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Y-mAbs Provides Regulatory Update on Omburtamab for the Treatment of Patients with Neuroblastoma

On June 23, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that it has recently concluded a Type B meeting with the U.S. Food and Drug Administration ("FDA") regarding omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma (Press release, Y-mAbs Therapeutics, JUN 23, 2021, View Source [SID1234584281]).

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At the Type B meeting with the FDA, available data from external historical control groups and plans for statistical analyses to compare such data with the data from Study 03-133 were discussed. Based on our discussions with the FDA, we believe we now have a clearer path towards the resubmission of the omburtamab BLA to the FDA. Y-mAbs agreed to provide the agency with additional detailed data and the statistical analysis plan ("SAP") and anticipates being able to do so during the third quarter of 2021. Upon receiving the FDA’s feedback on these items, we expect to move forward and request a Type B pre-BLA meeting. Pending a positive Type B pre-BLA meeting, we aim to initiate rolling resubmission of the omburtamab BLA by the end of the year.

"Although we are moving the timeline into the fourth quarter, we believe we now have a clearer path towards the resubmission of the BLA for omburtamab, which, if approved, would address an important unmet medical need," stated Thomas Gad, founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer, continued, "We are very pleased to be aligned with the FDA on the next step towards the resubmission of the omburtamab BLA, and believe that, if approved, omburtamab can be of significant benefit to children with CNS/leptomeningeal metastasis from neuroblastoma."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.

Seven and Eight Biopharmaceuticals Inc. Announces the First Patient Treated in a First-in-Human Clinical Trial of the TLR7/8 dual agonist BDB018 in Advanced Solid Tumors

On June 23, 2021 Seven and Eight Biopharmaceuticals Inc., a clinical stage biotechnology company focused on developing proprietary novel immuno-oncology therapies to activate the immune system against cancer, reported that the first patient was treated in a First-in-Human Phase 1 clinical trial evaluating BDB018 in advanced solid tumors at Florida Cancer Specialists & Research Institute in Sarasota, FL (Press release, Seven and Eight Biopharmaceuticals, JUN 23, 2021, View Source [SID1234584279]).

BDB018 is a next-generation intravenously administered Toll-Like Receptor 7 and 8 (TLR 7/8) dual agonist specifically designed to further enhance immune activation against cancer, while maintaining a favorable safety profile similar to its analogue, BDB001. BDB001 has shown to be well tolerated as monotherapy and in combination with an anti-PD-1 mAb, with responses seen in multiple advanced solid tumor types (SITC, 20201; ASCO (Free ASCO Whitepaper), 20212).

BDB018-101 (NCT04840394) is an open-label, dose escalation Phase I clinical trial evaluating the safety and tolerability of BDB018 in patients with advanced solid tumors that have relapsed or are refractory to standard treatments.

"We are excited to bring our next generation program with an intravenously administered TLR 7/8 dual agonist to the clinic, building on our success with BDB001," said Dr. Robert H.I. Andtbacka, Chief Medical Officer, Seven and Eight Biopharma, "The dosing of the first patient with BDB018 will begin to provide us with essential safety information needed to guide the future development of BDB018."

"Initiation of the BDB018-101 Phase I trial is another important milestone for Seven and Eight Biopharma in our mission to develop novel treatments for cancer and expand immuno-oncology treatments beyond targeting PD-1, PD-L1, and CTLA-4." said Dr. Walter Lau, Chief Executive Officer, Seven and Eight Biopharma.

Servier partners with BioLabs to open an incubator in Paris-Saclay for early stage life science start-ups

On June 23, 2021 Servier, a global independent pharmaceutical Group, and Biolabs Global, ("BioLabs") a developer and operator of premium co-working laboratories in the US and Europe, reported that they have entered into a services agreement to manage Servier’s start-up incubator located in the future Servier R&D Institute in Paris-Saclay due to open in 2023 (Press release, Servier, JUN 23, 2021, View Source [SID1234584278]).

The start-up co-working laboratory created by Servier within its Research and Development Institute in Paris-Saclay aims to be a major player in therapeutic innovation. The unprecedented synergy between the dynamism of young, promising companies in the healthcare sector and Servier’s pharmaceutical expertise offers unique conditions for developing and accelerating drug discovery, both in France and worldwide.

