On August 3, 2022 Sumitomo Pharma Oncology, Inc., a clinical-stage company focused on novel cancer therapeutics, reported the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for DSP-5336, an investigational small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein, for the treatment of acute myeloid leukemia (AML) (Press release, Sumitomo Pharmaceuticals, AUG 3, 2022, View Source [SID1234617431]).

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"We are pleased to have received this designation for DSP-5336 which reinforces the need to identify novel therapeutic options to improve outcomes for patients with AML," said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Pharma Oncology, Inc. "We are excited to contribute to the advancement of research in this hematologic malignancy."

The FDA’s Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. AML is a blood cancer that starts in bone marrow. Bone marrow typically produces white blood cells, red blood cells and platelets. However, in people with AML, the bone marrow makes abnormal cancerous white blood cells called myeloid blasts. AML swiftly moves from the bone marrow into your bloodstream and can even involve other parts of your body.1

"MLL gene rearrangements and nucleophosmin 1 (NPM1) mutations are potent drivers of leukemia growth, and menin is a necessary copilot. DSP-5336 is a small molecule that blocks the MLL-menin partnership which inhibits normal differentiation and promotes leukemia growth."2-5 detailed Jatin J. Shah, M.D., Chief Medical Officer of Sumitomo Pharma Oncology, Inc. "We’re encouraged by preclinical evidence showing that blocking the menin-MLL interaction may stop the development of leukemia and restore normal terminal differentiation in MLL rearranged and NPM1-mutant malignant myeloid cells."2,6

DSP-5336 is currently being evaluated in a Phase 1/2 clinical trial to evaluate the safety and efficacy of DSP-5336 in patients with Relapsed/Refractory AML/ ALL with or without MLL Rearrangement or NPM1 Mutation, which is being conducted in the United States and Japan. To learn more about the study and eligibility for enrollment, visit clinicaltrials.gov (NCT04988555).

This is the third recently announced Orphan Drug Designation from SMP Oncology. TP-3654, the company’s proprietary investigational oral inhibitor of PIM kinases, was granted Orphan Drug Designation for the treatment of myelofibrosis (NCT04176198) as well as DSP-0390, an investigational emopamil-binding protein (EBP) inhibitor, was also granted Orphan Drug Designation for the treatment of brain cancer (NCT05023551). These designations support the strength and diversity of SMP Oncology’s pipeline and commitment to oncology research and development.

About DSP-5336
DSP-5336 is an investigational small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein. Menin is a scaffold nuclear protein that plays various key roles in biological pathways, including cell growth regulation, cell cycle control, genomic stability, bone development, and hematopoiesis.2,3 In preclinical studies DSP-5336 has shown selective growth inhibition in human acute leukemia cell lines with MLL rearrangements or NPM1 mutations.2,6 DSP-5336 is currently being evaluated in a Phase 1/2 dose escalation/dose expansion study of DSP-5336 in patients with relapsed or refractory AML (NCT04988555).

On August 3, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported that Sean McCarthy, D.Phil., chief executive officer and chairman, will virtually participate in the following investor conferences in August (Press release, CytomX Therapeutics, AUG 3, 2022, View Source [SID1234617333]).

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BTIG Biotechnology Conference 2022
Date: Tuesday, August 9, 2022

2022 Wedbush PacGrow Healthcare Virtual Conference
Date: Wednesday, August 10, 2022
Panel Discussion: 2:20 p.m. ET

A live webcast of the Wedbush panel discussion will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.

On August 3, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported Scott Hutton, Chief Executive Officer of Biodesix, will present at the Canaccord Genuity 42nd Annual Growth Conference being held August 8-11, 2022 (Press release, Biodesix, AUG 3, 2022, View Source [SID1234617363]).

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Canaccord Genuity 42nd Annual Growth Conference
Date: Wednesday, August 10, 2022
Time: 3:00 PM ET
Location: InterContinental Boston

The presentation will be webcast live and available for replay under "News & Events" in the Investors section of the Company’s website at www.biodesix.com.

On August 3, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) (Kintara or the Company), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported it has entered into an equity purchase agreement for up to $20 million with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor (Press release, Kintara Therapeutics, AUG 3, 2022, View Source [SID1234617379]).

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Under the terms of and subject to satisfaction of the conditions contained in the agreement, Kintara will have the right in its sole discretion, but not the obligation, to sell to LPC up to $20 million worth of shares of its common stock from time to time over the 36-month term of the agreement. Kintara controls the timing and amount of any future sales of its shares of common stock and LPC is obligated to make purchases in accordance with the terms of the purchase agreement, subject to various limitations contained in the agreement, including those under the Nasdaq listing rules. Any common stock that is sold by Kintara to LPC under the agreement will occur at a purchase price that is based on the market prices prevailing at the time of each sale to LPC. There is no upper limit to the price per share that LPC may pay for future stock issuances under the purchase agreement, and LPC has agreed not to cause or engage in any direct or indirect short selling or hedging of Kintara’s common stock. No warrants are being issued in this transaction and the purchase agreement does not contain any rights of first refusal, participation rights, penalties or liquidated damages provisions in favor of any party. Kintara may terminate the purchase agreement at any time, at its sole discretion, without any cost or penalty.

The Company expects this commitment from LPC will provide financial flexibility and is aligned with Kintara’s long-term strategy for value creation. Kintara intends to use any net proceeds from the sale of its common stock to LPC for working capital and general corporate purposes, including development expenses for VAL-083 and REM-001.

