On July 7, 2023 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported that it has received approvals from China CDE (Center for Drug Evaluation) and South Korea MFDS (Ministry of Food and Drug Safety) to initiate TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy for the first-line treatment of patients with HER2 negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma (Press release, Transcenta, JUL 7, 2023, View Source [SID1234633113]). In addition, we are in the process of EU and FDA regulatory interaction.

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Gastric cancer (GC) is the 4th leading cause of cancer death worldwide, accounting for about 7.7% of all cancer related mortality. The five year survival rate for gastric cancer is still around 30%. Nivolumab, an anti-PD-1 antibody, has been approved globally for the first line treatment of patients with advanced or metastatic HER2-negative G/GEJ cancer.

Osemitamab (TST001) is a second generation humanized CLDN18.2 targeting antibody with enhanced ADCC. It has shown anti-tumor activities in preclinical models with a broad range of CLDN18.2 expression. Recently, the Company presented efficacy data of Osemitamab (TST001) in combination with CAPOX as the first-line treatment of G/GEJ cancer at 2023 ASCO (Free ASCO Whitepaper) annual meeting and 2023 ESMO (Free ESMO Whitepaper) GI. Among 64 patients with CLDN18.2 positive (defined as: IHC membrane staining ≥10% tumor cells with ≥1+ intensity per LDT assay, selecting approximately 55% of the screened patients) were treated, 49 at the dose of 6mg/kg. The data showed that the estimated median progression-free survival was 9.5 months from all dose groups, consistent across all CLDN18.2 expression levels, with a median duration of response of 9.9 months.

Preclinical studies have demonstrated synergistic anti-tumor activities between Osemitamab (TST001) and anti-PD-1 antibodies in CLDN18.2 expressing tumor models. Recently Transcenta has reported that 82 patients had been enrolled in TranStar 102 to assess the safety and efficacy of Osemitamab (TST001) in combination with Nivolumab and CAPOX. So far, the combination is well tolerated.

TranStar 301 is a global randomized, double-blind, placebo-controlled Phase III trial designed to evaluate Osemitamab (TST001) in combination with Nivolumab plus chemotherapy as the first-line treatment for patients with locally advanced or metastatic HER2 negative, CLDN18.2 expressing G/GEJ adenocarcinoma.

"We are actively progressing our plans to develop Osemitamab (TST001) in combination with Nivolumab and chemotherapy as first-line treatment for CLDN18.2 expressing G/GEJ adenocarcinomas in a large multinational Phase III clinical trial. CDE and MFDS approvals are exciting milestones, with several others coming soon. We are looking forward to sharing more information as it becomes available." said Dr. Caroline Germa, Transcenta’s Executive Vice President, Global Medicine Development and Chief Medical Officer.

References:
[1] 2023 ESMO (Free ESMO Whitepaper) Poster: View Source
[2] 2023 ASCO (Free ASCO Whitepaper) Poster: View Source

About Osemitamab (TST001)

Osemitamab (TST001) is a high affinity humanized anti- CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity ("ADCC"). It has shown potent anti-tumor activities in tumor xenograft models. Osemitamab (TST001) is the second most advanced CLDN18.2 targeting antibody being developed globally. Osemitamab (TST001) was generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. Osemitamab (TST001) kills CLDN18.2 expressing tumor cells by mechanisms of ADCC. Leveraging advanced bioprocessing technology, the fucose content of Osemitamab (TST001) was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of Osemitamab (TST001). Clinical trials for Osemitamab (TST001) are ongoing in the U.S. and China (NCT05190575, NCT04396821, NCT04495296, NCT05608785 / CTR20201281). Osemitamab (TST001) was granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) and pancreatic cancer.

On July 7, 2023 280Bio, Inc. a clinical stage biotechnology company focused on the development of precision oncology medicines, reported that the U.S. Food and Drug Administration (FDA) has granted the company’s Investigational New Drug (IND) application for the investigational drug YL-17231, a small molecule inhibitor of RAS signaling (Press release, 280Bio, JUL 7, 2023, View Source [SID1234633112]). The approval enables the initiation of the Phase 1 clinical study for YL-17231 in the US. KRAS, NRAS and HRAS genes are frequently mutated in many tumor indications with the oncogenic mutations leading to tumor cell growth. YL-17231 demonstrated in pre-clinical research to potently inhibit tumor cell proliferation in vitro and in vivo, exhibiting activity with a variety of RAS mutations, including tumors that have become resistant to KRAS G12C inhibitors. 280Bio will initiate a Phase 1 study for the treatment of advanced cancer patients with RAS mutations in their tumors.

