On November 9, 2023 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, reported financial results for the third quarter ended September 30, 2023, and provided a corporate update (Press release, Synlogic, NOV 9, 2023, View Source [SID1234637424]).

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"This quarter brought us important progress on multiple fronts, including the closing of a financing which extended our cash runway into the first half of 2025," said Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer. "We are pleased with our progress in Synpheny-3, our ongoing pivotal study in PKU, which is also expected to readout in the first half of 2025, and we are grateful to our investigators and their staff at our clinical trial sites, as well as the PKU community for their continued support and partnership as we execute this landmark trial."

Recent Business Highlights

Closing of $21.0 million underwritten public offering, extending the Company’s cash runway into the first half of 2025.
Progress with Synpheny-3, the pivotal study of labafenogene marselecobac for PKU, with operations across the United States and Canada, with additional countries expected before year-end 2023 and in early 2024.
Receipt of Fast Track Designation from the FDA for labafenogene marselecobac for the treatment of phenylketonuria.
Publication of Synpheny-1 Phase 2 study results for the PKU program in the journal Nature Metabolism.
Presentation of Synpheny-1 Phase 2 study results by lead investigator Dr. Jerry Vockley of the University of Pittsburgh at the 37th E.S.PKU Conference 2023.
Granting of an important US Patent (US Pat. No. 11,766,463), specifically covering the mutant PAL enzyme expressed by labafenogene marselecobac and extending the patent term exclusivity for SYNB1934 to 2041.
Earning of $2.5 million milestone payment for the achievement of prespecified success criteria under the research collaboration agreement with Roche for the discovery of a novel Synthetic Biotic for the treatment of inflammatory bowel disease (IBD).
Anticipated Milestones for Synpheny-3 Pivotal Study in PKU

Data safety monitoring board review of initial subset of data in the first half of 2024, potentially supporting study expansion to include 12- to 18-year-olds.
Completion of full study enrollment in the second half of 2024.
Release of top-line data in the first half of 2025.
Upcoming Scientific & Industry Presentations

Caroline Kurtz, Ph.D., Chief Development Officer at Synlogic, will present "Development of labafenogene marselecobac (SYNB1934), an engineered probiotic designed for the treatment of phenylketonuria (PKU)," on Thursday, November 16th at the 20th Orphan Drugs & Rare Diseases Global Congress 2023 Americas, held in Boston on November 16th and 17th.
David Lubkowicz, M.S., Head, Strain Engineering & Characterization and HCU Program Lead at Synlogic, will present "Improvements of SYNB1353, an Engineered Bacteria for the Treatment of Homocystinuria Lead to Increased in Vitro and In Vivo Degradation of Methionine," at the International Conference on Microbiome Engineering 2023, held in Berkley, California on December 8th to 10th.
Third Quarter 2023 Financial Results and Financial Outlook

As of September 30, 2023, Synlogic had cash, cash equivalents and short-term investments of $33.4 million, not inclusive of the October financing of $19.6 million (net), and an additional $2.5 million earned from the Roche research collaboration milestone announced in November.

Revenue for the three months ended September 30, 2023 was $0.4 million compared to $0.7 million for the corresponding period in 2022. Revenue in both periods was primarily associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic for the treatment of inflammatory bowel disease.

For the three months ended September 30, 2023, Synlogic reported a consolidated net loss of $12.1 million, or $2.57 per share, compared to a consolidated net loss of $17.9 million, or $3.73 per share, for the corresponding period in 2022.

Research and development expenses were $9.6 million for the three months ended September 30, 2023, compared to $14.6 million for the corresponding period in 2022.

General and administrative expenses were $3.4 million for the three months ended September 30, 2023, compared to $4.4 million for the corresponding period in 2022.

Based upon its current operating plan and inclusive of the net cash proceeds from the October financing and milestone payment from Roche, Synlogic expects to have sufficient cash to be able to fund operations further into the first half of 2025.

