On July 31, 2024 Oxford Vacmedix (OVM), developing therapeutic cancer vaccines, reported the grant of a prestigious non-dilutive Investor Partnership Award from Innovate UK, the UK’s innovation agency, to support the clinical development of OVM-200 (Press release, Oxford Vacmedix, JUL 31, 2024, View Source;utm_medium=rss&utm_campaign=innovate-uk-grant-for-ovm-200 [SID1234645194]). The application was supported by Proven Connect, with additional funding from Prostate Cancer Research when the award is made. The award demonstrates the confidence that Innovate UK have in OVM’s Recombinant Overlapping Peptide (ROP) technology and in the early clinical results with OVM-200.

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OVM-200 is OVM’s lead cancer vaccine, developed using the novel ROP techonogy pioneered by Professor Shisong Jiang at the University of Oxford. It targets survivin which is over expressed in many solid tumours, and is being trialled in the UK in five leading hospitals, to treat ovarian cancer, prostate cancer and non-small cell lung cancer. Phase 1a, the first part of a Phase 1 trial, was completed in 2023 and demonstrated both safety and a very strong immune response as well as allowing the selection of the optimal dose regime of OVM-200 for use to treat late stage cancer. Phase 1b using the dose selected is ongoing.

The Innovate UK Investor Partnership Award is for $900,000 (approx. £740,000) and is dependent on aligned investor funding of at least $1.8m (approx. £1.5m). The Proven Connect funding from Prostate Cancer Research will be in addition to the award from Innovate UK. OVM is currently seeking Series B investment of up to $15m to take OVM-200 into Phase 2 in combination and to accelerate other pipeline projects.

William Finch, CEO of Oxford Vacmedix said;

"We are delighted to have this non-dilutive Investor Partnership Award from Innovate UK and with the ongoing support from Proven Connect. The award shows the confidence that the UK’s innovation agency have both in our ROP technology and in the early clinical results for OVM-200. Continuing the clinical development for OVM-200 will bring hope to many patients and has the potential to meet real clinical need. We are confident of securing investment in our Series B fund and look forward to any additional contacts with potential investors."

On July 31, 2024 Prestige Biopharma, a pioneer in biopharmaceuticals, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for Tuznue, a Herceptin (trastuzumab) biosimilar (Press release, Prestige BioPharma, JUL 31, 2024, View Source [SID1234645215]). This milestone positions Prestige Biopharma to become the first Singaporean firm to commercialize its biosimilar in the European Union.

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The CHMP’s positive opinion is based on clinical evidence from Phase 1 and Phase 3 clinical studies that tested the biosimilarity of Tuznue to Herceptin. The Phase 1 clinical PK study in healthy volunteers demonstrated PK equivalence, as well as similarity in safety and immunogenicity. Finally, the global Phase 3 confirmatory efficacy and similarity study met its primary endpoint and demonstrated similarity in efficacy, PK, safety, and immunogenicity in HER2-positive patients with early breast cancer. This favourable decision is a crucial step toward final approval from the European Commission (EC). Once approved, Tuznue will be commercialized across Europe.

Prestige Biopharma has already established licensing agreements with major pharmaceutical partners for global marketing and sales. These agreements are set to generate immediate milestone payments and provide early revenue for the company. Negotiations are also underway to ensure a strong market entry for Tuznue in Europe.

"Receiving a positive CHMP opinion for Tuznue marks a major milestone for Prestige Biopharma, significantly advancing our revenue generation strategy and accelerating future pipeline approvals," said Lisa Park, the CEO of Prestige Biopharma. "This recognition solidifies our position as a leading biosimilar developer. We are committed to leveraging this achievement to enhance our market presence and drive continued success."

About TUZNUE (HD201, Herceptin biosimilar)

Tuznue is a biosimilar of Herceptin (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It maintains comparable efficacy and safety profiles to the original branded medication. Tuznue is indicated for the treatment of patients with HER2-positive metastatic breast cancer (MBC), HER2-positive early breast cancer (EBC), and HER2-positive metastatic gastric cancer (MGC).

