On May 23, 2024 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, reported that Bharatt Chowrira, Ph.D., J.D., Chief Executive Officer, and Eric Elenko, Ph.D., Co-founder and President, will participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 6th, 2024, at 10:00am EDT / 3:00pm BST (Press release, PureTech Health, MAY 23, 2024, View Source [SID1234643613]). A webcast of the presentation will be available at View Source

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On May 23, 2024 Orca Bio, a biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported it will present new data at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois, from May 31–June 4 (Press release, Orca Bio, MAY 23, 2024, View Source;utm_medium=rss&utm_campaign=orca-bio-to-present-positive-clinical-outcomes-with-orca-t-in-patients-with-aml-at-2024-asco-annual-meeting [SID1234643611]). The presentation will highlight outcomes of its lead investigational allogeneic T-cell immunotherapy, Orca-T, in patients with acute myeloid leukemia (AML).

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AML is an aggressive form of blood cancer and the most common acute leukemia in adults. There are an estimated 20,800 new diagnoses and nearly 11,200 deaths in the U.S. each year.

"Today, only a fraction of adults diagnosed with AML undergo curative treatment with standard of care allogeneic hematopoietic stem cell transplant due to the serious and life-threatening risks often associated with it," said Rawan Faramand, M.D., assistant member of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center. "These new findings suggest Orca-T has the potential to offer a cure with low rates of treatment-related mortality, and could provide an important option for patients with AML. With its goal of alleviating the tradeoff between the risk of relapse and the risk of toxicities observed with standard of care stem cell transplant, this novel approach has the potential to expand curative treatment to many more patients."

A new subanalysis from the ongoing multi-center Phase 1b single-arm trial evaluated outcomes with Orca-T among a subgroup of 37 patients with AML who had a median age of 51 years and median follow-up of 14 months. All patients received myeloablative conditioning (MAC) with busulfan, fludarabine and thiotepa (BFT), followed by Orca-T and single-agent graft versus host disease (GvHD) prophylaxis with tacrolimus. At 12 months, results found relapse-free survival was 82.5% (95% CI: 65.0, 91.7) and non-relapse mortality was 0%. Overall survival was 100% (95% CI: 100, 100) at 12 months. The safety profile of Orca-T in this subgroup was consistent with the larger Phase 1b population with no new safety signals identified. Across all patients, Orca-T was manufactured reliably and delivered with vein-to-vein times of 72 hours or less across the U.S.

"We’re pleased to present at ASCO (Free ASCO Whitepaper) for the first time and share the latest findings that support the potential for Orca-T to offer a curative solution and fulfill a significant unmet need for patients with AML," said Scott McClellan, M.D., Ph.D., chief medical officer at Orca Bio. "These data continue to advance our mission of expanding potentially life-saving treatment to patients and their providers who face limited viable options today."

Details of the Orca Bio presentation follow:

Title: Treatment of Acute Myeloid Leukemia with Orca-T

Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Abstract Number: 6552

Poster Code: 111

Date and Time: June 3, 2024, from 9AM – 12PM CDT

Location: Oncology Professionals Hall

The ASCO (Free ASCO Whitepaper) abstracts are available at View Source

About Orca-T
Orca-T is an investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies. Orca-T is comprised of highly purified regulatory T-cells, CD34+ stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors. Orca-T is currently being evaluated in a pivotal Phase 3 clinical trial at leading transplant centers across the U.S. and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

On May 23, 2024 NKGen Biotech, Inc. (Nasdaq: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer ("NK") cell therapeutics, reported an online publication, titled "Interim Analysis of a Phase I Study using Cryopreserved Non-genetically Modified Allogeneic Natural Killer Cells With Enhanced Cytotoxicity (SNK02) in Patients with Advanced Solid Tumors without Lymphodepletion" at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting to be held virtually and at the McCormick Place Convention Center in Chicago, Illinois from May 31–June 4, 2024 (Press release, NKGEN Biotech, MAY 23, 2024, View Source [SID1234643610]).

