On August 13, 2021 HCW Biologics Inc. (the "Company") (NASDAQ: HCWB), an innovative, biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, reported financial results and recent business highlights for its second quarter ended June 30, 2021 (Press release, HCW Biologics, AUG 13, 2021, View Source [SID1234586547]).

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"HCW Biologics delivered on a milestone as we achieved our goal of closing our initial public offering on July 22 to raise capital to advance the clinical development of our lead molecules," stated Hing C. Wong, Ph.D., founder and CEO of HCW Biologics Inc. "We started HCW Biologics three years ago with an idea to develop immunotherapeutic treatments for age-related diseases. Since that time, we applied our expertise in advanced protein engineering to internally develop our TOBITM (Tissue factOr-Based fusIon) discovery platform and successfully developed immunotherapeutic molecules based on TOBITM technology that can be administered by subcutaneous injection as well as used in adoptive cell therapy approaches. After extensive studies to assess the molecules we created, we selected two lead molecules, HCW9218 and HCW9302 for clinical development."

"HCW Biologics’ clinical development strategy is to prove the safety and efficacy of both lead molecules individually in future clinical trials, and eventually combine them as an immunotherapeutic for some of the most difficult to treat age-related diseases. Our gateway indication for our lead molecule, HCW9218, is cancer. Several scientific studies have revealed that increased normal tissue cellular senescence can promote tumor progression, creating a link between aging and cancer. In preclinical studies, HCW9218 has shown it can reduce chemotherapy-induced tumor and normal tissue senescence and decrease senescence associated secretory phenotype (i.e., proinflammatory) factors that senescent cells secrete, in particular TGF-ß. We are wrapping up IND-enabling activities and expect to submit an Investigational New Drug (IND) application for a Phase 1b/2 clinical trial to assess HCW9218 in the treatment of pancreatic cancer by the end of 2021."

Business Highlights:

Initial Public Offering: On July 22, 2021, the Company closed on its IPO with the sale of 7,000,000 shares of common stock at a public offering price of $8.00 per share, resulting in net proceeds of approximately $49.0 million, after deducting underwriting discounts and commissions and estimated offering-associated expenses.

As part of the preparations of becoming a public company, HCW Biologics shareholders elected two new independent board members in May 2021. Mr. Scott Garrett serves as the Chairman of the Board and Chairman of the Compensation Committee. His experience as a Chief Executive Officer and in other senior leadership positions with biomedical and diagnostics companies enables him to bring to the Board of Directors an operational perspective as well as valuable insights and experience. Mr. Rick Greene serves as the Chairman of the Audit Committee. His experience as a Chief Financial Officer and in other financial management and reporting, operations and business development positions in the healthcare industry enables him to bring financial expertise to the Board of Directors. The Company is committed to expanding the size of its Board of Directors to bring additional diversity and operational expertise.

As of June 30, 2021, the Company completed good laboratory practice (GLP) toxicology studies on nonhuman primates and mice to understand the onset, degree of severity, and time length up to which a particular dose of a drug demonstrates any toxic effects. The Company will continue to complete IND-enabling activities for HCW9218 and prepare for the IND filing in the second half of 2021.

The Company launched the execution of its strategy to use pivotal publications to establish its leadership in oncology and age-related diseases in scientific and clinical communities. The Company currently has two articles published online:

An article published online by Cancer Immunology Research describing the TOBITM discovery platform: Becker-Hapak MK, et al. A Fusion Protein Complex Combines IL-12, IL-15, and IL-18 Signaling to Induce Memory-like NK Cells for Cancer Immunotherapy. July 9, 2021.
An article published online by Molecular Therapy on the characterization of the Company’s lead molecules, HCW9218: Liu B et al. Bifunctional TGF-β Trap/IL-15 Protein Complex Elicits Potent NK Cell and CD8+ T Cell Immunity Against Solid Tumors. June 3, 2021.
Second Quarter Financial Results:

Cash and cash equivalents: On June 30, 2021, the Company’s cash balance was $5.1 million. Together with net proceeds of $49.0 million from the IPO, the Company estimates that it has sufficient cash to fund operations and capital expenditures for at least the next 24 months. This does not include potential sources of non-dilutive financing, which may be obtained as a result of entering out-licenses, such as upfront cash payment and shares of Wugen common stock that were received as a result of entering a license agreement with Wugen for limited rights to two of the Company’s molecules.
Research and development expenses: Research and development expenses were $1.7 million in the second quarter of 2021, as compared to $2.1 million for the second quarter of 2020. Higher costs in the second quarter of 2020 were a result of the ramp up costs required for initiation of cGMP manufacturing for five of the Company’s internally developed molecules.
General and administrative expenses: General and administrative expenses were $1.1 million in the second quarter of 2021, as compared to $0.7 million for the second quarter of 2020. The difference reflects additional general and administrative costs arising primarily from additional patent filings to broaden the protection of the Company’s intellectual property and performance-based bonuses.
Net loss: Net loss was $2.8 million in the second quarter of 2021, as compared to $2.8 million for the second quarter of 2020.

On August 13, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, and TRIUMF, Canada’s particle accelerator centre, reported that the companies have entered into the next phase of their collaboration agreement for the development, production, and supply of actinium-225 (Press release, Fusion Pharmaceuticals, AUG 13, 2021, View Source [SID1234586546]). Fusion will provide to TRIUMF funding to further develop technology to produce actinium-225 and in return Fusion will have rights, including preferred access and pricing, to the resulting alpha-emitting medical isotope.

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"As we advance our growing pipeline of actinium-based targeted alpha therapies (TATs), we are focused on expanding our manufacturing capabilities and continuing to proactively address and prioritize actinium supply. This supports our strategic plans to develop differentiated radiopharmaceuticals to treat a broad range of cancers with high unmet medical need," said Fusion Chief Executive Officer John Valliant, Ph.D. "We are excited to expand our collaborative relationship with TRIUMF, a leader in isotope production, marking an important step to further expand actinium-225 production and supply."

"Through its TAT platform technology, Fusion has the opportunity to unlock the full potential of actinium, an alpha-emitting isotope with the ability to deliver a potent, highly localized payload to cancer cells, " said TRIUMF Innovations CEO, Kathryn Hayashi. "With this next phase, we are solidifying our partnership with a premier developer of innovative actinium radiopharmaceuticals to deepen TRIUMF’s leadership position in isotope production and impact the cancer treatment landscape."

TRIUMF Director and CEO, Nigel Smith, Ph.D. added, "This marks an important milestone in the existing collaboration between Fusion and TRIUMF. Our partnership is generating new ideas and innovations that validate the important role TRIUMF has at the forefront of the global medical isotope ecosystem. Together TRIUMF and Fusion are laying the groundwork for major breakthroughs that will benefit the lives of countless patients around the world."

In December 2020, Fusion and TRIUMF entered a collaboration and supply agreement to develop, produce and procure the supply of actinium-225 to Fusion. As part of this agreement, Fusion will continue its investment of up to $25 million (CAD) in TRIUMF to advance technology and processes for actinium-225 production.

On August 13, 2021 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported financial results for the second quarter ended June 30, 2021 (Press release, Forma Therapeutics, AUG 13, 2021, View Source [SID1234586545]). The company also highlighted recent progress and upcoming milestones for its pipeline programs.

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"During the second quarter, we presented positive results from our ongoing Phase 1 trial demonstrating etavopivat’s highly differentiated profile and multimodal mechanism of action to improve markers of sickle cell disease and red blood cell health that are associated with vaso-occlusion," said Frank Lee, president and chief executive officer of Forma. "These results, in addition to the progress on our other clinical programs this quarter, position us well to deliver on our mission of transforming the lives of patients with rare hematologic diseases and cancers."

