On October 17, 2022 Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the first patient has been dosed in the Phase 2 portion of its registrational Phase 1/2 clinical trial evaluating GC007g for the treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL) being conducted in China (Press release, Gracell Biotechnologies, OCT 17, 2022, View Source [SID1234622066]).

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GC007g is Gracell’s allogeneic, human leukocyte antigen (HLA)-matched, donor-derived, CD19-directed CAR-T cell therapy candidate under development for the treatment of a subset of B-ALL patients who relapsed after allogeneic human stem cell transplant (allo-HSCT). This donor-derived CAR-T approach has been designed for r/r B-ALL patients who may not be eligible for autologous CAR-T therapy due to poor cell fitness, infections, and other unsuitable conditions.

Data from the Phase 1 trial showed encouraging efficacy and a favorable safety profile. The registrational Phase 2 trial is being conducted in China and will further assess the safety and efficacy of GC007g in r/r B-ALL patients at the recommended Phase 2 dose.

"B-ALL patients that relapse after allo-HSCT therapy often face poor prognoses, and remain a patient population with a clear unmet medical need. Donor-derived CAR-T therapy could provide a new option to some of these patients who might be ineligible for other treatments including autologous CAR-T therapy," said Dr. Wendy Li, Chief Medical Officer of Gracell. "We believe GC007g is a potential first-in-class donor-derived allogeneic CAR-T therapy in China. GC007g is also Gracell’s first therapeutic candidate to enter a registrational trial, marking an important milestone in our quest to transform cell therapy."

About GC007g

GC007g is an allogeneic CD19-targeted CAR-T cell therapy, derived from HLA-matched donors, under development for the treatment of r/r B-ALL patients who failed transplant and may not be eligible for autologous CAR-T therapy.

About ALL

Acute lymphoblastic leukemia (ALL) is a type of blood cancer characterized by proliferation of immature lymphocytes in the bone marrow, which can involve either T lymphocytes (T-ALL), or B lymphocytes (B-ALL). Globally, approximately 64,000 patients are diagnosed with ALL every year with an estimated 6,660 new cases to be diagnosed in the United States in 2022 [1]. B-ALL accounts for 75% of ALL diagnoses in adults.

On October 17, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported that an abstract reporting on preclinical studies of two the company’s oncology pipeline products targeting multiple types of cancer has been accepted for presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy 2022 (Press release, PDS Biotechnology, OCT 17, 2022, View Source [SID1234622065]). The AACR (Free AACR Whitepaper) Tumor Immunology and Immunotherapy Conference is being held October 21-24, 2022, in Boston.

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Versamune is PDS Biotech’s novel investigational T cell activating platform designed to stimulate a precise immune system response to cancer-specific proteins. The abstract accepted for presentation at the AACR (Free AACR Whitepaper) Tumor Immunology and Immunotherapy Conference highlights the development of Versamune based drug formulations containing multi-epitope peptide antigen sequences of the tumor-associated protein TARP (T cell receptor gamma chain Alternate Reading frame Protein) and modified sequences of novel Mucin 1 oncoprotein (MUC1). This research provided the foundation for the development of PDS0102 as a potential treatment for TARP-associated acute myeloid leukemia (AML), prostate, and breast cancers, and PDS0103 as a potential treatment for MUC1-associated breast, colon, lung, ovarian, and other cancers.

"Our Versamune platform provides an opportunity to address a myriad of cancers by combining the technology with unique proteins or peptides that are specific to the cancer. The research accepted for presentation at the AACR (Free AACR Whitepaper) Tumor Immunology and Immunotherapy Conference highlights this important versatility of the platform and, specifically, the rationale for our PDS0102 and PDS0103 programs," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "We welcome the opportunity to present at such a highly influential conference. Based on recently reported clinical results from our ongoing studies of PDS0101 in HPV-positive cancers such as anal, cervical, head and neck, penile, vaginal, and vulvar cancers, we continue to expand our Versamune based programs into TARP-associated AML, prostate and breast cancers, and MUC1-associated breast, colon, lung, ovarian and other cancers."

