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Nykode Therapeutics and Richter-Helm BioLogics Announce Strategic Manufacturing Partnership

On December 19, 2022 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that it has entered into a strategic manufacturing partnership with Richter-Helm BioLogics GmbH & Co KG to supply plasmid DNA for Nykode’s wholly owned and partnered product portfolio (Press release, Nykode Therapeutics, DEC 19, 2022, View Source [SID1234625374]).

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"We are excited about the strategic manufacturing partnership with Richter-Helm BioLogics. As a leading manufacturer of DNA vaccines, they will provide the long-term expertise and capacity needed to support our ambitious growth and pipeline development," stated Mette Husbyn, Chief Technology Officer of Nykode Therapeutics.

"We are thrilled to collaborate with Nykode Therapeutics and to support the development of their leading DNA vaccine platform. After 30 years of manufacturing plasmid DNA, we have gained an unparalleled amount of first-hand plasmid DNA process knowledge and experience working with regulatory agencies to ensure cGMP compliance for clinical trials and late-stage product candidates," said Dr. Kai Pohlmeyer, Managing Director of Richter-Helm BioLogics.

Manufacturing is a strategic focus area for Nykode and its license partners. Under the partnership agreement with Richter-Helm BioLogics, Nykode will have the option to tech transfer the proprietary manufacturing processes to its partners, if requested.

Biocytogen Announces FDA Clearance of IND Application for Bispecific Antibody YH008

On December 18, 2022 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) reported that the US FDA has approved the Investigational New Drug (IND) application for a phase I study of YH008, an internally developed first-in-class PD-1 x CD40 bispecific antibody (bsAb) (Press release, Biocytogen, DEC 18, 2022, View Source [SID1234625367]). The IND application was completed by Biocytogen’s wholly owned subsidiary Eucure Biopharma.

The trial is an open-label, dose-escalation study (No. YH008101) that will evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YH008 monotherapy in patients with PD-(L)1-resistant advanced solid tumors or hematological malignancies.

YH008 exerts antagonistic and agonistic activities on PD-1 and CD40, respectively. In vitro and in vivo studies indicate that activation of the CD40 signaling pathway is dependent on PD-1 expression. Therefore, YH008 can conditionally activate CD40 pathway in the tumor microenvironment where tumor specific PD-1+ T cells are enriched, without systemic CD40 non-specific activation. Additionally, YH008 was engineered with an Fc-silent IgG1 isotype to avoid Fc-receptor-mediated non-specific immune activation. YH008 demonstrated superior anti-tumor activity than parental monoclonal antibodies (mAbs) or combination therapy in vivo. Moreover, the anti-tumor activity of YH008 was also superior to benchmark PD-1 mAbs and PD-L1 x CD40 bsAbs in syngeneic models. In vivo pharmacodynamic studies indicate that YH008 can activate tumor-infiltrating DCs and T cells. In addition, both in vivo studies and GLP toxicology studies indicate improved safety of YH008 compared with benchmark CD40 mAbs.

"The CD40 agonistic activity of YH008 is PD-1-dependent, which allows for more targeted immune cell activation and synergies," said Dr. Yi Yang, Chief Scientific Officer (CSO) of Biocytogen. "These characteristics prevent occurrence of liver toxicity, even at high doses, while enhancing anti-tumor activity, giving YH008 high clinical potential."

"YH008 is a first-in-class bispecific antibody discovered through large-scale in vivo efficacy screening, where it demonstrated excellent anti-tumor activity, even in cold tumors," said Dr. Rong Chen, CEO and CMO of Eucure Biopharma, VP of Biocytogen. "With this IND clearance for YH008, the company will have more products with diversified modalities entering the clinic to benefit patients."

Second FDA approved clinical trial in patients with pancreatic cancer and metastatic colorectal

On December 18, 2022 ISK reported the official opening of its second FDA approved clinical trial in the US in patients with pancreatic cancer and metastatic colorectal cancer at Georgetown University in Washington, D.C (Press release, Immune System Key, DEC 18, 2022, View Source [SID1234625366]).

Bloom Science to Present Live at Biotech Showcase 2023

On December 21, 2022 Bloom Science founder & CEO Christopher Reyes, PhD reported he will present live at Biotech Showcase 2023 on Tuesday January 10 at 2:45PM Pacific Time (Press release, Bloom Science, DEC 17, 2022, View Source [SID1234625484]).

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year during the course of one of the industry’s largest gatherings and busiest weeks.

"We are delighted that Bloom Science will be joining us in San Francisco and presenting at Biotech Showcase this year," said Sara Demy, CEO of Demy-Colton. "Biotech Showcase is a prime occasion for life science entrepreneurs and investors to come together to discover the potential of innovative technologies that will drive the future of drug discovery."

TG ImmunoPharma (TGI) announces FDA clearance of IND application for TGI-2, a novel anti-PVRIG therapeutic antibody

On December 17, 2022 TG ImmunoPharma Co., Ltd. (Hefei, China), an innovative biotech company dedicated to the discovery of novel immunotherapeutic drugs and a leader in NK cell research globally, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for TGI-2/NM1F, a novel anti-PVRIG therapeutic antibody used in patients with advanced solid tumors (Press release, TG Immunopharma, DEC 17, 2022, View Source [SID1234625369]). Currently, no drugs targeting PVRIG have been approved globally.

TGI-2/NM1F is a humanized IgG1 monoclonal antibody targeting PVRIG for the treatment of malignant cancers. The antibody binds to PVRIG with high affinity to block the PVRIG/PVRL2 interaction and restore the antitumor immune functions of both NK cells and T cells. Preclinical data suggest that TGI-2/NM1F has a long half-life and is well tolerated at very high doses in nonhuman primates. Treatment with TGI-2/NM1F as a monotherapy demonstrates significant inhibition of tumor growth in human tumor xenograft mouse models, while it further enhances the antitumor effect in combination with a PD-1 inhibitor.

"It is a significant milestone for TGI, having received clearance from the FDA to advance TGI-2 into the clinical trials. TGI-2 offers remarkable antitumor function and good safety, with higher affinity and lower onset dose than its competitors, making it highly promising for clinical use," stated Zhigang Tian, PhD, members of Chinese Academy of Engineering and Academia Europaea, Founder of TGI. "We are excited to initiate a phase 1 clinical trial in multiple centers in the U.S. for patients with advanced solid tumors and for whom standard of care therapies are currently ineffective, which demand innovative drugs in the near future. In addition, IND in China is expected to be submitted soon.