On September 6, 2022 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported the publication of two abstracts that have been accepted for poster presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, which is taking place both virtually and at the Paris Expo Porte de Versailles in Paris, France from September 9 – 13, 2022 (Press release, Cardiff Oncology, SEP 6, 2022, View Source [SID1234619053]).

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The full texts of the published abstracts can be found on the ESMO (Free ESMO Whitepaper) Congress 2022 website. Details on the corresponding posters are shown below.

Poster Title: The PLK1 Inhibitor Onvansertib Overcomes Irinotecan Resistance in RAS-mutated (mRAS) Metastatic Colorectal Cancer (mCRC) In Vivo and in Patients
Speaker:
Poster Number:
Scott Kopetz, M.D., Ph.D.
366P
Session Title: Poster Session 7
Session Date: September 11, 2022
Session Hours: 9:00 AM – 5:00 PM CEST
Location: Poster Area, Hall 4

The abstract includes findings from an Expanded Access Program (EAP) in which patients with KRAS-mutated metastatic colorectal cancer (mCRC) who failed or progressed on standard-of-care, including irinotecan, were treated with onvansertib in combination with FOLFIRI/bevacizumab. These findings showed that early changes in KRAS mutant allelic frequency (MAF) were associated with increased benefit in the EAP. In addition, the abstract includes results from murine studies in patient-derived xenograft (PDX) models of RAS-mutated, irinotecan-resistant colorectal cancer. These data, together with findings from the EAP, suggest onvansertib can overcome irinotecan resistance in RAS-mutated colorectal cancer. Additional findings from the EAP and data from murine studies will be announced during the upcoming congress, in accordance with ESMO (Free ESMO Whitepaper)’s embargo policies.

Poster Title: Early Decreases in KRAS Mutant Allele Frequency (MAF) Predicts Clinical Benefit to the PLK1 Inhibitor Onvansertib in Combination with FOLFIRI/bev in 2L treatment of metastatic colorectal carcinoma (mCRC)
Speaker:
Poster Number:
Heinz-Josef Lenz, M.D.
397P
Session Title: Poster Session 8
Session Date: September 11, 2022
Session Hours: 9:00 AM – 5:00 PM CEST
Location: Poster Area, Hall 4

The abstract includes data from an ongoing Phase 1b/2 trial evaluating onvansertib in combination with FOLFIRI/bevacizumab in second-line KRAS-mutated mCRC. The data show that the subset of patients with ≥90% decreases in KRAS MAF in circulating tumor DNA after one cycle of treatment had a significantly greater objective response rate and significantly longer progression-free survival compared to the subset of patients with decreases in KRAS MAF <90%. Additional findings from the trial will be announced during the upcoming congress, in accordance with ESMO (Free ESMO Whitepaper)’s embargo policies.

Clinical and Corporate Update Conference Call and Webcast
Cardiff Oncology will host a webcast and conference call to provide a clinical and corporate update on Monday, September 12, 2022 at 4:30 PM ET. The event will feature discussions on the planned development pathway for onvansertib in KRAS-mutated metastatic colorectal cancer and updates on other development programs. In addition, company management will provide data updates from ongoing clinical trials. To access the call, please dial 1-877-407-9208 (domestic) or 1-201-493-6784 (international) and refer to conference ID 13731618. The conference call will also be webcast live and a link to the webcast can be accessed here. A replay of the webcast will be available by visiting the "Events" section of the Cardiff Oncology website after its conclusion.

On September 6, 2022 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of Master Key therapies, reported that its President and Chief Executive Officer, David M. Epstein, Ph.D., will present an update on the Company’s progress at the H.C. Wainwright 24th Annual Global Investment Conference (Press release, Black Diamond Therapeutics, SEP 6, 2022, View Source [SID1234619071]). The presentation will be available for on-demand viewing beginning Monday, September 12, 2022, starting at 7:00 AM ET.

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Black Diamond Therapeutics management will also participate in investor meetings at the Morgan Stanley 20th Annual Global Healthcare Conference being held from Monday, September 12th to Wednesday, September 14th, 2022, in New York, NY.

A webcast of the H.C. Wainwright presentation can be accessed by visiting the investors relations section of the Company’s website at: www.blackdiamondtherapeutics.com. A replay of the webcast will also be available and archived on for 90 days following the event.

On September 6, 2022 NaNotics LLC, a biopharmaceutical company developing NaNots, novel subtractive nanoparticles that treat disease by capturing and clearing pathogenic molecules from blood, reported a research collaboration with Mass General Cancer Center, a program of Massachusetts General Hospital (MGH) in Boston, to develop NaNots that target the soluble forms of Tumor Necrosis Factor Receptors, which are tumor-generated immune inhibitors, with the goal of initiating human trials by mid-2024 (Press release, NaNotics, SEP 6, 2022, View Source [SID1234619088]).

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Tumor necrosis factor-alpha (TNF-α) is an essential immune signaling molecule which, as the name implies, is toxic to cancer and other abnormal cells. Immune cells kill bad cells by delivering TNF-α to TNF receptors on the target cell membrane, inducing apoptosis (cell death). However, most if not all malignant tumors inhibit TNF-α by cleaving off the extracellular domains of their TNF receptors, producing a soluble receptor form called "sTNF-Rs". sTNF-Rs neutralize TNF-α molecules secreted by immune cells, preventing them from inducing apoptosis in cancer cells, thereby enabling immune evasion. This bioanimation by the Company illustrates the process.

sTNF-Rs have been undruggable targets. Functional membrane TNF receptors (mTNF-Rs) are essential for a broad range of normal immune functions. A drug that neutralizes sTNF-Rs would also block mTNF-Rs, given that the binding sites of both forms are identical. Instead, NaNots deplete soluble targets – in this case sTNF-Rs – without blocking membrane forms of the same target – in this case mTNF-Rs. NaNots represent a novel form of immunotherapy, targeting an important new immunosuppressive pathway. NaNots have been tested for safety in rodents at up to 100x the planned human dose, with no observed toxicity.

