On August 28, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported the closing of its previously announced public offering, upsized to 6,000,000 shares of its American Depository Shares ("ADSs")(or pre-funded warrants in lieu thereof), together with Series H warrants ("Series G Warrants") to purchase up to 6,000,000 ADSs at a combined public offering price of $1 per ADS (or pre-funded warrant in lieu thereof) and associated Series H Warrant (Press release, TC Biopharm, AUG 28, 2024, View Source [SID1234646168]). The Series H Warrants have an exercise price of £0.76 per ADS, are exercisable upon issuance and will expire one year from the date of issuance. Each ADS represents two hundred ordinary shares of the Company.

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The gross proceeds to the Company from the offering are $6.0 million, before deducting offering expenses payable by the Company. The Company intends to use the net proceeds from this offering to support its upcoming clinical trial focusing on relapse/refractory Acute Myeloid Leukemia, for market awareness and for continuing operating expenses and working capital.

The securities described above are being offered by the Company pursuant to a registration statement on Form F-1 (File No. 333-281613) previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC") on August 28, 2024 and an additional registration statement on Form F-1 filed pursuant to Rule 462(b) which became automatically effective on August 28, 2024. . The offering was made only by means of a prospectus, which is part of the effective registration statement. A final prospectus relating to the offering will be filed with the SEC. Electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source

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

On August 28, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that nearly 20 accepted clinical data of its novel oncology molecules, including six oral presentations, will be released at World Conference on Lung Cancer (WCLC) from Sept 7-10, 2024, in San Diego, U.S., and the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) from Sept 13-17, 2024, in Barcelona, Spain (Press release, Innovent Biologics, AUG 28, 2024, View Source [SID1234646167]).

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Key data showcase includes: an oral presentation of updated Phase 1 result of its first-in-class PD-1/IL-2α-bias (IBI363) in NSCLC (up to 3mg/kg dosage) at WCLC, updated Phase 1 results of IBI363 (PD-1/IL-2α-bias) combination therapy in colorectal cancer at ESMO (Free ESMO Whitepaper), an oral presentation of updated pivotal Phase 2 results of Dupert (fulzerasib, KRAS G12C inhibitor) in NSCLC at WCLC, an oral presentation of Phase 1 results of IBI354 (HER2 ADC) in HER2+ solid tumors at ESMO (Free ESMO Whitepaper), and multiple clinical results of TYVYT (sintilimab injection).

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are very pleased to present a robust set of clinical data for our next-generation innovative bispecific antibodies and ADC molecules across renowned medical conferences of 2024 including ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper) Plenary and ESMO (Free ESMO Whitepaper) GI in June, and WCLC and ESMO (Free ESMO Whitepaper) in September. We observed the preliminary efficacy and safety signals for those innovative candidates, underscoring their potential for further development and clinical value. As one of the few biopharmaceutical companies with both the technology platforms and robust pipeline in "IO+ADC" areas, Innovent remains dedicated to advancing cancer treatment and is committed to offering doctors and patients more innovative, effective, and safe therapeutic options."

Details on the abstracts are listed below:

WCLC: Oral Sessions

Abstract Title: First-in-Class PD-1/IL-2 Bispecific Antibody IBI363 In Patients with Advanced Non-Small Cell Lung Cancer in a Phase 1 Study
Abstract No: MA11.04
Session Type and Title: WCLC 2024-MA11. Building on the Foundations of Current Immunotherapies
Presentation Time: Tuesday, September 10, 2024, 13:37-13:42 PDT
Presenter: Jianya Zhou,The First Affiliated Hospital of Zhejiang University School of Medicine

Abstract Title: KRAS G12C Inhibitor IBI351 In Patients (pts) with Advanced Non-Small Cell Lung Cancer (NSCLC): Updated Results from a Pivotal Phase 2 Study
Abstract No: OA14.05
Session Type and Title: WCLC 2024-OA14. New Horizons in Targeting KRAS G12C
Presentation Time: Monday, September 9, 2024, 15:52-16:02 PDT
Presenter: Qing Zhou, Guangdong People’s Hospital

Abstract Title: Neoadjuvant Sintilimab plus Chemotherapy in EGFR-mutant NSCLC Followed by adjuvant Osimertinib or Observation: A Phase 2 CTONG2104 Trial
Abstract No: MA15.11
Session Type and Title: Mini Oral
Presentation Time: Tuesday, September 10, 2024 at 3:48-3:53 PM PDT
Presenter: Guangdong Lung Cancer Institute, C. Zhang

