On September 2, 2021 AstraZeneca reported that it will present new data across its diverse portfolio of cancer medicines at the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung Cancer (WCLC) and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, AstraZeneca, SEP 2, 2021, View Source [SID1234587152]).

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A total of 14 approved and potential new medicines from AstraZeneca will be featured across more than 100 abstracts at the two meetings. There will be five oral presentations including one Presidential Symposium at WCLC, hosted by the IASLC between 8 and 14 September. A total of 20 oral presentations including one Presidential Symposium will be featured at ESMO (Free ESMO Whitepaper) between 16 and 21 September.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "Imfinzi and Tagrisso have redefined outcomes for patients with lung cancer, becoming the established standards of care around the world in certain settings. Our data at WCLC and ESMO (Free ESMO Whitepaper) illustrate our commitment to building on the benefits of these medicines with novel combinations to extend them to more patients. Our data will also showcase the real-world impact of these medicines in clinical practice."

Susan Galbraith, Executive Vice President, Oncology R&D said: "The DESTINY-Breast03 data at ESMO (Free ESMO Whitepaper) will demonstrate the potential for Enhertu to transform the treatment of HER2-positive metastatic breast cancer with a safety profile that supports the potential for Enhertu in early-stage disease. Additionally, the data from COAST will support our aim to extend the benefit of Imfinzi in unresectable, Stage III non-small cell lung cancer by combining it with potential first-in-class immunotherapies. Also, new data on Lynparza will answer critical questions about retreatment with a PARP inhibitor in resistant disease."

Leading in lung cancer with established standards of care and novel combination
A Presidential Symposium will present results from the final analysis of the POSEIDON Phase III trial at WCLC showing a significant, clinically meaningful survival benefit for the combination of Imfinzi (durvalumab), tremelimumab and chemotherapy in metastatic non-small cell lung cancer (NSCLC).

A late-breaking presentation at ESMO (Free ESMO Whitepaper) will feature three-year overall survival (OS) data from the CASPIAN Phase III trial of Imfinzi in extensive-stage small cell lung cancer (ES-SCLC), the longest reported to date for a Phase III trial of chemotherapy and PD-1/PD-L1 immunotherapy in this disease setting. Imfinzi is the only PD-1/PD-L1 immunotherapy to demonstrate both a significant survival benefit and improved response rate in combination with a choice of chemotherapies in ES-SCLC.

In another late-breaking presentation at ESMO (Free ESMO Whitepaper), the COAST Phase II trial will highlight progression-free survival (PFS) results for novel Imfinzi combinations with potential new medicines including oleclumab, an anti-CD73 monoclonal antibody, and monalizumab, an anti-NKG2A monoclonal antibody, in unresectable, Stage III NSCLC, building on the PACIFIC Phase III trial results that established Imfinzi as the standard of care in this setting.

Data at ESMO (Free ESMO Whitepaper) will showcase research into combatting resistant disease, including interim results from the ORCHARD Phase II trial studying the combination of Tagrisso (osimertinib) and savolitinib, an oral, potent and highly selective MET tyrosine kinase inhibitor, in patients with advanced EGFR-mutated (EGFRm) NSCLC with MET alterations whose disease progressed on 1st-line Tagrisso.

Real-world data will provide new compelling evidence for the efficacy and safety profiles of Imfinzi and Tagrisso in NSCLC. At ESMO (Free ESMO Whitepaper), PFS and tolerability data will be shared from the PACIFIC-R global observational study of patients with unresectable, Stage III NSCLC treated with Imfinzi after chemoradiation therapy. At WCLC, an interim analysis from the US cohort of a global prospective study will reinforce the efficacy of 1st-line Tagrisso in a real-world population of patients with EGFRm NSCLC.

