On January 17, 2024 Cleveland Diagnostics, Inc., a clinical-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers reported the closing of over $75M in growth capital financing (Press release, Cleveland Diagnostics, JAN 17, 2024, View Source [SID1234639303]). The financing was led by Novo Holdings, a leading global life sciences investor, responsible for managing the assets of the Novo Nordisk Foundation, along with participation from existing investors as well as a credit facility from Symbiotic Capital. The financing will accelerate Cleveland Diagnostics’ commercial and corporate development goals.

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!

"We are pleased to have secured this growth capital and support from a mix of new and existing investors, exhibiting their confidence in our company’s growth potential and our ability to execute financial discipline as we anticipate increased test utilization and achievements of key clinical and regulatory milestones in 2024," said Arnon Chait, Ph.D., Cleveland Diagnostics CEO & co-founder. "These funds provide Cleveland Diagnostics the capital and flexibility to advance our portfolio of non-invasive tests as demonstrated by the rapidly increasing demand for our IsoPSA prostate cancer test."

IsoPSA is a blood test used to further stratify the risk of prostate cancer and aid in biopsy decisions for men identified at higher risk based on results from screening methods, such as PSA testing. Differentiating cancer from benign conditions, this protein-based test is critical for many patients to identify cancer at its earliest stage to minimize the cost of overdiagnosis and overtreatment – a vital test as 1 in every 8 men are expected to be diagnosed with prostate cancer in their lifetime. In 2023 alone, there were an estimated 288,000 new prostate cancer diagnoses and over 34,000 deaths in the United States, according to the American Cancer Society. IsoPSA can provide more specific insights to better inform healthcare providers and support actionable evidence when evaluating the ongoing unmet medical need for patients affected by prostate cancer.

Cleveland Diagnostics’ portfolio of oncology related tests will be expanding beyond prostate cancer into additional indications in 2024. Proceeds will accelerate the commercial strategy of IsoPSA, fund expanded infrastructure and R&D pipeline development, and broaden the geographic scope of its novel IsoPSA prostate cancer test.

"It’s all about the patients," said Noel Jee, Partner on the Growth Investments team at Novo Holdings US. "We believe that IsoPSA has the potential to improve treatment, reduce costs, and increase quality-of-life for patients who may have prostate cancer. The company’s differentiated blood-based approach presents an opportunity to further improve diagnostics for other cancers and diseases."

In connection with the financing, Jee will join the Cleveland Diagnostics Board of Directors.

"We are delighted to be a part of ClevelandDx’s growth trajectory and support the team as they tackle the diagnostic uncertainty that remains in urology and other therapeutic areas," added Jee.

On January 17, 2024 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported a clinical trial update of its Phase 1 MAST (Metastatic Advanced Solid Tumours) trial evaluating the safety and efficacy of novel cancer-killing virus CF33-hNIS (VAXINIA) (Press release, Imugene, JAN 17, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/239ef0da-fe2d-1182-07cf-4453d3a72429/Phase_1_CF33_hNIS_Study_Update_Positive_Early_Signals.pdf [SID1234639271]).

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!

As of 12 January 2024, 38 patients have been dosed with VAXINIA during the continuing dose escalation phase, comprised of 19 patients dosed intratumourally and 19 patients dosed intravenously as either monotherapy or in combination with pembrolizumab.
31 patients were evaluable for efficacy (received at least their first scan at day 42). In the IT cohorts (14 patients), 7 of 15 (47%) injected lesions had a reduction in tumour burden, 3 lesions were completely eradicated. 3 patients (21%) had an objective response: 1 complete response by iRECIST in a patient with cholangiocarcinoma (a type of biliary tract cancer); and 2 partial responses in patients with melanoma (skin cancer) by RECIST. In IV cohorts (17 patients), 53% of patients achieved stable disease as their best response. • Patients who received prior checkpoint blockade therapy derived clinical benefit with and without pembrolizumab.
Trial expansion is planned for 10-20 patients with biliary tract cancers.
Early results presented this week at the annual ASCO (Free ASCO Whitepaper)-GI Symposium in San Francisco, California, show that 7 patients with gastrointestinal cancers who received CF33-hNIS alone including 3 colorectal, 2 biliary tract, 1 pancreatic and 1 liver cancer showed positive treatment effects, with a disease control rate (all CR, PR and SD) of 86%. Importantly, in these patients, changes in tumour burden correlated with systemic immunological changes known to promote anti-tumour immunity. The poster "Oncolytic Virus CF33-hNIS Monotherapy for the Treatment of Gastrointestinal Malignancies" will be presented on 18 January 2024 during Session A: Cancers of the Esophagus and Stomach and Other GI Cancers from 11:45 AM-1:15 PM.
Imugene MD & CEO Leslie Chong said: "This latest data reinforces the early positive responses we’ve seen in gastrointestinal cancers and in particular for cholangiocarcinoma (bile duct cancer). It provides an excellent platform to investigate the impact of VAXINIA at higher dose levels as we also expand the trial to additional patients with hard-to-treat biliary tract cancers. It is a proud moment for us to be able to present these results at ASCO (Free ASCO Whitepaper)-GI, and promote the potential of VAXINIA and CF33 more broadly."

