On August 7, 2023 Akeso Inc. ("Akeso", the "Company"; 9926.HK), a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, reported that eClinical Medicine(IF:15.1), a sub-journal of The Lancet, recently published the results of a phase II clinical trial of ivonescimab(PD-1/VEGF bispecific antibody) combined with chemotherapy for the treatment of non-small cell lung cancer (NSCLC) (Press release, Akeso Biopharma, AUG 7, 2023, View Source [SID1234633898]). The study was led by Professor Li Zhang of the Sun Yat-Sen University Cancer Center.

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Ivonescimab is the world’s first PD-1/VEGF bispecific antibody for which a New Drug Application (NDA) has been submitted. Based on the published results, the combination of ivonescimab and platinum-doublet showed promising antitumor activity for first-line treatment of advanced NSCLC without driver mutation, as well as for advanced NSCLC patients with EGFR-activating mutation that failed prior EGFR-TKI therapy. Additionally, AK112 in combination with docetaxel has shown favorable antitumor activity in advanced NSCLC patients who failed prior treatments with systemic platinum-based chemotherapy and PD-1/L1 inhibitor.

Following the acceptance of marketing application for an indication of ivonescimab by the China CDE, four pivotal registrational Phase III clinical trials have been initiated/are being conducted worldwide, including three head-to-head trials with PD-1 monoclonal antibody as the positive control drug and two international multicenter Phase III clinical trials:

An international multicenter Phase III study (HARMONi) of Ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC progressing on third-generation EGFR-TKI therapy. This study was led by Professor Li Zhang. Akeso’s partner, Summit Therapeutics("Summit"), has completed the first patient dosing in the United States.
An international multicenter Phase III study of ivonescimab in combination with chemotherapy versus pembrolizumab monoclonal antibody in combination with chemotherapy as the first-line treatment for metastatic squamous NSCLC is conducted in the United States (HARMONi-3). Summit intends to dose the first patient in the second half of 2023.
A Phase III study of ivonescimab monotherapy versus pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression in China is undergoing. The enrollment will be completed soon.
A Phase III study in China for the first-line treatment of advanced squamous NSCLC with ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy is undergoing.
It is also notable that owing to its remarkable clinical value, ivonescimab has received breakthrough therapy designation status in China from the NMPA for three indications:

Ivonescimab combined with chemotherapy for the treatment of EGFR-mutated locally advanced or metastatic NSCLC patients who progressed on EGFR-TKI treatment.
Ivonescimab as the first-line treatment for locally advanced or metastatic NSCLC patients with positive PD-L1 expression.
Ivonescimab combined with docetaxel for the treatment of locally advanced or metastatic NSCLC patients who failed to respond to prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy.

On August 7, 2023 Gracell Biotechnologies Inc. ("Gracell" or the "Company", Nasdaq: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune diseases, reported that it has entered into a purchase agreement with a select group of institutional and accredited healthcare specialist investors for the private placement of (i) 138,900,000 ordinary shares of the Company (the "Ordinary Shares") (equivalent to 27,780,000 of the Company’s American depositary shares ("ADSs")), at a purchase price equivalent to $3.60 per ADS, and (ii) warrants to purchase up to 44,802,870 Ordinary Shares (equivalent to 8,960,574 ADSs) (the "Warrants") at an exercise price equivalent to $5.58 per ADS, representing a 55% premium to the purchase price of Ordinary Shares (Press release, Gracell Biotechnologies, AUG 7, 2023, View Source [SID1234633897]). Gracell will receive $100 million in proceeds from the private placement of Ordinary Shares, and up to an additional $50 million if the Warrants are fully exercised. The Warrants will remain exercisable at the election of the investors within 24 months after the closing of the private placement. The financing is expected to close on August 10, 2023, subject to customary closing conditions.

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The oversubscribed transaction includes participation from new and existing institutional investors and is being led by Vivo Capital, with participation from investors including Adage Capital Partners LP, Exome Asset Management, Janus Henderson Investors, Logos Capital, OrbiMed, Pivotal Life Sciences, RA Capital Management and TCGX.

"We are pleased that this high-quality healthcare investor group came together to support Gracell and our innovative and potentially best-in-class CAR-T therapies," said Dr. William Wei Cao, founder, Chairman, and CEO of Gracell. "We thank the investors for their confidence in the broad potential of our FasTCAR-T GC012F candidate for hematological cancers and autoimmune diseases, and their support for our mission to develop revolutionizing cell therapies. These additional funds should allow us to achieve critical milestones in the clinical development of GC012F in multiple myeloma and systemic lupus erythematosus."

