideal partner to accelerate the accessibility of Sugemalimab in the European market. Immunotherapies, currently priced based on US market standards, are facing new uncertainties in their global supply and payment models due to the controversy surrounding the US drug pricing system reform. Against this backdrop, expanding access to clinically significant therapies like Sugemalimab has become a top priority for the global healthcare community.

To date, we have reached four major commercialization collaborations for Sugemalimab in Europe, the Middle East and Africa, and Latin America, covering a total of more than 60 countries and regions. The overseas launch of Sugemalimab is about to be fully launched. We will accelerate global layout and commercialization by deeply integrating the advantageous resources of our partners, and fully unleash the clinical value and market potential of Sugemalimab. At the same time, we are also actively promoting cooperation negotiations in Southeast Asia, Canada and other regions , and continue to expand registration applications for other indications of Sugemalimab.

Alessandro Del Bono , CEO of Istituto Gentili, said: "Gentili is committed to providing innovative, high-quality treatment options for cancer patients. We are honored to partner with CStone Pharmaceuticals to bring sugemalimab, an innovative, clinically validated immunotherapy, to patients in Europe and the UK. Sugemalimab has demonstrated strong competitiveness in the immunotherapy field for Stage IV lung cancer, and with the potential for future expansion into Stage III NSCLC, it will provide an important solution to unmet clinical needs in the region."

Sugemalimab also demonstrates strong synergy with our existing pipeline and strategic focus areas. We look forward to working closely with CStone Pharmaceuticals to accelerate access to innovative therapies by building an efficient commercialization pathway, jointly driving medical advancements and providing better solutions to the growing health needs of patients in the region. This agreement is a significant milestone in our company’s development strategy, marking another key step in expanding our oncology pipeline and deepening our presence in the European market.

About Zegemet ( sugemalimab injection)

Sugemalimab was developed by CStone Pharmaceuticals using the OmniRat transgenic animal platform, a one-stop platform for generating fully human antibodies. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab closely resembles the natural G-type immunoglobulin 4 (IgG4) of the human body, minimizing the potential risk of immunogenicity and related toxicities in patients.

The European Commission (EC) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) have approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC who lack EGFR-sensitizing mutations or genomic tumor alterations in ALK, ROS1, or RET. A new indication application for sugemalimab was submitted to the EMA in March 2025 for the treatment of patients with unresectable Stage III NSCLC who have not progressed after concurrent or sequential chemoradiotherapy (CRT).

Currently, China’s National Medical Products Administration (NMPA) has approved five indications for sugemalimab:

First-line treatment in combination with chemotherapy for metastatic non-squamous NSCLC and metastatic squamous NSCLC without EGFR or ALK gene mutations;
For the treatment of patients with unresectable, stage III NSCLC who have not experienced disease progression after concurrent or sequential chemoradiotherapy;
Treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
Combined with fluorouracil and platinum chemotherapy drugs as the first-line treatment for patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
In combination with fluorouracil-containing and platinum-based chemotherapy, it is used for the first-line treatment of unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma that expresses PD-L1 (combined positive score [CPS] ≥ 5).

BriaCell Phase 2 Survival Achievement: 52% of Patients Surpass One-Year Milestone in Metastatic Breast Cancer

On July 8, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported updated survival data from its ongoing Phase 2 clinical study of Bria-IMT in patients with metastatic breast cancer (MBC) (Press release, BriaCell Therapeutics, JUL 8, 2025, View Source [SID1234654345]).

BriaCell’s most recent Phase 2 study cohort of 25 patients* achieved a 52% one-year survival rate (i.e. 52% of patients remained alive at least one year after starting on the study).
11 of these patients remain alive as of most recent contact, including one patient at 38.3 months and another at 30.3 months (see Table 1).
Survival rate exceeds the survival expectations with the current standard of care therapies in similar patient populations (see Table 2).
Notably, many patients had very advanced metastatic breast cancer, having already failed multiple prior lines of therapy including check point inhibitors (CPIs) and antibody-drug conjugates (ADCs) such as TRODELVY – (sacituzumab govitecan-hziy) and ENHERTU (fam-trastuzumab – deruxtecan-nxki).
No treatment discontinuations attributed to Bria-IMT have been reported.
Table 1: Select Long-Term Responders
Patient Months Survival Age Prior Regimens Cycles of Bria-IMT
01-009 38.3 74 5 13
07-001 30.3 55 7; including ENHERTU 8
11-018 21.6 66 8 28
11-019 20.0 63 9; including TRODELVY 6
16-003 19.4 80 5; including ENHERTU 8
"BriaCell’s Phase 2 data indicate a robust survival signal and a well-tolerated profile," stated Adam M. Brufsky, MD, PhD, FACP, Professor of Medicine at the University of Pittsburgh School of Medicine and Medical Director of the Magee-Women’s Cancer Program. "These results reinforce BriaCell’s potential to improve survival and tolerability for late-stage patients."

"Many patients with metastatic breast cancer unfortunately have disease progression despite treatment with CPIs and ADCs," added Aditya Bardia, MD, MPH, FASCO, a leading breast cancer expert. "BriaCell’s survival data in single arm Phase 2 trial highlights the potential activity of Bria-IMT in combination with CPIs and is subject to ongoing investigation in a Phase 3 randomized clinical trial in MBC."