Transforming treatment of advanced cancers with antibody drug conjugates (ADCs)
At ESMO (Free ESMO Whitepaper), a Presidential Symposium will present the results from the DESTINY-Breast03 Phase III trial demonstrating the potentially transformative impact of Enhertu (trastuzumab deruxtecan) for patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. DESTINY-Breast03 is the first global Phase III trial of Enhertu against an active control. In August 2021, the Independent Data Monitoring Committee recommended unblinding the trial based on a planned interim analysis showing a highly statistically significant and clinically meaningful improvement in the primary endpoint of PFS versus trastuzumab emtansine (T-DM1).

Also at ESMO (Free ESMO Whitepaper), data will include updated OS data from the DESTINY-Breast01 Phase II trial in HER2-positive metastatic breast cancer and late-breaking results from the DESTINY-Gastric02 Phase II trial in HER2-positive metastatic gastric cancer. A late-breaking presentation will feature primary analysis results from the HER2-mutant cohort of the DESTINY-Lung01 Phase II trial investigating Enhertu in patients with HER2-mutated metastatic NSCLC who have progressed following one or more systemic therapies, a setting where there are currently no approved HER2-directed treatments.

Updated data from the advanced/metastatic NSCLC cohort in the TROPION-PanTumor01 Phase I trial of datopotamab deruxtecan (Dato-DXd) will be presented at WCLC in a mini-oral presentation, and new NSCLC sub-analysis data will be shared in a late-breaking presentation at ESMO (Free ESMO Whitepaper) highlighting clinical activity in patients whose tumours have actionable genomic alterations. There are currently no TROP2-directed medicines approved for NSCLC, a setting where Dato-DXd has shown promising results in Phase I trials.

Changing treatment paradigms with industry-leading PARP inhibitors and next-wave DNA damage response therapies
At ESMO (Free ESMO Whitepaper), late-breaking data will be presented from the OReO/ENGOT Ov-38 Phase IIIb trial testing maintenance retreatment with Lynparza (olaparib) in patients with platinum-sensitive, relapsed epithelial ovarian cancer. OReO is the first Phase III trial to evaluate retreatment with a PARP inhibitor in resistant disease. Another presentation will feature subgroup analyses and updated safety data from the POLO Phase III trial of Lynparza in germline BRCA-mutated metastatic pancreatic cancer, a disease in which no other PARP inhibitor is approved.

An oral presentation will share interim data from an externally sponsored Phase II trial with ceralasertib, an ataxia telangiectasia and rad3-related (ATR) kinase inhibitor, testing anti-tumour activity in patients with ARID1A-deficient and -intact solid tumours.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza; with Daiichi Sankyo Company, Limited (Daiichi Sankyo) to develop and commercialise Enhertu and Dato-DXd, and with HUTCHMED to develop and commercialise savolitinib. AstraZeneca obtained full oncology rights to monalizumab from Innate Pharma in October 2018 through a co-development and commercialisation agreement initiated in 2015.

AstraZeneca to host virtual event on 15 September: "Spotting cancer before it has a chance: Can screening become universal?
To highlight diverse viewpoints on universal cancer screening, the Company will host a virtual event in collaboration with the European Alliance for Personalised Medicine on 15 September, 14:00 CEST. The event will bring together experts across disciplines to discuss the future of cancer screening and the barriers that persist to making screening universal. Registration for the event is open to the public.

Key AstraZeneca presentations during IASLC WCLC 20211

Lead author

Abstract title

Presentation details

Immuno-Oncology

Garassino, MC

Durvalumab ± Tremelimumab + Platinum-Etoposide in 1L ES-SCLC: Exploratory Analysis of HLA Genotype and Survival in CASPIAN

Abstract #MA16.06

Mini Oral Session: MA16 – SCLC: New Targets, Biomarkers, and Systemic Therapies

13 September 2021

20:35 – 20:40 MDT

14 September 2021

3:35 – 3:40 BST

Johnson, ML

Durvalumab ± Tremelimumab + Chemotherapy as First-line Treatment for mNSCLC: Results from the Phase 3 POSEIDON Study

