IDEAYA Biosciences Enters into Unique License with Hengrui Pharma for SHR-4849, a Novel Part 1 DLL3 Topo-I-Payload ADC Concentrating on SCLC and NET Stable Tumors

• Unique worldwide license outdoors of Larger China for SHR-4849, a Part 1 DLL3-targeting Topo-I antibody-drug conjugate (ADC)
• DLL3 extremely expressed in Small Cell Lung most cancers (SCLC) and neuroendocrine tumors (NET), respectively 85% and 20-40%
• Rational (LON:) mixture alternatives with IDEAYA DNA harm restore ( GDR (NYSE:)) scientific pipeline, together with section 1 PARG inhibitor IDE161
• Goal submitting of an IND in the USA for SHR-4849 within the first half of 2025

SOUTH SAN FRANCISCO, CA. And SHANGHAI, December 29, 2024 /PRNewswire/ — IDEAYA Biosciences (NASDAQ:), Inc. (NASDAQ: IDYA), a precision medication oncology firm engaged within the discovery and growth of focused therapeutics, introduced that it has entered into an unique licensing settlement for SHR-4849, a novel Topo-I payload ADC program focusing on DLL3 with Jiangsu Hengrui Prescribed drugs Co., Ltd. (Hengrui Pharma, SHA: 600276), an revolutionary international pharmaceutical firm headquartered in China centered on unmet scientific wants. Beneath the phrases of the settlement, IDEAYA will develop and commercialize SHR-4849 worldwide outdoors of Larger China.

“There’s a vital unmet medical want for DLL3-expressing strong tumors, and we’re excited concerning the alternative to develop SHR-4849, which has potential as a monotherapy in SCLC and NETs. SHR-4849 is effectively positioned competitively with top-notch potential. within the subject of DLL3 topo-I-payload ADCs, a therapeutic space that has demonstrated preliminary scientific validation as a monotherapy in SCLC,” mentioned Yujiro S. Hata, CEO and Founder, IDEAYA Biosciences. “Moreover, SHR-4849 accelerates IDEAYA’s strategic purpose of growing rational scientific mixtures of topo payload-based ADCs with our PARG inhibitor IDE161, the place we observe improved preclinical mixture efficacy in comparison with ADCs. topo payload evaluated alone,” mentioned Daniel A. Simon, Chief Industrial Officer, IDEAYA Biosciences.

Frank JiangChief Technique Officer and Board Director of Hengrui Pharma, mentioned: “SHR-4849 is a novel DLL3 focusing on ADCs displaying encouraging early scientific alerts in small cell lung most cancers with a manageable security profile. We’re excited to accomplice with IDEAYA to help the event of this ADC globally, which furthers our purpose of offering revolutionary medicines to profit sufferers world wide.

SHR-4849 has proven promising antitumor exercise in preclinical research, together with tumor regression as a single agent in a number of fashions. This drug is at the moment being evaluated in a section 1 scientific trial in superior strong tumors in China (NCT06443489). As a part of the continued Part 1 dose escalation, SHR-4849 reached therapeutic dose ranges at which a number of partial responses had been noticed as of the info cutoff of the December 10, 2024. Amongst 11 evaluable topics with small cell lung most cancers (SCLC) handled at therapeutic doses, 8 partial responses in keeping with RECIST 1.1 had been noticed, leading to an general response charge of roughly 73% (together with confirmed responses and unconfirmed, all unconfirmed responses had been pending analysis). As of the info cutoff, treatment-emergent adversarial occasions (TEAEs) had been primarily grade 1 or 2, and section 1 dose escalation is ongoing with no reported drug-related discontinuations, and dose most tolerated has not but been reached. Essentially the most generally noticed TRAEs had been decreased white blood cell depend, anemia, decreased neutrophil depend, nausea, and decreased platelet depend.

IDEAYA goals to file a US IND for SHR-4849 within the first half of 2025.

DLL3 has been reported to be expressed in a number of forms of strong tumors, together with SCLC and neuroendocrine tumors, at roughly 85% and 20-40%, respectively, primarily based on the Human Protein Atlas database (NYSE:) . DLL3 has restricted extracellular expression in regular tissues, making it a promising therapeutic goal in these tumor varieties, for which there stay vital unmet medical wants.

Beneath the phrases of the settlement, Hengrui Pharma is eligible to obtain upfront and milestone funds totaling $1.045 billiontogether with one $75 million preliminary prices, as much as 200 million {dollars} in growth and regulatory milestone funds, in addition to milestone funds primarily based on industrial success. Hengrui can also be eligible to obtain royalties within the 1-2 digit vary on web gross sales outdoors of Larger China. Preliminary and projected analysis and growth prices, together with potential milestone funds, don’t change the beforehand offered IDEAYA-guided exit monitor of not less than 2028.

About IDEAYA Biosciences

IDEAYA is a precision medication oncology firm engaged within the discovery and growth of focused therapies for chosen affected person populations utilizing molecular diagnostics. IDEAYA’s method integrates translational biomarker identification and validation capabilities with drug discovery to pick out affected person populations most certainly to profit from its focused therapies. IDEAYA is making use of its premier analysis and drug discovery capabilities to artificial lethality “which represents an rising class of targets in precision medication.”

About Hengrui Pharma

Jiangsu Hengrui Prescribed drugs Co., Ltd. (Hengrui Pharma) is an revolutionary international pharmaceutical firm centered on unmet scientific wants, with a robust monitor file in scientific and technological innovation. For the reason that approval of its first revolutionary drug in 2011, Hengrui Pharma has invested greater than $5.4 billion in R&D and established 14 R&D facilities in Lianyungang, ShanghaiTHE WEAnd Europe. It has 9 main manufacturing websites and a worldwide R&D group of greater than 5,000 professionals. Hengrui Pharma has independently established quite a lot of main know-how platforms reminiscent of its ADC platform, proteolysis focusing on chimera (PROTAC), molecular gels, bi/multi-specific antibodies and molecular design of AI, which represent a strong foundation for revolutionary R&D. Hengrui strives to repeatedly innovate and collaborate with international companions to serve a wholesome society. China and profit sufferers world wide.

Ahead-looking statements
This press launch incorporates forward-looking statements, together with, however not restricted to, statements regarding (i) the timing of a attainable IND submitting, (ii) potential growth methods, (iii) the estimated potential market and (iv) the potential therapeutic advantages of IDEAYA therapies. These forward-looking statements contain vital dangers and uncertainties that would trigger IDEAYA’s preclinical and scientific growth applications, future outcomes, efficiency or achievements to vary materially from these expressed or implied within the forward-looking statements. These dangers and uncertainties embody, amongst others, the uncertainties inherent within the drug growth course of, together with the early levels of growth of IDEAYA’s applications, the method of designing and conducting preclinical and scientific trials, the approval processes regulatory filings, the timing of regulatory filings, the challenges related to manufacturing pharmaceutical merchandise, IDEAYA’s capacity to efficiently set up, shield and defend its mental property, and different issues that would have an effect on the adequacy of present liquidity to finance operations. IDEAYA undertakes no obligation to replace or revise any forward-looking statements. For a extra detailed description of the dangers and uncertainties that would trigger precise outcomes to vary from these expressed in these forward-looking statements, in addition to dangers regarding IDEAYA’s enterprise usually, see IDEAYA’s Annual Report on Kind 10 -Ok dated February. 20 2024 and all present and periodic stories filed with the United States Securities and Change Fee.

Investor and media contact
IDEAYA BiosciencesAndres Ruiz BrisenoSenior Vice President, Head of Finance and Investor Relations
investor@ideayabio.com