On September 14, 2021 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications, reported that Angelos Stergiou, MD, ScD. h.c., President and Chief Executive Officer of SELLAS, will present at the 2021 Cantor Global Healthcare Conference to be held virtually on Tuesday, September 28, 2021, at 4:00 p.m. ET (Press release, Sellas Life Sciences, SEP 14, 2021, View Source [SID1234587676]).

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For more information about the conference, or to schedule a one-on-one meeting with SELLAS management, please contact your Cantor representative directly, or send an email to Cantor at [email protected] or KCSA Strategic Communications at [email protected].

On September 14, 2021 Convergent Therapeutics Inc., a clinical stage radiopharmaceutical company, and POINT Biopharma Global Inc., (Nasdaq: PNT) ("POINT") a company accelerating the discovery, development and global access to life changing radiopharmaceuticals, reported a collaboration to evaluate the combination of CONV 01-α (225Ac−J591, or rosopatamab-225Ac), Convergent’s antibody directed at prostate-specific membrane antigen (PSMA) coupled with Actinium-225 (225Ac), an alpha particle emitter and POINT’s PSMA radioligand PNT2002 linked to Lutetium-177 (177Lu), a beta particle emitter in men with progressive metastatic castration-resistant prostate cancer (mCRPC) in a Phase I/II investigator-initiated trial (Press release, Convergent Therapeutics, SEP 14, 2021, View Source;rosopatamab-225ac-in-combination-with-pnt2002-for-progressive-metastatic-castration-resistant-prostate-cancer-301375737.html [SID1234587692]). The study has begun patient accrual and is being conducted at Weill Cornell Medicine with Dr. Scott T. Tagawa, Professor of Medicine and Professor of Medicine in Urology at Weill Cornell Medicine, as Principal Investigator.

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The Phase I/II trial is enrolling up to 33 patients with progressive mCRPC who have received a prior androgen receptor signaling inhibitor (ARSI) and taxane chemotherapy and are PSMA PET-positive. The open-label Phase I dose-escalation portion of the study is designed to determine the maximum tolerated dose (MTD) for the combination of CONV 01-α and PNT2002. PNT2002 will be administered at the dose utilized in POINT Biopharma’s Phase III SPLASH trial. Escalating doses of CONV 01-α will be administered concurrently, starting with doses previously demonstrated to be well-tolerated. After the Phase I study has established the MTD of the CONV 01-α and PNT2002 combination, investigators will initiate the Phase II expansion study study at MTD. The primary objective of the Phase II study is to assess the number of patients who demonstrate a >50% prostate-specific antigen (PSA) decline following treatment.

The co-targeting treatment approach is based on the research of Dr. Neil Bander, the Bernard & Josephine Chaus Professor of Urologic Oncology at Weill Cornell Medicine, who discovered the synergy between radioligands and 225Ac−J591. The finding that antibodies synergistically improve the efficacy of ligand-targeted agents is the subject of patent filings by Cornell University that, in turn, have been exclusively licensed to Convergent Therapeutics, inc. At the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting in June, Dr. Tagawa presented proof of concept data that demonstrated that a single dose of CONV 01-α had anti-tumor activity in heavily pretreated men with mCRPC.

Dr. Philip Kantoff, Chief Executive Officer of Convergent Therapeutics, stated, "Within the field, there is significant and growing interest in our differentiated approach that leverages the complementary advantages of co-targeting surface cancer molecules such as PSMA with both antibodies and small molecule ligands, as well as alpha and beta radiopharmaceuticals. This collaboration with POINT Biopharma will, therefore, help to facilitate and validate our disruptive strategy of combining radioligands and antibodies carrying different payloads, directed at a cancer target, in order to significantly improve the efficacy of radiopharmaceutical therapies. Our long-term goal is to meaningfully improve outcomes in patients with prostate cancer and to leverage this combinatorial platform to treat other cancers. We look forward to evaluating the results once they are available."

