On June 9, 2026 Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, reported that the first participant has been dosed in the first-in-human Phase 1 clinical trial evaluating KT-485 (SAR447971), an oral, potent and selective IRAK4 degrader, in adult healthy volunteers and hidradenitis suppurativa (HS) patients. The Phase 1 trial (NCT07629336) is being conducted by the Company’s partner Sanofi. Under the terms of the collaboration, dosing of the first participant triggered a $20 million milestone payment to Kymera from Sanofi.

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Per the collaboration, Sanofi is leading development, regulatory, and commercial efforts for the program. Kymera is eligible to receive up to $975 million of potential clinical, regulatory and commercial milestones related to KT-485.

"Advancing KT-485, our second generation IRAK4 degrader, into the clinic is an important milestone for our collaboration with Sanofi and our efforts to ultimately bring this important oral therapy to patients," said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. "There remains a significant need for novel oral options that can address key inflammatory pathways implicated in several immuno-inflammatory conditions, and we are excited to collaborate with Sanofi on this work."

The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics and additional exploratory endpoints of orally administered KT-485. The three-part study includes double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, as well as an open-label MAD cohort.

About KT-485/SAR447971
KT-485 is a second generation, oral degrader of IRAK4, that demonstrated increased potency and specificity with a favorable safety profile in preclinical testing. IRAK4 is a scaffolding kinase and key protein of the myddosome complex that mediates signaling through IL-1 and toll-like receptors. IRAK4 acts at the interface of the innate and adaptive immune responses with a variety of functions depending on its kinase activity and scaffolding function. Eliminating IRAK4 completely through degradation impacts both the kinase and scaffolding functions, therefore having the potential to achieve a broad, well-tolerated, anti-inflammatory effect providing a novel oral therapeutic approach for a variety of immuno-inflammatory diseases. KT-485 is being developed under Kymera’s collaboration with Sanofi for IRAK4 degraders outside of oncology and immuno-oncology. Kymera has the option to participate in future development and commercialization, and 50/50 profit split, in the United States and double-digit tiered royalties in ROW.

(Press release, Kymera Therapeutics, JUN 9, 2026, View Source [SID1234666516])

On June 8, 2026 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), reported that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application that covers the use of ibudilast (MN-166) in combination with an immune checkpoint inhibitor, specifically an anti-PD-1 antibody, for the treatment of glioblastoma. This patent allowance is expected to further strengthen the intellectual property position supporting the Company’s combination therapy development strategy.

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Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, "This Notice of Allowance further strengthens our intellectual property estate for MN-166 in glioblastoma and supports continued evaluation of ibudilast-based combination strategies in this aggressive malignancy. The allowed claims encompass use in combination with anti-PD-1 antibodies across multiple treatment parameters, including dosing regimen, route of administration, and duration of therapy, which we believe is strategically important as we continue to assess the potential clinical utility of MN-166 in oncology. Given the persistent unmet need in glioblastoma, we believe this patent position provides important support for the ongoing development of rational combination approaches intended to improve therapeutic outcomes."

Once issued, this patent is expected to expire no earlier than September 2042. The allowed claims cover not only the combination of ibudilast with multiple anti-PD-1 antibodies, but also a broad range of treatment conditions, including duration of administration, dosing frequency, route of administration, dose levels, and dosing schedules.

About MN-166 (ibudilast)

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).

(Press release, MediciNova, JUN 8, 2026, https://investors.medicinova.com/news-releases/news-release-details/medicinova-receives-notice-allowance-new-patent-covering-use-mn [SID1234666484])

On June 8, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported an update on the safety profile of LYL273 in its ongoing U.S. Phase 1 clinical trial in patients with relapsed or refractory metastatic colorectal cancer (mCRC), and announced the Phase 1 trial has been amended to enable seamless expansion into a potential pivotal single-arm Phase 2 trial pending regulatory alignment.

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LYL273 is a guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile solid tumor microenvironment. A 50% overall response rate across Dose Levels 1 and 2 has been previously reported (data cutoff date of October 28, 2025) in third- or later-line (3L+) relapsed or refractory mCRC patients in the U.S. Phase 1 clinical trial. The FDA has granted LYL273 Fast Track designation for the treatment of mCRC.

