On June 5, 2023 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported that it has entered a strategic collaboration with Merck KGaA, Darmstadt, Germany to develop FoundationOneLiquid CDx and FoundationOneCDx as companion diagnostics in the U.S. market for selected marketed and pipeline treatments (Press release, Foundation Medicine, JUN 5, 2023, View Source [SID1234632502]). This new agreement builds on the data solutions partnership Merck KGaA, Darmstadt, Germany and Foundation Medicine entered in 2020 to help accelerate the development of novel targeted therapies, individually and in combination.

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"We look forward to ongoing collaboration as they leverage our portfolio of end-to-end solutions to generate meaningful evidence, help optimize therapy development, and deliver companion diagnostic solutions using our tissue and liquid comprehensive genomic profiling tests."

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If the companion diagnostic indications are approved, based on tissue availability and the presentation of individual patients, oncologists will be able to use FoundationOne CDx or FoundationOne Liquid CDx to identify those with genomic alterations that may make them eligible for a specific targeted therapy.

"We’re proud to announce this new phase of our partnership with Merck KGaA, Darmstadt, Germany, and continue building on our shared commitment to advance personalized treatment options for patients," said Jason Adams, vice president of biopharma enterprise partnerships at Foundation Medicine. "We look forward to ongoing collaboration as they leverage our portfolio of end-to-end solutions to generate meaningful evidence, help optimize therapy development, and deliver companion diagnostic solutions using our tissue and liquid comprehensive genomic profiling tests."

Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offer physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. The company’s robust suite of data and assay solutions support biopharmaceutical organizations as they work to design and deliver new targeted therapies, starting with biomarker discovery and clinical trial enrollment through to companion diagnostic development and commercialization.

On June 5, 2023 CatalYm reported first Phase 2a data from its ongoing GDFather-2 trial (GDF-15 Antibody-mediaTed Human Effector Cell Relocation Phase 2) (NCT04725474) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2023 in Chicago, Illinois (Press release, Catalym, JUN 5, 2023, View Source [SID1234632501]). The early data presented during today’s oral "Developmental Therapeutics-Immunotherapy" session revealed lasting and confirmed responses in several solid tumor types investigated following treatment with visugromab and the anti-PD-1 inhibitor nivolumab. In addition, the combination continues to demonstrate a good safety and tolerability profile across all cohorts. CatalYm’s lead candidate, visugromab, is a humanized, monoclonal antibody designed to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15), a central regulator of tumor resistance development.

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"These early data from our Phase 2a cohorts corroborate the encouraging anti-tumor-response we have seen in the Phase 1 study and further elucidate the considerable therapeutic potential of visugromab in very advanced and anti-PD1/PD-L1 relapsed/refractory solid tumor patient populations. They also confirm and further refine our scientifically guided indication selection to identify the solid tumor patients that would most benefit from a GDF-15 modulating approach," said Prof. Dr. Eugen Leo, Chief Medical Officer at CatalYm.

The presentation at ASCO (Free ASCO Whitepaper) by International Coordinating Investigator Prof. Dr. Ignacio Melero Bermejo, MD, Co-Director of Immunology and Immunotherapy (CIMA) at the Universidad de Navarra, Pamplona/Spain, builds on the further matured Phase 1 trial data announced in September 2022 which showed a significant clinical benefit in last line tumor patients that were anti-PD1/-L1 relapsed or refractory with an overall response rate of 17% in an advanced-stage mixed tumor population (RECIST, all responses confirmed). The Phase 2a study cohorts were selected based on a translational research program and include several major solid tumor types identified in Catalym’s translation research program as potentially being GDF-15 influenced.

The emerging phase 2a efficacy data further extend the initial encouraging data from Phase 1 with durable, confirmed responses as per RECIST criteria in several major tumor indications. Furthermore, investigation of potentially response-predictive biomarkers identified during phase 1 dose-escalation are ongoing through tumor biopsy analyses. The cumulative safety and tolerability profile for the Phase 1/2a study confirmed, so far, a well-acceptable safety profile when treating advanced-stage cancer patients, an important aspect for combination therapy in this critically ill patient population and earlier treatment lines.

