On November 13, 2020 Immunophotonics, Inc. reported the first patient treated in the phase 1b/2a clinical trial examining IP-001 in thermally ablated solid tumors (Press release, Immunophotonics, NOV 13, 2020, View Source [SID1234570921]). The trial, conducted in collaboration with the Swiss Group for Clinical Cancer Research (SAKK), will assess the safety, tolerability and anti-tumor activity of IP-001 administered intratumorally following tumor ablation.

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"The initiation of this clinical trial marks a significant milestone for Immunophotonics. The trial will serve as a foundation in demonstrating the potential of IP-001 to ignite the immune system, transforming a routine tumor ablation into a systemic immunotherapy," said Lu Alleruzzo, CEO of Immunophotonics. "IP-001 is the first of what is expected to be many novel agents and combinations that we bring into clinical development to help patients suffering from cancer."

Prof. Markus Jörger, M.D., Ph.D., Coordinating Investigator of the trial commented, "IP-001 combines the promise of modern immunotherapy with the trend towards intratumoral treatment. SAKK is excited to bring this novel treatment to patients in desperate need for new innovative treatment options."

Following the phase 1b all-comer portion of the trial, Immunophotonics intends to evaluate the safety and efficacy of IP-001, in conjunction with tumor ablation, in phase 2 cohorts of patients with specific types of cancer.

On November 13, 2020 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported that it will be announcing its results for the third quarter 2020 on Tuesday 17 November 2020 (Press release, BerGenBio, NOV 13, 2020, View Source [SID1234570916]). A webcast presentation by BerGenBio’s senior management team will take place at 10:00 am CET.

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The live webcast link will be available at www.bergenbio.com in the Investors/Financial Reports section. A recording will be available shortly after the webcast has finished.

The third quarter report and presentation will be available on the Company’s website in the Investors/Financial Reports section from 7:00 am CET the same day.

On November 13, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Roche’s Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) utilizing ENHANZE, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer (Press release, Halozyme, NOV 13, 2020, View Source [SID1234570914]). Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European Commission in the near future.

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"We are delighted that Phesgo, the first combination of two established monoclonal antibodies with our ENHANZE technology, administered in just 5-8 minutes, is one step closer to becoming available for patients with HER-2 positive breast cancer in the EU," said Dr. Helen Torley, president and chief executive officer.

Phesgo can be administered in approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose1. This is compared to approximately 150 minutes for a sequential infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines2,3.

The recommendation from the CHMP is based on results from the pivotal phase III FeDeriCa study, which met its primary endpoint, with Phesgo showing non-inferior levels of Perjeta in the blood during a given dosing interval (Ctrough), when compared to IV administration of Perjeta. The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus Herceptin and chemotherapy, and no new safety signals were identified, including no meaningful difference in cardiac toxicity. The most common adverse events in both arms were alopecia, nausea, diarrhea and anemia1,4.

The U.S. Food and Drug Administration recently expedited the approval of Phesgo for the treatment of early and metastatic HER2-positive breast cancer. Based on the decision of the treating physician and the preference of the patient, it can be administered by a healthcare professional in a treatment center or in a patient’s home.

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

On November 13, 2020 Ziopharm Oncology, Inc. (Nasdaq: ZIOP), reported that Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm, is scheduled to participate in a fireside chat at the Jefferies Virtual London Healthcare Conference on November 19, 2020 at 1:45 pm ET (Press release, Ziopharm, NOV 13, 2020, View Source [SID1234570912]).

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To access the live webcast presentation, or the subsequent archived recording, please visit the "Investors" section of the Ziopharm website at www.ziopharm.com.

On November 13, 2020 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, reported financial results for the third quarter ended September 30, 2020, and provided corporate highlights (Press release, PMV Pharma, NOV 13, 2020, View Source [SID1234570910]).

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"PMV Pharma has achieved important scientific, clinical, and operational milestones over the past quarter," said David Mack, Ph.D., President and Chief Executive Officer. "The Investigational New Drug (IND) application for our lead product candidate PC14586 was cleared by the U.S. FDA in September. We believe the capital raised to date will enable us to execute on the clinical development of PC14586, while also continuing to invest in our discovery pipeline of small molecule, tumor-agnostic precision medicine products."

Corporate Highlights

Received IND clearance from the FDA to initiate a Phase 1/2 study of PC14586 in patients with advanced solid tumors that have a p53 Y220C mutation. The Phase 1/2 study will enroll patients with a p53 Y220C mutation as determined by next generation sequencing. Phase 1 will evaluate escalating doses of PC14586 to determine the recommended Phase 2 dose and to assess safety, pharmacokinetics, and preliminary anti-tumor activity. Phase 2 will determine the overall response rate and duration of response. For more information, please visit www.clinicaltrials.gov (NCT study identifier NCT04585750).
In October, the U.S. FDA granted PMV Pharma Fast Track designation to PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.
Expanded PMV Pharma’s management team and Board of Directors by adding Robert Ticktin as General Counsel, along with Rich Heyman, Ph.D. as Chair of the Board of Directors, and Laurie Stelzer, as Audit Chair of the Board of Directors.
Advanced its R273H program, targeting a second p53 hot spot mutant, toward lead optimization, and progressed the Company’s pipeline derived from its proprietary discovery platform.
Raised $70.0 million in a Series D financing round in July 2020 with Avoro Capital, RA Capital Management, and Wellington Management Company joining existing investors OrbiMed Advisors, Nextech Invest, Viking Global Investors, and Boxer Capital of Tavistock Group.
Successfully completed an IPO at a public offering price of $18 per share, with gross proceeds totaling approximately $243.5 million.
Third Quarter 2020 Financial Highlights

PMV Pharma ended the third quarter with $373.1 million in cash, cash equivalents, and marketable securities compared to $101.5 million as of December 31, 2019. Net cash provided by financing activities for the nine months ended September 30, 2020 was $294.3 million compared to $0.1 million for the nine months ended September 30, 2019. Net cash used in operations was $22.4 million for the nine months ended September 30, 2020 compared to $17.0 million for the nine months ended September 30, 2019.
Net loss for the quarter ended September 30, 2020 was $8.8 million compared to $6.2 million for the quarter ended September 30, 2019.
Research and development (R&D) expenses were $6.0 million for the quarter ended September 30, 2020 compared to $4.9 million for the quarter ended September 30, 2019. The increase in R&D expenses was primarily related to increase in personnel, preclinical development, and IND filing of PC14586.
General and administrative (G&A) expenses were $2.7 million for the quarter ended September 30, 2020, compared to $1.5 million for the quarter ended September 30, 2019. The increase in G&A expenses was primarily due to an increase in personnel and other corporate costs related to building out infrastructure for growth.