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This Phase 1 clinical trial is a multi-center, open-label study evaluating the safety and tolerability of SNK02 in participants with pathologically confirmed solid tumors refractory to standard of care therapy. The study drug, SNK02, is a first-in-kind, cryopreserved allogeneic non-genetically modified NK cell product with significant anti-tumor cytotoxicity and over 90% expression of CD16, NKG2D, NKp46, and DNAM-1, that can be consistently produced on a large commercial scale. SNK02 was administered as an intravenous infusion (IV), weekly for eight weeks in patients with advanced solid tumors. The starting dose was 6×109 SNK02 cells. We hypothesized that higher doses of SNK02 (to overcome autodigestion) could be delivered frequently without the need for lymphodepletion and that it might demonstrate activity against solid tumors that have failed multiple prior standard-of-care treatment options. The primary endpoint was safety based on adverse events (AEs), vitals, laboratory tests, and physical exams. Tolerability of SNK02 and maximum tolerated dose were also evaluated.

"Interim data from our Phase 1 clinical study utilizing our second NK cell therapy product, SNK02, demonstrated that the treatment was well-tolerated as a monotherapy in patients with solid tumors refractory to standard of care therapy," said Paul Y. Song, MD, Chairman and CEO of NKGen. "We are particularly excited because SNK02 has the potential to be a first-in-class cryopreserved allogeneic NK cell therapy for solid tumors that does not require lymphodepletion before administration, which may lead to better overall synergy in future combination regimens especially with immune checkpoint inhibitors where a robust T-cell response is needed. Using our proprietary allogeneic manufacturing and cryopreservation processes, we are capable of producing hundreds of thousands of potential doses of enhanced NK cell therapies from materials collected from a single donor. Thus, our potential to treat a significant number of cancer patients with SNK02 is remarkably high. We are pleased to see such promising Phase 1 trial results for both of our unique cell therapy candidates: autologous SNK01 for neurodegenerative disease and allogeneic SNK02 for cancer."

For additional information on the SNK02 clinical trial, please visit View Source using the identifier NCT05990920.

Highlights from the online publication include:

Five patients with advanced refractory solid tumors were enrolled in the trial.
Patients had received an average of 4 lines of prior therapy.
Median age was 64 (range 44 – 71) and 3 were male.
The subtypes were 1 leiomyosarcoma, 1 angiosarcoma, 1 endometrial adenocarcinoma, 1 undifferentiated pleomorphic sarcoma, and 1 colorectal adenocarcinoma.
Four of five patients completed 8 cycles of SNK02. The best objective response of stable disease (tumor stopped growing) was demonstrated in 100% of patients that completed the 8 cycles.
Out of the 36 doses administered through Cycle 8, there were 17 Grade 1, 3 Grade 2, and 1 Grade 3 adverse events (AEs) related to investigational product (IP). The Grade 3 AE of increased fatigue resolved after 1 day with no intervention required.
There was 1 death on study, which was deemed unrelated to the IP.
Auto-antibodies appeared to develop around cycle 5 and appeared to correlate with AEs.
SNK02 was well tolerated as a monotherapy and appears to have some clinical activity against pretreated solid tumors despite the lack of lymphodepletion. SNK02 will continue to be studied as a monotherapy and in potential combination treatment regimens with monoclonal antibodies and immune checkpoint inhibitors.

A copy of the ePublication will be available on the Scientific Publications page of the Company’s website at View Source

About SNK02

SNK02 is a novel cell-based, donor-derived ex vivo expanded allogeneic natural killer ("NK") cell, immunotherapeutic drug candidate. NKGen Biotech, Inc. is developing SNK02 for the treatment of a broad range of cancers.

On May 23, 2024 Nimbus Therapeutics, LLC ("Nimbus Therapeutics" or "Nimbus"), a biotechnology company that designs and develops breakthrough medicines for patients through its powerful computational drug discovery engine, reported the presentation of new positive data from the company’s ongoing Phase 1/2 clinical trial of NDI-101150, a novel, oral small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor in development for the treatment of advanced solid tumors (NCT05128487) (Press release, Nimbus Therapeutics, MAY 23, 2024, View Source [SID1234643609]). Results are being highlighted in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL.

