On November 27, 2022 Lyvgen Biopharma, a leading innovative global biotech company dedicated to discovering, developing and commercializing first-in-class and best-in-class biotherapeutics for cancer, reported an open label, phase 2, multicenter, randomized trial of LVGN7409 plus docetaxel or, in collaboration with Bristol Myers Squibb, nivolumab in patients with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) (Press release, Lyvgen Biopharma, NOV 27, 2022, View Source [SID1234624463]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Lyvgen clinical collaboration with Bristol Myers Squibb underscores our commitment to exploring combination regimens from our portfolio with complementary mechanisms of action that may transform cancer care", said Jieyi Wang, Ph.D., Founder and CEO of Lyvgen. "We are excited to enter this clinical collaboration with Bristol Myers Squibb and look forward to initiating enrollment in these combination regimens for patients who cannot benefit from existing therapy worldwide."

LVGN7409, a recombinant monoclonal antibody that targets CD40 for activation optimally in tumor microenvironment, which is a member of the tumor necrosis factor (TNF) receptor family (TNFRSF5) and modulates immune responses by activating antigen presenting cells and reprograming the immuno-suppressive tumor microenvironment.

Bristol Myers Squibb’s nivolumab is a human monoclonal antibody that binds to the PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

Docetaxel is an anti-tubulin chemotherapy agent used to treat a number of types of cancer, including non-small-cell lung cancer, breast cancer, head and neck cancer, stomach cancer, and prostate cancer.

"Lyvgen believes that the combination therapy targeting co-stimulatory checkpoint CD40 and co-inhibitory checkpoint PD-1, may offer the greatest chance to increase immunotherapy effectiveness in patients with resistant or refractory diseases, further validating the synergy observed in our pre-clinical studies for the combination of LVGN7409 and an immune check-point inhibitors." said Hubert Chan, M.D., Ph.D., Chief Medical Officer. " We also believe LVGN7409 may be useful in combination with immune-modulating chemotherapy agents such as docetaxel. Through this phase 2 study, we are enthusiastic to demonstrate that the stimulation of CD40 has the potential to reverse an immune-suppressed tumor microenvironment characterized by drug resistance and to improve anti-tumor efficacy when added to the current ‘standard of care’ therapy. There is a significant unmet medical need for the refractory NSCLC patients, and we hope this study will bring promising results to those cancer patients." continued Dr. Chan.

Clinical benefits for patients must be proven through rigorous clinical studies. There are no shortcuts. Lyvgen’s focus on immune agonists is widely applicable for most cancer indications. Our xLinkAb platform helps achieve a balance between safety and efficacy, which can greatly increase the chances of success. The advantages of agonistic antibodies have been validated in several preclinical and clinical studies. At present, the agonistic antibody field is still young, but developing rapidly with huge potential as a hot field of cancer immunotherapy. Our strength and long-term engagement in immune-oncology agonistic antibodies are returning primary promising clinical results. The Lyvgen pipeline of biologics may be benefit-cost effective drugs for a large panel of cancer indications.

Under the terms of the Agreement, Lyvgen will sponsor the study and Bristol Myers Squibb will provide nivolumab for the combination trial. Lyvgen has global commercial and development rights to LVGN7409.

About LVGN7409

LVGN7409 is a next generation CD40 agonistic monoclonal antibody developed on Lyvgen xLinkAb platform, which activates CD40 to promote tumor antigen presentation and induction of cancer-fighting T cells, and "warms up" the immune-"cold" tumor microenvironment. Unique structure and functionality of LVGN7409 permits its higher tolerable dosage and broader clinical utility.

On November 27, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported that clinical data from multiple trials in relation to TYVYT (sintilimab injection), olverembatinib (BCL-ABL TIK), IBI188(anti-CD47 monoclonal antibody), IBI110 (anti-LAG-3 monoclonal antibody) and IBI939 (anti-TIGIT monoclonal antibody) will be presented at the upcoming international medical conferences (Press release, Innovent Biologics, NOV 27, 2022, View Source [SID1234624462]). A brief summary of the presentations is as follows:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

EUROPEAN SOCIETY OF MEDICAL ONCOLOGY IMMUNO-ONCOLOGY CONGRESS 2022 (Dec 7-9)

Topic: Efficacy and safety of IBI110 (anti-LAG-3 mAb) in combination with sintilimab (anti-PD-1 mAb) in advanced squamous non-small cell lung cancer (sqNSCLC): updated results of the Phase Ib study
Presentation Type: Poster
Poster Number: 86P
Main Researchers: Professor Caicun Zhou, Shanghai Pulmonary Hospital; Professor Nong Xu, The First Affiliated Hospital, School of Medicine, Zhejiang University.

Topic: A Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients with Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer (NSCLC)
Presentation Type: Poster
Poster Number: 77P
Main Researcher: Professor Ying Cheng, Jilin Cancer Hospital.

