On September 12, 2024 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that the Company accepted offers from multiple leading biotech institutional and individual investors to purchase an aggregate of approximately 10.35 million shares of the Company’s common stock at $22.70 per share, the closing price on Wednesday, September 11, 2024, for aggregate gross proceeds to the Company of approximately $235 million. The capital raise was completed without bankers’ fees (Press release, Summit Therapeutics, SEP 12, 2024, View Source [SID1234646552]).

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All of Summit’s Section 16 officers participated in the capital raise. A total of $79 million was raised by insiders, including Robert W. Duggan, Dr. Maky Zanganeh, Manmeet S. Soni, and Bhaskar Anand, as well as Jeff Huber, a member of the Board of Directors, who invested via a controlled entity. The remaining $156 million was raised with multiple leading biopharma institutional investors.

Summit intends to use the net proceeds to advance, in part, the clinical development of ivonescimab, including in non-small cell lung cancer and in settings outside of lung cancer by leveraging the data that will be presented at ESMO (Free ESMO Whitepaper), which may include, but is not limited to, colorectal cancer, and triple-negative breast cancer, in addition to working capital needs and general corporate purposes.

The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Summit has agreed to file a registration statement with the Securities and Exchange Commission (SEC) registering the resale of the shares of common stock following the closing of the securities purchase agreement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa, 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. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days (Zhong, et al, SITC (Free SITC Whitepaper), 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,800 patients have been treated with ivonescimab in clinical studies globally.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multi-regional Phase III clinical trials, HARMONi and HARMONi-3, with a plan to initiate HARMONi-7 in early 2025.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).

HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic squamous NSCLC.

HARMONi-7 is a planned Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 TPS > 50%).

In addition, Akeso has recently had positive read-outs in two single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC, HARMONi-A and HARMONi-2.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression (PD-L1 TPS >1%).

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024.

On September 12, 2024 BPGbio, Inc., a leading biology-first, AI-powered, clinical stage biopharma focused on mitochondrial biology and protein homeostasis, reported that researchers will present two posters on the ongoing phase 2 trial (NCT04752813) of BPGbio lead candidate, BPM31510, in patients with newly diagnosed glioblastoma multiforme (GBM) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, taking place September 13-17 in Barcelona (Press release, BPGbio, SEP 12, 2024, View Source [SID1234646551]).

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Seema Nagpal, MD, Clinical Professor of Neurology at Stanford Medicine and principal investigator of the trial, will be presenting the latest data from the ongoing trial which has enrolled sixteen (16) patients and seven (7) completed the study. Dr. Nagpal and her colleagues at Stanford will also present the cutting-edge quinomics assessment of BPM31510 which shows visualized in vivo effect of the drug on an experimental glioma model and in the brain and provides data validating metabolic activity.

"We are excited to present the latest data from the BPM31510 GBM phase 2 trial at the ESMO (Free ESMO Whitepaper) Congress," said Dr. Seema Nagpal, Clinical Professor of Neurology at Stanford Medicine and principal investigator of the trial. "GBM remains one of the most aggressive and lethal forms of brain cancer and the new data obtained from our clinical research have provided significant insights into its treatment."

"Being able to visually see exactly how a drug is working metabolically on an aggressive experimental brain tumor and in the brain uncovered new findings related to brain cancer therapeutic development," said Lawrence Recht, MD, Professor of Neurology and of Neurosurgery at Stanford Medicine. "We look forward to sharing this exciting data with industry peers and fellow researchers."

BPM31510, combined with Vitamin K and standard chemoradiation, is being tested in a single-arm Phase 2b trial across four U.S. sites, with a total target enrollment of 50 patients.

"The preliminary results from the ongoing clinical trial support our biology-first, AI-driven approach, optimizing patient selection and streamlining drug development," said Niven R. Narain, Ph.D., President and CEO of BPGbio, Inc. "We are eager to continue work with the Stanford team and to collaborate with researchers at other top medical centers to complete enrollment in the trial."

Poster Presentation Details:

Title: Trial in Progress (TiP): A Phase 2 Study of BPM31510 (a lipid nanodispersion of oxidized CoQ10) with Vitamin K in combination with Standard of Care (SOC) RT and TMZ in Glioblastoma Multiforme (GBM) patients without prior therapy

Date and Time: Monday, September 16, 2024, 9:00-17:00 CEST

Presentation Number: 499TiP

Speaker: Dr. Seema Nagpal

Title: Comprehensive Quinomics Assessment of BPM31510IV Treatment in Advanced Glioblastoma Multiforme Patients

Date and Time: Monday, September 16, 2024, 9:00-17:00 CEST

Presentation Number: 472P

Speaker: Dr. Seema Nagpal

These posters will be available on BPGbio.com following the ESMO (Free ESMO Whitepaper) meeting.

