On September 9, 2026 Bionova Scientific LLC., an Asahi Kasei company and bespoke contract development and manufacturing organization (CDMO), and Minaris, a global cell and gene therapy (CGT) CDMO and multimodal biosafety testing organization, reported a strategic partnership to expand access to high-quality plasmid DNA (pDNA) for advanced therapy development and manufacturing.

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The collaboration brings together the companies’ capabilities to help cell and gene therapy developers secure reliable, scalable, high-quality plasmid DNA throughout the product lifecycle. By combining Bionova Scientific’s premium-grade pDNA development and manufacturing capabilities with Minaris’ OXGENE plasmid technologies, the partnership provides customers with an integrated solution for advanced therapy development and manufacturing. This approach simplifies supply chain management, streamlines technology transfer, and accelerates the path from research to commercial manufacturing.

"Cell and gene therapy developers need confidence that critical starting materials will be available when they need them and capable of scaling as programs advance," said Eytan Abraham, Chief Technology and Commercial Officer, Minaris. "Through our partnership with Bionova Scientific, we will provide customers expanded access to best-in-class plasmids designed to enable higher yields and improve vector quality while helping simplify development and manufacturing."

Together, Bionova Scientific and Minaris support pDNA requirements for both adeno-associated virus (AAV) and lentiviral vector (LVV) manufacturing workflows. The offering pairs Minaris’ OXGENE’s sequence optimization technology with Bionova Scientific’s Clean Genome E. coli platform to enable scalable plasmid DNA production.

"Bionova Scientific is committed to delivering premium-grade plasmid DNA through scientifically robust process development, scalable manufacturing, and operational excellence," said Pratima Cherukuri, General Manager and Vice President of pDNA Process Development at Bionova Scientific. "Together with Minaris, we are providing developers with an integrated platform that reduces complexity, supports efficient technology transfer and process scale-up, and enables a seamless transition from research-use materials through clinical and commercial GMP manufacturing."

As part of the partnership, the companies are establishing a portfolio of 13 production-ready plasmids built on SnapFast technology, supporting fast and scalable viral vector manufacturing across CGT applications. The OXGENE Plasmids portfolio includes nine AAV plasmids spanning Rep/Cap serotypes 1-8 plus adenoviral helper functions, as along with four proven LVV plasmids covering the GOI transfer backbone, packaging, Rev, and envelope. Manufacturing is underway, with two plasmids already supporting an active customer program. Research-use materials are expected within about four weeks, with the remaining plasmids being released in phases over the coming months.

This expanding portfolio will provide developers with rapid access to standardized, scalable plasmid DNA solutions that shorten development timelines and offer greater flexibility.

"The promise of cell and gene therapies can only be realized when scientific innovation is supported by dependable manufacturing," said Darren Head, Chairman and President of Bionova Scientific. "This partnership brings together complementary expertise to simplify development, reduce supply chain risk, and provide customers with a seamless path from research through commercial manufacturing. Together, we’re helping innovators move promising therapies to patients faster."

Representatives from both companies will be available to discuss the partnership during the 11th CAR-TCR Summit in Boston in September 2026 and the Meeting on the Mesa in October 2026.

(Press release, Asahi Kasei, SEP 9, 2026, View Source [SID1234671079])

On September 9, 2026 Twist Bioscience Corporation (NASDAQ: TWST), a mid-cap growth and value biotech company, reported that Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience, and Adam Laponis, CFO of Twist Bioscience, will participate in a fireside chat at the Baird 2026 Global Healthcare Conference on Tuesday, September 15, 2026 at 1:25 pm Eastern Time in New York City.

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The fireside chat will be webcast live and can be accessed by visiting the "Investor Calendar" page of the investor relations section of the company’s website here. A replay of the fireside chat will be archived for a period of 30 days following the conclusion of the live events.

(Press release, Twist Bioscience, SEP 9, 2026, View Source [SID1234670712])

On September 9, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported that members of its management team will participate in the following industry and investor conferences in September 2026:

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Oncology & Immunology Innovation Partnering & Licensing Summit
Presentation date: September 9, 2026
Location: Hotel Commonwealth, Boston, MA
Format: Presentation
Presenter: Dr. Mitchell Shirvan, Chief Scientific and Development Officer

8th Annual RAS-Targeted Drug Development Summit
Presentation date: September 10, 2026
Location: The Colonnade Hotel, Boston, MA
Format: Presentation
Presenter: Dr. Mitchell Shirvan, Chief Scientific and Development Officer

H.C. Wainwright 28th Annual Global Investment Conference
Dates: September 14–16, 2026
Location: Lotte New York Palace Hotel, New York, NY
Format: One-on-one meetings
Attendees: Ilan Hadar, Chief Executive Officer; Mirit Horenshtein Hadar, Chief Financial Officer

Parties interested in meeting with Silexion’s management during the conferences should contact their conference representative or the Company’s Investor Relations team to arrange a meeting.