Poster Number: B24
Abstract Title: Development of targeted T cell cancer immunotherapies based on a novel enantiomeric cationic lipid that promotes antigen cross-presentation and upregulation of type I interferons
Authors: Siva K. Gandhapudi, Karuna Sundarapandiyan, Martin Ward, Afsheen Fatima, Mania Dorrani, Mary Banoub, Joe Dervan, Lauren Wood, Greg Conn, and Jerold G. Woodward
Session Date and Time: Sunday, October 23 at 6:00-8:30 pm ET

On October 17, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported the award of a U.S. Federal Supply Schedule contract which includes the Veterans Health Administration providing care for U.S. Veterans and Military Health System providing care for active-duty service members and their families (Press release, Biodesix, OCT 17, 2022, View Source [SID1234622064]). The contract covers the company’s entire lung diagnostic portfolio: Nodify XL2, Nodify CDT, VeriStrat, GeneStrat ddPCR, and GeneStrat NGS testing. The U.S. Department of Veterans Affairs ("VA") is the largest integrated health care system in the United States and provides care at 1,298 health care facilities, including 171 VA Medical Centers and 1,113 outpatient sites of care of varying complexity to over 9 million veterans enrolled in the VA health care program.

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"Partnering with the VA health system represents a large opportunity for Biodesix to help improve care for Veterans by integrating our five diagnostic tests into our country’s largest health system," said Scott Hutton, CEO of Biodesix. "An estimated 900,000 Veterans face an elevated risk and a 25% higher likelihood of developing lung cancer compared to the general population. We pride ourselves on being a patient-centric lung disease company, focused on providing healthcare professionals with diagnostic tools capable of transforming the standard of care and improving outcomes. We are pleased to be aligning with the VA in this effort to improve care for our Veterans."

Lung cancer is the deadliest cancer worldwide and despite the large number of treatments available to improve patient outcomes, it remains an area of unmet needs. Biodesix offers healthcare providers and patients a comprehensive suite of diagnostic tests capable of supporting clinical decision-making across the lung cancer continuum – from initial risk assessment of lung nodules with the Nodify Lung testing strategy, to post-cancer diagnosis treatment guidance and monitoring with the IQLung testing strategy. The Biodesix Nodify Lung testing strategy consists of two blood-based proteomic tests, the Nodify CDT and Nodify XL2 tests, designed to help healthcare professionals quickly and confidently decipher the risk of malignancy of a lung nodule. The Company’s IQLung Treatment Guidance testing consists of three blood-based tests, the GeneStrat NGS and the GeneStrat ddPCR genomic tests, and the VeriStrat proteomic test, which together provide a broader view of each patient’s disease state and empower healthcare professionals with a testing strategy for any stage of non-small cell lung cancer (NSCLC), delivering timely biological insights to help expedite personalized treatment decisions.

On October 17, 2022 NKGen Biotech, Inc., a biotechnology company harnessing the power of the body’s immune system through the development of natural killer (NK) cell therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance to commence a Phase 1, open-label, dose-escalation study of its cryopreserved "off-the-shelf" allogeneic blood-derived NK cell therapy (SNK02) to evaluate safety and tolerability in participants with pathologically confirmed solid tumors refractory to standard of care therapy (Press release, NKMax America, OCT 17, 2022, View Source [SID1234622063]).

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"We are excited to be able to proceed with our SNK02 clinical trial plans for treating refractory cancer patients who are left with limited options," said Paul Song, M.D., Vice Chairman of NKGen Biotech. "I believe that SNK02 is the first cryopreserved allogeneic NK cell therapy that does not require lymphodepletion before administration unlike other cell therapies. This clearance for SNK02 is an important milestone in our pursuit to bring life-changing therapies to cancer patients and will be our second clinical NK cell therapy program focusing on solid tumors, following our SNK01 autologous product entering Phase 2 studies next year."

The SNK02 clinical study will be a multi-center, open label, Phase 1 study of SNK02 in patients with advanced solid tumors who have failed at least one prior standard of care therapy. The objectives are to evaluate the safety and tolerability of SNK02 and to determine the maximum tolerated dose. Initiation of the Phase 1 study in the U.S. is expected in Q1 2023.

