On March 19, 2024 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, reported the pricing of an underwritten offering of 14,545,454 shares of its common stock at an offering price of $5.50 per share (Press release, Fate Therapeutics, MAR 19, 2024, View Source [SID1234641263]). The offering includes participation from new and existing institutional investors, including Adage Capital Partners LP., Boxer Capital, Deep Track Capital, OrbiMed, Suvretta Capital and a life-sciences focused investor.

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In addition, the Company announced the pricing of a concurrent private placement of pre-funded warrants to purchase 3,636,364 shares of its common stock at a purchase price of $5.499 per pre-funded warrant, which represents the offering price per share of common stock less the $0.001 exercise price per share of each pre-funded warrant, to certain institutional and other accredited investors affiliated with or managed by Redmile Group, LLC.

The gross proceeds from the underwritten offering and private placement are expected to be approximately $100.0 million before deducting underwriting discounts and commissions and other offering expenses. BofA Securities, Jefferies, and Leerink Partners are acting as the joint bookrunning managers for the underwritten offering.

All of the shares and pre-funded warrants are to be sold by the Company. The financing is expected to close on or about March 21, 2024, subject to customary closing conditions.

The Company intends to use the net proceeds from the underwritten offering and concurrent private placement for funding clinical trials and nonclinical studies of the Company’s product candidates, manufacturing expenses associated with the development of the Company’s product candidates, the conduct of preclinical research and development, and for other working capital and general corporate purposes.

A shelf registration statement on Form S-3 (File No. 333-275402) relating to the underwritten offering of the securities described above was filed with the Securities and Exchange Commission (the "SEC") on November 8, 2023 and became effective on November 27, 2023. A final prospectus supplement relating to and describing the terms of the underwritten offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the final prospectus supplement may also be obtained from BofA Securities, Inc. NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, Attn: Prospectus Department or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; or Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

The pre-funded warrants to be sold in the concurrent private placement have not been registered under the Securities Act or under any state securities laws and, unless so registered may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. The securities sold in the private placement will be issued in reliance upon the exemption from registration pursuant to Section 4(a)(2) under the Securities Act in a transaction not involving a public offering of such securities.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall 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 March 19, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported a Research & Development (R&D) Day focusing on its core AI-Immunology platform (Press release, Evaxion Biotech, MAR 19, 2024, View Source [SID1234641262]). The event will be hosted at our facilities in Hørsholm, Denmark, between 14.00 – 18.00 CET / 9.00 a.m. – 1.00 p.m. EST and can be accessed remotely here.

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The R&D Day features a series of talks providing in-depth insights into Evaxion’s clinically validated AI-Immunology platform for vaccine target discovery, design and development. AI-Immunology consists of a collection of in-house developed AI building blocks that can be intelligently combined into AI prediction models to address complex healthcare issues related to the immune system. With the AI prediction models, PIONEER, ObsERV, EDEN and RAVEN, we can identify clinically relevant vaccine targets within hours.

Christian Kanstrup, CEO of Evaxion, expresses enthusiasm: "We have been looking forward to this exciting day and welcome everyone interested in learning more about our technology and its potential for saving and improving lives. We believe that we hold a truly differentiated position driven by our validated AI-Immunology platform and the multi-disciplinary capability set we have built around it. The potential of AI-Immunology is evidenced by our strong pipeline of vaccine candidates and existing partnerships."

