On July 27, 2020 Immodulon, the immuno-oncology company, reported an expansion to its ongoing collaboration with Professor van Eijck and his team at the Erasmus University Medical Center Rotterdam ("Erasmus MC") (Press release, Immodulon Therapeutics, JUL 27, 2020, View Source [SID1234562740]). A phase I/II, open label study is being planned in patients with limited metastatic pancreatic cancer ("MEPANC -1") . The trial is designed to evaluate the safety and efficacy of IMM-101 administered in combination with stereotactic radiotherapy of metastases in the liver and lung in patients with limited metastatic pancreatic cancer. This follows the successful recruitment of 20 patients in a separate phase I/II study combining IMM-101 with stereotactic radiotherapy in locally advanced pancreatic cancer ("LAPC-2"). The MEPANC -1 study design will be submitted to the local Erasmus MC Medical Ethics Review Committee and the national Central Committee on Research Involving Human Subjects(CCMO) and, should it be approved, recruitment is expected to begin by the end of 2020.

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Professor Casper H J van Eijck, hepatobiliary surgeon and Professor in surgery, commented:
"We look forward to starting this new original study which has not been performed before in patients with limited metastatic pancreatic cancer. Since the recruitment in the LAPC-2 study is highly successful, we expect to include patients from all Dutch Pancreatic Cancer Group hospitals within the allocated time frame. We are pleased that Immodulon is providing us with the IMM-101 study drug again and their support and hope that combining IMM-101’s positive effects on the immune system in combination with radiotherapy will lead potentially to a major step forward in the search of new and effective treatments for pancreatic cancer."

Dr. Jaap Kampinga, Chief Executive Officer of Immodulon, commented:
"We are pleased with the progress of our collaboration with Professor van Eijck and his team at this Centre of Excellence for pancreatic cancer at Erasmus MC. The MEPANC -1 study, testing our lead drug candidate, IMM-101, in limited metastatic pancreatic cancer, is designed to complement the ongoing LAPC-2 study. We look forward to the potential initiation of the MEPANC -1 study before the end of 2020, pending approval from local and national regulatory authorities. Pancreatic cancer is a devasting disease and remains exceedingly challenging to treat effectively, despite the advances in other cancer treatments."

On July 27, 2020 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery technology company focused on improving the bio-delivery and biodistribution of medicines, reported that it has raised £0.75 million (before expenses) pursuant to a Broker Option following the completion of the UK Placing (Press release, Midatech Pharma, JUL 27, 2020, View Source [SID1234562695]). The result of the UK Placing of 18,518,518 Placing Shares at an Issue Price of £0.27 per share was announced earlier today. The UK Placing was significantly oversubscribed and brings new UK institutions into the Company’s shareholder base.

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The Company granted an option to Turner Pope under the Placing Agreement to enable them to deal with additional demand under the UK Placing in the event that requests to participate in the UK Placing from qualifying investors were received during the period from the time of the announcement of the UK Placing to 8.00 a.m. on 27 July 2020 up to a maximum of £0.75 million. Turner Pope has exercised the Broker Option to the maximum extent in respect of 2,777,777 Broker Option Shares at the same price as the UK Placing.

Accordingly, the total number of New Ordinary Shares to be issued by the Company pursuant to the UK Placing and the Broker Option is 21,296,295. The aggregate gross proceeds of the UK Placing and the Broker Option is £5.75 million. Aggregate proceeds, net of expenses, are expected to be £5.28 million.

Application for Admission to trading on AIM

Subject to all conditions being met, application will be been made for 21,296,295 New Ordinary Shares to be admitted to trading on AIM. It is expected that settlement of the Placing Shares and the Broker Option Shares and Admission will take place at 8.00 a.m. on or about 3 August 2020 and that dealings in the Placing Shares and, if applicable, the Broker Option Shares will commence at that time.

When issued the New Ordinary Shares will be fully paid and will rank pari passu in all respects with the existing Ordinary Shares.