On July 31, 2024 Clinical stage drug development company Syntara Limited (ASX: SNT) reported that it has completed full recruitment in its Phase 2 trial evaluating SNT-5055, in combination with ruxolitinib, treating the bone marrow cancer myelofibrosis (Press release, Syntara, JUL 31, 2024, View Source;v=70bc033a22188bdfefb8a0b8ad3c24897ef2837d [SID1234645175]).

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After commencement of the open-label study in December 2023, Syntara has reached the milestone with the 15ᵗʰ patient dosed yesterday and has already exceeded the minimum threshold of one month treatment for 12 patients proposed in FDA discussions for safety evaluation.

The trial is being conducted across 19 clinical trial sites in the USA, Australia, South Korea and Taiwan. SNT-5505 is a pan-LOX inhibitor and the lead asset in Syntara’s proprietary clinical pipeline.

Syntara expects to report interim results from the trial in late 2024, in conjunction with the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. In line with the excellent safety profile observed in earlier phase 1 and phase 2 studies, no drug related dropouts nor any serious adverse reactions have been observed to date.

The reassuring safety profile, alongside the interim data, is expected to allow Syntara to engage with and discuss pivotal study design with the FDA in Q1 2025, with the full 12month data set to be available in Q3 2025.

Syntara CEO Gary Phillips said:

"I’d like to thank the haematology clinics, investigators and the Syntara clinical team for achieving this significant milestone in such a timely fashion. We now look forward to presenting our interim data later in the year and building a solid foundation for the next stage of discussions with the FDA and potential strategic partners."

Syntara commenced the combination trial after it found encouraging efficacy and an excellent safety profile in a Phase 2 monotherapy trial of the drug, as presented at ASH (Free ASH Whitepaper) in December 2023. An effective pan-LOX inhibitor, such as SNT-5505, for myelofibrosis has disease modifying potential for patients and would unlock a market conservatively estimated to be more than $1 billion per annum.

SNT-5505 is a pan-LOX inhibitor that has also demonstrated compelling pre-clinical data when used in combination with standard of care in other haematological malignancies such as myelodysplastic syndrome and solid tumours like those found in hepatocellular carcinoma and pancreatic cancer.

On July 31, 2024 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported topline data from its Phase 2 ASPEN-06 clinical trial (Press release, ALX Oncology, JUL 31, 2024, View Source [SID1234645197]). The trial demonstrated clinically meaningful improvements in overall response rate and duration of response among patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.

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"The topline results from the ASPEN-06 clinical trial confirm the robust response that evorpacept can deliver, generating a clinically meaningful impact on key measures of anti-cancer activity for patients with gastric cancers and continuing to surpass benchmarks in the field," said Jason Lettmann, chief executive officer at ALX Oncology. "Additionally, they provide valuable insight beyond the interim data previously reported, offering a more conclusive look at the impact of evorpacept and identifying the most responsive patient population. Importantly, the level of clinical benefit seen in this trial provides support for developing evorpacept in combination with anti-cancer antibodies in additional tumor types and drives ALX’s development strategy."

ASPEN-06 is a randomized, multi-center, international trial evaluating evorpacept, ALX Oncology’s investigational CD47-blocking therapeutic that uniquely combines a high-affinity CD47-binding domain with an inactivated proprietary Fc domain, in combination with trastuzumab, CYRAMZA (ramucirumab) and paclitaxel (collectively, TRP) against TRP alone for the treatment of patients with HER2-positive gastric/GEJ cancer, where all patients had received an anti-HER2 agent in prior lines of therapy. Patients in the trial (N=127) were generally well-balanced across arms based on pre-specified stratification factors including line of therapy, prior ENHERTU (fam-trastuzumab deruxtecan-nxki) use, Asia region, tumor location (GC or GEJ), HER2 expression level (IHC3+ or IHC2+/ISH+) and HER2-positive biopsy (fresh or archival).

The trial’s primary endpoint is overall response rate (ORR). Key secondary endpoints are safety, median duration of response (mDOR), progression-free survival (PFS) and overall survival (OS).

