On June 2, 2023 Immunocore Holdings Plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious diseases and autoimmune conditions, reported that management will present at the following investor conferences in June (Press release, Immunocore, JUN 1, 2023, View Source [SID1234632391]):

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Jefferies Global Healthcare Conference
Fireside Chat: Wednesday, June 7, 2023, at 4:00 p.m. EDT
Goldman Sachs Annual Healthcare Conference
Fireside Chat: Wednesday, June 14, 2023, at 1:20 p.m. PDT
The presentations will be webcast live and can be accessed by visiting ‘Events’, under ‘News & Events’, via the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the events, a replay of the presentations will be made available for a limited time.

On June 1, 2023 invoX Pharma Limited ("invoX"), a U.K.-based wholly-owned subsidiary of Sino Biopharmaceutical Limited ("Sino Biopharm") (HKEX 1177 HK) with an advancing pipeline of innovative products, reported that it has completed a second tranche of investment in pHion Therapeutics ("pHion"), a next-generation mRNA vaccine company (Press release, InvoX Pharma, JUN 1, 2023, View Source [SID1234632380]). The transaction supports invoX’s strategy to be a fully integrated biopharmaceutical company and its ongoing commitment to deliver innovative life-saving therapies

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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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pHion is developing a pipeline of therapeutic and prophylactic vaccines focussed on oncology and infectious diseases. The company’s proprietary RALA platform can deliver anionic molecules such as mRNA and saRNA in a stealth-like way, evading detection, to generate a potent antigen-specific CD8+ T-cell response. The RALA peptide-based drug delivery system is based on a sequence of 30 amino acids which condenses anionic cargo, irrespective of size, into nanoparticles that are highly efficient at cellular entry and can outperform currently available technologies. Compared with traditional mRNA vaccine delivery platforms, the RALA platform has the added advantage of ease of scalability and logistics, including stability at room temperature.

Under the leadership of CEO and Founder, Prof Helen McCarthy, pHion has made significant progress since invoX’s initial investment in June 2021, with advances made across all pre-clinical programs and the establishment of a laboratory in Belfast, Northern Ireland for the production of pHion’s mRNA vaccines. The additional investment will support growth of the company’s proprietary RALA platform with an immediate focus on the advancement of pHion’s lead project, PTX_V1, into clinical trials in the first half of 2024. PTX_V1 is a first-in-class therapeutic vaccine for the treatment of human papilloma virus (HPV)-related cancers. Infection with HPV is responsible for approximately 90% of cervical cancers and up to 70% of oropharyngeal cancers, with a high unmet clinical need. pHion’s pipeline also includes differentiated therapeutic vaccines for the treatment of ovarian (PTX_V5) and prostate (PTX_V3) cancers.

This investment has received all required regulatory approvals, including clearance from the regulatory agency in charge of enforcing the U.K.’s National Security and Investment Act, testimony to invoX’s continued willingness to build trust and work closely with regulators.

On June 1, 2023 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (Press release, Summit Therapeutics, JUN 1, 2023, View Source [SID1234632379]). The poster with updated clinical data from Phase II clinical trials will be displayed on Sunday June 4 from 8:00 to 11:00am Central Time during the Lung Cancer – Non-Small Cell Metastatic Poster Session.

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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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The poster, which is presented by Dr. Li Zhang, Sun Yat-Sen University Cancer Center1 with data generated and analyzed by our collaboration and licensing partner, Akeso, Inc. (HKEX Code: 9926.HK), provides updated results from the Phase II study (NCT04736823) centered around the cohort of patients in which ivonescimab is combined with chemotherapy (n=135) for first line treatment of advanced or metastatic non-small cell lung cancer (NSCLC) in patients without actionable genomic alterations (i.e., positive for endothelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK)). The poster provides updated data supporting promising anti-tumor activity of ivonescimab in first line advanced or metastatic NSCLC, while displaying that ivonescimab may have an acceptable safety profile in combination with platinum-doublet chemotherapy for patients with squamous or non-squamous advanced or metastatic NSCLC in this clinical study.

Ivonescimab, known as SMT112 in the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. There is higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal, healthy tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) with over 10 fold increased binding affinity to PD-1 in the presence of VEGF in vitro in tumor cells.2 This tetravalent structure, the intentional design of the molecule, and bringing these two targets into a single bispecific antibody have the potential to steer ivonescimab to the tumor tissue versus healthy tissue, which are intended to improve side effects and safety concerns associated with these targets and have the potential to focus the antitumor activity of both targets. Over 750 patients have been treated with ivonescimab across multiple clinical studies in different indications in China and Australia.

