On June 1, 2022 Almac Discovery, a research driven drug discovery company and member of the Almac Group, reported the nomination of a new pre-clinical candidate molecule (ADP-c389), a novel Protein Drug Conjugate (PDC) targeting the tumour-associated antigen ROR1, for the treatment of refractory solid and haematological cancers (Press release, Almac, JUN 1, 2022, View Source [SID1234615313]). This follows an extensive profiling exercise in which ADP-c389 has demonstrated an excellent preclinical efficacy profile in a range of models, a large therapeutic index and robust preclinical development potential.

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This nomination represents the first candidate molecule to be generated using Almac Discovery’s novel PDC platform. The platform combines the use of single chain antigen binding domains with Almac’s proprietary linker:payload and conjugation technologies to produce first and best in class compounds that target unmet needs in oncology.

ROR1 is a novel tumour-associated antigen and was selected as the first target for the platform due to its selective expression pattern on different tumour types including triple-negative breast cancer, lung cancer, ovarian and colorectal cancer, and its functional role in tumorigenesis, disease progression and drug resistance. With ADP-c389 in hand, the Almac Discovery team are now also exploring additional clinical applications for the molecule in areas of high unmet need.

Dr Graham Cotton, Head of Protein Therapeutics at Almac Discovery, said: "The nomination of this candidate drug represents a significant value inflection point in in the development of our PDC platform and an important step forward in our search for new treatments for solid tumours. This particular molecule has arisen from our strategic collaboration with Elasmogen Ltd, (Aberdeen UK), with whom we have worked to identify a selective, high affinity single domain binding molecule derived from their shark Variable New Antigen Receptor (VNAR) platform. With this, and other differentiating features included in the design of this compound, we are confident that ADP-c389 has the potential to progress to a Best-in-Class drug against this clinically relevant target."

Dr Alan Lamont, VP Business Development and Licensing added: "We are now seeking to identify a partner to facilitate clinical development of this asset and take this molecule through the next stages of development."

On June 1, 2022 Taiho Pharmaceutical Co., Ltd. reported that it will donate a total of 4.17 million yen in matching gift to three projects for the first Taiho Smile Support, a program to support organizations and individuals working to solve social issues in the field of oncology (Press release, Taiho, JUN 1, 2022, View Source [SID1234615312]).

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Taiho Pharmaceutical planned the first Taiho Smile Support to contribute to Goal 3 of the SDGs: "Ensure healthy lives and promote well-being for all at all ages." It then called for projects to address various issues surrounding cancer. Three projects were selected from among the many applications, and all three applicants succeeded in crowdfunding their goal amounts. Taiho Pharmaceutical’s donation, totaling 4.17 million yen, represents 50% of the total funds needed to implement the three projects. Each project will be gradually implemented.

Yokohama Children’s Hospice
UMI TO SORA NO OUCHI (a home of sea and sky): "Connecting Through Green" Project

Through this program, Taiho Pharmaceutical aims to support the dreams of organizations and individuals who are working to address challenges in the field of oncology. In partnership with these organizations, individuals, and all of the people who support them via crowdfunding, Taiho Pharmaceutical seeks to create a world where the precious moments of everyday life keep flowing for people with cancer and their families.

First Taiho Smile Support (Available only in Japanese)
Taiho Smile Support is an initiative to support organizations and individuals seeking to solve various social issues in the field of oncology that cannot be solved by drugs alone. Taiho Pharmaceutical called for organizations and individuals who plan to use crowdfunding to raise funds to address these social issues. The selected organizations and individuals each conducted a crowdfunding campaign and reached their funding target.* They will each receive from Taiho Pharmaceutical, in the form of a donation, matching funds equal to the target they have raised.

* The crowdfunding target (not including the crowdfunding fee) is to be 50% of all funds needed to carry out the project. If the target is met, Taiho Pharmaceutical will provide the remaining 50%. Thus, the success of the crowdfunding campaign will determine whether or not Taiho Pharmaceutical will provide support.

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.