The presentations during the day will, among other things, cover:

The innovative modular architecture of AI-Immunology, where AI building blocks can be combined into AI prediction models, enhancing scalability
Insights into the novel AI-Immunology building block, EvaxMHC, which is used across the platform, significantly enhancing the predictive capabilities
The clinical validation of the predictive capabilities of the PIONEER model showing a statistically significant improvement in progression-free survival in metastatic melanoma patients
The novel tumor target sources, named Endogenous Retroviruses (ERVs), showing high relevance in low tumor mutation burden cancers, allowing for potentially more effective personal cancer vaccines
The EDEN model outperforms reverse vaccinology finding novel targets in hours instead of years. The EDEN designed EVX-B2 vaccine candidate showing stronger protection than a vaccine candidate developed by GSK’s Gonorrhea
RAVEN introduces novel vaccine concepts to enhance the effectiveness of T-cell-based vaccines
The ObsERV model allows for a novel precision vaccine approach toward addressing cancers which cannot be targeted with standard immunotherapies
Following the R&D Day, a replay of the event presentations will be available on our website.

About AI-Immunology 

AI-Immunology is a scalable and adaptable artificial intelligence technology platform at the forefront of vaccine discovery for infectious diseases and cancers. By integrating the collective power of proprietary AI models PIONEER, EDEN, RAVEN, and ObsERV, the platform can model the complexity of the patient’s immune system. AI-Immunology advanced computational modelling swiftly and uniquely identifies, predicts, and designs vaccine candidates, revolutionizing the landscape of immunotherapy by offering a holistic and personalized approach to combat fast-evolving pathogens and malignant cells.

On March 19, 2024 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported fourth quarter and full year 2023 financial results and provided a business update (Press release, Cyclacel, MAR 19, 2024, View Source [SID1234641261]).

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"Following the recently announced precision medicine strategy for oral fadraciclib, our CDK2/9 inhibitor, we have determined the recommended Phase 2 dose (RP2D) and are ready to start proof-of-concept studies," said Spiro Rombotis, President and Chief Executive Officer. "We expect two key data readouts for fadraciclib this year. These include pharmacokinetic (PK), pharmacodynamic (PD), safety and activity data from the dose escalation part of the 065-101 Phase 1/2 study. In addition, we expect to report initial clinical activity from the Phase 2 proof of concept part, evaluating cohorts of patients selected for their mutational profile and/or Phase 1 activity in various solid tumors and lymphoma. At the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2024, independent investigators will present preclinical proof-of-concept data for fadraciclib further demonstrating fadraciclib’s differentiated properties from other next generation CDK inhibitors."

"We have observed CDKN2A/CDKN2B alterations, including loss of function, in multiple, pretreated patients with various cancers, including gynecological, hepatobiliary, lung, and pancreatic, who benefitted from fadraciclib monotherapy. In addition, we have observed clinical activity in patients with T cell lymphoma, said Brian Schwartz, M.D., interim Chief Medical Officer. "We expect to report final Phase 1 results including details on patient genomic profiles at an upcoming medical conference. A precision medicine strategy is also emerging for plogosertib, our PLK1 inhibitor. Preclinical data from independent groups have shown that certain ARID1A- and SMARCA-mutated cancers may benefit from treatment with plogosertib. Before testing this hypothesis in our 140-101 dose escalation study, we plan to switch to a new oral formulation of plogosertib with improved bioavailability. We are excited about the potential precision medicine strategies for both our clinical programs, with initial data from the fadraciclib Phase 2 proof-of-concept study."

Key Highlights for 2024

· First patient dosed with oral fadraciclib in Phase 2 proof-of-concept part of 065-101 study in patients with advanced solid tumors and lymphoma
· Report final data from dose escalation stage from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma
· Report interim data from initial cohorts in Phase 2 open label, proof-of-concept part of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma
· Independent investigators to report preclinical proof-of-concept data for fadraciclib at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024

Financial Highlights

As of December 31, 2023, pro forma cash and cash equivalents totaled $6.3 million, including $2.9 million of United Kingdom research & development tax credits which were received after the end of the year. Cash and cash equivalents as of December 31, 2023, totaled $3.4 million, compared to $18.4 million as of December 31, 2022. Net cash used in operating activities was $16.1 million for the twelve months ended December 31, 2023 compared to $20.8 million for the same period of 2022. The Company estimates that its available cash, including the United Kingdom research & development tax credit of $2.9 million, will fund currently planned programs into the second quarter of 2024.

