Cothera Bioscience Acquires Zotiraciclib from Adastra Pharmaceuticals

On October 6, 2021 Cothera Bioscience Inc. and Adastra Pharmaceuticals Inc., private biopharmaceutical companies focused on the development of first-in-class therapeutics for the treatment of cancer, reported a definitive agreement under which Cothera has acquired zotiraciclib (ZTR), an oral kinase inhibitor that readily crosses the blood brain barrier and possesses a unique mechanism of action of Myc depletion via the inhibition of cyclin-dependent kinase 9 (CDK9) (Press release, Cothera Bioscience, OCT 6, 2021, View Source [SID1234627381]). Financial terms of the asset purchase were not disclosed.

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In June 2021, the results of the zotiraciclib Phase 1b clinical trial were published in Clinical Cancer Research. The conclusion of the Phase 1b trial found that Zotiraciclib combined with temozolomide (TMZ) is safe in patients with recurrent high-grade astrocytomas.

After the conclusion of the trial a successful Type B meeting with the U.S. Food and Drug Administration Division of Oncology (D02) was held. The transition of ZTR from Adastra to Cothera enables the execution of clinical development plans built on input from the FDA meeting, as well as insight from global neuro-oncology thought-leaders and clinical investigators.

"The acquisition of zotiraciclib fits nicely into the Cothera portfolio of differentiated drug candidates synergistically aligning to our current research efforts to address cancers driven by the Myc oncogene," said Alex Wu, Ph.D., President and Chief Executive Officer and Founder of Cothera. "Importantly, zotiraciclib adds to the Cothera portfolio of therapeutics that hold promise for cancer patients around the world."

Scott Megaffin, Chief Executive Officer of Adastra, said, "I want to thank all the physicians and dedicated healthcare providers who have put forward relentless effort on behalf of their patients as the Adastra team transitions zotiraciclib into Cothera."

Vernon Jiang, Ph.D., Executive Vice President and Co-Founder of Cothera, added, "We are grateful to Adastra for its important work with physicians within neuro-oncology. Cothera is enthusiastic to build upon these relationships, as we believe highly in the promise of zotiraciclib in high-grade gliomas and pediatric mid-line gliomas such as Diffuse Intrinsic Pointe Glioma (DIPG).

NANOBIOTIX to Present First Survival Data From Priority Head and Neck Cancer Program Among Five Presentations at the 2021 Annual Meeting of the American Society for Radiation Oncology

On October 6, 2021 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported two oral presentations and three poster presentations at the 2021 Annual Meeting of the American Society for Radiation Oncology (ASTRO) (Press release, Nanobiotix, OCT 6, 2021, View Source [SID1234590864]). The meeting will be held from October 24-27, 2021.

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"Bringing disruptive therapeutic solutions that expand treatment possibilities for patients with cancer starts with making a meaningful impact on survival," said Laurent Levy, co-founder and chairman of the executive board of Nanobiotix. "Delivering the first look at these exploratory endpoints in our phase I head and neck cancer study will provide useful insight into the potential of our innovation in our priority indication as we prepare to launch our global phase III. While we continue to develop NBTXR3 as a broadly applicable potential therapy across solid tumor types and therapeutic combinations in parallel, we also look forward to presenting updates in immunotherapy and soft tissue sarcoma as well."

Oral and Poster Presentation Details:

Local Control with NBTXR3 as a Single-Agent for Patients with Head and Neck Cancer

Poster presentation #2805: Phase I Study of Novel Radioenhancer NBTXR3 Activated by Radiotherapy in Cisplatin-Ineligible Locally Advanced HNSCC Patients by Christophe Le Tourneau, MD, PhD, on October 26 at 1:15 PM CDT / 8:15 PM CET
NBTXR3 Tumor-Agnostic, Therapeutic Combination-Agnostic Development Potential

Oral presentation #132: Overcoming Resistance to Anti-PD-1 With Tumor Agnostic NBTXR3: From Bench to Bedside by Tanguy Y. Seiwert, MD, on October 26 at 4:20 PM CDT / 11:20 PM CET
Priming Immune Response with NBTXR3 plus Anti-PD-1 in Advanced Cancers

