On June 3, 2023 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, together with CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093), reported promising initial clinical data for SYSA1801 (EO-3021) from the ongoing Phase 1 dose escalation and expansion study in China (Press release, Elevation Oncology, JUN 3, 2023, View Source;utm_medium=rss&utm_campaign=elevation-oncology-highlights-first-in-human-phase-1-sysa1801-eo-3021-clinical-data-to-be-presented-by-partner-cspc-pharmaceutical-group-limited-at-asco-2023 [SID1234632418]). These data will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting, being held June 2-6, 2023, in Chicago, IL.

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EO-3021 is a potential best-in-class antibody-drug conjugate (ADC) that has been designed to selectively deliver a cytotoxic payload directly to Claudin 18.2-expressing cancer cells to minimize toxicities and maximize anti-tumor activity. EO-3021 is a fully human monoclonal antibody (mAb) that targets Claudin 18.2 and is site-specifically conjugated to the cytotoxic agent monomethyl auristatin E (MMAE), via a cleavable linker with a drug-to-antibody ratio (DAR) of 2. Elevation Oncology’s partner, CSPC, is actively recruiting patients in the Phase 1 clinical trial of SYSA1801 (EO-3021) in China (NCT05009966).

"In these preliminary Phase 1 data, EO-3021 demonstrated an objective response rate of 47% in patients with resistant/refractory gastric cancer expressing Claudin 18.2, with a well-tolerated safety profile in a heavily pretreated patient population," said Valerie Malyvanh Jansen, M.D., Ph.D., Chief Medical Officer of Elevation Oncology. "While the study remains ongoing, the responses seen are particularly impressive, especially in the gastric cancer setting in tumors expressing Claudin 18.2. These results are highly informative as Elevation Oncology prepares to initiate a Phase 1 clinical trial of EO-3021 in the US in the second half of 2023."

"We are highly encouraged by these Phase 1 study data which demonstrate that SYSA1801 (EO-3021) is an active drug that has a well-tolerated safety profile in patients with difficult to treat cancers," said Chunlei Li, Ph.D., Chief Scientific Officer of CSPC Pharmaceutical Group Limited. "These data support the potential of this unique product candidate for patients with Claudin 18.2-expressing cancers."

Key Findings from the Phase 1 Study

As of the data cutoff date of November 5, 2022, 33 patients with resistant/refractory solid tumors that expressed Claudin 18.2 were enrolled
Patients received 0.5 mg/kg to 3 mg/kg of SYSA1801 (EO-3021) administered intravenously (IV) every 3 weeks (Q3W) as part of the dose escalation (n=17) portion of the study; in the dose expansion portion of the study, patients (n=16) were treated at effective doses (2.0 mg/kg IV Q3W and 2.5 mg/kg IV Q3W)
26 patients (78.8%) had gastric cancer (GC); 7 patients (21.2%) had pancreatic cancer
11 patients (33.3%) had been pretreated with ≥3 prior lines of therapy
21 patients (gastric cancer n=17; pancreatic cancer n=4) were evaluable for efficacy per RECIST v1.1
In gastric cancer, the objective response rate (ORR) was 47.1% (8 PRs, including 4 confirmed PRs) and the disease control rate (DCR) was 64.7%, including three patients with stable disease (SD)
The overall ORR was 38.1% (8 PRs, including 4 confirmed PRs) and DCR was 57.1% (including 4 SDs)
Of the 33 patients enrolled at the time of data cutoff, treatment-related adverse events (TRAEs) of any grade occurred in 25 patients (75.8%), including eight (24.2%) TRAEs of ≥Grade 3
The most common TRAEs (occurring in >20% of patients) were nausea (42.4%), vomiting (36.4%), dry eye syndrome (21.2%) and anemia (21.2%)
Two dose-limiting toxicities (DLTs) of Grade 3 nausea and vomiting occurred at the 3 mg/kg IV Q3W dose
No treatment-related deaths were reported
The dose escalation and expansion portion of the study in China is ongoing
Details for the ASCO (Free ASCO Whitepaper) 2023 Presentation are as Follows:

Title: First-in-human dose escalation and expansion study of SYSA1801, an antibody-drug conjugate targeting claudin 18.2 in patients with resistant/refractory solid tumors.
Presenter: Dr. Yakun Wang
Session Type: Poster Discussion Session
Session Title: Molecularly Targeted Agents and Tumor Biology
Poster Session Date and Time: Saturday, June 3, 2023, 8:00 a.m. – 11:00 a.m. CT
Poster Discussion Date and Time: Saturday, June 3, 2023, at 1:15 p.m. CT
Abstract Number: 3016
Poster Number: 214

The full presentation can be accessed under the resources and publications page of the Elevation Oncology website following the completion of the presentation session at ASCO (Free ASCO Whitepaper).

