Almac Group secures HPRA certification for biologics testing

On December 14, 2022 Almac Sciences Ireland, a member of the Almac Group, reported that it has secured certification from the Health Products Regulatory Authority (HPRA) for biologics testing after a successful audit (Press release, Almac, DEC 14, 2022, View Source [SID1234625248]).

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The certification adds to Almac’s existing GMP certificate, renewed in 2022, which covers testing raw materials, small molecules and microbiology. This additional certification enables Almac to perform biologics testing for the determination of product quality attributes throughout the drug development cycle, from development to commercialisation.

The analytical testing lab, based in Athlone, Ireland, provides a comprehensive range of flexible pharmaceutical testing services to support clients’ drug development programmes adhering to industry regulations including FDA, EMA and HPRA under GMP standards.

Almac’s biologic testing services include GMP lot release and stability testing to support clients’ drug substance and drug product programmes for both novel biologics and biosimilars. It also includes fit-for-purpose analytical method development / phase-appropriate method validation; raw material testing for microbial and mammalian expression systems that comply with pharmacopeial requirements and clients’ specifications.

The addition of this biologics certification complements the well-established range of analytical services already offered from Athlone as well as its global headquarters in Craigavon, UK and Almac’s facility in Pennsylvania, North America.

Dr Pavan Kumar Kunala, Biopharma Lab Manager for Almac Sciences said: "I am delighted that our lab has received this HPRA certification which will enable us to offer enhanced analytical testing services to our clients. With the current landscape of increased growth in biologics post-pandemic, Almac’s service offering for biologics testing reiterates the commitment to provide superior solutions in the advancement of human health."

Dr Simon Cocks, Site Manager of the Athlone laboratory, added: "Achieving this certification is testament to the commitment of the biologics testing team. Biologics have gained huge traction in the last decade and are poised for stronger growth in the coming years, with potential to significantly impact patient lives. We are confident that the addition of this biologics testing certification will continue to strengthen our competitive position in the marketplace."

Positive topline results from Clarity’s PROPELLER SAR-bisPSMA prostate cancer diagnostic trial

On December 13, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported positive topline results from its diagnostic Phase I trial of 64Cu SAR-bisPSMA in prostate cancer (PROPELLER NCT048393671) (Press release, Clarity Pharmaceuticals, DEC 14, 2022, View Source [SID1234625201]).

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The trial met its primary objectives and the 64Cu SAR-bisPSMA product was found to be safe, well tolerated and efficacious in detecting primary prostate cancer. PROPELLER also met its secondary objective of determining the optimal dose for subsequent investigation of 64Cu SAR-bisPSMA. The selected optimal dose level of 200 MBq is currently applied in all ongoing trials.

The PROPELLER trial was a first-in-human Positron Emission Tomography (PET) imaging trial of participants with confirmed prostate cancer using Clarity’s optimised PSMA agent, 64Cu SAR-bisPSMA. It was designed as a multi-centre, blinded review, dose ranging, non-randomised study administered to 30 participants with confirmed prostate cancer prior to undergoing radical prostatectomy. The trial also compared the diagnostic properties of 64Cu SAR-bisPSMA against 68Ga PSMA-11, which is approved for prostate cancer imaging in Australia and the US.

Primary objectives

Safety and tolerability of 64Cu-SAR-bisPSMA using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Efficacy of 64Cu-SAR-bisPSMA in the detection of primary prostate cancer compared to histopathology.
Secondary objectives

