On July 17, 2024 Draupnir Bio ("Draupnir"), a biotechnology company harnessing the natural machinery of the lysosome to develop oral, small molecule degraders of extracellular disease-causing proteins, reported equity investments totalling €12 million to support the Company’s ambition to revolutionise the field of targeted protein degradation (TPD).

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TPD is a rapidly emerging field in drug development, exploiting a cell’s own destruction machinery to tackle disease-causing proteins that have historically been highly challenging to target with conventional therapies. Yet first-generation approaches are exclusively limited to cytosolic targets, leaving extracellular and membrane-bound proteins – 40% of the human proteome – untouched.

Draupnir is extending the potential of TPD to target extracellular and membrane-bound proteins in a pioneering approach using its novel and differentiated, proprietary technology platform, utilising lysosome receptors, which holds the potential to revolutionise the field of TPD.

MP Healthcare, the corporate venture group of Mitsubishi Tanabe Pharma Corporation, and the Export and Investment Fund of Denmark (EIFO), a financing fund backed by the Danish government, join Draupnir’s existing investors, Gilde Healthcare Partners, Inkef Capital and Novo Holdings, investing a total of €12 million into the Company.

The proceeds from the financing will be used to further develop Draupnir’s risk-diversified preclinical pipeline of oral, small molecule protein degraders, which have been proven against targets that are validated and those that have been traditionally difficult to drug.

"Draupnir has a bold ambition to pioneer the next frontier of extracellular protein degradation. Our novel technology platform targeting extracellular and membrane-bound disease proteins for degradation holds great promise for targets that have previously been difficult to target with small molecules or have been undruggable, and enables the development of new therapeutic approaches for complex conditions. We are delighted to welcome MP Healthcare and the Export and Investment Fund of Denmark as investors in the Company and thank our existing investors, Gilde Healthcare Partners, Inkef Capital and Novo Holdings, for their continued support. Andrew Hotchkiss, Chief Executive Officer of Draupnir Bio.

(Press release, Draupnir Bio, JUL 17, 2024, View Source [SID1234662184])

On July 17, 2024 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, July 24, 2024 to discuss the company’s second quarter financial results (Press release, Alkermes, JUL 17, 2024, View Source [SID1234644920]).

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. A replay of the webcast will be available approximately two hours after the completion of the event and may be accessed by visiting Alkermes’ website.

On July 17, 2024 Integra Therapeutics, a global leader in creating cutting-edge gene writing tools to make advanced therapies safer and more effective, reported the company will receive a grant of €2.5 million and equity investment of up to €8 million from the European Commission via the European Innovation Council (EIC) Accelerator program (Press release, Integra Therapeutics, JUL 17, 2024, View Source [SID1234654538]).

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Of a total of 969 deeptech companies, the EC chose only 68 to benefit from the funds in a highly competitive process. The EIC Accelerator is currently the only program that combines grants and equity for emerging European deeptech companies.

Integra Therapeutics will earmark the initial €2.5 million to pre-marketing activities of its FiCAT platform for T cell and hematopoietic stem cell (HSC) engineering to develop cell therapies in rare diseases, autoimmune diseases, and oncology.

In parallel, the compant will generate FiCAT proof of concept data on its first gene therapy, using systemic administration with non-viral vectors through lipid nanoparticles (LNP) to treat a serious pediatric hepatic disease.

The European Commission plans to join Integra Therapeutics’s capital in 2025, which is when Series A is anticipated to close, and it may include up to €8 million to advance the clinical development of the first gene therapy product mentioned above.

"The funding from the EIC Accelerator is a huge impetus for Integra Therapeutics and our FiCAT gene writing platform because it will lead to the development of the first therapeutic product in the preclinical and clinical regulatory phases for a disease with a huge medical need in children that is currently unmet," said Dr. Avencia Sánchez-Mejías, CEO and co-founder of Integra Therapeutics.

"I am pleased to see that 21% of the companies chosen are led by women, which is an improvement over the previous call, although there is still room for improvement in the gender gap in leadership positions in our sector," she added.

Integra Therapeutics will also promote the expansion of the FiCAT platform to extra-hepatic indications. In this sense, the company is planning to award licenses and co-develop new therapies with the goal of allowing the maximum number patients to benefit from this state-of-the-art technology.

Integra Therapeutics was founded in 2020 by Dr. Marc Güell and Dr. Avencia Sánchez-Mejías as a spin-off of the Pompeu Fabra University (UPF). It is headquartered in Barcelona. It has secured the backing of international investors (AdBio Partners, Columbus Venture Partners, Invivo Capital, and Takeda Ventures) and organizations in the health and biomedical sector. It earned My Green Lab sustainability certification in 2023.

On July 17, 2024 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for tabelecleucel (tab-cel) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy (Press release, Atara Biotherapeutics, JUL 17, 2024, View Source [SID1234644921]). For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. There are no FDA approved therapies in this treatment setting.

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The BLA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of January 15, 2025.

"The acceptance of the tab-cel BLA is a significant milestone towards making this first-of-its-kind treatment available to patients in the U.S.," said Pascal Touchon, President and Chief Executive Officer of Atara. "The FDA’s granting of priority review highlights the high unmet need in EBV+ PTLD, which is a devastating disease with limited treatment options and a poor overall survival rate. We continue to work closely with the Pierre Fabre Laboratories team to help prepare for the potential launch in the U.S. in early 2025, along with the potential label expansion multicohort Phase 2 EBVision trial."

Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The BLA is supported by pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple life-threatening diseases including the latest pivotal ALLELE study data that demonstrated a statistically significant 48.8% Objective Response Rate (ORR) (p<0.0001) and favorable safety profile consistent with previous analyses.

Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation.

In December 2023, Atara announced the closing of the expanded global partnership with Pierre Fabre Laboratories for the U.S. and remaining global commercial markets for tab-cel, building on an initial partnership covering Europe, Middle East, Africa, and other select emerging markets. With the acceptance of the tab-cel BLA, Atara will receive a $20 million milestone payment from Pierre Fabre, with the potential to receive a $60 million milestone payment from Pierre Fabre contingent upon FDA approval of the tab-cel BLA. In addition, Pierre Fabre is reimbursing Atara for expected tab-cel global development costs through the BLA transfer and purchasing tab-cel inventory through the manufacturing transfer date. Atara is also eligible to receive sales milestones and double-digit tiered royalties on net sales of tab-cel in the U.S. and remaining global commercial markets referenced above.

Tab-cel was granted marketing authorization under the brand name Ebvallo in December 2022 by the European Commission. Marketing authorization was also granted by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in May 2023 and by Swissmedic in Switzerland in May 2024. In all three territories, Ebvallo is indicated as monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory EBV+ PTLD who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. Ebvallo was awarded the 2024 Prix Galien International Award for "Best Product for Orphan/Rare Diseases."

On July 17, 2024 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 2,878 million in the second quarter of 2024 (Press release, Genmab, JUL 17, 2024, View Source [SID1234644929]). Net trade sales were USD 1,641 million in the U.S. and USD 1,237 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to Janssen to develop, manufacture and commercialize daratumumab.

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