Key Phase 2 ASPEN-06 Clinical Trial Topline Results:

In the full intent-to-treat population (N=127), the addition of evorpacept to TRP demonstrated an ORR of 40.3% compared to the TRP control ORR of 26.6%
In patients with fresh HER2-positive biopsies (n=48), evorpacept plus TRP demonstrated an ORR of 54.8% compared to 23.1% for the TRP control
Median duration of response (DOR) in the evorpacept arm was 15.7 months [95% CI: 11.0; NE] compared to the TRP control of 7.6 months [95% CI: 6.3; NE] in the full intent-to-treat population
Secondary endpoints of PFS and OS were immature at the time of analysis
Evorpacept in combination with TRP was generally well tolerated and consistent with TRP control
"By meeting our clinically meaningful and pre-specified threshold of greater than 10% difference in response between the evorpacept treatment and control arms, these new data validate the mechanism of action and potential clinical utility of evorpacept for patients. Notably, this is now the first CD47 blocker to demonstrate clinical benefit and a well-tolerated safety profile in a randomized trial," said Sophia Randolph, M.D., Ph.D., chief medical officer at ALX Oncology. "ASPEN-06 also provides valuable insights into responding patient populations and the importance of HER2 target expression that will inform our clinical program. These data represent a significant advancement for immuno-oncology."

The ASPEN-06 full data set will be submitted for presentation at an upcoming medical conference.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to evorpacept for the second-line treatment of patients with HER2-positive gastric or GEJ carcinoma. Additionally, both the FDA and European Commission have granted Orphan Drug Designation for this indication.

Conference Call and Webcast on July 31 at 4:30 PM EDT
The Company will host a conference call and webcast today at 4:30 PM EDT. To access the live conference call, please dial (800) 715-9871 (U.S./Canada) or +44.800.260.6466 (internationally) at least 10 minutes prior to the start time and refer to conference ID 9637001. The link to the live webcast of the conference call will be posted in the News & Events section (see "Events") of the Company’s website at www.alxoncology.com. An archived replay will be accessible for 90 days following the event.

About the ASPEN-06 Phase 2 Clinical Trial
ASPEN-06 is a randomized Phase 2 (open-label) / Phase 3 (double-blinded), multi-center, international trial of patients with second- or third-line metastatic HER2-overexpressing gastric/GEJ adenocarcinoma that progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy (NCT05002127). HER2 status was determined by an FDA-approved test in the most recent gastric/GEJ cancer tissue sample. The primary analysis of the full intent-to-treat population included all randomized patients whose HER2 status was based on a tissue sample obtained at any time. An additional primary analysis was conducted on patients who had a recent HER2-positive tissue sample after prior anti-HER2 therapy ("fresh biopsy"). While trastuzumab is currently approved in combination with cisplatin and capecitabine/5-FU for HER2-positive gastric/GEJ cancers, it is not approved in combination with standard-of-care CYRAMZA + paclitaxel. The Phase 2 portion of the ASPEN-06 trial enrolled 127 patients. To determine the activity of evorpacept + trastuzumab + CYRAMZA + paclitaxel, in the Phase 2 portion of ASPEN-06, patients were randomized to receive either a four-drug combination regimen (evorpacept + trastuzumab + CYRAMZA + paclitaxel) or a three-drug combination regimen (trastuzumab + CYRAMZA + paclitaxel). This design enabled the assessment of evorpacept’s contribution to the standard of care plus trastuzumab and to global standard of care, CYRAMZA + paclitaxel.

On July 31, 2024 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical-stage immunology company advancing RNA therapeutics to conquer cancer, reported to have dosed the first patient with MT-303 in a Phase 1 study for hepatocellular carcinoma (HCC) (Press release, Myeloid Therapeutics, JUL 31, 2024, View Source [SID1234645216]). MT-303 is Myeloid’s second in vivo mRNA CAR program to enter the clinic from its pipeline of in vivo immune cell programming therapies. Dosing with MT-303 represents a significant milestone to bring advanced novel therapies to people with liver cancer.

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Dr. Matthew Maurer, Chief Medical Officer of Myeloid, commented, "We are thrilled to have swiftly advanced MT-303 into the clinic as the first in vivo CAR therapy applicable to the majority of liver cancers, and other cancers expressing GPC3. MT-303 can be administered like any other off-the-shelf intravenous therapy, without the need for pretreatment conditioning, and offers the potential to trigger a coordinated immune response against the cancer, reinforced and maintained with ongoing repeat dosing."

