On June 4, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported new efficacy data from its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo) in patients with advanced non-small cell lung cancer (NSCLC) who failed 2 or more standard-of-care therapy regimens (Press release, MAIA Biotechnology, JUN 4, 2024, View Source [SID1234644108]). Updated results show a favorable overall response rate (ORR) of 38% and a disease control rate (DCR) of 85% from THIO + CPI in third-line treatment. The new data was presented in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting on June 3, 2024.

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The primary objectives of THIO-101 Phase 2 trial are to examine the safety and tolerability of THIO as an anticancer drug and as an immune system primer, and to examine the clinical efficacy of THIO in the form of ORR. At the time of the most recent data cut-off (April 30, 2024), all evaluable patients had completed ≥1 post-baseline assessment.

Results from third-line treatment:

Disease control rate (DCR) was 85% for THIO vs. standard of care DCR of 25–35% for chemotherapy1
65% of patients crossed the 5.8-month overall survival (OS) threshold2
85% of patients crossed the 2.5-month progression-free survival (PFS) threshold3-4
Median survival follow-up time is currently 9.1 months (n=20)
Results from third-line treatment with THIO 180mg (optimal dose selection)

Median PFS of 5.5 months (24.1 weeks)
78% OS rate at 6 months
38% ORR vs. standard of care 6–10% for chemotherapy2
75% of patients crossed the 5.8-month OS threshold2
88% of patients crossed the 2.5-month PFS threshold3-4
Median survival follow-up time is currently 9.1 months (n=8)
1 Matsumoto H, et al. Transl Lung Cancer Res 2021;10:2278–89.
2 Girard N, et al. J Thorac Onc 2009;12:1544-1549.
3 Shepherd F, et al. N Engl J Med 2005;353:123-132.
4 Fossella F, et al. J Clin Oncol 2000;18(12):2354-62.

"All exceptional measures of efficacy in our trial to date have exceeded our own expectations and outperformed standard of care treatments," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "The data presented at ASCO (Free ASCO Whitepaper) advances THIO’s excellent clinical profile as a strong, safe, and highly effective alternative for patients who progressed following chemotherapy and other available treatments. We eagerly anticipate full efficacy data from THIO-101 in the second half of this year."

To date, treatment with THIO + cemiplimab has been generally well tolerated in a heavily pre-treated patient population. Full enrollment in THIO-101 was completed on February 19, 2024, earlier than expected as per trial design. The Company expects that THIO-101 will be the first completed clinical study of a telomere targeting agent in the field of cancer drug discovery and treatment.

The poster and updated Company presentations can be accessed on the company’s website.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

On June 4, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported favorable results from the Phase 2 TELLOMAK study with lacutamab in mycosis fungoides (MF) (Press release, Innate Pharma, JUN 4, 2024, View Source [SID1234644092]). The results were presented at the ASCO (Free ASCO Whitepaper) 2024 Annual Meeting, in Chicago, Illinois.

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As of October 13, 2023, data cutoff, MF patients (n=107) received a median of 4 prior systemic therapies and had a median follow-up of 11.8 months.

The data demonstrate that treatment with lacutamab resulted in meaningful antitumor activity, regardless of the KIR3DL2 baseline expression, and an overall favorable safety profile. The global objective response rate (ORR) was 16.8% (Olsen 2011) and 22.4% (Olsen 2022), including 2 complete responses (CR) and 16 partial responses (PR). In patients expressing a baseline KIR3DL2 ≥ 1%, the ORR was 20.8% (Olsen 2011) and 29.2% (Olsen 2022). Median progression-free survival was 10.2 months (95% CI 6.5, 16.8) for all MF patients and 12.0 months (95% CI 5.6, 20.0) in the KIR3DL2 ≥ 1% group. Time to response was 1.0 month (95% CI 1, 5).

"The anti-tumor activity observed in the Phase 2 TELLOMAK trial confirms that treatment with lacutamab achieves clinically meaningful outcomes for heavily pretreated patients with mycosis fungoides regardless of baseline KIR3DL2 expression level," commented Dr. Sonia Quaratino, Chief Medical Officer of Innate Pharma. "These results are very promising, considering the number of prior systemic therapies that the patients had received before, and the lack of available drugs. These data support further development of lacutamab to bring improved treatments to patients with cutaneous T cell lymphomas."