Dr. Joe McCann, Chief Executive Officer of POINT Biopharma, noted, "Combination therapies are a very exciting opportunity in the radiopharmaceutical space, as demonstrated by Dr. Bander’s research into combining different radioligand therapies to improve outcomes. To date, PNT2002 has shown promise as a monotherapy and we believe that this collaboration has the potential to not only improve patient outcomes, but also provide patients and physicians with new therapeutic options for advanced prostate cancers."

For additional information about this clinical trial, please visit www.clinicaltrials.gov, NCT04886986

Dr. Bander is a co-founder with equity and a paid scientific advisor for Convergent Therapeutics, Inc. Dr. Tagawa is a paid consultant and receives equity for Convergent Therapeutics, Inc.

About PNT2002
PNT2002 is a PSMA-targeted radioligand in development for the treatment of patients with metastatic castration-resistant prostate cancer who have progressed following treatment with ARSI therapy. The Phase 3 SPLASH study (NCT04647526) is a multi-center, randomized, open label assessment of PNT2002 in patients with PSMA-expressing mCRPC who have progressed on ARSI therapy and refuse or not eligible for chemotherapy. The next phase of the study is expected to enroll approximately 400 patients across North America, Europe and the UK, and top-line data from the SPLASH study is expected to report in mid-2023.

On September 14, 2021 Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, reported that it has entered into a collaboration agreement with the National Surgical Adjuvant Breast and Bowel Project (NSABP), a cooperative group founded by the National Cancer Institute (NCI) (Press release, Exact Sciences, SEP 14, 2021, View Source [SID1234587658]). Working together, Exact Sciences and the NSABP plan to conduct a prospective, multicenter validation study with stage II and III colorectal cancer (CRC) patients, demonstrating the ability of Exact Sciences’ ctDNA test to detect MRD . The study, called CORRECT-MRD II, is expected to enroll approximately 750 patients at 35 study sites in the U.S. and Canada and is part of Exact Sciences’ global initiative to generate clinical validation data for its tumor-informed MRD liquid biopsy test.

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Exact Sciences and NSABP Announce Validation Study to Detect Minimal Residual Disease in Colorectal Cancer Patients
"Our longstanding relationship with the NSABP, through our work to develop and validate the Oncotype DX Breast Recurrence Score and Colon Recurrence Score tests, represents a remarkable collaboration between academic and industry partners. This relationship has fueled major advancements in understanding the role of molecular profiling in breast and colon cancer," said Rick Baehner, MD, chief medical officer of Precision Oncology for Exact Sciences. "NSABP’s expertise in colon research makes them ideal collaborators to conduct this important MRD study in colorectal cancer. We look forward to working together on this tremendous opportunity to help shape the future of precision medicine."

Exact Sciences is well-positioned to bring a highly sensitive MRD solution to patients in need. Its recent exclusive license of the Targeted Digital Sequencing (TARDIS) blood biopsy technology and acquisition of Ashion Analytics help prepare Exact Sciences to develop a differentiated patient-specific solution in MRD testing. With proven evidence-generation abilities and deep commercial relationships, Exact Sciences has the capability to bring its solution to patients and providers in the U.S. quickly and efficiently. In addition, the patient specific MRD test may have the potential to be synergistic with the predictive and prognostic insights provided by the Exact Sciences’ Oncotype portfolio to further inform treatment decisions to help improve patient outcomes. The company aims to explore the full potential of its MRD technology across all solid tumor types.

"The NSABP is committed to designing and conducting clinical trials that improve the treatment of colorectal cancer by evaluating promising new diagnostics and treatments," said Norman

Wolmark, MD, chairman of the NSABP Foundation and of the NCTN group NRG Oncology. "Highly sensitive MRD tests have the potential to fundamentally change the solid tumor treatment and monitoring paradigm. Exact Sciences’ unique approach to MRD and its commitment to improving patient outcomes make them ideal collaborators for advancing this promising new technology."

Exact Sciences and the NSABP are also working with patient advocacy organization Fight Colorectal Cancer (Fight CRC) to help inform MRD study designs and identify potential barriers to study participation, particularly in underserved populations. This joint effort will help ensure patient recruitment and patient-facing study materials are clear and sensitive to diverse cultures and socioeconomic backgrounds.