GPC3 is a target of significant global interest given its high expression in HCC and limited expression in normal tissues. Unlike autologous cell therapies, Myeloid’s approach focuses on in vivo programming of immune cells with off-the-shelf mRNA-encoded CAR technology that expresses selectively within myeloid cells. MT-303 arms myeloid cells with a proprietary chimeric antigen receptor that enables these cells to kill hepatocellular carcinoma and to engage an adaptive immune response against the tumor. This coordinated immune response is essential to foster a sustained immune surveillance and defense against tumor recurrence.

Dr. Timothy Humphries, Linear Clinical Research, lead principal investigator on the MT-303 trial added, "Hepatocellular carcinoma is a highly lethal cancer with limited effective therapies. I am elated to bring the option and potential of MT-303, the first in vivo CAR therapy for this disease, to my patients with the hope of providing tolerable and durable clinical benefit."

"The Myeloid team continues to push forward and revolutionize cancer treatment with the world’s first clinical-stage in vivo mRNA CAR therapies," said Daniel Getts, Ph.D., CEO of Myeloid. "With multiple clinical trials ongoing that evaluate our therapeutic candidates, including MT-302, our novel TROP2-targeting mRNA CAR in dose escalation studies, and adding MT-303, we have a proven ability to translate cutting-edge mRNA CAR technology into clinical candidates. We are excited by the transformative potential of our in vivo immune cell programming for liver cancer patients."

Dr. Getts continued, "Strategically, these clinical programs provide insights as we continue to expand our development portfolio to other targets, to other immune cell types, and to novel receptor combinations for our in vivo CAR approaches."

Myeloid’s in vivo programming candidates are designed with proprietary insights to deliver personalized therapy, providing benefits to patients while reducing time and costs through the elimination of ex vivo handling of patient cells and complex neoantigen sequencing. The Myeloid platform integrates validated antibody/antigen binding with novel combinations of myeloid signaling domains, coded within a simple mRNA that can be delivered repeatedly using lipid nanoparticles (LNPs). The platform’s versatility provides a range of signaling domains and immune cell types useful for combination approaches.

About Liver Cancer

With limited treatment options, and over 850,000 new cases diagnosed globally each year, liver cancer has become the third leading cause of cancer death. After initial treatment success with small molecule therapies, the development of new treatment approaches in the field of liver cancer has been limited. Today, patients with liver cancer who are refractory to first line treatment are left with few treatment options, creating a substantial unmet medical need. Myeloid sees an opportunity to make a significant contribution to address this need, by providing a new CAR for these patients who are living with liver cancer. The CARs are capable of providing a coordinated and durable immune response to counter advanced disease. The CARs are combinable and will expand the treatment options for physicians.

About the Phase 1 Study of MT-303

The MT-303 Phase 1 study (NCT06478693) is an open-label dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-303 in adults with advanced or metastatic hepatocellular carcinoma that overexpresses GPC3. This study will also define the recommended Phase 2 dose (RP2D) of MT-303.

About MT-303

MT-303 represents the first candidate in a new therapeutic modality targeting hepatocellular carcinoma (HCC). This clinical candidate is a first-in-class, GPC3-FcA-LNP, with a strong preclinical profile supporting its advance into this first-in-human trial. GPC3 is overexpressed in most human hepatocellular carcinomas, with limited expression in corresponding normal tissues. Increased GPC3 expression has been linked to tumor growth.

Treatment with MT-303 as a monotherapy demonstrates activity in a GPC3/HCC preclinical model, confirming the tumor-fighting potency of programmed myeloid cells even in the model’s absence of T cells. MT-303 has demonstrated strong expression in myeloid cells and a favorable safety profile in rodents and non-human primates. Unlike other therapies, MT-303 brings the potential advantages of eliciting a full immune response by also presenting tumor neoantigen to stimulate T cells.

MT-303 represents Myeloid’s second in vivo CAR clinical program, building on the company’s innovative approach to cancer treatment through immune cell programming.