On December 1, 2022 ImmuneOnco Biopharmaceuticals (Shanghai) Inc.(hereinafter referred to as "ImmuneOnco") reported that phase II clinical studies of the first domestic SIRPαFc fusion protein targeting human CD47, IMM01，combined with PD-1 monoclonal antibody for solid tumors and lymphomas were officially launched (Press release, ImmuneOnco Biopharma, DEC 1, 2022, View Source [SID1234655667]).

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 data from clinical phase I study of IMM01 monotherapy is encouraging. From a quite low dose level, some patients with advanced lymphoma have been clinically benefited with good safe profile. IMM01 does not bind to human red blood cells, avoiding the "antigen sink effect", due to its differential molecular design. The molecule weight of IMM01 is only about half of the antibody so has better tissue permeability and bioavailability. What is more, preclinical in vivo drug efficacy test showed that IMM01 was very useful to combine with other targeting agents and immunotherapy drugs to gain synergic tumor suppressive activity.

PD-1 monoclonal antibody has been proven to have superior curative effect on a variety of tumors, but only responsive to small portion of patients due to limitation by the content of infiltrated T cells in tumor tissue, lack of infiltrated T cell is called "cold tumor". Macrophages are innate immune cells and antigen-presenting cells. After activated, they can turn ‘cold tumor’ to ‘hot tumor’ so as to improve curative effect of PD-1 monoclonal antibody and maintain for a long time.

1) Macrophages directly ‘swallow’ tumor cells and present tumor antigens to T cells to induce tumor antigen-specific T cell responses.

2) Macrophages release chemokines (such as CXCL9/CXCL10) to induce T cell motion to tumor tissue, thereby transforming "cold tumor" into "hot tumor".

Dr. Tian，Wenzhi, founder and chairman of ImmuneOnco, said，"I am very pleased to see that the phase II clinical trial of our IMM01 combined with PD-1 monoclonal antibody against solid tumors and lymphoma has been officially launched. Preclinical studies have shown that IMM01 combined with PD-1 monoclonal antibody has strong synergistic effects. Among patients enrolled in the phase I, it demonstrated good safety profile and tolerance. We are confident about clinical studies, IMM01 combined with PD-1 monoclonal antibody will show superior clinical efficacy and good safety. We hope to bring good news to more cancer patients as well."

Dr. Qiying Lu, Chief Medical Officer/Senior Vice President of ImmuneOnco said: "This is an important milestone. IMM01 is our key product and one of the important cornerstones of our company in the field of anti-tumor immunotherapy. This product has a variety of combination therapies (including AZA, PD-1 monoclonal antibody and other drugs) ) has entered phase II clinical development in multiple indications, covering hematological tumors and solid tumors. At present, more than 150 patients have been enrolled in multiple indications including solid tumors, lymphoma, AML, MDS, and CMML. It showed good safety and tolerability, as well as encouraging preliminary efficacy in various tumor indications. We look forward to rapidly advancing the clinical development of IMM01 products, bringing new treatment options to tumor patients to meet unmet clinical needs."

On December 1, 2022 PrimeLink reported the company has completed a financing of several hundred million RMB, led by Xiangfeng Investment and co-invested by Fosun Pharma and Kaitai Capital (Press release, PrimeLink Biotherapeutics, DEC 1, 2022, View Source [SID1234651598]). This round of financing will mainly be used for technology research and development, talent introduction, and laboratory construction.

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!

Pulin Bio was founded in 2021. Its R&D center is located in Suhua Science and Technology Park, Suzhou Industrial Park. It is a biopharmaceutical company focusing on the establishment of drug delivery platforms and the development of antibody-drug conjugates (ADCs). It aims to use international cutting-edge technology concepts and technology platforms to develop, screen and industrialize a new generation of ADCs .

Regarding the new generation of ADC drugs, Dr. Yin, the company’s founder and chief technology officer, explained to 36Kr that the company has established a flexible and modular technology platform to synthesize ADC drug pools, and screened the optimal ADC drug composition for each target through a unique screening platform. "Because any target has a specific and suitable ADC, its structure is different, and the same set of drug compositions cannot be used for different targets." To this end, Pulin Bio has built a connector platform with independent intellectual property rights . Based on this set of technology, Pulin Bio focuses on creating a "First in class & Best in class" product pipeline.