Assessment of image quality at varying dose levels of 64Cu SAR-bisPSMA for (100 MBq, 150 MBq and 200 MBq).
Clarity’s Executive Chairman, Dr Alan Taylor, commented, "The initial PROPELLER data further substantiates the utility of 64Cu SAR-bisPSMA in the diagnosis of prostate cancer. Combined with our clinical and pre-clinical trial data to date, this validates SAR-bisPSMA as a potential best-in-class PSMA agent for the diagnosis (with 64Cu) and subsequent treatment (with 67Cu) of prostate cancer. As such, we are thrilled to continue the development of SAR-bisPSMA as a theranostic pair in our SECuRE trial2 as well as in two diagnostic prostate cancer indications: pre-prostatectomy/pre-definitive treatment and suspected biochemical recurrence of the disease (COBRA trial3). We have already commenced work towards our diagnostic Phase III trials with 64Cu SAR-bisPSMA and we look forward to engaging with the United States Food and Drug Administration shortly as we get closer to our ultimate goal of improving treatment outcomes of people with cancer."

Prof Louise Emmett, (St Vincent’s Hospital Sydney), Principal Investigator in the PROPELLER trial, commented, "We are impressed by the high uptake of 64Cu SAR-bisPSMA and look forward to progressing its development and further analysing the data. We have seen to date the high uptake of the product in tumours and the ability to image 64Cu SAR-bisPSMA at later time points, which may improve the treatment paradigm for many men with prostate cancer. Being able to accurately stage cancer means that we can better develop a treatment approach that can more effectively prevent its further spread throughout the body. We are excited to continue analysing the data and present the initial results at the ASCO (Free ASCO Whitepaper) GU Symposium in February 2023."

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two prostate-specific membrane antigen (PSMA) binding motifs to Clarity’s proprietary sarcophagene (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide4. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease

RemedyBio today announces a research and evaluation agreement with GSK

On December 13, 2022 RemedyBio, an immune therapy discovery and development biotech company, combining the power of functional immune mapping through its proprietary Nanoreactor platform for the discovery of new immune oncology therapies, reported a research and evaluation agreement with Glaxo Smith Kline (GSK) to identify and analyse certain rare immune cells and their function within tumours (Press release, Remedy Biologics, DEC 13, 2022, View Source [SID1234644120]).

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The outputs from this evaluation may allow GSK to address certain biological questions that are difficult or impossible to answer via other methods.

"We are excited to collaborate closely with the immune oncology team at GSK.", said Dan Crowley, CEO and co-founder of RemedyBio. "Our work in immune cell function, with the scale and speed offered by our unique platform, has allowed us to decipher and understand the complexities associated with rare cell to cell interactions in the TME and tumour, directly exploring complex scientific questions in this GSK collaboration."

In addition to its collaborations with Pharma and oncology focussed institutions, RemedyBio continues to develop its own pipeline in the immune oncology space, through functional discovery of therapies directly from patient biology.

Erasca Announces FDA Clearance of IND Application for CNS-Penetrant KRAS G12C Inhibitor ERAS-3490 in KRAS G12C-Mutated Advanced or Metastatic Solid Tumors

On December 13, 2022 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported the United States Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for ERAS-3490, an orally available small molecule KRAS G12C inhibitor designed to have high central nervous system (CNS) penetration for the treatment of KRAS G12C-mutated solid tumors, including non-small cell lung cancer (NSCLC) (Press release, Erasca, DEC 13, 2022, View Source [SID1234639368]).

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"KRAS G12C is a prevalent oncogenic mutation that was historically considered undruggable. While first generation inhibitors have made great progress against this mutation, we believe that they do not sufficiently penetrate the blood-brain barrier which can lead to poor disease control, particularly in NSCLC, where up to 40% of patients may develop CNS metastases," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "ERAS-3490, our first homegrown development candidate, was selected for its robust CNS and systemic activity. We are pleased the FDA has cleared our IND for ERAS-3490."

In April, Erasca presented nonclinical data for ERAS-3490 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting showing robust anti-tumor activity in KRAS G12C mutant MIA PaCa-2, NCI-H1373, and NCI-H2122 CDX subcutaneous models. ERAS-3490 also demonstrated robust anti-tumor activity and dose-dependent survival benefit in the KRAS G12C NSCLC intracranial model NCI-H1373-luc, a nonclinical model of NSCLC CNS metastases.

