On August 5, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) ("Lexicon") reported the issuance and sale of an additional 2,526,540 shares of its common stock, par value $0.001 (the "Common Stock"), pursuant to the full exercise of the underwriters’ option to purchase additional shares in connection with Lexicon’s previously announced public offering of Common Stock (Press release, Lexicon Pharmaceuticals, AUG 5, 2022, View Source [SID1234617698]). After giving effect to the full exercise of the underwriters’ option to purchase additional shares, the total number of shares of Common Stock sold in the public offering was 19,370,140, and total gross proceeds from the public offering were approximately $48.4 million, before deducting underwriting discounts and commissions and other offering expenses.

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Two affiliates of Invus, L.P., Lexicon’s largest shareholder, have also exercised in full their options to purchase an additional 2,573,460 shares of Common Stock in the aggregate in connection with Lexicon’s previously announced concurrent private placement. After giving effect to the full exercises of the purchasers’ options to purchase additional shares, the total number of shares of Common Stock sold in the concurrent private placement was 19,729,860, and total gross proceeds from the concurrent private placement were approximately $49.3 million.

Lexicon currently intends to use the net proceeds from the public offering and the concurrent private placement, together with its existing cash and cash equivalents and short-term investments, for (i) funding pre-commercial and commercial launch activities for sotagliflozin in heart failure; (ii) funding continued development of sotagliflozin in heart failure and LX9211 in neuropathic pain; and (iii) working capital and other general corporate purposes.

Citigroup and Piper Sandler acted as joint book-running managers for the public offering.

A shelf registration statement on Form S-3 relating to the underwritten public offering was filed with the U.S. Securities and Exchange Commission ("SEC") on August 6, 2021 and declared effective by the SEC on September 14, 2021. The shares of Common Stock issued in the concurrent private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or the securities laws of any state or other jurisdiction in the United States, and may not be offered, pledged, sold, delivered or otherwise transferred, directly or indirectly, in the United States except pursuant to registration under the Securities Act, or an applicable exemption from the registration requirements of the Securities Act and, in each case, in compliance with other applicable securities laws. A final prospectus supplement and accompanying prospectus relating to the public offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may also be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146, or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, Attn: Prospectus Department, by telephone at 1-800-747-3924, or by email at [email protected].

This press release does 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 state or jurisdiction in which such offer, solicitation or sale is not permitted.

On August 5, 2022 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported the presentation of promising new data from an ongoing phase I clinical trial of paxalisib in combination with radiotherapy for the treatment of brain metastases, sponsored by Memorial Sloan Kettering Cancer Center in New York, NY (Press release, Kazia Therapeutics, AUG 5, 2022, View Source [SID1234617697]).

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Interim data from the first stage of the study reports that all 9 evaluable patients experienced complete or partial response, representing an overall response rate (ORR) of 100%. For comparison, a typical ORR associated with whole brain radiotherapy alone can commonly range from 20-45% in published studies, of which some representative examples are indicated below.

The data has been accepted for an oral presentation at the upcoming 2022 Annual Conference on CNS Clinical Trials and Brain Metastases, jointly organised by the Society for Neuro-Oncology (SNO) and the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper), and held in Toronto, Canada from 12-13 August 2022.

Key Points

Approximately 200,000 cancer patients develop brain metastases in the United States each year. Brain metastases are typically very challenging to treat and are associated with poor prognosis. Radiotherapy remains a mainstay of clinical management.

Dr. Jonathan Yang, Director, Metastatic Disease, Department of Radiation Oncology at Memorial Sloan Kettering Cancer Center is the Principal Investigator of this clinical trial that is examining the combination of paxalisib with whole brain radiotherapy for patients with brain metastases (NCT04192981). The trial is designed in two stages: an initial exploratory stage and a confirmatory expansion stage.

9 of 12 patients in the initial stage were evaluable for efficacy. All 9 patients exhibited complete or partial response, according to RANO-BM criteria, representing an ORR of 100%.

The patients comprised a range of primary tumours, with breast cancer the most common, representing one third of patients.

The safety profile of paxalisib in combination was broadly consistent with monotherapy experience in other clinical trials, and a maximum tolerated dose (MTD) of 45mg daily in combination with radiotherapy was confirmed.

