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Boston Immune Technologies and Therapeutics Raises $10M Series A Financing

On March 17, 2021 Boston Immune Technologies and Therapeutics, Inc. (BITT), a privately held developer of novel TNF Superfamily antagonist antibodies, reported that the company has completed $10 M Series A/A1 preferred stock financing (Press release, BITT, MAR 17, 2021, View Source [SID1234576821]). Investors in the Series A preferred stock financing include BeiGene, Ltd., along with undisclosed private investors and prior investors Hatteras Venture Partners and EGP Investments. Funds will support the clinical development of BIR2101, a novel, TNFR2 antagonist antibody for indications in oncology and infectious disease and additional pipeline candidates. The company also announced that Lusong Luo, Ph.D., Senior Vice President of External Innovation at BeiGene and Joseph McMahon, CEO of Bioventure Partners, will be joining BITT’s board of directors.

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"This funding, in combination with our recent option and license arrangement with BeiGene, means BITT has the resources to move BIR2101 into the clinic and support proof of concept studies for additional TNF Superfamily targets," said Russell LaMontagne, Co-founder and Chief Executive Officer of BITT.

BITT is exploring clinical trials for BIR2101 as monotherapy and in combination with checkpoint blockade. TNFR2 is highly expressed on the most suppressive cells in the tumor microenvironment and has been identified as a driver of resistance to checkpoint blockade. In multiple murine models, the combination of TNFR2 with PD-1 results in significantly higher cure rates. BITT anticipates filing an IND for BIR2101 by end of 2021. Discovery stage antagonist antibodies for additional TNF Superfamily targets are in development.

4D Pharma Announces Private Placement

On March 17, 2021 4D pharma plc (AIM: DDDD) ("4D" or the "Company"), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported that it has entered into Securities Purchase Agreements with a select group of U.S. and United Kingdom institutional investors and accredited investors to raise, in aggregate, approximately $24.03 million (£17.29 million) in a private placement (the "Fundraising") of new ordinary shares of £0.0025 each (the "Placing Shares") at $1.53 (£1.10) per share (the "Issue Price") (Press release, 4d Pharma, MAR 17, 2021, View Source [SID1234576820]). In addition, Duncan Peyton (Chief Executive Officer) and Alex Stevenson (Chief Scientific Officer) intend to subscribe for, in aggregate, $2.0 million (£1.44 million) once the Company has released the results for the year ended 31 December 2020, expected to be on or around 25 March 2021.

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The Issue Price represents a discount of 16.3 per cent. to the closing price of £1.315 on 16 March 2021 (being the last practicable trading day prior to release of this Announcement).

The Fundraising is conditional on, among other things, passing of the Resolutions by 4D shareholders at the General Meeting convened for 10:00 a.m. (GMT) on 18 March 2021 (the "General Meeting"), and completion of the merger with Longevity Acquisition Corporation (NASDAQ: LOAC) ("Longevity"), details of which were announced on 22 October 2020 (the "Merger"). Completion of the Merger, with admission of the Placing Shares to trading on AIM, and admission of the Consideration Shares to trading on NASDAQ as 4D American Depositary Shares ("ADSs") is expected to occur on 22 March 2021.

Chardan and Ladenburg Thalmann acted as co-placement agents to the Company in connection with the Fundraising.

"This Fundraising involves a broad range of institutional investors, strengthening our international investor base. Combined with the imminent Merger and listing on NASDAQ expected to occur on 22 March 2021, 4D pharma is in a strong position to continue the development of the Company and its pipeline of Live Biotherapeutics," said Duncan Peyton, Chief Executive Officer, 4D pharma. "The additional funds that these combined activities deliver will enable 4D pharma to continue the rapid pace of development on our pipeline of Live Biotherapeutics, including lead oncology program, MRx0518 targeting a range of cancers, as well as other therapeutic areas such as neurological conditions. We have a robust line up of milestones set for 2021 and with both our new US institutional support and upcoming NASDAQ listing, we look forward to providing updates from our novel, single-strain LBP programs to our expanded global audience."