Abstract Title: First-Line Treatment of Locally Advanced or Metastatic Pulmonary Lymphoepithelioma-like carcinoma: A Multicenter, Single-Arm, Phase 2 Trial
Abstract No: MA11.03
Session Type and Title: Mini Oral
Presentation Time: Tuesday, September 10, 2024 at 1:32-1:37 PM PDT
Presenter: The First Affiliated Hospital of Medical University, C. Zhou

ESMO: Oral Sessions

Abstract Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients (pts) with advanced solid tumors and breast cancer (BC): results from a Phase 1 study
Abstract No: 345MO
Session Type and Title: ESMO (Free ESMO Whitepaper) 2024-Mini oral session 1: Breast cancer, metastatic
Presentation Time: Sunday, September 15, 2024, 9:15-9:20 AM CEST
Presenter: Christina Teng, Scientia Clinical Research, Australia

Abstract Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients (pts) with advanced gynecological cancers (Gynecol C): results from a phase 1 study
Abstract No: 720MO
Session Type and Title: ESMO (Free ESMO Whitepaper) 2024-Mini oral session 2: Gynecological cancers
Presentation Time: Sunday, September 15, 2024, 15:45-15:50 CEST
Presenter: Jin Shu, Chongqing University Affiliated Cancer Hospital

WCLC: Posters

Abstract Title: Neoadjuvant Chemoimmunotherapy for Potentially Resectable IIIA/IIIB NSCLC: Survival Updates and Predictive Effect of MRD
Abstract No: EP.08D.01
Session Type and Title: E-Poster
Presentation Time: Saturday, September 7, 2024 at 11:58-11:59 AM PDT
Presenter: First Hospital of Jilin University, K. Ma

Abstract Title: Safety and Efficacy of Sintilimab Combined with Anlotinib in Patients with KRAS-Mutant Advanced Non-Small Cell Lung Cancer
Abstract No.: P4.11E.10
Session Type and Title: E-Poster
Presentation Time: Monday, September 9, 2024 at 6:30 PM PDT
Presenter: Peking University Shenzhen Hospital, F. Wang

ESMO: Posters

Abstract Title: First-in-class PD-1/IL-2 bispecific antibody fusion protein IBI363 + bevacizumab (beva) in patients (pts) with advanced colorectal cancer (CRC): A phase I study
Abstract No: 574P
Session Type and Title: ESMO (Free ESMO Whitepaper) 2024-Poster
Presentation Time: Monday, September 16, 2024 CEST
Presenter: Zhen Yu Lin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Abstract Title: Safety and efficacy of IBI354 (anti-HER2 ADC) in patients (pts) with advanced gastrointestinal (GI) cancers: results from a Phase 1 study
Abstract No: 576P
Session Type and Title: ESMO (Free ESMO Whitepaper) 2024-Poster
Presentation Time: Monday, September 16, 2024 CEST
Presenter: Jifang Gong, Peking University Cancer Hospital

Abstract Title: Hepatic Artery Infusion Chemotherapy (HAIC) Plus Sintilimab and Bevacizumab Biosimilar (IBI305) for Initial Unresectable Hepatocellular Carcinoma (HCC) in Patients with Child-Pugh B Liver Function: A prospective study
Abstract No.: 980P
Session Type and Title: Hepatocellular carcinoma (HCC) – Poster
Presentation Time: Monday, September 16, 2024
Presenter: Tianjin Medical University Cancer Institute & Hospital, Huikai Li

Abstract Title: Hepatic arterial infusion chemotherapy combined with Sintilimab and regorafenib as adjuvant therapy for colorectal liver metastasis patients with high risk of recurrent: a single-arm, Phase 2 study
Abstract No.: 539P
Session Type and Title: Colorectal cancer – Poster
Presentation Time: Monday, September 16, 2024
Presenter: Fudan University Shanghai Cancer Center, Lu Wang

Abstract Title: Fruquintinib combined with sintilimab and chemotherapy as the first-line treatment in advanced naïve EGFR- and ALK-negative non-squamous non-small cell lung cancer (nsq-NSCLC): Updated results
Abstract No: 1329P
Session Type and Title: NSCLC, metastatic – Poster
Presentation Time: Saturday, September 14, 2024
Presenter: Jiangsu Province Hospital, Pei Ma

