On November 17, 2020 Five Prime Therapeutics, Inc. (Nasdaq: FPRX) reported the closing of its upsized underwritten public offering of 8,280,000 shares of its common stock, which includes 1,080,000 shares sold upon the underwriters’ full exercise of their option to purchase additional shares, resulting in aggregate gross proceeds of approximately $173.9 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Five Prime (Press release, Five Prime Therapeutics, NOV 17, 2020, View Source [SID1234571259]).

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Cowen and SVB Leerink acted as joint book-running managers for the offering. Wedbush PacGrow acted as co-manager for the offering.

The shares of common stock were offering pursuant to a "shelf" registration statement previously filed with and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying prospectus, copies of which may be obtained 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], or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at (800) 808-7525, ext. 6132 or by e-mail at [email protected].

On November 17, 2020 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced the release of 10 abstracts that will be presented at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) from Dec 8-11, 2020 (Press release, Puma Biotechnology, NOV 17, 2020, View Source [SID1234571287]). Abstracts are available to the public online on the SABCS website at www.sabcs.org.

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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

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Spotlight poster discussions are as follows:

PD1-05

Title: Latest findings from the breast cancer cohort in SUMMIT – a phase 2 ‘basket’ trial of neratinib + trastuzumab + fulvestrant for HER2-mutant, hormone receptor-positive, metastatic breast cancer

Presenter: Komal Jhaveri, M.D., Ph.D

Wednesday, Dec. 9, 4:00 – 5:15 p.m. CT

PD3-03

Title: Continued efficacy of neratinib in patients with HER2-positive early-stage breast cancer: Final overall survival analysis from the randomized phase 3 ExteNET trial

Presenter: Frankie Ann Holmes, M.D., FACP

Wednesday, Dec. 9, 6:30 – 7:45 p.m. CT

PD13-09

Title: Impact of neratinib on outcomes in HER2-positive metastatic breast cancer patients with central nervous system disease at baseline: Findings from the phase 3 NALA trial

Presenter: Cristina Saura, M.D., Ph.D.

Friday, Dec. 11, 1:00 – 2:15 p.m. CT

Additional posters to be presented on Wednesday, Dec. 9, beginning at 8:00 a.m. CT are as follows:

PS13-20

Title: Bringing diarrhea under CONTROL: dose escalation reduces neratinib-associated diarrhea and improves tolerability in HER2-positive early-stage breast cancer

Presenter: Manuel Ruiz-Borrego, M.D.

PS9-02

Title: Neratinib + capecitabine sustains health-related quality of life (HRQoL) while improving progression-free survival (PFS) in patients with HER2+ metastatic breast cancer and ≥2 prior HER2-directed regimens

Presenter: Beverly Moy, M.D., M.P.H.

PS7-61

Title: The Neat-HER Virtual Registry: Results on HER2+ breast cancer patients receiving neratinib as extended adjuvant therapy

Presenter: Hope Rugo, M.D.

PS10-45

Title: Budget impact of introducing neratinib for third-line treatment of HER2+ metastatic breast cancer in the United States

Presenter: Seri Anderson, Ph.D.

PS9-33

Title: Cost-effectiveness of neratinib for the extended adjuvant treatment of adult patients with early-stage, HR+, HER2-overexpressed/amplified breast cancer who initiated neratinib within 1 year of completing trastuzumab in the US

Presenter: Adam Brufsky, M.D,, Ph.D.

PS9-54

Title: Healthcare costs for metastatic breast cancer patients treated with human epidermal growth factor receptor 2 targeted agents

Presenter: Reshma Mahtani, D.O.

PS10-22

Title: Breast cancer mortality in women with HER2+ disease treated in a large integrated healthcare system

Presenter: Reina Haque, Ph.D., M.P.H.

