On June 1, 2022 Sichuan Kelun-Biotech Biopharmaceutical Co, Ltd. ("Kelun-Biotech") and Levena Biopharma ("Levena"), a subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), reported the planned presentation of A166 data (Abstract #1037 and Poster #415) in patients with HER2-expressing locally advanced or metastatic solid tumors at the 2022 Annual Meeting of ASCO (Free ASCO Whitepaper), the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held on June 3-7 in Chicago, IL (Press release, Sorrento Therapeutics, JUN 1, 2022, View Source [SID1234615311]). A166 is a HER2 antibody-drug conjugate (ADC) developed by Kelun-Biotech in a partnership with Levena Biopharma, which provided the patent-protected technologies for the generation and production of A166 in relation to (1) Duostatin-5, a proprietary tubulin inhibitor, (2) K-Lock, a site-specific conjugation technology, and (3) an enzymatically cleavable linker.

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As previously reported, in Phase 1 of the study, A166 demonstrated a safety profile that compared favorably to its commercial competitors and potentially superior efficacy as shown by the overall response rate (ORR) of 59.1% and 71.4% in the 4.8 mg/kg cohort and 6.0 mg/kg cohort, respectively, in heavily pretreated patients with HER2-positive breast cancer (data presented at the 2021 ASCO (Free ASCO Whitepaper) meeting [NCT05311397; J Clin Oncol 39, 2021 (suppl 15; abstr 1024)].

At the upcoming 2022 ASCO (Free ASCO Whitepaper) meeting, Kelun-Biotech will report updated data from this Phase 1 trial (Abstract #1037 and Poster #415). The Phase 1 dose expansion of the study was conducted in several sites in China and enrolled a total of 58 female patients (n=23 at 4.8 mg/kg and n=35 at 6.0 mg/kg) treated with A166 in 3-week cycles.

The best ORR was 73.9% (17/23; 95% CI, 51.59 to 89.77) in the 4.8 mg/kg cohort and 68.6% (24/35; 95% CI, 50.71 to 83.15) in the 6.0 mg/kg cohort.
Median progression free survival (PFS) was 12.3 months (95% CI, 6.00-not reached) in the 4.8 mg/kg cohort and 9.4 months (95% CI, 4.00 to 10.40) in the 6.0 mg/kg cohort.
Of 23 patients treated in the 4.8 mg/kg cohort, one had a confirmed and sustained CR lasting 7+ months.
Next generation sequencing was performed on tissue-derived DNA and blood-derived circulating tumor DNA.
The detailed safety data, RECIST 1.1 response rate, and biomarker analyses will be presented in a poster (#415) at the 2022 ASCO (Free ASCO Whitepaper) meeting

On June 1, 2022 PharmaMar (MSE:PHM) reported that they and their partners will present eight new abstracts from several clinical studies with Zepzelca (lurbinectedin) and Yondelis (trabectedin) during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, to be held June 3-7, 2022 in situ in Chicago, USA and virtually (Press release, PharmaMar, JUN 1, 2022, View Source [SID1234615308]).

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Among the studies to be presented are the poster entitled "Analysis of patients with relapsed small cell lung cancer (SCLC) receiving single-agent lurbinectedin in the phase 3 ATLANTIS trial", which shows the results of a subgroup of 50 patients with SCLC from the phase III ATLANTIS trial who, after having received 10 cycles of lurbinectedin 2.0mg/m2 in combination with doxorubicin, went on to be treated with lurbinectedin as a single agent at the approved dose of 3.2 mg/m2. The results show that these patients tended to maintain or better the tumor response obtained with the combination when switched to lurbinectedin monotherapy, including an increase in the rate of complete responses. These patients also had favorable Overall Survival (OS), with a median of 20.7 months, and no new signs of toxicity were identified.

Under the title "Efficacy and safety of lurbinectedin as second-line therapy in Chinese patients with small cell lung cancer: Preliminary results of a phase 1 study", the results of the phase I trial will be presented, in which lurbinectedin monotherapy has shown promising efficacy as a second-line treatment in Chinese patients with SCLC, with acceptable tolerability and a manageable safety profile.