Bioasis Technologies Inc. Announces Merger with Midatech Pharma plc

On December 13, 2022 BIOASIS TECHNOLOGIES INC. (OTCQB:BIOAF; TSX.V:BTI) (the "Company" or "Bioasis"), a multi-asset rare and orphan disease biopharmaceutical company developing clinical stage programs based on epidermal growth factors and a differentiated, proprietary xB3 platform for delivering therapeutics across the blood-brain barrier ("BBB") and the treatment of central nervous system ("CNS") disorders in areas of high unmet medical need, reported that it has entered into a definitive agreement dated December 13, 2022 with Midatech Pharma plc (NASDAQ:MTP; AIM:MTPH) ("Midatech"), a company focused on the research and development of medicines that would benefit from improved bio-delivery or bio-distributions using proprietary drug delivery technologies, pursuant to which Midatech will acquire 100% of the issued and outstanding common shares in the capital of Bioasis from Bioasis’ shareholders in exchange for ordinary shares of Midatech in the form of American depositary shares ("ADSs") (Press release, Bioasis Technologies, DEC 13, 2022, View Source [SID1234625695]).

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Midatech has also entered into securities purchase agreement with an institutional investor for (i) a registered direct offering of ADSs for gross proceeds of approximately US$400,000 (the "Registered Direct Offering") that is expected to be completed on or about December 15, 2022 and (ii) a private placement equity financing for gross proceeds of approximately US$9.6M that will be completed concurrently with Midatech’s acquisition of Bioasis (the "PIPE", and together with the Registered Direct Offering, the "Midatech Financing").

The combination of Bioasis and Midatech will create a multi-asset rare and orphan disease company that will be renamed Biodexa Pharmaceuticals PLC ("Biodexa"). Bioasis and its shareholders are expected to benefit from Biodexa’s capital markets profile in the United States as a NASDAQ-listed company, as well as increased trading liquidity and broadened appeal to global index and generalist investors relative to Bioasis’ status as a TSXV-listed company. Biodexa is expected to have strengthened balance sheet with pro forma cash of approximately C$17.9 million as at June 30, 2022. Biodexa is also expected to benefit from the collective scientific, technical, and operational expertise of both Midatech and Bioasis as well as cost synergies as a result of the elimination of duplicative salaries, administrative and regulatory costs and other public company expenses. Through their ownership of ADSs, current Bioasis securityholders will maintain exposure to the value that is expected to be unlocked as Bioasis and Midatech’s pipeline programs progress through clinical development and the drug delivery technologies secure additional partnerships.

Bioasis’ Executive Chair, Deborah Rathjen PhD, commented "As shareholders are aware, in December 2021 we indicated that Bioasis would seek value accretive strategic alternatives and pursue opportunities that have the potential to unlock value and liquidity for shareholders. With this transaction and through the formation of Biodexa, it is anticipated that Bioasis’ pipeline will achieve value accretive milestones whilst continuing to monetize the xB3 platform through additional partnerships. Once the transaction is closed, Bioasis shareholders will have access to the benefits of a NASDAQ listing through their ownership of Biodexa. We are very excited by the prospects for this transaction given the evident synergies between Bioasis and Midatech".

Mr Stephen Stamp, Midatech CEO and incoming Biodexa CEO added "By combining the two groups to create Biodexa Pharmaceuticals, we have the opportunity to reposition the enlarged group as an emerging biotech company focused on the development of therapeutics for rare diseases, supported by Midatech and Bioasis’s enabling drug delivery platforms. We continue to believe there is substantial value to be unlocked from Midatech’s MTX110, particularly in glioblastoma, and to leverage our Q-Sphera technology. In combination with Bioasis’s promising development pipeline we have the opportunity to create a much stronger group."