Abstract Title: Sintilimab plus anlotinib in patients with advanced sarcomas (SINANLOSARC): a single-center, single-arm, Phase 2 trial
Abstract No.: 1735P
Session Type and Title: Sarcoma – Poster
Presentation Time: Saturday, September 14, 2024
Presenter: Shandong Cancer Institute, Shandong Cancer Hospital, Zengjun Liu

Abstract Title: Efficacy and safety of sintilimab in combination with anlotinib plus metronomic chemotherapy in advanced triple negative breast cancer (SPACE): preliminary results of a single-arm, multicenter Phase 2 trial
Abstract No.: 389P
Session Type and Title: Breast cancer, metastatic – Poster
Presentation Time: Monday, September 16, 2024
Presenter: Shandong Cancer Institute, Shandong Cancer Hospital, Huihui Li

Trial in Progress

Abstract Title: Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced G/GEJ cancer: A phase 1b/2 clinical trial (FUNCTION)
Abstract No.: 1475TiP
Session Type and Title: Oesophagogastric cancer, Poster
Presentation Time: Monday, September 16, 2024
Presenter: Henan Cancer Hospital, Bei-Bei Chen

On August 28, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, reported that it will be presenting at the the annual German Fall Conference to be held in Frankfurt from September 2-3, 2024 as well as at the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024 in New York and at the Baader Investment Conference from September 23-26, 2024 in Munich (Press release, MediGene, AUG 28, 2024, View Source [SID1234646166]).

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Corporate presentation – German Fall Conference 2024
View Source
Location: Le Meridien Hotel Frankfurt, Frankfurt, Germany
Date and time: Monday, September 2, 2024, 10 am – 10.40 am local time
Speaker: Dr. Selwyn Ho, CEO

Corporate presentation – H.C. Wainwright 26th Annual Global Investment Conference 2024
View Source
Location: Lotte New York Palace, New York, USA
Date and time: to be determined
Speaker: James Cornicelli, Senior Vice President, Head of Corporate Development & Strategy

Corporate presentation – Baader Investment Conference 2024
View Source
Location: Hotel Sofitel Munich Bayerpost, Munich, Germany
Date and time: Wednesday, September 25, 2024, 12.30 pm – 1.10pm local time, panel room 3
Speaker: Dr. Selwyn Ho, CEO

Members of Medigene’s management team will be available for one-on-one meetings with registered investors at the events.

On August 28, 2024 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that Jack Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat at the Wells Fargo Healthcare Conference on Wednesday, September 4, 2024, at 4:30 p.m. ET at the Encore Boston Harbor Hotel in Everett, Massachusetts (Press release, Supernus, AUG 28, 2024, View Source [SID1234646165]).

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Investors interested in arranging a meeting with company management during the conference should contact the Wells Fargo conference coordinator. A live audio webcast of the presentation can be accessed here or by visiting Events & Presentations in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available for 60 days on the Company’s website following the conference.

On August 28, 2024 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, reported that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for mirdametinib, an investigational MEK inhibitor, for the treatment of adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) (Press release, SpringWorks Therapeutics, AUG 28, 2024, View Source [SID1234646164]). The NDA was granted Priority Review and has been given a Prescription Drug User Fee Act (PDUFA) action date of February 28, 2025. In addition, the FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application. SpringWorks also announced today that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for mirdametinib for the treatment of adult and pediatric patients with NF1-PN. Mirdametinib has the potential to be the first approved therapy for the treatment of adult patients and a best-in-class therapy for children with NF1-PN.

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"These significant milestones bring us closer to our goal of delivering a transformative medicine to both adults and children with NF1-PN in the U.S. and Europe," said Saqib Islam, Chief Executive Officer of SpringWorks. "People living with NF1-PN are in need of new advances and we look forward to working with the FDA and EMA during their review processes as we prepare to bring our second medicine to patients suffering from devastating diseases."

The FDA grants Priority Review to applications for medicines that offer, if approved, significant improvements over available options or that provide a treatment option where no adequate therapy currently exists. The FDA and the European Commission have previously granted Orphan Drug designation for mirdametinib for the treatment of NF1. The FDA has also granted Fast Track designation for the treatment of patients ≥ 2 years of age with NF1-PN that are progressing or causing significant morbidity and Rare Pediatric Disease designation for the treatment of NF1.

