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IMMUTEP OPERATIONAL UPDATE

On December 15, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, reported that it provides an update on efti clinical programs (Press release, Immutep, DEC 15, 2020, View Source [SID1234572933]).

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Eftilagimod alpha ("efti") Update

AIPAC – Phase IIb clinical trial

The Company presented in a spotlight presentation at the San Antonio Breast Cancer Symposium 2020, first Overall Survival (OS) data and is on track to report final overall survival data and overall response rate by mid calendar year 2021. Currently there are more than 66% of events compared to approx. 60% which were the basis of the OS data presented at the San Antonio Breast Cancer Conference.

TACTI-002 – Phase II clinical trial

The 3rd stage of 1st line NSCLC with an additional 74 patients in the US, Australia and Europe is now open for recruitment. The TACTI-002 Phase II study, which is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada), has been expanded by 74 additional patients, following the results presented at SITC (Free SITC Whitepaper) in November 2020.

Recruitment is ongoing for stage 2 of Part C (second line head and neck squamous cell carcinoma) and it is expected to open recruitment of stage 2 of Part B (second line non-small cell lung cancer) in the next year.

Phase II Clinical Trial in Head and Neck Cancer

Immutep continues to prepare for a new randomised, controlled Phase II clinical study in approximately 160 1st line HNSCC patients. Patients will be 1:1 randomised to receive efti in combination with an anti-PD-1 treatment, or anti-PD-1 monotherapy. The trial is intended to take place across clinical trial sites in the United States, Australia and Europe.

TACTI-mel – Phase I clinical trial

The results of Immutep’s Phase I TACTI-mel trial were recently published in the Journal for ImmunoTherapy of Cancer. The trial was conducted in Australia and evaluated efti in combination with pembrolizumab in metastatic melanoma.

INSIGHT-004 – Phase I clinical trial

INSIGHT-004, the fourth arm of the INSIGHT trial (INSIGHT-004 is also known as Stratum D of INSIGHT) which is being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. is expected to deliver final data in 2021. First data from the study were presented at ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) 2020.

EOC Pharma – Phase II clinical trial

Preparations are ongoing for a new Phase II clinical study in China (152 patients) evaluating efti in combination with chemotherapy for the treatment of metastatic breast cancer.

Financial Update

In the current quarter, Immutep completed an equity financing and raised approximately A$29.6 million in a placement supported by high quality institutional investors from Australia and offshore.

In addition, given the recent exercise of warrants over American Depository Shares, which generated proceeds of approximately US$7.7 million (approx. AU$10.1 million), the Company is in an excellent financial position with a cash runway beyond end of calendar year 2022.

Peptomyc announces new equity financing round led by Aurora Science

On December 15, 2020 Peptomyc S.L., a biotech company specialized in the development of protein and peptide therapeutics for cancer treatment, reported the completion of an equity financing round of EUR 11.4 million (Press release, Peptomyc, DEC 15, 2020, View Source [SID1234572929]). The company is focused on the development of a new generation of cell penetrating peptides (CPPs) targeting the Myc oncoprotein for cancer treatment.

Peptomyc is relying on a strong syndicate of life sciences investors. This investment was led by AurorA Science and substantially supported by existing investors including Alta Life Sciences, HealthEquity, Business Angels and the CDTI. Also, Peptomyc’s employees had the opportunity to invest in the company.

This financing will enable Peptomyc to advance OMO103 until preliminary results of phase I clinical trial. OMO103 has already demonstrated its safety and anti-tumor activity in multiple types of experimental models of cancer and it is now ready to be tested in clinical studies. The treatment of the first patient with the lead candidate, OMO103, is expected to start in Q1, 2021.

"We are delighted to have attracted such high-profile investors to our company," said Laura Soucek, CEO of Peptomyc. "I am confident that their industrial background and extensive experience in bio-pharma and translational medicine will significantly contribute to the success of our product."

"We were excited to have the opportunity to participate in this financing" said Guido Guidi, chairman of AurorA Science. "Peptomyc is a promising company matching our industrial criteria, following a rigorous selection process managed by AurorA Science’s three partners, AurorA-TT, Rottapharm Biotech and Italfarmaco. We are glad to support a company with front edge science and outstanding potential to bring benefits to patients."

Of note: Peptomyc is already preparing for a new financing round for 2021 to ensure the swift execution of its ongoing and planned clinical development programs until completion of successful clinical Phase II studies.