64TH AMERICAN SOCIETY OF HEMATOLOGY ANNUAL MEETING & EXPOSITION (Dec 10-13)

Topic: A phase 1b study to evaluate safety and efficacy of IBI188 in combination with azacitidine (AZA) as a first-line treatment in subjects with newly diagnosed higher risk myelodysplastic syndrome
Presentation Type: Poster
Poster Number: 1759
Main Researchers: Professor Zhijian Xiao, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Professor Miao Miao, The First Affiliated Hospital of Suzhou University.

Topic: Updated Results of Pivotal Phase 2 Trials of Olverembatinib (HQP1351) in Patients (Pts) with Tyrosine Kinase Inhibitor (TKI)-Resistant Chronic- and Accelerated-Phase Chronic Myeloid Leukemia (CML-CP and CML-AP) with T315I Mutation
Presentation Type: Oral Presentation
Abstract Number: 170698
Main Researcher: Professor Qian Jiang, Peking University Institute of Hematology, Peking University People’s Hospital.

Topic: A Five-Year Follow-up on Safety and Efficacy of Olverembatinib (HQP1351), a Novel Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI）, in Patients with TKI-Resistant Chronic Myeloid Leukemia (CML) in China with T315I Mutation
Presentation Type: Oral Presentation
Abstract Number: 170868
Main Researcher: Professor Qian Jiang, Peking University Institute of Hematology, Peking University People’s Hospital.

On November 27, 2022 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) reported that it has entered into an evaluation and option agreement with ADC Therapeutics SA (Press release, Biocytogen, NOV 27, 2022, View Source [SID1234624461]). Biocytogen will grant ADC Therapeutics a license to evaluate Biocytogen’s proprietary antibodies against three tumor targets, with an option to license selected antibodies at a later date for global ADC development and commercialization. Biocytogen reserves all global rights for these antibodies beyond ADC development. Biocytogen will receive an upfront payment. For each option exercised, Biocytogen will be entitled to an option-exercise fee, and development and commercial milestone payments, which potentially total tens of millions of US dollars, as well as single-digit royalties on net sales.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the agreement, Biocytogen will provide ADC Therapeutics with monoclonal and/or biparatopic antibodies directed against three tumor targets, generated through Biocytogen’s Project Integrum (also called RenMiceTM HiTS Platform). ADC Therapeutics will carry out feasibility studies and be responsible for further development and commercialization of the ADC products if the company exercises an option.

"ADC Therapeutics is a leader in the development and commercialization of ADCs. We believe this collaboration with ADC Therapeutics will underscore the value of Biocytogen’s proprietary antibody discovery and screening platforms," said Dr. Yuelei Shen, President and CEO of Biocytogen. "We’ve been dedicated to expanding the possibilities of antibody-based therapeutics in disease treatment, through the exploration of new types of targets and modalities through Project Integrum. The combination of Biocytogen’s strength in antibody development with ADC Therapeutics’ expertise and track record in payload and linker technology may lead to the generation of novel ADC medicines for unmet medical needs in the future."

"We are pleased to enter this collaboration with Biocytogen as we continue expanding our toolbox to realize the full potential of our ADC platform," said Patrick van Berkel, PhD, Chief Scientific Officer of ADC Therapeutics. "We look forward to evaluating the fully human antibodies from Biocytogen’s proprietary discovery platform, which have the potential to accelerate the development of our novel ADCs."

On November 25, 2022 (the "Funding Date"), OncoSec Medical Incorporated (the "Company") reported entered into a Convertible Promissory Note and Security agreement with Grand Decade Developments Limited, a British Virgin Islands limited company and a wholly owned subsidiary of Grand Pharmaceutical Group Limited ("GDDL"), pursuant to which the Company issued a Secured Convertible Promissory Note (the "Note") to GDDL (Filing, 8-K, OncoSec Medical, NOV 25, 2022, View Source [SID1234624535]). The Note has a principal amount of $2,000,000, bears interest at a rate of 5% per annum until November 25, 2023 and 10% per annum thereafter (the "Interest Rate") and matures on November 25, 2024 (the "Maturity Date"), on which date the principal balance and all accrued interest under the Note shall be due and payable. The Interest Rate will be 10% per annum upon occurrence of an event of default, including, but not limited to, the failure by the Company to make payment of principal or interest due under the Note on the Maturity Date, and any commencement by the Company of a case under any applicable bankruptcy or insolvency laws. The principal and interest accrued on the Note may be prepaid without any further agreement of the parties to the Note, or converted (as described below) upon the agreement of the parties to the Note, at any time without penalty to the Company.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Subject to the consent of GDDL, the Note is convertible into such number of fully paid and non-assessable shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), into such number of fully paid and non-assessable shares of Common Stock as determined by dividing (i) any portion of the unpaid principal and accrued interest of the Note then outstanding by (ii) the greater of (a) the last closing bid price of a share of Common Stock as reported on the Nasdaq Capital Market ("Nasdaq") on the date the Company and GDDL agree to such conversion and (b) the average closing bid price of a share of Common Stock as reported on Nasdaq for the thirty trading days immediately preceding such date, subject to a share cap of 360,769 shares of Common Stock (the "Share Cap"), representing 19.99% of the total issued and outstanding shares of Common Stock as of November 25, 2022.