Gracell intends to use the net proceeds from the proposed financing to fund research and development of its clinical-stage product candidates and research programs and for working capital and other general corporate purposes. The aggregate proceeds from this proposed financing, combined with current cash, cash equivalents, is expected to be sufficient to fund the current operating plan into the second half of 2026.

The Securities sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file registration statements with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the Ordinary Shares issuable in connection with this private placement, including upon exercise of the Warrants.

Jefferies, Evercore ISI and Wells Fargo Securities are acting as the placement agents for the private placement.

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 offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

On August 7, 2023 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that its partner, Cleveland Clinic, has begun enrolling subjects in a treatment arm evaluating the combination of the Company’s breast cancer vaccine with Keytruda (pembrolizumab) (Press release, Anixa Biosciences, AUG 7, 2023, View Source [SID1234633896]). An expansion of the ongoing Phase 1 dose escalation trial of Anixa’s breast cancer vaccine, this treatment arm aims to determine if the vaccine/Keytruda combination increases immune response.

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Anixa’s breast cancer vaccine is designed to generate T cells that target triple negative breast cancer ("TNBC"). Keytruda, a therapy marketed by Merck (NYSE: MRK), is approved for use with chemotherapy before surgery and then alone after surgery to treat both high-risk early-stage and advanced TNBC.

Keytruda is a type of immunotherapy known as a checkpoint inhibitor. T cells, a type of white blood cell involved in the body’s immune system, have receptor proteins on their surface called checkpoints. These checkpoints are utilized by other immune cells to modulate the activity of T cells. Cancer cells, such as TNBC cells, have developed mechanisms to target checkpoints to inhibit the activity of T cells, as well as other immune cells. This inhibition enables the cancer cells to escape destruction by cytotoxic T cells. One of these key checkpoint receptors is known as PD-1 (Programmed Cell Death Protein-1). TNBC, like many other cancers, expresses a protein that binds to the PD-1 protein on T cells and essentially turns them "off." Keytruda is a monoclonal antibody, which blocks the ability of the cancer cells to inactivate T cells by shielding the PD-1 receptor.

Dr. Amit Kumar, Chairman and CEO of Anixa stated, "Cleveland Clinic has demonstrated in both preclinical and clinical studies that our breast cancer vaccine induces an immune response–including, we believe, production of T cells that can target TNBC–so we believe that the addition of Keytruda could have a synergistic effect. If a vaccine induces the creation of T cells targeting TNBC, and Keytruda generally maintains T cell activity, the combination could be very potent. We are grateful to the U.S. Department of Defense for providing the funding for this new arm of the trial and look forward to Cleveland Clinic’s presentation of the updated data from this trial at the San Antonio Breast Cancer Symposium (SABCS) in December."

About Anixa’s Breast Cancer Vaccine Clinical Trial
The Phase 1a study is designed to evaluate the safety of the vaccine, identify the Maximum Tolerated Dose (MTD), and monitor the immune response in vaccinated women. All participants in the Phase 1a study are women who have had triple negative breast cancer (TNBC) within the last three years and have been curatively treated having undergone standard of care. At the time of vaccination, these participants are tumor-free, as determined by standard diagnostic techniques, but are at high risk of recurrence.

About Triple-Negative Breast Cancer
One in eight women in the U.S. will be diagnosed with an invasive breast cancer at some point in their lives. Approximately 10-15% of those diagnoses are TNBC, however TNBC accounts for a disproportionately higher percentage of breast cancer deaths and has a higher rate of recurrence. This form of breast cancer is twice as likely to occur in African-American women, and approximately 70% to 80% of the breast tumors that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.

On August 7, 2023 Medivir AB (Nasdaq: MVIR) (Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported the formation of a Scientific Advisory Council as the company intensifies its plans for next phase of development (Press release, Medivir, AUG 7, 2023, View Source [SID1234633895]).

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In February, Medivir announced positive, preliminary results from the dose escalation cohorts of its candidate drug fostrox, in combination with Lenvima and initiated the phase 2a expansion cohort. Fostrox, designed to selectively treat liver cancers while minimizing systemic side effects, has the potential to become the first liver-targeted and orally administered drug for patients with hepatocellular carcinoma (HCC). The Scientific Advisory Council will work closely with Medivir to design the next phase of clinical development.

– "I am truly honored that we have been able to attract some of the world’s leading experts in liver cancer to our Scientific Advisory Council. As underlined by the outcome of the dose escalation cohorts and the swift recruitment in the ongoing dose expansion, it is an exciting time in the development of fostrox. The Scientific Advisory Council, with its expertise and deep clinical experience will be critical in moving the clinical development of fostrox forward," says Dr. Pia Baumann, CMO at Medivir.

