On January 30, 2023 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, reported an update on the ongoing development of its product candidates, efti and IMP761, for the quarter ended 31 December 2022 (Q2 of Fiscal Year 2023) (Press release, Immutep, JAN 30, 2023, View Source [SID1234626629]).

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EFTI DEVELOPMENT PROGRAM FOR CANCER

Planned late-stage trial in 1L NSCLC
The United States Food and Drug Administration (US FDA) granted Fast Track designation to efti in combination with pembrolizumab in October 2022 for the treatment of 1L NSCLC, which will be evaluated in the Company’s planned late-stage registrational trial. The designation was granted based on the encouraging Phase II clinical data in 1L NSCLC from the TACTI-002 all-comer trial in terms of PD-L1 status, presented at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2022. It is the second Fast Track designation issued by the FDA for efti (the first is for 1L HNSCC) and offers the potential for expedited development and review.

TACTI-002 (also designated KEYNOTE-PN798) Phase II clinical trial

Immutep reported compelling new clinical data from the TACTI-002 trial evaluating efti in combination with MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) in 1L NSCLC via a late-breaking abstract oral presentation at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting in November 2022. Immutep’s abstract was one of just nine to be showcased at the SITC (Free SITC Whitepaper) 2022 press briefing, out of more than 1,500 abstract submissions.

The results showed an ORR of 40.4% in the all-comer PD-L1 trial, meeting the primary endpoint of the 1L NSCLC part of the trial. The ORR improved across all PD-L1 status groups by central assessment compared with data reported at ASC0 2022. Additionally, the interim median Duration of Response (DoR) of 21.6 months, compares favourably to historical controls. Promising results were also achieved in the secondary endpoint of interim median Progression Free Survival (PFS) with overall PFS of 6.6 months and 9.3 months in patients with a PD-L1 TPS (Tumour Proportion Score) >1% for which efti in combination with pembrolizumab has Fast Track designation.

TACTI-003 – Phase IIb clinical trial

In October 2022, the IDMC for Immutep’s Phase IIb TACTI-003 trial reviewed the initial safety data from the study and recommended the trial continue with no modifications. The IDMC also reviewed initial efficacy data, although this was not the primary focus of the analysis. The recommendation validates Immutep’s decision to evaluate efti in the 1st line HNSCC setting following an encouraging ORR of 29.7% regardless of PD-L1 expression and five complete responses (CR) reported in the 2nd line HNSCC setting in TACTI-002.

The Company also presented a Trial in Progress poster on the TACTI-003 study at the SITC (Free SITC Whitepaper) 2022 meeting in November 2022. Recruitment is ongoing for the TACTI-003 trial, with more than 50% of the planned 154 patients enrolled till quarter end.

Planned Phase II/III trial in Metastatic Breast Cancer

Immutep reported the positive outcome of its follow-up Type C meeting with the US FDA regarding its latestage clinical development plans for efti in conjunction with standard-of-care chemotherapy for the treatment of MBC in December 2022. The Company and the FDA have agreed to an integrated Phase II/III trial design to help inform a Biologics License Application (BLA).

Based on the encouraging efficacy, favourable safety and learnings from the randomised AIPAC Phase IIb trial (which administered efti and chemotherapy on different days and ceased chemotherapy at six months), patients will receive efti and paclitaxel on the same day and treatment will continue until disease progression. In addition to HER2–/HR+ metastatic breast cancer, the patient population has also been expanded to include triple-negative breast cancer (TNBC), an aggressive form of breast cancer with limited treatment options.

Subject to regulatory and ethics committee feedback, the Phase II portion of the trial is expected to begin in Q3 FY23 with a safety lead in of 6 to 12 patients who will be given a higher 90mg dose of efti (compared to the completed AIPAC trial). This will be followed by 58 patients for the randomised Phase II portion of the trial. Depending on the Phase II results and Immutep’s resources, the Phase III portion will commence.

Phase II trial in Soft Tissue Sarcoma

Trial preparations continued during the quarter for a new investigator-initiated Phase II clinical trial which was announced in September 2022. The trial will be conducted in collaboration with the Maria SkłodowskaCurie National Research Institute in Poland and will evaluate efti in combination with pembrolizumab and radiotherapy, prior to surgery, in up to 40 patients with select soft tissue sarcoma. The trial is expected to commence in H1 of calendar year 2023.

