Sanofi and Orano join forces to develop next-generation radioligand medicines

On October 17, 2024 Sanofi and Orano Med, a subsidiary of the Orano Group and a pioneer in the development of targeted alphatherapies in oncology, reported to have entered into an agreement to combine their expertise in the fight against rare cancers and further accelerate the development of next-generation radioligand medicines (Press release, Sanofi, OCT 17, 2024, View Source [SID1234647289]).

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Building on the expertise and radioligand pipeline of Orano Med, Sanofi and Orano will invest in a new entity, operating under the Orano Med brand, and focusing on the discovery, design, and clinical development of next-generation radioligand therapies (RLTs) based on lead-212 (212Pb) alpha-emitting isotopes. This agreement follows Sanofi’s announcement of an exclusive licensing agreement with Orano Med and RadioMedix to advance radioligand therapies (RLTs) in rare cancers with a focus on one late-stage project, AlphaMedix.

Targeted alpha therapy relies on a simple concept: combining the ability of biological vectors to target cancer cells with the short-range and highly energetic cell-killing capabilities of alpha-emitting radioisotopes. The vector directs the radioisotope to the target cancer cells expressing the specific marker, even when they have spread throughout the body. This unique mechanism of action aims to damage or destroy target cancer cells, while limiting impact on nearby healthy cells. This novel precision medicine approach aims at changing the standard of care in some rare cancers to extend patients’ lives and improve their quality of life.

Paul Hudson

CEO, Sanofi

"We are excited to partner with Orano in establishing a French pioneer that unites our respective expertise in biopharma and nuclear technology to drive groundbreaking progress in the fight against cancer. As a French biopharmaceutical company, we are deeply committed to fostering and enabling innovation in our home country. This collaboration is part of a broader effort to strengthen our ties within the scientific community, both in France and globally, with the goal of advancing the development of cutting-edge treatments for patients."

Nicolas Maes

CEO, Orano Group

"The success of Orano Med is an example of our group’s ability to diversify beyond our core nuclear business. By applying our expertise in nuclear materials to fields like targeted alpha therapies, we are demonstrating that nuclear technology can have a positive societal impact, not just for energy and climate, but also for human health. This innovation reflects Orano’s commitment to exploring new opportunities and taking bold steps to address some of the world’s most pressing challenges."

Sanofi’s investment will further strengthen Orano Med and allow the company to accelerate the development of its pipeline, leveraging its unique capabilities in the discovery and development of lead-212 based therapies. Orano Med has also developed a highly differentiating global industrial platform, which, thanks to its vast stock of raw materials and patented manufacturing process, will ensure an independent, reliable, and scalable supply of lead-212 based therapies to patients worldwide.

In striving to become a leading immunoscience company globally, Sanofi remains committed to advancing oncology innovation. The pipeline is being reshaped and prioritized, leveraging expertise in immunoscience to drive progress. Efforts are centered on difficult-to-treat cancers such as select hematologic malignancies and solid tumors with critical unmet needs, including rare cancers such as multiple myeloma, acute myeloid leukemia, and certain types of lymphomas, as well as gastrointestinal and lung cancers.

Sanofi and Orano Med are members of the Paris Saclay Cancer Cluster and look forward to contributing to the ambitious agenda of the France 2030 plan to accelerate innovation in oncology.

This agreement is subject to standard regulatory approvals required for transactions of this nature.

Financial considerations

Under the terms of the agreement, Sanofi will make an equity investment of €300 million, approximately 16% equity stake in the new entity valued at €1.9bn.

Zai Lab to Host Webcast Presentation to Discuss Data from Early Clinical Program Evaluating Its Investigational DLL3-Targeted Antibody-Drug Conjugate (ADC) ZL-1310

On October 17, 2024 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that it will hold an investor webcast to discuss data from a Phase 1 clinical trial of ZL-1310, the Company’s investigational DLL3-targeted antibody-drug conjugate (ADC), in patients with advanced stage small cell lung cancer (SCLC) (Press release, Zai Laboratory, OCT 17, 2024, View Source [SID1234647260]). The live conference call and webcast will take place on Thursday, October 24, 2024, at 8:30 a.m. ET (8:30 p.m. HKT).

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Conference Call and Webcast Information

Listeners may access the live webcast by visiting the Company’s website at View Source Participants must register in advance of the conference call.