Abstract #PL02.01

Plenary: PL02 – Plenary 2: Presidential Symposium

9 September 2021

6:30 – 6:40 MDT

13:30 – 13:40 BST

Tumour drivers and resistance

Blakely, CM

A Phase II Trial of Neoadjuvant Osimertinib for Surgically Resectable EGFR-Mutant Non-Small Cell Lung Cancer: Updated Results

Abstract #P26.02

Posters: P26 – Locally Advanced Non-Small Cell Lung Cancer – EGFR Targeted Therapy

8 September 2021

Nieva, J

Real-World Study of Patients With EGFR Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer Treated With First-Line Osimertinib

Abstract #P48.17

Posters: P48 – Novel Therapeutics and Targeted Therapies – EGFR

8 September 2021

Sequist, LV

COMPEL: Chemotherapy With/Without Osimertinib in Patients With EGFRm Advanced NSCLC and Progression on First-Line Osimertinib

Abstract #P47.11

Posters: P47 – Novel Therapeutics and Targeted Therapies – Clinical Trial in Progress

8 September 2021

Antibody drug conjugates

Borghaei, H

TROPION-Lung04: Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab and Platinum-Based Chemotherapy in Advanced NSCLC

Abstract #P47.06

Posters: P47 – Novel Therapeutics and Targeted Therapies – Clinical Trial in Progress

8 September 2021

Garon, EB

TROPION-PanTumor01: Updated Results From the NSCLC Cohort of the Phase 1 Study of Datopotamab Deruxtecan in Solid Tumors

Abstract #MA03.02

Mini Oral Session: MA03 – Biomarkers for Immunotherapy: Are All Relevant?

8 September 2021

10:50 – 10:55 MDT

17:50 – 17:55 BST

Johnson, ML

A Phase 2 Study of Datopotamab Deruxtecan (Dato-DXd) in Advanced NSCLC With Actionable Genomic Alterations (TROPION-Lung05)

Abstract: #P47.05

Posters: P47 – Novel Therapeutics and Targeted Therapies – Clinical Trial in Progress

8 September 2021

Levy, B

TROPION-Lung02: Datopotamab Deruxtecan (Dato-DXd) Plus Pembrolizumab and Platinum-Based Chemotherapy in Advanced NSCLC

Abstract #P47.04

Posters: P47 – Novel Therapeutics and Targeted Therapies – Clinical Trial in Progress

8 September 2021

1 22 abstracts at IASLC WCLC 2021 will feature AstraZeneca medicines and pipeline molecules.

Key AstraZeneca presentations during ESMO (Free ESMO Whitepaper) Congress 2021

Lead author

Abstract title

Presentation details

Immuno-Oncology

Girard, N

PACIFIC-R Real-World Study: Treatment Duration and Interim Analysis of Progression-Free Survival in Unresectable Stage III NSCLC Patients Treated with Durvalumab After Chemoradiotherapy

Abstract #1171MO

Mini Oral session – Non-metastatic NSCLC and other thoracic malignancies

18 September 2021

17:55 – 18:00 CEST

16:55 – 17:00 BST

Martinez-Marti, A

COAST: an open-label, phase 2, multidrug platform study of durvalumab alone or in combination with novel agents in patients with unresectable, Stage III NSCLC

Abstract #LBA42

Proffered Paper session – Non-metastatic NSCLC and other thoracic malignancies

17 September 2021

14:20 – 14:30 CEST

13:20 – 13:30 BST

Paz-Ares, L

Durvalumab ± tremelimumab + platinum-etoposide in first-line extensive-stage SCLC (ES-SCLC): 36-month overall survival from the Phase 3 CASPIAN study

Abstract #LBA61

Mini Oral session – Non-metastatic NSCLC and other thoracic malignancies

18 September 2021

18:10 – 18:15 CEST

17:10 – 17:15 BST

Tumour drivers and resistance

Cheema, P

Modelling long-term survival outcomes in patients with stage (stg) IB–IIIA EGFR-mutated NSCLC from the ADAURA trial