Total Voting Rights

The Company’s issued share capital following the issue of equity noted above, will comprise 60,548,852 ordinary shares of 0.1p each with voting rights. The Company does not hold any shares in treasury. This figure of 60,548,852 may be used by shareholders in the Company as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change in their interest in, the share capital of the Company under the FCA’s Disclosure and Transparency Rules.

Capitalised terms used in this announcement have the meanings given to them in the announcement of the UK Placing earlier today.

Commenting, Stephen Stamp, Midatech CEO and CFO, said: "I am delighted with the result of the UK Placing and welcome on board our new shareholders. The oversubscription of the UK Placing followed by full take-up of the Broker Option is a massive vote of confidence in our new strategy and the progress we have made since we started our strategic review in April."

On July 27, 2020 TCR2 Therapeutics Inc. (Nasdaq: TCRR) ("TCR2" or the "Company"), a clinical-stage immunotherapy company with a pipeline of novel T cell therapies for patients suffering from cancer, reported that it has commenced an underwritten public offering of 6,000,000 shares of its common stock (Press release, TCR2 Therapeutics, JUL 27, 2020, View Source [SID1234562645]). TCR2 also intends to grant the underwriters a 30-day option to purchase up to an additional 900,000 shares of common stock. All of the shares in the proposed offering are to be sold by TCR2. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

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Jefferies, SVB Leerink, Piper Sandler and BMO Capital Markets are acting as joint book-running managers for the offering. SunTrust Robinson Humphrey is acting as co-manager for the offering.

TCR2 intends to use the net proceeds of the offering to advance its clinical and earlier stage programs and for research and development, working capital and general corporate purposes.

The securities described may be offered pursuant to a shelf registration statement on Form S-3 (File No. 333-236965), including a base prospectus that was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on April 28, 2020. The proposed offering will be made only by means of a prospectus. A preliminary prospectus supplement and a final prospectus supplement relating to, and describing the terms of, this offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus may also be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by phone at (877) 821-7388, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by email at [email protected], or by phone at (800) 808-7525, ext. 6218; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by email at [email protected], or by phone at (800) 747-3924; or BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, by email at [email protected], or by phone at (800) 414-3627.

Important Information

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

On July 27, 2020 Lynk Pharmaceuticals (Hangzhou, China) reported that exclusive licensing agreements with Kobe University (Kobe, Japan) and with RIKEN Research Institute (Saitama, Japan) to develop RAS inhibitors with a novel MOA (Press release, Lynk Pharma, JUL 27, 2020, View Source [SID1234562459]). The agreement with Kobe University also includes a joint collaboration which will continue to provide screening and structural support.

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RAS has been identified as a key driver in numerous cancers including pancreatic (95%), colon (50%) and lung adenocarcinomas (30%). RAS was first identified in the 1960’s and has been targeted for over 35 years with only limited success. While recent progress made by irreversible binding towards KRAS G12C subset, this approach cannot inhibit other more dominant KRAS mutants such as G12V and G12D.

Built on Kobe University and RIKEN’s early structural biology and screening outcome, Lynk Pharmaceuticals will utilize its medicinal chemistry and drug design expertise to develop RAS inhibitors with desirable properties to target a broader range of undruggable RAS onco-drivers and ultimately develop the compounds for clinical use. "This is a very ambitious approach for us to challenge a decades-old undruggable target, but we believe our approach, with an exciting novel mechanism of action, will bring better hope to the patients by jointing hands with two reputed research organizations in the world," said Dr. Zhao-Kui (ZK) Wan, Founder, Chairman and CEO of Lynk.

On July 27, 2020 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported financial results for the second quarter ended June 30, 2020 (Press release, CRISPR Therapeutics, JUL 27, 2020, View Source [SID1234562456]).

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"We continue to make substantial progress driving our multiple, ongoing clinical development programs. Enrollment in our immuno-oncology trials is ongoing, and we’ve re-initiated dosing in our CTX001 trials," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. "Further, we expect to report data from our CTX001 program targeting hemoglobinopathies and our CTX110 program later this year. Despite the challenges posed by COVID-19, we continue to execute on our programs and remain focused on our commitment to patients and their families."

