On August 1, 2022 Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the CYAD-101-002 (KEYNOTE-B79) Phase 1b trial after the Company made changes to the eligibility criteria for the trial (Press release, Celyad, AUG 1, 2022, View Source [SID1234617176]).

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"We are pleased that the FDA lifted the clinical hold on this trial. We remain confident in the potential development of not only the candidate itself, but the continued development with our proprietary TIM technology. CYAD-101 is currently our only clinical candidate co-expressing NKG2D and TIM, and we hope to continue to showcase our expertise with our non-gene edited technologies and explore additional opportunities to utilize NKG2D in allogeneic CAR T," said Dr. Charles Morris, Chief Medical Officer of Celyad Oncology.

As previously disclosed, on February 28, 2022, the Company announced that it was voluntarily pausing the CYAD-101-002 trial to investigate reports of two fatalities in the study. The trial was subsequently put on clinical hold in March 2022 by the FDA.

The CYAD-101-002 Phase 1b trial evaluates the TCR Inhibitory Molecule (TIM)-based allogeneic NKG2D CAR T cell investigational therapy CYAD-101 with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with refractory metastatic colorectal cancer (mCRC) with microsatellite stable (MSS) / mismatch-repair proficient disease.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On August 1, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported that it will host a conference call on August 15, 2022, at 4:30 PM Eastern Time to discuss results for its second quarter ended June 30, 2022 (Press release, Panbela Therapeutics, AUG 1, 2022, View Source;utm_medium=rss&utm_campaign=panbela-schedules-conference-call-on-8-15-22-to-report-2022-2nd-quarter-financial-results [SID1234617193]).

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About our Pipeline

The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.

SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months which is final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase 3 trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X

CPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment is well tolerated and has potential activity.

On August 1, 2022 Agenus Inc. (Nasdaq: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, reported that the first patient has been dosed in the Phase 1 study of AGEN1571 in advanced solid tumors (Press release, Agenus, AUG 1, 2022, View Source [SID1234617209]). The dose-escalation and expansion study will evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of AGEN1571, a novel anti-ILT2 antibody designed to modulate tumor-associated macrophages, T, NK, and NKT cells. Participants will receive treatment with AGEN1571 as a single agent or in combination with botensilimab (Fc-enhanced anti-CTLA-4) and/or balstilimab (anti-PD-1).

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"ILT2 is a major suppressor of anti-tumor immune responses and contributes to resistance to PD-1-directed therapies," said Steven O’Day, MD, Chief Medical Officer of Agenus. "We believe AGEN1571 has best-in-class potential to overcome this resistance and combining AGEN1571 with botensilimab and/or balstilimab may further enhance innate and adaptive anti-tumor immunity."

The initiation of the AGEN1571 study in patients with advanced solid tumors is based on preclinical data reported at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, demonstrating the ability of AGEN1571 to polarize macrophages to a pro-inflammatory phenotype and enhance the activation of CD8 T, NK, and NKT cells in the tumor microenvironment to overcome resistance to immune checkpoint blockade. These data demonstrate the superior potency and functional activity of AGEN1571 compared to the only known clinical-stage competitor and enhanced immune cell activation when combined with botensilimab or balstilimab.

The poster presentation on these data can be accessed in the investor section of the Agenus website at View Source

More information on the Phase I study (NCT05377528) is available at clinicaltrials.gov.

On August 1, 2022 Tavanta Therapeutics, a clinical-stage specialty pharmaceutical company developing a diverse pipeline of specialty drugs that bring clinically meaningful benefits to patients with serious or debilitating diseases, reported the completion of patient enrollment in the Company’s pivotal Phase 3 study for TAVT-45 (abiraterone acetate) Granules for Oral Suspension ("TAVT-45") (Press release, Tavanta Therapeutics, AUG 1, 2022, View Source [SID1234617225]). TAVT45CO2 is a global Phase 3 clinical trial evaluating TAVT-45 in patients with metastatic castrate-sensitive prostate cancer (mCSPC) and metastatic castrate-resistant prostate cancer (mCRPC). The primary objective of the study is to establish therapeutic equivalence between TAVT-45 and Zytiga tablets.

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TAVT-45 is designed to provide an easy-to-consume oral suspension of abiraterone acetate, reconstituted in water or juice, for patients with difficulty taking large tablets. Approximately 20 to 30 percent of cancer patients have difficulty swallowing pills and capsules (dysphagia) and may benefit from an alternate formulation. The prevalence of dysphagia also increases with age and is an issue for many patients with prostate cancer, whom have a median age of over 65 years old at time of diagnosis.