About EO-3021

EO-3021 (also known as SYSA1801) is a differentiated, clinical-stage antibody drug conjugate (ADC) comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and is site-specifically conjugated to the monomethyl auristatin E (MMAE) payload via a cleavable linker with a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is normally expressed in gastric epithelial cells. During malignant transformation in many solid tumors, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. An Investigational New Drug application for EO-3021 has been cleared by the U.S. Food and Drug Administration.

On June 3, 2023 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported positive lead-in data from its ongoing Phase 3 PEAK trial evaluating the selective KIT D816V inhibitor bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST) (Press release, Cogent Biosciences, JUN 3, 2023, View Source [SID1234632417]). The data are being presented today in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

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"The results presented today from the lead-in portion of the PEAK study are very encouraging, as the data continue to show that the combination of bezuclastinib and sunitinib has impressive clinical activity in highly refractory GIST patients and is well-tolerated," said Andrew Wagner, M.D., Ph.D., Senior Physician, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School. "These data reinforce the importance of the ongoing Phase 3 PEAK clinical trial, which has the potential to bring a new standard of care to imatinib-resistant GIST patients."

"These data reinforce our belief that the combination of bezuclastinib and sunitinib has the potential to become a new treatment option for second-line GIST patients," said Andrew Robbins, President, and Chief Executive Officer at Cogent Biosciences. "We are pleased to demonstrate in a robust clinical dataset that the addition of bezuclastinib to sunitinib does not appear to change the frequency or severity of adverse events associated with sunitinib monotherapy. In addition, we are encouraged by the performance of this combination in second-line GIST patients, the population we are currently enrolling in the Phase 3 PEAK clinical trial, with a disease control rate of 100% and 4 out of 7 patients now on treatment for more than 10 cycles."

PEAK Study Design
The PEAK study is a randomized, open-label, global, Phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib in GIST patients previously treated with imatinib. As of the data cutoff date of March 29, 2023, 39 patients had been treated in Part 1, with 19 patients in Part 1a and 20 patients in Part 1b. Seven patients had received only imatinib as prior therapy, and 32 patients had received at least 2 prior tyrosine kinase inhibitor (TKI) therapies.

Safety Data
As of the cutoff date of March 29, 2023, the combination of bezuclastinib and sunitinib was generally well-tolerated with an encouraging safety profile. The majority of treatment-emergent adverse events (TEAEs) were low-grade and reversible, with a low rate of Grade 3 or higher events observed. 23% of patients experienced dose reductions of either medication, and only two patients discontinued treatment due to adverse events. Across Part 1a and Part 1b, there were only two patients with serious adverse events reported that were possibly associated with either study medication including one patient with grade 2 neutrophil count decrease and pyrexia and grade 3 platelet count decrease and one patient with grade 2 bacterial peritonitis and grade 3 febrile neutropenia. Overall, the safety and tolerability profile of the combination appears consistent with that of single-agent sunitinib, suggesting that bezuclastinib is not adding to the overall frequency or severity of adverse events associated with single-agent sunitinib.

Clinical Activity Data
As of the cutoff date, 39 patients had been treated for at least one 28-day cycle, with a range of 1-13 cycles, and 25 of the 39 patients continue to receive treatment. Data were immature to estimate median progression free survival. Across the efficacy evaluable patients in Part 1, the disease control rate (CR + PR + durable SD) is currently 55%; including a 100% disease control rate and 17% ORR among the efficacy evaluable 2nd-line patients in Part 1a. Across the study, 21 patients have demonstrated radiographic evidence of reduction in target lesion diameter, including 4 patients who have achieved partial response. Among those responders the time to first response was as long as 8 cycles, suggesting that patients currently early in treatment may achieve responses over time.

