On March 30, 2021 LONDON, Silence Therapeutics plc, AIM: SLN and Nasdaq: SLN ("Silence" or "the Company"), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, reported its audited full year results for the year ended 31 December 2020 (Press release, Silence Therapeutics, MAR 30, 2021, View Source [SID1234577429]).

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!

Mark Rothera, President and CEO of Silence Therapeutics, commented: "2020 was a transformational year for Silence Therapeutics, driven by the remarkable resilience of our people in what was a challenging year for the world. We have made significant progress with our mRNAi GOLD platform, with both lead programmes now in the clinic and three data readouts due this year. Alongside advancing our wholly owned pipeline, we continue to progress our high-value partnerships and through this two-pronged approach, our goal is to deliver 2-3 INDs per year from 2023. We are well positioned for success and motivated by our vision to transform people’s lives through our precision engineered medicines."

Craig Tooman, CFO of Silence Therapeutics, commented: "Silence ended 2020 in a strong financial position, driven by non-dilutive funding from our collaborations. Our balance sheet has been further strengthened by the recent $45 million financing, which demonstrated the growing appreciation for Silence and expanded our global shareholder base. We will look to build upon this in 2021 as we continue to enhance our capabilities and maximise the opportunity of our mRNAi GOLD platform."

Operational Highlights

Advanced both wholly owned product candidates, SLN360 for cardiovascular disease due to high Lipoprotein(a), or Lp(a) levels and SLN124 for thalassaemia and myelodysplastic syndrome (MDS).

SLN360 received approval of an initial drug application (IND) by the FDA and Silence initiated the APOLLO Phase 1 study in people with high Lp(a) levels.

SLN124 was granted rare paediatric disease designation for thalassaemia as well as orphan drug designations for MDS and thalassaemia by the FDA.

Initiated the GEMINI Phase 1 study of SLN124 in healthy volunteers.

Secured a significant collaboration deal with AstraZeneca to discover and develop siRNA therapeutics for up to 10 targets in cardiovascular, renal, metabolic and respiratory diseases.

Upfront cash payment of $20m was received and another $40m is due in the first half of 2021.

Deal economics include up to $400m in milestone payments and royalties for each programme.

Expanded RNAi collaboration with Mallinckrodt for complement-mediated diseases with Mallinckrodt exercising options to license two additional targets from Silence, bringing the total to the maximum three programmes envisaged in the collaboration deal.

Commenced a technology evaluation with Takeda to explore the potential of using Silence’s mRNAi GOLD platform against a novel, undisclosed target.

Appointed Dr Giles Campion as Executive Director, Dr Marie Wikström Lindholm as Senior Vice President, Molecular Design, Dr Eric Floyd as Senior Vice President, Head of Global Regulatory Affairs and Quality Assurance and Dr Barbara Ruskin as Senior Vice President, General Counsel and Chief Patent Officer.

Launched a Scientific Advisory Board comprising world-leading scientists and clinicians to support the optimisation of Silence’s mRNAi GOLD platform and guide development strategies for SLN360 and SLN124.

Completed U.S. listing and our American Depository Shares (ADSs) began trading on the Nasdaq Capital Market (Nasdaq) under the symbol "SLN" on 8 September 2020.

Appointed Mark Rothera as our President, Chief Executive Officer and Board member.

Financial Highlights

Cash and cash equivalents and term deposits of £37.4m at year-end (2019: £33.5m). The Group had £97.5m on a proforma basis, which includes £37.4m at year-end, plus the £29.3m ($40m) receivable from AstraZeneca due in the first half of 2021, plus net proceeds of £30.8m from the February 2021 capital raise.

Cash flow from operating activities was £10.8m outflow (2019: £1.7m inflow) against an operating loss of £35.8m (2019: £22.7m). 2020 included receipts of $20m upfront from AstraZeneca, $2.0m in milestones from Mallinckrodt Pharmaceuticals, and a $2.0m upfront from Takeda.

2020 loss was higher primarily due to increased research and development spend in relation to our SLN360 and SLN124 proprietary programmes, as well as general and administrative expenses mainly relating to the Nasdaq listing.

Post Year-end

Appointed Dr Michael H. Davidson to the Silence Board of Directors as a Non-Executive Director and Craig Tooman to the Executive Leadership Team as Chief Financial Officer.

Completed an oversubscribed $45m (c. £33m) private placement led by top-tier US institutional healthcare funds.

Initiated dosing in the APOLLO Phase 1 study of SLN360 in people with high Lp(a) levels.

Initiated work with Mallinckrodt on the third complement target which triggered a $2.0m research milestone payment to Silence.

Completed enrolment in the GEMINI Phase 1 study of SLN124 in healthy volunteers.

Initiated the GEMINI II Phase 1b study of SLN124 in people with thalassemia and MDS.