On November 17, 2020 LabCorp reported that Seven leading diagnostics companies and laboratory service providers have formed the Access to Comprehensive Genomic Profiling Coalition (ACGP) (Press release, LabCorp, NOV 17, 2020, View Source [SID1234571227]). The goal of the organization is to collectively advocate for appropriate broad U.S. health insurance coverage of comprehensive genomic profiling (CGP) for patients living with advanced cancer. The current members of ACGP are Exact Sciences (NASDAQ: EXAS), Foundation Medicine, Illumina (NASDAQ: ILMN), LabCorp (NYSE: LH), QIAGEN (NYSE: QGEN), Roche Diagnostics (SIX: RO, ROG: OTCQX: RHHBY), and Thermo Fisher Scientific (NYSE: TMO).

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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

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CGP testing performed soon after a diagnosis of advanced cancer better informs medical management, including treatment decisions and patient care, which can improve clinical outcomes. In advocating for coverage of CGP, ACGP will educate health insurers and other healthcare stakeholders about the clinical utility and economic value of CGP.

CGP tests assess the genomic alterations within a patient’s cancer to help physicians make more informed decisions about personalized treatment approaches. Using next-generation sequencing (NGS) with a tissue biopsy or a blood sample, this testing method can detect the four main classes of alterations known to drive cancer growth: base substitutions, insertions and deletions, copy number alterations (CNAs), and rearrangements or fusions. These tests can reveal clinically relevant alterations and biomarkers in the tumor’s DNA and RNA. This helps identify patients who could respond to specific targeted therapies and immunotherapy that can be more effective and may have fewer side effects. Healthcare professionals can use CGP to help predict patient benefit across multiple targeted therapies and cancer indications, with benefits in progression-free survival for patients with non-small cell lung cancer (NSCLC) as one example.1

"Cancer is a disease of the genome, not solely the tissue. Tumor profiling has evolved tremendously in the last decade," said Jim Almas, MD, vice president and national medical director of clinical effectiveness at LabCorp, and the chairman of ACGP. "The manufacturers and laboratories forming the coalition have produced incredible assays to help identify the mutations driving advanced cancers, leading patients to better care through targeted cancer treatments."

Despite evidence of the benefits of this approach, some health insurers still use an outdated framework to evaluate coverage for CGP, creating a disparity in access across patient populations. Many commercial insurance plans do not cover this type of testing, while public or government plans like Medicare do. Limited insurance coverage options may prevent some treating physicians from ordering CGP for their patients.

"There is no question that obstacles to coverage have inhibited physicians from ordering comprehensive genomic profiling," said Almas. "Additionally, we believe some clinicians are not aware of the advantages of a comprehensive testing approach and the benefits of one CGP test to provide genomic profiling, detect microsatellite instability and tumor mutational burden, and help physicians identify clinical trials for which patients may be candidates."

On November 17, 2020 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company utilizing a proprietary human memory B cell platform to discover and develop first-in-class antibody therapeutics, with a focus on oncology and infectious diseases including COVID-19, reported third quarter 2020 financial results and recent highlights (Press release, Immunome, NOV 17, 2020, View Source [SID1234571261]).

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"The completion of our recent IPO marks a significant milestone for Immunome and positions us to further accelerate the output of new discoveries from our platform, and to rapidly advance our lead oncology and COVID-19 therapeutic antibody programs into the clinic," said Purnanand Sarma, PhD, President and CEO of Immunome. "We are on track to execute on our near-term clinical and strategic plans, including filing IND applications for two of our programs in 2021." Dr. Sarma further stated, "I am proud of the tremendous progress our team has made this year, particularly with regard to the notable effort and dedication supporting our accelerated development of antibody-based treatment targeting multiple viral antigens to treat the COVID-19 virus. As previously announced, Immunome was awarded a $13.3 million contract from the US Department of Defense to develop an antibody cocktail discovered by the interrogation of memory B cells from ‘super-responders’ to the SARS-CoV-2 virus (DoD Press Release)."