Details are as follows:

Registration Link: https://register.vevent.com/register/BI6f8ba8dc42d04cd3afd7095cf7c83d40

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

OS Therapies to Participate in a Fireside Chat at the 2024 Maxim Healthcare Virtual Summit

On October 17, 2024 OS Therapies (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, reported that Paul Romness, Chief Executive Officer, will be presenting at the 2024 Maxim Healthcare Virtual Summit (Press release, OS Therapies, OCT 17, 2024, View Source [SID1234647259]). The summit is being held virtually on October 15 – 17, 2024.

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Event:

Fireside Chat at 2024 Maxim Healthcare Virtual Summit

Date:

Thursday, October 17, 2024

Time:

3:00 PM ET

Webcast:

https://m-vest.com/events/healthcare-10152024

Hansa Biopharma Reports Third Quarter and Interim January – September 2024 Financial Results

On October 17, 2024 Hansa Biopharma Reports Third Quarter and Interim January – September 2024 Financial Results (Press release, Hansa Biopharma, OCT 17, 2024, View Source;september-2024-financial-results-302278809.html [SID1234647258]).

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Søren Tulstrup, President and CEO, Hansa Biopharma said, "The third quarter of 2024 marks the highest ever IDEFIRIX sales performance to date, resulting in four consecutive quarters of strong sales performance. The launch of IDEFIRIX in Europe continues to advance with adoption in international organ allocation systems and an increase in new and repeat utilization in leading transplant clinics. Equally, we see strong momentum in our clinical development programs in autoimmune, gene therapy and transplantation. Enrollment in the Phase 3 GOOD-IDES-02 study in anti-GBM has reached 86%. In the Post Authorization Efficacy and Safety (PAES) study in kidney transplant enrolment has reached 78%. Finally, just after quarter end, we communicated positive results from the 12-month analysis of NICE-01, demonstrating that HNSA-5487 can robustly and very rapidly reduce IgG levels, has clear redosing potential, and a favorable safety and tolerability profile. Initial clinical development will focus on neuromyelitis optica (NMO), myelin oligodendrocyte glycoprotein antibody disease (MOGAD), and myasthenia gravis (MG)."

Financial Performance

The Company recorded total revenue of 78.4 MSEK. Of this, 69.5 MSEK is attributed to IDEFIRIX sales, marking the highest ever quarterly in-market sales. This excludes the impact of a 29.7 MSEK provision related to potential price adjustments from cumulative sales since the launch of IDEFIRIX in Europe in 2020. Of the total provision only 4.9 MSEK was related to Q3 sales. Net of the provision, Q3 2024 IDEFIRIX sales were 39.8 MSEK and total year to date IDEFIRIX sales were 114.5 MSEK. Previously, the Company recorded a provision of 19.9 MSEK in Q2 2024. Of this, 2.0 MSEK was related to sales in Q2 2024. Of the total provision taken in Q2 and Q3 2024, 42.7 MSEK relates to previous periods since launch in 2020.

Pipeline Progress

Progress across the pipeline included the strong momentum in enrollment in the Phase 3 GOOD-IDES-02 study in anti-GBM (86%), and in the Post Authorization Efficacy and Safety (PAES) study in kidney transplantation (78%). Further efficacy data from the 15-HMedIdes-09 Phase 2 trial in Guillain-Barré Syndrome (GBS) is scheduled to read out by the end of 2024. The ConfIdeS trial continues to progress following completed randomization in May and data from the study is expected to provide the basis for a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) in the second half of 2025. On 7 October 2024, Hansa announced positive results from a 12-month follow up analysis from the NICE-01 trial of HNSA-5487, assessing IgG recovery, immunogenicity and redosing potential.

