On January 25, 2022 OSE Immunotherapeutics reported that the Japanese Patent Office has issued the notice of allowance for a new patent covering Tedopi, a combination of neoepitopes, for use after failure with PD-1 or PD-L1 immune checkpoint inhibitor treatment in HLA-A2 positive cancer patients (Press release, OSE Immunotherapeutics, JAN 25, 2022, View Source [SID1234646967]). This patent, which will further strengthen Tedopi’s global intellectual property portfolio in immuno-oncology, will provide the product with a new protection until 2037.

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This new patent recognises the innovation of a multiepitope composition (all peptides included in Tedopi) administered after immune checkpoint inhibitor (progression of the cancer), in particular in secondary resistance situation.

Dominique Costantini, Chief Executive Officer of OSE Immunotherapeutics, comments:
"This first notice of allowance for a Japanese patent for Tedopi after failure with immune checkpoint inhibitors, issued in a significant territory, is of major interest and is the first step to the corresponding patent family that has been filed internationally in many other territories.

In addition, it further supports the product’s clinical development focus and the positive results of the Atalante 1 Phase 3 trial of Tedopi in patients with advanced non-small cell lung cancer (NSCLC) with secondary resistance to PD-1/PD-L1 immune checkpoint inhibitor, a hard-to-treat patient population with high unmet medical need. Based on the finalized positive results of Atalante 1, we are preparing discussions with regulatory agencies on optimal paths for potential approval of Tedopi in patients with NSCLC in secondary resistance after immune checkpoint inhibitor treatment."

The Atalante 1 clinical trial evaluated the benefit of Tedopi in an HLA-A2 positive patient population with NSCLC at invasive stage IIIB or metastatic stage IV, in 2nd or 3rd line treatment following checkpoint inhibitor failure. The Tedopi treatment was compared to docetaxel or pemetrexed chemotherapy (CT) treatments in this patient population, with overall survival as the primary endpoint of the trial.

Tedopi demonstrated a favourable benefit/risk ratio versus standard of care (SoC) docetaxel or pemetrexed in advanced HLA-A2 positive NSCLC patients with secondary resistance to PD-1 or PD-L1 immune checkpoint inhibitors.

ABOUT LUNG CANCER
Lung cancer is the leading cause of cancer death (18.0% of the total cancer deaths) with an estimated 2.2 million
new cancer cases per year and with 1.8 million deaths (1). About 85% of lung cancers are Non-Small Cell Lung
Cancers (NSCLC) and for metastatic NSCLC, the 5-year survival rate is 7% (2)
.
Treatment regimens including immune checkpoint inhibitors (ICIs) have become the new standard of care for
the majority of patients with NSCLC. However, with the increasing use of ICIs in clinical practice, disease
progression can be observed in several patients. This therapeutic escape is described as a secondary resistance
(3)when it occurs after initial clinical benefit under ICI treatment. Over half of the patients will eventually develop
secondary resistance to ICIs.

On January 25, 2022 AmerisourceBergen, a global healthcare solutions leader, and TrakCel, the leading innovator of cellular orchestration solutions, reported an integrated technology platform designed to accelerate patient access to prescribed cell and gene therapies and deliver complete visibility throughout the treatment journey (Press release, TrakCel, JAN 25, 2022, View Source [SID1234607618]). The enhanced offering combines two platforms—OCELLOS, TrakCel’s advanced therapy orchestration platform, and Fusion, a customer relationship management and patient support ecosystem powered by AmerisourceBergen’s Lash Group, a market leader in patient support services.

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The platform increases connectivity between hub patient services and providers, resulting in a seamless and timely exchange of benefits and eligibility information which expedites patient enrollment and support, ultimately helping patients start on therapies sooner. The new offering adds to AmerisourceBergen’s robust portfolio of services and solutions that support the needs of cell and gene therapy innovators, providers and patients throughout the product and treatment journey—from pre-clinical and commercial logistics to market access and reimbursement consulting and patient support services.

"The fast-growing pipeline of cell and gene therapies represents immense hope for patients around the world, but their unique nature can pose challenges throughout the patient journey, such as eligibility and coverage barriers that can delay access to the treatment," said Willis Chandler, president of Manufacturer Services and Commercial Solutions at AmerisourceBergen. "By combining the capabilities of Fusion and OCELLOS, we’re streamlining the path to care, improving speed-to-therapy and creating a heightened level of connectivity across the supply chain. This represents an important step in AmerisourceBergen’s ongoing commitment to build an end-to-end service offering that supports innovators in enhancing patient access to these critical therapies."

TrakCel’s OCELLOS streamlines the orchestration of clinical and commercial stage therapies, from subject enrollment to treatment and administration, ensuring chain of custody and chain of identity are managed at each step of the patient journey. Fusion leverages emerging technologies, such as artificial intelligence and machine learning, for benefit verification, prior authorization, and multi-channel communication between payers, providers, and patients.

Through this integrated platform, the bi-directional flow of data starts when a provider creates a patient account and captures enrollment information within OCELLOS. The data is then securely delivered to the patient hub, where Fusion’s advanced technology begins to determine patients’ eligibility through benefits verification. If needed, a Lash Group coordinator will initiate benefits investigation and prior authorization. Providers receive a near real-time response of the patient’s coverage determination in OCELLOS and can take the next steps to move the prescribed treatment process forward.