Dr. Phil L’Huillier, Chief Executive Officer at CatalYm added: "The data revealed in today’s presentation illustrate the strides we have made in developing a completely novel treatment option by neutralizing GDF-15 in a variety of indications. We will continue in our broad multi-arm Phase 2 development program (GDFATHER-2) in 2023 and anticipate sharing more data and an update on our late-stage clinical development strategy later this year. I am grateful for the study patients and dedicated clinicians who have been a part of our clinical development program to this stage."

The Phase 2a GDFATHER-2 program was initiated in March 2022. The ongoing study consists of two segments with up to seven cohorts, expected to enroll a total of over 200 patients in Simon-2-stage designs and in a biomarker-evaluation directed cohort.

Mature data readouts for efficacy and safety data of the core phase 2a program as well as main biomarker-correlations are expected to become available before the end of 2023.

About the GDFATHER-2 Trials

The GDFATHER-2a trial (GDF-15 Antibody-mediaTed Human Effector Cell Relocation Phase 2) (NCT04725474) is an ongoing Phase 2a trial with several cohorts investigating the effect of visugromab (CTL-002) as monotherapy and/or in combination with a PD-1 checkpoint inhibitor in patients in various advanced-stage, relapse/refractory solid tumor types and a biomarker-selected cohort. The study can enroll > 200 patients in Simon-2-stage designs and a biomarker-evaluation directed cohort to confirm certain response rates and potential biomarker-based responder patient selection.

About Visugromab (CTL-002)

Visugromab is a humanized monoclonal antibody that neutralizes the tumor-derived Growth Differentiation Factor-15 (GDF-15). GDF-15 is an essential player in feto-maternal tolerance, a powerful mechanism that cancer cells hijack to create an immunosuppressive environment to evade destruction. By neutralizing GDF-15, visugromab reverses the immunosuppressive effects that block an efficient anti-tumor immune response in the tumor microenvironment and the draining lymph nodes. Visugromab drives an activated and differentiated immune cell infiltration into the solid tumor as well as enables priming of T cells and enhances the tumor killing effects of T cells and NK cells. GDF-15 is currently investigated in an ongoing Phase 2 program that includes confirmatory studies in multiple solid tumor indications and the analysis of a predictive response biomarker to better identify the patients benefiting from this new class of immunotherapy.

On June 5, 2023 Oncoinvent AS, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, reported the presentation of new 15-month safety and efficacy data from its ongoing Phase 1/2A clinical trial evaluating the safety, tolerability, and signal of efficacy of Radspherin in patients with peritoneal carcinomatosis from colorectal cancer at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held at McCormick Place in Chicago, IL from June 2- 6, 2023 (Press release, Oncoinvent, JUN 5, 2023, View Source [SID1234632500]). The poster, titled "15-month safety and efficacy data after intraperitoneal treatment with 224Radium-labelled microparticles after CRS-HIPEC for peritoneal metastasis from colorectal cancer" will be presented by Dr Stein Larsen from the Norwegian Radium Hospital during the "Gastrointestinal Cancer – Colorectal and Anal" session from 8:00 a.m. to 11:00 a.m. ET on June 5, 2023. There will additionally be a poster discussion session from 1:15 p.m. to 2:45 p.m. on June 5, 2023.

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"We are excited to share these compelling and critical safety and efficacy 15-month data at ASCO (Free ASCO Whitepaper), which continue to demonstrate that recommended dose levels of Radspherin are well tolerated and now also showing promising effects on recurrence levels," said Kari Myren, Chief Medical Officer of Oncoinvent. "The data presented continue to give us confidence in the potential of Radspherin to prolong time to peritoneal recurrence and improving progression free survival in patients with a difficult prognosis. In particular, with the recommended dose cohort of 7 MBq, only 25% of patients recurred and none of these patients had peritoneal recurrences; these data are highly encouraging and represents an improvement compared to the expectations of the current standard of care. We look forward to presenting longer-term results of Radspherin for both ongoing Phase 1/2A studies to treat peritoneal carcinomatosis from colorectal cancer and ovarian cancer, respectively."