On November 9, 2023 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported financial results for the quarter ended September 30, 2023, and provided recent business highlights (Press release, Shattuck Labs, NOV 9, 2023, View Source [SID1234637422]).

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"We are encouraged by the interim data for SL-172154 in combination with PLD in a group of PROC patients with advanced disease. These data are early, and require both additional patients and longer follow-up, but provide reason for optimism in this study because an overall response rate of 25-30% with SL-171514 in combination with PLD is distinct from a benchmark response rate of 4% with PLD alone," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "We look forward to sharing data from our ongoing combination clinical trial with AZA in frontline HR-MDS and TP53 mutant AML in December."

SL-172154 Clinical Update: Phase 1B Clinical Trial of SL-172154 in Combination with PLD in PROC

Key Takeaways: Observed three partial responses (one confirmed with 58% reduction in target lesion diameter and two unconfirmed with 100% and 31% reductions in target lesion diameter) out of 11 evaluable patients with PROC for SL-172154 in combination with PLD. The initial data suggest SL-172154 had an acceptable safety profile in combination with PLD.
•Data overview: As of the data cut-off date of October 31, 2023, 16 adult patients with PROC have been dosed in the ongoing Phase 1B clinical study, of which 11 patients were evaluable for response. Patients had a median of 1.5 prior lines of systemic therapy, 47% had bulky disease measuring >5 cm, 56% were pre-treated with bevacizumab and 88% were resistant to frontline platinum regimen.
•Preliminary anti-tumor activity: As of the data cut-off date of October 31, 2023, three partial responses (one confirmed, two unconfirmed) had been observed for SL-172154 in combination with PLD. As of November 9, 2023, both patients with unconfirmed partial responses remain on study and have not reached the date of confirmatory response assessment.
•Response rate benchmark for PLD: The patient population treated in this study to date is similar to the population enrolled in the Pfizer-sponsored JAVELIN Ovarian 200 clinical trial, wherein PLD monotherapy provided an overall response rate of 4%.

•SL-172154 plus PLD had an acceptable safety profile and is consistent with the safety profile of the individual agents:
◦As of the data cut-off date of October 31, 2023, among the 16 treated patients, the most common SL-172154-related adverse events were infusion related reaction, nausea, fatigue, headache and neutropenia, mostly in Grade 1-2. SL-172154-related adverse events in Grade 3 or 4 were observed in 6 patients: anemia (n=2), aspartate aminotransferase increased (n=2), neutropenia (n=2), alanine aminotransferase increased (n=1), embolism (n=1) and thrombocytopenia (n=1). SL-172154-related IRRs occurred in four patients but were manageable and did not prevent the completion of dosing or lead to discontinuation. There were no Grade 5 adverse events.
◦The Phase 1B combination trial in PROC of SL-172154 in combination with PLD is using the 3 mg/kg dose of SL-172154.
•Next steps and anticipated milestones:
◦Completion of planned enrollment of the Phase 1B dose-expansion cohort of SL-172154 in combination with PLD in PROC expected in the fourth quarter of 2023.
Upcoming Milestones
SL-172154 (SIRPα-Fc-CD40L)
•Topline data from Phase 1A/B dose escalation clinical trial of SL-172154 in R/R AML and HR-MDS to be presented at the 65th ASH (Free ASH Whitepaper) Annual Meeting.
•Initial data from the frontline TP53 mutant AML dose-expansion cohort and frontline HR-MDS dose-expansion cohort combining SL-172154 with AZA expected in the fourth quarter of 2023.
•Initial data from the ongoing Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in PROC expected mid-year 2024.
•Additional data from the ongoing Phase 1B clinical trial of SL-172154 in combination with PLD in PROC expected mid-year 2024.

