On September 29, 2020 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported a collaboration with Cullinan Oncology (Press release, Applied BioMath, SEP 29, 2020, View Source [SID1234567769]). Applied BioMath will develop a systems pharmacology model for CLN-049, a novel FLT3XCD3 bispecific antibody for Acute Myeloid Leukemia, being developed by Cullinan Florentine, a Cullinan Oncology company. This model will be used to determine first in human starting dose and to predict efficacious dose range in the clinic. "We look forward to leveraging the proven modeling approaches of Applied BioMath in our development project," said Jennifer Michaelson, Chief Development Officer, Biologics at Cullinan Oncology. "We see significant potential for Applied BioMath’s modeling efforts to augment our program, from predicting starting dose and efficacious dose ranges and informing optimal dose regimens in the clinic, to helping us design efficacy studies in mice and tolerability studies in non-human primates."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Applied BioMath employs a rigorous fit-for-purpose model development process which aims to quantitatively integrate knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "Our mechanistic approach to systems pharmacology modeling is the most accurate way to translate across species and prepare for first in human doses," said Dr. John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "We look forward to leveraging our modeling expertise to help Cullinan Oncology advance their therapeutic to the clinic."

On September 29, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, reported that it has commenced an underwritten public offering of its shares of common stock (Press release, Cardiff Oncology, SEP 29, 2020, View Source [SID1234567768]). In addition, Cardiff Oncology expects to grant the underwriters a 30-day option to purchase up to an additional 15% of its shares of common stock sold in the public offering. All of the shares are being offered by Cardiff Oncology.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cardiff Oncology intends to use the net proceeds from this offering for clinical development of its product candidate, onvansertib, working capital and for other general corporate purposes.

Cowen and Piper Sandler & Co. are acting as joint book-running managers for the offering. H.C. Wainwright & Co., LLC is acting as lead manager for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 which has been filed with the U.S. Securities and Exchange Commission (SEC) and declared effective on July 1, 2019. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement relating to the offering will be filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, may be obtained, when available, from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected] and Piper Sandler & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

On September 29, 2020 Penumbra, Inc. (NYSE: PEN) reported that it will host a conference call to discuss financial results for the third quarter 2020 after market close on Wednesday, October 28, 2020 at 4:30 PM Eastern Time (Press release, Penumbra, SEP 29, 2020, View Source [SID1234567767]). Penumbra is hosting its call in advance of Election Day 2020, which will be a paid company holiday for Penumbra’s U.S. employees to support their right to participate in our democracy. A press release with third quarter 2020 financial results will be issued after market close on October 28, 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Webcast & Conference Call Information
The conference call can be accessed live over the phone by dialing (833) 350-1434 for domestic and international callers (conference id: 3538526), or the webcast can be accessed on the "Events" section under the "Investors" tab of the Company’s website at: www.penumbrainc.com. The webcast will be available on the Company’s website for at least two weeks following the completion of the call.

On September 29, 2020 Neuropore Therapies, Inc. reported that it has licensed two mechanistically distinct classes of potent, selective and brain penetrating modulators of mTOR–regulated autophagy to Global Cancer Technology (Press release, Neuropore Therapies, SEP 29, 2020, View Source [SID1234567766]). This portfolio of small molecule autophagy modulators, targeting PI3K and VPS34, was discovered by Neuropore Therapies and characterized using its comprehensive platform of autophagy and lysosomal biogenesis cellular assays. Neuropore Therapies will continue to investigate the utility of autophagy modulators for the treatment of neurodegenerative disorders while Global Cancer Technology will pursue the use of these PI3K and VPS34 inhibitors for the treatment of cancers and other life-threatening diseases.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Doug Bonhaus, CEO of Neuropore Therapies, commented, "Modulators of autophagy have therapeutic potential in a wide range of diseases including cancers, metabolic and neurodegenerative disorders. While Neuropore Therapies continues to explore the therapeutic potential of autophagy modulators for neurodegenerative disorders, we are very pleased to see the therapeutic potential of these PI3K and VPS34 targeted compounds pursued for additional indications."

On September 29, 2020 ITM Medical Isotopes GmbH, a subsidiary of the biotechnology and radiopharmaceutical group of companies ITM Isotopen Technologien München AG (ITM), Bruce Power, an electricity company, and IsoGen, a joint venture between the two nuclear energy companies Framatome and Kinectrics, reported that Bruce Power and IsoGen have set the first critical milestone for a reliable and consistent irradiation service which will be provided to ITM exclusively for 15 years (Press release, ITM Isotopen Technologien Munchen, SEP 29, 2020, View Source [SID1234567763]). Thereby a dedicated mock-up of the isotope production system was developed for validation, testing and training which will start in fall 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The medical radioisotope Lutetium-177 (177Lu) will be obtained by irradiating Ytterbium-176 at the Bruce Power Reactors, as contractually stipulated in an exclusive agreement between Bruce Power, IsoGen and ITM Medical Isotopes GmbH. Bruce Power Reactors are uniquely positioned to fulfil the necessary requirements to reach ITM’s high standards validated in a successful feasibility study September last year. The construction of the isotope production system at Bruce Power by IsoGen is currently planned to start in January 2021 once the mock-up has been fully tested. The mock-up is currently in the final phase of engineering, evaluation, and design and will allow validation and training before deploying the isotope production system to Bruce Power’s units.

The intermediate material to be generated at Bruce Power over 15 years will be processed by ITM via its unique manufacturing methodology to the highly pure form of 177Lu, no-carrier-added (n.c.a.) 177Lu (EndolucinBeta), at ITM´s global network of radiopharmaceutical production facilities. N.c.a. 177Lu is supplied by ITM to clinics worldwide and is used as a therapeutic radiopharmaceutical precursor for Targeted Radionuclide Therapy of cancers such as neuroendocrine tumors, prostate cancer, Non-Hodgkin’s lymphoma, bone metastases and several further indications.

Steffen Schuster, CEO of ITM commented: "Seeing the great progress in the development of the isotope production system by Bruce Power and IsoGen, we are confident that this partnership secures another high-quality source of Lutetium-177 for ITM which further increases scalability of our production ensuring a steady supply of n.c.a. Lutetium-177 on a global scale. Our clinical and industry partner’s demand for the radiopharmaceutical precursor no-carrier-added Lutetium-177 is constantly growing and as a company we are dedicated to providing our highly pure radioisotope for Targeted Radionuclide Therapy to cancer patients worldwide."