On July 5, 2022 OBI Pharma, a Taiwan biopharma company (TPEx: 4174), reported discontinuation of the Phase 1/2 Study* for OBI 888, a Globo H antibody, upon completion of enrollment in our investigative sites (Press release, OBI Pharma, JUL 5, 2022, View Source [SID1234616494]).

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"We are pleased that the preliminary data from our Phase 1/2 study demonstrated that OBI 888 is a safe and well tolerated product and showed some trends of efficacy. However, due to the higher antibody amount required for the OBI-888 treatment compared to the ADC, OBI-999, and an unexpected low drug yield at the large manufacturing scale, OBI-888 no longer fulfills our goal of developing cost-effective therapies for cancer patients. We have therefore decided to discontinue OBI-888 development and focus on our novel cancer pipeline under Phase 3 (Adagloxad Simolenin-vaccine) and Phase 2 (OBI 999-ADC, OBI 833-vaccine and OBI 3424-small molecule) clinical development. The OBI-888 clinical study report is estimated to be finalized in Q4, 2022 and presented at a future medical conference.

"OBI Pharma is excited to develop and validate our novel anti-Globo H, AKR1C3 and Trop 2 pipeline to fulfill unmet medical needs of cancer patients," stated, Michael Chang, OBI Pharma Chairman and CEO.

On July 5, 2022 Spago Nanomedical reported that the company raised 58.4 MSEK in the completed capital round. The proceeds give the company the resources to maintain the pace in its two projects – SpagoPix in cancer diagnostics and Tumorad, in which it is developing a new radionuclide cancer treatment (Press release, Spago Nanomedical, JUL 5, 2022, View Source [SID1234616476]). BioStock reached out to CEO Mats Hansen for comments on recent events and what awaits in the coming six months.

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Spago Nanomedical recently raised 58.4 MSEK before costs in a completed rights issue. The capital will primarily be used to initiate a clinical phase I/II trial with the company’s radionuclide treatment for cancer, the Tumorad candidate drug 177Lu-SN201.

The SpagoPix project has also advanced during the year. The new gadolinium-free contrast agent for magnetic resonance imaging has shown positive clinical results in the company’s ongoing study on breast cancer. The study has been expanded to also include pancreatic cancer and Spago Nanomedical expects to complete the study before the end of the year. Read more.

The potential of Tumorad
The cancer treatment project Tumorad is based on Spago’s physiological targeting of cancer tumours with functional nanoparticles, which makes the treatment independent of the biology of tumour cells. This means that the potential application area for Tumorad is broad and not limited to a specific form of cancer, as a biological approach often is.

During the year, Spago has also become interested in using 177Lu-SN201 for ovarian cancer – the seventh most common cancer in women and the fifth most fatal. This direction allows Spago to apply for Orphan Drug Designation (ODD) for the candidate, providing benefits during the development phase and market exclusivity for an approved drug.

CEO on the progress towards clinical phase
The company is now working to produce materials according to Good Manufacturing Practice and to complete documentation to apply to start the phase I/IIa study with Tumorad.

BioStock reached out to CEO Mats Hansen to comment on the company’s past six months, the issue and what to expect during the rest of 2022.

Mats, the first half of 2022 is recently concluded – what milestones have been the most important to achieve for Spago Nanomedical so far this year?

– Last winter, we achieved good interim results in our clinical study with SpagoPix. The results are not only beneficial for our new contrast agent. Equally important, we have been able to clinically validate our technology platform – that our functional nanomaterial combined with physiological targeting of cancer tumours works in humans.

– Another milestone was the preclinical results with Tumorad. We successfully conducted the preclinical toxicology studies and presented promising efficacy data with the candidate in a preclinical model for colorectal cancer.

– Tumorad’s potential within cancer is wide, only within the ODD indication ovarian cancer is the commercial opportunity significantly greater than for SpagoPix in the contrast agent market.

The rights issue went ahead in difficult market conditions, how would you like to comment on it?

Mats Hansen, CEO Spago Nanomedical
Mats Hansen, CEO Spago Nanomedical
– It is obvious to everyone what the investment climate is like right now and given that, we are extremely happy and grateful for the support of our existing shareholders in this rights issue.

– With the financing in place, we now have the resources to keep up the pace and can hopefully start our clinical study with Tumorad around the end of the year.

Preparations are in full swing for the clinical study with Tumorad – what are the most important events in the coming six months for Spago Nanomedical?

– As mentioned, the preclinical data package is ready, right now we are finalising the application for our phase I/II study with 177Lu-SN201 and securing the manufacturing process for the candidate.

