On September 9, 2021 Vitalgenics Inc, a clinical stage biopharmaceutical company specializing in pancreatic cancer, reported that it has unraveled the etiology of pancreatic ductal adenocarcinoma (PDAC) with their FDA repurposed immunotherapy drug called Excindogen. 95% of all pancreatic cancers are PDAC with a 7%- 9% survival rate after 5 yearsb (Press release, Vitalgenics, SEP 9, 2021, View Source [SID1234587551]).

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!

PDAC consist of 40 continuous biological sequences within the pancreatic duct that upsets pancreatic duct homeostasis, initiated by bile toxicity, which starts a chain of events that make up tumor formation, tumor growth and metastasis. Some of the major sequences within the duct consist of neurotransmitters, cell signaling, ion channels, efflux pumps, hypoxia, DNA damage, several gene expressions such as KRAS, metabolic imbalances, manufacture of dense stroma and most important T- Cell exhaustion where the T- cells cannot attack and kill off the tumor. CEO Charles Owen states "it is like a faucet on full that cannot be turned off." To turn off the faucet, homeostasis of the pancreatic duct needs to be stabilized so the T-cells can be reactivated to attack and kill off the tumor. The tumor consists of three major cells- The acinar "cancer" cell, the hijacked macrophage cell and the inflammatory cell, causing a "vicious cycle" where they feed on each other and where they proliferate that cannot be resolved with current chemotherapy.

In preclinical studies, immunotherapy drug Excindogen, has proven to inhibit the major sequences listed above, having the capability of "turning off the faucet" and returning homeostasis back to normal so that T-cells can reactivate, attack and kill tumors, while programming adaptive immunity so the tumor has a less of a chance of returning. Preclinical studies have also shown that Excindogen is non- toxic with no major side effects which will make a huge impact with patients. Toxicity and side effects are the main reason patients are non-compliant with current chemotherapy drugs. Excindogen has received orphan drug designation.

Vitalgenics Inc, is seeking capital to enter a phase 1/2 clinical trial and FDA submissions for advanced stage pancreatic cancer. For more information on the biological sequences or Excindogen please contact:

On September 9, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that the first patient has been dosed in the SELECT-AML-1 clinical trial of tamibarotene, its first-in-class selective retinoic acid receptor alpha (RARα) agonist, in combination with venetoclax and azacitidine (Press release, Syros Pharmaceuticals, SEP 9, 2021, View Source [SID1234587550]). The randomized Phase 2 trial is enrolling RARA-positive newly diagnosed unfit patients with acute myeloid leukemia (AML).

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!

"Despite recent advances, one third of newly diagnosed unfit AML patients still don’t respond to front-line treatment and many more relapse," said Eytan M. Stein, M.D., Assistant Professor of Medicine and Director of the Program for Drug Development in Leukemia at Memorial Sloan Kettering Cancer Center. "These patients need new therapies that can deliver durable remissions with minimal or manageable toxicities. I am encouraged by tamibarotene’s distinct safety profile, as well as the compelling clinical and translational data that has emerged, suggesting it may benefit patients in the greatest need of new treatment options. I look forward to further exploring its potential in this clinical trial as part of a triplet regimen with venetoclax and azacitidine."

Tamibarotene has demonstrated promising results in combination with azacitidine in RARA-positive newly diagnosed AML patients who are not suitable candidates for standard chemotherapy. At the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020, Syros presented data from a Phase 2 clinical trial, demonstrating a 67% overall response rate and a 61% composite complete response (CR/CRi) rate. The data also showed that tamibarotene in combination with azacitidine was generally well-tolerated, with no evidence of increased myelosuppression compared to single-agent azacitidine.

Also at ASH (Free ASH Whitepaper), Syros presented translational data demonstrating that most RARA-positive newly diagnosed unfit AML patients in the Phase 2 trial of tamibarotene had a monocytic disease phenotype associated with resistance to venetoclax, which, in combination with azacitidine, is the standard of care for newly diagnosed unfit patients. These data suggest that the RARA biomarker selects for patients who are more likely to benefit from tamibarotene and who may be less likely to benefit from venetoclax.