– "Despite recent advancements in the treatment of HCC, a significant unmet medical need remains. Patients with advanced HCC have an underlying liver disease that can negatively impact their ability to benefit from systemic, medical treatments. Fostrox, with its unique, liver-targeted mechanism has the potential to minimize the tumor burden locally in the liver and provide synergistic activity with existing medical treatments and improve the anti-tumor activity" says Dr. Richard Finn, Professor of Medicine at the Geffen School of Medicine at UCLA.

The members of Medivir’s Scientific Advisory Council;

Dr. Jeff Evans is a Professor of Translational Cancer Research in the School of Cancer Sciences, University of Glasgow, and Honorary Consultant in Medical Oncology at the Beatson West of Scotland Cancer Centre, Glasgow, UK. He is the Lead of the Glasgow Experimental Cancer Medicine Centre (ECMC) and National Clinical Lead of the NHS Scotland Cancer Research Network. He is an investigator in the fostrox clinical development program.

Dr. Richard Finn is a Professor of Medicine at the Geffen School of Medicine at UCLA Department of Medicine, Division of Hematology/Oncology. Dr. Finn splits his time between patient care and directing the Translational Research Laboratory in the Division of Hematology/Oncology. His research interests are focused on the development of targeted therapeutics for solid tumors across histologies. Dr Finn has been the primary investigator of several, ground-breaking studies in HCC, including the ground-breaking ImBrave 150 study.

Dr. Jeong Heo is a Professor of Internal Medicine at Pusan National University School of Medicine and Director of Gastroenterology and Hepatology at Pusan National University Hospital. During his career, Professor Heo has held a number of academic positions, university and hospital appointments and has been principal investigator in many clinical trials for phase I-IV of hepatitis B, C and hepatocellular carcinoma. He is an investigator in the fostrox clinical program.

Dr. Maria Reig is the Head of the BCLC and Liver Oncology Unit at Hospital Clinic of Barcelona in Spain. Her expertise and area of interest is the development of prognostic models for patients with liver cancer and evaluation of treatment options with special emphasis in systemic therapy as well as new research about immune modulation and cancer emergence after antiviral treatment. She is an investigator in the fostrox clinical program.

Dr. Arndt Vogel is managing senior consultant and Professor in the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School. He is also head of the GI-Cancer Center and of the Center for Personalized Medicine at Medical School Hannover. His scientific focus is the translational and clinical research in gastrointestinal cancer. Professor Vogel is member and chairman of Hepatobiliary Cancer Study Group of the AIO, a collaborative group in clinical oncology in Germany. Within ESMO (Free ESMO Whitepaper), he is member of the ESMO (Free ESMO Whitepaper) Guidelines Steering Committee. Furthermore, Professor Vogel has responsibilities in the establishment of the national guideline and is the coordinator of the ESMO (Free ESMO Whitepaper) clinical practice guideline on the management of hepatocellular carcinoma and biliary tract cancer.

On August 7, 2023 BioCity Biopharma reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for a Phase 1 study of BC3448 (CD3/EGFR Bispecific antibody, BsAb) (Press release, Biocity Biopharmaceutics, AUG 7, 2023, View Source [SID1234633894]). As a result, BioCity Biopharma will initiate a dose escalation/expansion study with BC3448, enrolling patients with advanced solid tumors in the United States.

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BC3448 is a CD3-based BsAb that recruits T cells to tumors cells with high EGFR expression resulting in T cell-driven tumor cell killing. To reduce the possibility of cytokine release syndrome (CRS), a known safety issue associated with CD3-based BsAbs, BC3448 is designed to have differential binding affinities for EGFR and CD3, with a stronger binding affinity for EGFR than that for CD3.

BC3448 is being developed in solid tumors with high EGFR expression, including NSCLC, HNSCC, mCRC, and ESC. In preclinical studies, BC3448 demonstrated antitumor activity in multiple tumor types with high EGFR expression, regardless of mutational status of EGFR, KRAS or BRAF, indicating the potential for BC3448 to be an effective therapy for EGFR-expressing tumors, including those resistant to EGFR-TKI and EGFR mAbs.

Currently, there are few CD3/EGFR BsAb in clinical development globally, making BC3448 one of the leading programs. The Phase I trial of BC3448 conducted in China has completed several dose-escalation cohorts and shown a favorable safety profile. Opening of the US IND by BioCity will accelerate the clinical development of this innovative cancer therapy globally.