Abstract #1165P

ePoster

Hamilton, E

CAPItello-292: a phase 1b/3 study of capivasertib, palbociclib and fulvestrant versus placebo, palbociclib and fulvestrant in HR+/HER2-advanced breast cancer

Abstract #338TiP

ePoster

Yu, H

ORCHARD osimertinib + savolitinib interim analysis: A biomarker-directed Phase II platform study in patients (pts) with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on first-line (1L) osimertinib

Abstract #1239P

ePoster

Antibody drug conjugates

Saura, C

Trastuzumab Deruxtecan (T-DXd) in Patients with HER2-Positive Metastatic Breast Cancer (MBC): Updated Survival Results from a Phase 2 Trial (DESTINY-Breast01)

Abstract #279P

ePoster

Cortés, J

Trastuzumab Deruxtecan (T-DXd) vs Trastuzumab Emtansine (T-DM1) in Patients (Pts) With HER2+ Metastatic Breast Cancer (mBC): Results of the Randomized Phase 3 DESTINY-Breast03 Study

Abstract #LBA1

Presidential symposium 1

18 September 2021

15:05 – 15:20 CEST

14:05 – 14:20 BST

Van Cutsem, E

Primary Analysis of a Phase 2 Single-Arm Trial of Trastuzumab Deruxtecan (T-DXd) in Western Patients (Pts) With HER2-Positive (HER2+) Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Cancer Who Progressed on or After a Trastuzumab-containing Regimen

Abstract #LBA55

Mini oral session – Gastrointestinal tumours, non-colorectal

17 September 2021

17:45 – 17:50 CEST

16:45 – 16:50 BST

Li, BT

Primary Data from DESTINY-Lung01: A Phase 2 Trial of Trastuzumab Deruxtecan (T-DXd) in Patients (Pts) With HER2-Mutated (HER2m) Metastatic Non–Small Cell Lung Cancer (NSCLC)

Abstract #LBA45

Proffered Paper session – NSCLC, metastatic 1

18 September 2021

14:00 – 14:10 CEST

13:00 – 13:10 BST

Garon, EB

Efficacy of datopotamab deruxtecan (Dato-DXd) in patients (pts) with advanced/metastatic (adv/met) non-small cell lung cancer (NSCLC) and actionable genomic alterations (AGAs): preliminary results from the phase 1 TROPION-PanTumor01 study

Abstract #LBA49

Mini oral session – NSCLC, metastatic

19 September 2021

17:30 – 17:35 CEST

16:30 – 16:35 BST

DNA damage response

Pujade-Lauraine, E

Maintenance olaparib rechallenge in patients (pts) with ovarian carcinoma (OC) previously treated with a PARP inhibitor (PARPi): Phase IIIb OReO/ENGOT Ov-38 trial

Abstract #LBA33

Proffered Paper session – Gynaecological cancers

17 September 2021

14:20 – 14:30 CEST

13:20 – 13:30 BST

Aggarwal, R

Interim results from a phase 2 study of the ATR inhibitor ceralasertib in ARID1A-deficient and ARID1A-intact advanced solid tumor malignancies

Abstract #512O

Proffered Paper session – Developmental therapeutics

17 September 2021

13:40 – 13:50 CEST
12:40 – 12:50 BST

Lindemann, K

Olaparib maintenance monotherapy for non-germline BRCA1/2-mutated (non-gBRCAm) platinum-sensitive relapsed ovarian cancer (PSR OC): exploratory biomarker analyses of the Phase IIIb OPINION study

Abstract #740P

ePoster

Sabatier, R

Efficacy and safety of maintenance olaparib and bevacizumab (bev) in ovarian cancer (OC) patients (pts)aged ≥65 years (y) from the PAOLA-1/ENGOT-ov25 first-line trial

Abstract #739P

ePoster

Schweizer, MT

Bipolar Androgen Therapy (BAT) plus Olaparib in Men with Metastatic Castration-resistant Prostate Cancer (mCRPC)