"Ensuring that medicines are delivered efficiently and safely to patients is of utmost priority and progressing treatment pathways smoothly and quickly is critical both to successful treatment and to a good patient experience," said Ravi Nalliah, Chief Product and Strategy Officer for TrakCel. "These goals can only be achieved if data is shared securely, accurately and in real-time."

The integrated platform serves as the latest collaboration between AmerisourceBergen and TrakCel to support advanced therapy developers. AmerisourceBergen’s global specialty logistics provider, World Courier, collaborates with multiple orchestration platform providers, including TrakCel, to deliver systems that enable stakeholders to maintain chain of custody, chain of identity and traceability throughout shipments.

For more information on the integrated platform and AmerisourceBergen’s solutions to support cell and gene therapy manufacturers, visit View Source

On January 25, 2022 Cytovation AS, a clinical stage immune-oncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy, reported the successful closing of its Series A financing round, raising a total of NOK 180 million ($20 million) (Press release, Cytovation, JAN 25, 2022, View Source;utm_medium=rss&utm_campaign=cytovation-raises-20-million-in-series-a-financing-round-to-advance-clinical-development-of-cypep-1-a-first-in-class-targeted-tumor-membrane-immunotherapy [SID1234607559]).

Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: "We are extremely pleased with the strong support we have received during this latest investment round. We continue to make excellent progress with CyPep-1 in our Phase I/II CICILIA clinical trial and following promising data from the first monotherapy part of the study, we have begun patient dosing of CyPep-1 in combination with Keytruda in patients with a range of solid tumors. These new proceeds will enable us to further advance and expand our clinical development plans in cancer, and we look forward to reporting further data from this clinical program in 2022. Additionally, we will now have the financial flexibility to investigate opportunities to expand our CyPep-1 development pipeline."

The Series A round was led by Sandwater, a Norwegian venture capital firm that invests in groundbreaking companies across a range of industries including life sciences, and Canica, a large, privately owned investment company operating out of Norway and Switzerland focused on building highly innovative companies that aim to create value for investors and society as a whole.

The new funds will primarily be directed towards clinical development of Cytovation’s lead asset CyPep-1, a proprietary first-in-class targeted tumor membrane immunotherapy engineered to selectively target cancer cells. CyPep-1 eliminates cancer cells by forming pores in the plasma membrane, releasing cancer specific antigens to the immune system, promoting an inflammatory microenvironment and inducing a tumor-specific immune response by in situ vaccination. Preclinical data suggest this mode of action is highly synergistic in combination with checkpoint inhibitors.

Proceeds will be used to:
Progress the CyPep-1 oncology program to Phase II, including expansion of single-agent arms, as well as three combination arms with KEYTRUDA (pembrolizumab) in head and neck squamous cell carcinoma (HNSCC), triple negative breast cancer (TNBC), and melanoma, in collaboration with MSD
Explore opportunities for pipeline development with CyPep-1 targeting patients with high unmet medical need

Morten E. Iversen of Sandwater commented: "We are very pleased to be supporting Cytovation, a company that reflects our investment ethos of investing in innovative companies that we believe can make a real impact across society. We believe CyPep-1 has a very promising future, backed by an excellent and highly experienced management team."

Christer Kjos of Canica added: "Cytovation shares our entrepreneurial approach and willingness to take on new challenges with commitment and passion. We believe the company has reached an exciting point in its development and look forward to the time when this potential new treatment can bring benefit to a wide variety of cancer patients."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

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On January 25, 2022 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported a leadership transition plan (Press release, CytoDyn, JAN 25, 2022, View Source [SID1234607497]). Effective immediately, Antonio Migliarese, currently CytoDyn’s Chief Financial Officer, has been appointed interim President. The Board of Directors terminated the employment of Nader Z. Pourhassan, Ph.D., as President and CEO of the Company and he is no longer a member of the Board of Directors, effective January 24, 2022. The rest of CytoDyn’s executive team is continuing with the Company and is united in their commitment to advance the Company’s objectives.

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A committee of three Board members has been appointed to initiate the search for a new permanent CEO, with a focus on identifying a candidate possessing the requisite pharmaceutical industry experience to enhance the Company’s efforts to achieve regulatory approval and commercialization of leronlimab. Mr. Migliarese will also continue in his role as CFO of the Company during this interim period.

Scott A. Kelly, M.D, Chairman of the Board and Chief Medical Officer of CytoDyn, stated, "Now is the right time for the next phase of CytoDyn’s evolution, as we focus on continuing the clinical progress of leronlimab and ultimately securing regulatory approval and commercialization. Our Board is fully focused on identifying the best possible candidate to lead the Company forward, and we are focusing our search on finding an individual with the appropriate experience and skillsets to maximize the potential of leronlimab for patients, partners, and shareholders. In addition, in an effort to enhance the Board’s independence, I have elected to step down as Chairman of the Board but will remain on the Board of Directors. The Board has elected Tanya Durkee Urbach, an independent director who has experience in corporate governance, corporate finance, business growth and securities litigation, compliance and regulatory issues, as Chairman of the Board. We thank Dr. Pourhassan for his vision and passion for developing leronlimab into a platform molecule with the potential for multiple therapeutic indications."

CytoDyn will keep shareholders and stakeholders informed on the Company’s progress in implementing its leadership transition plan as and when appropriate.

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