On October 6, 2021 PanTher Therapeutics (PanTher), a clinical-stage oncology company developing next-generation targeted therapies for solid tumors, reported the dosing of the first two patients in its Phase 1 first-in-human clinical trial of PTM-101 for the treatment of pancreatic cancer (Press release, PanTher Therapeutics, OCT 6, 2021, View Source [SID1234590879]).

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PanTher’s proprietary treatment platform focuses on direct, localized, and sustained delivery of proven and novel therapeutic agents, attacking cancer at the source. Pancreatic cancer has one of the poorest prognoses of all malignancies, and responses to currently available systemic therapies are inadequate. PTM-101 is PanTher’s lead clinical candidate and is designed to intensively target pancreatic tumors and enhance therapeutic effect with minimal systemic toxicity.

This first-in-human trial will evaluate feasibility, safety, and pharmacokinetics of PTM-101 when used as part of a standard procedure for treatment of patients with locally advanced pancreatic adenocarcinoma.

"Launching the PTM-101 Phase 1 trial signals a major step toward our goal of improving therapeutic options for patients with difficult-to-treat solid tumors," said Laura Indolfi, PhD, Chief Executive Officer of PanTher Therapeutics. "We are thrilled to partner with Dr. Charles Pilgrim and his team at The Alfred Hospital in Melbourne as we incorporate PTM-101 into the treatment for patients with locally advanced pancreatic cancer."

The principal investigator of the PTM-101 clinical trial is Charles Pilgrim, MBBS, FRACS, PhD, FACS, who is an Associate Professor of Surgery at The Alfred, Central Clinical School, Monash University and a Senior trauma instructor and examiner for the Royal Australasian College of Surgeons. Dr. Pilgrim is a surgeon-scientist with a clinical and research focus on pancreas and hepatobiliary cancers, a PhD through the University of Melbourne at Peter MacCallum Cancer Centre, and a second fellowship in Surgical Oncology/HPB surgery at the Medical College of Wisconsin.

"Based upon the encouraging data in animal models of pancreatic cancer, we are optimistic about the clinical potential of PTM-101 to treat patients with this devastating disease," said J. Marc Pipas, MD, Chief Medical Officer of PanTher Therapeutics. "Our hope is that this technology will provide physicians a novel therapeutic modality without disrupting the current standard of care. The initiation of this first-in-human study could represent an important advance in the treatment of pancreatic cancer."

About PTM-101

PanTher’s lead clinical candidate, PTM-101, is a proprietary flexible biodegradable polymeric system for the sustained release of paclitaxel to the tumor site. It allows easy integration with standard procedures to specifically target the peritumoral area.

On October 6, 2021 Gerben Zondag, Founder & COO of Immunetune, reported that it will be attending the World Vaccine Congress Europe, taking place October 19-21, 2021, in Barcelona, Spain (Press release, ImmuneTune, OCT 6, 2021, View Source [SID1234590863]). Feel free to reach out to us to set up a meeting and explore collaboration opportunities.

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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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On October 6, 2021 MPM Capital ("MPM"), one of the world’s leading biotech investment firms, reported that it has raised $850 million for its second Oncology Impact Fund ("OIF 2" or "the Fund"), making it the world’s largest biotech impact investment fund (Press release, MPM Capital, OCT 6, 2021, View Source [SID1234590880]). OIF 2’s investment efforts are managed through BioImpact Capital, an affiliate of MPM that has been formed to broaden MPM’s investment offerings beyond venture capital into dedicated impact and public equities funds.

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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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OIF 2 will create and invest in companies that develop innovative treatments for cancer and other areas of highest unmet medical need. The Fund’s goals are to generate a compelling financial return and a long-term impact on patients’ lives. OIF 2 will invest in private and public companies to identify the most compelling drug development programs.

OIF 2 exceeded its fundraising target of $650 million, and far outpaced the $471 million raised in 2016 for MPM’s first Oncology Impact Fund ("OIF 1"), which at the time was also the largest biotech impact investment fund ever.

MPM and its BioImpact Capital team raised $650 million for OIF 2 through their unique partnership with UBS, the world’s leading global wealth manager. UBS clients invested from around the world including the US, the UK, Switzerland, Hong Kong, and Singapore. The remaining $200 million was raised by MPM and the BioImpact Capital team directly.

"Beyond oncology, OIF 2 will also expand its focus to additional cutting-edge technologies including cell, gene, and RNA therapies," said Ansbert Gadicke, M.D., Managing Partner of BioImpact Capital and MPM Managing Director. "Companies created by MPM remain at the vanguard of innovation, having received FDA approvals for over 50 drugs. Their continued success now stands to benefit an even greater range of investors and patients."

MPM and its BioImpact Capital team are equally committed to generating significant social and human impact through OIF 2 and doing so without affecting investor returns. A portion of its success fees from OIF 2, as well as a royalty from treatments created by its start-up companies, will be donated to the American Association for Cancer Research (AACR) (Free AACR Whitepaper), to help fund grants for next-generation cancer research, and to the UBS Optimus Foundation, to improve access to cancer care in the developing world.

"Through OIF 2, our mission is twofold: providing strong financial returns for our investors, while creating broader impact for patients even beyond the life-saving drugs we create," said Christiana Bardon, M.D., M.B.A., Co-Managing Partner of BioImpact Capital. "The companies that we invest in are all motivated to transform the lives of patients. Our novel investment model in partnership with philanthropic organizations can amplify the benefit to patients by supporting expanded patient access and the next generation of scientific insights."

"We are proud to connect our clients with brilliant scientists around the world who are working hard to alleviate the pain and suffering caused by cancer," said Mark Haefele, Chief Investment Officer at UBS Global Wealth Management. "With more than $1 billion raised so far, this is what reimagining the power of investing and connecting people for a better world can look like."

MPM’s BioImpact Capital team leverages its extensive company creation and clinical development experience along with its deep research and intellectual property expertise to successfully create and invest in companies through clinical proof of concept. In total, MPM has shepherded more than 100 companies through

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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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.

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]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"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.