Definitions

Capitalised terms used in this announcement shall, unless defined in this announcement or unless the context provides otherwise, bear the same meaning ascribed to them in the circular posted to 4D shareholders by the Company on 26 February 2021.

Details of the Fundraising

The Fundraising comprises the private placement of 15,713,309 new Ordinary Shares at the Issue Price to raise approximately $24.03 million (£17.29 million) before expenses. The Fundraising is conditional upon, among other things, passing of the Resolutions by 4D shareholders at the General Meeting, completion of the Merger and admission of the Placing Shares to trading on AIM.

A Circular was sent to Shareholders on 26 February 2021 and includes a notice convening a General Meeting on 18 March 2021, to be held at 4D’s corporate headquarters in Leeds, UK.

Application has been made to the London Stock Exchange for the Placing Shares to be admitted to trading on AIM ("Admission"). It is expected that Admission will become effective at 8.00 a.m. (GMT) on 22 March 2021.

Director participation in the Fundraising

Certain Directors have confirmed to the Board that they wish to participate in the Fundraising, however as the Company is intending to release the results for the year ended 31 December 2020 on or around 25 March 2021, the Directors are currently in a closed period and are prohibited from such participation. Accordingly, immediately following the publication of those results, Duncan Peyton and Alex Stevenson intend to subscribe for new Ordinary Shares, in each case at the Issue Price (together the "Subscriptions"). Mr Peyton and Dr Stevenson intend to subscribe for, in aggregate, $2.0 million (£1.44 million).

The Subscriptions, if made, will constitute related party transactions for the purposes of the AIM Rules for Companies and the Independent Directors of 4D will be obliged to consider whether the terms of the related party transactions are fair and reasonable insofar as the shareholders of the Company are concerned, having consulted with the Company’s nominated adviser, N+1 Singer, before the Subscriptions are entered into. A further announcement will be made in due course.

Use of Proceeds

The proceeds from the Fundraising will be used primarily:

to advance the expanded Part B of the ongoing Phase I/II combination study of MRx0518 and Keytruda to completion; enrolment is currently expected to complete in Q4 2021;
to continue engagement with the FDA in 2021 to discuss the development and approval pathway for MRx0518 in combination with an ICI in patients with solid tumours and secondary resistance to prior ICI therapy;
to investigate the efficacy of MRx0518 in additional cancer patient groups, treatment settings, and as part of additional combination therapies, including an ongoing Phase I trial in pancreatic cancer;
to commence a fourth clinical trial of MRx0518 in combination with ICI Bavencio as a first-line maintenance therapy for urothelial carcinoma, expected to commence in 2021;
to evaluate designs for a potential first-in-human clinical trial of MRx0029 in-patient clinical trial in neurodegenerative diseases such as Parkinson’s disease;
to continue to advance the vaccines discovery program in collaboration with MSD;
to complete a Phase II trial of MRx-4DP0004 to prevent or reduce the hyper-inflammatory response in hospitalized patients with COVID-19;
to complete ongoing Phase I/II study of MRx-4DP0004 in poorly controlled asthma in combination with existing long-term maintenance therapy; and
for general corporate purposes.
The Board expects that the resulting proceeds of the Fundraising will extend 4D’s cash runway into Q2 2022.

Total Voting Rights

Following the issue of the Placing Shares and the Transaction Shares to be issued in connection with the Merger, 4D’s enlarged issued share capital will comprise 178,330,363 Ordinary Shares. The total number of voting rights in the Company will be 178,330,363. This figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the share capital of the Company under the Disclosure Guidance and Transparency Rules of the Financial Conduct Authority.

Registration Rights

The Placing Shares have not been registered under the United States Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Pursuant to the Securities Purchase Agreements, the Company has agreed to register the Placing Shares for resale under the Securities Act. Pursuant to the Securities Purchase Agreements, the Company will prepare and file a registration statement with the Securities and Exchange Commission within 30 days of the Fundraising closing date (the "Filing Deadline") and has agreed to use commercially reasonable efforts to have the registration statement declared effective as soon as practicable, but in any event, no later than 60 days after the Filing Deadline, or 120 days if the registration statement is subject to a full review by the Securities and Exchange Commission.