The MGCC team is led by Keith Flaherty, M.D., Director of Clinical Research and a Professor of Medicine at Harvard Medical School. Dr. Flaherty is also a co-founder of multiple cancer therapeutics companies, including Loxo Oncology. Dr. Flaherty’s team includes Justin Gainor, MD, Director of Targeted Immunotherapy at MGCC.

"Despite the profound benefits of PD-1/PD-L1 antibody-based immunotherapy for approximately 10% of cancer patients, it is clear that we have not yet overcome the primary basis for immune evasion in the vast majority of cancer patients," said Dr. Flaherty. "TNF-α has been on the very short list of desired mechanisms to leverage for decades, but has been largely forgotten because there has been no feasible way of selectively delivering TNF-α to tumor cells. The NaNotics approach overcomes this barrier by depleting the molecules that tumor cells produce and shed in order to intercept TNF-α produced by immune cells."

"NaNotics is delighted to be collaborating with the Mass General Cancer Center in the study of NaNots against sTNF-Rs," said Lou Hawthorne, CEO of NaNotics and the inventor of NaNots. "We’re especially excited to be working with Dr. Flaherty – a brilliant scientist and clinician with a record of innovation and success – and his colleagues at MGCC, including Dr. Gainor, an expert in immunotherapy. They bring deep scientific insight and a wealth of clinical trial experience to our collaboration, enabling translation of the NaNot platform from novel science into therapeutics of potential benefit to millions of patients suffering deadly cancers."

As part of the collaboration, NaNotics will produce pre-clinical and then clinical NaNots against sTNF-Rs. MGCC will provide patient samples for preclinical validation of NaNots, following which the teams will work together on clinical trial design, leading to a study of NaNots against sTNF-Rs in cancer patients, centered at MGCC in 2024.

On September 6, 2022 DURECT Corporation ( Nasdaq: DRRX) reported that Dr. James E. Brown, President and CEO will be presenting virtually at the H.C. Wainwright 24th annual Global Investment Conference (Press release, DURECT, SEP 6, 2022, https://www.prnewswire.com/news-releases/durect-corporation-to-present-at-the-hc-wainwright-global-investment-conference-301617467.html [SID1234619107]).

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The webcast link of the presentation will also be available by accessing DURECT’s homepage at www.durect.com and clicking on "Event Calendar" under the "Investors" section.

Management will also be available for virtual 1×1 meetings from September 12-14, 2022 during the conference. If attendees would like to request a meeting, please contact H.C. Wainwright directly.

On September 6, 2022 Arsenal Biosciences, Inc. (ArsenalBio), a privately held programmable cell therapy company engineering advanced CAR T therapies for solid tumors, reported the close of a $220 million Series B financing round (Press release, Arsenal Bio, SEP 6, 2022, View Source [SID1234619017]). New investors Softbank Vision Fund 2, Bristol-Myers Squibb Company, Byers Capital, Emerson Collective Investments, Green Sands, Hitachi Ventures, Sixth Street, and others joined existing investors the Parker Institute for Cancer Immunotherapy (PICI), Westlake Village BioPartners, the University of California, San Francisco (UCSF) Foundation Investment Company, Euclidean Capital, Waycross Ventures, and Kleiner Perkins, in supporting the oversubscribed round.

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Proceeds from the financing will help the company expand its programmable cell therapy research activities and grow its pipeline of therapeutic candidates for solid tumor malignancies across a range of cancer indications. The fundraising comes as the company begins planning for clinical trials of its lead program AB-1015, an ovarian cancer candidate for which FDA IND clearance and first patient dosing are targeted for later this year. The company also has candidates in early development for kidney, prostate, and other cancer indications.

"ArsenalBio’s programmable cell therapy technology has shown great promise in preclinical development, giving us confidence that our approach may help address the unmet medical needs of cancer patients, ultimately helping alleviate human suffering," said Ken Drazan, M.D., ArsenalBio’s founder and Chief Executive Officer. "We look forward to entering the clinic so we can more fully understand the promise of our technology in treating ovarian and ultimately other devastating cancers."

Valentin (Vali) Barsan, M.D., investor for SoftBank Investment Advisers and attending pediatric oncology physician at Stanford University School of Medicine, has joined the ArsenalBio Board of Directors. He holds a medical degree from the Baylor College of Medicine and has clinical experience with the use of both FDA-approved as well as investigational CAR T cell therapies in pediatric and adult liquid and solid tumors. In addition to ArsenalBio, he serves on the Board of Directors for Neuron23 and Umoja Biopharma.

"Whereas CAR T-cell therapy has shown remarkable success in hematological malignancies, solid tumors have proven more challenging. Advances in genome engineering technologies such as CRISPR-Cas enable us to perceive mechanisms and develop tools that address T-cell exhaustion and improve memory, retain stemness, and enable persistence. I look forward to working closely with the ArsenalBio team to improve cancer immunotherapy through synthetic and computational biology techniques that will advance our ability to apply these cutting-edge therapies in patient care," said Dr. Barsan.