On April 11, 2022 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, reported an amendment of the agreement with Phoenixus AG, formerly known as Vyera Pharmaceuticals AG ("Vyera"), for the development of SLS-002 (intranasal racemic ketamine) to repurchase in cash and stock the remaining royalties payable on any future net sales of SLS-002, all future success and commercial based milestones and the change of control fee in the event SLS-002 is acquired (Press release, Apricus Biosciences, APR 11, 2022, View Source [SID1234611975]).

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On March 6, 2018, Seelos entered into an asset purchase agreement (the "Purchase Agreement") with Vyera, currently known as Phoenixus AG, to acquire the assets and liabilities of Vyera’s intranasal racemic ketamine program, which Seelos now calls SLS-002. As additional consideration to certain upfront cash and equity payments and success-based milestone payments contemplated under the prior agreement, Seelos agreed to pay a mid-teens percentage royalty on any future net sales of SLS-002. In February 2021, Seelos amended the asset purchase agreement, for three additional cash payments, agreeing to repurchase 9% of the future royalties and reduce its royalty obligations to a mid-single digit percentage on any future net sales of SLS-002. Seelos completed those payments in February, June, and September of 2021. Under the amendment entered into on April 8, 2022, for additional cash and stock payments due by April 2022, July 2022 and January 2023, the parties have agreed to terminate in full all contingent payment obligations to Vyera and its related entities under the Purchase Agreement, effective upon the payment and issuance of all cash and stock payments.

"We believe this repurchase of the remaining financial obligations owed or that may become payable on SLS-002 has the potential to return meaningful future value to Seelos’ stockholders, assuming we are successful in the clinical development, regulatory approval processes, and commercialization of the intranasal ketamine program," said Raj Mehra, Ph.D., Chairman and CEO of Seelos.

"This amendment removes all future royalties due to Vyera, nearly $100 million of potential future milestones and a change of control fee in the event this program were to be acquired as a standalone transaction or as part of a larger transaction," said Michael Golembiewski, CFO of Seelos.

About SLS-002

SLS-002 is intranasal racemic ketamine with two investigational new drug applications for the treatment

of Acute Suicidal Ideation and Behavior in Major Depressive Disorder or Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. SLS-002 looks to address an unmet need for a therapy to treat suicidality in the U.S. Traditionally, anti-depressants have been used in this setting but many of the existing treatments are known to contribute to an increased risk of suicidal thoughts in some circumstances, and if they are effective, it often takes weeks for the full therapeutic effect to be manifested. The clinical development program for SLS-002 included two parallel healthy volunteer studies (Phase I) and is being followed by pivotal registration studies after meeting with the FDA. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were more than 1,000,000 visits to emergency rooms for suicide attempts in 2019 in the U.S. alone. Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for depression and suicidality.

On April 11, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that Brian M. Culley, the Company’s Chief Executive Officer, will be presenting at NobleCon18 – Noble Capital Markets’ Eighteenth Annual Investor Conference on April 20th, 2022 at 4:30pm ET in Seminole Ballroom A (Press release, Lineage Cell Therapeutics, APR 11, 2022, View Source [SID1234611974]). NobleCon18 is taking place at the Hard Rock Hotel & Casino in Hollywood, Florida, April 19th – 21st, 2022.

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An archived webcast of the corporate presentation will be available starting April 21st, 2022 on the Events and Presentations page of the Lineage website, and as part of a complete catalog of presentations available on the conference website: www.nobleconference.com and on Channelchek www.channelchek.com, the investor portal created by Noble Capital Markets. Additional videos are available on the Media page of the Lineage website.

On April 11, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the Company’s TakeAim Lymphoma study (NCT03328078) (Press release, Curis, APR 11, 2022, View Source [SID1234611973]). The TakeAim Lymphoma study is a Phase 1/2 open-label dose escalating clinical trial investigating emavusertib in patients with B-cell malignancies.

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This notification from the FDA Division of Hematologic Malignancies 2 (DHM2), which regulates clinical studies in lymphoma, is separate from the notification previously received from the FDA Division of Hematologic Malignancies 1 (DHM1), which regulates clinical studies in leukemia.