Recruitment to the expansion stage has already commenced, with the objective of recruiting an additional 12 patients.
Kazia CEO, Dr. James Garner, commented, "We are encouraged by this data and by the potential benefit it may indicate to this substantial and high-need group of patients. Radiotherapy is a ubiquitous component of the treatment paradigm for brain metastases, but resistance is common. Dr. Yang’s study has shown a very promising signal that paxalisib may help to potentiate the effect of radiotherapy. We also learned recently that the ongoing Alliance study in brain metastases had graduated to an expansion stage in the breast cancer cohort, so this now represents the second positive signal for paxalisib in brain metastases, which we increasingly believe represents a very promising opportunity for the product candidate."

Brain Metastases

It is estimated that as many as 20% of all patients with cancer will develop brain metastases (secondary tumours in the central nervous system). The most common primary tumours that spread to the brain include lung, breast, colorectal, melanoma, and renal cell carcinoma. Median overall survival for patients diagnosed with brain metastases ranges from 2.3 to 7.7 months.[1] It is estimated that approximately 200,000 patients are diagnosed with brain metastases each year in the United States alone.[2]

Radiotherapy is the mainstay of treatment for brain metastases, and generally consists in either stereotactic radiosurgery (SRS) or whole brain radiotherapy (WBRT) or some combination thereof. The efficacy of WBRT differs according to the type of tumour and the number and volume of brain metastases, but several recent publications cite overall response rates of 20-45%.

Clinical Study Rationale and Design

Research by Dr. Yang and others has shown that activation of the PI3K pathway is common in brain metastases, even in some cases where it is not present in the primary tumour. Moreover, PI3K pathway activation appears to be induced by radiotherapy, and to confer upon the tumour resistance to radiotherapy. These observations provide a strong rationale for testing the combination of a brain-penetrant PI3K inhibitor with radiotherapy.

This phase I study is a single-arm prospective trial comprising patients with brain metastases or leptomeningeal metastases from any primary tumour. The primary objective is safety and tolerability. All patients have PI3K pathway mutations at baseline. The first stage of the study is intended to establish the MTD of paxalisib in combination with WBRT and to characterise safety and tolerability. The second stage is intended to elicit confirmatory signals of efficacy, with the intent to recruit a further 12 patients.

Next Steps

Enrolment to the second stage of the study is already underway and we currently estimate preliminary data from the second part of the phase I clinical trial in CY2023.

Kazia expects to discuss emerging data from this study, along with other research in brain metastases, with its scientific advisors and regulatory consultants in due course, with potential FDA consultation at a future date.

Summary of Abstract

Session 2: Multimodality Approaches to Primary and Secondary Brain Tumors – Invited
Speakers and Oral Abstracts
Friday, 12 August 2022
11am – 1pm

Abstract MMAP-05 – Phase I study of concurrent paxalisib and radiation therapy in patients with solid tumor brain metastases or leptomeningeal metastases harboring PI3K pathway mutations: results from the dose-escalation cohort (NCT04192981)
Lead Author: T Jonathan Yang, MD, PhD
Institution: Memorial Sloan Kettering Cancer Center, New York, NY

On August 5, 2022 IMV Inc. ("IMV" or the "Company") (Nasdaq: IMV; TSX: IMV) a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported that it plans to maintain its existing at-the-market facility initially announced on October 16, 2020 under its recently renewed base shelf prospectus, which is effective for a period of 25 months from July 25, 2022 (Press release, IMV, AUG 5, 2022, View Source [SID1234617696]). IMV has entered into an equity distribution agreement (the "EDA") dated August 4, 2022 with Piper Sandler & Co. ("Piper Sandler") pursuant to which the Company may from time to time sell through "at-the-market" offerings (the "ATM Offering"), with Piper Sandler acting as sales agent, on the Nasdaq Capital Market (the "Nasdaq") such number of common shares that have an aggregate offering price of up to US$50 million under the ATM Prospectus Supplement (as defined below).

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The ATM Offering will be made by way of a prospectus supplement (the "ATM Prospectus Supplement") to the Company’s Canadian final base shelf prospectus dated July 22, 2022, and the Company’s United States final base shelf prospectus which is contained in the Company’s U.S. registration statement on Form F-10 dated July 25, 2022, as amended (File No. 333-266082) (the "Registration Statement"). The Registration Statement was effective on filing with the United States Securities and Exchange Commission (the "SEC") on July 25, 2022. The ATM Prospectus Supplement has been filed with the Nova Scotia Securities Commission, as principal regulator in Canada, and in the United States with the SEC. The common shares that may be issued by the Company through the ATM Offering have been conditionally approved for listing on the Toronto Stock Exchange ("TSX") and the required notices related to the ATM Offering have been filed with the Nasdaq as well. In obtaining TSX listing approval, the Company has relied on the "Eligible Interlisted Issuer" exemption from TSX rules under section 602.1 of the TSX Company Manual.