"AML is a complex, heterogenous disease, and many patients may present upfront with both monocytic and non-monocytic leukemia cells," said David A. Roth, M.D., Chief Medical Officer at Syros. "By employing a triplet strategy that combines tamibarotene with venetoclax and azacitidine, we believe we can simultaneously target both cell types, reducing the emergence of resistant disease and increasing the likelihood of deeper and more durable responses. We are excited to be actively enrolling patients in this study, as we advance our portfolio of targeted hematology therapies with the aim of setting new standards of care for people with acute leukemias and myelodysplastic syndrome."

The SELECT-AML-1 trial is designed with a single-arm safety lead-in, followed by the randomized portion of the trial, which will evaluate the safety and efficacy of tamibarotene in combination with venetoclax and azacitidine compared to venetoclax and azacitidine in approximately 80 patients randomized 1:1. The trial will also evaluate the triplet regimen as a salvage strategy in patients in the control arm who do not respond to venetoclax and azacitidine. The primary endpoint of the trial will be composite CR rate.

Syros is also evaluating tamibarotene in combination with azacitidine in the SELECT-MDS-1 Phase 3 clinical trial in RARA-positive patients with newly diagnosed higher-risk myelodysplastic syndrome.

On September 9, 2021 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, today announces that 4D pharma management will present at the following virtual investor conferences (Press release, 4d Pharma, SEP 9, 2021, View Source [SID1234587549]):

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!

H.C. Wainwright 23rd Annual Global Investment Conference at 07:00 ET (12:00 BST) on Monday, September 13, 2021
Oppenheimer Fall Healthcare Life Sciences & MedTech Summit at 08:15 ET (13:15 BST) on Wednesday, September 22, 2021
A webcast of each presentation will be available via the ‘Events’ section of the 4D pharma website at www.4dpharmaplc.com. Archived replays of the webcasts will be available for 90 days following the presentation.

On September 9, 2021 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, reported that management will present at the following investor conferences in September (Press release, Tempest Therapeutics, SEP 9, 2021, View Source [SID1234587544]):

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!

H.C. Wainwright 23rd Annual Global Investment Conference available on-demand Monday, September 13, 2021 at 7:00 a.m. ET
Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Wednesday September 22, 2021 at 9:55 a.m. ET
To access the live or archived recording of the company presentations, please visit the investor section of the Tempest website at View Source

On September 9, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported that results from its 178-patient, randomized, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer will be featured in a proffered paper oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, Corcept Therapeutics, SEP 9, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-announces-presentation-positive-results-randomized [SID1234587543]). The congress will take place from September 16 – 21, 2021.

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 extremely excited by the potential of relacorilant to treat women with recurrent platinum-resistant ovarian cancer," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "As we announced when we released our preliminary results, delaying disease progression without increasing side effect burden was a tremendous benefit to the women in this trial. In the first quarter of next year, we plan to initiate a pivotal Phase 3 trial to confirm these positive results."

Presentation Title: Relacorilant, a selective glucocorticoid receptor modulator, in combination with nab-paclitaxel improves progression-free survival in patients with recurrent platinum-resistant ovarian cancer: A 3-arm, randomized, open-label, phase II study

Speaker: Dr. Domenica Lorusso, Gynecologic Oncology Unit Fondazione Policlinico Universitario Gemelli IRCCS

Presentation Number: 721O

Session: Gynecological Cancers Proffered Paper Session

Presentation Date/Time: Friday, September 17, 2021 at 13:40 – 13:50 CEST | Channel 3

About Relacorilant

Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, adrenal and castration-resistant prostate cancer and Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. It has received orphan drug designation in the United States for the treatment of Cushing’s syndrome and pancreatic cancer.