INSIGHT-003 – Phase I triple combination with standard-of-care anti-PD-1 therapy and chemotherapy

Initial clinical data was reported from the investigator-initiated INSIGHT-003 trial in November at the SITC (Free SITC Whitepaper) 2022 conference. The poster provided initial efficacy details on 11 of the 14 patients with metastatic NSCLC adenocarcinomas that had been enrolled as of the 14 October 2022 cut-off date, plus safety data on all 14 patients. The data shows the triple-combination approach is well-tolerated and provides promising early signals of therapeutic activity with an ORR of 72.7% (8/11) and a Disease Control Rate (DCR) of 90.9% (10/11).

INSIGHT-005 – New Phase I trial with Merck KGaA, Darmstadt, Germany, and Pfizer

Immutep signed a Clinical Trial Collaboration and Supply Agreement with Merck KGaA, Darmstadt, Germany and Pfizer in November 2022 for a new Phase I clinical study in patients with urothelial cancer, called INSIGHT005. It is the second agreement entered into by Immutep with Merck KGaA and Pfizer and builds on the encouraging clinical data reported from the completed INSIGHT-004 study in multiple solid tumour indications from efti and avelumab (BAVENCIO). Under the Agreement, Immutep and Merck KGaA will jointly fund the study, which is expected to start in mid-calendar year 2023.

Efti Manufacturing Scale-Up

Immutep successfully scaled-up the manufacturing process for efti with the completion of its first 2,000L manufacturing run by the Company’s manufacturing partner, WuXi Biologics. This large-scale manufacturing capability is a significant achievement. Immutep plans to introduce the material manufactured into ongoing and future Phase II/III clinical trials.

IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASES

During the quarter, Immutep established a GMP-compliant manufacturing processfor IMP761, its proprietary preclinical candidate for autoimmune diseases. The 200L scale manufacturing process was developed by the Company’s manufacturing partner, Northway Biotech and will provide supply of IMP761 for Investigational New Drug (IND)-enabling studies and clinical trials.

INTELLECTUAL PROPERTY

Immutep was granted four new patents during the quarter. The first two patents were filed as divisional applications and were granted by the Japanese and South Korean Patent Offices. These patents protect Immutep’s intellectual property relating to combination preparations comprising efti and a chemotherapy agent which is oxaliplatin, carboplatin, or topotecan. They follow the grant of the Japanese parent patent and corresponding patentsin the United States, Europe, China and Australia, as announced in 2019 through 2021. The Company was granted another patent by the South Korean Patent Office, which relates to a potency assay for release testing of efti. The assay is used in Immutep’s commercial-scale (2,000L) manufacturing process.

Immutep was also granted a new patent by the Chinese Patent Office. The patent protects IMP731 in the territory of mainland China. The patent is co-owned with the French Institute of Health and Medical Research (INSERM) and exclusively licensed to GSK, Immutep’s development partner for IMP731.

FINANCIAL SUMMARY

Immutep’s financial performance over the quarter (Q2 FY23) continues to reflect prudent cash management. The Company’s cash runway was expanded to the end of FY24 (previously early H2 FY24).

Cash receipts from customers Q2 FY23 were $8k, compared to $33k in Q1 FY23. The Company received a A$986,286 cash rebate from the Australian Federal Government’s R&D tax incentive program in relation to expenditure incurred on eligible R&D activities conducted in Australia in the 2021 fiscal year.

The net cash used in G&A activities in the quarter was $734k compared to $595k in Q1 FY23.

Payments to Related Parties, detailed in Item 6 of the Appendix 4C cash flow report for the quarter, includes $402k in payment of Non-Executive Director’s fees and Executive Director’s remuneration.

The net cash used in R&D activities in the quarter was $5.87 million, compared to $7.17 million in Q1 FY23. The decrease was mainly due to a reduction in manufacturing activities during the quarter.

Total net cash outflows used in operating activities in the quarter were $7.02 million compared to $6.35 million in Q1 FY23.

Immutep’s cash and cash equivalent balance at 31 December 2022 was approximately $68.38 million, giving the Company an expected cash reach based on current estimates to the end of FY24. Immutep will continue to manage its strong cash balance carefully as it pursues its overall clinical development strategy.