Abstract #592P

ePoster

1 88 abstracts at ESMO (Free ESMO Whitepaper) Congress 2021 will feature AstraZeneca medicines and pipeline molecules.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On September 2, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that Bristol Myers Squibb Company (NYSE:BMY) has exercised its option to enter into an exclusive global license for EVT8683 which comes from a broader neurodegeneration collaboration (Press release, Evotec, SEP 2, 2021, View Source;announcements/press-releases/p/evotec-announces-bristol-myers-squibb-opt-in-of-evt8683-as-the-first-programme-from-ipsc-based-neurodegeneration-collaboration-6090 [SID1234587150]). EVT8683 is a small molecule targeting a key cellular stress response that holds great promise in various neurodegenerative indications and is ready to enter clinical development. The programme originated from a phenotypic screening approach based on Evotec’s leading iPSC platform and reached IND filing within only 5 years. Under an option agreement with Celgene (which is now a Bristol Myers Squibb company), Bristol Myers Squibb has rights to additional programmes in neurodegenerative diseases.

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In neurodegeneration, currently approved drugs only offer short-term management of patients’ symptoms and there is a huge unmet medical need for innovative therapies that slow down and reverse disease progression. The neurodegeneration alliance was built on Evotec’s industrialised iPSC platform using patient-derived disease models, to discover and select potentially disease-modifying approaches for neurodegenerative diseases. Evotec’s iPSC platform allows the screening of human iPSC-based disease models at high throughput in combination with unbiased transcriptome analysis. The seamless integration of the iPSC platform with Evotec’s proven small molecule discovery and development capabilities all the way to IND filing enabled the development of EVT8683 in only 5 years from a cell based phenotypic screen to successful IND filing.

Just 4.5 years after initiating the partnership, Bristol Myers Squibb has now exercised its option to enter into a global License Agreement for EVT8683. The programme targets a key cellular stress response mechanism which has the potential to deliver disease-modifying treatments for several devastating neurodegenerative diseases. Following the successful compound optimisation, the seamless integration from project initiation to IND, also using Evotec’s INDiGO platform, led to the recent registration as an Investigational New Drug ("IND") with the U.S. Food and Drug Administration ("FDA").

Dr Cord Dohrmann, Chief Scientific Officer of Evotec SE, commented: "We are very excited to bring a first drug candidate which originated from Evotec’s iPSC discovery platform into the clinic. EVT8683 is targeting a highly promising mechanism of the cellular stress response and has already demonstrated a very compelling pre-clinical efficacy and safety profile. We are proud to continue the further clinical development of EVT8683 together with BMS’ neuroscience team, which clearly belongs to the best in the industry.

iPSC technology is only starting to deliver on its enormous potential. Developing drug candidates with convincing efficacy in disease models which have been directly derived from patients gives us hope that these next generation of drug candidates will lead to more effective drugs and thus better outcomes for patients afflicted by neurodegenerative diseases."

Dr Richard Hargreaves, Senior Vice President of Bristol Myers Squibb’s Neuroscience Thematic Research Center, added: "Entering the clinic for this innovative program marks a key step for BMS Neuroscience. Targeting one of the mechanisms which may play a key role within neurodegeneration makes us hopeful that our further development of the program may result in providing treatments for many people suffering from these devastating neurological disorders. Based on Evotec’s scientific expertise and seamless integration, we are delighted to continue development of this clinical candidate."

Through this opt-in, Bristol Myers Squibb will lead further development and commercialisation. Evotec receives an option payment of $ 20 m and is eligible to earn up to $ 250 m in milestone payments and up to low double-digit royalties.

On September 2, 2021 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that two oral presentations will be highlighted at the ESMO (Free ESMO Whitepaper) 2021 Virtual Congress (Press release, Innate Pharma, SEP 2, 2021, View Source [SID1234587147]).