Notably, 1 patient with biliary tract cancer, treated IT with mid-dose level displayed pseudoprogression (see below) with a 49% increase in tumour burden after 2 cycles of therapy. However, by the 4th cycle they achieved a Complete Response (iCR) with no known recurrence in over 430 days. A second patient with bile duct cancer, who previously progressed on prior drug therapies, achieved Stable Disease (SD) for > 4 months upon receiving IV-administered CF33-hNIS.

About Biliary Tract Cancers
Bile duct cancers are difficult to treat and typically respond modestly to immunotherapy drugs. Pseudoprogression is a phenomenon in which the cancer initially appears to be growing, largely due to the cancer cells being infected by the virus then followed by infiltration of cancer fighting immune cells. However, it is usually followed by a decrease in tumour burden when the therapy takes effect. This phenomenon can benefit patients receiving immunotherapy but often leads to premature discontinuation of treatment owing to the false impression the cancer is growing.

About the MAST Trial
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. The City of Hope-developed 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 cancer 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 Intratumourally 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 17, 2024 Biomica Ltd., a clinical-stage biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN), reported that the final patient has been enrolled in its Phase I clinical trial (Press release, Evogene, JAN 17, 2024, View Source [SID1234639287]).

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!

Initiated on July 11, 2022, the Phase I trial was specifically designed to evaluate the safety and tolerability of Biomica’s microbiome-based immuno-oncology drug candidate, BMC128, in combination with immune checkpoint inhibitor (ICI) immunotherapy, in patients with either non-small cell lung cancer (NSCLC), melanoma or renal cell carcinoma (RCC), who previously progressed on immunotherapy. Bristol Myers Squibb’s Opdivo is the immune checkpoint inhibitor in the trial. The study takes place at The Davidoff Center and the Rambam Health Care Campus in Israel.
Biomica remains on track with preliminary results, and the first data point readout is expected in H1 2024.

Dr. Elran Haber, CEO of Biomica, stated: "We are pleased to complete the Phase 1 Proof of Concept study enrollment, marking a critical step forward in developing our groundbreaking BMC128. We are excited about the progress made thus far and confident about the potential of BMC128 to address the unmet needs in the treatment of ICI-refractory cancer patients."

About BMC128:
BMC128 is a rationally designed microbial consortium identified and selected through a detailed functional microbiome analysis using PRISM, a proprietary high-resolution microbiome analysis platform powered by MicroBoost AI tech engine.
Developed as a Live Bacterial Product (LBP), BMC128 is an LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity through multiple biological processes.

Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria.

On January 17, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported that management will be participating in the following investor conference (Press release, Gritstone Bio, JAN 17, 2024, View Source [SID1234639289]):

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!

B. Riley Securities’ 4th Annual Oncology Conference (Fireside Chat)
Date and Time: Thursday, January 18, 2024 at 1:30pm ET
Presenter: Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer

A live webcast of the fireside chat will be available via View Source An archived replay will be accessible for 30 days following each event.

On January 17, 2024 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported the pricing of an underwritten public offering of 10,869,566 shares of its common stock for total gross proceeds of $75 million before deducting underwriting discounts and commissions and estimated offering expenses payable by Alector (Press release, Alector, JAN 17, 2024, View Source [SID1234639322]). The offering is expected to close on January 19, 2024, subject to satisfaction of customary closing conditions. All of the shares in the offering are being sold by Alector.

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!

Alector has granted the underwriter a 30-day option to purchase up to an additional 1,630,434 shares of its common stock offered in the public offering, at the public offering price, less underwriting discounts and commissions.

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

The offering is being 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 is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website at View Source A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, 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.