Silexion is currently developing SIL204, an investigational pan-KRAS RNA interference therapy, in an ongoing Phase 2/3 clinical program in locally advanced pancreatic cancer.

(Press release, Silexion Therapeutics, SEP 9, 2026, View Source [SID1234670711])

On September 9, 2026 ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic therapy (VTP) to treat a range of solid tumors, reported the completion of treatment for all required patients enrolled in its Phase 3 ENLIGHTED trial evaluating Padeliporfin VTP in patients with low-grade upper tract urothelial carcinoma (LG-UTUC). Completion of treatment, along with a positive pre-NDA meeting held with the U.S. Food and Drug Administration (FDA) in April 2026, supports the Company’s planned reporting of topline data and anticipated NDA submission in 2027.

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"The completion of treatment for all required patients in the Phase 3 ENLIGHTED trial represents a major milestone towards our goal of delivering a next-generation treatment option for patients with low-grade UTUC," said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. "Preliminary clinical data to date show encouraging complete response rates, durability of response, and a consistent safety profile, further supporting Padeliporfin VTP’s potential to provide a minimally invasive, organ-sparing treatment option in LG-UTUC. This, alongside the existing dataset for Padeliporfin across solid tumor indications, gives us confidence in its potential to shift the treatment paradigm for these difficult-to-treat diseases and improve patient outcomes."

Following ImPact’s positive pre-NDA meeting in April 2026, "the FDA acknowledged the clinical considerations around the potential clinical meaningfulness of Padeliporfin-VTP as a treatment option for low-grade UTUC including the potential clinical value of durable CR in the treated area." The agency has confirmed the registrational pathway and streamlined package requirements allowing ImPact to leverage supplemental non-clinical modules from a prior NDA submission for Padeliporfin VTP in advanced localized prostate cancer for submission in LG-UTUC in 2027.

Additionally, the Company has engaged in discussions with the FDA regarding a potential expanded access program (EAP) for eligible patients with LG-UTUC in the US. The program would enable access to Padeliporfin VTP to qualifying patients prior to potential regulatory approval.

"With treatment now complete in the Phase 3 ENLIGHTED trial and following positive recent interactions with the FDA, our focus remains on bringing Padeliporfin VTP to patients as efficiently as possible," said Barak Palatchi, Chief Executive Officer of ImPact Biotech. "The FDA’s feedback further supports our confidence in the program and its path toward regulatory submission. Recognizing the significant unmet need among LG-UTUC patients, the potential for an expanded access program for Padeliporfin VTP underscores our commitment to expanding patient access and supporting treating physicians. We look forward to reporting topline results and advancing towards regulatory submission in 2027, while evaluating strategic commercialization opportunities to maximize patient reach."

ImPact plans to present interim data from the Phase 3 ENLIGHTED trial in LG-UTUC at the ESMO (Free ESMO Whitepaper) Congress taking place from October 23-27, 2026 in Madrid.

ePoster Title: Non-Thermal, Drug-Activated Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP) for Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC): ENLIGHTED Phase 3 Trial
Presenter: Asaf Shvero, M.D., Department of Urology, Sheba Medical Center
Poster Number: 4860eTiP
Category: Urothelial Cancer

About ENLIGHTED

The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across 29 clinical sites globally, ImPact enrolled 91 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and a Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy was performed, via an ureteroscopy which applied a laser fiber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) was achieved; MTP follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months. The study’s primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response.

(Press release, ImPact Biotech, SEP 9, 2026, View Source [SID1234670710])

On September 9, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported positive initial results from the RESTORE-PV Phase 2 trial of DISC-3405 in patients with polycythemia vera (PV). The data, presented in a poster session at the 2026 Society of Hematologic Oncology (SOHO) annual meeting in Houston, TX, demonstrated that treatment with DISC-3405 increased hepcidin and lowered serum iron, translating to reduction in phlebotomy, controlled hematocrit, and improved symptom burden in patients with PV. These data will be featured in an oral presentation at the SOHO conference tomorrow, September 10. Disc also presented an encore of the positive results from the Phase 2 RALLY-MF trial of selcodebart (DISC-0974) in patients with anemia of myelofibrosis (MF) and a new systematic literature review characterizing the humanistic burden of anemia associated with MF through patient reported outcomes.