Transaction Details

Bioasis and Midatech have entered into an arrangement agreement (the "Arrangement Agreement") pursuant to which Midatech will acquire all of the issued and outstanding common shares in the capital of Bioasis from Bioasis’ shareholders by way of a statutory plan of arrangement (the "Arrangement") under the Business Corporations Act (British Columbia) in exchange for ordinary shares of Midatech (in the form of ADSs) on the basis of 0.9556 Midatech ordinary shares (or approximately 0.0382 ADSs) for each Bioasis share.

Upon completion of the Arrangement and the Midatech Financing, it is expected that the current Midatech securityholders, the current Bioasis securityholders and the Midatech Financing investor will own approximately 39.8%, 30.7% and 9.9%, respectively, of the issued and outstanding Biodexa shares on a non-diluted diluted basis and 10.5%, 9.3% and, subject to the ownership limitations described below, 66.1%, respectively, of the issued and outstanding Biodexa shares on a fully-diluted diluted basis, with the balance held by Lind (as defined below) and Ladenburg (as defined below) or reserved for issuance to the vendors pursuant to Bioasis’ contingent payment obligations under the terms of the asset purchase agreement dated June 15, 2022 among Bioasis and the owners of Cresence AS (see Bioasis press release dated June 16, 2022 for further details).

Pursuant to the terms of the Midatech Financing, the investor in the Midatech Financing may not (i) exercise any of the warrants to be issued to it in the Midatech Financing to the extent that, after giving effect to such exercise, it (together with its affiliates or any person with whom it is acting in concert under the UK Takeover Code) would own more than 9.99% of the outstanding ordinary shares or (ii) at any time (together with its affiliates or any person with whom it is acting in concert under the UK Takeover Code), directly or indirectly own more than 29.9% of the outstanding ordinary shares.

Completion of the Arrangement is subject to the completion of the Midatech Financing and Midatech shareholder approval along with other closing conditions customary for transaction of this nature including, among other things, approval of the Arrangement by the Supreme Court of British Columbia and the approval of at least two-thirds of the votes cast by (i) all Bioasis shareholders, and (ii) Bioasis shareholders together with Bioasis warrantholders and optionholders, voting together as a single class, determined on an as-converted to Bioasis share basis, in each case, present in person or by proxy at the annual and special meeting called for purposes of reviewing and approving the Arrangement (the "Bioasis Meeting"). The Arrangement Agreement includes customary deal protection provisions pursuant to which each party (i) has agreed not to solicit any other acquisition proposal (subject to customary fiduciary out rights and, in the case of Midatech, exceptions required under UK law) and (ii) will pay a termination fee of US$330,000 to the other party (subject, in the case of Midatech, to certain exceptions required under UK law) if the Arrangement Agreement is terminated in certain circumstances. The directors and officers of Bioasis, together with certain other shareholders, who collectively own approximately 8.2% of Bioasis’ issued and outstanding common shares, have entered into transaction support agreements with Midatech pursuant to which they have agreed to vote their Bioasis shares in favour of the Arrangement at the Bioasis Meeting.

Under the Arrangement Agreement, Midatech has agreed to advance a bridge loan in the amount of US$750,000 to Bioasis following the completion of the Registered Direct Offering (the "Midatech Bridge Loan"). The Midatech Bridge Loan will bear interest at the rate of 2.0% per month and is repayable on the earlier to occur of (i) completion of the Arrangement, (ii) the occurrence of an event of default and (iii) June 30, 2023. Bioasis’ obligations under the Midatech Bridge Loan are secured by a second-ranking pledge of all of its assets. Bioasis will use the proceeds of the Midatech Bridge Loan for working capital purposes.