Piper Sandler, at IMV’s discretion and instruction, will use its commercially reasonable efforts to sell the common shares at market prices from time to time. No offers or sales of common shares will be made in Canada or through the facilities of the TSX or any other trading market in Canada.

The Company plans to use the net proceeds from the ATM Offering for general corporate purposes, including but not limited to working capital expenditures, capital expenditures, research and development expenditures, and clinical trial expenditures.

Copies of the ATM Prospectus Supplement and the accompanying final base shelf prospectus relating to the offered common shares may be obtained for free from the offices of Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, via telephone at (800) 747-3924 or via email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these common shares in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualifications under the securities laws of any such jurisdiction.

On August 5, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that studies utilizing its portfolio of blood tests and real-world data will be presented at the IASLC 2022 World Conference on Lung Cancer (WCLC 2022), hosted by the International Association for the Study of Lung Cancer, August 6-9 in Vienna, Austria (Press release, Guardant Health, AUG 5, 2022, View Source [SID1234617695]). Among the 10 abstracts are oral presentations and posters highlighting the use of Guardant360 to help physicians inform treatment decisions, GuardantOMNI to advance cancer therapy trials, and GuardantINFORM for targeted drug development to improve outcomes for patients with lung cancer.

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"We look forward to sharing new data at WCLC that demonstrate the utility of our liquid biopsy tests and datasets to create more accurate tumor profiles and impact outcomes for lung cancer patients around the world," said Helmy Eltoukhy, Guardant Health co-CEO. "The data from retrospective and real-world analyses will show how blood-based tests provide critical insights into tumor evolution and treatment resistance throughout each lung cancer patient’s treatment journey and contribute more broadly to further developing the field of thoracic oncology."

Full List of Presentations:

Guardant360

Clinical and molecular profile of patients with non-small cell lung cancer (NSCLC) with incidental pathogenic germline variants detected in cfDNA (oral)
Patterns of KEAP1 genomic co-alterations in advanced lung cancer as identified by plasma-based genotyping (e-poster)
Germline HRR mutations in metastatic NSCLC and impact on progression-free survival: A single-center retrospective study (e-poster)
Targetable alterations in non-small cell lung cancer according to age and sex (e-poster)
Liquid biopsies first to make treatment decisions in patients with metastatic non-small cell lung cancer (NSCLC) (e-poster)
Landscape of EGFR extracellular domain mutations in advanced non-small cell lung carcinoma (e-poster)
The patient impact of liquid biopsy – health-related quality of life in patients undergoing liquid biopsy for advanced non-small cell lung cancer (e-poster)
GuardantINFORM

Impact of germline BRCA1/2 alterations on EGFR mutant advanced non-small cell lung cancer outcomes (e-poster)
Real-world landscape of EGFR C797X mutation as a resistance mechanism to osimertinib in non-small cell lung cancer (oral)
GuardantOMNI

Durvalumab + olaparib vs. durvalumab alone as maintenance therapy in metastatic NSCLC: Outcomes from the phase 2 ORION study (poster)

On August 5, 2022 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease, prostate cancer and other rare hematologic diseases and cancers, reported financial results for the second quarter ended June 30, 2022 (Press release, Forma Therapeutics, AUG 5, 2022, View Source [SID1234617694]). The company also highlighted recent progress and upcoming milestones for its pipeline programs.

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"In the second quarter, we announced encouraging new analyses from the etavopivat program in sickle cell disease at our inaugural R&D Day. We also recently appointed two new members of our executive team to help drive our next phase of global development and commercialization and entered into a license agreement for olutasidenib," said Frank Lee, President and Chief Executive Officer of Forma. "We are well-positioned to continue to advance our pipeline and are actively managing expenses as we progress in our mission to deliver transformative medicines to patients with rare hematologic diseases and cancers."

