On May 14, 2021 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 quarter ended March 31, 2021 and provided corporate highlights (Press release, PMV Pharma, MAY 14, 2021, View Source [SID1234579983]).

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"PMV had a successful first quarter. We continued to advance our clinical and discovery programs, and our presentation at AACR (Free AACR Whitepaper) provided compelling evidence that PC14586 selectively reactivates the p53 Y220C mutant protein, both in vitro and in vivo," said David Mack, Ph.D., President and Chief Executive Officer. "Enrollment in our Phase 1/2 trial of PC14586, our first in class p53 Y220C reactivator, is progressing as planned. We are also thrilled to have welcomed Chuck Baum to our Board and Gigi Lozano to our SAB and look forward to leveraging their deep expertise in precision therapeutics and genetic drivers of cancer."

Corporate Highlights:

In March 2021, PMV Pharma presented late breaking preclinical data on PC14586, the Company’s first-in-class, tumor-agnostic, investigational small molecule p53 Y220C reactivator at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021. The Oral presentation titled, "PC14586: The First Orally Bioavailable Small Molecule Reactivator of Y220C Mutant p53 in Clinical Development" was given by Melissa L. Dumble, Ph.D., Vice President Preclinical Development and Translational Science of PMV.
PMV Pharma continued to enroll patients in the Phase 1 portion of a Phase 1/2 clinical trial of PC14586 (NCT04585750). PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.
Appointment of Charles Baum, M.D., Ph.D., to the Board of Directors. Dr. Baum is the President and Chief Executive Officer and a Board Member of Mirati Therapeutics Inc.
Expanded Scientific Advisory Board with the appointment of p53 pioneer Dr. Guillermina (Gigi) Lozano, Professor and Chair, Department of Genetics, MD Anderson Cancer Center.
PMV Pharma is the process of relocating to a state-of-the-art laboratory and office building located in Princeton, NJ.
First Quarter 2021 Financial Results

PMV Pharma ended the fourth quarter with $348.4 million in cash, cash equivalents, and marketable securities, compared to $361.4 million as of December 31, 2020. Net cash used in operations was $12.9 million for the three months ended March 31, 2021 compared to $8.1 million for the three months ended March 31, 2020.
Net loss for the quarter ended March 31, 2021 was $11.6 million compared to $7.3 million for the quarter ended March 31, 2020.
Research and development (R&D) expenses were $7.5 million for the three months ended March 31, 2021 compared to $6.0 million for the three months ended March 31, 2020. The increase in R&D expenses was primarily related to increased headcount and clinical expenses for advancing development of PC14586, the Company’s lead drug candidate.
General and administrative (G&A) expenses were $4.2 million for the three months ended March 31, 2021, compared to $1.7 million for the three months ended March 31, 2020. The increase in G&A expenses was primarily due to expanding the infrastructure necessary for operating as a public company.
About p53

p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.

About PC14586

PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have the p53 Y220C mutation and has been granted Fast Track designation by the U.S. FDA.

On May 14, 2021 Mission Therapeutics ("Mission"), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), reported that management team members will be attending and presenting at Bio€quity Europe (17-19 May) (Press release, Mission Therapeutics, MAY 14, 2021, View Source [SID1234579981]).

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Anker Lundemose, CEO, David Luther, CFO, and Paul Wallace, CBO, will attend the digital event and will be available for partnering meetings. Mission’s corporate presentation is available to all delegates via the partneringONE digital event platform.

In addition, Anker will present on 19 May at 10:00 CET as part of the 10th CEO Workshop: Hiring and Team Building in the Age of COVID. The workshop will explore how best practices for hiring A-list talent have evolved during the pandemic, including what is expected to be the long-term impact. The panel will also discuss how they have kept their teams motivated and productive over the past year.

Bio€quity Europe Digital is an international networking platform that enables financial dealmakers and biopharma executives to meet rising biotechs. Industry leaders will debate the big questions framing the future of biopharma innovation and identify where Europe will continue to be a global leader. The three-day virtual event will include strategic panels focused on ‘Europe’s Next Act’ and will support one-to-one virtual meetings, with over 130 corporate presentations available from European and Asian biotechs.

On May 14, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal third quarter ended March 31, 2021 and provided a corporate update (Press release, Kintara Therapeutics, MAY 14, 2021, View Source [SID1234579980]).

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Fiscal Third Quarter Highlights and Recent Developments

Commenced patient recruitment of Kintara’s VAL-083 arm of the glioblastoma multiforme (GBM) AGILE registrational study sponsored by the Global Coalition for Adaptive Research (GCAR). VAL-083 is currently the only therapeutic agent being evaluated in all three GBM patient subtypes: newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent.

Continued to advance development of REM-001 for the treatment of Cutaneous Metastatic Breast Cancer (CMBC), including taking critical steps toward manufacturing sufficient quantity of drug to allow for initiation and completion of our CMBC Phase 3 trial for CMBC patients.

Extended calendar year cash runway from previously announced Q4 2021 to Q2 2022 primarily due to the exercise of previously issued warrants as well as operational and resource synergies realized through the Adgero acquisition.

Enhanced corporate and scientific leadership teams with appointments of Tamara A. Seymour to the Board of Directors and Dr. Mario Lacouture to the Scientific Advisory Board with an initial focus on CMBC.