– At the same time, we are waiting for preclinical data with the candidate in ovarian cancer. These results will be significant for our ODD application, which we plan to submit in the autumn.

– With good results in SpagoPix, preparatory work according to plan in Tumorad and a completed capital round, we are confidently progressing the development.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

On July 5, 2022, Adamis Pharmaceuticals Corporation, a Delaware corporation (the "Company"), reported that entered into a Securities Purchase Agreement (the "Purchase Agreement") with Lincoln Park Capital Fund, LLC (the "Investor" or the "Purchaser"), pursuant to which the Company issued on July 5, 2022 (the "Closing Date"), in a private placement transaction (the "Offering" or the "Transaction"), an aggregate of 3,000 shares (the "Shares") of Series C Convertible Preferred Stock, par value $0.0001 per share (the "Series C Preferred"), together with warrants (the "Warrants") to purchase up to an aggregate of 750,000 shares (the "Warrant Shares") of common stock of the Company ("Common Stock") at an exercise price of $0.47 per share (subject to adjustment as provided in the Warrants, the "Exercise Price"), for an aggregate subscription amount equal to $300,000 (Filing, 8-K, Adamis Pharmaceuticals, JUL 5, 2022, View Source [SID1234616495]). The Warrant becomes exercisable commencing January 3, 2023, and has a term ending on January 5, 2028.

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The Company previously filed a preliminary proxy statement with the Securities and Exchange Commission (the "SEC" or the "Commission") relating to its upcoming 2022 annual meeting of stockholders (the "Meeting"). As disclosed in the preliminary proxy statement, one of the items to be considered by the Company’s stockholders at the Meeting is a proposal to adopt and approve a proposed amendment to the Company’s Restated Certificate of Incorporation and authorize the Board of Directors of the Company (the "Board"), in its sole discretion, to effect a reverse stock split of the outstanding shares of Common Stock at any time on or before December 31, 2022, at a reverse stock split ratio ranging from 1-for-2 to 1-for-15, as determined by the Board at a later date. The Purchase Agreement requires that the Company convene, no later than August 15, 2022 (assuming no review of the Company’s proxy statement by the Commission), an annual meeting or special meeting of stockholders for the purpose of presenting to the Company’s stockholders a proposal (the "Proposal") to approve a reverse stock split of its outstanding Common Stock (the "Reverse Stock Split"), with the recommendation of the Board that the Proposal be approved, and that the Company use reasonable best efforts to obtain approval of the Proposal.

Pursuant to the Purchase Agreement, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock (the "Certificate of Designation") with the Secretary of State of Delaware designating the rights, preferences and limitations of the Series C Preferred. The Certificate of Designation provides, among other things, that except as otherwise provided in the Certificate of Designation or as otherwise required by law, the Series C Preferred will have no voting rights (other than the right to vote as a class on certain matters as provided in the Certificate of Designation). However, pursuant to the Certificate of Designation, each share of Series C Preferred entitles the holder thereof (i) to vote on the Proposal and any proposal to adjourn any meeting of stockholders called for the purpose of voting on the Proposal, and (ii) to 1,000,000 votes per share of Series C Preferred on the Proposal and any such adjournment proposal. The Series C Preferred shall, except as required by law, vote together with the Common Stock (and other issued and outstanding shares of preferred stock entitled to vote), as a single class; provided, however, that such shares of Series C Preferred shall, to the extent cast on the Proposal or any such adjournment proposal, be automatically and without further action of the holders thereof voted in the same proportion as the shares of Common Stock (excluding any shares of Common Stock that are not voted) and any other issued and outstanding shares of preferred stock of the Company entitled to vote (other than the Series C Preferred or shares of such other preferred stock, if any, not voted) are voted on the Proposal. The Purchaser has agreed in the Purchase Agreement to vote the shares of Series C Preferred purchased in the Offering in favor of the Proposal, in the manner and to the extent set forth in the Certificate of Designation, in a manner that "mirrors" the proportions on which the shares of Common Stock (excluding any shares of Common Stock that are not voted) and any other issued and outstanding shares of preferred stock of the Company entitled to vote (excluding the Series C Preferred and shares of such other preferred stock, if any, not voted) are voted on the Proposal.

On July 5, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the strategic transaction to acquire Rigenerand Srl, signed in May 2022, has been completed (Press release, Evotec, JUL 5, 2022, View Source [SID1234616461]). Based out of Medolla, Italy, the cell technology company with leading edge in the field of cGMP manufacturing of cell therapies will operate as Evotec (Modena) Srl going forward.

