On October 17, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported the publication of promising new pre-clinical data from the Company’s next-generation radioligand therapy (RLT) program for prostate cancer, PNT2001 (Press release, Point Biopharma, OCT 17, 2022, View Source [SID1234622073]).

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!

"We are entering an exciting stage in POINT’s prostate cancer franchise," said Joe McCann, Ph.D., Chief Executive Officer of POINT Biopharma. "Our PNT2001 actinium-225 program exemplifies our team’s deep expertise in the rapid development of new and innovative radioligands. And while we are advancing the next generation of PSMA-targeted radioligand therapy, we are simultaneously continuing our pre-commercial planning for our lead asset, PNT2002, by evaluating the most capital efficient approaches to commercialization including resourcing of internal commercial capabilities and exploring strategic commercial partnership options."

PNT2001 builds on POINT’s first-generation, lutetium-based program with a next-generation ligand optimized for use with the alpha-emitting radioisotope actinium-225.

The new PNT2001 data were shared in E-poster #039, "Development and characterization of a next-generation 225Ac-PMSA radioligand", at the 35th Annual Congress of the European Association of Nuclear Medicine, currently taking place in Barcelona, Spain.

In pre-clinical models, 225Ac-PNT2001 demonstrated:

Increased internalization by tumor cells in vitro, compared to that of a first-generation ligand
More precise tumor targeting in vivo (due to decreased kidney uptake, high tumor retention, and rapid renal clearance), leading to a promising safety profile in murine models
Compelling therapeutic activity, including suppression of tumor growth and metastases, along with improved survival, following the administration of a single dose in mice
These pre-clinical findings support the advancement of 225Ac-PNT2001 to clinical evaluation.

Having secured access to actinium-225 from the US Department of Energy, as well as agreements with Ionetix, TerraPower, and Northstar, POINT aims to accelerate radiochemistry and formulation optimization, as well as cGMP process and method development and validation, to facilitate progression to an IND/CTA submission in H1 2023.

About the SPLASH Trial
The phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in participants with PSMA-expressing mCRPC who have progressed on androgen receptor pathway inhibitor (ARPI) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study is expected to enroll approximately 400 participants across North America, Europe, and the United Kingdom. Participants will be randomized 2:1 with participants in arm A receiving PNT2002 and participants in arm B receiving either abiraterone or enzalutamide. Participants in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from their first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall response rate, overall survival, and pharmacokinetics.

On October 17, 2022 Leap Therapeutics, Inc. (NASDAQ: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that the first patient has been enrolled in the Phase 2 DeFianCe study evaluating DKN-01, Leap’s anti-Dickkopf-1 antibody (DKK1), in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with advanced colorectal cancer (CRC) (Press release, Leap Therapeutics, OCT 17, 2022, View Source [SID1234622072]).

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!

"We believe that DKN-01 has broad clinical potential. Based on the role of DKK1 in suppressing the immune system in the tumor microenvironment and enabling resistance to chemotherapy in CRC, we are excited to explore this new indication, one of the most frequent and dangerous types of GI cancers where patients continue to look for new treatment options," said Cynthia Sirard, M.D., Chief Medical Officer of Leap Therapeutics. "Enrolling the first CRC patient is an important milestone for the DKN-01 clinical program, and we look forward to reporting initial data from this study in mid-2023."

The DeFianCe study (NCT05480306) is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy. The study is designed with an initial 20 patient cohort and to then expand into a 130-patient randomized controlled trial against bevacizumab and standard of care chemotherapy. The primary objective is progression free survival. Secondary objectives include overall response rate, duration of response, and overall survival.

About DKN-01
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways and has an important role in promoting tumor proliferation, metastasis, angiogenesis, and in mediating an immune suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells.

About Colorectal Cancer
Colorectal cancer is the third most frequent cancer globally and the second leading cause of death. According to the WHO, there were nearly 2 million new cases of colorectal cancer in 2020, with nearly 1 million deaths. Colorectal cancer includes colon cancer (57.5%), rectal cancers (35%), and anal cancer (2.5%). When the symptoms of CRC appear, such as rectal bleeding, anemia, or abdominal pain, most patients are already in the advanced stage where cancers are aggressive, malignant, and metastatic.

On October 17, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that it will host an update call on its Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) on November 14, 2022 (Press release, Sellas Life Sciences, OCT 17, 2022, View Source [SID1234622071]).

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!

The call will be facilitated by SELLAS management, including SELLAS’ President and CEO, Angelos Stergiou, MD, ScD h.c., and Senior Vice President, Clinical Development, Dragan Cicic, MD, who will be joined by leading cancer researcher, M. Yair Levy, M.D., Director of Hematologic Malignancies Research at the Baylor University Medical Center, and member of the REGAL Steering Committee. Further details regarding how to access the update call will be provided in the coming weeks.

