On January 19, 2024, IDEAYA Biosciences, Inc. (the "Company") entered into an Open Market Sales Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies"), with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.0001 per share (the "Common Stock"), having aggregate gross proceeds of up to $350.0 million (the "Shares") through Jefferies as its sales agent (Filing, 8-K, Ideaya Biosciences, JAN 19, 2024, View Source [SID1234639364]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Under the Sales Agreement, the Company will set the parameters for the sale of Shares, including the number of Shares to be issued, the time period during which sales are requested to be made, limitations on the number of Shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms of the Sales Agreement, Jefferies may sell the Shares by any method that is deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on The Nasdaq Global Select Market or any other trading market for the Common Stock. The Company will pay Jefferies a commission of up to three percent (3.0%) of the gross sales proceeds of any Shares sold through Jefferies under the Sales Agreement, and has provided Jefferies with customary indemnification and contribution rights. The Sales Agreement will terminate upon the earlier of (i) the sale of all Shares subject to the Sales Agreement or (ii) termination of the Sales Agreement in accordance with its terms.

Any Shares to be offered and sold under the Sales Agreement will be issued and sold pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-272936), which became automatically effective upon its filing on June 26, 2023. The Company filed a prospectus supplement with the Securities and Exchange Commission on January 19, 2024 in connection with the offer and sale of the Shares pursuant to the Sales Agreement.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is furnished as Exhibit 1.1 to this Current Report on Form 8-K (this "Current Report") and is incorporated herein by reference.

Latham & Watkins LLP, counsel to the Company, has issued an opinion to the Company, dated January 19, 2024, relating to the validity of the Shares to be issued and sold pursuant to the Sales Agreement, a copy of which is filed as Exhibit 5.1 to this Current Report.

This Current Report shall not constitute an offer to sell or the solicitation of an offer to buy any Shares, nor shall there be any offer, solicitation or sale of the Shares in any state or country in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or country.

On January 19, 2024 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported the closing of its underwritten public offering of shares of its common stock. Alector sold 10,869,566 shares of its common stock in the offering (Press release, Alector, JAN 19, 2024, View Source [SID1234639363]). Alector has granted the underwriter a 30-day option to purchase up to an additional 1,630,434 shares of its common stock. The gross proceeds to Alector from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are approximately $75 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Cantor Fitzgerald & Co. acted as sole book-running manager for the offering.

The offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333- 270126) that was previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC") on May 1, 2023. The offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by e-mail 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 securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On January 19, 2024 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported further details from its poster presentation at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI) currently being conducted in San Francisco (Press release, Imugene, JAN 19, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/39befa96-9c07-f014-8948-4f0774a3ed3b/Imugene_CF33_hNIS_VAXINIA_MAST_Study_Featured_at_ASCO_GI.pdf [SID1234639339]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The poster "Oncolytic Virus CF33-hNIS Monotherapy for the Treatment of Gastrointestinal Malignancies" was presented at 11:45am-1:15pm Pacific time on 18 January 2024 during Session A: Cancers of the Esophagus and Stomach and Other GI Cancers.

Dr Daneng Li, from the City of Hope National Comprehensive Cancer Centre presented the poster which detailed background on CF33, the MAST study design, objectives and results observed to date.

Conclusions of the poster presentation included:

Preliminary data from the first three dose levels demonstrates encouraging anti-tumor activity with CF33-hNIS monotherapy, including one patient with cholangiocarcinoma, treated intratumorally, who achieved an immunological complete response (CR) with no known recurrence after one year.
CF33-hNIS monotherapy may be an effective and safe treatment option for GI (gastrointestinal) malignancies and warrants further investigation in biliary tract cancer patients.
Immunological changes in CF33-hNIS responding patients show a robust innate and adaptive immune response known to promote anti-tumor immunity and underscores the immunomodulatory potential of this therapy.
The poster can be downloaded from the Imugene website at: View Source

ASCO-GI is an annual international event highlighting the latest innovative science, strategies, developments and breakthroughs in gastrointestinal cancer treatment. It is estimated that more than 4,000 scientific figures, clinical researchers, academics, oncologists and medical practitioners from around the world attend the event.

