On October 11, 2021 Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, reported that the clinical trial of ALK-1 antibody (GT90001C) and Nivolumab (Opdivo) combination therapy for the treatment of systemic therapy naïve patients with advanced hepatocellular carcinoma ("HCC") was approved by the National Medical Products Administration (the "NMPA") of China on October 9, 2021 (Press release, Suzhou Kintor Pharmaceuticals, OCT 11, 2021, View Source [SID1234591040]).

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ALK-1 antibody is a fully human IgG2 neutralizing monoclonal antibody that inhibits ALK-1/TGF-β signal transduction and tumor angiogenesis. Kintor Pharma obtained an exclusive global license for all oncological applications for ALK-1 antibody from Pfizer, Inc., in February 2018.

The phase II clinical trial of the combination therapy of ALK-1 antibody and Nivolumab on patients with advanced HCC has started on May 7, 2019 in Taiwan, China ("Taiwan phase II clinical trial"), evaluated the efficacy and safety of ALK-1 antibody in combination with Nivolumab in patients with advanced HCC who were progressed on or intolerant to first-line therapy with Sorafenib or Lenvatinib. The preliminary data of the ongoing Taiwan phase II clinical trial was released at the ASCO (Free ASCO Whitepaper) GI 2021 (held between January 15 – 17, 2021), and showed positive efficacy and safety results. The overall response rate ("ORR") was 40%.

On 11 February 2021, the investigational new drug application of multiregional phase II clinical trial of combination therapy of ALK-1 antibody and Nivolumab for the second-line treatment of advanced HCC was greenlighted by the United States Food and Drug Administration.

Dr. Youzhi Tong, founder, Chairman and CEO of Kintor Pharma, commented, "Liver cancer has been ranked no. 4 in terms of incident rate and no. 2 in terms of mortality rate in China, and HCC accounts for 75-85% of liver cancer. ALK-1 antibody was in-licensed from Pfizer, which has made Kintor the leader in the clinical development of this anti-cancer angiogenesis inhibitor with the first-in-class potential globally. ALK-1 antibody, in combination with Nivolumab, has demonstrated very positive results in the clinical trial of treating HCC patients who failed sorafenib or Lenvatinib. Currently we are in co-development with Alphamab to test ALK-1’s combo therapy with KN046 bispecific for treating a bunch of solid tumors including HCC. NMPA’s formal approval of ALK-1 antibody in combination with Nivolumab as the first-line treatment of HCC, which provides a great opportunity for this combo therapy as a potential standard of care for HCC. If successful, the market prospect and commercial value are very promising."

On October 11, 2021 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported the addition of two CNS-penetrant Bruton’s tyrosine kinase (BTK) inhibitors to its product candidate pipeline (Press release, Gossamer Bio, OCT 11, 2021, View Source [SID1234591061]).

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Gossamer plans to initiate first-in-human studies of the first of these candidates, GB5121, in the fourth quarter of 2021. Gossamer intends to develop GB5121 in CNS-oncology indications, including relapsed / refractory primary CNS lymphoma (PCNSL), for which a potentially registrational Phase 1b / 2 study is expected to initiate in the first half of 2022.

The second product candidate, GB7208, is currently in IND-enabling studies and is expected to enter the clinic in the second half of 2022. In a BTK-dependent pre-clinical disease model, GB7208 demonstrated superior outcomes vs. tolebrutinib, a BTK inhibitor being studied in a broad Phase 3 program for multiple sclerosis (MS).

"We are thrilled to be able to share our latest product candidates, the CNS-penetrant BTK inhibitors GB5121 and GB7208," said Faheem Hasnain, Chairman, co-founder and CEO of Gossamer Bio. "These two promising product candidates are the result of intensive internal research, and we are excited to advance them into the clinic where there remains a high unmet need in treating malignant brain tumors and neurologic diseases."

"BTK inhibitors have emerged as an important class of treatment, particularly in oncology, but existing molecules have not been optimized for the treatment of central nervous system disorders," said Laura Carter, Ph.D., Chief Scientific Officer of Gossamer Bio. "GB5121 and GB7208 were designed specifically with these disorders in mind, and in pre-clinical models, they have been shown to be potent, highly selective BTK inhibitors, with potentially best-in-class brain penetrance and target occupancy."

GB5121: Oral, CNS-Penetrant, Irreversible BTK Inhibitor for Treatment of PCNSL

Superior CNS penetration in preclinical models compared to other BTK inhibitors in development for oncology
Highly selective for BTK, with no non-TEC kinases inhibited at greater than 50% in a broad kinome scan
First-in-human Phase 1 clinical trial expected to initiate in the fourth quarter of 2021
First-in-patient Phase 1b/2 clinical trial in patients with relapsed / refractory CNS lymphoma expected to initiate in the first half of 2022
Relapsed and refractory PCNSL provides potential accelerated path to registration
GB7208: Oral, CNS-Penetrant, Irreversible BTK Inhibitor for Treatment of MS

Potentially best-in-class brain penetrance among BTK inhibitors being developed for neuroinflammatory and neurodegenerative diseases based on pre-clinical models
In a BTK-dependent pre-clinical disease model, demonstrated superiority vs. tolebrutinib, a CNS-penetrant BTK inhibitor in Phase 3 development for MS
Potent inhibition of microglia inflammation in vitro and in vivo
First-in-human Phase 1 clinical trial expected to initiate in the second half of 2022
Gossamer will host a conference call and webcast today, Monday, October 11, 2021, for investors and analysts at 2:30pm ET to discuss its new product candidates. As part of the event, Gossamer Bio management will be available for questions.