Third Quarter 2023 Recent Business Highlights and Other Recent Developments

ARC Clinical-Stage Pipeline

SL-172154 (SIRPα-Fc-CD40L)
•Enrollment completed in the TP53 mutant AML dose expansion cohort of the Phase 1A/B Clinical Trial of SL-172154 in combination with AZA; enrollment in the HR-MDS cohort expected to complete in the fourth quarter: This trial is evaluating SL-172154 in combination with AZA in both frontline HR-MDS patients and frontline TP53 mutant AML patients. The data from the dose-escalation portion of the clinical trial in primarily R/R patients, which preceded the expansion cohorts in frontline patients, will be presented at the 65th ASH (Free ASH Whitepaper) Annual Meeting. The abstract was made available on November 2, 2023. As of the May 25, 2023 data cut-off date used for the ASH (Free ASH Whitepaper) abstract, 37 patients with R/R AML or HR-MDS had received SL-172154 as monotherapy or in combination with AZA in the parallel staggered dose-escalation portion of the clinical trial. Patients had a median of two prior lines of therapy. As of the data cut-off date of July 10, 2023 used for efficacy evaluation for the ASH (Free ASH Whitepaper) abstract, a monotherapy response in a R/R AML patient and early signals of anti-leukemic activity (in the form of blast count reductions) in patients with R/R AML who received SL-172154 in combination with AZA were observed in a dose-dependent manner. Early signals of activity with SL-172154 in combination with AZA in frontline patients with TP53 mutant HR-MDS were also observed. Out of four evaluable previously untreated TP53 mutant HR-MDS patients, there was one complete response, one marrow complete response, and two stable disease. SL-172154 had an acceptable safety profile as monotherapy and in combination with AZA. Shattuck remains on track to share initial data in the fourth quarter of 2023 from the frontline expansion cohorts in TP53 mutant AML and HR-MDS.

•Continued Dosing of Patients in Phase 1B Clinical Trial of SL-172154 in Combination with Mirvetuximab Soravtansine in PROC. This trial is evaluating the safety, pharmacokinetics, pharmacodynamic effects, and preliminary anti-tumor activity of SL-172154 administered in combination with mirvetuximab soravtansine in patients with PROC. Mirvetuximab soravtansine is an antibody-drug conjugate targeting folate receptor alpha (FRα), which provides for both direct tumor cell killing as well as enhanced macrophage phagocytosis through binding with Fc gamma receptors and has received accelerated approval for PROC patients whose tumors are shown to be FRα positive, defined as ≥75%, as determined by the VENTANA FOLR1 (FOLR1-2.1) Assay. Preclinical studies have shown that both of these killing mechanisms are complementary to the mechanism of SL-172154 by enhancing the activity of macrophages to phagocytose FRα- expressing ovarian cancer cells, and that SL-172154 may broaden the activity of mirvetuximab soravtansine, particularly in patients with tumors that express lower levels of FRα. Shattuck intends to enroll patients with broader FRα expression, including those with "high" (greater than ≥75%), "medium" (≥50% to <75%), and "low" (≥25% to <50%) expression of FRα, as determined by the VENTANA FOLR1 Assay. Shattuck expects to present initial data from the trial midyear 2024.
Upcoming Events
•Shattuck plans to attend the following investor conference. Details will be announced prior to the event.
◦Evercore ISI HealthCONx Conference (Miami, FL), November 28-30, 2023
•65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, December 9-12, 2023
◦Poster presentation on topline data from the dose escalation portion of Phase 1 A/B clinical trial of SL-172154 as monotherapy and in combination with AZA in primarily R/R AML and HR-MDS patients. The full abstract (#4278) is accessible on the ASH (Free ASH Whitepaper) Congress portal and additional details are provided here.
◦Shattuck plans to hold a company-sponsored event following ASH (Free ASH Whitepaper) to discuss complete data from the dose-escalation portion of the Phase 1 A/B clinical trial of SL-172154 in R/R patients and initial data from the frontline expansion cohorts in HR-MDS and TP53 mutant AML. Details will be announced prior to the event.
Conference Call
Shattuck Labs will host a conference call at 8:00 a.m. ET today to review third quarter 2023 financial results and provide a general business overview. Investors may participate in the live call via telephone via the toll-free dial-in (888) 440-4368 and using the conference ID: 5023003. To listen to the live webcast, please visit the Investor Relations page of the Shattuck Labs website here. Participants may register for the call here. While not required, interested participants are encouraged to join 10 minutes prior to the start of the event.
A replay of the webcast will be available following the conclusion of the live call and will be accessible on the Company’s website.
Third-Quarter 2023 Financial Results
•Cash and Cash Equivalents and Investments: As of September 30, 2023, cash and cash equivalents and investments were $101.1 million, as compared to $185.1 million as of September 30, 2022.
•Research and Development (R&D) Expenses: R&D expenses were $24.2 million for the quarter ended September 30, 2023, as compared to $18.9 million for the quarter ended September 30, 2022. This increase was primarily driven by an increase in expense associated with an increase in clinical trial costs due to increased clinical trial activity and the manufacture of clinical trial materials to support the ongoing clinical trials of SL-172154, as well as development costs for potential pipeline candidates.
•General and Administrative (G&A) Expenses: G&A expenses were $5.1 million for the quarter ended September 30, 2023, as compared to $6.6 million for the quarter ended September 30, 2022. This decrease was primarily driven by the recognition of a litigation settlement agreement in the third quarter of 2022.