On March 30, 2021 Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, reported the pricing of its initial public offering in the United States of 9,750,000 American Depositary Shares ("ADSs") representing 9,750,000 ordinary shares at an initial public offering price of $18.00 per ADS for total gross proceeds of $175.5 million (Press release, UCLB, MAR 30, 2021, View Source [SID1234577415]). All ADSs sold in the offering are being offered by Achilles. The ADSs are expected to begin trading on The Nasdaq Global Select Market on March 31, 2021 under the ticker symbol "ACHL." In addition, Achilles has granted the underwriters a 30-day option to purchase up to an additional 1,462,500 ADSs at the initial public offering price, less underwriting discounts and commissions. The offering is expected to close on April 6, 2021, subject to customary closing conditions.

J.P. Morgan, BofA Securities and Piper Sandler are acting as joint book-running managers for the offering. Chardan, Oppenheimer & Co, and Kempen & Co are acting as co-managers.

A registration statement relating to these securities was declared effective on March 30, 2021. The securities referred to in this announcement are to be offered only by means of a prospectus. A copy of the final prospectus, when available, may be obtained from:

J.P. Morgan Securities LLC, Attention Equity Syndicate Desk, 383 Madison Avenue, New York, New York 10179, or via email: [email protected];
BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, or via email: [email protected]; or
Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or via email: [email protected].

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!

On March 30, 2021 Race Oncology Limited ("Race") reported that it has entered into a new collaborative preclinical research program with The University of Newcastle (Press release, Race Oncology, MAR 30, 2021, View Source [SID1234577414]). This work will be led by the eminent cancer researcher, Associate Professor Nikki Verrills, who successfully ran Race’s preclinical breast and ovarian program (ASX announcements: 24 November 2020, 23 February 2021, 9 March 2021).

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 aim of this project is to support the clinical use of Bisantrene as a novel treatment for extramedullary AML, a difficult to treat form of AML, using an extramedullary mouse model developed by A/Prof Verrills’ team. Extramedullary AML occurs when the leukaemia spreads from the bone marrow and forms solid tumours in tissues such as the skin, breast, kidney, brain, or other organs1. A 2020 prospective positron imaging trial identified that up to 22% of AML patients have extramedullary AML2.

In a recent Sheba Medical Centre Phase II clinical trial conducted in relapsed and refractory (R/R) AML patients (ASX announcement: 16 June 2020), Bisantrene was observed to be highly effective in patients with extramedullary AML, with all patients with this subtype (4/4) showing a clinical response3. Patients with extramedullary AML currently have limited treatment choices with no approved, and very limited experimental treatment options4.
Race is pursuing Bisantrene therapies targeting AML, as part of its Three Pillar strategy (ASX announcement: 30 Nov 2020). This new program could lead to AML treatments with improved safety and efficacy for patients with extramedullary AML.

In addition, this study will be used to provide supportive data for a pivotal (Phase II/III) trial of Bisantrene in extramedullary AML patients with the aim of providing a rapid path to FDA approval for Bisantrene as an orphan drug under the 505(b)(2) track. Orphan drug designation provides for seven years post approval marketing exclusivity in the USA and 10 years in the EU/UK, as well as other tax and regulatory benefits.

"This is a key project for Race using Associate Professor Verrills’ extramedullary AML mouse model. Recent clinical evidence has identified Bisantrene as an effective treatment option for patients with the difficult-to-treat extramedullary form of AML. We believe that we have identified a low-risk pathway to rapid approval of Bisantrene via this indication that offers significant upside for Race in a crowded clinical space."

Chief Scientific Officer, Dr Daniel Tillett
This project is to start immediately with the pre-clinical results expected to be reported over the coming 12 months.

About Associate Professor Verrills
Since completing her PhD in 2005 on chemotherapy resistance in childhood leukaemia, Associate Professor Verrills was awarded a Peter Doherty Postdoctoral Fellowship from the National Health and Medical Research Council in 2006. In the same year she was the inaugural recipient of a Hunter Medical Research Foundation grant for young cancer researchers. Since then she has established an innovative research lab at the University of Newcastle studying the differences between cancer cells that respond well to drug treatments and those that do not.

Prof Verrills is currently supported by a fellowship from the Australian Research Council and project funding from the National Health and Medical Research Council. She has published over 60 journal articles with an H-index of 24.

On March 30, 2021 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V:BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, reported that it has been selected to present at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, a virtual meeting, held over two weeks (Week 1: April 10-15; Week 2: May 17-21) (Press release, BriaCell Therapeutics, MAR 30, 2021, View Source [SID1234577404]).

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!

BriaCell will be presenting the results of its analysis of clinical and pathological data of its lead candidate, Bria-IMT, a novel immunotherapy for advanced breast cancer, as monotherapy and a Phase I/IIa clinical study of Bria-IMT in combination with immune checkpoint inhibitors, including pembrolizumab (KEYTRUDA; manufactured by Merck & Co., Inc.) and, more recently, Incyte’s INCMGA00012 (under a corporate collaboration with Incyte Corporation). The patient data belong to previously-disclosed patients (i.e., no incremental numbers enrolled).