"Participating in a clinical study or trial is a personal journey and decision that includes many different factors and considerations for each patient," said Anjee Davis, president of Fight CRC. "Collaboration between patients, patient advocates, and clinical study professionals is vital. We’re proud to work with Exact Sciences and the NSABP on this important research, ensuring colorectal cancer patients from all backgrounds are represented and their voices are kept at the forefront."

About Minimal Residual Disease
Minimal residual disease (MRD) refers to the presence of tumor-specific DNA in the body after cancer treatment. These fragments of genetic information, known as circulating tumor DNA (ctDNA), are shed into the blood by solid tumors as part of the tumor growth cycle. Their presence may indicate that a tumor is likely to return. Solid tumors are typically undetected until they are advanced enough to be picked up by a medical image or physician examination. The detection of ctDNA at extremely low levels has the potential to provide crucial insights that may help discover cancer recurrence earlier and inform treatment decisions.

About Exact Sciences’ MRD Program
The Exact Sciences’ MRD solution is being designed to utilize a tumor-informed (bespoke) approach with whole genome sequencing. This approach identifies somatic genetic alterations in DNA extracted from the patient’s tumor tissue and detects a subset of these mutations in ctDNA present in the patient’s blood. The MRD test that Exact Sciences is developing is intended for patients diagnosed with solid tumor malignancies to detect ctDNA before, during, and after cancer treatment. Such information may be used for guidance of adjuvant or neoadjuvant therapy decisions and/or for monitoring of recurrence after completion of adjuvant or neoadjuvant therapy, in conjunction with other clinicopathological findings. The company estimates that more than 1.5 million patients1 in the United States alone could benefit from this type of MRD testing.

On September 14, 2021 IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win technology platform, reported that it has entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada), through a subsidiary (Press release, IO Biotech, SEP 14, 2021, View Source [SID1234587693]). The purpose of the collaboration is to evaluate IO Biotech’s lead candidate, IO102-IO103, in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 (programmed death receptor-1) therapy, in patients with previously untreated, unresectable or metastatic (advanced) melanoma. IO102-IO103 is an investigational cancer vaccine designed to target the immunosuppressive mechanisms mediated by key immunosuppressive proteins such as Indoleamine 2,3-dehydrogenase (IDO) and PD-L1.

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"We are pleased to collaborate with MSD to study the potential of our IDO and PD-L1 derived immune-modulating therapy in combination with KEYTRUDA as part of our broad, late-stage development program," said Mai-Britt Zocca, PhD, CEO and founder of IO Biotech. "Although therapies are available to treat metastatic melanoma, the clinical outcomes for patients with advanced disease remain poor and novel therapeutic options are desperately needed. We look forward to expanding our data set on IO102-IO103 with KEYTRUDA combination results, which we believe will support the potential approval of IO102-IO103 as a first-line therapy for melanoma and other difficult-treat-cancers."

The planned Phase 3 trial will be an open label, randomized clinical trial that will evaluate the combination of IO102-IO103 with MSD’s anti-PD-1 therapy, KEYTRUDA, versus KEYTRUDA alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Biomarker studies will also be conducted. Under the terms of the agreement, IO Biotech will sponsor the Phase 3 trial and MSD will supply KEYTRUDA.

In a Phase 1/2 clinical trial of 30 patients with metastatic melanoma, IO102-IO103, in combination with anti PD1 mAb, demonstrated an ability to induce meaningful tumor regression and establish durable antitumor response while achieving a manageable tolerability profile for patients. In this trial, we observed a confirmed overall response rate (ORR) of 73% and a complete response (CR) rate of 47%. Based on the results from this trial, IO102-IO103, in combination with pembrolizumab, was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for treatment of unresectable/metastatic melanoma.

About IO102-IO103/KEYNOTE-D18:

An open label, randomized Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma

Biomarker studies will be conducted in parallel to the above.