•Net Loss: Net loss was $27.5 million for the quarter ended September 30, 2023, or $0.65 per basic and diluted share, as compared to a net loss of $24.6 million for the quarter ended September 30, 2022, or $0.58 per basic and diluted share.
2023 Financial Guidance
Shattuck believes its cash and cash equivalents and investments will be sufficient to fund its operations through year-end 2024, beyond results from its Phase 1 clinical trials of SL-172154. This cash runway guidance is based on the Company’s current operational plans and excludes any additional capital that may be received, proceeds from business development transactions, and/or additional costs associated with clinical development activities that may be undertaken.
About SL-172154
SL-172154 (SIRPα-Fc-CD40L) is an investigational ARC fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor to bolster an anti-tumor immune response in patients with advanced cancer. Multiple Phase 1 clinical trials are ongoing for patients with PROC (NCT04406623, NCT05483933) and patients with AML and HR-MDS (NCT05275439).

On November 9, 2023 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported financial results for the quarter ended September 30, 2023, and highlighted recent business updates (Press release, Carisma Therapeutics, NOV 9, 2023, View Source [SID1234637421]).

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"During the third quarter, Carisma made several key advancements across our clinical and pre-clinical programs and reported data from both our Phase 1 clinical study of CT-0508 and our pre-clinical work with Moderna developing in vivo CAR-M," said Steven Kelly, President and Chief Executive Officer of Carisma. "We continue to progress CT-0508 and CT-0525, our assets targeting HER2 overexpressing tumors, as we work to validate our first-in-class engineered macrophage platform. We believe that we have value-driving, next-generation cell therapies in our pipeline that have the potential to improve the treatments available for patients with cancer and other serious disorders."

Third Quarter 2023 and Recent Business Highlights

· CT-0508

o Announced updated data from the Company’s Phase 1 clinical trial of CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M), which included data from the first five patients from group 2 (single-day bolus dosing). Preliminary results from the nine patients in group 1 (fractionated dosing) were presented in November 2022. The group 2 data, which were presented at the 8th Annual CAR-TCR Summit, support primary safety and manufacturing feasibility endpoints of single-day bolus dosing. The Company believes that translational analyses on early data from the combined groups 1 and 2 show that biomarkers of tumor microenvironment activation, T cell activation, and HER2 status correlate with best overall response of stable disease, providing further evidence of the CT-0508 mechanism of action.

· CT-1119

o Selected a clinical candidate for the CT-1119 program, a CAR-Monocyte for mesothelin overexpressing solid tumors. CT-1119 will incorporate two key enhancements: a next-generation CAR that, as demonstrated in pre-clinical studies, leads to a significant increase in tumor killing and cytokine release, and the incorporation of SIRPα knockdown to overcome the CD47 immune checkpoint. SIRPα knockdown is achieved using Carisma’s proprietary intronic shRNA platform, which enables CAR delivery and gene knockdown using a single vector. The Company is targeting an Investigational New Drug Application (IND) for CT-1119 in 2025.