Details of the poster presentation are as follows:

Poster Presentation Title: 15-month safety and efficacy data after intraperitoneal treatment with 224Radium-labelled microparticles after CRS-HIPEC for peritoneal metastasis from colorectal cancer.
Session Title: Poster Discussion Session – Gastrointestinal Cancer—Colorectal and Anal
Poster Session Display Date and Time: 6/5/2023, 8:00 a.m.-11:00 a.m. ET
Poster Board Number: 218
Poster Discussion Session Date and Time: 6/5/2023, 1:15 p.m.-2:45 p.m. ET

This Phase 1/2A study is designed to evaluate the safety, tolerability, and signal of efficacy of Radspherin injected intraperitoneally two days after the completion of CRS-HIPEC. A dose of 7 MBq was recommended following the completion of dose escalation 1-2-4-7 MBq. A total of 23 patients with peritoneal metastasis from colorectal cancer were enrolled; 12 received the recommended dose of 7MBq with 9 receiving a single dose and 3 receiving split doses of 3.5 MBq each. Assessment of safety and efficacy was performed every three months; this dataset includes safety and survival data at the 15-month mark.

Key results:

Only 2.5% of all adverse events reported were found to be related to Radspherin, all of which were grade 1-2
No serious adverse events were reported as related to the treatment of Radspherin
At 15 months, 39% of patients had recurred, with less than half recurring in the peritoneum
25% of patients recurred with the recommended dose cohort of 7MB but none had peritoneal recurrences
Median PFS was not reached in both populations
Radspherin is also being evaluated at the 7Mbq dose in a Phase 1 clinical trial in subjects with peritoneal carcinomatosis from ovarian cancer following complete cytoreductive surgery.

On June 5, 2023 CERo Therapeutics, Inc. ("CERo"), an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, and Phoenix Biotech Acquisition Corp. (NASDAQ:PBAX) ("PBAX"), a special purpose acquisition company formed for the purpose of acquiring or merging with one or more businesses, reported they have entered into a definitive business combination agreement (Press release, Cero Therapeutics, JUN 5, 2023, View Source [SID1234632499]). Upon closing of the transaction, anticipated to occur in the second half of 2023, the combined company will be named CERo Therapeutics Holdings, Inc. and will be led by CERo and PBAX’s founding members, including Daniel Corey, M.D., CERo’s CEO, Chris Ehrlich, PBAX’s CEO, and Brian G. Atwood, the Chairman of PBAX. The combined company’s common stock is expected to be listed on the Nasdaq Capital Market under the ticker symbol "CERO." Mr. Atwood will serve as Chief Executive Officer of the combined company, Mr. Ehrlich will serve as its Chief Financial Officer and Chief Operating Officer and Dr. Corey will serve as its Chief Technology Officer.

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"We are thrilled to join forces with PBAX ," said Daniel Corey, CEO of CERo. "With CERo technology we see an opportunity to engage the body’s full immune repertoire for optimized cellular immunotherapy. Chris and Brian bring a wealth of experience to the CERo team during this important time as we look to test the first CER T cell therapeutic candidate in the clinic."

"After an exhaustive search for the right target for PBAX, we are thrilled to merge with CERo. The talented founding team has done a tremendous job of creating value in a timely and capital efficient manner and we look forward to working together with them to advance their promising technology to the next level," stated Chris Ehrlich, CEO and director of PBAX.

"CERo technology is an exciting step forward in cancer cell therapy and I’ve been following the significant progress the company has made since its first round of institutional funding in 2019," said Brian G. Atwood, Chairman of PBAX. "I’m excited to join Daniel Corey and his team to lead the company’s first therapy, CER-1236, into clinical trials beginning in lymphoma and leukemia, and shortly afterward solid tumors."