Results from the Phase I trial of lurbinectedin in combination with immunotherapy will also be presented. This poster, entitled "A phase 1/2 trial of lurbinectedin (L) in combination with pembrolizumab (P) in relapsed small cell lung cancer (SCLC): The LUPER study", shows the phase I results of this trial, which demonstrates a manageable safety profile and preliminary antitumor activity of the combination of lurbinectedin with pembrolizaumab in second-line patients with relapsed SCLC, and the trial’s expansion phase is already ongoing.

Finally, with regards to lurbinectedin, data from the cohort of patients with BRCA1/2-associated breast cancer from the Phase II trial with lurbinectedin as a single agent will be presented. The poster "Lurbinectedin in patients with pretreated BRCA1/2-associated metastatic breast cancer: Results from a phase II basket study" confirms the activity of lurbinectedin previously observed in this indication.

Studio e la Cura dei Tumori (Italy) will give an oral presentation of the abstract entitled "Neoadjuvant chemotherapy in high-risk soft tissue sarcomas: Results of the expanded cohort of myxoid liposarcoma of the randomized clinical trial from the Italian Sarcoma Group (ISG), the Spanish Sarcoma Group (GEIS), the French Sarcoma Group (FSG), and the Polish Sarcoma Group (PSG)", in which he will present the efficacy results of trabectedin in high-grade myxoid liposarcoma. Thanks to the previous results obtained in this study, the ESMO (Free ESMO Whitepaper) Guidelines included trabectedin as a treatment option for this subtype of sarcoma in 2021.

All ASCO (Free ASCO Whitepaper) poster presentations are available on request to registered participants for 180 days from May 26, 2022: View Source

Highlighted studies at ASCO (Free ASCO Whitepaper) 2022

Zepzelca (lurbinectedin)

TITLE
LEAD AUTHOR ABSTRACT
Analysis of patients with relapsed small cell lung cancer (SCLC) receiving single-agent lurbinectedin in the phase 3 ATLANTIS trial Alejandro Navarro MD ABSTRACT: 207436 POSTER SESION: Lung Cancer—Non-Small Cell Local-Regional/Small
Efficacy and safety of lurbinectedin as second-line therapy in Chinese patients with small cell lung cancer: Preliminary results of a phase 1 study Ying Cheng MD ABSTRACT: 207457 POSTER SESSION: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
A phase 1/2 trial of lurbinectedin (L) in combination with pembrolizumab (P) in relapsed small cell lung cancer (SCLC): The LUPER study Antonio Calles MD, MSc ABSTRACT: 210025 POSTER SESSION: Breast Cancer—Metastatic
Lurbinectedin in patients with pretreated BRCA1/2-associated metastatic breast cancer: Results from a phase II basket study Valentina Boni MD ABSTRACT: 210025 POSTER SESSION: Breast Cancer—Metastatic
Efficacy of lurbinectedin in a clinical trial versus other standard of care in a real-world comparator arm in relapsed/refractory small cell lung cancer patients Apar Kishor Ganti MD ABSTRACT: 208920 PUBLICATION ONLY: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Yondelis (trabectedin)

Neoadjuvant chemotherapy in high-risk soft tissue sarcomas: Results of the expanded cohort of myxoid liposarcoma of the randomized clinical trial from the Italian Sarcoma Group (ISG), the Spanish Sarcoma Group (GEIS), the French Sarcoma Group (FSG), and the Polish Sarcoma Group (PSG) Alessandro Gronchi MD ABSTRACT: 208036 ORAL ABSTRACT SESSION: Sarcoma
Randomized phase III trial on trabectedin (ET-743) single agent versus clinician’s choice chemotherapy in recurrent ovarian, primary peritoneal, or fallopian tube cancers of BRCA-mutated or BRCAness phenotype patients (MITO23) Giovanni Scambia MD ABSTRACT: 206849 ORAL ABSTRACT SESSION: Gynecologic Cancer
Trabectedin in advanced retroperitoneal well differentiated/dedifferentiated liposarcoma and leiomyosarcoma (TRAVELL): Results of a phase 2 study from Italian sarcoma group (ISG) Roberta Sanfilippo MD ABSTRACT: 211471 POSTER SESSION: Sarcoma

On June 1, 2022 Nykode Therapeutics AS (Euronext Growth (Oslo): NYKD), a clinicalstage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported that its Chief Executive Officer, Michael Engsig, and Chief Innovation and Strategy Officer, Agnete Fredriksen, will present and provide a corporate update at the 2022 Jefferies Healthcare Conference on June 8, 2022 at 8.30 p.m. CET/ 2.30 p.m. ET and are available for 1:1 investor meetings.

