Joint development of brain tumor drug with Panolos and AimedBio

On January 3, 2022 Panolos Bioscience reported on the 27th that it has signed a joint research and development contract with AimedBio, a brain disease treatment development company, for brain tumor new drug ”PB101” (Press release, Panolos Bioscience, JAN 3, 2022, View Source [SID1234633688]). Panolos is a new drug development biotech based on a multifunctional recombinant protein platform.

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PB101 is currently in the preclinical toxicity test phase, and is aiming to apply for a phase 1 clinical trial protocol (IND) next year. In addition, Panolos has signed a consignment development (CDO) contract with Samsung Biologics for PB101.

Aimed Bio plans to cooperate with Panolos by participating in the establishment of strategies for preclinical and clinical development of PB101.

Specifically, in this joint study, AimedBio selected indications for clinical development of PB101 through big data-based biomarker selection and PDC/PDX (patient derived cell/patient derived xenograft) experiments, as well as clinical trials such as non-clinical research and development of combined administration. We plan to collaborate to increase the test success rate.

PB101 is VEGF-Grab, a fusion protein in which IgG1 Fc is coupled with glycosylated VEGF1 receptor (VEGFR1). According to Panolos, PB101 can suppress all angiogenic factors such as VEGF-A, VEGF-B, and placental growth factor (PlGF) that are overexpressed in the tumor microenvironment.

Avastin, a VEGF drug currently on the market, inhibits VEGF-A, while Eylia mainly inhibits VEGF-A/B with VEGF-Trap. In addition, PIGF expression increases with the administration of existing VEGF drugs, and PIGF overexpression is associated with poor prognosis of patients, so higher anticancer efficacy is expected as PIGF is inhibited.

In addition, as a result of recent preclinical studies, it was confirmed that Panolos is superior to existing VEGF drugs in terms of cancer cell growth inhibition, blood vessel normalization, and tumor microenvironment control. The company expects additional efficacy when administered in combination with immune checkpoint inhibitors.

Nam Do-hyun, CEO of AimdBio, said, "Intractable solid cancers, including brain tumors, do not have treatments and have high unmet needs. Selecting the correct indication and establishing a clinical development strategy accordingly determines the success of new drug development." Through collaboration with transplant models and clinical experts, we want to make PB101 a success story for the solid cancer market where there is no current treatment."

Meanwhile, Panolos is building a follow-up bi-antibody/multi-antibody project that attaches additional tumor targeting and immune activating factors based on PB101 ”αARTTM”, which inhibits multiple angiogenesis factor targets.

CStone Pharmaceuticals announced the IND approval of CS5001, a potential global best-in-class ROR1-targeting ADC by the U.S. Food and Drug Administration

On January 2, 2022 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, reported that the investigational new drug (IND) application of CS5001, a potential global best-in-class antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1) has received a STUDY MAY PROCEED (SMP) letter from the U.S. Food and Drug Administration (FDA) (Press release, CStone Pharmaceauticals, JAN 2, 2022, View Source [SID1234597904]). CS5001 will commence in the clinic as one of the three most advanced ROR1 ADCs globally, marking another important milestone for CStone’s Pipeline 2.0 strategy.

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ROR1 is an oncofetal protein with low or no expression in adult tissues but high expression in a variety of cancers including various forms of leukemia and non-Hodgkin lymphoma, breast, lung, and ovarian cancers, making it an ideal ADC target. CS5001 is an ADC targeting ROR1 with multiple differentiated features including proprietary site-specific conjugation, tumor-selective cleavable linker and pro-drug technology. Results from pre-clinical studies showed that CS5001 exhibited potent and selective cytotoxicity to a variety of ROR1-expressing cancer cell lines and demonstrated remarkable in vivo antitumor activity in both hematological and solid tumor xenograft models.

Dr. Archie Tse, Chief Scientific Officer of CStone, said, "We are glad that the IND application of CS5001 received the SMP letter from the U.S. FDA in 2021. The preclinical pharmacology data were encouraging and demonstrated CS5001’s therapeutic potential in multiple hematological and solid malignancies. There are only three ROR1 ADCs including CS5001 in clinical development. The upcoming first-in-human Phase I study aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS5001 in advanced B cell lymphomas and solid tumors. We will make every effort to advance this clinical trial of CS5001, meanwhile we have already submitted the CTN application in Australia and plan to submit the IND application in China soon."

About CS5001(ROR1 ADC)

In October 2020, CStone signed a licensing agreement with LegoChem Biosciences, Inc. (LCB) for the development and commercialization of CS5001 which was originally generated by collaboration of LCB and ABL Bio, both South Korea-based leading biotech companies. Under the agreement, CStone obtains the exclusive global right to lead development and commercialization of CS5001 outside the Republic of Korea.