Prof. Pierluigi Porcu, Director, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, Jefferson Health, Philadelphia, and Principal Investigator in the TELLOMAK study, added: "Mycosis fungoides patients have few efficacious and safe therapeutic options at advanced stages. It is promising to see lacutamab achieving remarkable efficacy along with excellent tolerability in this heavily pre-treated population. We express our gratitude to the investigators, clinical research coordinators, patients and caregivers involved in the TELLOMAK program."

Efficacy in MF patients and according to KIR3DL2 subgroup
ITT set All MF
N=107
KIR3DL2 ≥ 1%
N=48
KIR3DL2 <1%
N=59
Olsen 2011 Global ORR % (95%CI)
16.8%
(10.9, 25.0)
20.8%
(11.7, 34.3)
13.6%
(7.0, 24.5)
Olsen 2022 Global ORR % (95%CI)
22.4%
(15.6, 31.2)
29.2%
(18.2, 43.2)
16.9%
(9.5, 28.5)
CR n (%) 2 (1.9) 2 (4.2) 0 (0.0)
PR n (%) 16 (15.0) 8 (16.7) 8 (13.6)
SD n (%)1
74 (69.2) 30 (62.5) 44 (74.6)
PD n (%) 13 (12.1) 6 (12.5) 7 (11.9)
NE n (%) 2 (1.9) 2 (4.2) 0 (0.0)
Time to global response (mo) median (range) 1.0 (1-5) 1.0 (1-5) 1.9 (1-4)

1 SD includes 2 pts uPR confirmed after DCO & 1 new uPR after DCO.

Skin response (n=107)
% (95%CI)
29.0%
(21.2;38.2)
33.3%
(21.7;47.5)
25.4%
(16.1;37.8)
PFS (months) median (95%CI) 10.2 (6.5, 16.8) 12.0 (5.6, 20.0) 8.5 (6.5, 17.5)

*****
Virtual KOL Event Details
Tuesday, June 11, 2024 at 4:00PM CEST (9:00AM EDT)

The live webcast will be available at the following link:
View Source

Participants may also join via telephone using the following registration link: View Source
This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.
*****

About Lacutamab
Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous lymphomas of T lymphocytes have a poor prognosis with few efficacious and safe therapeutic options at advanced stages.

KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues.

Lacutamab is granted European Medicines Agency (EMA) PRIME designation and US Food and Drug Administration (FDA) granted Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. Lacutamab is granted orphan drug status in the European Union and in the United States for the treatment of CTCL.
About TELLOMAK
TELLOMAK (NCT03902184) is a global, open-label, multi-cohort Phase 2 clinical trial in patients with Sézary syndrome and mycosis fungoides (MF) in the United States and Europe. Specifically:
•Cohort 1: lacutamab being evaluated as a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior systemic therapies, including mogamulizumab. The Sézary syndrome cohort of the study could enable the registration of lacutamab in this indication.
•Cohort 2: lacutamab being evaluated as a single agent in patients with MF that express KIR3DL2, as determined at baseline with a Simon 2-stage design.
•Cohort 3: lacutamab being evaluated as a single agent in patients with MF that do not express KIR3DL2, as determined at baseline, with a Simon-2 stage design.
•All comers: lacutamab being evaluated as a single agent in patients with both KIR3DL2 expressing and non-expressing MF to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay under development as a companion diagnostic.

The trial is fully enrolled. The primary endpoint of the trial is objective global response rate. Key secondary endpoints are progression-free survival, duration of response, overall survival, quality of life, pharmacokinetics and immunogenicity and adverse events.

On June 4, 2024 Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, reported the launch of a new version of its Guardant360 TissueNext test that expands the number of genes it identifies in a tumor tissue sample to 498 (Press release, Guardant Health, JUN 4, 2024, View Source [SID1234644109])c. These genes, or cancer biomarkers, enable oncologists to identify the targeted therapies or treatment strategies that are most effective for patients with advanced cancer. In addition to the panel expansion, Guardant has improved the test’s operational workflow for a faster turnaround time.

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The new Guardant360 TissueNext test will be covered for Medicare fee-for-service patients with advanced solid tumor cancers as a standalone service, based on coverage conveyed by Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), under the existing local coverage determination.

"The launch of the new Guardant360 TissueNext test is another step forward in our mission to conquer cancer with data," said Helmy Eltouky, Guardant Health chairman and co-CEO. "In addition to identifying guideline-recommended biomarkers, the upgraded test now provides more comprehensive gene coverage, so oncologists can make better informed decisions about the optimal treatment strategy for their patients with advanced cancer and help improve their outcomes."