Non-Solicitation

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the Placing Shares, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

Additional Information

The person responsible for arranging the release of this information on behalf of the Company is Duncan Peyton.

Carmot Therapeutics Expands Leadership Team With Appointment of Manu Chakravarthy, MD, PhD as Chief Medical Officer and Executive Vice President of R&D

On March 17, 2021 Carmot Therapeutics, Inc. (Berkeley, CA), a clinical stage biotechnology company advancing transformative therapies for patients with metabolic diseases, reported the appointment of Manu Chakravarthy, MD, PhD as Chief Medical Officer and EVP of R&D, and member of the executive leadership team (Press release, Carmot, MAR 17, 2021, View Source [SID1234576819]). Dr. Chakravarthy will be based in Boston and lead the expansion of Carmot with an east-coast presence.

"Dr. Chakravarthy joins Carmot at a very exciting time, as we initiate phase 1 and 2 clinical studies in metabolic diseases and advance our rapidly growing portfolio of pre-clinical programs" commented Stig K. Hansen, PhD, Carmot’s co-founder and Chief Executive Officer. "Treatment of type 2 diabetes and associated metabolic diseases is currently undergoing a paradigm shift with the advent of dual modulators of the GLP-1 and GIP incretin pathways. Carmot is at the forefront of this transformation with novel therapeutics built on unique insights into GLP-1 and GIP biology supported by Chemotype Evolution, our proprietary drug discovery platform. Manu is a highly respected medical expert and a scientific leader with a strong research background and will guide the success of our growing pipeline."

"I am thrilled to join Carmot at this stage of the Company’s evolution", said Dr. Chakravarthy. "Carmot’s ability to dissect biological pathways and discover novel chemical matter has enabled new treatment modalities including CT-868 and CT-388, Carmot’s dual incretin receptor modulators, entering phase 2 and 1 studies in 1H21. I am excited to apply my experience to complement Carmot’s science-driven culture and transform the treatment of diabetes and its many co-morbidities."

Dr. Chakravarthy joins Carmot Therapeutics from Axcella Health, where he has served as Executive Vice President and Chief Medical Officer and a member of the executive team with direct oversight of all phases of clinical development, regulatory affairs, quality, and scientific communications.

Prior to Axcella, Dr. Chakravarthy served as the Vice President and Global Head of External R&D and Innovation Strategy in Diabetes and Cardiovascular Research at Eli Lilly. Before his global leadership role at Lilly, Dr. Chakravarthy worked across the R&D spectrum at Merck from discovery, clinical pharmacology, biomarker development and late-stage drug development covering diverse disease areas. His work in clinical pharmacology supported regulatory filings for successful drug approvals in endocrine, neuroscience, and infectious diseases. He assumed positions of increasing responsibility and leadership within Merck, and as a Distinguished Scientist, led Discovery Medicine for the Diabetes and Cardiometabolic therapeutic area. Dr. Chakravarthy earned his M.D. from the University of Texas Houston Medical School and a Ph.D. in Cell Biology & Physiology from the MD Anderson Cancer Center and University of Texas Graduate School of Biomedical Sciences combined MD-PhD program. He trained in Internal Medicine at the Hospital of the University of Pennsylvania, and in Endocrinology, Diabetes and Metabolism at Washington University School of Medicine in St. Louis. Dr. Chakravarthy continues to serve patients as an Adjunct Clinical Asst. Professor of Medicine at the Rutgers School of Medicine in New Jersey. He is internationally recognized as a thought leader in metabolic diseases, reflected by his published work in numerous high-impact peer-reviewed scientific journals and invited speakerships.