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The live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website here.

On June 1, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and GO Therapeutics, Inc. (Co-Founder and CEO: Constantine Theodoropulos, "GO") reported that Xyphos Biosciences, Inc., (a wholly owned subsidiary of Astellas, "Xyphos") and GO have entered into a strategic research collaboration and license agreement to develop novel Immuno-Oncology therapeutics (Press release, Astellas, JUN 1, 2022, View Source [SID1234615305]).

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GO is applying new advances in glycoproteomics to develop antibody-based cancer therapeutics that specifically target cancer cells. Xyphos holds a novel and proprietary ACCELTM technology platform that uses its convertibleCAR (convertible Chimeric Antigen Receptor) on immune cells.

Under the terms of the agreement, the two companies will collaborate exclusively to identify novel antibodies with high affinity to two different glycoprotein targets and apply these antibodies to a range of therapeutic modalities. GO will lead the collaboration to discover high-affinity antibodies against the two targets, and Astellas will be responsible for research activities, clinical development and commercialization of the therapeutics derived from the antibodies provided by GO.

Under the terms of the agreement, Xyphos will pay GO Therapeutics US$20.5 million in upfront cash. Milestone and contingency payments could total up to another US$763 million.

"We are excited to collaborate with Astellas to develop a new class of Immuno-Oncology therapeutics," said Constantine Theodoropulos, co-founder and CEO of GO Therapeutics. "The combination of GO’s targets and antibodies and Astellas’ ACCEL technology promises to create a new generation of cancer treatments that have a greater therapeutic index. This will enable oncologists to increase the efficacy of antibody-based immunotherapies for solid tumors with less damage to healthy tissues."

Naoki Okamura, Chief Strategy Officer at Astellas said, "At Astellas, we have positioned Immuno-Oncology as one of the Primary Focuses of our R&D strategy. We believe that this collaboration will bring synergies between the two companies’ cutting-edge research, and will ultimately lead to the development of new therapeutics for patients with great unmet medical needs."

On June 1, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that an abstract titled "A phase I/II study of onatasertib, a dual TORC1/2 inhibitor, combined with the PD-1 antibody toripalimab in patients with advanced solid tumors (TORCH-2)" will be presented as a poster during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2022), taking place from June 3rd to 7th in Chicago, Illinois via in person or virtual attendance (Press release, Antengene, JUN 1, 2022, View Source [SID1234615296]).

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"Antengene is very pleased to share the clinical data from the TORCH-2 study with the oncology community. Based on the data outlined in the abstract, we are very enthusiastic to further explore the combination of ATG-008 and the PD-1 inhibitor, toripalimab, in the treatment of patients with advanced solid tumors, including cervical cancer. We hope to validate these encouraging early data and thereby help guide the next steps in our clinical development program with ATG-008." said Dr. Kevin Lynch, Antengene’s Chief Medical Officer.

As of the data cut-off on December 20, 2021, the overall response rate (ORR) was 28.6% (based on 6 patients with 5 confirmed responses) and the disease control rate (DCR) was 71.4%. These data are based on 21 efficacy evaluable patients of 28 patients with advanced solid tumors enrolled in the dose-escalation and dose-expansion phases of the Phase I/II TORCH-2 study (median of 2 prior lines of therapy). No dose-limiting toxicities were reported in the dose escalation phase. Most common adverse events (grade 3 or greater) included lymphocyte count decrease, rash and hyperglycemia etc.

Toripalimab was developed by Junshi Biosciences.

The abstract provided several observations regarding cohorts in the efficacy evaluable patients:

Efficacy Evaluable Cervical Cancer Cohort: Among the 5 efficacy evaluable patients in the cervical cancer cohort, 1 patient with negative PD-L1 expression experienced a complete response (CR) and 3 patients experienced a partial response (PR); all responses were confirmed.
Additional Responses in the Efficacy Evaluable Patients: the study reported two additional PRs (one nasopharyngeal carcinoma and one ovarian cancer).
Progression Free Survival (PFS) and Duration of Response: The median PFS for all 28 efficacy evaluable patients was 3.52 months and the 18-month PFS rate was 31.2% (as of December 20, 2021). Note that the patient who achieved CR in the cervical cancer cohort had remained on treatment for 580 days.
The Recommended Phase II Dose was determined.