Table 2: Comparable Analysis of One-Year Survival
Reference Breast Cancer Type Median prior lines of therapy Percent Survival at 1 year
Bria-IMT plus CPI All types:
61% HR+
33% TNBC
6% HER2+ 6 52%*
Cortes et al. 1 All types:
57% HR+
18-19% TNBC
18-20% HER2+ 4 ~38-40%
Kazmi et al. 2 All types:
51-52% HR+
25-29% TNBC
9-24% HER2+ 2 30-38%
Bardia et al.
(TPC arm) 3 TNBC 2-3 ~23%
Rugo et al
(TPC arm) 4 HR+ HER2- 2 47%
* 25 patients treated with the Phase 3 formulation since 2022
Cortes J, et al. Annals of Oncology 2018
Kazmi S, et al. Breast Cancer Res Treat. 2020
Bardia A, et al. J Clin Oncol. 2024
Rugo HS, et al. The Lancet. 2023
Abbreviations:

HR+: hormone receptor-positive
TNBC: Triple-negative breast cancer (lacks or has low levels of the estrogen receptor, progesterone receptor, and human epidermal growth factor 2 (HER2))
HER2+: Human epidermal growth factor receptor 2 positive
HR+ HER2-: hormone receptor-positive and human epidermal growth factor receptor 2 negative
TPC: Treatment of Physicians Choice

BriaCell’s Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (median number of prior treatments = 6) who received the Bria-IMT regimen plus checkpoint inhibitor. Of these 54 patients, 37 were treated with the formulation currently being used in BriaCell’s ongoing pivotal Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612 ). Final median overall survival calculation for the Phase 2 study is pending for some sub populations as many patients remain alive. No Bria-IMT-related discontinuations have been reported to date.

Entry into a Material Definitive Agreement

On July 8, 2025, Personalis, Inc. (the "Company") and Tempus AI, Inc. ("Tempus") reported to have entered into Amendment No. 4 (the "Amendment") to the Commercialization and Reference Laboratory Agreement, dated November 25, 2023, by and between the Company (as amended by Amendment No. 1, dated August 16, 2024, Amendment No. 2, dated September 20, 2024, and Amendment No. 3, dated December 13, 2024, the "Tempus Agreement") pursuant to which the Company authorizes Tempus to market NeXT Personal, the Company’s ultra-sensitive tumor-informed minimal residual disease test, in a fourth indication, colorectal cancer, on the same terms as Tempus’ marketing of the other indications subject to the Tempus Agreement (breast cancer, lung cancer and immuno-oncology monitoring, together with colorectal cancer, the "Indications") and the parties extended the term of the Tempus Agreement through November 25, 2029 (Filing, 8-K, Personalis, JUL 8, 2025, View Source [SID1234654311]).

In addition, the Amendment includes colorectal cancer as an indication subject to exclusivity in the Tempus Agreement and extends the time period during which the Company will not allow any third party (other than an acquiror of the Company or any affiliates of such acquiror) to market the NeXT Personal in any of the Indications and Tempus will not market another tumor-informed molecular residual disease assay indicated for use in such indications (whether its own or that of a third party) to December 31, 2028, in each case subject to certain exceptions and to the extent they do not expire earlier (the "Exclusivity Period").

The Amendment modified the term of certain customary standstill restrictions agreed to by Tempus in the Tempus Agreement such that they will automatically expire on the earlier of (i) June 4, 2027 and (ii) the expiration or termination of the Exclusivity Period.

Cogent Biosciences Announces Pricing of Upsized Public Offering of Shares of Common Stock

On July 8, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the pricing of its previously announced underwritten public offering of 22,222,223 shares of its common stock, offered at a public offering price of $9.00 per share (Press release, Cogent Biosciences, JUL 8, 2025, View Source [SID1234654305]). The aggregate gross proceeds to Cogent from this offering are expected to be approximately $200 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Cogent has granted the underwriters a 30-day option to purchase up to an additional 3,333,333 shares of its common stock on the same terms and conditions. All of the securities in the offering are being sold by Cogent. The offering is expected to close on or about July 10, 2025, subject to the satisfaction of customary closing conditions.

Cogent intends to use the net proceeds from the offering for continued development, regulatory and commercial preparation activities relating to bezuclastinib and other product candidates, activities to support the planned commercial launch of bezuclastinib as well as for working capital and general corporate purposes.

J.P. Morgan, Leerink Partners and Guggenheim Securities are acting as joint book-running managers for the offering. LifeSci Capital is also acting as lead manager for the offering.

The securities described above are being offered pursuant to an automatic shelf registration statement on Form S-3ASR (File No. 333-269707), which was filed with the Securities and Exchange Commission (SEC) on February 10, 2023 and automatically became effective upon filing.

A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering were filed with the SEC on July 8, 2025. A final prospectus supplement and the accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. The offering can be made only by means of a prospectus supplement and accompanying base prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Ave., New York, NY 10017, or by telephone at (212) 518-9544, or by email at [email protected].