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"The IND approval by the FDA enables 280Bio to initiate the Phase 1 clinical trial of our novel KRAS inhibitor marking a major milestone for the company’s clinical development program." said Michael Hui, Chief Executive Officer of 280Bio Inc., "We are excited to explore the therapeutic potential of YL-17231 targeting a broad patient population with RAS mutations to potentially create a transformative therapy option."

280Bio will advance YL-17231 into a U.S.-based Phase 1 clinical study at multiple clinical cancer research centers in the U.S including the MD Anderson Cancer Center, Houston, Texas. The Company plans to start enrollment of patients in the dose escalation part of Phase1 in the fourth quarter of 2023.

Reflecting on the high unmet need for newly developed cancer agents, Dr. Zusheng Xu, General Manager and Head of Research and Development of Yingli Pharma, said "We are excited that YL-17231 has emerged from the company’s discovery platform, exemplifying the utility of our strong medicinal chemistry capabilities. YL-17231 has a broader activity than many current KRAS inhibitors and demonstrated strong inhibition of in vivo KRAS mutant xenograft tumor growth in our preclinical investigations. With its excellent pharmacologic properties, we are hopeful that YL-17231 will demonstrate to be safe and efficacious during continuous oral dosing in patients."

YL-17231 has been co-developed by 280Bio and Yingli Pharma and emerges from the strategic collaboration of 280Bio with The University of Texas MD Anderson Cancer Center, where further preclinical research of the investigational drug is continuing.

On July 7, 2023 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory, and liver diseases, reported it has been invited to present at the Emerging Growth Conference on Thursday, July 13, 2023 at 11:25 AM ET (Press release, Can-Fite BioPharma, JUL 7, 2023, View Source [SID1234633111]).

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This live, interactive online event will give existing shareholders and the investment community the opportunity to interact with Can-Fite’s CEO, Motti Farbstein, in real time.

Mr. Farbstein will present and subsequently open the floor for questions. Please submit your questions in advance to [email protected] or ask your questions during the event and Mr. Farbstein will do his best to get through as many of them as possible.

Please register here LINK to ensure you are able to attend the conference and receive any updates that are released.

If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com and on the Emerging Growth YouTube Channel, View Source We will release a link to that after the event.

On July 7, 2023 IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the "Company" or "IPA") (NASDAQ: IPA), an AI-driven biotherapeutic research and technology company, reported financial results for the full fiscal year 2023 ended April 30, 2023 (Press release, ImmunoPrecise Antibodies, JUL 7, 2023, View Source [SID1234633110]).

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"As we usher in Fiscal Year 2024, we carry with us a strong momentum from the impressive strides we made in the previous year. In the fiscal year ended April 30, 2023, we achieved a revenue of $20.7 million, marking a notable 6.7% (or 9% when adjusting for the effects of currency translation) increase compared to the year ended April 30, 2022. We also recorded our highest quarterly revenue total of $5.6 million in the last quarter ending April 30, 2023. These milestones serve as a testament to the soundness of our strategies and the dedication of our team.

As we look ahead to Fiscal Year 2024, we see immense potential for our in silico suite of services and data management capabilities to further bolster our growth. We expect these innovative offerings to significantly contribute to our financial performance this year and set the stage for long-term success.

Our unwavering commitment to excellence, coupled with our robust pipeline and agile execution, position us to deliver continued strong performance this year and beyond. This is a thrilling period for our company, and we are eager to embark on the new fiscal year, further driving innovation and growth." Stated Dr. Jennifer Bath, CEO of IPA.