Recent Highlights

In October 2020, Immunome completed an IPO, including the full exercise of the underwriters’ option to purchase additional shares, resulting in gross proceeds of $44.9 million, before deducting underwriting commissions and offering expenses.
IMM-BCP-01: Unlike approaches solely directed at neutralizing the Spike protein by other companies, we aim to develop an antibody cocktail directed at multiple SARS-CoV-2 antigens. Unbiased interrogation of SARS-CoV-2 "super-responder" memory B cells using Immunome’s discovery engine has resulted in the following advances:
We discovered that more than 50% of the antibodies isolated from super-responders are directed at non-Spike antigens, suggesting non-Spike related antibodies may play a significant role in the effective immunological clearance of this virus.
We also identified multiple neutralizing antibodies with picomolar affinity directed at SARS-CoV-2 Spike protein.
We discovered that, in addition to affinity matured IgG antibodies, COVID-19 "super-responders" appear to mount robust affinity-matured IgA responses. IgA antibodies are naturally found at the surface of respiratory track and function to prevent initial viral infection.
IMM-ONC-01: Our further pre-clinical testing continues to demonstrate that IL-38 appears to be a novel immune checkpoint. In animal models, our inhibitory antibody demonstrates antitumor effects in IL-38 expressing tumors.
Third Quarter 2020 Financial Results:

Cash and cash equivalents: Cash and cash equivalents were $6.7 million as of September 30, 2020 compared to $2.5 million as of December 31, 2019.
IPO and net proceeds: On October 2, 2020 the Company’s common stock began trading on the Nasdaq Capital Market under the ticker (IMNM) and on October 6, 2020 the IPO closed with the Company receiving net proceeds of $41.7 million, after deducting underwriting discounts but before deducting other offering expenses. After deducting other offering costs of approximately $2.8 million, aggregate net IPO proceeds to the Company were $38.9 million.
Research and development (R&D) expenses: R&D expenses were $1.6 million for the quarter ended September 30, 2020 compared to $2.2 million for the quarter ended September 30, 2019 and $5.7 million for the nine month period ended September 30, 2020 compared to $6.4 million for the nine month period ended September 30, 2019.
General and administrative (G&A) expenses: G&A expenses were $1.2 million for the quarter ended September 30, 2020 compared to $0.5 million for the quarter ended September 30, 2019 and $2.5 million for the nine month period ended September 30, 2020 compared to $1.1 million for the nine month period ended September 30, 2019.
Net loss: Net loss attributable to common stockholders was $8.4 million or $7.52 per share for the quarter ended September 30, 2020 compared to $2.7 million or $2.50 per share for the quarter ended September 30, 2019 and $13.8 million or $12.44 per share for the nine month period ended September 30, 2020 compared to $7.5 million or $6.88 per share for the nine month period ended September 30, 2019.

On November 17, 2020 Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, reported to share a summary of new paxalisib data presented at the Society for Neuro-Oncology (SNO) Annual Meeting, which is being held virtually from 19-21 November 2020 (Press release, Kazia Therapeutics, NOV 17, 2020, View Source [SID1234571289]).

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Key Points

New interim analysis of paxalisib phase II study in glioblastoma (NCT03522298) is highly consistent with prior data
Median progression-free survival (PFS) of 8.4 months reported on this analysis (versus 5.3 months for temozolomide, the existing standard of care)
Median overall survival (OS) of 17.5 months reported (versus 12.7 months for temozolomide)
First substantial presentation of safety data at a 60mg dose shows profile very similar to prior experience, with the most common toxicities including rash, stomatitis (mouth ulcers), and hyperglycemia (high blood sugar), consistent with other PI3K and mTOR inhibitors
Phase I study in DIPG (NCT03696355) shows paediatric maximum tolerated dose (MTD) of 27 mg/m2, with safety profile and pharmacokinetics similar to adult data
Kazia CEO, Dr James Garner, commented, "this is very reassuring data from the glioblastoma study, confirming our earlier results with the data now much more mature. In studies such as this, volatility is the enemy of dependability. From the very first efficacy data we reported from this study, in November 2019, through the ASCO (Free ASCO Whitepaper) and AACR (Free AACR Whitepaper) presentations in June 2020, to today’s latest analysis, the PFS and OS figures have remained extremely stable as the study has progressed. This gives us a great deal of confidence that what we are seeing is representative and reliable."

He added, "we expect this study to conclude in the first half of calendar 2021, but it has already provided useful information to guide the development of paxalisib. We have moved into the operational phase of the GBM AGILE pivotal study, and we expect that study to now be the primary focus of our work in glioblastoma from this point forward."