This week’s notification extends the partial hold across both studies. This is not unexpected, as both studies treat patients with emavusertib. And, as previously announced, the Company had already voluntarily paused enrollment in the TakeAim Lymphoma study in connection with its announcement on April 4, 2022 of the FDA’s partial clinical hold on the TakeAim Leukemia study.

"We reiterate our previous comments: we are committed to ensuring the safety of patients in our studies and to working collaboratively with the FDA to develop therapies that meaningfully improve and extend patients’ lives," said James Dentzer, Chief Executive Officer of Curis. "Given the clinical profile of emavusertib observed to date, we are hopeful that the study can be resumed soon, after appropriate review. We continue to be confident in the potential of emavusertib to address the high unmet need of patients with B-cell cancers, AML, or MDS."

While the partial hold on the TakeAim Lymphoma study is in place, no new patients will be enrolled in that study, and current study participants benefiting from treatment may continue to be treated with emavusertib at doses of 300mg BID or lower after being reconsented.

Consistent with the previous notification, FDA is requesting additional safety, efficacy, and other data relating to emavusertib, including data related to rhabdomyolysis and the Company’s determination of the Recommended Phase 2 Dose for emavusertib.

Curis expects to provide updated guidance on the timing of discussing the potential for a rapid registrational path for emavusertib with the FDA after the partial clinical holds are resolved and the related impact on the trials can be determined.

On April 11, 2022 Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance reported favorable safety and efficacy data supporting the advancement of CM24, a first-in-class clinical stage monoclonal antibody with the potential to treat multiple solid tumor cancers (Press release, Purple Biotech, APR 11, 2022, View Source [SID1234611972]). Data from the Phase 1b study of CM24 in combination with Opdivo (nivolumab) is being presented in a poster entitled "Interim Safety and Efficacy Results from a Phase 1b Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors" at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting.

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In the Phase 1 part of the study (NCT04731467), patients with refractory cancers including PDAC were administered with CM24 at 10, 15, and 20mg/kg q2w and Opdivo 480mg q4w. The primary objective of this part of the study is to evaluate safety, tolerability, PK and determine the recommended Phase 2 dose (RP2D). As of March 8th, 2022, a total of 11 patients were evaluated in the dose escalation phase, for dose limiting toxicity (DLT) determination, including 8 with pancreatic cancer (PDAC), two with colorectal cancer (CRC) and one with papillary thyroid cancer (PTC). All patients but two had received 2 prior regimens for metastatic disease.

No DLTs were observed across all dose levels; no Grade 4 AEs or treatment related deaths have been reported. Six Grade 3 adverse events (AEs) that were unrelated to CM24 or Opdivo were observed, each in a single patient, including diarrhea, hypokalemia, abdominal pain, small bowel obstruction, atrial flutter, and GI bleed.

Of the evaluated patients, best overall response included one confirmed PR (PDAC patient) and three SD (two PDAC and one PTC patient), with a disease control rate of 36%. In addition, nine patients continue to remain in the study follow-up, suggesting a potential promising clinical benefit of CM24 for patients with hard-to-treat, advanced pancreatic cancer and PTC.

Pharmacokinetic analysis of CM24 shows exposure is dose-proportional across the three doses assessed in this study; Complete receptor occupancy of peripheral CEACAM1 receptors on T cells and neutrophils was demonstrated following the first administration of CM24 doses of 15 or 20mg/kg.

"We are encouraged by these compelling interim data," said Michael Schickler, PhD, Head of Clinical and Regulatory Affairs of Purple Biotech. "Pancreatic cancer is responsible for roughly 8% of all new cancer deaths in the US, while current treatment options for pancreatic cancer are limited and have yet to demonstrate continued efficacy. The good safety profile of CM24 in combination with Opdivo and the positive efficacy signals in our study, specifically the response of PDAC patient to a novel treatment with two immunotherapy agents, are encouraging as we continue our clinical development."

"CM24 is currently the most advanced humanized monoclonal antibody that blocks CEACAM1, a novel immune checkpoint protein that supports tumor immune evasion and survival through multiple pathways," said Isaac Israel, CEO of Purple Biotech. "Purple Biotech has built a pipeline of novel agents and we are looking forward to advancing our therapeutic candidates to different indications and to report more data during 2022."

