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Kineta Announces New Research Agreement to Evaluate VISTA Biomarker Expression

On September 18, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported a research agreement with Fred Hutchinson Cancer Center to evaluate VISTA expression as a potential biomarker in cancer patients from Kineta’s ongoing Phase 1/2 clinical trial evaluating KVA12123, the company’s VISTA blocking immunotherapy, alone and in combination with pembrolizumab (Press release, Kineta, SEP 18, 2023, View Source;utm_medium=rss&utm_campaign=kineta-announces-new-research-agreement-to-evaluate-vista-biomarker-expression [SID1234635205]).

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The primary objective is to evaluate VISTA as a biomarker to guide patient selection and treatment optimization for VISTA-targeted therapies where no standardized scoring method currently exists. Similar to standards established for PD-L1 immune checkpoint, there is a need to quantify VISTA expression in the tumor microenvironment (TME) to properly guide patient selection.

"We are excited to work with the Fred Hutchinson Cancer Center and tap into their cancer pathology expertise as we advance the clinical development of KVA12123," said Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta. "VISTA expression has the potential to be a clinically relevant biomarker that we can use to inform our Phase 2 clinical study design with KVA12123 and ultimately predict positive anti-tumor responses to treatment."

VISTA is a negative immune checkpoint that suppresses T cell function in a variety of solid tumors. High VISTA expression in tumor correlates with poor survival in cancer patients and has been associated with a lack of response to other immune checkpoint inhibitors. Blocking VISTA induces an efficient polyfunctional immune response to address immunosuppression and drives anti-tumor responses.

KVA12123 is a fully human engineered IgG1 monoclonal antibody that was designed to bind to VISTA through a unique epitope at both physiologic and acidic pH levels. KVA12123 may be an effective immunotherapy for many types of cancer including NSCLC (lung), colorectal, renal cell carcinoma, head and neck, and ovarian. Initial clinical data from Kineta’s ongoing Phase 1/2 study of KVA12123 in advanced solid tumors is anticipated by end of 2023.

KayoThera, Inc. Nominates First-in-Class, Oral Inhibitor of the Retinoid Pathway in Genetically Defined Oncology Indications as a Development Candidate

On September 18, 2023 KayoThera, Inc. ("KayoThera"), an early-stage therapeutics company developing first-in-class, oral, small molecule inhibitors of the retinoid pathway, reported that it has selected KAYO-1609 as its first drug development candidate (Press release, KayoThera, SEP 18, 2023, View Source [SID1234635204]). KAYO-1609 has demonstrated a differentiated safety profile across a variety of species with ideal drug-like properties. Preclinical studies in multiple models of cancer support the potential of KAYO-1609 in the treatment of genetically-defined cancers based on the molecule’s mechanism of action. With the nomination of KAYO-1609 as the development candidate, KayoThera is well-positioned for IND-enabling studies, clinical planning, and partnering activities.

Retinoid signaling is known to both inhibit helper CD4 T cells that mediate tumor cell destruction, and cause maturation of regulatory T cells that dampen the immune system’s response to cancer. Retinoid signaling further forces differentiation of monocytes into tumor-associated macrophages that can promote tumor growth and metastasis. Collectively, these activities reduce the immune system’s ability to detect and eliminate malignant cells. Inhibition of the amplified retinoid signaling found in unique tumor types could potentially restore or enhance the anti-tumor immune activity, enabling a unique approach to cancer immunotherapy in patients with few therapeutic options.

"Despite its known roles in blunting the body’s anti-tumor immune defense, previous efforts to develop retinoid signaling antagonists have failed due to unacceptable toxicity in preclinical development," said Mark Esposito, Ph.D., vice president of R&D, and co-founder of KayoThera. "The discoveries on which KayoThera was founded enable the development of orally available, small molecule inhibitors of this important signaling pathway that have very favorable safety profiles. The preclinical safety and efficacy data generated to date in studies of KAYO-1609 are exceptionally promising, and we intend to move as rapidly as possible toward initiating human clinical trials of this novel molecule in genetically-defined cancers."

KAYO-1609 has demonstrated excellent safety and tolerability, with no dose-limiting toxicities observed in studies across five different species. Preclinical studies also have identified a dose-responsive biomarker for target engagement that is expected to facilitate the IND-enabling studies. KayoThera expects to initiate IND-enabling studies of KAYO-1609 in the third quarter of 2023 and anticipates filing an IND application with the FDA by the end of 2024. Following acceptance of the IND, the company plans to initiate a human clinical trial of KAYO-1609 in patients with genetically-defined cancers that are most likely to demonstrate clinical benefit based on the mechanism of action of KAYO-1609.

"The selection of KAYO-1609 as our lead oncology development candidate is the most recent demonstration of the significant progress, we have made over the past few months to position KayoThera for success," said Kendall Mohler Ph.D., chief development officer and board member of KayoThera. "In May we announced the expansion of our pipeline into the cardiometabolic disease space, with a focus on Type 2 diabetes and in July we strengthened our financial position with multiple grants and the expansion of our Series A financing. Taken together, we now have the financial resources to advance exciting and differentiated candidates in cancer and Type 2 diabetes, diseases with significant unmet clinical need that are associated with significant mortality and morbidity. We are committed to developing retinoid signaling pathway inhibitors as novel therapeutic modalities that can improve outcomes for patients living with these and other serious diseases."