On October 17, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that Jeff Baxter, VBI’s President and CEO, and David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, will participate in an analyst-led fireside chat at the H.C. Wainwright 3rd Annual Hepatitis B Virus (HBV) Conference on Tuesday, October 18, 2022 (Press release, VBI Vaccines, OCT 17, 2022, View Source [SID1234622070]).

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!

Presentation Details

Event: H.C. Wainwright 3rd Annual Hepatitis B Virus (HBV) Conference
Date: Tuesday, October 18, 2022
Time: 9:00-9:30 AM ET

A live webcast of the presentation will be available on the Investors page of VBI’s website at: View Source A replay of the webcast will be archived on the Company’s website following the presentation.

On October 17, 2022 SURGE Therapeutics (SURGE) reported the completion of a $26 million Series A financing led by Camford Capital, with participation from Khosla Ventures, Intuitive Ventures, Pitango HealthTech, 8VC, Alumni Ventures, and the Cancer Research Institute (Press release, SURGE Therapeutics, OCT 17, 2022, View Source [SID1234622069]). The funds will be used to accelerate development of the SURGE intraoperative immunotherapy approach, expand the team, and initiate clinical trials for its injectable biodegradable hydrogel.

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!

While surgery is the standard of care for patients with solid tumors, surgery can lead to the return and spread of the cancer. Such recurrence and metastasis are very challenging to treat, so the ability to prevent them from manifesting would be highly desirable. To this end, SURGE is developing immunotherapies that can be injected directly into the site of tumor resection (intraoperative immunotherapy), to improve cancer patient survival and, ultimately, the standard of care.

Built upon groundbreaking research conducted in founder and CEO Dr. Michael Goldberg’s laboratory at Harvard Medical School, the SURGE Therapeutics injectable biodegradable hydrogel enables extended, localized release of cancer immunotherapy at the site of surgical tumor resection. In multiple aggressive murine models of metastasizing cancer, intraoperative immunotherapy vastly improved survival benefit relative to traditional routes of administration, whether systemic or local. Dr. Goldberg completed his PhD and post-doctoral training at MIT under the mentorship of Robert Langer and Phillip Sharp, respectively.

The proprietary hydrogel has been shown to reduce post-surgical recurrence and metastasis, which account for 90 percent of cancer-related deaths and have been linked to the immune suppression caused by surgery. Reprogramming the body’s response to surgery from immunosuppressive to immunostimulatory can trigger the patient’s immune system to destroy both local and distal residual cancer cells, reducing recurrence and improving survival.

"SURGE seeks to radically redefine the process of care for cancer patients, creating a simple and effective treatment that could potentially be administered during any surgical oncology procedure. SURGE’s novel approach has the potential to usher in a new pillar of cancer immunotherapy that could markedly enhance survival outcomes," said Robert Langer, Chair of the Scientific Advisory Board, SURGE Therapeutics.

"Even after a tumor has been removed, it is common for a small number of cancer cells to remain behind, whether at the site of the primary tumor or elsewhere in the body. Indeed, 40% of cancer patients who undergo surgery relapse within five years, so this is a major unmet medical need," said Dr. Michael Goldberg, CEO & Founder of SURGE Therapeutics. "I left my faculty position at Harvard to focus full-time on developing this innovation, which we believe will improve the standard of care for cancer patients. The Series A financing enables us to advance our proprietary intraoperative immunotherapies into clinical trials so that nobody has to grieve the loss of a loved one owing to cancer recurrence after surgery."

"At Intuitive Ventures, we look for companies taking minimally invasive care to the next level – SURGE is in the process of putting powerful immunotherapies into the hands of surgeons at a moment of great potential impact for cancer patients," said Dr. Oliver Keown, M.D., Managing Director of Intuitive Ventures. "We are excited to work alongside Michael and his world-class team as they pioneer the field of localized therapeutics strategically placed and timed to enhance treatment for cancer patients."

SURGE has a team of operators and advisors that include leaders in localized therapeutics, drug delivery, translational immunotherapy, surgical oncology, drug development, and immune-engineering: Charles ("Chuck") Carignan, MD (former Chief Medical Officer of Boston Scientific), Robert Langer, ScD (founder of Moderna), Elizabeth Jaffee, MD (Past-President of the American Association for Cancer Research (AACR) (Free AACR Whitepaper)), Timothy Eberlein, MD (Past-President of the Society of Surgical Oncology), Francis Cuss, MD (former Chief Scientific Officer of Bristol Myers Squibb), and Darrell Irvine, PhD (HHMI Investigator).

The SURGERx platform is designed to improve the efficacy and safety of immunotherapy treatment, concentrating 100 percent of the effective dose where and when it can yield tremendous impact. It also increases the number of addressable patients for highly potent molecules that are currently limited to treatment of accessible lesions via intratumoral injection.