Financial Summary

MSEK, unless otherwise stated – unaudited

Q3 2024

Q3 2023

9M 2024

9M 2023

Total Revenue

78.4

22.8

188.6

83.7

Provision1

(29.7)

(49.6)

Net revenue after provision

48.7

22.8

139.0

83.7

SG&A expenses

(75.8)

(111.7)

(255.3)

(344.5)

R&D expenses

(79.6)

(95.6)

(274.3)

(303.1)

Loss from operations

(116.9)

(202.2)

(463.7)

(613.0)

Loss for the period

(103.8)

(250.7)

(530.3)

(707.3)

Net cash used in operations

(148.8)

(193.8)

(527.1)

(582.7)

Cash and short-term investments

553.5

908.2

553.5

908.2

EPS before and after dilution (SEK)

(1.53)

(4.78)

(8.67)

(13.49)

Number of outstanding shares

67,814,241

52,671,796

67,814,241

52,671,796

Weighted average number of shares before and after dilution

67,814,241

52,597,502

61,162,934

52,495,705

No of employees at the end of the period

135

168

135

168

1 Product sales in the third quarter 2024 totaled 69.5 MSEK. Sales were offset by a provision totaling 29.7 MSEK for potential credits associated with volume discounts and rebates. Year to date 2024 IDEFIRIX product sales totaled 164.1 MSEK and were offset by a provision totaling 49.6 MSEK. Net of the provision, year-to-date 2024 product sales totaled 114.5 MSEK.

Conference Call Details

Hansa Biopharma will host a telephone conference today Thursday, October 17, 2024, at 14:00 CET / 8:00 am ET.

The event will be hosted by Søren Tulstrup, President and CEO, Evan Ballantyne, CFO, and Hitto Kaufmann, CR&DO. The call will include a review of the interim results and a business and pipeline update. It will be held in English.

Slides used in the presentation will be live on the company website during the call under Events & Presentations and will also be made available online after the call.

To participate in the telephone conference, please use the dial-in details provided below:

Participant Dial In (Toll Free): 1-877-270-2148
Participant International Dial In: 1-412-902-6510
*Please ask to be joined into the Hansa Biopharma call

UMCG and SHINE Europe Receive €10.5 Million Grant to Advance European Terbium Isotope Production for Cancer Theranostics

On October 17, 2024 University Medical Center Groningen (UMCG) and SHINE Europe reported a €10.5 million grant from the Dutch government to advance the Terbium for Life project, an initiative aimed at bolstering Europe’s cancer treatment capabilities and enhancing supply chain security within the European Medical Isotope market (Press release, SHINE Technologies, OCT 17, 2024, View Source [SID1234647257]). The initiative will establish a European supply chain for terbium isotopes, reducing reliance on foreign sources and securing a stable supply of critical isotopes for cancer theranostics – a field that combines diagnosis and therapy in one targeted approach.

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Early-onset cancers – cancer cases diagnosed in people under 50 – have increased globally by a staggering 79%. As a result, increasing access to treatment has become critical as cancer cases continue to rise. The Terbium for Life project will serve cancer patients by enabling access to innovative treatment options. Terbium-161 (Tb-161), a primary isotope in the project, has been shown to have the potential to extend lifetimes, improve quality of life, and result in fewer side effects. Additional terbium isotopes, such as Tb-155, Tb-152, and Tb-149, also hold potential for diagnostic and therapy applications. Establishing a reliable and high-quality supply chain for terbium isotopes, independent of foreign sources, is now more important than ever.

The Terbium for Life project is made possible through the partnership between UMCG and SHINE Europe. The project will play a critical role in advancing Europe’s cancer-fighting efforts by promoting research into terbium isotopes with both therapeutic and diagnostic applications. This effort supports Europe’s broader cancer-fighting initiatives and aligns with the Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA), which plays a crucial role in guiding the development and implementation of radiological and nuclear technology in Europe.

"This exciting collaboration between UMCG, Department of Nuclear Medicine and Molecular Imaging, PARTREC, and SHINE brings together unique expertise in nuclear medicine, molecular imaging, and radiotheranostics. Our goal is to develop innovative treatments that offer new hope for cancer patients," said Dr. Philip H. Elsinga, professor of PET Radiochemistry at UMCG.

"We thank the Dutch government and the European Commission for their support in our terbium efforts," said Harrie Buurlage, VP of Strategic Alliances at SHINE Europe. "This grant will go a long way in supporting our work, alongside UMCG, to provide European patients with easier access to promising new therapies that can support their ongoing fight against cancer."

A project proposal for Terbium for Life was submitted to and approved by the Dutch government, and subsequently awarded to the UMCG-SHINE joint Terbium for Life project. SHINE Europe maintains a strategic partnership with UMCG, focused on advancing research and development in medical isotopes. This partnership is at the heart of the project, leveraging UMCG’s extensive research expertise and state-of-the-art facilities to drive progress in cancer research and treatment in the region.