Glycostem announces treatment of first patient in pivotal phase I/IIa trial of oNKord® in patients with Acute Myeloid Leukemia

On December 15, 2020 Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic off-the-shelf Natural Killer (NK) cells, reported that the first patient has been dosed in its pivotal phase I/IIa trial of oNKord for the treatment of Acute Myeloid Leukemia (AML) (Press release, Glycostem Therapeutics, DEC 15, 2020, View Source [SID1234572900]). The WiNK trial will enroll 33 AML patients at eight clinical sites based in five European countries. oNKord is the company’s first-generation off-the-shelf allogeneic NK cellular immunotherapy product. Glycostem is furthermore developing a range of second (CAR-NK) and third generation (TCR-NK) NK products in-house.

"We are thrilled about the first patient being dosed in this pivotal trial. This important milestone potentially paves the way for a positive impact on the lives of patients with AML who are at high risk of relapse. The preliminary efficacy data obtained with oNKord is very promising and we are looking forward to the data from this study, which will allow us to draw conclusions regarding oNKord safety and tolerability and most importantly its efficacy for treatment of AML patients," tells Troels Jordansen, CEO at Glycostem.

"We are very excited about being involved in the WiNK trial and to learn what the efficacy of oNKord will be on eradicating measurable residual disease (MRD) in AML patients," tells Professor Heuser, Investigator and Head of the central laboratory for MRD assessment at the Hannover Medical School in Germany. "Currently, two thirds of MRD-positive AML patients who are in complete morphologic remission will relapse, and unfortunately, there is no cure for this group of patients if allogeneic stem cell transplantation is not an option. Therefore, the outcome of this trial is literally of vital importance and positive results could have a very significant impact on the prospects of current and future patients we are treating."

Evaluating safety, tolerability and efficacy

WiNK (ClinicalTrials.gov identifier: NCT04632316) is a prospective two-stage, open-label, single arm, multicenter phase I/IIa trial to evaluate the safety and efficacy of oNKord, an off-the-shelf, ex vivo-cultured allogeneic NK cell preparation, in 33 adults with AML who are in complete morphologic remission with residual measurable disease and with no strong indication for hematopoietic stem cell transplantation.

Stage A of the trial is designed to assess the safety and tolerability of escalating doses of oNKord in three cohorts of three subjects each. An Independent Data Monitoring Committee (IDMC) will review safety data of all treated subjects in each cohort and make recommendations before moving to the next dose. Stage B of the trial will enroll an additional 24 subjects to evaluate the safety, tolerability and efficacy of oNKord at the recommended phase II dose, as identified from stage A.

PreludeDx™ Presents New Data at SABCS Spotlight Session Re-Classifying Patients Meeting RTOG 9804 Low Risk Criteria as Elevated Risk Using DCISionRT®

On December 15, 2020 Prelude Corporation (PreludeDxä), a leader in molecular diagnostics and precision medicine for early stage breast cancer, presented clinical outcomes data last week at the San Antonio Breast Cancer Symposium (SABCS) that further validates the DCISionRT test results of an independent study by Kaiser Permanente Northwest published earlier this year in Clinical Cancer Research (Press release, Prelude Therapeutics, DEC 15, 2020, View Source [SID1234572899]). DCISionRT is a biologic risk signature that assess the 10-yr risk of a subsequent breast cancer recurrence. A Spotlight Poster presented at SABCS, showed that the DCISionRT test reclassified 45% of patients meeting RTOG 9804 low risk or ‘good risk’ criteria for Ductal Carcinoma In Situ (DCIS) as Decision Score (DS) Elevated Risk. These patients who were reclassified by the DCISionRT test to DS Elevated Risk had clinically elevated 10-year breast cancer rates when treated without radiation therapy (RT) and demonstrated an 84% relative benefit with RT.

The company’s Spotlight Poster, entitled DCIS biosignature reclassified patients, who met RTOG 9804 or ECOG-ACRIN E5194 low-risk clinicopathologic criteria into an elevated invasive risk group who benefited significantly from radiation therapy, was presented on Thursday, December 10 by Dr. Chirag Shah, Director of Breast Radiation Oncology and Director of Clinical Research – Radiation Oncology at Cleveland Clinic.

RTOG 9804 criteria is based on traditional clinical and pathological features and is used to identify low risk or ‘good risk’ DCIS patients. In this study, complete biomarker data was available for 535 women meeting ‘good risk’ clinicopathologic RTOG 9804-like criteria. In the DCISionRT DS Low Risk group there was no significant reduction from RT. However, in the DCISionRT DS Elevated Risk group, RT significantly reduced invasive breast cancer risk by 84%.