Key Business Updates

On July 27, 2022 Forma entered into an exclusive worldwide license agreement with Rigel Pharmaceuticals, Inc. to develop, manufacture, and commercialize olutasidenib. Olutasidenib is a mutant isocitrate dehydrogenase-1 (mIDH1) inhibitor for the treatment of relapsed or refractory acute myeloid leukemia. Under the terms of the agreement, Forma will receive an upfront payment of $2.0 million, and is eligible to receive an additional $17.5 million upon the achievement of certain near-term regulatory, approval, and first commercial sale milestones. In addition, Forma is eligible to receive a total of up to an additional $215.5 million in connection with the achievement of certain development and commercial milestones. Forma is also eligible to receive tiered royalties in the low-teens to mid-thirties. The U.S. Food and Drug Administration (FDA) has accepted Forma’s new drug application (NDA) for olutasidenib. The Prescription Drug User Fee Act (PDUFA) target action date is February 15, 2023.
Agustín Melián, M.D., named Executive Vice President, Head of Research and Development. Dr. Melián is a physician-scientist with over 20 years of experience developing patient-centric, rare, and orphan disease therapeutics across multiple therapeutic areas, modalities, and phases of development.
Linea Aspesi named Senior Vice President, Chief Human Resources Officer. Ms. Aspesi brings over 25 years of human resources leadership experience in life sciences and health care services and has a track record of aligning talent plans to company vision and strategy while fostering an equitable and inclusive environment.
Forma presented new data on the etavopivat clinical development program at multiple hematology conferences. Presentations included analyses from the Phase I open-label extension study of etavopivat in sickle cell disease indicating that etavopivat decreased the frequency and severity of pain-related adverse events, and the design of the Phase II Gladiolus study of etavopivat in patients with sickle cell disease (SCD) receiving chronic transfusions or transfusion-dependent or non-transfusion-dependent thalassemia. These data were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress, the Foundation for Sickle Cell Disease Research (FSCDR) Sickle Cell Disease Research and Educational Symposium and Sickle Cell Disease Scientific Meeting, and the Global Congress on Sickle Cell Disease (GCSCD).
Forma hosted its first Research and Development (R&D) Day. The company provided an overview of its clinical development programs and research pipeline strategy.
Upcoming Milestones

Patient enrollment ongoing in global pivotal Phase II/III trial of etavopivat for the treatment of SCD, the Hibiscus Study. The first interim analysis (IA1) in the Hibiscus Study is expected to be reached by the end of 2022. IA1 is designed to select the dose for the Phase III portion of the trial.
Additional etavopivat development programs. Forma has initiated a Phase II trial in patients with either TD-SCD, TD-thalassemia, or non-TD-thalassemia, with initial results expected in late 2022. By year-end 2022, Forma plans to begin clinical trials in pediatric SCD and lower-risk myelodysplastic syndrome (MDS).
Update on FT-7051 clinical trial in mCRPC. Forma is planning to evaluate an alternative dosing schedule in a less heavily pretreated population and is currently processing the protocol amendment. Forma plans to provide updated results in the first half of 2023.
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 trials, have been impacted by the COVID-19 pandemic. Clinical trial sites implementing new policies in response to COVID-19 have impacted enrollment of clinical trials and/or the ability to access sites participating in clinical trials.
Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $395.9 million as of June 30, 2022, as compared to $490.3 million as of December 31, 2021. Current cash runway is projected through the third quarter of 2024.
R&D Expenses: R&D expenses were $39.1 million for the quarter ended June 30, 2022, as compared to $31.6 million for the quarter ended June 30, 2021. The increase was primarily attributable to the increase in research and development staff to support the advancement of etavopivat and other programs, including the conduct of our Phase II/III Hibiscus trial in SCD patients and Phase II trial of etavopivat in thalassemia.
General and Administrative (G&A) Expenses: G&A expenses were $13.9 million for the quarter ended June 30, 2022, as compared to $12.5 million for the quarter ended June 30, 2021. The increase was primarily attributable to professional services, costs due to executive and staff hiring, and other related general and administrative costs.
Net Loss: Net loss was $52.6 million for the quarter ended June 30, 2022, as compared to net loss of $43.6 million for the quarter ended June 30, 2021.
Forma will conduct a conference call and webcast August 5, 2022 at 8:00 a.m. Eastern Daylight Time (EDT) to discuss second quarter 2022 results and business updates. Investors may participate in the call by using the registration link here. Once registered, participants will receive a dial-in number as well as a PIN to enter the event.

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