"The current standard of care treatment for metastatic prostate cancer requires patients to ingest multiple large tablets, and under strict fasting conditions due to the risk of increased and highly variable abiraterone exposures with food," said Kenneth M. Kernen, M.D., study investigator and partner in the Michigan Institute of Urology. "Dysphagia is an issue for many – and it occurs more frequently in elderly patients. If TAVT-45 proves successful in this trial, clinicians may soon have access to an alternative, easy-to-drink formulation of abiraterone acetate with improved bioavailability and reduced systemic variability, which may ultimately help patients achieve better clinical outcomes."

This Phase 3 registrational trial (NCT04887506) is a global, randomized, multi-center, open-label trial designed to evaluate the pharmacodynamic effect and safety profile of TAVT-45 Granules compared to Zytiga tablets, in combination with prednisone, in patients with mCSPC and mCRPC. In addition to establishing therapeutic equivalence between TAVT-45 Granules and Zytiga tablets, the study aims to characterize the multiple-dose pharmacokinetic profile of TAVT-45 Granules. Topline results for the trial are expected by the end of this year.

"On behalf of Tavanta, we would like to thank the clinical study site investigators and the patients who are participating in and supporting this pivotal trial, especially in light of the ongoing challenges of the COVID-19 pandemic. We look forward to completing the dosing and follow-up phases of the study," said Lynne Powell, chief executive officer of Tavanta Therapeutics. "As we work to complete this registrational trial for TAVT-45, we will begin preparing for the submission of our New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2023, while also evaluating strategic options for commercialization of TAVT-45."

About TAVT-45 Granules
TAVT-45 Granules is an enhanced formulation of abiraterone acetate for the treatment of metastatic prostate cancer. When reconstituted with water or juice to yield an oral suspension, TAVT-45 Granules may provide an alternative for the 20 to 30 percent of patients who suffer from dysphagia or have difficulty swallowing tablets and may increase the bioavailability of abiraterone and therefore allow a lower dose to be administered. In addition to the multiple large tablets required daily, other limitations of Zytiga include the requirement to be taken on an empty stomach and the high variability in systemic exposure. This high variability in systemic exposure has been shown to result in patients with low abiraterone plasma concentrations and exposure, which can lead to suboptimal clinical outcomes.i,ii It is anticipated that TAVT-45 Granules may be given regardless of food consumption and may result in fewer patients having sub-optimal abiraterone trough plasma concentrations.

On August 01, 2022 BioInvent International reported treatment of the first patient in a Phase 1/2a trial of its second anti-FcyRIIB antibody BI-1607 in combination with trastuzumab in HER2+ solid tumors (Press release, BioInvent, AUG 1, 2022, View Source [SID1234618934]).

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The first-in-human Phase 1 trial is a dose escalation study of BI-1607 combined with trastuzumab in HER2+ advanced or metastatic solid tumors. The selected dose of BI-1607 will be studied in a subsequent Phase 2a part of the trial along with trastuzumab in advanced breast, metastatic gastric and gastroesophageal junction HER2+ cancers.

The first patient has been recruited to the Phase 1 part of the study which is expected to recruit between 12 and 26 subjects. The Phase 2a aims to recruit 30 patients in two cohorts of 15 subjects each (one cohort in breast and one in gastric and gastroesophageal cancers). The study will be carried out at 7-12 sites in Spain, the UK, Germany, and in the U.S.

"This new study with our exciting anti-FcyRIIB antibody BI-1607 marks BioInvent’s fifth clinical trial, with four distinct drug candidates, and it is a further demonstration of the productivity of our technology platform. Preclinical data have shown that a BI-1607 surrogate antibody enhances the therapeutic efficacy of anti-HER2 antibodies, and we look forward to further investigating this effect in human subjects," said Martin Welschof, CEO of BioInvent.

Like BI-1206, BioInvent’s lead FcyRIIB antibody, BI-1607 is intended to enhance the efficacy and overcome resistance to existing cancer treatments such as trastuzumab. Trastuzumab alone or in combination with chemotherapy significantly improves overall survival of HER2+ breast cancer patients. However, many patients remain uncured and develop resistance to trastuzumab resulting in relapse or progression of the disease. BI-1607 differs from BI-1206 in that BI-1607 has been engineered for reduced Fc-binding to FcyRs. This alteration generates a major differentiating factor between the two antibodies, and specifically with respect to the best combination partners.

Preclinical data presented at this year’s AACR (Free AACR Whitepaper), indicate that treatment with BI-1607 enhances the efficacy of current anti-HER2 regimens such as trastuzumab. HER2 is a driver of tumor formation and growth in approximately 20% of breast cancers, the most common cancer worldwide in women, and in gastric and gastroesophageal junction adenocarcinoma.