Key Business and Clinical Highlights

PKR Program in Sickle Cell Disease (SCD):

Clinical data presented at EHA (Free EHA Whitepaper) Virtual Congress support potential of investigational agent etavopivat to significantly impact RBC health and lifespan. Updated results were presented from the two week multiple ascending dose (MAD) cohorts and initial open-label extension (OLE) results administering etavopivat for up to 12 weeks, including:
Sustained increases in hemoglobin levels. In the MAD cohorts 73% of patients (11/15) achieved a hemoglobin increase of ≥ 1 g/dL at the end of two-weeks of treatment. In the OLE, hemoglobin levels increased >1g/dL in 88% of patients (7/8) receiving once daily treatment for at least two weeks, and this increase was sustained in those patients receiving continued treatment for up to 12 weeks.
Improvements in RBC oxygenation and deformability. RBC’s from 14 patients in the MAD cohorts showed increased hemoglobin-oxygen affinity, a significant shift in the point of sickling (POS), and improved deformability.
Significant reduction in hemolysis with markers approaching normal levels. Reticulocyte counts were reduced in 100% of patients (15/15), with normalization in some patients at the end of 2 weeks of treatment. The majority of patients demonstrated a marked decrease in lactate dehydrogenase levels (LDH) and indirect bilirubin levels as compared to baseline levels.
Reduction in systemic biomarkers related to inflammation and hypercoagulability. Initial results from the OLE showed improvement in systemic biomarkers such as lower levels of TNF-alpha, a marker of inflammation and decreases in prothrombin 1.2 and D-dimer, markers of coagulation activation.
Etavopivat was well tolerated with a safety profile consistent with underlying sickle cell disease. Etavopivat was well tolerated at doses up to 600mg daily (150% of the maximum dose in the ongoing Phase 2/3 Hibiscus Study).
CPB/p300 Program in Prostate Cancer:

FT-7051 Phase 1 clinical trial enrollment is ongoing. In January 2021, Forma announced the first patient dosed in the ongoing Phase 1 clinical trial evaluating FT-7051 for the treatment of mCRPC. The trial is a multicenter, open-label evaluation of the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and preliminary anti-tumor activity, of FT-7051 in men with mCRPC who have progressed despite prior therapy with at least one anti-androgen therapy. The adaptive trial design is intended to accelerate the dose escalation to potentially therapeutic doses and yield important safety information, as well as to identify biomarkers of clinical benefit such as PSA response. Genetic mutation analysis will be conducted to correlate genetic changes with resistance to standard-of-care and will also evaluate expression of the AR-v7 splice variant, for which there are no approved therapies.
IDH1 Program in AML and Glioma:

Phase 2 registrational results for olutasidenib in R/R AML were presented at scientific conferences. Olutasidenib data in R/R AML were presented at both the annual ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) meetings in June 2021. The primary efficacy evaluable population, comprised of 123 patients, received 150 mg of olutasidenib twice daily for at least six months prior to the planned interim analysis. The primary endpoint, a composite complete remission (CR) or CR plus CR with partial hematologic recovery (CRh), was achieved in 33.3% (30% CR and 3% CRh) of patients. While the median duration of response was not yet reached, in a sensitivity analysis with hematopoietic stem cell transplant considered as the end of a response, the median duration was 13.8 months. The median overall survival (OS) was 10.5 months. Although a median OS has not yet been reached for the CR/CRh population, 18-month survival is estimated at 87% for that response category, and median survival is 15.0 months for non-CR/CRh responders. In addition, among patients with a CR who were transfusion-dependent at baseline, 56-day transfusion independence was achieved in 100% of patients as measured by platelets and 80% as measured by RBC’s. Olutasidenib was well-tolerated, and adverse events were consistent with the late stage disease in this heavily pre-treated patient population. Based upon these results, Forma is preparing an NDA for the R/R AML indication.
Corporate