Research and development (R&D) expenses were $3.5 million and $19.2 million for the three months and year ended December 31, 2023, as compared to $6.7 million and $20.3 million for the same period in 2022. R&D expenses relating to fadraciclib were $2.7 million and $13.4 million for the three months and year ended December 31, 2023, as compared to $5.3 million and $14.0 million for the same period in 2022 due to decrease in clinical trial costs offset by an increase in manufacturing and other non-clinical expenditures. R&D expenses related to plogosertib were $0.7 million and $5.0 million for the three months and year ended December 31, 2023, as compared to $1.3 million and $5.5 million for the same period in 2022 due to decrease in manufacturing and other non-clinical expenditures.

General and administrative expenses for the three months and year ended December 31, 2023, were $1.9 million and $6.7 million, compared to $2.1 million and $7.4 million for the same period of the previous year due to a decrease in professional fees.

Total other income, net, for the three months and year ended December 31, 2023, were an expense of $0.3 million and expense of $0.1 million, compared to an expense of $0.2 million and income of $1.7 million for the same period of the previous year. The decrease of $1.8 million for the year ended December 31, 2023, is primarily related to royalty income received in the previous year.

United Kingdom research & development tax credits for the three months and year ended December 31, 2023 were $0.4 million and $3.0 million compared to $1.6 million and $4.7 million for the same period of the previous year and are directly correlated to qualifying research and development expenditure.

Net loss for the three months and year ended December 31, 2023, was $5.3 million and $22.6 million (including stock based compensation expense of $0.3 million and $1.5 million respectively), compared to $7.4 million and $21.2 million (including stock based compensation expense of $0.3 million and $1.5 million respectively) for the same period in 2022.

On March 19, 2024 Curium, a world leader in nuclear medicine, reported that in the Netherlands the first commercial dose of PYLCLARI has been sold (Press release, Curium, MAR 19, 2024, View Source [SID1234641260]). PYLCLARI (INN: Piflufolastat (18F) also known as (18 F)-DCFPyL, is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in the following clinical settings:

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Primary staging of patients with high-risk prostate cancer prior to initial curative therapy
To localize recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent
Benoit Woessmer, PET Europe CEO at Curium commented, "We are pleased that with today’s news of first commercial supply in the Netherlands, PYLCLARI is now available to more nuclear medicine physicians and their patients in three European countries – Greece, Italy, and in the Netherlands where the production will be done by our partner BV Cyclotron VU in Amsterdam. With our focus on redefining the experience of cancer through our trusted legacy in nuclear medicine, Curium is proud to be improving the choice of diagnostic modalities available to our customers across Europe – ultimately for the benefit of patients with prostate cancer."

Today’s announcement follows the decision in July 2023 by the European Commission granting marketing authorization for PYLCLARI in the European Union, followed by first commercial doses in Greece in November 2023, and in Italy in February 2024.

On March 19, 2024 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, reported a business update and reported financial results for the fourth quarter and year ended December 31, 2023 (Press release, Corvus Pharmaceuticals, MAR 19, 2024, View Source [SID1234641259]).

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"Corvus is pioneering the development of ITK inhibition with a focus on advancing our lead program, soquelitinib, into a registrational Phase 3 trial for patients with relapsed PTCL," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We believe we are well positioned to execute on this trial, with recent positive updates from our Phase 1/1b clinical trial, alignment on the final study protocol with FDA, interest from leading academic centers in North America, and the receipt of Orphan Drug Designation for soquelitinib. We also continue to expand our knowledge and experience with ITK-mediated immunomodulation as a novel therapeutic for a broad range of cancers and immune diseases. We have several exciting opportunities in immunology, including plans for a randomized, placebo controlled clinical trial of soquelitinib in atopic dermatitis. In addition, we continue to progress our next-generation ITK inhibitors, which have been designed to optimize T cell modulation for specific immune indications. Based on current timelines, we anticipate the atopic dermatitis trial will be initiated in the second quarter of 2024 with initial data potentially available by year end, and we anticipate the PTCL trial will be initiated in the third quarter."