Guardant360 TissueNext identifies clinically relevant actionable biomarkers in tumor tissue to help oncologists select patients with advanced cancer who may benefit from biomarker-informed treatment. Results are provided in less than two weeks.

The test, which first received Medicare coverage in March 2022, is part of Guardant’s comprehensive portfolio of blood- and tissue-based genomic profiling tests, including Guardant360 CDx, the first liquid biopsy test approved by the FDA for comprehensive genomic profiling of all solid tumors. The Guardant360 TissueNext test can be ordered alone or in combination with Guardant360 CDx to support guideline-recommended complementary liquid and tissue genomic profiling testing for advanced breast and lung cancer.

On June 4, 2024 National Cancer Center (President: Hitoshi Nakagama) Hospital East (Director: Toshihiko Doi) and PeptiDream Inc., a public Kanagawa, Japan-based biopharmaceutical company (President: Patrick C. Reid, hereinafter "PeptiDream")(Tokyo: 4587) reported the dosing of the first patient in the human imaging study of PeptiDream’s 64Cu-PD-32766, a 64Cu-labelled radiopharmaceutical targeting Carbonic Anhydrase IX (CAIX), for patients with clear cell renal cell carcinoma (ccRCC) conducted at the National Cancer Center Hospital East ("the clinical research") (Press release, National Cancer Center of Japan, JUN 4, 2024, View Source [SID1234644110]).

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Details

The clinical research, which was approved by the National Cancer Center Japan’s clinical review board in April 2024, is a first-in-human imaging study of 64Cu-PD-32766 conducted in collaboration with the National Cancer Center Japan and PeptiDream. This study is intended to evaluate the safety, pharmacokinetics, and accumulation of 64Cu-PD-32766 in tumors using PET in patients with newly diagnosed, relapsed or suspected relapsed ccRCC.

Overview of Clinical Research

Title

Early-phase clinical trial of 64Cu-PD-32766 for the patients with clear cell renal cell carcinoma

Principal Investigator

Anri Inaki (National Cancer Center Hospital East)

Objectives

To evaluate the safety, pharmacokinetics, and exposure dose of PET/CT test with 64Cu-PD-32766 in patients with newly diagnosed, relapsed or suspected to have relapsed ccRCC.

Inclusion Criteria

Proven ccRCC patients with the presence of distant metastatic lesions (including distant metastatic recurrence) or local recurrence lesions from the site of removal after total nephrectomy of the diseased kidney

Number of Subjects

6

Primary outcome

Per-patient PET sensitivity

Secondary outcomes

Per-lesion PET sensitivity, safety, pharmacokinetics and estimated irradiation dose

JRCT trial identifier: jRCTs031240046

CAIX is a cell surface antigen highly expressed in ~95% of ccRCC with minimal expression in normal tissues, making it a potentially ideal target for the diagnosis and treatment of ccRCC. PeptiDream discovered and developed PD-32766 using its proprietary Peptide Discovery Platform System (PDPS) technology, with in vivo imaging and efficacy studies conducted by PDRadiopharma Inc. (PeptiDream’s wholly owned subsidiary). Key advantages of this clinical research are the ability to generate early human imaging data (often referred to as a Phase 0 study) using diagnostic 64Cu agent directly in the target patient population which provides an early look at the diagnostic usefulness of the agent, the likelihood of therapeutic benefit when labeled with a therapeutic radioisotope, and additional critical information that can be used in designing subsequent clinical studies, thereby significantly accelerating clinical development.

Comments of Dr. Toshihiko Doi, Director, National Cancer Center Hospital East

We are delighted to report the initiation of this human imaging study, with the first administration of 64Cu-PD-32766 in patients diagnosed with ccRCC. As one of the leading cancer centers in Japan, our mission is to continuously improve healthcare in Japan, by bringing innovative life changing therapeutics to our patients in need, and we believe that combining PeptiDream’s cancer targeting peptides with the imaging and cancer killing power of radionuclides, represents a highly promising new therapeutic approach toward the diagnosis and treatment of patients with ccRCC.