Poster presentation #2739: NBTXR3 Activated by Radiotherapy in Combination with Nivolumab or Pembrolizumab in Patients with Advanced Cancers: A Phase I Trial by Colette Shen, MD, PhD, on October 25 at 4:00 PM CDT / 11:00 PM CET
Local Control with NBTXR3 as a Single-Agent for Patients with Soft Tissue Sarcoma

Oral presentation #77: Study of Novel Radioenhancer NBTXR3 Plus Radiotherapy in Patients with Locally Advanced Soft Tissue Sarcoma: Results of the Long-Term Evaluation in the Phase II/III Act.In.Sarc Trial by Sylvie Bonvalot, MD, PhD, on October 26 at 5:15 PM CDT / 12:15 AM CET
Preclinical Data on NBTXR3 plus Anti-PD-1 in Lung Cancer Model

Poster presentation #2865: NBTXR3 Nanoparticle with ImmunoRadiation Might Reshape Metastatic Tumor-Infiltrating T Cell Repertoire in Murine Lung Cancer Model by Chike O. Abana, MD, PhD, on October 26 3:30 PM CDT / 10:30 PM CET
About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy; and a phase III global registrational study is planned to launch in 2021. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the planned phase III study.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company sponsored phase I clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3 , Nanobiotix has engaged in a strategic collaboration strategy with world class partners to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

NANOBIOTIX to Present First Survival Data From Priority Head and Neck Cancer Program Among Five Presentations at the 2021 Annual Meeting of the American Society for Radiation Oncology

On October 6, 2021 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported two oral presentations and three poster presentations at the 2021 Annual Meeting of the American Society for Radiation Oncology (ASTRO). The meeting will be held from October 24-27, 2021 (Press release, Nanobiotix, OCT 6, 2021, View Source [SID1234590881]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Bringing disruptive therapeutic solutions that expand treatment possibilities for patients with cancer starts with making a meaningful impact on survival," said Laurent Levy, co-founder and chairman of the executive board of Nanobiotix. "Delivering the first look at these exploratory endpoints in our phase I head and neck cancer study will provide useful insight into the potential of our innovation in our priority indication as we prepare to launch our global phase III. While we continue to develop NBTXR3 as a broadly applicable potential therapy across solid tumor types and therapeutic combinations in parallel, we also look forward to presenting updates in immunotherapy and soft tissue sarcoma as well."

Oral and Poster Presentation Details:

Local Control with NBTXR3 as a Single-Agent for Patients with Head and Neck Cancer

Poster presentation #2805: Phase I Study of Novel Radioenhancer NBTXR3 Activated by Radiotherapy in Cisplatin-Ineligible Locally Advanced HNSCC Patients by Christophe Le Tourneau, MD, PhD, on October 26 at 1:15 PM CDT / 8:15 PM CET
NBTXR3 Tumor-Agnostic, Therapeutic Combination-Agnostic Development Potential

Oral presentation #132: Overcoming Resistance to Anti-PD-1 With Tumor Agnostic NBTXR3: From Bench to Bedside by Tanguy Y. Seiwert, MD, on October 26 at 4:20 PM CDT / 11:20 PM CET
Priming Immune Response with NBTXR3 plus Anti-PD-1 in Advanced Cancers

Poster presentation #2739: NBTXR3 Activated by Radiotherapy in Combination with Nivolumab or Pembrolizumab in Patients with Advanced Cancers: A Phase I Trial by Colette Shen, MD, PhD, on October 25 at 4:00 PM CDT / 11:00 PM CET
Local Control with NBTXR3 as a Single-Agent for Patients with Soft Tissue Sarcoma