In June 2021, Forma announced the appointment of John E. Bishop, Ph.D., as chief technology officer. Dr. Bishop leads chemistry, manufacturing and control (CMC)-related functions and quality, encompassing Forma’s early pipeline through commercial product. Dr. Bishop’s background includes extensive expertise with CMC development in oncology and hematology. Prior to joining Forma, Dr. Bishop served as senior vice president of pharmaceutical sciences at Epizyme, Inc., where he was a member of the executive team and held overall responsibility for the CMC and quality assurance functions.
Upcoming Milestones

Scientific conference presentation of updated Phase 1 etavopivat results in SCD. Updated results of safety, clinical activity, and biomarkers from the 12-week OLE are expected to be presented at a scientific congress in late 2021. Up to 20 patients are being administered etavopivat 400mg once daily and assessed for hematologic and hemolytic response, improvements in RBC oxygenation and deformability, and systemic markers of SCD.
Initiation of etavopivat trials in thalassemia and pediatric sickle cell patients. Enrollment in a Phase 2 trial of etavopivat in thalassemia patients is expected to begin prior to the end of the year, with results anticipated in 2022. The trial may enroll up to 60 patients with either thalassemia or SCD who are receiving chronic red blood cell transfusions, or thalassemia without chronic red blood cell transfusions. A trial in pediatric sickle cell disease patients is planned to begin in the first half of 2022.
Scientific conference presentation of initial Phase 1 FT-7051 clinical results in mCRPC. An abstract from this ongoing trial has been accepted for presentation at the NCI/AACR/EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) taking place Oct. 7-10, 2021. The presentation will include preclinical data and initial clinical results on safety, tolerability and PK/PD from patients undergoing dose escalation.
Possibility of COVID-19 impact remains. The COVID-19 pandemic remains a factor in the successful completion of these milestones and ongoing clinical trials. Many clinical trials across the biopharma industry, including Forma’s, have been impacted by the COVID-19 pandemic. Clinical trial sites implementing new policies in response to COVID-19 may result in potential delays to enrollment of clinical trials or changes in the ability to access sites participating in clinical trials.
Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $570.8 million as of June 30, 2021, as compared to $645.6 million as of Dec. 31, 2020. Current cash runway is projected through the third quarter of 2024.
Research and Development (R&D) Expenses: R&D expenses were $31.6 million for the quarter ended June 30, 2021, compared to $20.5 million for the quarter ended June 30, 2020. The increase was primarily attributable to etavopivat development, as well as increases in staff and stock-based compensation.
General and Administrative (G&A) Expenses: G&A expenses were $12.5 million for the quarter ended June 30, 2021, compared to $6.4 million for the quarter ended June 30, 2020. The increase in was primarily attributable to increased stock-based compensation, executive and staff hiring, professional fees, and insurance.
Net Loss: Net loss was $43.6 million for the quarter ended June 2021, compared to net loss of $25.4 million for the quarter ended June 30, 2020.
Forma will conduct a conference call and webcast Aug.13 at 8:00 a.m. Eastern Daylight Time (EDT) to discuss second quarter 2021 results and business updates. The call can be accessed by dialing (833) 301-1146 in the U.S., and (914) 987-7386 internationally, with conference ID 9155938.

The live webcast will be available in the "News & Investors" section of Forma’s website www.formatherapeutics.com.

On August 13, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that the performance of its Oncoguard Liver liquid biopsy test is now published online in the peer-reviewed journal Clinical Gastroenterology and Hepatology (CGH) (Press release, Exact Sciences, AUG 13, 2021, View Source [SID1234586544]). The test delivers 82% early-stage sensitivity, and an overall 88% sensitivity and 87% specificity1 for the detection of hepatocellular carcinoma (HCC), the leading form of liver cancer.

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Oncoguard Liver test sensitivity highlights the potential for significant advances in early-stage HCC detection
An estimated 3 million2 Americans are eligible for HCC testing. Currently, only one in three3 at-risk patients receive recommended testing.