CERo Therapeutics is pioneering a new and powerful class of cell-based therapies that combine the innate and adaptive arms of the immune system into single T cells, effectively creating cells that both phagocytose ("eat") and lyse ("explode") targeted cancer cells. This technology drives a more comprehensive and durable anti-tumor response, and demonstrated this in the company’s experiments. Since its Series A financing in 2019, the company has repeatedly demonstrated the ability to destroy cancer cells and tumors across several experimental models of liquid and solid tumors, in both in vivo and in vitro experiments. The company plans to file its first IND in 2024.

The resources of the combined company are expected to provide CERo with the capital to advance CER-1236, its lead product candidate, into clinical trials for hematologic malignancies and expand the clinical development of CER-1236 into other difficult to treat cancers, including solid tumors.

Key Transaction Terms

Upon the closing of the business combination, and assuming no redemptions of shares of PBAX by its public stockholders, CERo would expect to receive up to $13.7 million of cash held in trust. The business combination reflects a pre-money equity value of $50 million for CERo and a pro forma capitalization of the combined company of $145 million. The business combination is subject to a minimum cash condition of $30 million, net of transaction expenses, which is expected to be funded through proceeds of the trust account and additional financing, including investments from existing stockholders of CERo. The parties intend to seek to secure such additional financing through a private placement.

The boards of directors of both CERo and PBAX have unanimously approved the proposed transaction with expected completion in the second half of 2023. The closing of the transaction is subject to approval of PBAX shareholders and the satisfaction, or waiver of, the minimum cash condition and certain other customary closing conditions.

Additional information about the transaction will be provided in a Current Report on Form 8-K to be filed by PBAX with the Securities and Exchange Commission ("SEC") and will be available on the SEC’s website at www.sec.gov. In addition, PBAX intends to file a registration statement on Form S-4 with the SEC, which will include a proxy statement/prospectus, and will file other documents regarding the proposed transaction with the SEC.

Advisors

Cooley LLP and Ellenoff Grossman & Schole LLP are acting as legal counsel to CERo. Cohen and Company Capital Markets, a Division of J.V.B. Financial Group, LLC is acting as the financial advisor and lead placement agent to PBAX. Goodwin Procter LLP is serving as legal counsel to PBAX.

On June 5, 2023 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, reported data from a Phase 1/1b clinical study of FID-007 in treating various solid tumors was presented in a poster session at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL on June 3, 2023 (Press release, Fulgent Pharma, JUN 5, 2023, View Source [SID1234632498]).

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Of 40 evaluable patients with weekly dose levels from 15 mg/m2 to 160 mg/m2, 7 (18%) had a partial response by RECIST 1.1 (pancreatic, biliary tract, and HNSCC) and 14 (35%) had stable disease. Three out of 4 HNSCC patients with PR had previously been treated with taxane. The duration of follow-up (months), median (range) is 12.0 (0.4 – 38.9). No high-grade neuropathy has been noted to date. FID-007 demonstrates preliminary evidence of anti-tumor activity in heavily pre-treated patients across various tumor types. Based on overall tolerability, pharmacokinetics, and efficacy, 125mg/m2 has been chosen as the recommended Phase 2 dose (RP2D).

Commenting on the data, Ming Hsieh, Chairman of the Board and Chief Executive Officer, said, "We are pleased with the progress we are making with the clinical program for FID-007 and this encouraging data, that FID-007 may potentially address a number of unmet needs in various cancers. We look forward to next steps with this program, including initiation of a Phase 2 clinical study for the treatment of head and neck cancer later this year or early next year."

The poster is available on the News & Events section of the company’s Investor Relations website at View Source

About FID-007

FID-007 consists of paclitaxel encapsulated in a polyethyloxazoline (PEOX) polymer excipient designed to enhance PK, biodistribution, and tolerability. In addition to allowing the drug to remain in solution until it can enter a cancer cell, the PEOX nanoparticle is designed to preferentially deliver paclitaxel to the tumor through the leaky hyperpermeable vasculature.