As of June 1, 2023 four of the seven 2nd-line patients in Part 1a remain on study with at least 10 cycles of therapy.

Bezuclastinib Clinical Development
Cogent is actively enrolling patients in Part 2 of the Phase 3 registration-enabling PEAK trial, which is expected to include approximately 388 second-line, post imatinib GIST patients. Additionally, Cogent remains on track to present initial clinical data from SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 trial of bezuclastinib in patients with nonadvanced systemic mastocytosis in the second half of 2023. Data will include safety/tolerability, pharmacokinetics, and measures of clinical activity. The Company also expects to present clinical data from approximately 30 patients in Part 1 of the Phase 2 APEX trial in patients with advanced systemic mastocytosis at a scientific meeting in the second half of 2023.

Webcast Information and ASCO (Free ASCO Whitepaper) Poster
Cogent will host a webcast on Monday, June 5, 2023 at 8:00 a.m. ET (7:00 a.m. CT) to discuss today’s update, with participation from Andrew Wagner, M.D., Ph.D., Senior Physician, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School. The live event can be accessed on the Investor page of Cogent’s website at investors.cogentbio.com. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days.

The ASCO (Free ASCO Whitepaper) poster is available to registered conference attendees and is also in the Posters and Publications section of Cogent’s website at www.cogentbio.com/research.

On June 3, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported long-term follow up data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A in patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, Allogene, JUN 3, 2023, View Source [SID1234632413]). These data will also be presented in a poster session at the European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress on June 9, 2023.

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"We are excited to be the first to demonstrate the potential of allogeneic CD19 CAR T to induce durable complete remissions at a rate similar to approved autologous CD19 CAR T therapies. Our Phase 2 regimen also had a safety profile, including immune recovery, in line with approved options," said Zachary Roberts, M.D., Ph.D., Executive Vice President, Research & Development and Chief Medical Officer. "We believe our AlloCAR T product candidates have the potential to break down widespread access barriers to CAR T, and ultimately establish a new paradigm in cell therapy. These data underlie the excitement we and investigators have for our ongoing potentially pivotal Phase 2 ALPHA2 trial."

The updated analysis of ALPHA/ALPHA2 examined data from 12 CAR T-naïve patients with r/r LBCL who received a single dose of ALLO-501/501A manufactured using the Alloy process following a lymphodepletion regimen (FCA90) comprised of fludarabine (30 mg/m2/day x 3 days) and cyclophosphamide (300 mg/m2/day x 3 days) plus ALLO-647 (30 mg/day x 3 days). The median time from enrollment to the start of therapy was three days and all 12 patients were followed through a minimum of six months (data cutoff April 20, 2023).

Patients Treated with Phase 2 Regimen
(n=12)
Overall Response Rate (ORR), n (%) 8 (67)
Complete Response Rate (CR), n (%) 7 (58)
6 Month Complete Response, n (%) 5 (42)
As of the data cutoff, 7 of 12 (58%) patients achieved a CR and five (42%) maintained a CR through Month 6. Of the five patients who were in CR at 6 months, four (80%) remained in CR. The fifth patient had disease progression at 24 months. The median duration of response was 23.1 months with three patients remaining in remission for over 24 months and the longest remaining in remission for over 31 months.

All r/r CAR T naïve LBCL (N=33) Patients Treated with Phase 2 Regimen (N=12)
All Gr
N (%) Gr 3+
N (%) All Gr
N (%) Gr 3+
N (%)
CRS 8 (24) 0 4 (33) 0
ICANS 0 0 0 0
Neurotoxicity 13 (39) 2 (6) 4 (33) 0
GvHD 0 0 0 0
IRR 16 (49) 3 (9) 8 (67) 0
Infection 19 (58) 5 (15) 8 (67) 1 (8)
Prolonged Gr3+ Cytopenia - 4 (12) - 2 (17)
A safety analysis of 33 CAR T-naïve LBCL patients receiving Alloy process ALLO-501/501A product candidates at any dose and lymphodepletion schedule, including the 12 patients treated with the Phase 2 regimen, was also conducted. Treatment was generally well tolerated with no incidences of Grade 3 or greater cytokine release syndrome, and no cases of immune effector cell-associated neurotoxicity syndrome or graft versus host disease. Cytopenias and infections were manageable and comparable to the experience with autologous CAR T cell therapies in patients with r/r LBCL.