The poster presentation is available for download via the Kazia website at:-

View Source

Summary of Paxalisib Data in Comparison to Temozolomide (existing standard of care)

Temozolomide[1]
(FDA-approved treatment)

Paxalisib

(interim phase II data)

Progression-Free Survival (PFS)

5.3 months

8.4 months

Overall Survival (OS)

12.7 months

17.5 months

Professor Patrick Wen, the first author on the poster, commented "as this study has matured, we have seen encouraging results that are very stable over successive analyses, and very consistent with prior clinical experience in this drug. Paxalisib is now moving into the GBM AGILE study in glioblastoma, and we expect this to provide definitive data regarding the drug’s potential use in this disease and, if successful, a basis for regulatory approval. There remains a profound need for new treatments in glioblastoma, and paxalisib has proven to be an exciting potential candidate."

Initial Data from St Jude Study of Paxalisib in DIPG and Diffuse Midline Gliomas

Dr Christopher Tinkle, lead investigator for the SJPI3K study of paxalisib in DIPG and diffuse midline glioma (NCT03696355), gave an invited oral presentation on interim results from that study.

The SJPI3K study is a first-in-paediatric study, designed to establish the safety and pharmacokinetics of paxalisib in children, and to explore potential early signals of efficacy in this patient population.

The study recruited 27 patients, ranging from 3 to 16 years of age. Four patients discontinued participation prior to receiving a first dose of paxalisib, generally due to disease progression. At the time of analysis, five patients remain on paxalisib treatment, and several patients remain in post-treatment follow-up.

The paediatric maximum tolerated dose (MTD) was determined to be 27 mg/m2. The dose-limiting toxicities (DLTs) included hyperglycaemia, oral mucositis, and rash, which are entirely consistent with the adult experience.

The pharmacokinetics of the drug, a term which describes the concentration of the drug in plasma over time, was very consistent with the adult experience. The study found no meaningful difference between administration of intact capsules and administration via opening of capsules and sprinkling of contents onto a food carrier.

The study has not at this stage shown a clear survival benefit for paxalisib in comparison to historical controls. In terms of PFS, the proportion of patients alive and progression-free at six months (PFS6) was 96%, which compares favourably to an historical control of 58%[2]. However, the authors note that PFS can be a complex endpoint to interpret in DIPG trials due to the confounding effect of incidental radiological changes associated with radiation therapy.

Dr Tinkle commented, "my colleagues and I are very pleased with the outcome of this study. We have determined an appropriate dose for future paediatric work, established an acceptable tolerability profile in children, and demonstrated pharmacokinetic equivalence between intact capsule and open and sprinkled administration, which are critical steps in the development of any new drug for paediatric cancer."

He added, "DIPG is an extremely treatment-resistant disease, and no drug has ever shown convincing efficacy as a monotherapy. Our view has always been that the treatment of this disease will consist in combination therapy, and we have shown that paxalisib is eminently suitable to now be evaluated alongside other agents. We look forward to discussing follow-on work that will explore these opportunities and further investigate paxalisib’s potential."

Dr Garner commented, "we are grateful to have had the opportunity to collaborate with one of the world’s leading paediatric oncology hospitals in this study. The results provide an excellent foundation for the further development of paxalisib in DIPG, and we will be excited to discuss the next phase of work with our collaborators in coming months."

Next Steps

The paxalisib phase II study remains ongoing, with final data expected in 1H CY2021. The paxalisib arm of the GBM AGILE study has moved into an operational phase, and first patient in is expected early in 1Q CY2021.

The St Jude study in DIPG remains ongoing, with final data expected during 1H CY2021.

Investor Conference Call

Kazia is pleased to invite investors to attend a conference call to discuss the results further.

The call will be held on Thursday 19 November 2020 at 12:00pm, Sydney time (AEDT), which is 5pm on Wednesday 18 November 2020 in San Francisco (PST) and 8pm on Wednesday 18 November 2020 in New York (EST).

Participants will need to pre-register for the call via the following link:

View Source

Click the ‘Register Now’ button and follow the prompts to complete pre-registration. You will then receive a calendar invite with dial in numbers, a passcode and a PIN to dial into the conference call.