This poster presentation is available at: View Source

OPDIVO is a registered trademark of Bristol-Myers Squibb Company.

On April 11, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported two poster presentations at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting taking place April 8-13, 2022 (Press release, Cogent Biosciences, APR 11, 2022, View Source [SID1234611970]). The first included updated nonclinical bezuclastinib data reinforcing its potential to be a differentiated, best-in-class KIT mutant inhibitor. The second focused on nonclinical data from Cogent’s next-generation fibroblast growth factor receptor 2 (FGFR2) research program, designed to spare FGFR1 while potently covering all gatekeeper and molecular brake mutations. Finally, the company shared additional details at an R&D Investor Event, on its portfolio expansion plans by highlighting its early efforts to develop an ErbB2 mutant selective inhibitor for patients with non-exon 20 mutations.

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"We continue to make significant progress establishing Cogent as an emerging leader in precision medicines for genetically defined diseases," said Andrew Robbins, President and Chief Executive Officer of Cogent Biosciences. "This weekend we presented updated nonclinical data adding to a growing body of evidence supporting bezuclastinib as a potential best-in-class KIT mutant inhibitor for systemic mastocytosis and gastrointestinal stromal tumor (GIST) patients. Separately, we introduced two novel programs from the Cogent Research Team which highlighted our growing portfolio of novel, small-molecule targeted therapies for patients fighting genetically driven diseases. We continue to enroll patients into our APEX, SUMMIT and PEAK trials and look forward to sharing initial clinical results from the APEX study later this quarter."

Bezuclastinib Nonclinical Data
Bezuclastinib is a tyrosine kinase inhibitor that is active against KIT mutations relevant to both systemic mastocytosis (SM) and gastrointestinal stromal tumors (GIST). New nonclinical data, presented at AACR (Free AACR Whitepaper), demonstrates that bezuclastinib potently inhibits A loop-mutations exquisitely selective against other closely related kinases, and differentiates bezuclastinib by its lack of brain penetration. These data support that bezuclastinib inhibits KIT downstream signaling and is able to drive tumor regressions at clinically achievable doses.

"Currently approved KIT inhibitors are limited by off-target toxicities related to broad-spectrum kinase inhibition, secondary activation loop mutations, CNS-related adverse events, and sub-optimal clinical dosing," said Jessica Sachs, MD, Cogent’s Chief Medical Officer. "With KIT mutations serving as driver mutations in up to 80% of GIST and over 90% of systemic mastocytosis, we’re excited with the growing validation of bezuclastinib as a highly potent and selective inhibitor of KIT D816V and remain focused on advancing our ongoing clinical trials."

Growing Pipeline of Small Molecule Inhibitors
Cogent’s research team is also building a pipeline of small molecule inhibitors. FGFR inhibitors are well-established oncogenic drivers in multiple diseases, but approved medicines fail to capture the full landscape of FGFR altered tumor types, with FGFR1-mediated hyperphosphatemia serving as the most common dose-limiting toxicity for pan-FGFR inhibitors. Based on preclinical data presented, the Company’s FGFR program has the potential to both spare FGFR1 inhibition, avoiding related toxicity, as well as potently cover the relevant molecular brake and gatekeeper mutations associated with this target. Cogent is advancing a potent, selective FGFR2 inhibitor program toward candidate selection later this year and expects to file this first internally developed Investigational New Drug application (IND) in the second half of 2023.

The Company also shared an early look at a novel, non-exon 20 ErbB2 mutant program. ErbB2 is a tyrosine kinase receptor that belongs to a family of four receptors, which are also known as HER1, HER2, HER3 and HER4, respectively. A significant unmet need remains for patients with non-exon 20 ErbB2 mutations. Activating mutations in the ErbB2 gene have been identified in multiple cancers and demonstrate a tumorigenic role similar to that of ErbB2 amplification.

"We’ve made tremendous progress moving our programs from early discovery into lead generation," said John Robinson, PhD, Cogent’s Chief Scientific Officer. "We are pleased to share the latest developments which highlight the ability of our team to discover new treatment candidates in genetically defined diseases with high unmet need, and we look forward to discussing additional programs in the future, including potential first-to-market opportunities."