A copy of the Appendix 4C-Quarterly Cash Flow Report for the quarter is attached.

On January 30, 2023 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new drug candidates for the treatment for cancer and fibrosis, reported further progress across its small molecule, focal adhesion kinase (FAK) inhibitor program and the release of its Appendix 4C Cash Flow Report (attached) for the quarter ending 31 December 2022 (Press release, Amplia Therapeutics, JAN 30, 2023, View Source [SID1234626628]).

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Key Highlights from the Quarter

• Completion of recruitment of first cohort of patients into ACCENT Phase 2 clinical trial of AMP945 in pancreatic cancer;
• Encouraging data for AMP886 in a preclinical model of Acute Myeloid Leukemia (AML);
• Dr Christopher Burns appointed as CEO.

Operations Update
Clinical Development
During the Quarter, Amplia announced completion of enrolment of the first cohort of patients in the Company’s Phase 1b/2a ACCENT clinical trial of focal adhesion kinase inhibitor AMP945. The trial tests whether AMP945 enhances the efficacy of gemcitabine/nab-paclitaxel standard-of-care chemotherapy in frontline patients with advanced pancreatic cancer.

By the end of 2022, seven sites in Melbourne, Sydney and Brisbane had been opened to recruit patients into the ACCENT trial. To help raise the profile of the trial amongst pancreatic cancer specialists and oncologists, the company sponsored and attended the Australasian Gastro-Intestinal Trials Group (AGITG) Annual Scientific Meeting in Melbourne in November.

Non-clinical Development

Studies completed during the Quarter also showed that AMP886, Amplia’s second FAK inhibitor, may have utility in the treatment of acute myeloid leukemia (AML). In addition to inhibiting FAK, AMP886 also potently blocks activity of the two related kinases FLT3 and VEGFR3. The company has now shown that AMP886 inhibits AML in an industry-standard MV4-11 disease model carrying a common mutation in FLT3. Patients whose disease carries this mutation often have more rapid progression and significantly worse prognosis. Furthermore, in this model AMP886 enhances the efficacy of venetoclax, a drug approved to treat AML as part of combination therapy. Additional studies exploring the potential of AMP886 in AML and other cancers are underway.

Management

Dr Christopher Burns was appointed as CEO and Managing Director of Amplia Therapeutics on 5th December. Dr Burns was a founder of Amplia Therapeutics and has been a Board member since May 2018.

Financial update

Amplia finished the December 2022 quarter with cash of $10.6 million (September 2022: $11.7 million). During the quarter, the Company had net cash outflows of $1.1 million in relation to operating activities (September 2022: $1.1 million).
Operating cashflows included outflows and inflows of:
• $0.7 million for staff and administration/corporate costs; and
• $0.5 million for research and development costs, which primarily related to Contract Research Organisation (CRO), manufacturing and other CMC related costs incurred in relation to the first stage of the Phase 2 clinical trial for AMP945. Research and development expenditure is forecast to increase in the coming quarters in line with the progression of Phase 1b/2a of the ACCENT clinical trial for AMP945.

Payments to Related Entities

In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1 of the Appendix 4C incorporates directors’ fees, salaries and superannuation. Total payments made for the quarter equals $172,929 and relate to payments to the CEO/Managing Director’s in line with employment contracts and payments to the Non-Executive Directors. Outlook and future activities In the coming quarter, the Company expects to report further progress in the ACCENT trial including updates on progression towards optimal dose selection. Work on a regulatory submission to South Korea is well advanced which, if approved, will allow sites to be opened that should further enhance recruitment rate.

Studies continue on the novel metabolite of AMP945 identified in samples from the Phase 1 clinical trial. The presence of the metabolite is not anticipated to impact timelines for the pancreatic cancer trial currently underway.

Non-clinical studies of Amplia’s second FAK inhibitor, AMP886, are ongoing to identify the best clinical opportunities for this compound. Additional non-clinical studies with AMP945 are also underway to explore and support clinical application of the drug in other oncology and non-oncology indications. Data generated from these studies will be communicated as they are received.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On January 29, 2021 Amgen reported that its investigational KRASG12C inhibitor sotorasib was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) (Press release, Amgen, JAN 29, 2023, View Source [SID1234633506]). The designation is for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. This is the first BTD submission for Amgen in China, as well as the first under Amgen’s strategic collaboration with BeiGene.