Recent Highlights and Outlook

Beta Thalassemia and Sickle Cell Disease

CRISPR Therapeutics and its partner Vertex provided new clinical data at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress from the two ongoing Phase 1/2 studies of the investigational CRISPR/Cas9 gene-editing therapy CTX001 in patients with transfusion-dependent beta thalassemia (TDT) and in patients with severe sickle cell disease (SCD). Data from two TDT patients demonstrated clinical proof-of-concept for CTX001 in this disease, and longer duration data from one SCD patient showed durable effects on fetal hemoglobin (HbF) levels and the patient was free of vaso-occlusive crises. Screening, enrollment and mobilization in these studies are ongoing; conditioning and dosing have been resumed following temporary COVID-19-related pauses in both studies. CRISPR Therapeutics and Vertex expect to report data from additional patients in the second half of 2020.

In May, CRISPR Therapeutics and its partner Vertex announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to CTX001, an investigational, autologous, gene-edited hematopoietic stem cell therapy, for the treatment of TDT and SCD. In addition to RMAT designation, CTX001 has received Orphan Drug Designation from the U.S. FDA for TDT and SCD and from the European Commission for TDT and SCD. CTX001 also has Fast Track Designation from the U.S. FDA for both TDT and SCD.

Immuno-Oncology

Patient dosing continues in a clinical trial to assess the safety and efficacy of CTX110, CRISPR Therapeutics’ wholly-owned allogeneic CAR-T cell therapy targeting relapsed or refractory CD19+ B-cell malignancies. The Company expects to report top-line data for CTX110 at the end of 2020.

Patient dosing continues in a clinical trial to assess the safety and efficacy of CTX120, CRISPR Therapeutics’ wholly-owned allogeneic CAR-T cell therapy targeting BCMA for the treatment of relapsed or refractory multiple myeloma.

Two independent clinical trials assessing the safety and efficacy of CTX130, CRISPR Therapeutics’ wholly-owned allogeneic CAR-T cell therapy targeting CD70 for the treatment of both solid tumors and certain hematologic malignancies, are open for enrollment.

Other Corporate Matters

In June, CRISPR Therapeutics announced the pricing of an underwritten public offering of 6,428,572 common shares at a public offering price of $70.00 per share, plus the exercise in full of the underwriters’ option to purchase 964,285 additional common shares. Gross proceeds from the offering (including the exercise of the underwriters’ option), before deducting underwriting discounts and commissions and other offering expenses, were $517.5 million. The common stock offering and the option to purchase additional shares closed in July 2020.

CRISPR Therapeutics reported a research agreement with UHN, Canada’s largest research hospital, affiliated with the University of Toronto, and a member of the Toronto Academic Health Science Network. Through UHN’s McEwen Stem Cell Institute, the aim of the collaboration is to combine CRISPR Therapeutics’ gene editing technology with UHN’s methods for differentiating stem cells into hepatocytes at high yield and purity, with the goal of developing regenerative medicine cell therapies for a number of different diseases. The agreement provides CRISPR Therapeutics an option to commercialize the technology.

In June, CRISPR Therapeutics presented four posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II. The posters addressed the potential of CRISPR-modified CAR-T cells as follows: an assessment of CRISPR-modified CAR-T cells in patients with non-small cell lung cancer; functionality in vivo and in vitro of allogeneic CAR-T cell products containing multiple CRISPR/Cas9 gene edits; assessment of allogeneic anti-PTK7 CAR-T cells for the treatment of solid tumors; and the potential of CRISPR/Cas9-generated anti-CD70 allogeneic CAR-T cells to target T cell lymphomas.

CRISPR Therapeutics reported it entered into a lease agreement with Breakthrough Properties for a new location in Boston, Massachusetts. The new facility will consolidate CRISPR’s various office and laboratory locations in the greater Boston area into a single location and support the Company’s anticipated future growth for five to seven years from the date of occupancy, which is expected in 2022.

