On January 3, 2021 Amberstone Biosciences (www.amberstonebio.com), an emerging biotherapeutics company with unique expertise in conditionally active immunotherapeutics, reported the completion of a $12 million Series A financing round (Press release, Amberstone Biosciences, JAN 3, 2022, View Source [SID1234597984]). The funding was led by Viva BioInnovator, Co-win Ventures and Sinovation Ventures, with additional support from ChangRong Capital, Lifespan Investments and existing shareholders.

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Amberstone will use the proceeds from the financing to advance its highly differentiated tumor microenvironment activated therapeutic programs including bispecific antibodies and immunocytokines to the investigational new drug application (IND) enabling stage.

"We are tremendously grateful for the strong support from our new and existing investors," said Amberstone Biosciences President and CEO, George Wu, PhD. "With our unique Tumor Microenvironment Activated Therapeutics (T-MATE) programs, we aim to develop safer and more effective therapies to benefit cancer patients. The funding and broad expertise and resources in the field provided by our investors will take us another step closer to our mission."

"Amberstone’s T-MATE therapeutic molecules enabled by its innovative single-cell discovery engine represents a real breakthrough in immune-oncology. We are thoroughly impressed by Amberstone team’s rich experience in the cancer biology space. Viva is excited to work with Amberstone and syndicate partners to support its mission to provide next-generation innovative treatment options to patients," said Han Dai, PhD, Chief Innovation Officer of Viva Biotech and Head of Viva BioInnovator.

"T cell immunotherapy has encountered great challenges in the complex microenvironment of solid tumors. The T-MATE molecules discovered through Amberstone’s world-leading cross-disciplinary drug discovery engine will break through the bottleneck of traditional methods and bring new hope to the treatment of solid tumors. Co-win Ventures is thrilled to work with Amberstone’s team and co-investors to explore the next generation of immunotherapies in solid tumors," said Xin Huang, MD/PhD, a managing partner of Co-win Ventures.

"The expertise and strengths of Amberstone core team synergize well with one another. We are optimistic with the company’s uncapped growth potential. Amberstone exemplifies our firm’s investment strategy and mission to support deep-tech innovative entrepreneurs and companies," said Sinovation Ventures’ partner in healthcare, Mr. Peter Wu.

On January 3, 2022 Oncorus, Inc. (NASDAQ: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported that President and Chief Executive Officer, Theodore (Ted) Ashburn, M.D., Ph.D., will participate in a fireside chat at the H.C. Wainwright BioConnect Conference (Press release, Oncorus, JAN 3, 2022, View Source [SID1234597968]).

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The fireside chat will be available for on-demand viewing beginning Monday, January 10, 2022 at 7:00am ET under the Investors & Media section of Oncorus’ website at View Source A replay of the presentation will be archived on Oncorus’ site for 90 days following the event.

On January 3, 2022 GC Cell (KOSDAQ:144510) and Rivaara Immune Private Limited reported that they have entered into an exclusive licensing agreement, pursuant to which Rivaara Immune has agreed to develop and commercialize Immuncell-LC in India, Sri Lanka, and Bangladeshi (Press release, GC Cell, JAN 3, 2022, View Source [SID1234597985]). Developed by GC Cell, Immuncell-LC is a patient-derived autologous T-cell immunotherapy for liver cancer, which was approved by the Korean MFDS back in 2007.

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Under the terms of the agreement, Rivaara Immune has obtained the exclusive right to develop and commercialize Immuncell-LC within India for liver cancer. In return, GC Cell is entitled to receive an undisclosed upfront payment, as well as payments for the achievement of commercial milestones, with royalties based upon the sales.

In addition, GC Cell will also receive a partial stake of Rivaara Immune and exclusive rights to supply media which is essential for the production of Immuncell-LC.

The number of cancer patients in India is more than 1.3 million, about 6 times that of Korea, and India’s liver cancer market is 2.3 times that of Korea’s. Notably, 5-year liver cancer survival rate is 4%, which is very low compared to 37% of Korea, so new treatments are urgently needed.

"Immuncell-LC’s overseas expansion is based on its domestic success, pushing for technology transfer by country, and signing contract with Rivaara Immune in India is the first outcome," said Dae-woo Park, CEO of GC Cell. "Both companies will cooperate in a win-win strategic partnership, and are also closely discussing with a number of partners in China and other countries in the Middle East."

"Rivaara Immune is pleased to partner with GC Cell, a leader in Immune Cell Therapy in Korea. With this partnership we will be among the first, to bring to the Indian market, customized solutions to cater to the unmet needs of the liver cancer sufferers," said Syd Daftary, Director of Rivaara Immune.

About Immuncell-LC

Immuncell-LC is a customized anti-cancer drug that is made from a patient’s blood. Professionals extract a sample of a patient’s T-cells from the blood and genetically modify it into a robust immune cell that has maximized anticancer functions and is incubated for about two weeks before they infuse it into the patient. Immuncell-LC received approval for the liver cancer immunotherapy from the Korean MFDS in 2007. It also received FDA Orphan Drug Designation for the Treatment of liver cancer, brain tumor, and pancreatic cancer. More than 7800 individuals have been treated with Immuncell-LC which recorded the highest selling of anti-cancer immune cell therapy in Korea.

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.

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.