"The substantial reduction of Grade 2 or higher diarrhea or colitis, and absence of Grade 3 or higher CRS and ICANS in patients treated under our gastrointestinal prophylaxis and standardized safety management plan suggest we can manage the safety profile of LYL273 in patients with relapsed or refractory metastatic colorectal cancer," said Lynn Seely, M.D., President and Chief Executive Officer of Lyell. "We are continuing to move forward to selection of the recommended Phase 2 dose and are on track for an End-of-Phase 1 meeting with the FDA by the end of the year."

Updated Safety Data from U.S. Phase 1 Clinical Trial Evaluating LYL273 in Patients with Relapsed or Refractory Third- or Later-Line mCRC

Nineteen patients have been enrolled in the U.S. Phase 1 clinical trial across Dose Levels 1 and 2 (1 and 2 x 106 CAR+ cells/kg) as of the data cutoff date of May 5, 2026. Ten of these patients were enrolled under the new gastrointestinal (GI) prophylaxis regimen including infliximab, vedolizumab and budesonide, along with a standardized safety management plan. Notably, the GI prophylaxis and standardized safety management plan reduced Grade > 2 diarrhea or colitis from 55% to 10% in patients without (N = 9) and with (N = 10) GI prophylaxis, respectively. These ten patients did not experience Grade ≥ 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). No additional adverse events of interest have been identified. There was no difference observed in GCC-CAR+ cell expansion either in terms of maximum cell expansion or area under the curve in those patients who received GI prophylaxis and those who did not.

Dose escalation continues in the U.S. Phase 1 clinical trial; the maximum tolerated dose has not been determined.

Phase 1 Clinical Trial Amended to Phase 1/2 Design

The U.S. Phase 1 clinical trial evaluating LYL273 in relapsed or refractory 3L+ mCRC has been amended to a Phase 1/2 design (CARABINER). The amended design enables seamless expansion into a potential pivotal single-arm Phase 2 trial once the recommended Phase 2 dose has been determined, subject to discussions with the U.S. Food and Drug Administration (FDA). New centers are being added to the trial in preparation for initiating the dose expansion portion of the Phase 1/2 trial.

The Phase 1 portion of the clinical trial includes four dose-escalation cohorts at Dose Levels 1 through 4 (1, 2, 3, 4 x 106 CAR+ cells/kg). Each dose-escalation cohort is designed to include three or six patients, with up to twenty-four patients across the four dose-escalation cohorts.

In addition to the existing 3L+ cohorts, the amendment adds new cohorts, including a second-line cohort and a cohort evaluating a combination strategy with radiotherapy. Up to sixty patients are expected to be enrolled across the new cohorts. The Phase 2 portion will expand enrollment at the recommended Phase 2 dose in an open-label, single-arm cohort.

Upcoming LYL273 Milestones

In the second half of 2026, additional Phase 1 clinical data, including clinical outcomes, and an End-of-Phase 1 meeting with the FDA are expected.

(Press release, Lyell Immunopharma, JUN 8, 2026, View Source [SID1234666501])

On June 8, 2026 IDEAYA Biosciences, Inc. (Nasdaq:IDYA) reported the pricing of an underwritten public offering of common stock and pre-funded warrants. IDEAYA is selling 5,555,556 shares of common stock and pre-funded warrants to purchase 5,555,576 shares of common stock in the offering. The shares of common stock are being sold at a public offering price of $27.00 per share, before underwriting discounts and commissions, and the pre-funded warrants are being sold at a public offering price of $26.9999 per pre-funded warrant. The exercise price of the pre-funded warrants is $0.0001 per share. In addition, IDEAYA has granted the underwriters a 30-day option to purchase up to an additional 1,666,669 shares of its common stock at the public offering price per share, before underwriting discounts and commissions. The aggregate gross proceeds to IDEAYA from this offering are expected to be approximately $300.0 million, before deducting underwriting discounts and commissions and other offering expenses, and excluding the exercise of any pre-funded warrants. The offering is expected to close on or about June 10, 2026, subject to the satisfaction of customary closing conditions.