Summit has begun its clinical development of ivonescimab in two NSCLC indications:

Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (HARMONi trial or AK112-301)
Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (HARMONi-3 trial)
In May 2023, the first patient was treated in Summit’s licensed territories in the Phase III HARMONi clinical trial. Summit intends to dose patients in the HARMONi-3 trial during the second half of 2023. Lung cancer is believed to impact approximately 238,0003 people in the United States each year and approximately 477,0004 in Europe. NSCLC is the most prevalent type of lung cancer and represents approximately 80% to 85% of all incidences.5 Among patients with non-squamous NSCLC, approximately 15% have EGFR-sensitizing mutations in the United States and Europe.6 Patients with squamous histology represent approximately 25% to 30% of NSCLC patients.7

About the ASCO (Free ASCO Whitepaper) Poster

Poster Title: Phase II results of Ivonescimab (AK112/SMT112) a novel PD-1/VEGF bispecific in combination with chemotherapy for first line treatment of advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA) in EGFR/ALK

ASCO Abstract No.: 9087

ASCO Poster Session: Lung Cancer – Non-Small Cell Metastatic Poster Session.

Session Date & Time: Sunday June 4, 8:00 to 11:00am CT

On June 1, 2023 Eikon Therapeutics, Inc., a biotechnology company that is advancing breakthrough therapeutics through the purposeful integration of engineering and science, reported it has acquired exclusive rights to multiple early- to mid-stage assets, leveraging its proprietary Single Molecule Tracking (SMT) technology to drive strategic decisions around its new drug pipeline (Press release, Eikon Therapeutics, JUN 1, 2023, View Source [SID1234632378]).

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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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Eikon successfully completed three transactions, including the acquisition of global rights to develop and commercialize clinical-stage Toll-like receptor 7 and 8 (TLR7/8) agonist immune modulators from Seven and Eight Biotherapeutics Corp. that have been tested in over 150 patients with advanced, refractory, solid tumors. These immune modulators have shown tolerable safety and activity both as monotherapy and in combination with PD-(L)1 inhibitors.

The company has also licensed a portfolio of PARP1-selective inhibitors invented by Impact Therapeutics and intended to improve upon existing unselective dual PARP1/2 inhibitory agents in cancer treatment. Lastly, Eikon has acquired a suite of preclinical assets from Cleave Therapeutics that address targets involved in protein homeostasis, DNA damage repair and chromatin remodeling, areas that have importance in cancer and in neurodegenerative disease.

"With the acquisition of these very different clinical assets, Eikon has taken an important step in building a diverse portfolio, at different stages of the development cycle, which address significant unmet medical needs. Our team brings decades of clinical and regulatory experience to these development programs, combined with scientific rigor born from the integration of advanced engineering, sophisticated data analysis, and breakthrough research utilizing AI-powered super-resolution microscopy," said Roger M. Perlmutter, M.D., Ph.D., CEO and Board Chair of Eikon Therapeutics. "Each of these new programs will complement the progress we have made in our pioneering discovery platform, translating protein population dynamics measurements into discoveries that will enable the development of important new medicines."

Beyond completing these business development transactions, Eikon has closed the first tranche of a Series C equity financing, adding nearly $106 million that will provide meaningful support for the clinical programs. This first Series C close brings Eikon’s total capital raised to nearly $775 million since its founding in late 2019. The financing included strong participation from existing investors as well as adding several new strategic investors.

"We are delighted the Eikon team will continue our progress in the TLR7/8 field and will conduct the future clinical development and ultimately commercialize our novel TLR7/8 agonists. Eikon and its highly experienced immuno-oncology team has a proven track record of developing and commercializing industry leading anti-PD-1 therapies, and we believe they will be uniquely positioned to advance our first-in-class TLR7/8 agonists as potential treatments for multiple tumor types," said Walter Lau, Ph.D., CEO of Seven and Eight Biotherapeutics.

As part of its agreement with Impact Therapeutics, Eikon will work to bring the IND-ready asset IMP1734, a highly selective PARP1 inhibitor, into clinical development. Under the collaboration agreement, Eikon received an exclusive license to co-develop, register, manufacture and commercialize IMP1734 and other PARP1 selective inhibitors globally, excluding Greater China (mainland China, Hong Kong, Macau, and Taiwan). Eikon and Impact plan to file a U.S. Investigational New Drug (IND) Application for this program by the end of the third quarter of 2023. The partnership also includes a second brain-penetrant PARP1-selective inhibitor that Eikon will collaborate with Impact to take forward into the clinic.

Impact CEO Sui Xiong Cai, Ph.D., said, "The Eikon team brings years of experience in oncology to the development of these important assets. Our companies are aligned in our vision of providing new and better treatment options to cancer patients globally."