The clinical trials will be sponsored by IO Biotech. IO Biotech maintains global commercial rights to IO102-IO103.

On September 14, 2021 Pacylex Pharmaceuticals, Inc. reported that it initiated a Phase 1 clinical trial of PCLX-001, a first-in-class, orally bioavailable small molecule inhibitor of N-myristoyltransferase 1 and 2 (NMT1, NMT2), at the University of Alberta Cross Cancer Institute (Press release, Pacylex Pharmaceuticals, SEP 14, 2021, View Source [SID1234645062]). This open label, dose escalation study will examine the safety and tolerability of PCLX-001 and determine the dose to be used in initial efficacy studies. Pacylex received a No Objection Letter from Health Canada on March 8, 2021, authorizing the planned Phase 1 Trial of PCLX-001 in relapsed/refractory B-cell Non-Hodgkin’s Lymphoma and advanced solid malignancies. PCLX-001 is believed to be the first NMT inhibitor that will be clinically tested.

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PCLX-001 is the first clinical candidate sponsored by Pacylex Pharmaceuticals to reach the clinical stage. "We are excited to see PCLX-001 transition to helping serious refractory cancer patients," said Michael Weickert, CEO of Pacylex Pharmaceuticals. "Our mission is to bring this new potential cancer breakthrough to patients, and we are especially privileged to be working with the Cross Cancer Institute on this clinical program."

"We are genuinely excited to initiate a new therapeutic candidate for these very challenging patients," said Dr. John Mackey, the Chief Medical Officer of Pacylex Pharmaceuticals. "Based on its unique mechanism of action and preclinical results, we hope this therapy will provide at least some patients with relief from their disease."

Dr. Randeep Sangha is the principal investigator for the study of PCLX-001 at the Cross Cancer Institute in Edmonton. "We plan to test PCLX-001 on patients who have tried everything else. Testing something really new is the goal of every cancer researcher since it may open the door for new treatments for patients" said Dr. Sangha.

Patient enrollment and dosing will also begin soon at Princess Margaret Hospital in Toronto and the BC Cancer Agency in Vancouver. The study will enroll 20-30 patients in the initial phase. Three principal investigators will oversee the clinical study at the three clinical sites in Canada: Dr. John Kuruvilla at Princess Margaret Cancer Centre in Toronto, Dr. Randeep Sangha at the Cross Cancer Institute in Edmonton, and Dr. Laurie Sehn at the British Columbia Cancer Center in Vancouver.

This study is registered at ClinicalTrials.gov Identifier: NCT04836195.

About Non-Hodgkin’s Lymphoma

Non-Hodgkin’s Lymphoma (NHL) is the most common hematologic malignancy and the eleventh most common cancer worldwide, with nearly 510,000 new cases diagnosed in 2018. It accounted for nearly 249,000 deaths worldwide in 2018. The most prevalent form of NHL, accounting for about 40% of newly diagnosed NHL cases, is an aggressive form called diffuse large B-cell lymphoma (DLBCL), that comes with a life expectancy of weeks or months if left untreated.

PCLX-001

PCLX-001 is a small molecule, first-in-class N-myristoyltransferase (NMT) inhibitor, originally developed by the University of Dundee Drug Discovery Unit as part of a program to treat African sleeping sickness funded by Wellcome Trust. Pacylex is developing PCLX-001, which has excellent oral bioavailability, to treat leukemia and lymphoma. PCLX-001 selectively kills cancer cells and completely regresses (eliminates) tumors in animal models of acute myeloid leukemia (AML), diffuse large B-cell lymphoma (DLBCL) and Burkitt lymphoma (BL). PCLX-001 has also been shown to strongly inhibit the growth of lung and breast cancer tumors in animal models. In leukemia, lymphoma and breast cancer patients, the level of NMT2 is correlated with survival, suggesting an important biological role in these cancers. In tests using cultured cancer cells in vitro, PCLX-001 is at least ten times as potent as ibrutinib (Imbruvica) and dasatinib (Sprycel), two clinically approved drugs currently used to treat hematologic malignancies.