Recent and Fiscal 2023 Operational Highlights

Talem entered into exclusive research collaboration and license option agreement with Astellas targeting an undisclosed protein in the tumor microenvironment (TME)
Talem presented its latest data on the development of bispecific T-cell engagers targeting TrkB at the annual AACR (Free AACR Whitepaper) meeting in Orlando, Florida, in April 2023.
Talem entered into a multi-target license agreement with OmniAb, Inc to further the development and commercialization of immuno-oncology antibody panels.
BioStrand entered into a research collaboration and license agreement with BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT)
IPA’s subsidiary, BioStrand, secured second €460,000 VLAIO research grant.
BioStrand has successfully solved the Information Integration Dilemma (IID)
BioStrand publicly unveiled use case showing solution of the Information Integration Dilemma (IID)
BioStrand completed the full integration of 20 million Structural HYFTs with DeepMind’s AlphaFold and META’s ESM-2 Fold platforms.
EPO granted BioKey’s patent application covering the company’s HYFT Technology used to organize and analyze biological sequence information.
IPA achieved a record global CRO revenue of $5.6 million in Q4 FY23, representing a 7.3% increase from the previous year, reflecting strong demand and stability.
IPA secured $4.65M sales orders for future fee-for-service work in Q4, demonstrating market confidence and high demand for services.
IPA Europe’s human phage display and humanization offerings experienced financial growth and improved capabilities with newly generated phage libraries and modernized workflows.
IPA expanded its single B cell screening capabilities to include species from the camelid family, leading to increased requests for VHH-based discovery programs and new revenue opportunities.
Talem, a subsidiary of IPA, elevated three key programs with significant value potential, generating interest from prospective partners and focusing on partnering discussions with larger corporations.
IPA’s revenue streams consist of non-cannibalistic in silico technologies, in silico de novo antibody discovery and development partnerships, and a Data Organization and Management Platform, all demonstrating robust growth.
IPA’s commitment to innovation is reflected in its unique platform that integrates biological data dimensions using AI and HYFT technology to unlock valuable insights and connections.
The ongoing advancements in software development, including LENSai software, have enabled IPA to solve real-life biological problems and overcome the challenges of omics data integration and analysis.
IPA has strategically positioned itself to capture opportunities in multiple revenue streams, including in silico technologies, de novo antibody discovery, and data organization and management.
The investor call will dive deeper into IPA’s achievements, discuss exciting prospects, and invite participants to join in driving innovation in AI-driven antibody discovery.
Financial Results

Revenue

The Company achieved record revenue of $20.7 million during the year ended April 30, 2023, a 6.7% increase from the year ended April 30, 2022. Revenue growth from the prior year was 9.0% when adjusting for the effect of currency translations. The increase in revenue was primarily driven by growth in the Company’s B cell Select platform and protein manufacturing services.

Research and development

During the year ended April 30, 2023, research and development expenses increased to $12.3 million from $7.7 million during the year ended April 30, 2022. Expenditures on research activities totaled $10.8 million during the year ended April 30, 2023 (2022 – $6.7 million), including $8.3 million on Talem’s PolyTope antibody combination therapy. Additional expenditures include compensation expense of $1.2 million (2022 – $0.7 million), and depreciation of $0.2 million (2022 – $0.2 million).

Sales and marketing

Sales and marketing expenses totaled $3.6 million during the year ended April 30, 2023, compared to $2.7 million during the year ended April 30, 2022. Expenditures during the year ended April 30, 2023, include $2.5 million in compensation expense (2022 – $2.1 million), $0.7 million in advertising costs (2022 – $0.5 million), and $0.2 million in travel costs (2022 – $0.03 million).

General and administrative

During the year ended April 30, 2023, general and administrative expenses totaled $19.8 million, an increase of $4.4 million compared to the year ended April 30, 2022. Salaries and benefits increased $2.1 million due primarily to the addition of staff at BioStrand and routine pay increases. The Company recorded an impairment charge of $2.5 million related to the BioStrand cash-generating unit. Professional fees decreased $0.2 million, driven primarily by a decrease in legal costs. Management fees increased $1.3 million due to contracted general managers at the BioStrand site. Share-based payment expenses decreased by $1.0 million.

Other Income / Expense

The Company recorded other income of $0.8 during the year ended April 30, 2023, compared to other income of $0.9 million during the year ended April 30, 2022. The most noteworthy variance is the decrease in unrealized foreign exchange gain of $0.4 million compared to the year ended April 30, 2022, a result of currency revaluations at the current quarter-end exchange rate. Grant income increased $0.3 million compared to the year prior, as the Company recorded the first round of grant funding from VLAIO (Flanders Innovation & Entrepreneurship), the research fund of the Flemish regional government in Belgium.

