On June 8, 2022 Harbour BioMed ("HBM", HKEX: 02142) reported that China National Medical Products Administration (NMPA) had approved the investigational new drug (IND) application to commence phase I trial of its B7H4x4-1BB bispecific antibody (HBM7008) in China (Press release, Harbour BioMed, JUN 8, 2022, View Source [SID1234615792]). This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of HBM7008 in patients with solid tumors. It has successfully completed the dosing of first patient in the phase I trial of HBM7008 in Australia on 25 May 2022.

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HBM7008 is generated from HBM’s unique and innovative HBICE platform. It is a first-in-class bispecific antibody targeting B7H4 and 4-1BB. The bispecific antibody can engage and activate T cells by 4-1BB only in B7H4 positive tumor microenvironment. B7H4 is overexpressed on a variety of solid malignancies, including breast, ovarian, endometrial, and non-small cell lung cancers. With its crosslinking-dependent specificity on tumors and potent immune modulation activity, HBM7008 has shown excellent safety profile with strong anti-tumor efficacy in the pre-clinical study, including completed response observed in the mouse tumor model.

"4-1BB is one of the most promising anti-tumor immune targets, providing new solutions for cancer treatment. As the first-in-class bispecific antibody targeting B7H4 and 4-1BB, HBM7008 is expected to lead the development of next-generation immunotherapeutics. Based on preclinical study data, we are highly confident in B7H4x4-1BB bispecific antibody. We will efficiently promote this clinical study to provide a novel, effective and safe treatment for patients, so that more cancer patients can benefit from the innovative therapeutic." said Dr. Humphrey Gardner, CMO of Harbour BioMed.

About HBM7008

HBM7008 is a bispecific antibody targeting Tumor-Associated Antigen B7H4x4-1BB that not only displays high potency in the T cell co-stimulation and tumor growth inhibition, and potentially may also translate to better safety due to its strict dependency of TAA-mediated crosslinking T cell activation. HBM7008 is one of the fully human bispecific antibodies developed from the HBICE platform of the Company. It is the only bispecific antibody against these two targets globally. Its unique specificity on tumors and immune modulation activity makes it a promising therapeutic in PD-L1 negative or PD-1/PD-L1 resistant patients. It also has the potential to avoid 4-1BB liver toxicity risk observed in other products with the benefit of its innovative biology mechanisms and bispecific design.

On June 8, 2022 Race Oncology Limited ("Race") reported it is expanding the FTO-targeted BISECT (RAC-006) clinical trial in extramedullary Acute Myeloid Leukaemia (EMD AML) and Myelodysplastic Syndromes (MDS) to include five additional trial sites in Spain and Italy and has signed a new clinical support agreement with global Clinical Research Organisation, Parexel International to support the additional trial monitoring activities (Press release, Race Oncology, JUN 8, 2022, View Source [SID1234615743]).

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BISECT (RAC-006) is an open label Phase 1b/2a clinical trial in patients with EMD AML and MDS which recently received Ethics and Governance approval to commence patient recruitment at the Calvary Mater Hospital Newcastle (ASX announcements: 6 April 2022 and 12 May 2022). The intention to expand the BISECT trial to Europe was announced at the 2021 Race Annual General Meeting (ASX Announcement: 23 November 2021).

"We are pleased that we have received strong interest in our BISECT (RAC-006) EMD AML and MDS study from experienced European haematologists. These clinicians identify a significant unmet need for the treatment of EMD AML and MDS and want to be actively involved in EMD clinical research. We look forward to activating these sites once we have cleared the necessary European Regulatory and Ethics approval process."

Race CMO Dr David Fuller
The total study costs are expected to be in the range of A$7.7 million to a maximum of A$15.4 million. The final cost is dependent on the location and number of patients screened and enrolled in the trial. Due to the adaptive (Bayesian) design of this study, the total study costs cannot be precisely determined, but are expected to be lower than the maximum cited here.

Payments will be made to Parexel throughout the study upon reaching key milestones as patients are recruited and other operational variables are achieved.

On June 8, 2022 The Parker Institute for Cancer Immunotherapy (PICI), a network of the largest concentration of immuno-oncology (IO) expertise in the world, and National Resilience, Inc. (Resilience), a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, reported the launch of a five-year strategic alliance to develop next-generation cancer therapies generated from PICI’s network of leading immunotherapy research centers (Press release, Parker Institute for Cancer Immunotherapy, JUN 8, 2022, View Source [SID1234615777]).

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Together, PICI and Resilience aim to bring novel cell and gene therapies to market through the creation and incubation of new companies with a commitment of up to $50 million in funding. These startups will leverage groundbreaking technologies from across the PICI Network and have direct access to Resilience’s biomanufacturing capacity, capability, and know-how.

"This strategic alliance is representative of the transformative growth underway at PICI as we take our vision to the next level with new company investments and incubation," stated Sean Parker, PICI founder and chairman. "Now, in collaboration with Resilience, we are closing the loop with access to critical biological manufacturing that will further accelerate our mission of delivering breakthrough immune therapies to patients and transforming all cancers into curable diseases."

Under the agreement, Resilience will also collaborate with PICI Network investigators on challenges related to biomanufacturing and novel treatment modalities. As PICI’s first valued manufacturing partner for complex modalities Resilience will be well positioned to work with PICI Affiliated Partners (PICI-invested companies, PICI Network Institutions, and Network Investigators) on developing enabling biomanufacturing technology and to lower the barriers for technology access across the PICI network and more broadly within the therapeutic development community.

