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
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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
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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 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the Ministry of Health, Labour and Welfare (MHLW) has approved today the additional indication of Alecensa (generic name: alectinib), a Chugai originated antineoplastic agent/ALK inhibitor, for "adjuvant therapy for ALK fusion gene-positive non-small cell lung cancer (Press release, Chugai, AUG 28, 2024, View Source [SID1234646151])." The application for regulatory approval for Alecensa was filed in December 2023, followed by an orphan drug designation subject to priority review, in the same month.

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"We are very pleased that Alecensa, a Chugai originated medicine, received approval in Japan following the U.S. and Europe for the additional indication of adjuvant therapy for ALK-positive NSCLC. In early-stage NSCLC, approximately half of patients who received tumor resection surgery may experience recurrence. With this additional indication, we are confident in not only reducing the risk of post-operative recurrence but also being able to expect complete cure and long-term survival in patients with ALK-positive NSCLC in Japan. We believe this greatly improves the quality of life for patients and their families. We will continue working to promptly provide proper use information," said Chugai’s President and CEO, Dr. Osamu Okuda.

The approval is based on results from the ALINA study, a global Phase 3 study conducted in patients with completely resected ALK-positive early NSCLC stage IB (tumors ≥ 4 cm) to IIIA (UICC/AJCC 7th edition). In the study, Alecensa reduced the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.0001) compared with platinum-based chemotherapy in people with completely resected IB to IIIA ALK-positive NSCLC.1 The safety and tolerability of Alecensa in the ALINA trial were generally consistent with previous trials in the metastatic setting and no unexpected safety findings were observed.1

Chugai Pharmaceutical, a leading oncology company, is committed to promoting the proper use of Alecensa so that it can contribute to the treatment of ALK-positive early non-small cell lung cancer as a new treatment option in the adjuvant setting.

Electronic Package Insert Information ※Underlined parts were changed and added
Brand Name : ALECENSA Capsules 150 mg
Generic Name : alectinib capsules
Indications : Adjuvant therapy for ALK fusion gene-positive non-small cell lung cancer
Dosage and administration :

The usual adult dosage is 600 mg of alectinib administered orally twice daily after a meal. The treatment period should be up to 24 months, and the dose may be reduced according to the patient’s condition.

[Reference Information]
Chugai’s Alecensa Reduces the Risk of Disease Recurrence or Death by 76% in People with ALK-Positive Early-Stage Non-Small Cell Lung Cancer (Press release on October 20, 2023)
View Source

About the ALINA study
The ALINA study [NCT03456076] is a Phase III, randomized, active-controlled, multicenter, open-label study evaluating the efficacy and safety of adjuvant Alecensa (alectinib) compared with platinum-based chemotherapy in people with resected Stage IB (tumors ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). The study included 257 patients who were randomly assigned to either the Alecensa or chemotherapy treatment arm. The primary endpoint is disease-free survival. Secondary outcome measures include overall survival and percentage of patients with adverse events.

About Alecensa
Alecensa is a highly selective, central nervous system-active, oral medicine created at Chugai, a member of the Roche Group, for people with NSCLC whose tumors are identified as ALK-positive. Alecensa is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK-positive, metastatic NSCLC, including in the United States, Europe, Japan, China and Taiwan. ALK-positive lung cancer is said to account for approximately 3-5% of non-small cell lung cancers2. In Japan, Alecensa has also been approved for the treatment of recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma.
Alecensa was approved by the U.S. Food and Drug Administration (FDA) in April 2024 as adjuvant treatment following tumor resection for patients with ALK-positive NSCLC (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test, and in June 2024 by the European Commission, as a monotherapy for adjuvant treatment following tumor resection for adult patients with ALK-positive NSCLC at high risk of recurrence (Stage IB [tumors ≥ 4 cm]–IIIA NSCLC [7th edition UICC/AJCC]). In addition, it has been approved in Japan as an adjuvant therapy following complete tumor resection for ALK-positive NSCLC.

About lung cancer
Lung cancer is one of the leading causes of cancer death globally3. Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day3. In Japan, 127 thousand people are affected by this disease (2019)4. Lung cancer can be broadly divided into two major types: non-small cell lung cancer (NSCLC) and small-cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases5. Today, about half of all people with early lung cancer (45-76%, depending on disease stage) still experience a cancer recurrence following surgery, despite adjuvant chemotherapy6. Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure7.

Trademarks used or mentioned in this release are protected by law.