"The start-up incubator encourages a new level of knowledge sharing. Networked innovation without barriers is crucial for serving patients’ unmet needs even more effectively and rapidly. Agile methods to accelerate R&D programs are based on synergies and teamwork," comments Christophe Thurieau, Executive Director of Servier Research.

This incubator inside the Servier Research and Development Institute will offer a unique combination of space and services in France, and represents Servier’s ambition to renew itself and its new approach to R&D. It will allow start-ups to have their independence regarding Servier, while being close-by and benefiting from Servier’s scientific and technological expertise.

A place for innovation
Spanning 1,850 m2, the co-working laboratory has been designed with a capacity for, approximately 20 companies with space for over 100 scientists. The beautifully designed spaces will offer fully equipped and permitted premium shared and private laboratory spaces, conference facilities, central café and adjacent office and hot desks for the start-up companies. Residents will have access to the central Servier support spaces and core facilities and benefit from an easy to use e-procurement solution and integrated biohazard and chemical waste management. Additionally, residents are connected to fellow entrepreneurs from around the globe and to sponsor companies from many industries through the BioLabs network. Participants join this fertile ecosystem on their first day at the lab.

Admission to the Center will be through an application and selection process managed by BioLabs. The application process will be opened in Summer 2022. To promote and facilitate interactions prior to opening, Servier and BioLabs are offering regular webinars, Masterclasses and mentoring programs. The first Masterclass mentoring workshop for start-ups will take place on November 2021 in Boston.

A recognized player with international experience to offer a unique range of services
Servier will partner with BioLabs to operate and manage this tailor-made space. BioLabs is experienced and recognized in health/life sciences at a global level. Both companies are interested and highly motivated to support the acceleration of R&D projects.

"Launching this site in collaboration with Servier is an extraordinary opportunity for us. Servier has been a valuable partner in the US and has shown that they have the vision and enthusiasm to support entrepreneurs at this very early stage. This commitment to health science innovation matches our own mission and values. We look forward to supporting the community alongside Servier with webinars, masterclasses and mentoring prior to the launch and welcoming quality start-ups in 2023," said Johannes Fruehauf, Founder, President & CEO of Biolabs.

BioLabs will oversee the day-to-day management of the site, the provision of supplies, services and equipment, the practical support and events and programming specific to the interests of life science start-ups. They will also establish contacts with industry leaders and the entrepreneurial ecosystem at large, in Saclay and throughout France and beyond.

Paris-Saclay, an unprecedented location to bio-innovate in France
With 15% of national research, 40% of public and private research jobs in Île-de-France with the jewels of French academic and private research, the scientific and technological cluster of Paris-Saclay is among the eight most powerful innovation hubs in the world. This density and variety of resources makes Paris-Saclay unique. It gives Paris-Saclay all the advantages of one of the most attractive innovation clusters for investors, innovators and entrepreneurs from all over the world.

The Paris-Saclay cluster offers a promising array of potential future partners.
"Combining this unique place for health start-ups to grow and learn from experienced professionals with the vibrant ecosystem of Paris Saclay makes a unique opportunity to support therapeutic and technology innovation and improve the life of patients," concludes Olivier Nosjean, Head of Global Open Innovation and Scientific Affairs at Servier.

Entry into a Material Definitive Agreement

On June 16, 2021, Ocuphire Pharma, Inc. ("Ocuphire") reported that entered into a License Agreement (the "License Agreement") with Processa Pharmaceuticals, Inc. ("Processa"), pursuant to which Ocuphire granted Processa an exclusive license to develop, manufacture and commercialize RX-3117 globally, excluding China (Filing, 8-K, Rexahn, JUN 16, 2021, View Source [SID1234584277]).

As consideration for the License Agreement, Ocuphire will receive 44,689 shares of Processa common stock and a $200,000 cash payment. As additional consideration, Processa will pay Ocuphire development and regulatory milestone payments upon the achievement of certain milestones, which primarily consist of dosing a patient in pivotal trials or having a drug indication approved by a regulatory authority in the United States or another country. In addition, Processa must pay Ocuphire one-time sales milestone payments based on the achievement during a calendar year of one or more thresholds for annual sales for products made and pay royalties based on annual licensing sales. Processa is also required to give 32% of any milestone payments received to Ocuphire based on any sub-license agreement it may enter into with respect to the Licensing Agreement.