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"This first look at data from the RESTORE-PV trial shows that the established pharmacodynamics of DISC-3405 are translating well on important clinical measures," said John Quisel, JD, PhD, President and Chief Executive Officer of Disc Medicine. "Iron restriction is proving to be a transformative treatment approach for a large population of patients with polycythemia vera, with the potential to address their crucial need for hematocrit control while managing symptom burden and reducing reliance on phlebotomy. Our goal for DISC-3405 is to deliver an optimal product presentation combining durable disease control with straightforward, controllable, and convenient dosing using a novel antibody approach. Between this update in PV and our earlier progress in MF this year, we have strengthened our commitment to hematologic oncology and now have two programs advancing toward potential pivotal development in myeloproliferative neoplasms."

The Phase 2 multi-center, open-label RESTORE-PV trial enrolled 40 adult participants with PV, including 20 participants in Cohort A and 20 participants in Cohort B. In the trial, following a 4- to 12-week observation, participants undergo a 12-week dose escalation, then receive DISC-3405 subcutaneously at 300 mg Q2 weeks (Cohort A) or Q4 weeks (Cohort B) for 20 weeks, followed by up to 20 additional weeks of treatment at these respective doses. At the time of the data cut, all 20 participants in Cohort A were dosed and n=13 patients completed 26 weeks of the study, and 18 of 20 participants in Cohort B were dosed. Efficacy data was presented for Cohort A and baseline and safety data were presented for Cohorts A and B. Across escalation and maintenance periods, results demonstrated:

Dose-proportional PK, elevation of hepcidin, reduction of serum iron, and increase in ferritin (Cohort A)
Control of hematocrit, with mean hematocrit maintained stably <45% through week 26 which led to initial improvement in symptom burden (Cohort A)
DISC-3405 significantly reduced phlebotomy events in Cohort A participants. For n=13 patients completing 26 weeks of study:
Mean total phlebotomy events significantly decreased from 4.0 in 26 weeks at baseline to 0.6 in 26 weeks post-Day 1 (p<0.0001)
61.5% of participants remained entirely phlebotomy-free post-baseline through 26 weeks
Of those who completed the first maintenance period (weeks 12-32, n=9), 77.8% of participants remained phlebotomy free during this period
DISC-3405 was generally well-tolerated with adverse events that are consistent with underlying disease and a low rate of injection site reactions which were mild and self-limited (Cohorts A and B)

Disc plans to provide an update on RESTORE-PV, as well as initial data from the Phase 1b trial of DISC-3405 in sickle cell disease, by the end of 2026.

With respect to selcodebart, the company also expects to share feedback from an end of phase 2 meeting with the U.S. Food and Drug Administration (FDA) and plans for pivotal development in anemia of MF by the end of the year.

About DISC-3405

DISC-3405 is an investigational, anti-TMPRSS6 (Transmembrane Serine Protease 6, also known as Matriptase-2) monoclonal antibody designed to increase hepcidin production and suppress serum iron. Disc in-licensed DISC-3405 from Mabwell Therapeutics in January 2023. The therapeutic potential for hepcidin induction includes treatment of diseases associated with iron overload, diseases of excess red blood cell production, or diseases otherwise enabled by iron availability. Disc has established clinical proof-of-mechanism of DISC-3405 in a Phase 1 study in healthy volunteers and initiated a Phase 2 trial in patients with polycythemia vera and a Phase 1b trial in patients with sickle cell disease.

DISC-3405 is an investigational agent and is not approved for use as a therapy in any jurisdiction worldwide.

About Polycythemia Vera

Polycythemia vera (PV) is a chronic and rare myeloproliferative neoplasm characterized by the abnormal proliferation of red blood cells. PV affects approximately 150,000 patients in the U.S. and has a similar prevalence in Europe. The overproduction of red blood cells alters the viscosity of blood, causing it to thicken and placing patients at an elevated risk of cardiovascular and thromboembolic events, such as heart attack and stroke. Patients also experience complications such as enlarged spleen and symptoms of their disease such as fatigue, pruritis, difficulty concentrating and others. Current therapy involves phlebotomy to physically remove blood and iron to limit erythropoiesis or treatment with cytoreductive agents, with the goal of reducing red blood cell count and managing symptoms.

(Press release, Disc Medicine, SEP 9, 2026, View Source [SID1234670709])