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 SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, reported that it will host a virtual R&D Day on Wednesday, October 13, 2021, at 10:00 a.m. ET to showcase its versatile DiversitAb platform and pipeline of clinical and preclinical programs (Press release, SAB Biotherapeutics, OCT 6, 2021, View Source [SID1234590878]).

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The event will feature SAB management and key opinion leaders, including:

Arturo Casadevall, MD, PhD – The Alfred and Jill Sommer Professor and Chair, W. Harry Feinstone Department of Molecular Microbiology & Immunology, Bloomberg Distinguished Professor, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins School of Medicine
Michael Haller, MD, MS-CI – Professor and Chief, Silverstein Family Eminent Scholar, Pediatric Endocrinology in the College of Medicine, University of Florida
A live webcast of the event will be accessible through the "News" section of the company’s website at www.sabbiotherapeutics.com. A replay of the webcast will be available on the SAB website following the event.

On June 22, 2021, SAB announced a planned merger with Big Cypress Acquisition Corp. (NASDAQ: BCYP). The transaction is expected to close in the fourth quarter of 2021.

On October 6, 2021 NextEra Energy, Inc. (NYSE: NEE) reported that it plans to report third-quarter 2021 financial results before the opening of the New York Stock Exchange on Wednesday, Oct. 20, 2021, in a news release to be posted on the company’s website at www.NextEraEnergy.com/FinancialResults (Press release, Nextera, OCT 6, 2021, View Source [SID1234590875]). The company will issue an advisory news release over PR Newswire the morning of Oct. 20, with a link to the financial results news release on the company’s website. As previously communicated, the company will make available its financial results only on its website.

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Jim Robo, chairman and chief executive officer of NextEra Energy, Rebecca Kujawa, executive vice president, finance and chief financial officer of NextEra Energy, and other members of the company’s senior management team will discuss the company’s third-quarter 2021 financial results during an investor presentation to be webcast live, beginning at 9 a.m. ET on Oct. 20. Results for NextEra Energy Partners, LP (NYSE: NEP) also will be discussed during the same investor presentation.

The listen-only webcast will be available on NextEra Energy’s website by accessing the following link: www.NextEraEnergy.com/FinancialResults. The financial results news release and the slides accompanying the presentation may be downloaded at www.NextEraEnergy.com/FinancialResults, beginning at 7:30 a.m. ET on the day of the webcast. A replay will be available for 90 days by accessing the same link as listed above.

On October 6, 2021 OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of elite cancer responders, reported that it will present three abstracts at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting being held in Washington D.C. and virtually November 10-14, 2021 (Press release, OncoResponse, OCT 6, 2021, View Source [SID1234590874]).

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"We are pleased to be highlighting several preclinical findings at the SITC (Free SITC Whitepaper) conference demonstrating the application of our propriety immunotherapy platform we are utilizing to discover and develop therapeutic antibodies that modulate the tumor microenvironment. This includes preclinical findings for our lead therapeutic candidate, OR2805, which has entered clinical development," said Clifford Stocks, Chief Executive Officer of OncoResponse.

Details of the poster presentations are as follows:

Title: Development of OR2805, an anti-CD163 antibody derived from an elite responder to checkpoint inhibitor therapy that relieves immunosuppression caused by M2c macrophages

Poster/Abstract Number: 271
Date/Time: Friday, November 12, 7:00 a.m. to 8:30 p.m. ET

Title: Preclinical characterization of humanized anti-Siglec-15 antibodies that rescue T cells from macrophage-mediated immune suppression

Poster/Abstract Number: 262
Date/Time: Saturday, November 13, 2021, 7:00 a.m. – 8:30 p.m. EST

Title: Discovery and preclinical characterization of anti-LILRB2 antibodies that rescue T cells from macrophage-mediated immune suppression

Poster/Abstract Number: 276
Date/Time: Saturday, November 13, 2021, 7:00 a.m. – 8:30 p.m. EST

Poster presentations will be accessible in person and virtually. Onsite posters will be displayed in the SITC (Free SITC Whitepaper) Poster Hall located in Hall E of the convention center. ePosters will be available for SITC (Free SITC Whitepaper) attendees on Nov. 12 at 7 am ET and can be accessed on the SITC (Free SITC Whitepaper) virtual meeting site.