CS5001 is now a clinical-stage antibody-drug conjugate (ADC) targeting ROR1 (receptor tyrosine kinase-like orphan receptor 1). CS5001 has uniquely designed and LCB’s proprietary tumor-cleavable linker and pyrrolobenzodiazepine (PBD) prodrug. Only after reaching the tumor, the linker and prodrug are cleaved to release the PBD toxin, resulting in lethal DNA cross-links in cancer cells. The use of the linker plus PBD prodrug effectively helps addressing the toxicity problem associated with traditional PBD payloads, leading to a better safety profile. Additionally, CS5001 utilizes site-specific conjugation for a precise drug antibody ratio of 2 which enables homogeneous production and large-scale manufacturing.

Helix BioPharma Corp. Provides Corporate Update

On December 31, 2021 Helix BioPharma Corp. (TSX: HBP) ("Helix" or the "Company"), an immuno-oncology
company developing innovative drug candidates for the prevention and treatment of cancer, reported a
corporate update on initiatives that were undertaken by the Company in 2021 (Press release, Helix BioPharma, DEC 31, 2021, View Source [SID1234608311]).

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Despite the challenges brought about by the COVID-19 pandemic, 2021 was a productive year for the Company.
During the second half of 2021, the Company initiated efforts to validate Helix and its lead clinical program with
external stakeholders to bring in an outside perspective to the company’s strategy and future, including but not limited to the following actions:
• In May of 2021, Helix engaged the consulting services of Dr. Christof Boehler, PhD, a seasoned biotechnology
scientist and entrepreneur to assess Helix and its assets. The outcome of this engagement was a positive outlook
on the potentials of L-DOS47, which has been demonstrated as safe in approximately 100 patients to date in the
Company’s Phase 1 clinical trials. Given the limitations of the current standard of care in addressing the high
unmet medical needs in oncology, the Company believes that the unique characteristics of L-DOS47 position
Helix as one of the leaders in the development of newer avenues like tumor microenvironments (change of tumor
pH), with an aim of improving the outcome of treatment of various malignancies with the use of L-DOS47 in
combination with immunotherapy and/or chemotherapy.
• In addition to Dr. Boehler’s assessment, Helix also retained the services of a highly experienced oncology
consultancy, Cello Healthcare ("Cello"), in August of 2021. A major aspect of this engagement included
interviews with certain key opinion leaders in the field to obtain their feedback and recommendations on the
Company’s L-DOS47 technology platform. The outcome of these interviews conducted by Cello both validated
the clinical work completed by Helix to date, and also helped the Company identify additional opportunities to
further strengthen and de-risk the Company’s clinical program, including optimal selection of patients for trials
(stratification) based on objective biomarkers, among other criteria. The Company anticipates that these activities
will facilitate strategic dialogue with potential market leaders in cancer treatment, and that the additional preclinical data obtained will further enhance the Company’s clinical program design.
• Finally, in September of 2021, Helix retained the consultancy services of Dr. Atul Deshpande, PhD, MBA, another
seasoned biotech executive who helped his previous employer, an immuno-oncology company, raise significant
funds from venture capital funds, and designed a focused strategy and execution plan in furtherance of the
Company’s public listing and significant concurrent financing. In his consulting role, Dr. Deshpande has been
tasked with implementing a refreshed corporate strategy and clinical plans to help the Company reach its goals.

Dr. Slawomir Majewski, Interim CEO and Director, states "We are hopeful that this kind of external validation
combined with internal expertise and experience will enable Helix to remain focused on the progression towards
developing unique therapies in the field of immuno-oncology for the treatment of cancer. We will continue to partner with these experienced advisors and experts in the field with an aim of enhancing the value of our platform and assets."

"Our clinical program remains our highest priority to ensure we deliver on a substantial data package that would
ultimately benefit patients and stakeholders alike. We await the final trial reports of the Phase I and II studies in lung
cancer in 2022. The other clinical trial in pancreatic cancer continues and we remain committed to this study. In
addition, in May 2021, we announced an agreement with Lind Global Macro Fund, LP, and subsequently closed a
first tranche financing for gross proceeds of $3,500,000. We are also working diligently to identify potential candidates to act as the Company’s permanent CEO," continued Dr. Majewski.

GenFleet Therapeutics Raises $75 Million in Series C Financing Led by Huagai Capital, to Advance Innovative Pipeline Highlighting Cutting-edge Therapies

On December 31, 2021 GenFleet Therapeutics, a clinical-stage biotechnology company with a focus in cutting-edge therapies in oncology and immunology, reported the completion of $75 million (~500 million RMB) series C financing (Press release, GenFleet Therapeutics, DEC 31, 2021, View Source [SID1234597889]). This round of financing is led by Huagai Capital, with participation by new investors including Suxin Venture Capital, Cherami Investment Group, ABC International, DYEE Capital, Qiaojing Eastern Investment, Baidu Venture, and Wenzhou Capital. Existing investors including Lake Bleu Capital, Panlin Capital, Shanjin Asset, CDH Venture and Growth Capital, HM Capital also participated. Start Point Advisors act as the sole financial advisor.