Additionally, if at any time after the Funding Date the last closing bid price of a share of Common Stock as reported on the Nasdaq for ten consecutive trading days or the average closing bid price of a share Common Stock as reported on Nasdaq for the thirty trading days immediately preceding such date is equal to or exceeds $44.00 (subject to any reorganization, recapitalization, reclassification, stock dividend, stock split, reverse stock split or other substantially similar transaction), GDDL may require that the Company prepay the Note through conversion of the then outstanding principal and/or any accrued interest thereon into shares of Common Stock, in whole or in part.

The unpaid principal of and any accrued interest on the Note constitute unsubordinated obligations of the Company and are senior and preferred in right of payment to all equity securities of the Company outstanding as of the Funding Date, which are secured by all of the Company’s right, title and interest, in and to certain of the Company’s intellectual property rights in Hong Kong, Taiwan, China and South Korea, as specified in the Note; provided, however, that the Company may incur or guarantee additional indebtedness after the Funding Date, whether such indebtedness are senior, pari passu or junior to the obligations under the Note.

The foregoing description of the Note is qualified in its entirety by reference to the full text of such Note, a copy of which is attached hereto as exhibits 10.1, and incorporated herein by reference.

On November 25, 2022 Nordic Nanovector ASA (OSE: NANOV) ("Nordic Nanovector" or the "Company") reported that launched a new dedicated area on its website (www.nordicnanovector.com) with information in Norwegian for shareholders relating to its proposed merger with APIM Therapeutics ("APIM") (Press release, Nordic Nanovector, NOV 25, 2022, View Source [SID1234624429]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The new area includes a recording of the webcast and Question & Answer session, which was held for interested parties, including shareholders, on 24 November. During the webcast, shareholders were provided with a more-detailed presentation of the proposed merger with APIM and were given the opportunity to ask their specific questions regarding the merger plans.

Malene Brondberg, Interim CEO and CFO of Nordic Nanovector, says: "We are happy that so many shareholders attended the webcast we hosted yesterday, where we provided more background on the proposed merger with APIM Therapeutics. After a week of highly productive meetings between the Nordic Nanovector and APIM teams, our confidence in a merged company is even stronger than before. Our largest shareholder Folketrygdfondet confirms that it supports the Board’s proposal. We are certain that there is no better alternative, and we encourage all shareholders to vote in favour of the merger proposal."

The proposed merger, which is backed by the Boards of Directors of both companies, is the result of an extensive review conducted by Nordic Nanovector in conjunction with Carnegie Investment Bank ("Carnegie") that explored a range of strategic options for the Company. This review included carefully evaluating a potential stand-alone strategy for Nordic Nanovector, which was deemed not to be a viable option by the Board.

After evaluating 25 possible merger and acquisition opportunities, the Company determined that the merger transaction with APIM represents the best and most exciting opportunity for all of Nordic Nanovector’s shareholders given, among other things, the significant and broad potential of ATX-101, a novel anti-cancer peptide currently in Phase 2 trials. In addition, the combined company will have the discovery and development expertise to potentially generate multiple value-enhancing new drug candidates from its technology platforms.

How to register for the general meeting

Shareholders wishing to attend the general meeting must register no later than 29 November 2022 at 16:00 hours (CET). Shareholders can attend in person, by proxy or by casting advance votes. The deadline is the same for proxies and advance votes as personal attendance. Until the deadline, votes already cast may be changed or withdrawn.

Electronic registration of attendance, proxies and advance voting is easily available through the link posted at the Company’s website: www.nordicnanovector.com. An individual ref. no. and PIN-code required to access the service have been sent to all shareholders with known address.

Registration of personal attendance and proxies can also be made by mail to Nordea Bank Abp, Norwegian branch, Issuer Services, P.O. Box 1166 Sentrum, N-0107 Oslo, Norway, or e-mail to: [email protected] within the deadline. No ref. no. and PIN-code is required for registration by mail or e-mail.

The form of registration of attendance (in person or by proxy) is attached with the notice as made available on Nordic Nanovector’s website and on the company’s ticker on newsweb.no

Advisers

Carnegie Investment Bank is acting as financial advisor to Nordic Nanovector. Advokatfirmaet Selmer AS is acting as legal advisor to Nordic Nanovector and KPMG AS assisted Nordic Nanovector with financial due diligence and a fairness opinion of the exchange ratio.

Advokatfirmaet Schjødt AS is acting as legal advisor to APIM. The valuation of APIM Therapeutics was conducted by Venture Valuation AG, which has now agreed to be identified.