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AstraZeneca will present a late-breaker abstract on the COAST Phase 2 trial, highlighting progression-free survival (PFS) results for novel durvalumab combinations with potential new medicines, including Innate’s monalizumab, and oleclumab, an anti-CD73 monoclonal antibody, in unresectable, Stage III non-small cell lung cancer (NSCLC). Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

In addition, Innate will present pre-clinical data from its next-generation, proprietary, multi-specific NK cell engager platform known as ANKETTM (Antibody-based NK cell Engager Therapeutics).

"We’re pleased with the continued progress of monalizumab, particularly in a combination trial with durvalumab in unresectable, Stage III non-small cell lung cancer," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "Furthermore, the pre-clinical ANKETTM data at ESMO (Free ESMO Whitepaper) validates the importance of NK cell science and its role in the next wave of immunotherapy, while serving as the scientific engine to further advance our clinical pipeline. We look forward to seeing both oral presentations at ESMO (Free ESMO Whitepaper)."

Presentation details

Monalizumab:

Title: COAST: an open-label, randomised, phase 2 platform study of durvalumab alone or in combination with novel agents in patients with locally advanced, unresectable, Stage III NSCLC
Date and time: September 17, 2021, at 2:20 p.m. CEST
Presentation number: LBA42

Alexandre Martinez-Marti (Barcelona, Spain) will deliver the presentation.

ANKET:

Title: Harnessing innate immunity in cancer therapies: the example of Natural Killer Cell Engagers
Date and time: September 18, 2021 at 1:30 p.m. CEST
Presentation number: 1O

Professor Eric Vivier, DVM, Chief Scientific Officer of Innate Pharma, will deliver the presentation.

About Monalizumab:

Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Monalizumab may reestablish a broad anti-tumor response mediated by NK and T cells, and may enhance the cytotoxic potential of other therapeutic antibodies1.

AstraZeneca obtained full oncology rights to monalizumab in October 2018 through a co-development and commercialization agreement initiated in 2015. The ongoing development for monalizumab is focused on investigating monalizumab in various combination strategies in different malignancies.

About COAST Trial:

COAST is a Phase 2, multi-arm, randomised trial investigating durvalumab alone or in combination with either monalizumab, an anti-NKG2A monoclonal antibody, or oleclumab, an anti-CD73 monoclonal antibody, in 189 patients with locally advanced, unresectable Stage III NSCLC who had not progressed after concurrent CRT.

COAST is being conducted by AstraZeneca in 82 centers across nine countries in North America, Europe and Asia. The primary endpoint of the trial is overall response rate (ORR) as a measure of anti-tumor activity. Secondary endpoints include safety, duration of response, overall survival and PFS.

About ANKETTM:

ANKETTM (Antibody-based NK cell Engager Therapeutics) is Innate Pharma’s proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer. The Company’s latest innovation, its tetra-specific ANKET molecule, is the first NK cell engager technology to engage activating receptors (NKp46 and CD16), a tumor antigen and a cytokine (IL-2v) via a single molecule. This leverages the advantages of harnessing NK cell effector functions against cancer cells and also provides proliferation and activation signals targeted to NK cells.

In preclinical studies, Innate’s tri-2 and tetra-specific technology has demonstrated potent NK cell activation, cytotoxicity and efficient control of tumor growth in preclinical models. This versatile fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

On September 2, 2021 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for inflammatory and fibrotic diseases with high unmet need, reported it has appointed Dale R. Pfost, PhD, as Chief Executive Officer (CEO) (Press release, Anchiano Therapeutics, SEP 2, 2021, View Source [SID1234587145]). Dr. Adi Mor, Company co-founder and current CEO, will continue in her role as Chief Scientific Officer (CSO) and remain as a member of the Board of Directors. The addition of Dr. Pfost, who brings more than 30 years of diverse experience as a life science senior executive, entrepreneur and venture investor, reflects a planned strategic expansion of the Chemomab senior management team. Dr. Pfost is expected to join the Company’s Board of Directors and subsequently become the company’s Chairman in 2022.