Processa is required to use commercially reasonable efforts, at its sole cost and expense to oversee such commercialization efforts, to research, develop and commercialize products in one or more countries, including meeting specific diligence milestones that consist of: (i) first patient administered drug in a clinical trial of a licensed product prior to the three (3) year anniversary of the effective date; and (ii) first patient administered drug in a pivotal clinical trial of a licensed product or first patient administered drug in a clinical trial for a second indication of a licensed product prior to the five (5) year anniversary of the effective date. Either party may terminate the agreement in the event of a material breach of the agreement that has not been cured following written notice and a 120-day opportunity to cure such breach, and Processa may terminate the agreement for any reason upon 120 days prior written notice to Ocuphire.

Positive survival data for Novartis investigational radioligand therapy 177Lu-PSMA-617 published in The New England Journal of Medicine

On June 23, 2021 Novartis reported that VISION data published in The New England Journal of Medicine (NEJM) shows that 177Lu-PSMA-617 plus standard of care (SOC) significantly improved both overall survival (HR = 0.62 [95% CI: 0.52−0.74]; P<0.001; median 15.3 vs 11.3 months) and imaging-based progression-free survival (HR = 0.40 [99.2% CI: 0.29−0.57]; P<0.001; median, 8.7 vs 3.4 months) versus SOC alone in patients with progressive PSMA-positive mCRPC1 (Press release, Novartis, JUN 23, 2021, View Source [SID1234584276]). VISION data were first presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 6 (see media release).

"We are proud of these data showing that 177Lu-PSMA-617 can significantly shrink tumors and extend life for patients with prostate cancer, who have been heavily pre-treated and currently have limited treatment options," said Jeff Legos, Global Head of Oncology Development, Novartis. "We believe that radioligand therapy with 177Lu-PSMA-617 has great potential to improve outcomes in advanced prostate cancer and have already started two new Phase III studies in earlier lines of treatment."

Other data highlighted in the publication and ASCO (Free ASCO Whitepaper) presentation:

Median time to first symptomatic skeletal event or death was 11.5 months in the 177Lu-PSMA-617 plus SOC arm versus 6.8 months in the SOC only arm (P<0.001; α=0.05; HR = 0.50 [95% CI: 0.40, 0.62])1
Overall response rate in patients with measurable or non-measurable disease at baseline was 29.8% partial or complete response in the 177Lu-PSMA-617 plus SOC arm compared to 1.7% partial response in the SOC only arm (two-sided p-value: <0.001)1
The incidence of grade ≥3 treatment-emergent adverse effects was 52.7% in the 177Lu-PSMA-617 plus SOC arm vs 38.0% in the SOC only arm1
Serious drug-related treatment emergent adverse events occurred in 9.3% of patients in the 177Lu-PSMA-617 plus SOC arm compared to 2.4% in the SOC only arm2
Two additional studies with 177Lu-PSMA-617 radioligand therapy in earlier lines of treatment for metastatic prostate cancer are ongoing, investigating potential clinical utility in the mCRPC pre-taxane setting (PSMAfore) and in the metastatic hormone-sensitive setting (PSMAddition). Novartis is also evaluating opportunities to investigate 177Lu-PSMA-617 radioligand therapy in earlier stages of prostate cancer.

The NEJM publication is available online at www.NEJM.org

About 177Lu-PSMA-617
177Lu-PSMA-617 is an investigational PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer. It is a type of precision cancer treatment combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle)3-5. After administration into the bloodstream, 177Lu-PSMA-617 binds to prostate cancer cells that express PSMA6, a transmembrane protein, with high tumor-to-normal tissue uptake3,7,8. Once bound, emissions from the radioisotope damage tumor cells, disrupting their ability to replicate and/or triggering cell death9-11. The radiation from the radioisotope works over very short distances to limit damage to surrounding cells1,3,7.

About VISION
VISION is an international, prospective, randomized, open-label, multicenter, phase III study to assess the efficacy and safety of 177Lu-PSMA-617 (7.4 GBq administered by intravenous infusion every 6 weeks for a maximum of 6 cycles) plus investigator-chosen standard of care in the investigational arm, versus standard of care in the control arm1. Patients with PSMA PET-scan positive mCRPC, and progression after prior taxane and androgen receptor pathway inhibitors, were randomized in a 2:1 ratio in favor of the investigational arm1. The alternate primary endpoints were rPFS and OS1. The study enrolled 831 patients1.