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J.P. Morgan, Jefferies, TD Cowen, UBS Investment Bank, and Cantor are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as lead manager for this offering.

The securities described above are being offered by IDEAYA pursuant to an automatically effective shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission, or the SEC. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, copies of which may be obtained, when available, by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; TD Securities, by mail at TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected]; UBS Investment Bank, by mail at UBS Securities LLC, 11 Madison Avenue, New York, NY 10010, Attention: Equity Syndicate, or by email at [email protected]; or Cantor, by mail at Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Ideaya Biosciences, JUN 8, 2026, View Source [SID1234666485])

On June 8, 2026 Photocure ASA (OSE: PHO), the Bladder Cancer Company, and Artera, a leading precision medicine company, reported launch of a joint research initiative. The collaboration encompasses Photocure’s blue light cystoscopy (BLC) registry in bladder cancer and the ArteraAI Bladder Test, an AI-powered digital pathology test currently in development for patients with bladder cancer.

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As healthcare systems increasingly embrace precision medicine, the demand for advanced precision diagnostics in uro-oncology continues to grow. Photocure, already recognized for its proven leadership in bladder cancer diagnostics where accuracy is critical, is well positioned to meet this need. This research initiative with Artera underscores Photocure’s commitment to grow an array of complementary diagnostic solutions to address the evolving needs of patients, physicians, and the broader healthcare community, towards more personalized, data-driven care in uro-oncology, enabling better clinical outcomes and supporting the shift toward precision medicine.

The research collaboration will provide Artera with access to high-quality data from the Photocure U.S. BLC registry to further validate the ArteraAI Bladder Test. Together, the companies will utilize real world evidence to help urologists more effectively identify bladder cancer and manage its treatment. Unlike many other cancers, there are fewer well-established biomarkers in bladder cancer, which currently limits clinicians from personalizing treatment options. The partnership between Photocure and Artera is dedicated to advancing research that guides smarter treatment decisions and helps patients receive therapies best suited to their disease.

The objectives of using the BLC registry’s long-term clinical practice data are to develop, evaluate, and optimize the performance of Artera’s multimodal AI (MMAI) histopathology biomarkers in patients with non-muscle invasive bladder cancer (NMIBC). The joint research aims to validate the prognostic and predictive capabilities of the ArteraAI Bladder by addressing critical clinical questions.

"With this collaboration, we are exploring additional ways to enter scientific collaborations that may utilize Photocure’s BLC registry to advance the field of precision diagnostics. When urologists use BLC, they often perform biopsies and resection to achieve a more accurate diagnosis and a more complete procedural outcome. By pairing the BLC captured specimen with the ArteraAI Bladder Test, we aim to accurately determine the grade and stage of disease while also providing a readout on whether these patients are optimal candidates for specific follow-up drug therapy. BLC and Artera’s AI-powered biomarkers have the promise to set patients on the right course of bladder cancer management, streamlining the decision-making for pathologists and urologists," said Anders Neijber, Chief Medical Officer of Photocure.

"Artera is excited to be working with Photocure to expand the application of our MMAI algorithms into other genitourinary cancers. Given the impact we’ve made to date in the prostate cancer realm, we hope to make a similar impact in bladder cancer and deliver personalized prognostic and predictive insights to patients and physicians," said Andre Esteva, co-founder and CEO of Artera.

"Building on the success of BLC, Photocure is expanding its vision to develop a complementary suite of precision diagnostic solutions. With established expertise, relationships and a track record in bladder cancer, we are uniquely placed to drive progress and set new standards in the future of uro-oncology precision diagnostics. Today we are seeking to accelerate the advancement of personalized care in a manner that has not previously been achieved. Along with Artera, we are truly excited about what we can do for urologists, their staff and their patients," said Dan Schneider, President and CEO of Photocure.

(Press release, PhotoCure, JUN 8, 2026, View Source [SID1234666486])