After the completion of the Arrangement and subject to the receipt of any Midatech shareholder approvals required by AIM, Midatech will use its commercially reasonable efforts delist its shares from AIM, change its name to Biodexa Pharmaceuticals PLC and restructure its board of directors and officers with Stephen Parker serving as non-executive chairman, Deborah Rathjen (currently Bioasis’ executive chair and Chief Executive Officer), Mario Saltarelli (currently a Bioasis director) and Simon Turton serving as non-executive directors and Stephen Stamp serving as Chief Executive Officer and director.

The board of directors of Bioasis (the "Board") has unanimously approved the Arrangement Agreement and resolved to recommend that Bioasis securityholders vote in favour of the Arrangement at the Bioasis Meeting. The Board has obtained an opinion from Evans & Evans Inc. that, subject to the assumptions, limitations and qualifications on which such opinion is based, the consideration to be received by Bioasis shareholders in connection with the Arrangement is fair, from a financial point of view, to such shareholders.

Subject to all conditions precedent to completion of the Arrangement being met, the Arrangement is expected to close in the first quarter of 2023. In connection with the closing of the Arrangement, Bioasis will apply to have its shares delisted from the TSX Venture Exchange.

Amendments to Lind Convertible Security Funding Agreement and Bridge Loan

In connection with the execution of the Arrangement Agreement, Bioasis and Lind Global Macro Fund, LP ("Lind") entered into a waiver and amending agreement (the "Lind Amending Agreement") in respect of the convertible security funding agreement between Bioasis and Lind dated June 21, 2021 (the "CSFA").

Pursuant to the Lind Amending Agreement, among other things, Lind agreed to (i) waive Bioasis’ repayment obligations under the CSFA until December 31, 2022, (ii) consent to the completion of the Arrangement and (iii) advance a C$350,000 bridge loan to Bioasis (the "Lind Bridge Loan"), net of amounts payable to Lind in respect of its legal fees and expenses. In consideration of the foregoing, Bioasis agreed to issue a promissory note to Lind in the amount of C$510,000 (the "Holiday Note") along with a promissory note in the principal amount of the Lind Bridge Loan. The Holiday Note and the Lind Bridge Loan bear interest at the rate of 2.0% per month and are repayable on the earlier to occur of (i) completion of the Arrangement, (ii) the occurrence of an event of default and (iii) June 30, 2023. Bioasis’ obligations under the Holiday Note and the Lind Bridge Loan are secured by a first-ranking pledge of all of its assets. Bioasis will use the proceeds of the Lind Bridge Loan to fund transaction expenses related to the Arrangement.

Concurrently with the execution of the Lind Amending Agreement, Bioasis, Midatech and Lind entered into a tripartite agreement (the "Tripartite Agreement") pursuant to which, among other things, Midatech agreed to (i) assume Bioasis’ obligations under the CSFA concurrently with the completion of the Arrangement, (ii) repay to Lind, upon completion of the Arrangement, 50% of the outstanding principal and 100% of the accrued pre-paid interest under the CSFA and all amounts owing under the Lind Bridge Loan and the Holiday Note. Lind agreed that the remaining 50% of the principal owing under the CSFA will be satisfied by way of the issuance to Lind by Midatech of the securities issuable under the PIPE at the same price at which such securities are issued in the PIPE.

Additional Information

Full details of the Arrangement are set out in the Arrangement Agreement, which will be filed by Bioasis, along with copies of the Lind Amending Agreement and the Tripartite Agreement, under its profile on SEDAR at www.sedar.com. In addition, further information regarding the Arrangement will be contained in a management information circular of the Company to be prepared in connection with the Meeting. All securityholders of Bioasis are urged to read the management information circular once it becomes available, as it will contain additional important information concerning the Arrangement.

Advisors

Goodmans LLP and Lawson Lundell LLP are Bioasis’ Canadian legal advisors. Ladenburg Thalmann & Co. Inc. ("Ladenburg") is Bioasis’ financial advisor. Pursuant to the terms of Ladenburg’s engagement by Bioasis, Ladenburg is entitled to receive a fee upon the completion of the Arrangement in the form of Midatech securities.