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"We are grateful to Huagai Capital and other investors for their recognition of our strategy to develop cutting-edge therapies, our innovative discovery platform, and our differentiated pipeline in both small molecules and biologics. We believe that it is our unique strategy, platform and pipeline that can not only minimize but may even eliminate the uncertainties induced by the market fluctuations or investment cycles. We can therefore provide a sound foundation for continuous growth and to distinguish ourselves from an extremely competitive environment to bring to patients globally innovative therapies from China." said Dr. Qiang Lu, Co-founder and Chairman of GenFleet Therapeutics.

"GenFleet’s pipeline highlights our focuses in cutting-edge therapies with novel mechanisms and global IP. We have built a highly differentiated pipeline sustained by our proprietary discovery platform. As we expect more programs to move into late-stage clinical development in 2022, GenFleet will continue to march toward commercialization and globalization. We hope to help patients across the world through scientific breakthroughs and achieve positive financial results for our stakeholders." said Dr. Jiong Lan, Co-founder and Chief Executive Officer of GenFleet Therapeutics.

"HuaGai Capital feels honored to join GenFleet and to lead this round of financing. GenFleet is dedicated to serving unmet medical needs and we are impressed with its industry-leading progress as well as its efficient execution. Under the leadership of Dr. Lu and Dr. Lan, GenFleet truly stands out among competitors to bring life-saving treatments and better healthcare solutions to global patients." said Zhiqiang Zeng, Managing Partner of HuaGai Healthcare.

"We are pleased to lead this round of financing. GenFleet has established its proprietary R&D platform based on the deep understanding of disease biology and translational medicine. Its cutting-edge portfolio highlights innovative therapies with global IP, and we look forward to its prospects of globalization and long-term development in the industry." said Jingyang Zhu, Vice President of HuaGai Healthcare.

I-Mab Announces Upcoming Participation at January Conferences

On December 31, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported its participation in the following conferences in January 2022 (Press release, I-Mab Biopharma, DEC 31, 2021, View Source [SID1234597890]). Details of the conferences and management presentation are as follows:

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40th Annual J.P. Morgan Healthcare Conference

Presentation: Tuesday, January 11, 2022, at 4:30 p.m. E.S.T.

Presenter: Dr. Jingwu Zang, Founder, Chairman, Acting CEO and Director

Webcast link: View Source;kiosk=true The webcast will also be available under "Event Calendar" on IMAB’s IR website at View Source .

One-on-one and small group meetings: January 19-21, 2022

Management participants: Dr. Jingwu Zang, Founder, Chairman, Acting CEO and Director, Dr. Andrew Zhu, Director and President, Mr. John Long, Director and Chief Financial Officer, Mr. Tianyi Zhang, Vice President Investor Relations, Mr. Tyler Ehler, Senior Director Investor Relations and Phoebe Peng, Associate Director Investor Relations

For more information, please contact your J.P. Morgan representative.

Morgan Stanley Virtual China New Economy Summit 2022

One-on-one and small group meetings: January 5-7, 2022

Management participants: Dr. Jingwu Zang, Founder, Chairman, Acting CEO and Director, Dr. Andrew Zhu, Director and President, Mr. John Long, Director and Chief Financial Officer, Mr. Tianyi Zhang, Vice President Investor Relations, Mr. Tyler Ehler, Senior Director Investor Relations and Phoebe Peng, Associate Director Investor Relations

For more information, please contact your Morgan Stanley representative.

H.C. Wainwright Virtual BioConnect Conference

One-on-one and small group meetings: January 10 – 13, 2021

Management participants: Dr. Jingwu Zang, Founder, Chairman, Acting CEO and Director, Dr. Andrew Zhu, Director and President, Mr. John Long, Director and Chief Financial Officer, Mr. Tianyi Zhang, Vice President Investor Relations, Mr. Tyler Ehler, Senior Director Investor Relations and Phoebe Peng, Associate Director Investor Relations

For more information, please contact your H.C.Wainwright representative.

UBS Greater China Conference 2022

One-on-one and small group meetings: January 11-14, 2022

Management participants: Dr. Jingwu Zang, Founder, Chairman, Acting CEO and Director, Dr. Andrew Zhu, Director and President, Mr. John Long, Director and Chief Financial Officer, Mr. Tianyi Zhang, Vice President Investor Relations, Mr. Tyler Ehler, Senior Director Investor Relations and Phoebe Peng, Associate Director Investor Relations

For more information, please contact your UBS representative.