Source:

Solomon B, et al. ALINA: efficacy and safety of adjuvant alectinib versus chemotherapy in patients with early-stage ALK+ non-small cell lung cancer (NSCLC). Presentation at: European Society for Medical oncology Congress; 2023 October 20-24. Late-breaking abstract #LBA2.
Biomarker Committee of the Japan Lung Cancer Society. Guidance for ALK Gene Testing in Lung Cancer Patients Version 4.0 (Japanese only)
Thandra KC, et al. Epidemiology of lung cancer. Contemp Oncol. 2021;21(1):45-52.
Cancer Statistics, Cancer Information Service, National Cancer Center, Japan (National Cancer Registry) [Internet; cited 2024 August] Available from: View Source (Japanese Only)
American Cancer Society: What Is Lung Cancer? [Internet; cited 2024 August] Available from:
View Source
Pignon JP, et al. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE collaborative group. J Clin Oncol. 2008;20;26(21):3552-9.
Hendricks LE, et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO (Free ESMO Whitepaper) Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(4):339-357.

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, BioMarin Pharmaceutical Inc., a Delaware corporation (the "Company"), reported to have entered into a Credit Agreement (the "Credit Agreement") with Citibank, N.A., as Administrative Agent ("Citibank" or the "Administrative Agent"), and the Lenders party thereto (the "Lenders") (Filing, 8-K, BioMarin, AUG 28, 2024, View Source [SID1234646337]).

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The Credit Agreement provides for up to $600 million in revolving loans (the "Revolving Credit Facility"), none of which was drawn at closing. Subject to the satisfaction of certain conditions precedent, the Company will be entitled to draw funds at its discretion until the Revolving Credit Facility matures on August 28, 2029 (the "Maturity Date"), at which time all outstanding loans shall become due and payable and all outstanding letters of credit shall be cash collateralized. The Company expects to use the proceeds of the Revolving Credit Facility to finance ongoing working capital needs and for other general corporate purposes.

Loans under the Credit Agreement will bear interest at a floating rate per annum based on (i) in the case of US dollar denominated loans, either (x) the Secured Overnight Financing Rate (subject to a zero percent floor), plus a spread adjustment of 10 bps ("Term SOFR"), plus a margin ranging from 112.5 bps to 175 bps per annum, based upon the Company’s total net leverage ratio or (y) the Base Rate, which is the highest of (A) the Federal Funds Rate plus 50 bps, (B) Citibank’s "prime rate", or (C) Term SOFR plus 100 bps, plus a margin ranging from 12.5 bps to 75 bps per annum, based upon the Company’s total net leverage ratio; (ii) in the case of euro denominated loans, the Euro Interbank Offered Rate ("EURIBOR"), plus a margin ranging from 112.5 bps to 175 bps per annum, based upon the Company’s total net leverage ratio; and (iii) in the case of sterling denominated loans, the Sterling Over Night Indexed Average, plus a margin ranging from 112.5 bps to 175 bps per annum, based upon the Company’s total net leverage ratio. Unutilized commitments under the Credit Agreement will accrue an unused line fee ranging from 12.5 bps to 20 bps per annum, based upon the Company’s total net leverage ratio, to be paid quarterly in arrears.

The Company will have the right, but not the obligation, to prepay the Revolving Credit Facility in whole or in part and/or terminate the Revolving Credit Facility without premium or penalty on or prior to the Maturity Date.

The Credit Agreement includes customary representations, warranties and covenants, including, among other things, restrictions on the Company’s and certain of its subsidiaries’ ability to incur additional indebtedness, dispose of its assets, incur liens, make investments, and pay dividends or other distributions, in each case subject to specified exceptions. The Credit Agreement also contains customary indemnification obligations and customary events of default, including, but not limited to, failure to timely make payments when due under the Credit Agreement, failure to comply with any of the covenants under the Credit Agreement or any other loan document, the occurrence of certain insolvency or bankruptcy-related events, cross-default to certain other material indebtedness and the occurrence of a "change of control" (as defined in the Credit Agreement).

During the occurrence and continuance of an event of default by the Company under the Credit Agreement, the Lenders would be entitled to exercise their remedies thereunder, including termination of the commitment of each Lender to make loans and any obligation of the issuer of letters of credit under the Revolving Credit Facility to make credit extensions, and the right to accelerate any outstanding obligations under the Credit Agreement.

A copy of the Credit Agreement is filed as Exhibit 10.1 hereto.

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.