"Plexiform neurofibromas may sit next to or surround vital organs and can cause serious medical complications for patients. While progress has been made, there remains a pressing need for more treatment options, particularly for adults who currently have no approved therapy," said Annette Bakker, Ph.D., Chief Executive Officer of the Children’s Tumor Foundation (CTF) and Board Chair of CTF Europe. "CTF is dedicated to deploying its time, talent and funding towards accelerating the development of new treatments. We congratulate our long-term partner SpringWorks on this important milestone and we are thrilled that patients in the United States and Europe could soon have a new therapy available to them."

Both submissions include data from the pivotal Phase 2b ReNeu trial, which evaluated mirdametinib in patients ≥ 2 years of age with NF1-associated PN causing significant morbidity. Results were presented in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and demonstrated that mirdametinib treatment resulted in robust objective response rates confirmed by blinded independent central review, deep and durable responses, improvement in pain and health-related quality of life as well as a manageable safety profile across both the adult and pediatric cohorts.1

About the ReNeu Trial

ReNeu (NCT03962543) is an ongoing, multi-center, open-label Phase 2b trial evaluating the efficacy, safety, and tolerability of mirdametinib in patients ≥ 2 years of age with an inoperable NF1-associated PN causing significant morbidity. The study enrolled 114 patients to receive mirdametinib at a dose of 2 mg/m2 twice daily (maximum dose of 4 mg twice daily) without regard to food. Mirdametinib was administered orally in a 3-week on, 1-week off dosing schedule as either a capsule or dispersible tablet. The primary endpoint is confirmed objective response rate assessed by proportion of patients with ≥ 20% reduction in target tumor volume on consecutive scans during the 24 cycle treatment phase, as measured by MRI and assessed by blinded independent central review. Secondary endpoints include safety and tolerability, duration of response, and changes in patient reported outcomes from baseline to Cycle 13. The treatment phase of the trial is complete and results were presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Patients who completed the treatment phase were eligible to continue receiving treatment in the optional long-term follow up portion of the study, which is ongoing.

About NF1-PN

Neurofibromatosis type 1 (NF1) is a rare genetic disorder that arises from loss-of-function variants in the NF1 gene, which encodes for neurofibromin, a key suppressor of the MAPK pathway.2,3 NF1 is the most common form of neurofibromatosis, with an estimated global birth incidence of approximately 1 in 2,500 individuals, and approximately 100,000 patients living with NF1 in the United States.4,5 The clinical course of NF1 is heterogeneous and manifests as a variety of symptoms across numerous organ systems, including abnormal skin pigmentation, skeletal deformities, tumor growth, and neurological complications such as cognitive impairment.6 Patients with NF1 have an 8 to 15-year mean reduction in their life expectancy compared to the general population.3

NF1 patients have approximately a 30-50% lifetime risk of developing plexiform neurofibromas, or PN, which are tumors that grow in an infiltrative pattern along the peripheral nerve sheath and that can cause severe disfigurement, pain and functional impairment; in rare cases, NF1-PN may be fatal.7,8 NF1-PNs are most often diagnosed in the first two decades of life.7 These tumors can be aggressive and are associated with clinically significant morbidities; typically, they grow more rapidly during childhood.9,10 Surgical removal of these tumors is challenging due to the infiltrative tumor growth pattern along nerves and can lead to permanent nerve damage and disfigurement.11 MEK inhibitors have emerged as a validated class of treatment for NF1-PN.12

About Mirdametinib

Mirdametinib is a potent, oral, CNS-penetrant, allosteric small molecule MEK inhibitor in development as a monotherapy treatment for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) and low-grade glioma (LGG), and as a combination therapy for the treatment of several subsets of biomarker-defined metastatic solid tumors. Mirdametinib is an investigational drug for which safety and efficacy have not been established.

Mirdametinib is designed to inhibit MEK1 and MEK2, which occupy pivotal positions in the MAPK pathway. The MAPK pathway is a key signaling network that regulates cell growth and survival and plays a central role in multiple cancers and rare diseases when genetically altered.

The FDA and the European Commission have granted Orphan Drug designation for mirdametinib for the treatment of NF1. The FDA has also granted Fast Track designation for the treatment of patients ≥ 2 years of age with NF1-PN that are progressing or causing significant morbidity and Rare Pediatric Disease designation for the treatment of NF1.