· In Vivo CAR-M (Moderna Collaboration)

o Presented pre-clinical proof of concept data demonstrating feasibility, tolerability, and early efficacy of mRNA/LNP in vivo CAR-M therapy at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting. Accepted as a late-breaking abstract and oral presentation, "In vivo CAR-M: Redirecting endogenous myeloid cells with mRNA for cancer immunotherapy," showcased data that demonstrated CAR-M can be directly produced in vivo, or within the body, successfully redirecting endogenous myeloid cells against tumor-associated antigens using mRNA/LNP. This novel approach to cancer immunotherapy offers an off-the-shelf solution that has the potential to increase access to CAR-based therapies and be the basis of up to 12 oncology programs developed under the Carisma and Moderna collaboration.

Upcoming Milestones

· The Company recently submitted an IND to the U.S. Food and Drug Administration (FDA) for CT-0525. Subject to regulatory feedback, the Company expects to treat the first patient in the first half of 2024.

· The Company expects to present data from the sub-study of its Phase 1 clinical trial of CT-0508 in combination with pembrolizumab in the first half of 2024.

· The Company expects pre-clinical proof of concept data for its initial program outside of oncology, in liver fibrosis, in the first half of 2024.

· The Company is targeting an IND for CT-1119 in 2025.

Third Quarter 2023 Financial Results

· Cash, cash equivalents and marketable securities as of September 30, 2023, were $94.1 million, compared to $117.1 million as of June 30, 2023.

· Research & development expenses were $19.6 million for the third quarter of 2023, compared to $15.6 million for the same period in 2022. The increase of $4.0 million was primarily due to a $2.9 million increase in direct costs associated with the pre-clinical development of CT-0525, a $1.2 million increase in personnel costs due to growth in research and development employee headcount, and a $0.3 million increase in direct costs associated with the pre-clinical development related to CT-1119, partially offset by a $0.2 million decrease in direct costs associated with CT-0508 and a $0.1 million decrease of other clinical and pre-clinical development expenses associated with tracking CT-0525 and CT-1119 separately.

· General & administrative expenses were $6.6 million for the third quarter of 2023, compared to $3.8 million for the same period in 2022. The increase of $2.8 million was primarily due to a $1.4 million increase of higher personnel costs as a result of an increase in headcount, a $0.4 million increase in facilities and supplies due to an increase in office expenditures, a $0.6 million increase in legal and professional fees in support of our patent portfolio and expanding infrastructure, as well as a $0.4 million increase in other expenses due to an increase in travel expenses and subscriptions.

· Net loss was $21.4 million for the third quarter of 2023, compared to net loss of $18.3 million for the same period in 2022, primarily due to increased research and development expenses to support CT-0525 as well as an increase in expanding headcount and infrastructure, which was partially offset by Moderna collaboration revenue.

Outlook

Carisma believes that its cash, cash equivalents and marketable securities of $94.1 million as of September 30, 2023, are sufficient to sustain Carisma’s planned operations into the first quarter of 2025.

About CT-0508

CT-0508 is a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M). It is being evaluated in a landmark Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers do not have approved HER2-targeted therapies or who do not respond to treatment. Carisma is selecting participants who have tumors of any anatomical origin, but with the commonality of overexpressing the HER2 receptor on the cell surface, which is the target for its CAR-M. The Phase 1 clinical trial marks the first time that engineered macrophages are being studied in humans. The trial continues to enroll patients at seven clinical sites in the U.S., including (i) the University of Pennsylvania Abramson Cancer Center, (ii) the University of North Carolina Lineberger Comprehensive Cancer Center, (iii) the City of Hope National Medical Center, (iv) the MD Anderson Cancer Center, (v) the Sarah Cannon Cancer Research Institute, (vi) Oregon Health & Science University and (vii) Fred Hutchinson Cancer Center.