About BPM31510

BPM31510 is BPGbio’s lead candidate in late-stage development for glioblastoma multiforme (GBM) and pancreatic cancer. The compound has demonstrated a tolerable safety profile and shown potential clinical benefit in both populations. The mechanism of action of BPM31510 was first validated by data from BPGbio’s NAi Interrogative Biology platform, which suggested that there is a hallmark shift in the tumor microenvironment (TME) induced by BPM31510 which modulates mitochondrial oxidative phosphorylation in highly aggressive tumors. BPM31510 has been granted Orphan Drug Designation by the FDA for both GBM and pancreatic cancer indications.

On September 12, 2024 REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, reported both the development and the clinical validation of TNBCDX, the first genomic test designed specifically for patients with early-stage TNBC (Press release, REVEAL GENOMICS, SEP 12, 2024, View Source [SID1234646550]). This dual milestone will be presented at the ESMO (Free ESMO Whitepaper) Congress 2024 in Barcelona (Spain).

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TNBCDX represents a significant advancement in the management of TNBC, a subtype of breast cancer that is particularly challenging to treat due to its lack of hormone receptors and HER2 expression. This disease is typically treated with neoadjuvant multi-agent chemotherapy regimens that include taxanes, anthracyclines, cyclophosphamide, carboplatin, and pembrolizumab. However, these therapies often pose significant toxicities for patients and can lead to a considerable financial burden and increased use of healthcare resources.

Meanwhile, less intensive systemic therapies involving taxanes and carboplatin without anthracyclines and pembrolizumab are showing outstanding outcomes in selected patients. In this context, a biomarker such as TNBCDX was needed to guide treatment decisions and safely identify patients who could benefit from de-escalation of therapy.

Across two independent validation studies with 418 patients, the TNBCDX scores showed a strong association with pathological complete response (pCR), distant disease-free survival (DDFS), and overall survival (OS), providing a more refined risk stratification. Notably, the TNBCDX test outperformed tumor-infiltrating lymphocytes (TILs) in predicting both pCR and survival outcomes.

The first validation study, ADAPT-TN, led by Dr. Nadia Harbeck and Dr. Oleg Gluz of the West German Study Group, was a phase II prospective neoadjuvant trial (WSG-ADAPT TN Trial, NCT01815242) that enrolled patients diagnosed with stage I–III TNBC. The study involved a treatment regimen of nab-paclitaxel combined with either gemcitabine or carboplatin. Patients who did not achieve a pCR were given additional anthracycline-based chemotherapy. The second validation study, MMJ-CAR-2014-01 (NCT01560663), led by Dr. Miguel Martin, is an ongoing prospective, multicenter, nonrandomized trial in Spain investigating the antitumor activity of neoadjuvant carboplatin and docetaxel in early-stage TNBC. This study includes patients with stage I–III TNBC, treated with six cycles of carboplatin and docetaxel.

Dr. Miguel Martin, Chair of Medical Oncology at the Hospital General Universitario Gregorio Marañón in Madrid, and a recognized leader in breast cancer, will present the findings during the ESMO (Free ESMO Whitepaper) session scheduled for 10:50 a.m. on September 14th, 2024, at Barcelona Auditorium.

"The development and validation of TNBCDX are significant achievements in the field of precision oncology for TNBC. This test will enable oncologists to tailor treatments more effectively, offering new hope for individuals managing this aggressive form of breast cancer," commented Dr. Miguel Martin. He added, "The ability of TNBCDX to provide critical genomic insights, with a special focus on the immune system, marks an important step forward in the treatment of TNBC."

Dr. Patricia Villagrasa, CEO and Co-founder of REVEAL GENOMICS, added, "The introduction of TNBCDX into clinical practice will transform the treatment landscape for those diagnosed with TNBC. We are committed to ensuring global access to this important diagnostic tool."

About the TNBCDX Test
TNBCDX is the first genomic test designed specifically for patients with early-stage TNBC. The test integrates clinical variables with key tumor and immune biological factors across 15 genes to provide a comprehensive risk assessment, guiding treatment decisions in a clinical setting. TNBCDX includes two scores: a risk score and a pCR (pathological complete response) likelihood score. Additionally, the test measures the levels of ERBB2 to ensure that the tumor is accurately classified as TNBC.

TNBCDX is currently available in a Research Use Only (RUO) format. The company is in the process of standardizing the assay, with plans to offer it through the Biomedical Diagnostic Center (CDB) at Hospital Clínic by 2025.

About TNBC
TNBC accounts for approximately 15-20% of all breast cancer diagnoses. Unlike other breast cancer subtypes, TNBC does not express estrogen receptor, progesterone receptor, or HER2, making it more difficult to treat with conventional therapies. TNBC is known for its aggressive nature and poor prognosis; however, it also exhibits substantial biological and clinical heterogeneity, underscoring the need for more precise diagnostic and therapeutic approaches.