Details below:

Conference Call and Webcast

Gossamer will host a conference call and live audio webcast today, Monday, October 11, 2021, at 2:30 pm ET to discuss its new product candidates. The live audio webcast may be accessed through the "Events / Presentations" page in the "Investors" section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

A replay of the audio webcast will be available for 30 days on the "Investors" section of the Company’s website, www.gossamerbio.com.

On October 11, 2021 CatalYm, reported an update from the dose escalation part of the ongoing first-in-human trial "GDFather" (GDF-15 Antibody-mediated Effector cell Relocation) investigating its lead product candidate, CTL-002, both in monotherapy and in combination with an immune checkpoint inhibitor, nivolumab. CTL-002 is a neutralizing antibody that specifically targets growth and differentiation factor 15 (GDF-15), which is recognized as a negative regulator of antitumoral T cell activity preventing T cell recruitment to the tumor microenvironment as well as potently suppressing an adaptive immune response by additional mechanisms recently identified (Press release, Catalym, OCT 11, 2021, View Source [SID1234591078]). Patients treated with CTL-002 and nivolumab at the first four of five dose levels to be evaluated showed an excellent tolerability profile and no dose limiting toxicities (DLT). Preliminary sequential tumor biopsy analyses for dose level 1-3 showed signs for a tumor-selective influx of T cell under CTL-002 treatment. GDFather is the most advanced clinical trial of a GDF-15-targeting therapeutic in immuno-oncology. The data was presented in an oral presentation at the plenary session ‘New Drugs on the Horizon II’ at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), on October 9, 2021.

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Prof. Dr. Eugen Leo, Chief Medical Officer at CatalYm commented, "GDF-15 has been recently identified by us and others as a tumor-derived key negative regulator of the immune response against cancer. We are delighted to see the excellent tolerability of CTL-002 in combination with nivolumab and initial evidence for targeted activity from dose level 1 onwards, which is reflected by induction of a tumor-selective influx of T cells. Additional biomarker analyses and relevant data for all cohorts will be available before year-end and we are very keen to take this drug forward into the next stage of clinical development to serve the anti-PD1/PD-L1 refractory patient population, which represents a significant number of patients in many solid tumors."

Dr. Phil L’Huillier, Chief Executive Officer at CatalYm added, "The opportunity to provide this data update at the "New Drugs on the Horizon" plenary session of the ACR-NCI-EORTC conference reflects the scientific innovation and clinical relevance presented by our approach. Although the data is still preliminary at this stage, it corroborates our preclinical data and confirms the proposed mode of action of CTL-002. Our ultimate goal is to provide meaningful clinical benefit to a patient population with very poor prognosis, refractory to checkpoint inhibitors and all other standard of care treatments. We look forward to further evaluating CTL-002 in this heavily pretreated patient population."

The ongoing first-in-human GDFather trial (GDF-15 antibody-mediated effector cell relocation) consists of two parts. In the dose escalation phase (Part A), up to 24 patients will receive escalating doses of CTL-002 in a "3+3" manner with the lead candidate given as a monotherapy and followed by combination with an anti-PD-1 checkpoint inhibitor. In the second dose expansion phase (Part B, phase 2a), several cohorts with tumors identified to be GDF-15-dependent will be treated to further evaluate safety and preliminary efficacy of CTL-002 treatment. Additional biomarker data, safety information and first efficacy readouts from all dose levels tested in dose escalation of CTL-002 both for monotherapy and in combination with nivolumab may be available by year-end.

About CTL-002

CTL-002 is a humanized, monoclonal antibody designed to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15). GDF-15 secretion by the tumor has been shown to prevent T cell migration into the tumor and suppresses T cell function and the adaptive immune response in the tumor microenvironment. This enables the tumor to evade the immune system and become resistant to standard of care and current immunotherapy approaches such as checkpoint inhibitors. CTL-002 counteracts these immuno-suppressive mechanisms by neutralizing GDF-15, enhancing the infiltration of immune cells into the tumor, improving both priming of T cells by dendritic cells and tumor killing by T cells and NK cells.

On October 10, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that it has filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission ("SEC") relating to a proposed offering and sale in the United States of shares of Evotec represented by American Depositary Shares ("ADSs") (Press release, Evotec, OCT 10, 2021, View Source;announcements/press-releases/p/evotec-se-files-registration-statement-for-proposed-offering-of-american-depositary-shares-6102 [SID1234591046]). The Registration Statement has not yet become effective and the final number of ADSs to be offered and their price have not yet been determined.

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Evotec’s shares are listed on the regulated market of the Frankfurt Stock Exchange in Germany with additional admission obligations of the Prime Standard Segment. Evotec has applied for a secondary listing of the ADSs on the Nasdaq Global Select Market in the United States under the ticker symbol "EVO". The new shares underlying the ADSs will be issued from Evotec’s authorised capital.

The ADSs will be issued under Evotec’s revised ADS program, which continues to be administered by JP Morgan Chase Bank, N.A. BofA Securities and Morgan Stanley are acting as lead joint book-running managers for the offering. Citigroup, Jefferies, Cowen and RBC Capital Markets are acting as joint book-running managers for the offering.

The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus, when available, may be obtained from BofA Securities, NC1-004-03-43; 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department or by email at [email protected], Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected].

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities law of any such state or jurisdiction.

On October 10, 2021 MobileODT reported that we are Finalist in the Hospital Diagnostics category for a UCSF 2021 Health Award (Press release, MobileODT, OCT 10, 2021, https://www.mobileodt.com/various/mobileodt-selected-as-ucsf-2021-health-awards-finalist/ [SID1234591048]). The UCSF Health Awards honor outstanding health technologies and innovations dramatically transforming healthcare.

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MobileODT was selected out of thousands of companies, through rigorous judgment rounds, performed by over 300 judges from all over the world. We are extremely honored by this selection, which is a testament to the impact that our technology is making on women’s health.