Net Loss

The Company recorded a net loss of $26.6 million during the year ended April 30, 2023, compared to a net loss of $16.7 million during the year ended April 30, 2022. The increased net loss is the result of an increase in gross profit of $0.6 million, offset by an increase in research and development expenses of $4.6 million, an increase in sales and marketing expenses of $0.9 million, an increase in general and administrative expenses of $4.4 million.

Liquidity and Capital Resources

As of April 30, 2023, the Company had cash on hand of $8.4 million compared to $30.0 million as of April 30, 2022, and had working capital of $11.1 million (April 30, 2022 – $28.2 million). During the year ended April 30, 2023, the cash used in operating activities was $19.8 million. As part of investing activities, the Company made equipment purchases of $1.5 million, and paid deferred acquisition payments of $0.6 million. As part of financing activities, the Company received $0.7 million from issuing common shares, and incurred lease repayments of $1.3 million.

Conference Call:

Event Date: July 07, 2023
Event Time: 10:30 ET

Participant Details:

Conference ID: 9236374
Participant Toll-Free Dial-In Number: 1 (888) 550-5658
Participant Toll Dial-In Number: 1 (646) 960-0289
Attendee URL: View Source

On July 7, 2023 Ichnos Sciences Inc., a global clinical-stage biotechnology company developing innovative multispecific immune cell engager antibodies in oncology, reported that it has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for its first-in-class T-cell engaging trispecific antibody, ISB 2001, for the treatment of multiple myeloma (Press release, Ichnos Sciences, JUL 7, 2023, View Source [SID1234633109]).

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ISB 2001, Ichnos’ third clinical-stage asset to receive ODD for the treatment of multiple myeloma, is the company’s first BCMA x CD38 x CD3 TREATTM1 trispecific antibody based on the company’s proprietary BEAT platform2, which enables the development of immune cell engagers. This designation closely follows that of Ichnos’ first-in-class CD38 x CD47 biparatopic bispecific antibody innate cell modulator, ISB 1442, which was granted ODD by the FDA in March 2023.

"The FDA’s decision to grant orphan drug designation to ISB 2001 – our third clinical-stage asset to receive that designation in five years – underscores the importance of the work our team is doing to develop potentially curative therapies for the treatment of multiple myeloma," said Cyril Konto, M.D., President and Chief Executive Officer of Ichnos Sciences. "As new multiple myeloma diagnoses continue to climb, our charge of providing patients more innovative, novel therapies that can overcome the limitations of options available to them today becomes that much more urgent."

This milestone is achieved as Ichnos prepares to initiate a Phase 1 first-in-human dose-escalation dose-expansion study of ISB 2001 later this summer, after securing approval from the Human Research Ethics Committee (HREC) in Australia and IND clearance from the FDA.

"The entire team at Ichnos – across every role and function – comes to work focused on realizing our vision of a world free of multiple myeloma. This decision by the FDA reinforces that we are on the right path," said Lida Pacaud, M.D., Chief Medical Officer of Ichnos Sciences. "Securing orphan drug designation for ISB 2001 is a critical milestone as we advance the clinical development of this promising asset, and it comes at a pivotal moment as we prepare to initiate a Phase 1 clinical trial."

ISB 2001 combines three proprietary Fab arms binding to CD3 on T cells, as well asBCMA and CD38 on multiple myeloma cells. Through targeting two tumor-associated antigens, ISB 2001 has increased binding specificity to multiple myeloma cells due to enhanced avidity-based binding, and it has demonstrated increased killing of tumor cells in vitro across variable levels of expression of both BCMA and CD38 compared to teclistamab, alnuctamab and EM-801. Additionally, ISB 2001 exhibits higher potency in vitro when compared to the combination of daratumumab and teclistamab currently under clinical investigation, as demonstrated by data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023.

The FDA grants ODD to therapies that show promise in the treatment, prevention, or diagnosis of rare disease or conditions that affect fewer than 200,000 people in the United States, such as multiple myeloma, which is a rare cancer of plasma cells. According to the National Cancer Institute, in 2019, there were an estimated 159,787 people living with myeloma in the United States with approximately 34,470 new cases estimated in 20223. While there has been headway in the treatment of multiple myeloma, there remains a significant unmet need for therapies that can overcome developed resistance and decreased effectiveness over time.