"We are excited to enter into this transaction with Lincoln Park Capital and believe that this agreement provides us an opportunity to access capital in a very efficient manner," said Robert E. Hoffman, President and Chief Executive Officer of Kintara. "We believe that the financial flexibility provided by this agreement will further support our clinical development efforts with VAL-083 in glioblastoma and REM-001 in cutaneous metastatic breast cancer."

Additional information regarding the purchase agreement is set forth in a Current Report on Form 8-K, which Kintara will file with the Securities and Exchange Commission (SEC).

The securities described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254662) filed with the SEC on March 24, 2021 and declared effective on April 1, 2021. The offering of the securities described herein will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by request from Kintara Therapeutics at 9920 Pacific Heights Blvd., Suite 150, San Diego, CA 92121 or at (858) 350-4364.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will 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 any such jurisdiction.

On August 3, 2022 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and business highlights for the second quarter of 2022 as well as upcoming anticipated corporate milestones (Press release, Surface Oncology, AUG 3, 2022, View Source [SID1234617395]).

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"In the second quarter, we presented encouraging new SRF388 clinical data in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting," said Rob Ross, M.D., chief executive officer. "SRF388, our first-in-class anti-IL27 antibody, demonstrated activity as both a monotherapy and in combination with other IO agents, bolstering our belief that this agent holds the potential to treat a broad range of tumor types. With cash runway into 2024, we believe we are well positioned to deliver a series of meaningful clinical data updates across our pipeline beginning later this year and through the first half of 2023."

Second Quarter and Subsequent Corporate Highlights

In June, Surface announced the publication of a new study highlighting the role of the IL-27 pathway in hepatocellular carcinoma (HCC). Surface collaborated with Cedars-Sinai Medical Center and Fox Chase Cancer Center to conduct the study which evaluated the role of the IL-27 pathway in the development of HCC. The study was published in the online edition of Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

In June, Surface presented new SRF388 Phase 1/1b clinical data at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. SRF388 demonstrated clinical activity in multiple solid tumor types with three partial responses across non-small-cell lung cancer (NSCLC), renal cell carcinoma (RCC) and HCC. Surface also announced plans to conduct a new expansion study of SRF388 in combination with pembrolizumab in up to 40 patients with relapsed/refractory NSCLC.

In June, Surface announced the appointment of Carsten Brunn, Ph.D., to the board of directors. Dr. Brunn brings more than 25 years of senior leadership experience within multiple biotech and pharmaceutical companies worldwide.

In April, Surface announced the initiation of two Phase 2 clinical studies evaluating SRF388 in multiple tumor types, including a randomized Phase 2 clinical study evaluating SRF388 in combination with atezolizumab and bevacizumab in patients with treatment-naïve HCC and a Phase 2 monotherapy study in patients with previously-treated NSCLC. In addition, the company announced an expansion of the open-label lead-in of the SRF388 randomized Phase 2 study in first-line HCC. The 30-patient lead-in is expected to inform the start of the randomized stage and could elucidate important biomarkers to support enriched patient selection.

At the AACR (Free AACR Whitepaper) Annual Meeting 2022 in April, Surface presented preclinical and translational data supporting the SRF388 recommended Phase 2 monotherapy dose of 10 mg/kg administered intravenously every four weeks.

In April, the company announced that it was recognized by the Boston Business Journal as one of the Best Places to Work for the second year in a row

In Q2, Surface received the anticipated $30 million milestone payment from GlaxoSmithKline for the initiation of the first Phase 1 study for GSK4381562. As part of the licensing agreement, Surface is eligible to receive up to $700 million in potential milestone payments, as well as tiered royalties on global net sales.

The company granted non-qualified stock options to one new employee to purchase 80,000 shares of the company’s common stock with a per share exercise price of $1.64, the closing price on August 1, 2022. The option grant was made under Surface’s 2021 Inducement Plan (the Plan) as an inducement material to the employee entering into employment with the company in accordance with Nasdaq Listing Rule 5635(c)(4) and was granted pursuant to the terms of the Plan.
Selected Anticipated Near-term Corporate Milestones

The company expects to provide a clinical data update on SRF617, a fully human antibody designed to inhibit CD39, in the fourth quarter of 2022.

Surface remains on track to file an Investigational New Drug (IND) application for SRF114, a fully human IgG1 anti-CCR8 antibody, before the end of the year.

Surface anticipates providing multiple SRF388 clinical updates in the first half of 2023, including initial safety and efficacy data from the expanded 30 patient lead-in to the Phase 2 study in first-line HCC.
Financial Results
As of June 30, 2022, cash, cash equivalents and marketable securities were $156.6 million, compared to $154.1 million on December 31, 2021.

General and administrative (G&A) expenses were $6.4 million for both the second quarter ended June 30, 2022, and for the same period in 2021. Decreases in legal and professional fees were partially offset by increased personnel related costs and increased insurance premiums. G&A expenses included $1.3 million in stock-based compensation expense for the second quarter ended June 30, 2022.

Research and development (R&D) expenses were $18.2 million for the second quarter ended June 30, 2022, compared to $12.7 million for the same period in 2021. This increase was primarily driven by progress on our SRF617 and SRF388 Phase 1 and Phase 2 clinical trials. R&D expenses included $0.8 million in stock-based compensation expense for the second quarter ended June 30, 2022.

For the second quarter ended June 30, 2022, net loss was $25.2 million, or basic and diluted net loss per share of $0.46. Net loss was $19.0 million for the same period in 2021, or basic and diluted net loss per share of $0.44.

Surface Oncology continues to project that current cash and cash equivalents are sufficient to fund the company into 2024.