Regarding the new generation of ADC drugs, Dr. Yin, the company’s founder and chief technology officer, explained to 36Kr that the company has established a flexible and modular technology platform to synthesize ADC drug pools, and screened the optimal ADC drug composition for each target through a unique screening platform. "Because any target has a specific and suitable ADC, its structure is different, and the same set of drug compositions cannot be used for different targets." To this end, Pulin Bio has built a connector platform with independent intellectual property rights . Based on this set of technology, Pulin Bio focuses on creating a "First in class & Best in class" product pipeline.

Under this set of R&D concepts, Dr. Yin revealed that the company follows the product pipeline development strategy of "stability and innovation" in the selection of targets and indications , that is, walking on two legs:

First, focus on clinically validated targets, especially those that have failed in Phase II and Phase III clinical trials, and analyze the reasons for failure to optimize them;
Second, develop "First in class" products.

According to Dr. Yi, the company’s founder and chief operating officer, the company’s technology platform has been verified by experimental data at the cellular level . These results suggest ample potential and prospects for the company to develop a differentiated ADC platform. It is expected that one drug will complete IND submission in 2024.

When talking about the industry prospects, Dr. Yin said that in the entire field of medical innovation, ADC drugs have unique advantages: first, small molecule drugs and antibody drugs seem to have entered a "bottleneck period". In comparison, ADC drugs have better drugability, which is also the core reason why many antibody drug companies have started to make ADCs; in addition, in terms of indications, ADCs are currently better than the popular gene and cell therapy (CGT) in terms of efficacy in treating solid tumors.

In addition, he also said that ADC drugs are also the fastest-growing sector in the pharmaceutical field, which can be reflected in the sales data of recent years: global annual sales in 2022 will be US$8.08 billion, and it is expected to reach US$22.87 billion in 2023. The compound growth rate from 2021 to 2030 will reach 16.4%, and the market prospects are excellent.

Behind the advantages, industry barriers also exist. Dr. Yin said, "Whether it is upstream target discovery, drug development, or downstream CMC and other production links, they are all very complicated and require the participation of very experienced people. However, experienced talents are scarce, and those with successful experience are even scarcer."

As a startup company, the core task of Pulin Biotech in the initial stage is to establish a new ADC drug toolbox and verify a new technology platform with independent intellectual property rights. It is worth mentioning that in order to improve Pulin Biotech’s toolbox, Pulin Biotech has reached an agreement with a US company to authorize the introduction of its antibody sugar modification and site-specific coupling technology, which enables Pulin Biotech to synthesize homogenized ADC drugs, thus providing a necessary technical option for optimizing the therapeutic window of ADC candidate drugs. According to Dr. Yin, "This technology will make it easier for us to produce ADC drugs in the future, saving a lot of time and money."

Finally, let me introduce the company team. The founder, Dr. Yin, has nearly 20 years of experience in ADC drug development, including the design and development of payloads and connectors, coupling process development, etc. He has worked at Mersana Therapeutics for 15 years and has dozens of international patents. Dr. Yin is the number one employee of Mersana and the core inventor of Mersana’s first and second generation linkers. He has led the team through the cycle from early exploration to IND research, forming Mersana’s unique technology platform. At present, Mersana’s technology platform has derived a rich product line. The core product has completed phase III clinical trials and will submit a BLA application. There are also multiple pipelines that are undergoing clinical research or forming strategic cooperation with international pharmaceutical companies.

In addition, Dr. Yi, the company’s founder and COO, has 15 years of experience and knowledge in antibody and ADC drugs, and has participated in the research and development of two ADC drugs. Currently, the company has more than 20 people, with a "Bo content" of more than 50% .

The company has now launched a new round of financing.

On December 1, 2022 Optieum Biotechnologies reported that the company has entered into a research collaboration agreement with the National Cancer Center Japan("NCC") to initiate multiple projects to discover and develop innovative CAR-T cell therapy assets targeting solid tumors (Press release, Optieum Biotechnologies, DEC 1, 2022, View Source [SID1234639141]).

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!