Oral presentation #77: Study of Novel Radioenhancer NBTXR3 Plus Radiotherapy in Patients with Locally Advanced Soft Tissue Sarcoma: Results of the Long-Term Evaluation in the Phase II/III Act.In.Sarc Trial by Sylvie Bonvalot, MD, PhD, on October 26 at 5:15 PM CDT / 12:15 AM CET
Preclinical Data on NBTXR3 plus Anti-PD-1 in Lung Cancer Model

Poster presentation #2865: NBTXR3 Nanoparticle with ImmunoRadiation Might Reshape Metastatic Tumor-Infiltrating T Cell Repertoire in Murine Lung Cancer Model by Chike O. Abana, MD, PhD, on October 26 3:30 PM CDT / 10:30 PM CET
About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy; and a phase III global registrational study is planned to launch in 2021. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the planned phase III study.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company sponsored phase I clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3 , Nanobiotix has engaged in a strategic collaboration strategy with world class partners to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

Entry into a Material Definitive Agreement.

On October 6, 2021, XOMA (US) LLC ("XOMA"), a wholly-owned subsidiary of XOMA Corporation (the "Company"), reported that entered into a commercial payment purchase agreement (the "Agreement") with Affitech Research AS, a Norwegian biotech company ("Affitech") (Filing, 8-K, Xoma, OCT 6, 2021, View Source [SID1234591012]). Pursuant to the Agreement, XOMA has purchased a future stream of commercial payment rights to Roche’s faricimab from Affitech for $6 million. XOMA is eligible to receive an economic interest of 0.50% of net sales of faricimab for a ten-year period following first commercial sales in each applicable jurisdiction. XOMA may pay up to an additional $20 million to Affitech based upon the achievement of certain regulatory and sales milestones.

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The Agreement contains certain covenants, representations and warranties regarding Affitech’s rights and obligations with respect to the existing licenses and customary covenants and representations for a transaction of this nature.

PerkinElmer’s Horizon Discovery CHOSOURCE™ Platform Expanding To Include CHO-K1 ADCC+ Expression Cell Line for Development of Therapeutic Antibodies in Oncology, Infectious Disease and Autoimmune Conditions

On October 6, 2021 PerkinElmer Inc., a global leader committed to innovating for a healthier world, reported that its Horizon Discovery CHOSOURCE platform is expanding to include a new expression cell line, CHO-K1 ADCC+ (Press release, PerkinElmer, OCT 6, 2021, View Source [SID1234590882]). This new expression host was built from Horizon’s established biomanufacturing cell line, CHO-K1 GS KO, by knocking out the fucose gene to increase antibody-dependant cellular cytotoxicity (ADCC) activity. This approach may improve potency and efficacy of therapeutic antibodies and fusion protein biotherapeutics, as well as reduce dosage requirements and side effects for patients.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The use of afucosylated antibodies and fusion proteins is expanding from oncology applications to infectious diseases like flu, Ebola, SARS and Covid-19, and most recently, autoimmune conditions. The availability of production tools, like the CHO-K1 ADCC+ cell line, is key to helping companies develop innovative and critical treatments across broader indications.

"Horizon has a long track-record in gene editing technologies that enable us to expand our CHOSOURCE platform to offer global scientists new and improved expression cell lines and service offerings to meet their evolving biotherapeutic development needs," said Jesus Zurdo, head of cell and gene therapy and bioproduction for Horizon, a PerkinElmer company. "We are extremely excited about this new addition to the CHOSOURCE family which we will continue to add to in the future."

The CHOSOURCE platform, now with CHO GS-KO and ADCC+ expression cell lines, is easily adaptable for implementation in proprietary biomanufacturing processes in the early stages of discovery and development of therapeutic programs. In addition, the CHOSOURCE platform continues to offer beneficial licensing solutions that enable technology access to any business, from virtual start-ups to established pharmaceutical companies and contract-manufacturing organizations.

For further information on Horizon’s CHOSOURCE platform, please visit: View Source

Horizon’s gene editing and gene modulation products and services are part of PerkinElmer’s comprehensive portfolio of solutions, software and services for life science and cell and gene therapy customers. Learn more here: Life Sciences Research Solutions.