On January 19, 2024 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that its Phase 1 MAST (metastatic advanced solid tumours) trial evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA), has continued to progress with the first patients dosed in each arm of the higher dose cohort as part of the Phase 1 study (Press release, Imugene, JAN 19, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/bd9faf72-2b60-04da-3899-77e9cf4d3704/VAXINIA_Phase_1_trial_doses_patients_in_higher_dose_cohorts.pdf [SID1234639338]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

In the monotherapy dose escalation, cohort 5 of the trial’s intratumoural (IT) and intravenous (IV) arm are now open with the first patients dosed on 16 January and 18 January 2024, respectively. The combination study, where VAXINIA is administered with pembrolizumab, also continues to actively enrol new patients with 13 patients enrolled to date.

Imugene Managing Director & CEO Leslie Chong said: "Following the positive news on VAXINIA’s early signals and FDA Fast Track Designation to end 2023, we are pleased to start the new year by announcing the ongoing progress of the MAST trial as we continue to see no safety issues with the drug. We also look forward to expanding the trial to take a closer look at bile duct cancer where we’ve seen early encouraging results."

The multicenter, Phase 1, MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. With no safety signals identified to date, the trial has since progressed through the monotherapy dose escalation cohorts as well as the combination study, whereby VAXINIA is administered with well-known checkpoint inhibitor pembrolizumab. The City of Hope-developed CF33 oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models. Overall, the study aims to recruit up to 100 patients across approximately 10 trial sites in the United States and Australia.

The clinical trial is titled "A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)." The trial commenced in May 2022 and is anticipated to run for approximately 24 months while being funded from existing budgets and resources.

Full study details can also be found on clinicaltrials.gov under study ID: NCT05346484.

On January 19, 2024 Starpharma (ASX: SPL, OTCQX: SPHRY) reported the presentation of the positive results from its Phase 2 clinical trial of DEP cabazitaxel at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium[1], which is being held from 18 to 20 January 2024 in San Francisco, US (Press release, Starpharma, JAN 19, 2024, View Source;mc_eid=bf52dd3418 [SID1234639337]). ASCO (Free ASCO Whitepaper) is the world’s leading professional organisation for physicians and oncology professionals. The ASCO (Free ASCO Whitepaper) GI Cancers Symposium is the only global meeting of its kind focusing on the latest innovative science and clinical developments in GI cancer treatment, research, and care. It brings together oncology thought leaders, practising clinicians, novel drug developers, and GI specialists from around the world.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Starpharma’s scientific poster presents the key results from the Phase 2 trial of DEP cabazitaxel in patients with advanced gastro-oesophageal cancers, announced on 18 October 2023[2], and additional efficacy data for DEP cabazitaxel in two subgroups of the gastro-oesophageal cohort with different types of cancers: adenocarcinoma and squamous cell carcinoma (SCC). DEP cabazitaxel achieved disease control rates of 100% and 50%, respectively, in these advanced and typically hard-to-treat gastro-oesophageal cancers, which have a one-year survival rate of approximately 20%[3],[4].

The ASCO (Free ASCO Whitepaper) GI Cancers Symposium poster will be presented by Associate Professor David Pinato, a leading Clinician Scientist and Consultant Medical Oncologist at the Imperial College London and an investigator for the DEP cabazitaxel study.

Associate Professor David Pinato, MD, MRCP (UK), MRes, PhD, Clinical Reader and Consultant Medical Oncologist, Director of Developmental Cancer Therapeutics Imperial College London, and Investigator for the trial, said:

"I am excited to share the impressive data on Starpharma’s novel dendrimer formulation of cabazitaxel with the gastrointestinal cancer community at this specialist ASCO (Free ASCO Whitepaper) GI cancers conference.