Optieum has a platform technology to elicit functional and improved scFvs that can lead to superior antitumor reactivity of CAR-T cells. NCC, Exploratory Oncology Research and Clinical Trial Center (NCC-EPOC) has expertise in clinical research and development of cancer immunotherapy, and is capable of accelerating translational research by integrating its clinical resources into this collaboration.

With the completion of signing, Optieum and Division of Cancer Immunotherapy (Chief, Dr. Tetsuya Nakatsura) of NCC-EPOC, will begin joint research to develop CAR-T cell therapies for patients with solid tumors.

On December 1, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will host an investor event on December 10 during the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in New Orleans, LA (Press release, Affimed, DEC 1, 2022, View Source [SID1234624722]).

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!

Investor event information
Date and Time: Saturday, December 10 at 4:00 p.m. CST / 5:00 p.m. EST / 23:00 CET
Location: New Orleans, LA and virtual
Affimed will host an investor event to review AFM13 clinical data and development plans in CD30 expressing malignancies. The investor event will take place in-person and virtually and a webcast of the event will be available in the "Webcasts" section on the "Investors" page of Affimed’s website at View Source
To access the event via phone, please dial +1 (929) 205-6099 for U.S. callers, or +44 (203) 481-5240 for international callers, and reference meeting ID 847 4106 6227 approximately 15 minutes prior to the call.
To reserve your place in the live event, please contact Alex Fudukidis via e-mail at [email protected].
A replay of the webcast/call will be archived on Affimed’s website for 30 days after the call.

About AFM13
AFM13 is a CD30/CD16A bispecific Innate Cell Engager (ICE) that is investigated in Hodgkin Lymphoma (HL) and T cell lymphoma (TCL). AFM13 has shown single agent efficacy in HL and TCL and is currently being evaluated as monotherapy in a single arm registration-directed trial in peripheral TCL (REDIRECT). In addition, AFM13 showed high response rates in combination with the anti-PD-1 antibody Keytruda (ORR: 88%, CR: 46%) and in combination with allogeneic cord blood-derived NK cells (ORR: 100%, CR: 71%). Affimed recently entered into a partnership with Artiva to develop AFM13 in combination with Artiva’s allogeneic, cryopreserved, NK cell product AB-101 in HL and TCL.

On December 6, 2022 OREGA Biotech reported an exclusive license agreement under which OREGA Biotech grants Genmab full, worldwide rights to its first-in-class immuno-oncology antibody program against a novel and undisclosed target (Press release, OREGA BIOTECH, DEC 1, 2022, View Source [SID1234624745]). This license agreement results from a fruitful research collaboration between the two companies initiated in 2020.

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!

"We are thrilled to partner with Genmab, the renowned international biotechnology company", said Jeremy Bastid, Chief Executive Officer of OREGA Biotech. "Our team discovered the role of this novel target in impairing the response to the PD1/PDL1 immune checkpoint inhibitors and demonstrated that a neutralizing antibody could reverse this effect and improve the response to cancer immunotherapy. We have been working very closely with Genmab’s scientific team for more than 2 years and we are convinced that their scientific skills and development capabilities will be of paramount importance to further develop this asset", he added.

Gilles Alberici, President of OREGA Biotech, further commented: "This licensing agreement marks another major step forward for our company and team after the successful out-licensing of our CD39 antibody program which is now entering phase 2 clinical trial. Given the track record of Genmab in developing and delivering innovations to the patients, we believe that Genmab is very well positioned to bring this novel antibody program to the clinic", he added.

Genmab will be responsible for the research, development, manufacturing and commercialization of the antibody. The parties will aim to enter into an additional agreement for OREGA Biotech to support Genmab’s preclinical research activities related to this antibody.

"I would like to take the opportunity of this announcement to congratulate our scientists who did a fantastic work in advancing this antibody program and collaborating successfully with our Genmab’s colleagues despite the Covid-19 pandemic. I also would like to thank our partners from Inserm Transfert for their continued support during the licensing process", Jeremy Bastid concluded.

Financial Terms

OREGA Biotech will receive an upfront payment and is eligible to receive development, regulatory and commercial milestone payments plus royalties on commercial sales. The financial terms of the agreement have not been disclosed.