Business Update and Strategy

Prioritized Program: Soquelitinib (formerly CPI-818, Corvus’ selective ITK inhibitor)

Soquelitinib for T Cell Lymphoma

Corvus continues to follow patients with relapsed T cell lymphoma in a Phase 1/1b clinical trial evaluating single agent therapy with soquelitinib. Updated interim data as of January 22, 2024 (data shown below in Figures 1-2):
A total of 23 patients were enrolled in the Phase 1/1b trial at the optimum 200 mg two-times a day dose and meet the eligibility criteria for the planned registrational Phase 3 clinical trial based on ≥1 and ≤3 prior therapies (eligible patient population), including 21 evaluable patients.
For the 21 evaluable patients, objective responses (complete response, CR plus partial response, PR) were seen in seven patients, including four CRs and three PRs. Compared to the prior data (as of November 21, 2023) reported from the trial in December 2023 in conjunction with the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, one of the patients achieving a PR continued to respond and achieved a CR.
Disease control (CR, PR and stable disease) was seen in 12 of 21 patients. The stable disease group included five patients who achieved tumor reductions that did not meet the criteria for a PR, with two of these patients continuing to receive therapy. Several patients experiencing tumor regression are continuing to receive therapy.
The Company presented a poster at ASH (Free ASH Whitepaper) that included additional data from the Phase 1/1b clinical trial and complementary preclinical data, including the evaluation of blood samples and tumor biopsies from eight patients who participated in the trial. The results support soquelitinib’s novel mechanism of action, and demonstrated increases in cytotoxic killer T cells and reductions in markers of T cell exhaustion.
Figure 1: Waterfall Plot for Patients in the 200 mg Dose Cohort of the Soquelitinib Phase 1/1b Clinical Trial for Peripheral T Cell Lymphoma. The plot shows the best percent change in tumor volume in the 21 evaluable patients (eligible patient population), as of January 22, 2024, that were measurable by CT scan or by Modified Severity-Weighted Assessment Tool (mSWAT) for patients with cutaneous involvement.

Waterfall Plot for Patients in the 200 mg Dose Cohort of the Soquelitinib Phase 1/1b Clinical Trial for Peripheral T Cell Lymphoma. The plot shows the best percent change in tumor volume in the 21 evaluable patients (eligible patient population), as of January 22, 2024, that were measurable by CT scan or by Modified Severity-Weighted Assessment Tool (mSWAT) for patients with cutaneous involvement.

Figure 2: Swimmer Plot of Eligible Patient Population Demonstrating Response and Time on Therapy. Tumor histologies, as of January 22, 2024, are also shown indicating different types of T cell lymphoma. PTCL-NOS, peripheral T cell lymphoma not otherwise specified; CTCL, cutaneous T cell lymphoma of either Sezary or mycosis fungoides type; NKTCL, natural killer cell T cell lymphoma; ALCL, anaplastic large cell lymphoma; AITL, angioimmunoblastic T cell lymphoma.

Swimmer Plot of Eligible Patient Population Demonstrating Response and Time on Therapy. Tumor histologies, as of January 22, 2024, are also shown indicating different types of T cell lymphoma. PTCL-NOS, peripheral T cell lymphoma not otherwise specified; CTCL, cutaneous T cell lymphoma of either Sezary or mycosis fungoides type; NKTCL, natural killer cell T cell lymphoma; ALCL, anaplastic large cell lymphoma.