NKGen Biotech’s patented manufacturing process produces billions of NK cells with a high level of purity and receptor expression while our cryopreservation process allows us to maintain significant cytotoxicity making SNK02 an ideal candidate for clinical trials treating solid tumors. The company expects to see promising clinical results in the future as it continues to advance its cell therapy pipeline to address areas of unmet medical needs.

On October 17, 2022 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that preclinical data for its two lead RAS programs – a next-generation KRASG12C dual inhibitor program and a novel PI3Kα:RAS breaker program – in an oral presentation at the Fourth RAS Initiative Symposium in Frederick, MD (Press release, BridgeBio, OCT 17, 2022, View Source [SID1234622062]). BridgeBio will also be hosting an investor call at 1:30 ET today to discuss the data.

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KRAS G12C dual inhibitor:
BridgeBio has selected a next-generation KRASG12C dual inhibitor development candidate, BBO-8520, and plans to enter the clinic in 2023. BBO-8520 is the first-known small molecule that directly binds and inhibits KRASG12C in both its active (GTP bound) and inactive (GDP bound) conformations. BridgeBio believes this could lead to differentiated activity in cancer patients with KRASG12C driven disease, as all other known clinical stage direct KRASG12C inhibitors do not inhibit the active oncogenic form of the protein (GTP-bound KRASG12C).

Presentation highlights:
The KRASG12C GTP/GDP dual inhibitor development candidate

Using mass spectrometry, BBO-8520 was shown to completely modify both GTP (active) and GDP (inactive) forms of KRASG12C
BBO-8520 shows exceptional potency and selectivity – significantly greater potency than first-generation KRASG12C GDP-only inhibitors across multiple in vitro and in vivo assays including KRASG12C:RAF1 effector binding
Targeting KRASG12C GTP allows BBO-8520 to overcome growth factor override that is an important source of resistance for 1st-generation KRASG12C GDP-only inhibitors
BBO-8520 shows strong efficacy in KRASG12C models, including deep regressions in an NSCLC model and differentiated activity vs a first-generation KRASG12C GDP-only inhibitor in a patient-derived xenograft model
PI3Kα:RAS breaker:
BridgeBio is also pursuing PI3Kα:RAS breakers, small molecules that block RAS driven PI3Kα activation. Inhibiting PI3Kα activity by preventing its interaction with RAS can provide a "tumor selective" mechanism that spares glucose metabolism. This novel approach could, if successful, potentially have broad utility against oncogene-driven tumors (including RAS mutant tumors, PI3Kα mutant tumors, and tumors driven by RTK activation of RAS signaling) as both a monotherapy and in combination with other agents.

Presentation highlights:
PI3Kα:RAS breakers

Exhibited potent inhibition of AKT activation in KRAS G12X, PIK3CA helical mutation and HER family driven populations
Showed potent efficacy in multiple models without hyperglycemia, a common dose-limiting adverse reaction among PI3Kα kinase inhibitors
"We are excited about our next-generation KRASG12C GTP/GDP dual inhibitor development candidate and are hopeful that it has the opportunity to deliver improved outcomes for patients given the considerable unmet need remaining in the KRAS-driven cancer space," said Eli Wallace, Chief Scientific Officer, Oncology at BridgeBio. "We also think that the progress of our novel PI3Kα:RAS breaker program is very compelling, especially its in vivo demonstration of efficacy without hyperglycemia, which has proven a challenge for standard PI3Ka inhibitor treatments. We look forward to developing both programs further and hope to be able to serve the patients impacted by these two common oncogenes who are in need of innovative treatments."

Webcast Information
BridgeBio will host an investor call and simultaneous webcast to discuss preclinical data from both lead RAS programs and the selection of the KRASG12C dual inhibitor development candidate today, October 17, 2022, at 1:30 pm ET. To access this call via phone, participants will need to register using the following link where they will be provided a phone number and access code: (https://register.vevent.com/register/BIbd4d7a752dcc4ade970571556d4060e5). The webcast and presentation slides can be viewed during the time of the call via a link on the event calendar page of BridgeBio’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website and will be available for at least 30 days following the event.