"By combining our organizations’ capabilities in drug discovery, development and cutting-edge biomanufacturing technologies, we aim to advance a new wave of treatments to patients in need," said Rahul Singhvi, ScD, Chief Executive Officer of Resilience. "This alliance with PICI will demonstrate the power of new business models in finding and advancing cancer therapies."

Resilience and PICI will establish a Joint Steering Committee to approve investments and new company opportunities, monitor and track the progress of alliance portfolio companies, and identify innovation challenge focus areas, among other duties.

"Through this strategic alliance, we have an opportunity to deliver unparalleled access to innovation in cancer immunotherapy and manufacturing across PICI-invested companies and the PICI Network," stated PICI Chief Scientific Officer, John Connolly, PhD. "The combination of PICI’s bench-to-market-to-patient philosophy and Resilience’s end-to-end biomanufacturing solutions support novel idea generation and development, delivering cutting-edge therapeutics to patients with cancer faster."

"By working closely with PICI Network Investigators, we can develop the advanced manufacturing technologies needed to bring cutting-edge therapies to patients that need them," said Rich Stoner, PhD, Chief Scientific Officer, Resilience. "Our goal is to ensure these therapies can be made at the quality and scale required to bring transformative immune therapies to people with cancer."

On June 8, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation at the 2022 Jefferies Global Healthcare Conference (Press release, Ideaya Biosciences, JUN 8, 2022, View Source [SID1234615793]).

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2022 Jefferies Global Healthcare Conference
Wednesday, June 8 at 11:00am ET

Fireside chat with Yujiro Hata, Chief Executive Officer, IDEAYA Biosciences, hosted by
Maury Raycroft, Ph.D. Equity Research Analyst, Biotechnology

A live audio webcast of the event will be available, as permitted by conference host, at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of available webcasts will be accessible for 30 days following the live event.

On June 08, 2022 Anagenex, a pioneering drug discovery company pairing large-scale data generation with machine learning to discover the next generation of small molecule medicines, reported that it has closed a $30 million Series A financing round led by Catalio Capital Management, with participation from existing investors Lux Capital, Khosla Ventures, Obvious Ventures, Air Street Capital, and Menlo Ventures (Press release, Anagenex, JUN 8, 2022, View Source [SID1234648814]). Catalio’s George Petrocheilos and Dr. Matthew Hobson will be joining the company’s Board as a Director and Observer respectively. Anagenex will use its Series A funds to further expand its novel data generating platform and build a robust pipeline of programs addressing historically challenging unmet medical needs.

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"At Lux, we’ve repeatedly seen how merging state-of-the-art computational tools with custom built lab operations transforms drug discovery to bring innovative medicines to patients"

"Traditional small molecule drugs, which account for the majority of FDA approvals, remain the best and most cost-effective medicines for most patients," said Nicolas Tilmans, CEO of Anagenex. "However, they are still very challenging to develop. At Anagenex we’ve built a closed-loop iterative system inspired by evolution that alternates between massive lab experiments and next-generation, machine learning-powered predictions so that we can deliver novel small molecule medicines to patients faster."

The Anagenex platform iteratively assesses up to billions of compounds in parallel to generate extraordinarily high quality data. First, Anagenex experimentally tests billions of compounds in parallel using a mix of technologies such as DNA Encoded Libraries (DELs) and Affinity Selected Mass Spectrometry. Those measurements feed into proprietary machine learning (ML) algorithms that consider not only the results of that experiment, but also hundreds of billions of other datapoints from internal databases. The trained ML models then design the next "evolved" generation of compounds to test, which Anagenex then synthesizes and tests. This creates a virtuous cycle of real data perfecting ML models, in turn, driving better data with each cycle. Armed with these enormous datasets and highly accurate models, Anagenex has the tools to address some of the hardest targets in drug discovery.

"We see a lot of platform technologies, but were blown away by Anagenex’s potential to fundamentally reshape how small molecule drugs are discovered," said George Petrocheilos, General Partner at Catalio. "Going after targets that have frustrated the industry for decades is always a risky business. The power and efficiency of Anagenex’s platform makes that risk tolerable, especially considering the potential payout."

Since beginning operations in the fall of 2020, Anagenex has built a customized parallel biochemistry lab miniaturizing, automating and carefully measuring every step in its parallel processes. This means Anagenex can rapidly generate data of unmatched quality, giving its ML algorithms an unprecedented clear view of chemical space.

"At Lux, we’ve repeatedly seen how merging state-of-the-art computational tools with custom built lab operations transforms drug discovery to bring innovative medicines to patients," said Zavain Dar, founding investor and Venture Partner at Lux Capital. "By controlling its process from start to finish, Anagenex’s expert team can build tailored neural networks and lab methodologies to achieve game-changing results."

Rapid Progress to Date

Prior to this Series A financing, Anagenex raised $7.2 million in a seed round led by Lux Capital in 2020, with participation from Obvious, Air Street Capital, Menlo, and Khosla. Since then, Anagenex’s team has applied their decades of experience in ML, parallel chemistry and biochemistry to build and validate the first generation of the company’s platform. With the Series A funding, Anagenex has now raised a total $37.2 million in financing to date.

To date, the Anagenex platform has processed over 25 targets and identified biochemically active compounds for eight of those with more coming weekly. Anagenex’s directed evolution platform has also identified small molecule compounds for a validated "undruggable" target. These powerful results have enabled Anagenex to develop a strong pipeline, including several early-stage drugs for cardiovascular and oncology indications.

For more information about Anagenex, go to www.anagenex.com.