T-Cure Bioscience Enters Into Agreement With Rutgers to Conduct Clinical Research of Novel T Cell Receptor Therapy for Treatment of Variety of Cancers

On March 17, 2021 T-Cure Bioscience, Inc., a privately held company focused on developing T cell receptor (TCR) therapy products for the treatment of solid tumors, reported that the Company has entered into a clinical research agreement with Rutgers, The State University of New Jersey, to fund a Phase I clinical study testing a TCR-based product candidate for the treatment of tumors expressing Kita-Kyushu lung cancer antigen 1 (KK-LC-1), such as gastric, cervical, lung, and triple negative breast cancers (Press release, T-Cure Bioscience, MAR 17, 2021, View Source [SID1234576818]). T-Cure acquired the KK-LC-1 TCR therapy under an exclusive, worldwide license with the National Cancer Institute (NCI) in 2020. The Principal Investigator who will conduct the clinical research is Christian S. Hinrichs, M.D., Chief of the Section of Cancer Immunotherapy and Co-Director of the Cancer Immunology and Metabolism Center of Excellence at Rutgers Cancer Institute of New Jersey. Dr. Hinrichs is an expert in cancer immunology and immunotherapy and was recruited from the NCI where he served as Senior Investigator at the Genitourinary Malignancies Branch. T-Cure anticipates the KK-LC-1 TCR therapy will enter a multi-site Phase 1 clinical study in the second quarter of 2021 at the NCI, with the clinical study responsibilities to be transferred to Rutgers in the second half of 2021.

"I joined the Cancer Immunology and Metabolism Center of Excellence because I believe that Rutgers Cancer Institute can be a global leader in cancer and tumor immunology research and development. In support of that mission, I am excited to partner with T-Cure to launch the first cell therapy clinical trial targeting the KK-LC-1 antigen," stated Dr. Hinrichs. "I began collaborating with the T-Cure team on this T cell receptor therapy while at the NCI, and I am pleased to continue working with them to advance this therapy at Rutgers."

"We look forward to our partnership with Dr. Hinrichs at Rutgers as a continuation of the work we undertook with him and his team at the NCI to advance this novel TCR product candidate through preclinical and clinical development," stated Gang Zeng, Ph.D., Chief Executive Officer of T-Cure. "The TCR was isolated from the tumor-infiltrating lymphocytes of a patient who had a complete response to a safely administered immunotherapy. Accordingly, we believe it holds great promise for engineering patients’ immune cells to effectively target and destroy cancer cells without being harmful to healthy tissue."

Future Planet Invests in Vaccitech’s Series B Financing

On March 17, 2021 Future Planet Capital has invested in a $168m Series B financing reported by Vaccitech Ltd. Future Planet joins other leading investors including M&G Investment Management, Tencent, Gilead Sciences, Monaco Constitutional Reserve Fund and fellow existing investor, Oxford Sciences Innovation (Press release, Vaccitech, MAR 17, 2021, View Source [SID1234576817]). As part of the Series B financing, $43 million in convertible loan notes previously issued by Vaccitech will convert into Series B shares, resulting in total gross proceeds to Vaccitech of $168 million before expenses.

Douglas Hansen-Luke, Executive Chairman of Future Planet Capital, explained: "Our decision to support Vaccitech last year, before the results of the COVID-19 Vaccine AstraZeneca trials were known, has been vindicated by the vaccine’s approval for emergency use by national and international regulators. The success of the COVID-19 Vaccine AstraZeneca has increased our confidence in Vaccitech’s immunotherapy platform and our continuing support is signalled by our investment today."

Bill Enright, CEO of Vaccitech, said: "We expect this financing to enable us to reach key value inflection points for our lead programs. We now look forward to advancing key programs towards generating proof-of-concept data in indications with significant need of effective new treatments."

Ed Phillips, Head of Origination at Future Planet, concluded: "This is a concrete example of our vision in action – financing the best minds to address global challenges. We look forward to working with other entrepreneurs and businesses dedicated to solving global challenges in the future."

Vaccitech is a clinical stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer; in 2020 it co-invented a COVID-19 vaccine candidate with the University of Oxford, AZD1222, which is known as the COVID-19 Vaccine AstraZeneca.