Eikon’s internally developed programs currently focus on preclinical drug candidates targeting indications in oncology, immunology, and neurologic disease. The development of these early-stage candidates is supported by Eikon’s pioneering applications of super-resolution microscopy, which permit protein population dynamics measurements in millions of live cells per day, in real time. Such measurements provide fundamental information about the interactions among proteins in normal and diseased cells. Eikon’s proprietary instruments will also be employed to help advance the TLR7/8 agonists, PARP1-selective inhibitors, and other in-licensed therapeutic candidates. These highly sophisticated, AI-driven, protein population dynamics measurements will influence the design of clinical trials.

"Our business development strategy is focused on high-potential assets that Eikon is uniquely positioned to develop, and which complement our internal discovery programs," said Roy Baynes, M.D., Ph.D., Chief Medical Officer of Eikon. "Our team has a well-documented track record of developing some of the world’s most therapeutically meaningful and commercially successful medicines. This positions Eikon well to bring a broad range of new drug candidates successfully through regulatory review and approval to people who seek better treatments for a range of grievous illnesses."

On June 1, 2023 Sarah Cannon Research Institute (SCRI) reported that its network of research leaders have been selected to deliver insights through more than 135 abstracts and presentations at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting June 2-6, 2023 (Press release, Sarah Cannon Research Institute, JUN 1, 2023, View Source [SID1234632377]). More than 80 experts from SCRI’s research network participated in key research that will be presented at the Annual Meeting, including important updates for 64 early-phase studies as well as a number of late-phase trials for multiple types of cancer, including breast, lung, hematologic malignancies, and more.

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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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In 2022, SCRI joined together with US Oncology Research as one company to transform oncology research and improve care in more than 24 states across the U.S. Operating as SCRI, the unified research network has over 1,300 physicians enrolling patients to more than 1,000 trials annually.

"The collaborations across SCRI’s expanded network are accelerating progress and serving more patients closer to where they live," says Howard A. "Skip" Burris III, MD, President, SCRI. "We are looking forward to this year’s Annual Meeting where we will be discussing the results of trials that are advancing therapies across a variety of cancers."

For a comprehensive list of abstracts and presentations, click here.

Noteworthy Presentations:

Breast Cancer:

Erika Hamilton, MD, SCRI at Tennessee Oncology, will give two oral presentations – "Efficacy and Safety Results by Age in monarchE: Adjuvant Abemaciclib Combined with Endocrine Therapy in Patients with HR+, HER2-, Node-Positive, High-Risk Early Breast Cancer" on June 2 at 2:45 p.m. CDT in Hall D1 and "A Phase 2 Study of HER3-DXd in Patients with Metastatic Breast Cancer" on June 5 at 11:30 a.m. CDT in Hall B1.
Denise Yardley, MD, SCRI at Tennessee Oncology, contributed to research featured in the oral presentation, "Ribociclib and Endocrine Therapy as Adjuvant Treatment in Patients with HR+/HER2− Early Breast Cancer: Primary Results from the Phase III NATALEE Trial," which will take place on June 2 at 2:45 p.m. CDT in Hall D1.
Genitourinary Cancer:

Thomas Hutson, DO, PharmD, SCRI at Texas Oncology I The US Oncology Network, will deliver "Final Prespecified Overall Survival Analysis of CLEAR: 4-Year Follow-Up of Lenvatinib Plus Pembrolizumab vs Sunitinib in Patients with Advanced Renal Cell Carcinoma" in an oral presentation on June 5 at 11:30 a.m. CDT in Hall D1.
Lung Cancer:

Melissa Johnson, MD, SCRI at Tennessee Oncology, will present "ARC-7: Randomized Phase 2 Study of Domvanalimab + Zimberelimab Etrumadenant vs Zimberelimab in First-Line, Metastatic, PD-L1-High Non-Small Cell Lung Cancer" in the ASCO (Free ASCO Whitepaper) Plenary Series: Rapid Abstract Updates on June 3 at 12:30 p.m. CDT in the Arie Crown Theater. Dr. Johnson also co-authored research that will be featured in the oral presentation, "First-in-Human Study of ABBV-011, a Seizure-Related Homolog Protein 6 –Targeting Antibody-Drug Conjugate, in Patients with Small Cell Lung Cancer," on June 5 at 8 a.m. CDT in Hall D2.
Melanoma/Skin Cancer:

Meredith McKean, MD, MPH, SCRI at Tennessee Oncology, participated in research that will be featured in the oral presentation, "Distant Metastasis-Free Survival Results from the Randomized, Phase 2 mRNA-4157-P201/KEYNOTE-942 Trial," on June 5 at 3 p.m. CDT in Hall D1.
In addition to the scientific presentations, SCRI leadership will participate in and lead ASCO (Free ASCO Whitepaper) sessions, including:

Dr. McKean will chair the education session, New Drugs in Oncology: Incorporation into Practice, on June 2 at 2:45 p.m. CDT in E450.
Benjamin Garmezy, MD, SCRI at Tennessee Oncology, will discuss "The Power of Patients’ Experiences to Inform Therapeutic Decisions" in the poster discussion session, Genitourinary Cancer—Kidney and Bladder, on June 3 at 3 p.m. CDT in E450.
Dr. Hamilton will chair the Highlights of the Day session on June 4 at 8:15 a.m. CDT in Hall D1 and present "The Next Frontier: Resistance to ADCs and Combination Strategies" in the education session, Next-Generation Antibody-Drug Conjugates: Past, Present, and Future, on June 4 at 4:30 p.m. CDT in Hall D2.
Cesar Perez, MD, SCRI at Florida Cancer Specialists, will chair the Head and Neck Cancer oral abstract session on June 5 at 8 a.m. CDT in Hall B1.
Manojkumar Bupathi, MD, MS, SCRI at Rocky Mountain Cancer Centers I The US Oncology Network, will chair the oral abstract session, Genitourinary Cancer – Kidney and Bladder, on June 5 at 11:30 a.m. CDT in E450.
Additional Poster Presentations with SCRI First Authors:

Saturday, June 3, 2023

"Phase 1/1b Study of SY-5609, a Selective and Potent CDK7 Inhibitor, in Advanced Solid Tumors and in 2L/3L Pancreatic Ductal Adenocarcinoma in Combination with Gemcitabine +/- Nab-Paclitaxel," Babar Bashir, MD, SCRI at Sidney Kimmel Cancer Center, 8 a.m. CDT, Hall A
"First-in-Human Phase 1 Study of Pimicotinib, a CSF-1R Inhibitor, in Patients with Advanced Solid Tumors," Gerald Falchook, MD, MS, SCRI at HealthONE, 8 a.m. CDT, Hall A
"Safety and Efficacy of DB-1303 in Patients with Advanced/Metastatic Solid Tumors: A Multicenter, Open-Label, First-in-Human, Phase 1/2a Study," Kathleen Moore, MD, MS, SCRI at Stephenson Cancer Center, 8 a.m. CDT, Hall A
"BLU-222, an Oral, Potent and Selective CDK2 Inhibitor, in Patients with Advanced Solid Tumors: Phase 1 Monotherapy Dose Escalation," Manish Patel, MD, SCRI at Florida Cancer Specialists, 8 a.m. CDT, Hall A
"MyTACTIC: Efficacy and Safety of Atezolizumab + Chemotherapy in Patients with Advanced Unresectable/Metastatic Solid Tumors with High Tumor Mutational Burden or High Microsatellite Instability/Deficient Mismatch Repair," David Spigel, MD, SCRI at Tennessee Oncology, 8 a.m. CDT, Hall A
"A Phase 1 Study of TPST-1495 as a Single Agent and in Combination with Pembrolizumab in Patients with Advanced Solid Tumors," Susanna Ulahannan, MD, MMed, SCRI at Stephenson Cancer Center, 8 a.m. CDT, Hall A
"A Phase 1 Dose-Escalation Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamic Activity of cln-619 Alone and in Combination with Pembrolizumab in Patients with Advanced Solid Tumors," Judy Wang, MD, SCRI at Florida Cancer Specialists, 8 a.m. CDT, Hall A
Sunday, June 4, 2023

"Management of Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer Who Received Brain Radiotherapy on Study in the Phase 3 CROWN Trial," Todd Bauer, MD, SCRI at Tennessee Oncology, 8 a.m. CDT, Hall A
Monday, June 5, 2023

"Correlating Expression of NaPi2b and FRa in High Grade Serous Ovarian Cancer," Debra Richardson, MD, FACS, FACOG, SCRI at Stephenson Cancer Center, 1:15 p.m. CDT, Hall A
"Preliminary Results from ERAS-007 Plus Palbociclib in Patients with KRAS/NRAS Mutant Colorectal Cancer or KRASm Pancreatic Ductal Adenocarcinoma in HERKULES-3 Study: A Phase 1b/2 Study of Agents Targeting the Mitogen-Activated Protein Kinase Pathway in Pts with Advanced Gastrointestinal Malignancies," Susanna Ulahannan, MD, MMed, SCRI at Stephenson Cancer Center, 8 a.m. CDT, Hall A