In February 2024, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for soquelitinib for the treatment of T cell lymphoma, providing potential benefits including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity. The Company has also obtained alignment with FDA on its protocol for a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL and anticipate initiating the trial in the third quarter of 2024. There are currently no FDA fully approved agents for the treatment of relapsed PTCL.
Soquelitinib for Immune Diseases

Corvus plans to initiate a randomized, placebo-controlled Phase 1 trial of soquelitinib in patients with moderate to severe atopic dermatitis in the second quarter of 2024, with the potential for initial data from the trial before year end 2024. The trial is planned to enroll 64 patients that have failed at least one prior therapy across four different 28-day dosing regimens of soquelitinib compared to a placebo group. The endpoints include safety and improvement in Eczema Area and Severity Index ("EASI"). Patients and physicians will be blinded to treatment assignment.
In February 2024, Corvus presented preclinical data for soquelitinib at the Keystone Symposia on Systemic Autoimmunity and Autoinflammatory Diseases. The data included the first description of Corvus’ next-generation ITK inhibitor preclinical product candidates, which were designed to deliver precise T-cell modulation that is optimized for specific immunology indications. These preclinical product candidates exhibit specific biologic properties that are anticipated to enable more precise inhibition of Th1, Th2 and/or Th17 cell function. Atopic dermatitis and asthma are thought to be mediated primarily by Th2 lymphocytes. Th17 cells are associated with psoriasis and psoriatic arthritis. The results suggest that chemical structures may be refined to perform more specific biologic functions and may enable targeting of various types of immune disease. This data builds on the publication of preclinical data on soquelitinib as a preprint at bioRxiv in November 2023 that demonstrated ITK’s selective inhibition which produced therapeutic benefits in several autoimmune and allergy preclinical models including psoriasis, asthma, pulmonary fibrosis, scleroderma and graft versus host disease.
In February 2024, the Company appointed Jeffrey Arcara as Chief Business Officer, with responsibility for leading corporate strategy, business development, portfolio strategy, and new product planning. This includes an initial focus on maximizing the potential of the Company’s ITK inhibitor programs, both internally and through partnerships. Mr. Arcara previously served as senior vice president, head global marketing & portfolio and strategy for the innovative medicines and biosimilars business at Teva Pharmaceuticals.
Partner Led Programs: Ciforadenant (adenosine 2a receptor inhibitor) and Mupadolimab (anti-CD73)

The Kidney Cancer Research Consortium is enrolling a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The Phase 1b portion of this trial has been completed and patients are now being enrolled in the Phase 2 portion. The clinical trial is expected to enroll up to 60 patients and initial data is anticipated in the first half of 2024.
Angel Pharmaceuticals, Corvus’ partner in China, is enrolling patients in a Phase 1/1b clinical trial of mupadolimab in patients with non-small cell lung cancer (NSCLC) and head and neck squamous cell cancers (HNSCC). In this clinical trial, patients will receive mupadolimab monotherapy or in combination with pembrolizumab.
Financial Results
As of December 31, 2023, Corvus had cash, cash equivalents and marketable securities of $27.1 million as compared to $42.3 million as of December 31, 2022. During the year ending December 31, 2023, the Company sold 2,461,903 shares of its common stock through its at-the-market program, generating net proceeds to the Company of approximately $7.8 million.

Research and development expenses for the three months and full year ended December 31, 2023 totaled $4.0 million and $16.5 million, respectively, compared to $4.1 million and $24.5 million for the same periods in 2022. For the full year 2023, the decrease of $8.0 million was primarily due to lower clinical trial and manufacturing costs associated with the development of mupadolimab.

The net loss for the three months ended December 31, 2023 was $6.7 million compared to a net loss of $9.8 million for the same period in 2022. Total stock compensation expense for the three months ended December 31, 2023 and 2022 was $0.6 million and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $1.4 million for the three months ended December 31, 2023 compared to $4.6 million in the same period in 2022.

Conference Call Details
Corvus will host a conference call and webcast today, Tuesday, March 19, 2024, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter and full year 2023 financial results. The conference call can be accessed by dialing 1-877-407-0784 (toll-free domestic) or 1-201-689-8560 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.