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The Phase 1/2 multicenter, open-label trial is designed to assess NDI-101150 as a monotherapy (50-200 mg dose) and in combination with 200 mg pembrolizumab in the treatment of adults with advanced solid tumors. The results being presented at the ASCO (Free ASCO Whitepaper) Annual Meeting include updated data from 44 patients in the dose escalation cohorts (n=38 on monotherapy, n=6 on combination therapy) and additional data from 15 patients in the dose expansion cohorts. Results, as of March 18, 2024, showed:

Treatment with NDI-101150 monotherapy was associated with clinical benefit in five out of 30 (16.7%) response-evaluable patients.
One patient with renal cell carcinoma (RCC) in the dose escalation cohort exhibited a complete response, and one patient with RCC in the dose expansion cohort exhibited a partial response. Both patients were pre-treated with multiple lines of therapies including checkpoint inhibitors.
Three patients with RCC, pancreatic cancer and endometrial cancer, respectively, maintained durable stable disease (SD) for more than six months while on treatment (21 months for the patient with RCC).
In the RCC patient population, six out of eight response-evaluable patients had a best overall response of SD or better.
NDI-101150 showed an increase in activated CD8+ T cells and dendritic cell infiltration in on-treatment patient biopsies compared to archival biopsies, consistent with nonclinical studies of NDI-101150 showing immune cell infiltration and robust anti-tumor activity in murine syngeneic tumor models.
NDI-101150 is well-tolerated and the overall safety of NDI-101150 remains acceptable.
"We are encouraged by these results being presented at ASCO (Free ASCO Whitepaper) and additional observations to date showing monotherapy clinical benefit and an acceptable safety profile of NDI-101150, further validating HPK1 as a differentiated next-generation immunotherapy target for people living with advanced solid tumors in need of new effective treatment options," said Nathalie Franchimont, M.D., Ph.D., Chief Medical Officer at Nimbus. "HPK1 inhibition is a promising therapeutic approach as it is shown to activate T cells, B cells and dendritic cells to mount a robust anti-tumor response, whereas currently approved checkpoint inhibitors activate T cells. NDI-101150 is a potent and highly selective HPK1 inhibitor that has the potential to achieve significant tumor growth inhibition and make a meaningful difference for patients."

The study abstract is available on the ASCO (Free ASCO Whitepaper) website here and the details of the poster presentation are as follows:

Title: Phase 1/2 Trial of the HPK1 Inhibitor NDI-101150 as Monotherapy and in Combination with Pembrolizumab: Clinical Update

Lead Author: Marcus Noel, M.D.

Date: Saturday, June 1, 2024

Time: 9:00 a.m. – 12:00 p.m. CT

Session Title: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology

Abstract Number: 3083

On May 23, 2024 Mythic Therapeutics, a clinical-stage biotechnology company committed to the development of next-generation antibody-drug conjugate (ADC) therapies for the treatment of a wide range of cancers, reported that it will present initial dose escalation results from its Phase 1 KisMET-01 study evaluating its investigational cMET-targeting ADC, MYTX-011, in patients with previously treated, locally advanced or metastatic non-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Mythic Therapeutics, MAY 23, 2024, View Source;utm_medium=rss&utm_campaign=mythic-therapeutics-to-present-data-from-phase-1-kismet-01-study-on-mytx-011-at-the-american-society-of-clinical-oncology-asco-annual-meeting [SID1234643608]).

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"We are pleased to present clinical data showcasing the potential of our lead program, MYTX-011, for patients impacted by non-small cell lung cancer," said Gilles Gallant, BPharm, Ph.D., FOPQ, Chief Development Officer at Mythic Therapeutics. "The initial dose escalation results from our ongoing KisMET-01 trial mark an important milestone in our journey, and we look forward to sharing these results with the scientific community at ASCO (Free ASCO Whitepaper)."

Details of the presentation are as follows:

Title: MYTX-011 in patients with previously treated locally advanced or metastatic NSCLC: Initial dose escalation results in the phase 1 KisMET-01 study.
Presenter: Melissa Johnson, M.D., Director, Lung Cancer Research, Sarah Cannon Research Institute
Session Title: Lung Cancer—Non-Small Cell Metastatic
Session Date and Time: Monday, June 3, 1:30 – 4:30 PM CDT
Location: Hall A | On Demand
Poster Board Number: 422
Published Abstract Number: 8558

About MYTX-011

MYTX-011, an investigational cMET-targeting ADC, leverages Mythic’s innovative FateControl technology which is designed to allow ADCs to actively navigate inside of cells, potentially increasing delivery of anti-cancer agents to tumor cells with less impact on healthy cells. This breakthrough approach takes the next step beyond linker-payload technologies and is designed to improve ADC efficacy against a broad set of molecular targets and patient profiles. MYTX-011 is currently being evaluated in the Phase 1 KisMET-01 clinical trial, a first-in-human, open-label, multi-center, dose escalation and dose expansion study enrolling patients with locally advanced, recurrent or metastatic NSCLC (NCT05652868).