Completed patient enrollment of the recurrent arm of the Phase 2 clinical study of VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson) for GBM patients who have been pre-treated with temozolomide prior to disease recurrence.

Presented positive data updates at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from the ongoing Phase 2 clinical studies in newly-diagnosed first-line, newly-diagnosed adjuvant, and recurrent GBM.
"As we head into the final fiscal quarter of 2021, we continue to make steady progress on our late-stage clinical pipeline, as well as making valuable additions to our leadership and advisory teams, and continuing to secure our foothold as a leader in oncology indications with clear unmet medical needs," commented Saiid Zarrabian, Kintara’s President and Chief Executive Officer. "Commencing VAL-083’s enrollment in the GBM AGILE registrational study was a significant milestone during the period, along with continued progress with both of our ongoing Phase 2 clinical trials, of which the MD Anderson study is anticipated to report topline results in the second quarter of calendar 2021."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2021 THIRD QUARTER ENDED MARCH 31, 2021

At March 31, 2021, the Company had cash and cash equivalents of approximately $15.7 million. The cash and cash equivalents at March 31, 2021 are expected to be sufficient to fund the Company’s planned operations into the second quarter of calendar year 2022.

For the three months ended March 31, 2021, the Company reported a net loss of approximately $6.6 million, or $0.23 per share, compared to a net loss of approximately $2.0 million, or $0.17 per share, for the three months ended March 31, 2020. For the nine months ended March 31, 2021, the Company reported a net loss of approximately $31.6 million, or $1.47 per share, compared to a net loss of approximately $5.3 million, or $0.52 per share, for the nine months ended March 31, 2020. The increase in loss for the nine months ended March 31, 2021 compared to the nine months ended March 31, 2020 was largely due to the recognition of $16.1 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the merger with Adgero Biopharmaceuticals Holdings, Inc. and an expanded rate of expenditures with the initiation of the GCAR study and REM-001 development.

On May 14, 2021 Genenta Science, a clinical-stage biotechnology company pioneering the development of an investigational hematopoietic stem progenitor cell immuno-gene therapy for cancer (Temferon), reported that it will present new clinical data from a Phase I/IIa study of Temferon in patients affected by glioblastoma multiforme (GBM) in an oral presentation at the 2021 American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place virtually on May 11-14, 2021 (Press release, Genenta Science, MAY 14, 2021, View Source [SID1234579979]).

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The data presented at ASGCT (Free ASGCT Whitepaper) are from Genenta’s ongoing trial of Temferon in patients with GBM. The presentation focuses specifically on patients who have undergone a follow-up surgical procedure for their cancer. In addition to being a treatment option, follow-on surgery provides investigators with an opportunity to understand the impact of therapies at a cellular and molecular level.

The ASGCT (Free ASGCT Whitepaper) presentation shows that genetic markers of Genenta’s Temferon were detectable in tumor specimens from all four patients with progressive disease who underwent follow-on surgery. Furthermore, the expression of interferon- (IFN) responsive gene signatures in those tumors was increased compared with pre-treatment levels, which suggests that interferon-α (IFN-α) had been released locally in the tumor by cells derived from Genenta’s investigational treatment.

Carlo Russo, Chief Medical Officer at Genenta Science, said: "These preliminary results provide exciting indications that Temferon acts in the way we anticipated even in the relatively inaccessible setting of glioblastoma multiforme. The data are encouraging and in line with our pre-clinical results, with early evidence that Temferon delivers biological effects that may impact the progression of individual lesions."

One of the four patients had two lesions removed at the second surgery; one was a prior lesion that had not been removed during the first surgery and was stable; the other was a relapsing progressing lesion that had developed at the first surgery site. Compared with the progressing tumor, the stable lesion displayed a higher proportion of T cells and Tie2 Expressing Monocytes (TEMs) within the myeloid infiltrate and had a higher IFN-response signature.

The data presented at ASGCT (Free ASGCT Whitepaper) also supported the initial safety and tolerability profile of Temferon. Concentrations of IFN-α in the plasma and cerebrospinal fluid of patients remained low, while IFN-α responses were identified in myeloid cells that infiltrate tumors. Temferon-derived differentiated cells also persisted in peripheral blood and bone marrow for up to 18 months at lower levels, indicating the potential durability of the intervention. No dose limiting toxicities have been identified.

Presentation Details:

Title: Changes in the Tumor Microenvironment in Patients with Glioblastoma Multiforme Treated with IFN-a Immune Cell & Gene Therapy (TEM-GBM_001 Study)

Time: Friday May 14, 2021 at 1.30 PM Eastern Time (7.30 PM CET)

Presenting: Carlo Russo, CMO

On May 14, 2021 Fresenius Medical Care, the world’s leading provider of products and services for individuals with renal diseases, reported that it has agreed to issue bonds with an aggregate principal amount of USD 1.5 billion across two tranches (Press release, Fresenius, MAY 14, 2021, View Source [SID1234579978]):

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USD 850 million bonds with a maturity in December 2026 and an annual coupon of 1.875% and
USD 650 million bonds with a maturity in December 2031 and an annual coupon of 3.000%.
The proceeds will be used for general corporate purposes, including the refinancing of outstanding indebtedness.

The expected settlement date is May 18, 2021.