The ALPHA/ALPHA2 Phase 1 trials were designed to assess the safety, tolerability, and preliminary efficacy at increasing dose levels of ALLO-501 and ALLO-501A, allogeneic CAR T cell product candidates that target CD19. In addition to exploring cell doses, these studies evaluated various doses of ALLO-647, Allogene’s proprietary lymphodepleting antibody designed to prevent premature rejection of AlloCAR T cells. Allogene is currently enrolling the potentially pivotal Phase 2 ALPHA2 trial of ALLO-501A in LBCL and expects to complete enrollment in 1H2024.

About ALLO-501 and ALLO-501A
ALLO-501 and ALLO-501A are anti-CD19 AlloCAR T investigational products for the treatment of large B cell lymphoma. ALLO-501A, a next-generation anti-CD19 AlloCAR T, eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure. This product candidate is currently being studied in an ongoing potentially pivotal Phase 2 trial. In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in r/r LBCL.

On June 2, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing IgM antibodies, reported an update on its clinical development program for IGM-8444, a novel multivalent death receptor 5 (DR5) agonist, in patients with metastatic colorectal cancer (Press release, IGM Biosciences, JUN 2, 2023, View Source [SID1234632823]).

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"We continue to be very pleased with the indications of clinical activity that we are observing with IGM-8444," said Chris Takimoto, M.D., Ph.D., F.A.C.P., Chief Medical Officer of IGM Biosciences. "We are also very pleased with the excellent safety profile that we have seen to date. The absence of clinically significant hepatotoxicity is particularly important, as this has been a challenge for other multivalent DR5 agonists. The long progression-free survival that we have seen in some patients, especially those who have progressed on prior chemotherapy, is quite encouraging as we proceed to further clinical development with FOLFIRI and other combination agents. Our ongoing randomized trial with FOLFIRI plus bevacizumab is designed to confirm and quantify the activity of IGM-8444 in patients with second-line colorectal cancer."

Phase 1 data reported from a cohort of patients treated with IGM-8444 in combination with FOLFIRI, with and without bevacizumab, showed a very encouraging safety profile which was broadly comparable to that expected from chemotherapy alone in this setting. Specifically, in the 51 CRC patients treated with IGM-8444 plus FOLFIRI, with and without bevacizumab, no drug related clinically significant hepatotoxicity was observed and only grade 1 and grade 2 transient liver enzyme elevations were noted, through the data cut-off date of April 12, 2023.

The majority of colorectal patients in this study were on their third-line of treatment or beyond and over 70 percent of the patients treated with the combination regimens had previously been treated with irinotecan-based chemotherapy.

In these predominantly third-line metastatic colorectal cancer patients, the combination of IGM-8444 dosed at 3 mg/kg and FOLFIRI without bevacizumab showed promising activity. This is the group of patients which had the longest treatment follow up. In this 24 patient group, the median progression-free survival (PFS) in the 24 patients was 5.6 months as of the data cut-off date of April 12, 2023, which is higher than the historical median progression-free survival of approximately 2 months with standard of care third-line colorectal cancer treatment without bevacizumab. The longest observed progression-free survival in this group has extended beyond 16 months and 11 of these 24 patients remained on treatment as of the data cut-off. Importantly, multiple patients showed longer durations of treatment with IGM-8444 and FOLFIRI than they had with their previous FOLFIRI regimens.

More recently, the Company began treating patients with the addition of bevacizumab to 3 mg/kg of IGM-8444 and FOLFIRI. For the 17 evaluable patients in this group, the median progression-free survival was not reached and 13 of the 17 patients remained on study, as of the data cut-off.

At the time of the data cut-off, multiple confirmed partial responses were observed among the patients treated with 3 mg/kg of IGM-8444 and FOLFIRI, with and without bevacizumab, including some patients who had previously progressed on FOLFIRI treatment.

Encouraged by these results, IGM has initiated a randomized trial in second-line patients with metastatic colorectal cancer to assess the benefit of 3 mg/kg of IGM-8444 combined with the current standard of care regimen of FOLFIRI and bevacizumab. This open-label trial began in the first quarter of 2023, and the Company hopes to have enrolled approximately 110 patients in the trial by the first quarter of 2024 and to have median progression-free survival data from these patients by the end of 2024.