In June, CRISPR Therapeutics announced that it is building a new cell therapy manufacturing facility in Framingham, Massachusetts, for clinical and commercial production of the Company’s investigational cell therapy product candidates. The facility is being designed to provide GMP manufacturing according to FDA and European Medicines Agency (EMA) regulations and guidelines to support clinical supply and commercial product upon potential regulatory approval.
Second Quarter 2020 Financial Results

Cash Position: Cash and cash equivalents as of June 30, 2020 were $945.1 million compared to $889.7 million as of March 31, 2020, an increase of $55.4 million. The increase in cash was primarily driven by financing activities during the quarter of $89.5 million and the $25.0 million milestone received from Vertex in April. The increase was offset by cash used in operating activities during the quarter of $54.3 million (exclusive of the $25.0 million milestone received by Vertex in April) to support spending on the Company’s clinical and pre-clinical programs, as well as payroll and payroll-related expenses to support growth. After including the $484.8 million in net proceeds from our underwritten public offering completed in July, pro forma cash exceeds $1.4 billion.

Revenue: Total collaboration revenue was less than $0.1 million for the second quarter of 2020 compared to $0.3 million for second quarter of 2019. Collaboration revenue primarily consisted of charges to partners for research activities.

R&D Expenses: R&D expenses were $59.4 million for the second quarter of 2020 compared to $39.5 million for the second quarter of 2019. The increase in expenses was driven by increased headcount and development activities supporting the advancement of the hemoglobinopathies program and wholly-owned immuno-oncology programs.

G&A Expenses: General and administrative expenses were $21.4 million for the second quarter of 2020 compared to $15.8 million for the second quarter of 2019. The increase in general and administrative expenses for the year was driven by headcount-related expense and higher facilities cost.

Net Loss: Net loss was $79.7 million for the second quarter of 2020 compared to net loss of $53.7 million for the second quarter of 2019.
About CTX001
CTX001 is an investigational ex vivo CRISPR gene-edited therapy that is being evaluated for patients suffering from TDT or severe SCD in which a patient’s hematopoietic stem cells are engineered to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is a form of the oxygen-carrying hemoglobin that is naturally present at birth and is then replaced by the adult form of hemoglobin. The elevation of HbF by CTX001 has the potential to alleviate transfusion requirements for TDT patients and painful and debilitating sickle crises for SCD patients.

CTX001 is being developed under a co-development and co-commercialization agreement between CRISPR Therapeutics and Vertex.

About CTX110
CTX110 is a healthy donor-derived gene-edited allogeneic CAR-T therapy targeting cluster differentiation 19, or CD19, for the treatment of CD19+ malignancies. A wholly-owned asset of CRISPR Therapeutics, CTX110 is being investigated in a clinical trial designed to assess the safety and efficacy of CTX110 for the treatment of relapsed or refractory B-cell malignancies. The multi-center, open-label clinical trial is designed to enroll up to 131 patients and investigate several dose levels of CTX110.

About CTX120
CTX120 is a healthy donor-derived gene-edited allogeneic CAR-T therapy targeting B-cell maturation antigen, or BCMA. A wholly-owned asset of CRISPR Therapeutics, CTX120 is being investigated in a clinical trial designed to assess the safety and efficacy of CTX120 for the treatment of relapsed or refractory multiple myeloma. The multi-center, open-label clinical trial is designed to enroll up to 88 patients and investigate several dose levels of CTX120.

About CTX130
CTX130 is a healthy donor-derived gene-edited allogeneic CAR-T therapy targeting cluster of differentiation 70, or CD70, an antigen expressed on various solid tumors and hematologic malignancies. CTX130 is being developed for the treatment of both solid tumors, such as renal cell carcinoma, and T-cell and B-cell hematologic malignancies. A wholly-owned asset of CRISPR Therapeutics, CTX130 is being investigated in two independent clinical trials that are designed to assess the safety and efficacy of CTX130 for the treatment of relapsed or refractory renal cell carcinoma and various subtypes of lymphoma, respectively. The multi-center, open-label clinical trial investigating CTX130 for the treatment of relapsed or refractory renal cell carcinoma is designed to enroll approximately 95 patients and investigate several dose levels of CTX130. The multi-center, open-label clinical trial investigating CTX130 for the treatment of various lymphomas is designed to enroll approximately 46 patients and investigate several dose levels of CTX130.