On November 9, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported a business update and announced its financial results for the quarter ended September 30, 2023 (Press release, Sellas Life Sciences, NOV 9, 2023, View Source [SID1234637420]).

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"In the last several weeks, SELLAS has achieved several exciting milestones. We reported initial positive topline Phase 2a data at the 45 mg (safety) dose level demonstrating that SLS009 in combination with venetoclax and azacitidine (aza/ven) exhibited anti-leukemic effects with a favorable safety profile in AML patients resistant to venetoclax combination therapies. Importantly, as of the last follow-up, six of the seven patients enrolled to date were alive. The first patient enrolled in the study achieved a complete response and is in the sixth month of treatment and the second enrolled patient is in the fifth month of treatment, underscoring the potential benefit of adding CDK9 inhibition to the aza/ven regimen. We will share further topline data, including data of patients treated with the recommended Phase 2 dose level of 60 mg, by the end of the year. We also shared compelling topline results from the lymphoma group of patients in our Phase 1 trial of SLS009, showing anti-tumor activity and clinical responses with a tumor burden reduction of up to 68.9%," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "SLS009 continues to emerge as a promising treatment for hematologic malignancies and we are pleased by the FDA’s recognition of its potential by the grant of Fast Track Designation for PTCL and Orphan Drug Designation for AML. These designations position us to expedite SLS009 clinical development with the goal of delivering this groundbreaking treatment to patients in need."

Dr. Stergiou further stated "We are also on track to complete enrollment (other than 20-25 patients from China) of the Phase 3 registrational REGAL study of GPS in patients with AML this month and, while the interim and final analyses are event (death) driven and therefore not within our control, we expect interim data from the study by the end of this year or early next year based upon our assumptions in our statistical analysis plan. We also look forward to the upcoming meeting of the Independent Data Monitoring Committee for the REGAL study towards the end of the month. Last, but not least, we are planning to hold a corporate update call with our shareholders in December to provide an update on the REGAL study and the SLS009 clinical programs as well as our projected outlook for 2024."

Pipeline Update:

Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic

Phase 3 REGAL study in AML:

In August 2023, the Independent Data Monitoring Committee (IDMC) recommended that REGAL continue as planned, following a routine, prespecified risk-benefit assessment of unblinded data from the study. The next routine IDMC meeting is scheduled for the end of November 2023. The Company expects to complete enrollment in the REGAL study, other than the 20-25 patients to be enrolled in China, in November 2023 and anticipates that 3D Medicines Inc., its commercialization partner for GPS in Greater China, will begin enrolling patients in China in the fourth quarter of 2023, subject to any further delays as a result of supply chain or other operational reasons, which will trigger two development milestone payments totaling $13.0 million.

The interim analysis of the REGAL study is expected in late 2023 or early 2024; however, because these analyses are event-driven, they may occur at a different time than currently expected.

Phase 1/2 Study in combination with pembrolizumab (Keytruda) in ovarian cancer:

Final data were presented in November 2023 at the International Gynecologic Cancer Society Annual 2023 Annual Global Meeting. The topline data showed clinical benefit of GPS and anti-PD-1 pembrolizumab combination therapy in WT1-positive relapsed or refractory platinum-resistant advanced metastatic ovarian cancer patients with a 50% disease control rate and a median overall survival benefit of 18.4 months as compared to 13.8 months with pembrolizumab monotherapy in a similar patient population shown in the KEYNOTE-028 study and historical values in comparable patients of 11-14 months with standard of care chemotherapy.