"The Oncoguard Liver test advances our work to defeat cancer through earlier detection and bring effective, accessible liquid biopsy tests to health care providers and patients," said Kevin Conroy, chairman and CEO of Exact Sciences. "The clinical validation study published in CGH is the third peer-reviewed publication for our liver test, reflecting Exact Sciences’ commitment to scientific rigor and innovation."

The newly published clinical validation study details the performance of the Oncoguard Liver test in a group representative of the U.S. population recommended for HCC surveillance. The sensitivity demonstrated by the Oncoguard Liver test highlights the potential for significant advances in early-stage HCC detection. Early-stage detection can increase five-year survival rates for HCC from less than 12%4, 5 to upwards of 70%.6

"We have been working for years to build a simple, high performing blood test for HCC surveillance, and these results indicate that the Oncoguard Liver test is poised to be the major advancement our patients deserve and need," said Dr. Naga Chalasani, interim chair of the Department of Medicine at Indiana University and lead author of the Clinical Gastroenterology and Hepatology-published paper. "The robust validation results were due to a rigorously conducted study, which could not have been possible without diligence and commitment of the entire study team and Exact Sciences’ commitment to developing early cancer detection biomarkers."

The current standard of care7 for HCC surveillance is visual monitoring via ultrasound, with or without an alpha-fetoprotein (AFP) blood test. These methods have variable sensitivity for detecting early-stage disease.5, 8

EARLY-STAGE HCC SENSITIVITY

Oncoguard Liver test: 82% 1
Alpha-fetoprotein: 40%1
Ultrasound: 47%6
Ultrasound with AFP: 63%6
The Oncoguard Liver test aims to bridge gaps in ongoing HCC testing. It offers a single, blood-based test analyzing a unique panel of DNA methylation and protein biomarkers. The test is intended as an aid in the detection of HCC for adults with liver cirrhosis and/or chronic hepatitis B who are at risk for HCC.

"The Oncoguard Liver test was created with the hope of enhancing early detection of liver cancer, thus putting improved outcomes within reach and empowering patients to stay current with recommended testing ordered by their health care provider," said Mayo Clinic’s Dr. Lewis Roberts, who helped develop the test. "It’s rewarding and exciting to be a part of the team that is bringing this new test to patient care."

The Oncoguard Liver test is currently available via an early access program designed to familiarize provider offices with the test and its Patient Engagement Program. The test identifies biomarkers associated with HCC. A positive Oncoguard Liver test should be followed with a conventional diagnostic work up.

To learn more about the Oncoguard Liver test visit www.OncoguardLiver.com.

The CGH article is available at: View Source(21)00866-1/fulltext#%20.

Investor Contact

Megan Jones, Exact Sciences, 608-535-8815, [email protected]
Media Contacts

Scott Larrivee, Exact Sciences, 608-287-9261, [email protected]
Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, [email protected]

On August 13, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted therapies for rare and difficult-to-treat cancers, reported it will present data on Rhenium-186 NanoLiposome (186RNL) from its Phase 1 ReSPECT clinical trial in recurrent glioblastoma (GBM) at the American Association of Neurological Surgeons 2021 Annual Scientific Meeting (AANS) being held virtually August 21-25, 2021 (Press release, Cytori Therapeutics, AUG 13, 2021, View Source [SID1234586543]).

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Details of the ePoster presentation are as follows:

Title A two-part, Phase 1 study of Rhenium-186 NanoLiposome (186RNL) delivered by convection enhanced delivery for recurrent, refractory, or progressive ependymoma and high-grade glioma (HGG) and newly diagnosed diffuse intrinsic pontine glioma (DIPG)
Date Poster presentations will become available to conference participants on-demand beginning Saturday, August 21, 2021
Presenter Michael G. DeCuypere, MD, PhD, FAANS, Northwestern University Feinberg School of Medicine, and study investigator
A copy of the poster will be made available under the Presentations tab of the Investors section of the Company’s website at the time of the presentation at www.plustherapeutics.com.