"DEP cabazitaxel showed very encouraging efficacy signals in hard-to-treat gastro-oesophageal cancers, in addition to prostate cancer and advanced platinum-resistant ovarian cancer. The patients in this trial had a poor prognosis with few treatment options remaining.

"In the study, DEP cabazitaxel was well tolerated, including in patients with high-risk clinical features. A number of our patients experienced reduced cancer-related pain, leading to reduced opiate usage, and other improvements in quality of life.

"Based on the data and my experience with DEP cabazitaxel, it represents a well-tolerated and promising treatment alternative for gastro-oesophageal cancers, with the benefit of less frequent treatment than the standard-of-care taxane option."

The key results from the Phase 2 trial of DEP cabazitaxel demonstrated highly encouraging anti-tumour activity in advanced gastro-oesophageal cancers in multiple anatomic locations (oesophagus, gastro-oesophageal junction and stomach), including a median progression-free survival (PFS) of 4.0 months and a median overall survival (OS) of 8.6 months.

The results for DEP cabazitaxel in advanced gastro-oesophageal cancers compare very favourably to standard-of-care paclitaxel treatment in patients with oesophageal or gastro-oesophageal junction cancers. DEP cabazitaxel achieved clinically meaningful improvements with a more than 50% longer median progression-free survival and a 29% longer median overall survival than published data on paclitaxel administered weekly as a second-line treatment[5].

Despite the majority of patients with gastro-oesophageal cancer in Starpharma’s study being refractory to first-line therapy, DEP cabazitaxel achieved a disease control rate (DCR) of 80% and an objective response rate (ORR) of 30%, including stable disease (SD) for up to 27 weeks and partial responses (PR) for up to 17 weeks in evaluable gastro-oesophageal cancer patients.

The DEP cabazitaxel efficacy results in gastro-oesophageal cancer patients, along with highly encouraging efficacy results in patients with metastatic castrate-resistant prostate cancer and platinum-resistant ovarian cancer, indicate the promising clinical potential of DEP cabazitaxel in multiple cancer types, including cancers for which conventional cabazitaxel is not indicated[6].

As reported previously, DEP cabazitaxel was also well-tolerated, with most treatment-related adverse events (TRAEs) being mild to moderate (Grade 1/2, 83%).

Starpharma Chief Executive Officer, Cheryl Maley, commented:

"We are pleased to present the data on DEP cabazitaxel in gastro-oesophageal cancers at the ASCO (Free ASCO Whitepaper) GI cancers meeting. Starpharma’s dendrimer platform has shown promise in multiple therapeutic areas, and the recent Phase 2 results have clinically validated the effectiveness and safety of Starpharma’s DEP technology, which is designed to improve the therapeutic benefits of drugs while minimising their side effects. We are encouraged by these results and the feedback from patients and clinical trial investigators, which underscore the potential of Starpharma’s DEP technology and its ability to improve treatment outcomes for patients."

View/download the ASX Announcement: DEP cabazitaxel data presentation at ASCO (Free ASCO Whitepaper) GI cancer meeting.

View/download the ASCO (Free ASCO Whitepaper) GI Cancer Symposium poster.

About DEP cabazitaxel

Developed by Starpharma, DEP cabazitaxel is a patented, dendrimer nanoparticle version of conventional cabazitaxel, which is marketed as Jevtana and widely used in the treatment of prostate cancer. Unlike standard cabazitaxel, DEP cabazitaxel is highly water soluble, does not contain toxic detergent-like excipients associated with anaphylaxis, and avoids the need for steroid pre-medication. In both preclinical and clinical studies, DEP cabazitaxel has shown an improved side effect profile, notably markedly reduced bone marrow toxicity demonstrated by lower rates of severe neutropenia, thrombocytopenia, and severe anaemia, which are all reportedly experienced by a significant proportion of patients treated with Jevtana.