Details include:

Abstract Control Number: 4932
Title: Predictors of response to a modified whole tumor cell immunotherapy in patients with advanced breast cancer from two phase I/IIa trials
Session Type: E-Poster Session
Session Category: Phase I Clinical Trials
Session Title: Phase I Clinical Trials
Permanent Abstract Number: CT102
Session Date and Time: Saturday, April 10 at 8:30 a.m. ET. E-posters will remain available for viewing through Monday, June 21.

Following the presentation, a copy of the poster will be posted on View Source

Additionally, the Board of Directors of the Company (the "Board") unanimously approved the grant of an aggregate of 617,300 incentive stock options ("Stock Options") to directors, officers, employees and consultants under the Company’s stock option plan ("Stock Option Grant"). Of the Stock Option Grant, 560,000 Stock Options will be granted to Insiders, as such term is defined in the Securities Act (British Columbia). The Stock Options are exercisable at US$4.24 per common share in the capital of the Company ("Common Share"), will vest immediately, and will expire in 5 years from the date of issuance. Following the Stock Option Grant, the Company has 635,352 Stock Options outstanding.

The Stock Option Grant to certain Insiders constitutes a "related party transaction" within the meaning of Exchange Policy 5.9, which incorporates Multilateral Instrument 61-101 ("MI 61-101"). The Company is exempt from shareholder approval in accordance with section 5.7.1(a) of MI 61-101. The Stock Option Grant will not result in a new Control Person.

On March 30, 2021 AffaMed Therapeutics ("AffaMed"), a global clinical-stage biopharmaceutical company dedicated to addressing critical unmet patient need in ophthalmic, neurological and psychiatric disorders, reported the completion of over US$170 million in Series B financing (Press release, AffaMed Therapeutics, MAR 30, 2021, View Source [SID1234577392]). The oversubscribed financing was led by Lake Bleu Capital, with participation by new investors including Partners Investment, Superstring Capital, Orion Science Capital, and Fountainhead Partners, and with continuing support of its founding investor CBC Group. Proceeds from the financing will be used to advance clinical development of AffaMed’s robust pipeline of innovative therapeutic candidates, progress business development and partnering activities, and support preparations for future commercialization.

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!

Since its inception in 2019, AffaMed has built an exceptional global platform to develop therapeutics and solutions to serve patients in Greater China and worldwide. AffaMed has assembled world-class capabilities in clinical development, regulatory affairs and business development under the leadership of its CEO, Dr. Dayao Zhao, a seasoned industry veteran who has previously served as Head of China R&D for Pfizer; as Head of China R&D at the Janssen Pharmaceutical Companies of Johnson & Johnson; and as Genzyme’s head of Japan and Asia Pacific R&D.

Dr. Zhao commented: "AffaMed has established a strong portfolio of therapeutic candidates in ophthalmology and neuroscience and has made significant progress in developing its pipeline over the past year. With the support of this outstanding syndicate of investors who share our vision, we are well-positioned to transform AffaMed into a leading biopharmaceutical company in our chosen therapeutic areas while advancing our pipeline and pursuing new strategic partnerships."

Dr. Bin Li, Founding Partner, CEO and Chief Investment Officer of Lake Bleu Capital said: "AffaMed is a promising biopharmaceutical company with an unparalleled pipeline targeting neurological, psychiatric and ophthalmic disorders. We believe in AffaMed’s world-class management team, clear China and global business development plan, and impressive execution capabilities. Lake Bleu Capital is delighted to partner with the AffaMed team to support their globalization strategy and help unlock new treatment paradigms that will ultimately make a tangible difference to patients globally."

Wei Fu, CEO of CBC Group, commented: "AffaMed has built a robust clinical-stage portfolio with significant market potential, and has articulated a clear and transformative strategy for developing new therapies. Investing in the human talent behind biopharmaceutical companies like AffaMed is at the core of CBC Group’s value creation strategy. We look forward to continuing to support AffaMed’s strong leadership team as it accelerates growth to the next level."

AffaMed Appoints Dr. Ji Li as President and Board Member

In addition to today’s financing news, AffaMed has announced the appointment of Dr. Ji Li as President and member of its Board of Directors. A highly accomplished senior pharmaceutical executive with extensive business development and R&D experience, Dr. Li has previously served as Executive Vice President and Global Head of Business Development at BeiGene; as Vice President of Business Development and Licensing at Merck Research Laboratories, a subsidiary of Merck & Co. Inc.; and as Executive Director of External R&D at Amgen. Dr. Li holds a Ph.D. in Neuroscience from Mount Sinai School of Medicine, and a B.S. in Pharmacology from Shanghai Medical University.

Dr. Li commented: "I am pleased to join AffaMed at this pivotal time in the company’s development. The management team deeply appreciates the trust shown in AffaMed by our existing and new investors, and we are confident we will successfully advance AffaMed’s strategic plan to strengthen and broaden our portfolio towards serving the unmet medical needs of millions of patients in Greater China and the rest of the world."