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NSCLC is the most common form of lung cancer, accounting for approximately 80-85% of all cases worldwide.1 KRAS G12C is the most common KRAS mutation in NSCLC.2,3 The mutation is a biomarker of poor prognosis in Chinese NSCLC patients, which may be improved by G12C-specific inhibitors.4 Research has shown that about 3-5% have the KRAS G12C mutation – found most commonly in smokers.4,5

"Given that Breakthrough Therapy Designation is a new pathway in China, we are pleased to receive this designation for sotorasib," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "This designation underscores the importance of sotorasib and we look forward to working with regulatory authorities in China to bring the first potential targeted therapy to NSCLC patients with the KRAS G12C mutation."

The Breakthrough Therapy Designation is supported by the positive CodeBreaK 100 Phase 2 results in patients with advanced NSCLC whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy. In the study, treatment with sotorasib demonstrated durable anticancer activity with a positive benefit-risk profile.6 These results will be presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) Presidential Symposium from 3:50-4 p.m. PST on Friday, Jan. 29.

The NMPA’s BTD process is designed to expedite the development and review of therapies that are intended for the prevention or treatment of serious life-threatening diseases for which there is no existing treatment and where preliminary evidence indicates advantages of the therapy over available treatment options.7 This designation shows the potential for sotorasib to become the first targeted treatment available in China for KRAS G12C-mutated NSCLC.

Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, the first KRASG12C inhibitor to enter the clinic.8 Sotorasib is being studied in the broadest clinical program exploring 10 combinations with global sites spanning across four continents. In just over two years, the sotorasib clinical trial program has also established the deepest clinical data set with nearly 700 patients studied across 13 tumor types.

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled nearly 700 patients across 13 tumor types since its inception.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer is fully enrolled and topline results are expected in 2021.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) is currently recruiting. Amgen also has more than 10 Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.

For information, please visit www.codebreaktrials.com.

On January 29, 2023 Alpha Biopharma, a developer of innovative drugs, reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for Zorifertinib, a next-generation EGFR-TKI specially designed to treat advanced EGFR-mutated non-small cell lung cancer (NSCLC) patients with central nervous system (CNS) metastases (Press release, Alpha Biopharma, JAN 29, 2023, View Source [SID1234626630]). Zorifertinib is the first EGFR-TKI to be tested in a prospective, controlled registration clinical study for this difficult-to-treat patient population, and if approved, it will bring a much-needed new treatment option for these patients.

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Data released by the International Agency for Research on Cancer (IARC) of the World Health Organization (SHO) showed that there were 9.96 million cancer deaths worldwide in 2020, and 1.8 million deaths were from lung cancers, making it the most common cause of cancer deaths. Due to the low CNS penetration rate of most current lung cancer drugs, lung cancers metastasized to the CNS were poorly controlled and have become one of the leading causes of NSCLC patient deaths.

Zorifertinib is a next-generation EGFR-TKI targeting sensitive EGFR mutations (exon 19 deletion and exon 21 L858R) designed for complete blood-brain barrier (BBB) permeability. In addition, Zorifertinib is not a substrate for the efflux transporters P-gp and BCRP, which allows it to achieve and maintain effective drug exposure in the brain tissues and the cerebrospinal fluid.

The EVEREST study was a multinational, multicenter, randomized, open-label, controlled phase II/III clinical trial designed to evaluate the efficacy and safety of Zorifertinib as a first-line treatment for advanced EGFR-mutated NSCLC patients with CNS metastases. The study was carried out in 55 study sites located in the Chinese mainland, Taiwan, South Korea, and Singapore, with a total enrollment of 492 patients. The last patient last visit (LPLV) of the EVEREST study was completed in the third quarter of 2022. Results from the EVEREST study demonstrated that Zorifertinib effectively reduced the risk of disease progression and patient deaths in the target patient population and showed significant efficacy in treating metastatic lesions in the CNS. In addition, Zorifertinib’s safety profile is comparable to other approved EGFR-TKI’s. The primary resistance mutation at the time of disease progression is the EGFR T790M mutation.