SLS009: highly selective CDK9 inhibitor

Phase 1 clinical trial in relapsed/refractory (r/r) hematological malignancies completed:

In September, the Company reported positive topline data from the cohort of patients with lymphomas from the Phase 1 dose escalation clinical trial of SLS009 showing that the study met all the primary and secondary endpoints supporting its advancement to Phase 2. The maximum tolerated dose was not reached. A dose-limiting toxicity occurred in one out of five patients in the lymphoma cohort treated at the 100 mg dose level. No dose-limiting toxicities were observed at any other dose level, and there were no unexpected toxicities across the study. Among 34 evaluable r/r lymphoma patients, five (14.7%) achieved a clinical response with a reduction in tumor burden of up to 68.9%. An additional seven patients (20.6%) achieved stable disease (SD) resulting in an overall disease control rate of 35.3%. In the subgroup of PTCL patients, four out of 11 (36.4%) evaluable patients achieved a clinical response. Additionally, one patient achieved a complete response (CR) in late October 2023, and remains on the trial after 16 weeks of treatment. The recommended Phase 2 dose for patients with lymphoma was established at 100 mg.

Phase 2a clinical trial in AML:

In October 2023, SELLAS announced positive, initial results from the Phase 2a study of SLS009 combination treatment with aza/ven in r/r AML patients who did not respond or stopped responding to venetoclax-based therapies. The Phase 2a clinical trial is an open-label, single-arm, multi-center study that is designed to evaluate safety, tolerability, and efficacy at two dose levels of SLS009. Six of the seven patients enrolled are still alive as of the latest follow-up, five remain on treatment and the first enrolled patientachieved a complete response and is in the sixth month of treatment while the second enrolled patient is in the fifth month of treatment. Anti-leukemic effects have been observed in all patients without any significant safety issues to date. Patients with AML who fail venetoclax-based therapies have limited treatment options and a poor prognosis with a median overall survival of approximately 2.5 months.

Phase 1b/2 clinical trial in r/r peripheral T-cell lymphomas:

The Company announced in October 2023 that the first patient was dosed in the Phase 1b/2 trial evaluating SLS009 in r/r PTCL. The open-label, single-arm trial will enroll up to 95 patients to evaluate safety and efficacy and, based on the results, may serve as a registrational study. This initial PTCL study is fully funded by GenFleet Therapeutics (Shanghai), Inc., and is being conducted in China.

Regulatory matters:

In October 2023, the FDA granted Orphan Drug Designation (ODD) for SLS009 for the treatment of AML.

In October 2023, the FDA granted Fast Track Designation to SLS009 for the treatment of r/r PTCL. The Fast Track Designation is intended to facilitate the development and review of drugs.

Financial Results for the Third Quarter 2023:

Research and Development Expenses: Research and development expenses for the third quarter of 2023 were $5.8 million, compared to $4.3 million for the same period in 2022. The increase was primarily due to an increase in clinical trial expenses related to the ongoing Phase 3 REGAL clinical trial of GPS in AML patients and the Phase 2a and Phase 1 clinical trials of SLS009 in hematological malignancies, an increase in manufacturing costs related to clinical drug supply purchases, and an increase in clinical and regulatory consulting. Research and development expenses were $18.9 million for the first nine months of 2023, compared to $14.4 million for the same period in 2022. The increase was primarily due to an increase in clinical trial expenses, an increase in clinical and regulatory consulting, and an increase in personnel related expenses due to increased headcount.

General and Administrative Expenses: General and administrative expenses for the third quarter of 2023 were $3.5 million, as compared to $2.9 million for the same period in 2022. The increase was primarily due to an increase in outside services and public company costs and an increase in legal and intellectual property fees. General and administrative expenses were $10.8 million for the first nine months of 2023, compared to $9.0 million for the same period in 2022. The increase was primarily due to personnel-related expenses due to increased headcount, an increase in legal and intellectual property fees, and an increase in outside services and public company costs.

Acquired In-Process Research and Development: There was no acquired in-process research and development in the third quarter of 2023 or the third quarter of 2022. There was no acquired in-process research and development in the first nine months of 2023, compared to $10.0 million for the same period in 2022, resulting from the in-licensing of SLS009.