Comments of Dr. Patrick C. Reid, President & CEO of PeptiDream

We are excited to announce that our collaborators at the National Cancer Center Japan have dosed the first patient in the human imaging study of PD-32766, our CAIX targeting macrocyclic peptide radiolabeled with 64Cu, for the potential diagnosis and treatment of patients with ccRCC. I am extremely proud of the entire PeptiDream team, and grateful to our National Cancer Center Japan collaborators, for this wonderful achievement, and we look forward to sharing the results as they become available. We are deeply committed to utilizing our peptide expertise to develop the next generation of targeted radiopharmaceuticals, which we believe will have a tremendous impact on cancer patient care.

About Renal Cell Carcinoma (RCC)

RCC is the 9th most common cancer in the United States, representing 2% of all global cancer diagnoses and death, with 5-year survival rates at 12% (worldwide an estimated 400,000 people were diagnosed with kidney cancer in 2020, with roughly 9 out of 10 kidney cancers being RCCs). There are largely three main types of RCC, clear cell ("ccRCC"), papillary ("pRCC-type 1 and type 2"), and chromophobe ("chRCC"), with ccRCC representing roughly 70% of RCC cases.

Reference

A novel Carbonic Anhydrase IX targeting radiopeptide, 64Cu-PD-32766 and 177Lu-PD32766, exhibit promising theranostic potential in ccRCC tumors. (American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024)

Glossary

(Note) Radiotheranostics
Radiotheranostics refers to the use of radioisotope-labelled agents to diagnose and treat patients by using different nuclides. Theranostics integrate the diagnosis and treatment of cancer, narrow down patients who is likely to be effective in treatment and monitor the effectiveness of treatment.

On June 4, 2024 Akari Therapeutics Plc (Nasdaq: AKTX), an innovative biotechnology company advancing therapies for autoimmune and inflammatory diseases, reported the successful initial closing of a private placement financing round (Press release, Akari Therapeutics, JUN 4, 2024, View Source [SID1234644076]). This transaction is expected to raise an aggregate of approximately $7.6 million in gross proceeds from both new and existing investors.

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"We are pleased to announce this financing for Akari Therapeutics," said Samir R. Patel, MD, Interim President and CEO of Akari Therapeutics. "The overwhelming interest from investors allowed the company to upsize the transaction to $7.6 million and highlights the excitement surrounding our science and the strategic direction of the company, and our merger with Peak Bio, which we expect to close in the third quarter of 2024."

The majority of the private placement financing was supported by new investors, with continued support from certain existing investors, led by Akari’s Chairman, Dr. Ray Prudo, and Interim President and CEO, Samir R. Patel, MD, underscoring their strong confidence in the company’s future. "I believe investors share our enthusiasm for the Akari-Peak go-forward strategy and combined scientific potential. The financing supports investors’ belief in our strategic vision and the future of our combined companies and the management team," added Dr. Patel.

The company entered into a definitive agreement for the private placement with the investors on May 29, 2024, pursuant to which the Company agreed to sell and issue an aggregate of 4,029,754 unregistered American Depository Shares ("ADSs"), each representing 2,000 of the Company’s ordinary shares, and Series C Warrants (the "warrants") to purchase up to 4,029,754 ADSs, at a per unit price of $1.885 per ADS and warrant. The warrants have a term of 3 years from the closing date of the private placement and have cashless exercise provisions. The warrants (other than those issued to Dr. Ray Prudo and Samir R. Patel, M.D.) have an exercise price of $1.76 per ADS, which is equal to the Nasdaq have an exercise price of $1.76 per ADS, which is equal to the Nasdaq official closing price of the Company’s ADSs on the Nasdaq Capital Market on May 29, 2024. The warrants issued to Dr. Ray Prudo and Samir R. Patel, M.D., have an exercise price of $1.79 per ADS, which is equal to the price at which the Company’s ADSs were last sold on the Nasdaq Capital Market on May 29, 2024.

In connection with the initial closing of the private placement on May 31, 2024, the Company received gross proceeds of approximately $7.2 million, and issued 3,817,553 unregistered ADSs and warrants to purchase up to an aggregate of 3,817,553 ADSs. The remaining 212,201 ADSs and warrants to purchase up to 212,201 ADSs are expected to be issued and sold by the Company within 90 days of May 31, 2024, subject to receipt of payment related thereto.

Paulson Investment Company LLC acted as the exclusive placement agent for the financing.

The securities described above were offered and sold in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and have not been registered under the Act or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from such registration requirements.

No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to subscribe for, buy or sell or the solicitation of an offer to subscribe for, buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of, or offer to sell or buy, securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. This communication is for informational purposes only. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended, and otherwise in accordance with applicable law.