ImmunoGen Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On September 18, 2023 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that in connection with the previously announced appointment of Ms. Lauren White as ImmunoGen’s Senior Vice President and Chief Financial Officer, the compensation committee of the Company’s Board of Directors (the "Compensation Committee") approved grants of non-qualified stock options to purchase 295,975 shares of its common stock and restricted stock units ("RSUs") covering 51,625 shares of its common stock under the Inducement Plan to Ms. White (Press release, ImmunoGen, SEP 18, 2023, View Source [SID1234635203]).

The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of ImmunoGen (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with ImmunoGen, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

The options have an exercise price of $15.71 per share, which is equal to the closing price of ImmunoGen’s common stock on the Nasdaq Global Select Market on September 18, 2023. Each option will vest as to 25% of the shares underlying such option on the first anniversary of the grant date and as to an additional 6.25% of the shares underlying the option quarterly thereafter, subject to Ms. White’s continued employment on each vesting date. Each RSU will vest as to 25% of the shares underlying the RSU award on the first anniversary of the grant date and as to an additional 25% of the shares underlying the RSU award annually thereafter, subject to Ms. White’s continued employment on each vesting date. Each option and RSU is subject to the terms and conditions of the Inducement Plan and the terms and conditions of a stock option agreement and an RSU agreement covering the respective grants.

Galera Schedules Type A Meeting with FDA to Discuss Next Steps for Avasopasem

On September 18, 2023 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported that a Type A Meeting has been scheduled for September 28, 2023 with the U.S. Food and Drug Administration (FDA) regarding the Complete Response Letter (CRL) received for the Company’s New Drug Application (NDA) for avasopasem manganese (avasopasem) (Press release, Galera Therapeutics, SEP 18, 2023, View Source [SID1234635202]). The FDA is expected to issue written meeting minutes approximately 30 days following the meeting.

"We look forward to further understanding the FDA’s review of our NDA for avasopasem and the data from our two randomized placebo-controlled clinical trials," said Mel Sorensen, M.D., Galera’s President and CEO. "We believe in avasopasem’s potential to bring meaningful benefit to patients with head and neck cancer suffering from severe oral mucositis. With clarity on the perspective of the FDA reviewers from the meeting and subsequent minutes, we hope to identify necessary steps to bring avasopasem to these patients."

The Company intends to gain an understanding from the FDA of its evaluation of avasopasem for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment and next steps to support an NDA resubmission. The Type A Meeting is the highest priority classification of meeting that the FDA grants to NDA sponsors.

Aptose to Present at the Cantor Global Healthcare Conference

On September 18, 2023 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported that the Aptose management team will participate in the Cantor Global Healthcare Conference being held September 26-28, 2023, in New York City (Press release, Aptose Biosciences, SEP 18, 2023, View Source [SID1234635200]).

Dr. William G. Rice, Chairman, President and CEO of Aptose, will participate on a panel, Targeted Therapies for AML, and with Mr. Fletcher Payne, CFO of Aptose, will be hosting one-on-one meetings during the conference. To schedule a one-on-one meeting with the Aptose management team, please contact your conference representative.

Cantor Global Healthcare Conference 2023

Date: Wednesday, September 27, 2023
Presentation Time: 9:10 – 9:40 AM (Track 2)
Format: Panel Presentation, Webcast
Speaker: William G. Rice, PhD, Chairman, President and Chief Executive Officer
Webcast Link: Click here (View Source)

Recent Clinical Data Highlight with Tuspetinib

Aptose recently provided an update from the ongoing APTIVATE Phase 1/2 clinical trial with lead agent, tuspetinib, a once daily oral agent with a unique kinase targeting pattern being developed for the treatment of patients with relapsed/refractory (R/R) AML. As of August 1, 2023, fifteen (15) patients had been dosed with the tuspetinib/venetoclax (TUS/VEN) doublet, ten (10) had reached an efficacy evaluable stage, and five (5) of the ten evaluable patients had achieved early responses (composite Complete Response rate (CRc) includes any CR, CRh, CRi and CRp). Among the ten (10) evaluable patients, nine (9) had failed prior venetoclax treatment (Prior-VEN), representing an emerging population with severe unmet medical need. Four (4) of the nine (9) Prior-VEN failure patients had already achieved responses with TUS/VEN (44% CRc). Three (3) responses emerged among seven (7) of the evaluable patients with wildtype FLT3 (43% CRc), which accounts for approximately 70% of the AML population, yet there are few treatment options and little in development for the wildtype patient population. Additionally, two (2) of three (3) patients with mutated FLT3 (67%) achieved responses. As a single agent, TUS at its RP2D of 80mg achieved a 42% CR/CRh rate in patients who had not failed prior therapy with venetoclax, and as the TUS/VEN doublet achieved a 44% CRc rate in Prio-VEN failure patients, demonstrating the utility of TUS across AML populations. Importantly, TUS as a single agent and the TUS/VEN combination continue to be safe and well tolerated.

AML Subgroup CRc Responses to TUS/VEN
Evaluable (10) 50% (5 of 10)
Prior-VEN (9) 44% (4 of 9)
FLT3-WT (7) 43% (3 of 7)
FLT3-MUT (3) 67% (2 of 3)
Aptose expects to update these data and release data on additional evaluable patients next month during the European School of Haematology (ESH) meeting in Estoril, Portugal.