Net Loss: Net loss was $9.3 million for the third quarter of 2023, or a basic and diluted loss per share of $0.33, compared to a net loss of $7.0 million for the same period in 2022, or a basic and diluted loss per share of $0.34. Net loss was $29.2 million for the first nine months of 2023, or a basic and diluted loss per share of $1.09, compared to a net loss of $32.2 million for the same period in 2022, or a basic and diluted net loss per share of $1.70.

Cash Position: As of September 30, 2023, cash and cash equivalents totaled approximately $4.0 million. Following the end of the quarter, on November 2, 2023, the Company received gross proceeds of approximately $4.0 million from a registered direct offering at-the-market of shares of common stock, pre-funded warrants to acquire shares of common stock, and warrants to acquire shares of common stock with a single, healthcare-focused investor. Additionally, the Company is anticipating $13.0 million in milestone payments from 3D Medicines, Inc. upon patients enrolling in China in the REGAL study which the Company expects to be triggered in the fourth quarter of 2023, subject to any further delays as a result of supply chain or other operational reasons.

On November 9, 2023 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported that it has closed its acquisition of EQRx, Inc (Press release, Revolution Medicines, NOV 9, 2023, View Source [SID1234637419]).

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Through the acquisition, Revolution Medicines expects to add approximately $1.1 billion in net cash proceeds to its balance sheet, after estimated post-closing EQRx wind-down and transition costs. Each share of common stock of EQRx issued has been converted into the right to receive 0.1112 shares of common stock of Revolution Medicines. Revolution Medicines expects to issue approximately 55 million shares of its common stock in connection with the merger (excluding assumed warrants and earn-out shares). EQRx common stock has ceased trading on the Nasdaq Global Market and all EQRx programs are being wound down.

"Revolution Medicines has reached an important milestone with the completion of this transaction that brings a significant additional quantum of capital to support our rapidly advancing clinical programs. On the foundation of exciting recent scientific disclosures, we will be able to make significant investments on behalf of the parallel clinical development strategy for our compelling RASMULTI(ON) Inhibitor, RMC-6236, and mutant-selective RAS(ON) Inhibitors, RMC-6291 (G12C), and RMC-9805 (G12D), which we believe have the potential to change the standard of care for patients with RAS-addicted cancers," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "We are also delighted to welcome Dr. Sandra Horning, a seasoned oncologist and late-stage clinical development leader, to the Revolution Medicines board of directors. We remain deeply committed to advancing our rich pipeline of promising oncology assets to address unmet patient needs, and I am extremely grateful to the employees and shareholders of Revolution Medicines and EQRx who have supported us to a successful transaction."

Update to Revolution Medicines Board of Directors
Dr. Sandra Horning joined Revolution Medicines’ board of directors at the closing of the EQRx acquisition as a Class II director, with a term expiring at the company’s 2025 annual meeting of stockholders.

Dr. Horning brings significant and relevant experience to Revolution Medicines, having previously served as the executive vice president, chief medical officer and global head of product development at Genentech. During her decade-long career with the company, she helped bring 15 new medicines to patients across a variety of disease areas, including cancer. Prior to her tenure at Genentech, Dr. Horning served as a practicing oncologist for 25 years at Stanford University, where she remains a professor of medicine emerita. Throughout her impressive career, Dr. Horning has received numerous prestigious awards and recognitions, including the Healthcare Businesswomen’s Association 2020-2021 Woman of the Year and the Duane Roth Achievement Award from the UC San Diego Moores Cancer Center. She currently serves as a member of the boards of directors of Moderna, Inc. and Olema Pharmaceuticals, Inc. and was a director of EQRx until its acquisition. Dr. Horning received her M.D. from University of Iowa School of Medicine and completed her post-graduate fellowship in Oncology and Cancer Biology at Stanford University.

Advisors
Guggenheim Securities, LLC served as Revolution Medicines’ financial advisor and Latham & Watkins LLP served as its legal counsel. Goldman Sachs & Co. acted as lead financial advisor to EQRx. MTS Health Partners, L.P. also acted as financial advisor to EQRx. Goodwin Procter LLP acted as legal counsel for EQRx.