"The Board and I welcome Dale and thank Adi for her tremendous contributions as founding chief executive of Chemomab," said Stephen Squinto, PhD, Chairman of the Board at Chemomab and an Executive Partner at OrbiMed. "Adi built both the scientific and business platforms for Chemomab and she will continue to be instrumental in the development of our first-in-class therapeutic addressing a novel target for multiple inflammatory and fibrotic diseases, helping position the company for future success. We look forward to her continued contributions as we evolve and grow."

Dr. Pfost has served as CEO of six biotechnology companies, three of which became publicly traded with valuations exceeding two billion dollars. He has successfully completed dozens of financings, overseen numerous M&A transactions and served as a director at multiple public and private life science firms.

Dr. Squinto continued, "We are delighted that Dale is coming on board as CEO. He is a seasoned biotechnology industry veteran with deep relationships and a history of successfully building innovative companies through organic growth and strategic acquisitions. With two Phase 2 studies underway and a third poised to kick off in the coming months, Chemomab is making excellent progress on realizing its potential as a premier company addressing diseases with large unmet medical needs. We look forward to Dale’s astute leadership during the next stage of growth."

Dr. Pfost said, "Adi and the Chemomab team have built an impressive company based on a unique asset with multiple high value applications. They have demonstrated exceptional skill in undertaking translational work and establishing clinical programs, and we look forward to extending the company’s already strong network of scientific and clinical collaborators in the U.S. This is an exciting time to join, as the company is well-positioned for both continued progress with its current programs and for leveraging strategic growth opportunities."

Dr. Mor said, "We advanced our novel anti-CCL24 antibody from the lab to the clinic and executed a successful merger earlier in the year. Now is the right time to add to our leadership team as we expand our strategic scope and our geographic presence in the U.S. Dale has a terrific track record of successfully growing biotech companies and I welcome the opportunity to work with him to build on the strong foundation we have achieved to date."

Until it was acquired in May of this year, Dr. Pfost was Chairman and CEO of innovative drug discovery firm Lodo Therapeutics. Previously, he was the U.S.-based General Partner at London-based venture capital firm Advent Life Sciences and served as Executive Chairman of portfolio companies CN Creative and Vestagen Protective Technologies. He co-founded and was acting CEO of MicroBiome Therapeutics in the year leading up to its acquisition. Dr. Pfost also was founding CEO of Acuity Pharmaceuticals, which merged to form OPKO Health. He was the founding CEO of Oxford GlycoSciences and genomics pioneer Orchid BioSciences. Dr. Pfost was also CEO at anti-cancer company Receptor BioLogix, where he led its successful acquisition. His first company, which he started in graduate school, was acquired by SmithKline Beckman and produced the Biomek, still a leading laboratory automation system today. Dr. Pfost is the co-author of 10 scientific papers and an inventor on 10 patents. He earned a BS degree from the University of California Santa Barbara and a PhD in physics from Brown University.

Dr. Pfost’s appointment as CEO and member of the Board will become effective upon the approval of Chemomab shareholders, as is required for public companies based in Israel. A shareholder vote is expected in the fourth quarter of 2021. His expected appointment as Chairman in 2022 will also require shareholder approval.

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On September 2, 2021 Alligator Bioscience AB ("Alligator" or the "Company") reported that the Company, in order to enable further progress, will begin evaluating potential financing alternatives, which may include issuance of equity (Press release, Alligator Bioscience, SEP 2, 2021, View Source [SID1234587144]). Alligator’s board has appointed financial advisors and the Company has received support from certain of the Company’s largest shareholders for continued funding of the Company.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To give Alligator’s new and experienced management team the right opportunities to develop the Company, the Board’s current assessment is that working capital will need to be strengthened in order to enable phase II studies for Mitazalimab, phase II preparations for ATOR-1017 as well as the development of other pipeline candidates and general corporate purposes. The Company will now continue dialogues with relevant stakeholders, evaluate its available funding alternatives, and revert to the market with more information in due course.

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 12:00 p.m. CEST on September 2, 2021.