Conference Call and Webcast

The Company will host a conference call and live webcast to provide an update on its clinical development program for IGM-8444 at 7:00 p.m. ET today, June 2, 2023. The webcast can be accessed by clicking the link: View Source, and will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website. A replay of the webcast will be archived on the Company’s website for 90 days following the presentation. A more detailed presentation of the results will be made available on the Company’s website at www.igmbio.com.

About IGM-8444

IGM-8444 is an IgM antibody targeting death receptor 5 (DR5) that is being developed for the treatment of patients with solid and hematologic malignancies. DR5 is a member of the tumor necrosis factor receptor superfamily (TNFrSF) and is often expressed on the surface of cancer cells. Strong activation of the DR5 pathway requires multiple receptors to be cross-linked simultaneously by an antibody or other binding agent to create an apoptotic death signal to the cell. Unlike traditional IgG antibodies, IGM-8444 has 10 binding units, enabling it to cross-link multiple DR5 receptors at the same time, sending a stronger signal to cause cancer cell death. The Company is currently conducting a multicenter, open-label clinical trial to determine the safety, tolerability, and pharmacokinetics of IGM-8444 as a single agent and in combination in subjects with relapsed and/or refractory solid or hematologic cancers.

On June 2, 2023 Cytovation ASA, a clinical stage immune-oncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy CyPep-1, reported the successful closing of its $8 million (NOK 85 million) Series A extension financing round (Press release, Cytovation, JUN 2, 2023, View Source;utm_medium=rss&utm_campaign=cytovation-raises-8-million-in-series-a-extension-financing-round-for-clinical-advancement-of-cypep-1-a-first-in-class-targeted-tumor-membrane-immunotherapy [SID1234632468]). This new investment will support the progress of Cytovation’s lead asset, CyPep-1, into a full Phase 2 program for the treatment of solid tumors.

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CyPep-1 has the potential to transform the treatment of solid tumors through its unique multi-modal mechanism of action, eliminating cancer cells by:

targeting phospholipids in cancer cells,
forming pores in the plasma membrane,
releasing antigens to the immune system,
promoting an inflammatory microenvironment, and
inducing a tumor-specific immune response by in situ vaccination
Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: "We are delighted to announce the successful closing of this latest financing round following our initial $20 million Series A round in January 2022, allowing us to advance CyPep-1 towards clinical proof of concept in Phase 2. We continue to make excellent progress in our ongoing Phase 1/2 CICILIA solid tumor basket trial, and with our IND in hand we will now expand clinical development to the US. We look forward to announcing initial results from CICILIA, including in combination with pembrolizumab, in the second half of 2023."

The financing round extension was co-led by existing investors Sandwater, a Norwegian venture capital firm that invests in ground-breaking companies with a positive impact across a range of industries including life science, and Canica, a large, privately owned investment company operating out of Norway and Switzerland that is focused on building highly innovative companies that aim to create value for investors and society. Cytovation also welcomed participation from several new investors reflecting the growing interest in the potential of CyPep-1 as a first-in-class targeted tumor membrane immunotherapy.

Cytovation’s 57-patient Phase 1/2 CICILIA solid tumor basket trial is now well advanced, with top line results due in H2 2023. The Phase 2a monotherapy expansion arm builds on strong Phase 1 monotherapy data, which demonstrated a favorable safety profile along with early signals of efficacy in several tumor types. CICILIA also includes an arm in which CyPep-1 is combined with pembrolizumab, as part of an ongoing clinical trial collaboration and supply agreement with Merck/MSD.

Cytovation is seeking to develop CyPep-1 in selected neoplastic orphan indications that may allow an expedited pathway to a first approval, while supporting the broader potential of CyPep-1 across a range of solid tumors.

Given the significant potential of CyPep-1, Cytovation recently announced the expansion of its senior management team with the hiring of Iman Barilero, PharmD, PhD, as Chief Development Officer, and

Helen Blanco, MBA, as VP Operations. These new team members will be central to the Company’s mission to develop CyPep-1 to enhance the lives of cancer patients suffering from a variety of solid tumors.