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Cell therapy is a fast-growing and highly promising field of biomedical research with the potential to achieve substantial disease-modifying or even curative effects within a single treatment. Deriving cell therapy products from induced pluripotent stem cells ("iPSCs") has opened up an almost unlimited source of consistent-quality material for large patient numbers. However, the scalability of the approach from bench to bedside is central for moving cell therapy approaches into clinical phases and thus, essential for the approval of any such therapy.

Evotec’s cell therapy platform EVOcells integrates the full end-to-end spectrum from the discovery and development to the manufacturing of off-the-shelf iPSC-based cell therapy products. With a leading team of cell therapy experts, Evotec (Modena) adds a high-quality cGMP manufacturing site to the EVOcells platform therefore adding capacity, critical expertise and capabilities to the critical scale-up of complex cell-based therapies.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "The Evotec Cell Accelerator gives us the opportunity to take our cell therapy business to the next level. We are extremely confident that this important addition to our EVOcells platform will enable us to progress our internal portfolio of early innovative projects. Further, the addition will allow us to enter new partnerships and support many projects towards clinical applications and onto the market in a very efficient way. This will have a significant impact to a great number of patients who are significantly under-served with the currently available treatment regimens."

Prof. Massimo Dominici, Scientific Director, Evotec (Modena) and Professor of Oncology at the University of Modena and Reggio Emilia, said: "We are very pleased that the acquisition of Rigenerand has been finalised and the teams have started working together as one. The concept of the Evotec Cell Accelerator is already coming to life and matches what is happening in Modena: enriching the pre-existing know-how through the experienced Evotec team. I am therefore convinced that the field has a new player capable of addressing the challenges of next generation cell therapy products, accelerating their development and manufacturing towards the clinic."

On July 5, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immuneoncology vaccines and drug delivery technologies, is pleased to reported an update on its ADC programsin development using Defence’s AccumTM, including key in vivo studies with worldwide collaborators (Press release, Defence Therapeutics, JUL 5, 2022, View Source [SID1234626251]).

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The world-renowned Curie Institute, one of Defence’s collaborator, is currently performing therapeutic efficacy study of AccumTM-T-DM1 Antibody Drug Conjugate ("ADC") in patientderived xenograft ("PDX") model of breast cancer, including in 3 HER2+ and in 1 triple-negative PDX. It will be immediately followed by a head-to-head toxicology and pharmacokinetic profile comparisons study of T-DM1 versus AccumTM T-DM1 in mice. Results are expected in Q3-Q4 of this year. T-DM1 (Kadcyla) is currently used to treat women with metastatic HER2-positive breast cancer. This study is to prove that the current treatment may be optimized using Defence’s AccumTM technology to enhance the drug delivery to the tumor cells. Estimated sales of Kadcyla in 2022 are $3.02 Billion USD.

Defence is continuing its collaboration with the HUS Comprehensive Cancer Center, Finland’s largest and most versatile cancer treatment center, which is currently performing advanced in vivo studies, including head-to-head comparisons of T-DM1 vs AccumTM-T-DM1 vs co-treatment with intratumorally injection of AccuTOXTM variants using different PDX models with established and non-established tumors. Linking the AccumTM to an ADC triggers endosomal escape increasing therefore ADCs intracellular accumulation and cytotoxicity potency. AccuTOXTM variants induce cancer cell death through ROS production and endosome rupture. Results of those key studies with HUS are expected in Q4 of this year.

The Institut de Recherche en Cancérologie de Montpellier (IRCM), an internationally recognized institute for its translational research and expertise’s in immunotherapy and radiotherapy, is currently performing in vivo studies using AccumTM with radio-immuno-therapeutic conjugates. Combining the AccumTM technology to the radio-immuno-conjugate is expected to amplify the therapeutic index of the drug while minimizing side effects observed in patients undergoing the therapy. Results of those studies with IRCM are expected to be known in Q3-Q4 of 2022. The Radiopharmaceuticals Market is projected to reach US$ 13.818 billion by 2028 from US$ 7.55 billion in 2021; it is expected to grow at a CAGR of 9.0% during 2021–2028.

Defence is also collaborating with WASSC Technologies, a biotech company specialized in protein conjugations, small molecules, and ADCs, to develop a new small molecule for ADC application. Toxicity results of variants are expected for Q3 of 2022 and antibody conjugation shall begin in Q4 of 2022.

"Defence’s AccumTM platform has been primarily developed and tested in vitro and in vivo to enhance the intranuclear drug delivery on multiple FDA approved antibody-conjugates or new conjugates under development. We strongly believe that all those key results coming this year related to AccumTM-ADCs will continue to demonstrate the potency of our AccumTM technology and bring Defence to another level", says Mr. Sebastien Plouffe, the CEO of Defence Therapeutics