Professor Yilong Wu, President of the Chinese Thoracic Oncology Group (CTONG) and the leading principal investigator (PI) of the EVEREST study, said, "Clinical results from this high-quality, controlled study demonstrated that Zorifertinib provided consistent and statistically significant benefits to EGFR-mutated NSCLC patients with different levels of CNS metastasis. It could provide a much-needed new treatment option for these difficult-to-treat patients. The development of Zorifertinib represents a great example of a patient-centric, targeted precision approach to address unmet medical needs.

Eric Zhang, CEO of Alpha Biopharma, said, "after many years of dedicated research and development, we are very pleased to witness that all pre-clinical and clinical data have demonstrated that Zorifertinib can achieve and maintain high CNS exposures, that it is safe, and it is advantageous in controlling CNS and overall disease progression in this difficult-to-treat population. We look forward to working closely with the regulatory agencies around the world to bring this innovative treatment option to patients in dire need.

About Zorifertinib

Zorifertinib is a potent, oral, reversible inhibitor of mutated EGFR (Exon19Del and Exon21L858R). EGFR is widely expressed in human epidermal and stromal cells and is highly expressed in various human malignancies, such as NSCLC. EGFR gene mutation will cause excessive epidermal growth factor receptors on the cell membrane surface, accelerate the abnormal growth and division of cells, and eventually lead to tumorigenesis. CNS metastases are common in EGFR-mutated NSCLC patients and are accompanied by a poor prognosis of earlier disease progression, shorter survival, and lower quality of life. The BBB significantly increases the difficulty of drug penetration into the CNS, which allows the CNS to be a refuge for lung cancer cells. Zorifertinib is a next-generation EGFR-TKI with full blood-brain barrier penetration targeting advanced NSCLC patients with CNS metastases and EGFR-sensitizing mutations. Zorifertinib is currently under NDA submission and has global patent protection.

On January 27, 2023 Marengo Therapeutics, Inc., a company pioneering novel therapeutics targeting the T cell receptor (TCR) Vβ to selectively activate the right T cell subsets to fight cancer, reported that the first patient has been dosed in its ongoing clinical trial of STAR0602 (START-001) (Press release, Marengo Therapeutics, JAN 27, 2023, View Source [SID1234626625]). Marengo’s START-001 trial is a seamless Phase 1/2 clinical trial evaluating the safety and clinical activity of STAR0602 as monotherapy in a biomarker-enriched cohort of patients with PD-1 refractory advanced solid tumors.

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The START-001 trial (NCT05592626) is currently enrolling patients at two top US cancer research institutes, National Institutes of Health (NIH)’s National Cancer Institute (NCI) and Mass General Hospital (MGH)/Harvard Medical School, co-led by seasoned clinical and translational researchers James Gulley, M.D., Ph.D., of NCI and Ryan Sullivan, M.D., of MGH. Additional top cancer centers are planned to join these clinical sites to support the further expansion of the study.

"The Center for Cancer Research’s Center for Immuno-Oncology at the NCI was recently established to explore fundamental questions of cancer immunotherapy through rigorous preclinical studies and translate these findings into clinical trials with the goal of developing novel therapies for a spectrum of cancers with high unmet medical needs. We look forward to studying this novel TCR agonist that selectively activates a subset of αβ T cells in cancer patients at the NCI," said Dr. Gulley, Co-Director of the Center for Immuno-Oncology (CIO), Deputy Director of the Center for Cancer Research (CCR) at the NCI, and acting Clinical Director, NCI.

"The initiation of our first clinical trial with STAR0602 is an important milestone for Marengo and our selective T cell-targeted STAR platform," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo. "The START-001 trial leverages a deep biology-driven study design to address high unmet clinical needs in patients for whom PD-1 therapies are no longer effective. Our clinical development approach utilizes a biomarker-enriched, tumor-agnostic strategy that offers a much-needed novel approach to cancer drug development. We are confident that evaluating STAR0602 in well-defined populations will allow us to efficiently investigate biological and clinical activity, paving the way for further investigation."

"Cancer immunotherapy has transformed standard of care across many tumor settings and has significantly improved overall survival for patients with cancer. Despite these innovative therapies, most patients progress following treatment creating an urgent need to develop the next wave of novel therapeutics," said Dr. Sullivan, Associate Director, Melanoma Program, MGH Cancer Center. "We are excited to test this novel biology via reinvigorating the T cell compartment in tumors to promote an antitumor immune response distinct from the PD-1 mechanism."