On September 12, 2024 OmRx Oncology, or "OmRx," a new biopharmaceutical venture with investment from Scripps Research, launched with a Phase 2 clinical asset in-licensed from Gilead Sciences, Inc. and a vision for expanding access to immunotherapy in countries where biologic checkpoint inhibitors are often unaffordable and unavailable to patients (Press release, OmRx Oncology, SEP 12, 2024, View Source [SID1234646549]).

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The clinical-stage asset, OX-4224, discovered and initially developed by Gilead Sciences, is an investigational oral immune checkpoint inhibitor that targets the PD-1/PD-L1 pathway and will be evaluated by OmRx for the treatment of patients with non-small cell lung cancer (NSCLC). OmRx in-licensed the Phase 2-ready asset and plans to develop it for patients in countries where an oral small molecule would present a more affordable, accessible, and potentially equally effective option to traditional antibody checkpoint inhibitors such as Keytruda and Opdivo.

OmRx is wholly focused on advancing this clinical-stage program, first as a monotherapy in low and middle-income countries, and eventually, globally for potential all-oral combination therapies. OmRx’s mission to serve patients in low and middle-income countries is shared by Scripps Research, which actively supports a significant number of R&D initiatives addressing global health needs. The company is led by a high-caliber team with expertise in cancer R&D, clinical development, entrepreneurship, and corporate development. The OmRx team includes Dr. William Lee, Ph.D., who serves as Chairman and brings 30 years of experience from his tenure as the former Executive Vice President of Research at Gilead Sciences.

"Immune checkpoint inhibitor monoclonal antibodies represent one of the most important treatment advances in cancer in the past two decades, but they are essentially unavailable to cancer patients outside of the major commercial markets. Oral checkpoint inhibitors, meanwhile, could have important advantages over antibodies – they would not require infusions or infusion centers, dosing and patient exposure could be rapidly modulated in the case of immune-related side effects, and they would be significantly cheaper to manufacture," said Isy Goldwasser, CEO, OmRx. "With the launch of OmRx we can advance a promising oral checkpoint inhibitor that could bring immunotherapy to more people in an affordable way with the goal of reducing the worldwide cancer burden."

OX-4224 will initially be studied as a second-line monotherapy in patients with metastatic NSCLC whose tumors express PD-L1. The Phase 2 randomized, open-label study in India will establish safety and efficacy of OX-4224 in subjects with NSCLC who have not received immune checkpoint inhibitors.

"One of the highlights of my career was overseeing the discovery of a small molecule that blocked the PD-1/PD-L1 immune checkpoint and by doing so, could impact cancer therapy globally," said Dr. William Lee, Chairman, OmRx. "I am extremely grateful to the Scripps team for sharing this vision and investing in OmRx. If OX-4224 demonstrates the safety and efficacy projected, it will make a difference for patients everywhere, and especially in resource-constrained countries like India."

OX-4224 is an investigational product and statements regarding the potential benefits and future development of this investigational product are forward-looking and subject to risks and uncertainties.

On September 12, 2024 IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, reported the U.S. Food and Drug Administration’s ("FDA") Medical Device Advisory Committee Panel (the "Advisory Panel") is scheduled to take place on Thursday, November 7, 2024 (Press release, IceCure Medical, SEP 12, 2024, View Source [SID1234646548]). The purpose of the Advisory Panel is for the FDA to obtain independent expert advice on scientific, technical and policy matters related to the De Novo Classification Request for marketing authorization of ProSense for the indication of treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy.

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"This public forum transparency ensures key stakeholders, including women with early-stage low risk breast cancer, their doctors and payors, can exchange views and data regarding the potential benefits of minimally invasive cryoablation with ProSense as an alternative to surgery," stated IceCure’s CEO, Eyal Shamir. "Following the Advisory Panel, we anticipate that the FDA will make a decision regarding marketing clearance of ProSense by early 2025."

The Advisory Panel will include breast surgeons, interventional radiologists and industry representatives from the regulatory community. The vast body of data available on ProSense as a treatment for early-stage low risk breast cancer will be reviewed by the Advisory Panel, including results from the Company’s ICE3 study, the largest controlled multicenter clinical trial ever performed for liquid nitrogen-based cryoablation of early-stage malignant breast tumors. Per the analysis, at the 5-year follow-up evaluation, 96.3% of the subgroup of patients treated with ProSense cryoablation, followed by adjuvant endocrine therapy, were estimated to be free from local recurrence. 100% patient and physician satisfaction was reported. The Advisory Panel is expected to make its recommendations at the conclusion of the meeting, at which time the FDA will commence its review process.

The FDA generally makes Advisory Panel meeting materials and the live webcast link available to the public no later than two business days before the meeting, at which time IceCure intends to share the link with shareholders via a press release.

About ProSense

The ProSense Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.

ProSense enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense opens that door to fast and convenient office-based procedure for breast tumors.