About OR2805

OR2805 is a fully human antibody discovered using B cells derived from an elite responder to checkpoint inhibitor (CPI) therapy. This antibody binds to CD163 which is highly expressed on tumor associated macrophages (TAMs) that create an immunosuppressive tumor microenvironment and inhibit anti-tumor T-cell responses. High frequency of CD163-expressing TAMs generally predicts an unfavorable prognosis in solid tumors. OR2805 is designed to improve anti-tumor T-cell responses, by reversing the immunosuppression of TAMs, as a therapeutic strategy for monotherapy and in combination with CPI.

On October 6, 2021 Dialectic Therapeutics, Inc. (Dialectic), a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer, reported the dosing of the first patient in a first-in-human, dose escalation Phase 1 trial evaluating DT2216, the first generation compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD) technology, in patients with relapsed or refractory solid tumor and hematologic malignancies (Press release, Dialectic Therapeutics, OCT 6, 2021, View Source [SID1234590873]).

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"Advancing our first generation APTaD DT2216 into the clinic is the culmination of a tremendous amount foundational research conducted by our scientific team supported by extensive preclinical studies. This also marks the first time a protein degrader targeting the antiapoptotic BCL family of proteins has been administered in humans. We believe DT2216 has the potential to be a first-in-class anticancer agent targeting BCL-XL, the most commonly over-expressed antiapoptotic protein in cancer, as a single agent and in combination with chemotherapy regimens and other therapeutics. We look forward to learning more about the safety, tolerability and anti-tumor activity of DT2216 in this trial and presenting future data" said Dr. David Genecov, Dialectic’s President and Chief Executive Officer. "With DT2216 in the clinic, we look forward to leveraging our novel APTaD technology platform to advance the next generations of our degrader compounds."

The multicenter Phase 1 clinical trial is designed as an open-label, first-in-human, dose escalation study in patients with histologically or cytologically confirmed advanced or metastatic solid tumors and hematologic malignancies who are no longer responsive to approved or accepted standard-of-care interventions. The Phase 1 trial is anticipated to enroll between 20-40 patients that will receive a single intravenous (IV) infusion of DT2216 twice weekly for at least 4 weeks, with each cycle consisting of 28 days.

Renowned cancer centers participating in the trial include Mays Cancer Center at UT Health San Antonio, Mary Crowley Cancer Research in Dallas, Texas and The Lurie Cancer Center at Northwestern University in Chicago, Illinois. Additional information about the clinical trial is available at ClinicalTrials.gov (NCT04886622).

About DT2216 and the APTaD Technology Platform
In preclinical studies supported through a Seed Award from the Cancer Prevention & Research Institute of Texas (CPRIT), DT2216 selectively induces the degradation of B-cell lymphoma extra-large, or BCL-XL, in cancer cells and either stimulates the return of cellular apoptosis or sensitizes the cells to be more susceptible to chemotherapy, and thus cellular destruction. DT2216 has been shown to be effective in various hematologic and solid tumors as a single agent and in combination with chemotherapy. Further, these preclinical studies show cancer cells are less likely to develop resistance to DT2216 compared to other chemotherapy drugs. DT2216 accomplishes this with very little toxicity, particularly to platelets.

As with BCL-XL, there are many other significant proteins associated with cancer that cannot be targeted with current therapies. Our proprietary APTaD technology platform is a novel approach that can be applied to the broader BCL family and other protein targets. Our current research and preclinical efforts are focused on developing next generation APTaD candidates to address this high unmet need.