"In this study we examined the utility of the DCISionRT test to identify patients who otherwise met traditional ‘good-risk’ criteria but remained at an elevated invasive risk after lumpectomy," said
Dr. Shah. "The study supports the use of DCISionRT, which provides a ten-year breast event risk with and without radiation therapy after lumpectomy, as compared to traditional clinical and pathological features when making radiation therapy decisions following breast conserving surgery in patients with DCIS."

Similar results were previously reported by an independent validation of DCISionRT conducted by Kaiser Permanente Northwest (KPNW), which included a 455 patient cohort. DCISionRT reclassified approximately 50% of patients meeting ‘good risk’ criteria like RTOG 9804 as DS Elevated Risk. Women in the DS Elevated Risk category in the KPNW cohort had a 21% 10-yr invasive recurrence rate when treated with lumpectomy and without RT, and a 6% rate when receiving radiation therapy.

"We appreciate the opportunity to have worked alongside such esteemed physicians and organizations and are thrilled to announce another strong data set supporting the integration of DCISionRT into clinical practice management for DCIS," said Daniel Forche, President and CEO of PreludeDx. "Women and their physicians contemplating the next treatment steps now can make a personalized decision for radiation therapy that includes their individual tumor biology to add or omit radiation therapy after breast conserving surgery."

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with artificial intelligence and machine learning to assess a woman’s individual tumor biology along with other risk factors and provide a personalized recurrence risk. The test provides a Decision ScoreTM that identifies a woman’s risk as low or elevated. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.

Nektar Therapeutics Announces Dosing of First Patients in Phase 1/2 Study of its IL-15 Agonist, NKTR-255, in Combination with Cetuximab in Patients with Head and Neck Squamous Cell Carcinoma or Colorectal Cancer

On December 15, 2020 Nektar Therapeutics (NASDAQ:NKTR) reported that the first patient has been dosed in the Phase 1/2 trial of NKTR-255, Nektar’s investigational IL-15 pathway agonist, in patients with relapsed or refractory (R/R) head and neck squamous cell carcinoma (HNSCC) or colorectal cancer (CRC) at the START Center for Cancer Care in San Antonio, TX (Press release, Nektar Therapeutics, DEC 15, 2020, View Source [SID1234572897]). The study is evaluating NKTR-255 plus cetuximab in up to 80 patients at approximately 15 investigator sites in the United States and European Union.

NKTR-255 is designed to activate the IL-15 pathway and expand Natural Killer (NK) cells as well as promote the survival and expansion of CD8+ T cells without inducing suppressive regulatory T cells. Cetuximab is a monoclonal antibody against epidermal growth factor receptor (EGFR) and is approved for the treatment of advanced HNSCC and CRC.

"An NK-cell agent such as NKTR-255 is a perfect and unique complement to monoclonal antibody therapies which induce antibody-dependent cellular cytotoxicity," said Wei Lin, MD, Head of Development at Nektar. "Our body of preclinical and clinical data for NKTR-255 demonstrates that this novel agent not only induces NK cell proliferation but also enhances their cytotoxic immune effector function. With this new Phase 1/2 study in HNSCC and CRC, we are excited to expand our NKTR-255 development program beyond the hematological setting into solid tumors."

Nektar recently presented the first clinical data for NKTR-255 at the most recent 2020 Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November. The data demonstrated that NKTR-255 was well tolerated and biologically active, and treatment resulted in consistent expansion of lymphocytes, with durable and sustained increases in NK and CD8+ T cells in a highly refractory population of patients with multiple myeloma (MM) and non-Hodgkin lymphoma (NHL).

The new Phase 1b/2 study will test the combination of NKTR-255 with cetuximab in two groups of patients. One group will consist of R/R head and neck cancer patients who have progressed after treatment with platinum-based chemotherapy and a checkpoint inhibitor. The second group will include patients with metastatic colorectal cancer who have received two prior treatments for metastatic disease. The trial will begin with a dose-finding portion for the combination, which will then be expanded into dedicated cohorts for head and neck and colorectal cancer patients.

About NKTR-255

NKTR-255 is an investigational IL-15 receptor agonist designed to activate the IL-15 pathway and expand NK cells and promote the survival and expansion of memory CD8+ T cells without inducing suppressive regulatory T cells. Through optimal engagement of the IL-15Rα/IL-2Rβγ receptor complex, NKTR-255 enhances functional NK cell population and formation of long-term immunological memory, which may lead to sustained anti-tumor immune response. NKTR-255 is uniquely designed to overcome the challenges of recombinant IL-15 and other IL-15 agonists, which are rapidly cleared from the body and have shown diminishing response to successive doses.1 NKTR-255 is wholly-owned by Nektar.